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If you are an industry expert with years of experience and would welcome the
opportunity to strengthen your reputation as a thought leader, we would love to
hear from you.

Our Speaker Faculty is constantly evolving, for consideration or to nominate an
industry leader, please call us at 416-829-6500 or email us
at info@executiveplatforms.com.

Please check back as our speaker faculty is frequently updated.

2024 SPEAKERS

JERH COLLINS
CHIEF TECHNICAL OPERATIONS AND QUALITY OFFICER AT MODERNA

As Chief Technical Operations and Quality Officer, Dr. Collins is responsible
for the technical development, quality, and supply of preclinical, clinical and
commercial programs within Moderna’s portfolio. Dr. Collins joined Moderna from
Novartis, where he held […]
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JERH COLLINS

Chief Technical Operations and Quality Officer at Moderna

As Chief Technical Operations and Quality Officer, Dr. Collins is responsible
for the technical development, quality, and supply of preclinical, clinical and
commercial programs within Moderna’s portfolio.

Dr. Collins joined Moderna from Novartis, where he held roles of increasing
responsibility over the last nearly 30 years, focused on pharmaceutical
production and manufacturing, including roles serving as Head of Global Chemical
Operations and Anti-Infectives and as Head of Global Chemical Operations.

Dr. Collins received his Bachelor of Science in Chemistry and his Ph.D. in
Organic Chemistry from University College Cork, Ireland. He also conducted
post-doctoral cancer research at Arizona State University.



ROBIN KUMOLUYI
VP & CHIEF QUALITY OFFICER AT JOHNSON & JOHNSON

A relentless visionary, Robin Kumoluyi consistently moves people and
organizations forward. Throughout her career, she has expertly crafted complex
quality management strategies for multi-billion-dollar matrixed organizations.
Committed to the belief that patients and customers must have […]
Read more


ROBIN KUMOLUYI

VP & Chief Quality Officer at Johnson & Johnson

A relentless visionary, Robin Kumoluyi consistently moves people and
organizations forward. Throughout her career, she has expertly crafted complex
quality management strategies for multi-billion-dollar matrixed organizations.
Committed to the belief that patients and customers must have access to
effective medicine, Robin intentionally chose the quality function within the
pharmaceutical indutry.

Robin Kumoluyi is the Vice President and Chief Quality Officer, Pharmaceuticals
at Johnson & Johnson Corporation. Robin has responsibility for Quality &
Compliance for the Global Pharmaceuticals Segment in Pre-Market R&D, Supply
Chain and Post Market Commercial. Prior to her current role, Robin was VP,
Global Quality Services at Johnson & Johnson, where she drove the organization’s
Enterprise Quality transformation by defining, leading, and executing the
strategic direction and oversight of the Quality Policies, Standards, Digital
Healthcare, Innovation and Analytics, Value Chain Quality, and the overall Q&C
Strategy and associated processes.

Her proven track record spans thirty years of robust experience leading change
while holding senior leadership roles within Quality, R&D, and Manufacturing
Compliance in the pharmaceutical and food industries. Her broad expertise
encompasses a wide portfolio of product types including OTC, Biological,
Pharmaceutical, Devices, Veterinarian, Nutraceuticals, and Food and Beverage
products.

Robin is a transformative leader who can steadily garner followership. Her keen
ability to co-create for best outcomes led to the successful results in complex
start-up and turn-around situations such as new operations, consent decrees, and
warning letter remediations.

As a leader, Robin knows it is her responsibility to enable people to achieve
their fullest potential. She is committed to the well-being of her colleagues,
peers, and community, actively collaborating with people and teams in the name
of career growth and progress. She is a champion for diversity and inclusion,
which she knows fosters innovation and drives business success. Steadfast in the
belief that what is good for the person is good for the organization, she fully
embraces her role as a guide and coach and considers it the most rewarding part
of her work. She actively engages with industry and leadership organizations
such as ISPE (Women in Pharma), PDA, and Rx360, where she was co-leader of the
audit operations group. She is an active member of Advancing Women Executives
(AWE), an organization creating equity and economic development in the
workplace, and Achieving Women’s Excellence in Supply chain Operations,
Management and Education (AWESOME) and United Way.

Robin holds a bachelor’s degree in Biological Sciences (specializing in
microbiology) from Rutgers University and a master’s degree in Quality Assurance
and Regulatory Affairs from Temple University School of Pharmacy. A native of
New Jersey Robin currently lives in North Carolina with her husband and son.

Family, Faith, Service, Curiosity and Growth are words that best describe
Robin’s passion and purpose. When she is not driving transformation, Robin can
be found spending time with her family enjoying a movie or a new park; emerging
in “beautiful environments” whether it is art, music, a spa, or silence;
learning something new; cooking; and asking with an open heart-what can I do to
help someone today.



E. MORREY ATKINSON
EVP CHIEF TECHNICAL OPERATIONS OFFICER AT VERTEX PHARMACEUTICALS

As EVP Chief Technical Operations Officer, Morrey’s current responsibilities
include defining the commercial manufacturing and supply chain strategy needs,
as well as, designing and building a global organization and supply network. In
addition, Morrey is responsible […]
Read more


E. MORREY ATKINSON

EVP Chief Technical Operations Officer at Vertex Pharmaceuticals

As EVP Chief Technical Operations Officer, Morrey’s current responsibilities
include defining the commercial manufacturing and supply chain strategy needs,
as well as, designing and building a global organization and supply network. In
addition, Morrey is responsible for assuring reliable supply of Vertex’s
transformative medicines.

Morrey is a trained laboratory scientist who brings more than 25 years of
experience leading the development and commercial manufacturing of multiple
products at organizations like Eli Lilly and Bristol Myers Squibb. An
accomplished leader and builder of strong scientific, engineering, and
operations teams, Morrey also has prior experience in process development for
cell and gene therapies, including the development and manufacturing of one of
the first gene therapy candidates for cystic fibrosis.



CHRIS STEVENS
CHIEF PATIENT SUPPLY OFFICER AT SPARK THERAPEUTICS

As Spark Therapeutics’ Chief Patient Supply Officer, Chris Stevens leads a team
of dedicated professionals working together in manufacturing and technical
operations, supply chain, quality and compliance to deliver transformational
therapies for patients globally. Chris is […]
Read more


CHRIS STEVENS

Chief Patient Supply Officer at Spark Therapeutics

As Spark Therapeutics’ Chief Patient Supply Officer, Chris Stevens leads a team
of dedicated professionals working together in manufacturing and technical
operations, supply chain, quality and compliance to deliver transformational
therapies for patients globally. Chris is also responsible for capital
investments, engineering, EHS, real estate and facilities management across the
enterprise.

Since joining Spark in 2017, Chris has effectively led teams in several key
areas, initially serving as Head of Manufacturing where he led the development
of Spark’s manufacturing network through the filing and launch of Luxturna, the
first approved gene therapy for genetic disease in both the US and EU. Later,
Chris held the role of Asset General Manager, Hemophilia A where he had end to
end responsibility for Spark’s Hem A program before being promoted to Head of
Product Strategy where he led the team responsible for all programs in Spark’s
portfolio. Chris was appointed Chief Patient Supply Officer for Spark in the
fall of 2022.

With more than 25 years’ end to end leadership experience in gene therapy,
biotech, pharmaceutical and consumer products industries, Chris is an industry
veteran with deep expertise in designing and operating supply chains in complex
regulatory environments, manufacturing science and technology, technology
transfer, quality, compliance, product strategy and P&L management.

Prior to Spark, Chris led teams at GlaxoSmithKline (GSK) focused on strategy,
operations and planning, as well as GMP clinical manufacturing operations
including process transfer and cell banking. Earlier in his career he held roles
of increasing responsibility at Bristol-Myers Squibb (BMS) in process
engineering, manufacturing and supply chain in Massachusetts, Indiana and Puerto
Rico.

Beyond his role with Spark, Chris currently serves as Vice President of the
Board at A Haven – a non-profit family grief center in Chester County,
Pennsylvania. He received his M.S. in Industrial Management from the University
of Southern Indiana and a B.S. in Chemical Engineering from Purdue University.



HOLGER WEINTRITT
EVP, HEAD PHARMACEUTICALS PRODUCT SUPPLY AT BAYER

Holger has more than 20 years of industry experience in operations and supply
chain. He started his career in the areas of process development, manufacturing,
and general management. Afterwards, he held various positions with increasing
responsibility in […]
Read more


HOLGER WEINTRITT

EVP, Head Pharmaceuticals Product Supply at Bayer

Holger has more than 20 years of industry experience in operations and supply
chain. He started his career in the areas of process development, manufacturing,
and general management. Afterwards, he held various positions with increasing
responsibility in Supply Chain Management, both in Germany and the US. After
having led global operations for API manufacturing, he assumed his current role
as Head of Product Supply for the Bayer Pharmaceuticals division being
responsible for global technical operations and supply chain.

Holger Weintritt holds a PhD in organic chemistry from the Max Planck Institute
in Muelheim an der Ruhr, Germany.



FLEMMING DAHL
SVP; HEAD OF PRODUCT SUPPLY FILL & FINISH EXPANSIONS AT NOVO NORDISK

Flemming Dahl is Senior Vice President at Novo Nordisk heading up the area Fill
& Finish Expansions which is responsible for all major fill & finish expansion
projects across Novo Nordisk globally. A key focus area […]
Read more


FLEMMING DAHL

SVP; Head of Product Supply Fill & Finish Expansions at Novo Nordisk

Flemming Dahl is Senior Vice President at Novo Nordisk heading up the area Fill
& Finish Expansions which is responsible for all major fill & finish expansion
projects across Novo Nordisk globally. A key focus area in Mr. Dahl’s role is a
focused drive to professionalize and standardize fill & finish facilities via a
modular approach to aseptic production, finished production, intralogistics and
quality control while designing the facilities for flexibility, automation and
compliance. Mr. Dahl runs a double-digit billion DKK portfolio of expansion
projects spanning multiple time zones. He has been with Novo Nordisk since 1994
and held several senior leadership positions, including Senior Vice President
for the global Quality organisation covering all units in Novo Nordisk and has
headed up the company’s biopharmaceutical production also as Senior Vice
President. Mr. Dahl holds a Master Degree in Chemical Engineering from the
Technical University of Denmark.



BRENDAN O’CALLAGHAN
EVP, HEAD OF MANUFACTURING AND SUPPLY AT SANOFI

Brendan O’Callaghan leads an international network of manufacturing and
distribution sites. His ambition is to enable successful commercialization of
Sanofi’s diverse pipeline, to build world-class standards of manufacturing and
supply chain excellence and to future proof […]
Read more


BRENDAN O’CALLAGHAN

EVP, Head of Manufacturing and Supply at Sanofi

Brendan O’Callaghan leads an international network of manufacturing and
distribution sites. His ambition is to enable successful commercialization of
Sanofi’s diverse pipeline, to build world-class standards of manufacturing and
supply chain excellence and to future proof Sanofi’s manufacturing network,
leveraging the latest digital, process and technology solutions, to ensure the
continued reliable supply of essential, high-quality medicines to patients
worldwide.

Brendan joined Sanofi in 2015 and was previously our Global Head of Biologics
and Manufacturing and Supply head of the Specialty Care portfolio. He has played
a key role in supporting our transformation to a fully integrated BioPharma
company and advancing the digital transformation of our manufacturing network,
notably the Framingham site in the US, which was awarded the prestigious
International Society for Pharmaceutical Engineering Factory of the Future and
Facility of the Year Awards in 2020. Prior to Sanofi, Brendan worked at
Schering-Plough before moving to Merck / MSD as Head of Biologics and later Vice
President of its Europe, Middle East and Africa Operations. Brendan graduated in
chemical engineering from the University College of Dublin, where he currently
serves as an honorary adjunct Professor of Chemical and Biochemical Engineering.
He is married with four sons. A keen sports enthusiast, Brendan is a UEFA
qualified soccer coach, with a specialization in Goalkeepers.



DAVID MARALDO
SVP OPERATIONS AT MERCK

Dave Maraldo leads Global Biologics Operations within the Merck Manufacturing
Division (MMD). In this role, he oversees manufacturing and supply of Merck’s
Biologic portfolio of products. Dave has been part of Merck for over 20 years.
[…]
Read more


DAVID MARALDO

SVP Operations at Merck

Dave Maraldo leads Global Biologics Operations within the Merck Manufacturing
Division (MMD). In this role, he oversees manufacturing and supply of Merck’s
Biologic portfolio of products. Dave has been part of Merck for over 20 years.
Over his career, Dave has supported all of Merck’s current vaccines and
biologics franchises at various stages of their life-cycle, including multiple
roles in process development, commercialization, operations, and manufacturing
science & technology. He served as committee Co-Chair overseeing
cross-functional pharmaceutical development and manufacturing strategy across
all modalities. Dave has recently joined the Board of Advisors of the School of
Engineering at Widener University. Dave’s most advanced degrees include a Ph.D.
in Chemical Engineering from Drexel University and MBA degree from Lehigh
University.



ANIL SAWANT
SVP GLOBAL QUALITY COMPLIANCE AT MERCK

Anil Sawant is Senior Vice President, Global Quality Compliance at Merck. He is
a healthcare Executive with over 35 years of operations experience in Quality
Operations, Ethics & Compliance, Research Integrity and Auditing functions. A
strategic […]
Read more


ANIL SAWANT

SVP Global Quality Compliance at Merck

Anil Sawant is Senior Vice President, Global Quality Compliance at Merck. He is
a healthcare Executive with over 35 years of operations experience in Quality
Operations, Ethics & Compliance, Research Integrity and Auditing functions. A
strategic thinker experienced in development and deployment of management
controls, governance processes, and quality and compliance systems in diverse
business environments and cultures. Anil leads groups managing branded and
generic products, small molecules, vaccines, bio-pharmaceutical, medical devices
and consumer products. He was part of the teams that commercialized the first
antibody-drug conjugate product and first photoactive drug. Expertise in
interpretation of GMPs, GLPs, and GCPs. Good understanding of SOX,
Anti-Kickback, Anti-Trust, Privacy and FCPA. Skilled crisis manager and
pragmatic thinker with excellent understanding of regulatory requirements,
global pharmaceutical supply chain and R&D operations. Extensive experience in
resolving compliance matters with US FDA and international regulatory agencies.
Subject matter expert in pharmaceutical microbiology and aseptic processing.



VALERIE BROWN
SVP, GLOBAL QUALITY ASSURANCE AT GILEAD SCIENCES INC.

Valerie Brown is senior vice president of quality assurance in pharmaceutical
development and manufacturing at Gilead Sciences, Inc. She leads a global team,
including internal sites and PDM affiliates, responsible for quality and
compliance in producing […]
Read more


VALERIE BROWN

SVP, Global Quality Assurance at Gilead Sciences Inc.

Valerie Brown is senior vice president of quality assurance in pharmaceutical
development and manufacturing at Gilead Sciences, Inc. She leads a global team,
including internal sites and PDM affiliates, responsible for quality and
compliance in producing active pharmaceutical ingredients, drug product
intermediates, oral solid dosage forms, parenterals, and medical devices for
world-wide development and commercial markets. She has over twenty-five years of
experience in the pharmaceutical and biopharmaceutical industry with expertise
in quality control, quality assurance, and worldwide health authority
regulations. In 2010, Brown joined Gilead to lead the Commercial API Quality
group responsible for external supply of active pharmaceutical ingredients
formulated in drug products and, in 2013, she assumed the additional
responsibility for commercial quality and compliance oversight of finished
dosage forms manufactured for and on behalf of Gilead. Brown holds a BS degree
in biology and chemistry from Averett College and a master’s in healthcare
management from Saint Joseph’s University.



NKEM OGBECHIE
HEAD OF OPERATIONS STRATEGIC PLANNING, RISK AND ANALYTICS AT AMGEN

Nkem Ogbechie is Head of Operations Strategic Planning, Risk, and Analytics and
is responsible for planning Amgen’s internal network capacity and investments to
enable the proper technology, platforms, and modalities for Amgen’s commercial
portfolio and pipeline […]
Read more


NKEM OGBECHIE

Head of Operations Strategic Planning, Risk and Analytics at Amgen
Nkem Ogbechie is Head of Operations Strategic Planning, Risk, and Analytics and
is responsible for planning Amgen’s internal network capacity and investments to
enable the proper technology, platforms, and modalities for Amgen’s commercial
portfolio and pipeline of emerging products.

Most recently, Nkem served as General Manager for Amgen’s $3 billion bone health
franchise (Prolia® and EVENITY®) and brings over 15 years of leadership,
strategy, and execution experience in biopharma spanning therapeutic areas, drug
development stages, and regions.

Before his General Manager role, Nkem served as Head of Corporate Strategy and
led enterprise-wide strategic planning efforts, supported critically integrated
actions across our portfolio, target disease areas, and key geographies.  Nkem
also supported the CEO and CEO staff in the implementation of Amgen’s executive
governance system, enabled resource allocation that connected strategy,
transformation, and financial performance, and directed CEO regional operating
reviews.  Nkem joined Amgen in 2011 and led numerous licensing, mergers &
acquisitions, and R&D agreement opportunities as a Transaction Lead in Business
Development.

Nkem joined Amgen following eight years in investment banking, starting with
Goldman Sachs & Company in New York City as part of the healthcare finance group
and then in mergers & acquisitions in Los Angeles.

Nkem has a bachelor’s degree in Human Biology from Stanford University, an
M.B.A. in Finance and Healthcare Management from Rice University, and a graduate
certificate in Biotechnology Management from Harvard University.


ANTHONY MIRE-SLUIS
SVP, HEAD OF GLOBAL QUALITY AT ASTRAZENECA

Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca.  He was
previously Vice President, North America, Contract, Singapore and Product
Quality at Amgen Inc.  Prior to working at Amgen, he was Principal Advisor,
Regulatory Science […]
Read more


ANTHONY MIRE-SLUIS

SVP, Head of Global Quality at AstraZeneca

Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca.  He was
previously Vice President, North America, Contract, Singapore and Product
Quality at Amgen Inc.  Prior to working at Amgen, he was Principal Advisor,
Regulatory Science and Review, Office of Biotechnology Products, CDER and Head
of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in
Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell
biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in
the Division of Immunobiology at the National Institute for Biological Standards
and Control, Potters Bar, UK.  Dr Mire-Sluis specialized in the development of
assays for the characterization and quantitation of biological products. He then
became Director of BioAnalytical Sciences at Genentech and prior to joining FDA,
was Executive Director of Analytical Sciences at CancerVax Corporation, San
Diego.



RYAN BARTOCK
HEAD OF ENGINEERING, TECHNICAL & DIGITAL AT SPARK THERAPEUTICS

Ryan Bartock is Vice President and Head of Engineering, Technical & Digital at
Spark Therapeutics, a fully integrated gene therapy company and member of the
Roche group. Ryan joined Spark Therapeutics as Head of Supply Chain […]
Read more


RYAN BARTOCK

Head of Engineering, Technical & Digital at Spark Therapeutics

Ryan Bartock is Vice President and Head of Engineering, Technical & Digital at
Spark Therapeutics, a fully integrated gene therapy company and member of the
Roche group.

Ryan joined Spark Therapeutics as Head of Supply Chain and Network Strategy in
2017 where he established Spark’s Supply Chain function and launched the first
ever FDA approved Gene Therapy, LUXTURNATM. Additionally, Ryan has held interim
roles as the Head of Technical Development, overseeing Process and Analytical
development, Automation and Pre-Clinical Manufacturing as well as the Head of
Quality Assurance.

He is currently responsible for all things process and data related at Spark
including MSAT, CMC Program Management, Engineering, Automation, Instrumentation
& Digital Transformation.

Ryan holds B.Sc. in Engineering and Business from Drexel University. His 20
years of experience spans process & analytical development, manufacturing
operations, supply chain, QA, CMC, product strategy and new product launches in
vaccines, consumer health, biologics and gene therapies.



EVELYN MARCHANY-GARCIA
SVP, CHIEF QUALITY OFFICER, TECHNICAL OPERATIONS AT BIOMARIN

Speaker Bio Evelyn is a seasoned leader in the pharmaceutical industry,
currently serving as Senior Vice President, Chief Quality Officer Technical
Operations at BioMarin. Her journey began as a chemist in San Juan, Puerto Rico,
and […]
Read more


EVELYN MARCHANY-GARCIA

SVP, Chief Quality Officer, Technical Operations at BioMarin

Speaker Bio Evelyn is a seasoned leader in the pharmaceutical industry,
currently serving as Senior Vice President, Chief Quality Officer Technical
Operations at BioMarin. Her journey began as a chemist in San Juan, Puerto Rico,
and over the years, her natural leadership abilities propelled her into roles of
increasing responsibility. She recently worked for Bristol Myers Squibb as the
Vice President, Global Product Development & Supply Enterprise Strategy. Evelyn
is known for her commitment to people and patients, focusing on problem-solving
and fostering open communication. She has a track record of developing and
executing strategies that bring organizations to the next level of performance
in a sustainable manner. Evelyn has accomplished significant transformational
shifts in diferent business settings and functions in areas such as Quality,
Operations, Technical Services, New Product Introduction, Packaging Engineering,
Technical Training, Site Management among others. Evelyn’s leadership principles
center around trust, respect, accountability, and delivering results. She is
also an advocate for openness and collaboration across departments, and her
inclusive approach has contributed to her remarkable success in the industry.



CHARLES L. COONEY
ROBERT T. HASLAM PROFESSOR OF CHEMICAL ENGINEERING, EMERITUS, AND FACULTY
DIRECTOR, EMERITUS DESHPANDE CENTER FOR TECHNOLOGICAL INNOVATION AT MIT

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and
Biochemical Engineering, Emeritus in the Department of Chemical Engineering at
MIT and founding Faculty Director, Emeritus of the Deshpande Center for
Technological Innovation. […]
Read more


CHARLES L. COONEY

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty
Director, Emeritus Deshpande Center for Technological Innovation at MIT

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and
Biochemical Engineering, Emeritus in the Department of Chemical Engineering at
MIT and founding Faculty Director, Emeritus of the Deshpande Center for
Technological Innovation. He has been involved as founder, advisor or board
member of over 25 companies and currently sits on the Boards of Directors of
Codiak Bioscience, Innovent Biologics (1801.HK), Levitronix Technologies, and is
chairman of GreenLight Bioscience and Mitra RxDx. In addition, he is Trustee
Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and
Trustee of the Leventhal Map Center. Other interests include: high altitude
mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro,
Huascaran). and antique map collecting.



PATRICK GAMMELL
VP, GLOBAL MANUFACTURING SCIENCES AT BIOGEN

Patrick leads the Global Manufacturing Sciences (GMS) Organization in Biogen’s
Global Manufacturing & Technical Operations (GMTO) function and has a range of
CMC responsibilities across the full portfolio of commercial and pipeline
products. Patrick’s GMS team […]
Read more


PATRICK GAMMELL

VP, Global Manufacturing Sciences at Biogen

Patrick leads the Global Manufacturing Sciences (GMS) Organization in Biogen’s
Global Manufacturing & Technical Operations (GMTO) function and has a range of
CMC responsibilities across the full portfolio of commercial and pipeline
products. Patrick’s GMS team includes process sciences, material sciences, cell
banking and tech transfer of Biogen internal assets and strategic partner
programs into internal factories and external CDMO plants. Patrick and his team
are the primary conduit from the manufacturing organization to Biogen’s
Development organization to support clinical transitions across biologics, small
molecules, oligonucleotides and gene therapy. Prior to Biogen, Patrick was an
Executive Director within Amgen’s Process Development (PD) organization where he
led various functions including PD site head at the Rhode Island manufacturing
facility and Head of the Material Attributes and Technologies function. Patrick
has also worked at Pfizer (formerly Wyeth) and spent a number of years as a
post-doctoral researcher with a particular focus on the molecular and cellular
biology of Chinese Hamster Ovary Cells. Patrick received a Bachelor of Science
degree and PhD in Biotechnology from Dublin City University, Ireland.



JOANNE BECK
CHIEF TECHNOLOGY OFFICER AT AERIUM THERAPEUTICS

Dr. Joanne Beck is currently Chief Technology Officer at Aerium Therapeutics, a
startup dedicated to the discovery & development of antibodies and small
molecule antivirals against SARS-CoV-2 and other epidemic & pandemic threats.
Prior to this, […]
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JOANNE BECK

Chief Technology Officer at Aerium Therapeutics

Dr. Joanne Beck is currently Chief Technology Officer at Aerium Therapeutics, a
startup dedicated to the discovery & development of antibodies and small
molecule antivirals against SARS-CoV-2 and other epidemic & pandemic threats.
Prior to this, she served as COO at Boston Pharmaceuticals, a private company
developing candidates across multiple indications in cardiometabolic, oncology,
and immune/inflammatory diseases. Prior to joining Boston Pharmaceuticals, she
was Executive Vice President of Global Pharmaceutical Development and Operations
at Celgene where she oversaw the company’s Product Development, Global
Manufacturing Operations, Supply Chain, Engineering and Quality. Prior to
Celgene, she was SVP of Pharmaceutical Development at Shire. Prior to Shire she
held roles of increasing responsibility in Process Development at Genentech and
Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions. Beck
holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry
and Molecular Biology from University of Oregon Medical School and completed a
postdoctoral fellowship in the department of Pharmaceutical Chemistry at the
University of California, San Francisco. Dr. Beck serves on the board of
directors for Orchard Therapeutics and Astria Therapeutics.



PAT YANG
VICE CHAIRMAN & CO-FOUNDER AT RESILIENCE, INC.

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives
and technical operations leaders in the industry. From 2017 to 2019, Pat was
executive vice president at Juno Therapeutics, a leading CAR-T biotech company
[…]
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PAT YANG

Vice Chairman & Co-Founder at Resilience, Inc.

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives
and technical operations leaders in the industry.

From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a
leading CAR-T biotech company (now part of BMS) based in Seattle.

Previously, from 2009 to 2013, Pat was Executive Vice President and Global Head
of Technical Operations at F. Hoffman-La Roche based in Basel, Switzerland. In
this role, he was responsible for Roche’s biopharma process research and
development, analytical sciences, engineering, quality, technical regulatory,
supply chain and all manufacturing plants with approximately 15,000 employees
around the world. From 2003 to 2009, Pat was Executive Vice President of Product
Operations at Genentech. He assumed his role as Global Head of the combined
technical operations of Roche and Genentech upon the acquisition of Genentech by
Roche in 2009.

Before Genentech, Pat worked for 11 years at Merck & Company from 1992 to 2003,
based in New Jersey, in various leadership positions including vice president of
Asia Pacific Operations and vice president of Global Supply Chain Management.
Prior to joining Merck in 1992, Pat spent 12 years at General Electric, serving
in research, engineering, technology, and manufacturing leadership roles with
increasing scope of responsibilities.

Pat holds a Bachelor of Science from the National Chiaotung University in
Taiwan, a Master of Science from the University of Cincinnati, and a Ph.D. in
engineering from Ohio State University.

Pat is a member of the Board of Directors of three public companies, Amyris,
Codexis and PharmaEssentia. In addition, he is on the board of several private
companies, including Acepodia, AltruBio, Antheia and Sana Biotechnology.



CARLO DE NOTARISTEFANI
FORMER LEAD, MANUFACTURING & SUPPLY CHAIN ADVISOR AT OPERATION WARP SPEED

An international operations executive with global technical, operational, and
P&L experience, Carlo has deep expertise in designing and operating global
supply chains in complex regulatory environments, leading accretive M&A activity
and devising and executing value-creating strategies […]
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CARLO DE NOTARISTEFANI

Former Lead, Manufacturing & Supply Chain Advisor at Operation Warp Speed

An international operations executive with global technical, operational, and
P&L experience, Carlo has deep expertise in designing and operating global
supply chains in complex regulatory environments, leading accretive M&A activity
and devising and executing value-creating strategies in global markets.

Since May 2020, Carlo has been the lead advisor for Manufacturing and Supply
Chain to Operation Warp Speed/Federal Covid Response, the US government
initiative to support the acceleration of development and supply of Covid-19
vaccines and therapeutics. He has collaborated with the sponsors, suppliers and
CDMOs to ensure the fast scale-up of manufacturing and distribution for the
entire US.

In Carlo’s most recent corporate position, he was Executive Vice President of
Operations at Teva Pharmaceuticals Inc.  In this role he was responsible for all
Manufacturing, Technology and Capital Investments, Supply Chain, Quality and
Compliance and Procurement operations, as well as the global API and CMO
business. Carlo retired from this position in October 2019

Before joining Teva Pharmaceuticals in 2012, Carlo was the President, Technical
Operations and Global Support Functions for Bristol Myers Squibb from 2004 to
2011. At BMS he significantly contributed to their successful transformation to
a focused biopharma company.

Carlo received his Doctorate in Chemical Engineering and graduated Summa Cum
Laude from the University of Naples in Naples, Italy.



JACK GARVEY
CEO/ MANAGING PARTNER AT COMPLIANCE ARCHITECTS LLC

Jack Garvey, founder of Compliance Architects®, is a seasoned FDA compliance
expert with nearly 30 years of leadership experience at industry giants like
Johnson & Johnson and C.R. Bard. Combining his chemical engineering and law
background, […]
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JACK GARVEY

CEO/ Managing Partner at Compliance Architects LLC

Jack Garvey, founder of Compliance Architects®, is a seasoned FDA compliance
expert with nearly 30 years of leadership experience at industry giants like
Johnson & Johnson and C.R. Bard. Combining his chemical engineering and law
background, Jack provides practical solutions to minimize FDA enforcement risk.
His firm specializes in hands-on GMP consulting, quality, and compliance. Jack
is celebrated for his straightforward FDA compliance approach, showcased through
blogs, webinars, and public speaking. He’s committed to reducing enforcement
risk through diligence, investment, and innovation.



KARI BORROEL
HEAD OF OPERATIONS QUALITY LEARNING & DEVELOPMENT AT ASTRAZENECA

An accomplished, strategic senior leader who drives global business
transformation and continuous improvement in the pharmaceutical and technology
spaces. Kari has excelled in areas that require a strong, broad view,
visualizing connections/gaps and helping organizations to […]
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KARI BORROEL

Head of Operations Quality Learning & Development at AstraZeneca

An accomplished, strategic senior leader who drives global business
transformation and continuous improvement in the pharmaceutical and technology
spaces. Kari has excelled in areas that require a strong, broad view,
visualizing connections/gaps and helping organizations to improve their
operations and execution in a regulatory and compliance industry. She is
recognized as a trusted partner to commercial, technical and scientific
colleagues alike. 20+ years Learning & Development, Performance Management,
Talent Development, Organizational Development and Learning Technology.



2023 SPEAKERS

STEFFEN LANG
PRESIDENT OF OPERATIONS AT NOVARTIS

As President, Operations, Steffen Lang leads a team of 35,000 associates
dedicated to manufacturing and supplying high-quality medicines to patients, and
providing operational support to the entire Novartis enterprise. Novartis
Operations incorporates the company’s manufacturing, quality, […]
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STEFFEN LANG

President of Operations at Novartis

As President, Operations, Steffen Lang leads a team of 35,000 associates
dedicated to manufacturing and supplying high-quality medicines to patients, and
providing operational support to the entire Novartis enterprise. Novartis
Operations incorporates the company’s manufacturing, quality, and supply
organization, as well as information technology, data and digital, procurement,
environmental sustainability, facility services, and other global services.

Prior to taking on this role, Steffen was Global Head of Novartis Technical
Operations (NTO). Under his leadership, NTO underwent a transformation to become
one of the leading manufacturing and supply organizations in the industry,
providing agile, efficient support to the business, and reliably delivering
life-changing medicines to patients around the world. During this time, the unit
adapted its manufacturing capacity and capabilities to the changing needs of the
Novartis strategy and product portfolio, maximizing the potential of its assets
and expertise. As well as delivering technological innovation to enable the
production of advanced therapeutic platforms, the unit collaborated with
industry partners to support global demand for COVID-19 vaccines and therapies.

“I’m inspired by our patients, steered by our people, and passionate about data
science and technologies. I am proud that through the diversity and unique
expertise of our organization, our collaborative approach, and our strong focus
on operational excellence, we are enabling Novartis to deliver transformational
solutions that are helping us to expand the positive impact we have for our
patients, our associates, the business, and society.”

Steffen draws on a wealth of experience in the pharmaceutical industry, with a
career that ranges from research through development to manufacturing and
supply. He joined Novartis in 1994 as Head of Laboratory in Research, and held
positions of increasing responsibility before taking on his present role in
2022.

In his spare time, Steffen enjoys indoor and outdoor sports, and spending time
with his family and friends.



KARIN SHANAHAN
EVP, GLOBAL PRODUCT DEVELOPMENT AND SUPPLY AT BRISTOL-MYERS SQUIBB

Karin Shanahan oversees worldwide product development, manufacturing and supply
for Bristol Myers Squibb as executive vice president, Global Product Development
& Supply (GPS). GPS develops and produces active ingredients and drug products
and delivers the company’s medicines […]
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KARIN SHANAHAN

EVP, Global Product Development and Supply at Bristol-Myers Squibb

Karin Shanahan oversees worldwide product development, manufacturing and supply
for Bristol Myers Squibb as executive vice president, Global Product Development
& Supply (GPS). GPS develops and produces active ingredients and drug products
and delivers the company’s medicines throughout the world. The GPS team achieves
this mission through a relentless focus on innovation, quality, safety and
agility.

“I’m excited to return to Bristol Myers Squibb, where I began my career in the
pharmaceutical industry. Though I’ve worn many hats in the industry since then,
I was drawn back to Bristol Myers Squibb because of its unwavering dedication to
quality and delivering innovative medicines to patients in need,” says Karin. “I
am honored to help lead the integral GPS team as we navigate an everchanging
landscape.”

Karin began her career in the pharmaceutical industry at Bristol Myers Squibb in
corporate procurement, global supply chain, and global quality. Karin moved into
manufacturing operations, leading two manufacturing sites in Billerica, MA, and
Latina, Italy. After almost 14 years with Bristol Myers Squibb, Karin joined
Becton-Dickenson as a leader of global operations, followed by Catalent
Pharmaceuticals where she led global Biologics operations. In 2013, Karin joined
Teva Pharmaceuticals as senior vice president and chief operating officer of
global operations, where she led global Manufacturing Science & Technology
(MS&T) and Network Strategy and a network of 25 sites across Europe and the
Americas. Most recently, Karin served as senior vice president of Global
Biologics & Sterile Operations at Merck.

Karin earned a bachelor’s degree in political science and international
relations from Rutgers University and a master’s degree in jurisprudence (MSJ),
pharmaceutical and device law, from Seton Hall Law School.



PETER MARKS
DIRECTOR – CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) AT FDA

Peter Marks received his graduate degree in cell and molecular biology and his
medical degree at New York University and completed Internal Medicine residency
and Hematology/Medical Oncology training at Brigham and Women’s Hospital in
Boston. He […]
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PETER MARKS

Director – Center for Biologics Evaluation and Research (CBER) at FDA

Peter Marks received his graduate degree in cell and molecular biology and his
medical degree at New York University and completed Internal Medicine residency
and Hematology/Medical Oncology training at Brigham and Women’s Hospital in
Boston. He has worked in academic settings teaching and caring for patients and
in industry on drug development. He joined the FDA in 2012 as Deputy Center
Director for CBER and became Center Director in January 2016.



JIM CAFONE
SVP - GLOBAL SUPPLY CHAIN AT PFIZER

Jim Cafone has been with Pifzer since 2010.  In his current role as Senior Vice
President, Global Supply Chain, Jim oversees global demand forecasting, demand
and supply planning, worldwide logistics, and inventory management for Pfizer.
In […]
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JIM CAFONE

SVP - Global Supply Chain at Pfizer

Jim Cafone has been with Pifzer since 2010.  In his current role as Senior Vice
President, Global Supply Chain, Jim oversees global demand forecasting, demand
and supply planning, worldwide logistics, and inventory management for Pfizer.

In his previous role, as Vice President, Network Design & Performance, Jim was
responsible for business development, supply chain network design, Pfizer’s lean
production system, all performance reporting and analytics, innovation, and
recognition programs.

Prior to joining Pfizer Jim spent almost two decades with Wyeth Pharmaceuticals
as part of the manufacturing and operations analysis team. He held numerous
positions within manufacturing, materials management, customer order management,
physical distribution, and information technology functions. This included Vice
President, EMEA Manufacturing and Supply (2003-2007) and Vice President,
Worldwide Logistics (2008-2009).

Jim holds a Bachelor of Science degree in Industrial Engineering, and a Master
of Science degree in Mechanical Engineering, both from the University of Rhode
Island. In addition, Jim holds a Master of Science in Technology Management from
the University of Pennsylvania, College of Engineering, and the Wharton Business
School.

Jim resides in Collegeville, Pennsylvania with his wife and two sons. When the
weather permits, you’ll find him deep sea fishing in the ocean somewhere off the
East Coast.



CHARLES L. COONEY
ROBERT T. HASLAM PROFESSOR OF CHEMICAL ENGINEERING, EMERITUS, AND FACULTY
DIRECTOR, EMERITUS DESHPANDE CENTER FOR TECHNOLOGICAL INNOVATION AT MIT

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and
Biochemical Engineering, Emeritus in the Department of Chemical Engineering at
MIT and founding Faculty Director, Emeritus of the Deshpande Center for
Technological Innovation. […]
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CHARLES L. COONEY

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty
Director, Emeritus Deshpande Center for Technological Innovation at MIT

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and
Biochemical Engineering, Emeritus in the Department of Chemical Engineering at
MIT and founding Faculty Director, Emeritus of the Deshpande Center for
Technological Innovation. He has been involved as founder, advisor or board
member of over 25 companies and currently sits on the Boards of Directors of
Codiak Bioscience, Innovent Biologics (1801.HK), Levitronix Technologies, and is
chairman of GreenLight Bioscience and Mitra RxDx. In addition, he is Trustee
Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and
Trustee of the Leventhal Map Center. Other interests include: high altitude
mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro,
Huascaran). and antique map collecting.



PAT YANG
VICE CHAIRMAN & CO-FOUNDER AT RESILIENCE, INC.

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives
and technical operations leaders in the industry. From 2017 to 2019, Pat was
executive vice president at Juno Therapeutics, a leading CAR-T biotech company
[…]
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PAT YANG

Vice Chairman & Co-Founder at Resilience, Inc.

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives
and technical operations leaders in the industry.

From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a
leading CAR-T biotech company (now part of BMS) based in Seattle.

Previously, from 2009 to 2013, Pat was Executive Vice President and Global Head
of Technical Operations at F. Hoffman-La Roche based in Basel, Switzerland. In
this role, he was responsible for Roche’s biopharma process research and
development, analytical sciences, engineering, quality, technical regulatory,
supply chain and all manufacturing plants with approximately 15,000 employees
around the world. From 2003 to 2009, Pat was Executive Vice President of Product
Operations at Genentech. He assumed his role as Global Head of the combined
technical operations of Roche and Genentech upon the acquisition of Genentech by
Roche in 2009.

Before Genentech, Pat worked for 11 years at Merck & Company from 1992 to 2003,
based in New Jersey, in various leadership positions including vice president of
Asia Pacific Operations and vice president of Global Supply Chain Management.
Prior to joining Merck in 1992, Pat spent 12 years at General Electric, serving
in research, engineering, technology, and manufacturing leadership roles with
increasing scope of responsibilities.

Pat holds a Bachelor of Science from the National Chiaotung University in
Taiwan, a Master of Science from the University of Cincinnati, and a Ph.D. in
engineering from Ohio State University.

Pat is a member of the Board of Directors of three public companies, Amyris,
Codexis and PharmaEssentia. In addition, he is on the board of several private
companies, including Acepodia, AltruBio, Antheia and Sana Biotechnology.



CARLO DE NOTARISTEFANI
LEAD, MANUFACTURING & SUPPLY CHAIN ADVISOR AT OPERATION WARP SPEED

An international operations executive with global technical, operational, and
P&L experience, Carlo has deep expertise in designing and operating global
supply chains in complex regulatory environments, leading accretive M&A activity
and devising and executing value-creating strategies […]
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CARLO DE NOTARISTEFANI

Lead, Manufacturing & Supply Chain Advisor at Operation Warp Speed

An international operations executive with global technical, operational, and
P&L experience, Carlo has deep expertise in designing and operating global
supply chains in complex regulatory environments, leading accretive M&A activity
and devising and executing value-creating strategies in global markets.

Since May 2020, Carlo has been the lead advisor for Manufacturing and Supply
Chain to Operation Warp Speed/Federal Covid Response, the US government
initiative to support the acceleration of development and supply of Covid-19
vaccines and therapeutics. He has collaborated with the sponsors, suppliers and
CDMOs to ensure the fast scale-up of manufacturing and distribution for the
entire US.

In Carlo’s most recent corporate position, he was Executive Vice President of
Operations at Teva Pharmaceuticals Inc.  In this role he was responsible for all
Manufacturing, Technology and Capital Investments, Supply Chain, Quality and
Compliance and Procurement operations, as well as the global API and CMO
business. Carlo retired from this position in October 2019

Before joining Teva Pharmaceuticals in 2012, Carlo was the President, Technical
Operations and Global Support Functions for Bristol Myers Squibb from 2004 to
2011. At BMS he significantly contributed to their successful transformation to
a focused biopharma company.

Carlo received his Doctorate in Chemical Engineering and graduated Summa Cum
Laude from the University of Naples in Naples, Italy.



MICHAEL KAMARCK
BOARD OF DIRECTORS AT PASSAGE BIO

Michael Kamarck was the Chief Technology Officer at Vir. Previously, he was
senior vice president of Global Vaccines and Biologics Manufacturing and
president of Merck BioVentures where he was responsible for the establishment of
Merck’s global […]
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MICHAEL KAMARCK

Board of Directors at Passage Bio

Michael Kamarck was the Chief Technology Officer at Vir. Previously, he was
senior vice president of Global Vaccines and Biologics Manufacturing and
president of Merck BioVentures where he was responsible for the establishment of
Merck’s global biosimilars business.

Prior to joining Merck BioVentures, Dr. Kamarck held positions of increasing
responsibility in Biotechnology and Vaccines Operations at Wyeth, including
leading the development of the global biotechnology network with $3.5 billion of
capital investment. While at Wyeth, he also was responsible for global technical
operations for all of the Company’s businesses. Dr. Kamarck began his career in
biotechnology and pharmaceutical research at Bayer AG.

Dr. Kamarck graduated from Oberlin College where he currently serves as a
Trustee. He received his Ph.D. in biochemistry from the Massachusetts Institute
of Technology and is the author of more than 50 peer-reviewed publications and
20 issued patents. He also holds an Honorary Doctorate of Science from
University College Dublin.



ANDY WIRTHS
SVP SUPPLY AMERICAS AT ASTRAZENECA

Andrew (Andy) Wirths is a senior pharmaceutical operations leader with over 30
years’ experience in the industry spanning small and large molecule
manufacturing. Andy joined AstraZeneca in 2015 and is currently Senior Vice
President, Americas Supply, […]
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ANDY WIRTHS

SVP Supply Americas at AstraZeneca

Andrew (Andy) Wirths is a senior pharmaceutical operations leader with over 30
years’ experience in the industry spanning small and large molecule
manufacturing.

Andy joined AstraZeneca in 2015 and is currently Senior Vice President, Americas
Supply, where he is responsible for overseeing the manufacturing operations of 8
sites in North and South America.

Previously Andy held various senior positions at Merck where he was fundamental
to the development of their manufacturing strategy and its execution at multiple
sites.

Andy holds an MSc in Engineering Technology from the University of Pennsylvania
and an MBA and Bachelor of Science from Lehigh University in Pennsylvania.



TIM MOORE
EVP, CHIEF TECHNICAL OFFICER AT ALLOGENE

Tim Moore is Executive Vice President, Chief Technical Officer for Allogene,
overseeing product sciences, supply chain, manufacturing, quality and technical
operations. Tim has more than three decades of leadership experience in
biopharmaceutical manufacturing and operations and […]
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TIM MOORE

EVP, Chief Technical Officer at Allogene

Tim Moore is Executive Vice President, Chief Technical Officer for Allogene,
overseeing product sciences, supply chain, manufacturing, quality and technical
operations. Tim has more than three decades of leadership experience in
biopharmaceutical manufacturing and operations and was responsible for the
global development of two of the most successful autologous CAR T manufacturing
processes in the industry. Prior to roles as Chief Operating Officer of Instil
Bio, and President and Chief Operating Officer of PACT Pharma, Tim was Executive
Vice President, Technical Operations at Kite Pharma (now a Gilead company) from
2016 to 2019, where he was responsible for the process development,
manufacturing, quality and supply chain for Yescarta®, the first FDA approved
CAR T therapy for the treatment of non-Hodgkin lymphoma. He and his team also
developed the manufacturing process for Kite’s second FDA approved autologous
CAR T therapy, Tecartus®. Tim previously served as Senior Vice President, Head
of Global Technical Operations – Biologics of Genentech, Inc. and as a member of
the Genentech Executive Committee where he oversaw global leadership for more
than 7,500 professionals across 10 internal sites and over 37 contract
manufacturing organizations, as well as global manufacturing and end-to-end
quality supply performance of more than 20 biological product families. Tim
serves as a Board member for Cerus and BioLife Solutions. He received a B.S. in
Chemical Engineering from Tulsa University and a M.S. in Engineering Management
from Northwestern University.



JOANNE BECK
CHIEF TECHNOLOGY OFFICER AT AERIUM THERAPEUTICS

Dr. Joanne Beck is currently Chief Technology Officer at Aerium Therapeutics, a
startup dedicated to the discovery & development of antibodies and small
molecule antivirals against SARS-CoV-2 and other epidemic & pandemic threats. 
Prior to this, […]
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JOANNE BECK

Chief Technology Officer at Aerium Therapeutics

Dr. Joanne Beck is currently Chief Technology Officer at Aerium Therapeutics, a
startup dedicated to the discovery & development of antibodies and small
molecule antivirals against SARS-CoV-2 and other epidemic & pandemic threats. 
Prior to this, she served as COO at Boston Pharmaceuticals, a private company
developing candidates across multiple indications in cardiometabolic, oncology,
and immune/inflammatory diseases.  Prior to joining Boston Pharmaceuticals, she
was Executive Vice President of Global Pharmaceutical Development and Operations
at Celgene where she oversaw the company’s Product Development, Global
Manufacturing Operations, Supply Chain, Engineering and Quality.  Prior to
Celgene, she was SVP of Pharmaceutical Development at Shire.  Prior to Shire she
held roles of increasing responsibility in Process Development at Genentech and
Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions.  Beck
holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry
and Molecular Biology from University of Oregon Medical School and completed a
postdoctoral fellowship in the department of Pharmaceutical Chemistry at the
University of California, San Francisco.  Dr. Beck serves on the board of
directors for Orchard Therapeutics and Astria Therapeutics.



CRAIG BEASLEY
CHIEF TECHNOLOGY OFFICER AT BLUEROCK THERAPEUTICS

Craig Beasley is the Chief Technical Officer at BlueRock Therapeutics. Prior to
joining BlueRock, Craig was the Vice President, Cell Therapy Supply Chain at
BMS, where he oversaw supply chain for BMS’s clinical and commercial stage cell
[…]
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CRAIG BEASLEY

Chief Technology Officer at BlueRock Therapeutics

Craig Beasley is the Chief Technical Officer at BlueRock Therapeutics. Prior to
joining BlueRock, Craig was the Vice President, Cell Therapy Supply Chain at
BMS, where he oversaw supply chain for BMS’s clinical and commercial stage cell
therapy assets. Previously, Craig was Head of Manufacturing and Supply Chain at
Juno Therapeutics and Vice President of Next Generation Manufacturing at Biogen.
Prior to working in biotechnology, Craig worked for Union Carbide in process
development. Craig holds a B.S. in Chemical Engineering from Purdue University.



MORREY ATKINSON
SVP & HEAD, COMMERCIAL MANUFACTURING AND SUPPLY CHAIN AT VERTEX PHARMACEUTICALS

As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current
responsibilities include defining the commercial manufacturing and supply chain
strategy needs, as well as, designing and building a global organization and
supply network. In […]
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MORREY ATKINSON

SVP & Head, Commercial Manufacturing and Supply Chain at Vertex Pharmaceuticals

As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current
responsibilities include defining the commercial manufacturing and supply chain
strategy needs, as well as, designing and building a global organization and
supply network. In addition, Morrey is responsible for assuring reliable supply
of Vertex’s transformative medicines.

Morrey is a trained laboratory scientist who brings more than 25 years of
experience leading the development and commercial manufacturing of multiple
products at organizations like Eli Lilly and Bristol Myers Squibb. An
accomplished leader and builder of strong scientific, engineering, and
operations teams, Morrey also has prior experience in process development for
cell and gene therapies, including the development and manufacturing of one of
the first gene therapy candidates for cystic fibrosis.



JENS VOGEL
SVP & GLOBAL HEAD OF BIOTECH AT BAYER AG

Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the
Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of
professional and leadership experience in the area of […]
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JENS VOGEL

SVP & Global Head of Biotech at Bayer AG

Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the
Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of
professional and leadership experience in the area of biologics operations,
development and technology management. From 2012 until 2020, he held positions
of increasing responsibility at Boehringer Ingelheim (BI), including as
President and CEO of BI Fremont Inc and member of BI’s Biopharma Executive
Committee. Prior to his years at BI, Dr. Vogel was a member of the Biologics
Development Leadership team at Bayer in Berkeley. Jens holds a PhD in
Biotechnology from University of Braunschweig, Institute of Technology, Germany.



LUIS ROMAN
VP GLOBAL PLATFORM LEADER- SMALL MOLECULES AT JOHNSON & JOHNSON

Currently, Luis is responsible for management of Janssen Supply Chain’s global
Small Molecule Platform. This includes oversight of the global internal and
external network, management of critical strategic partnerships, reliability,
and continuous improvement. His main focus […]
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LUIS ROMAN

VP Global Platform Leader- Small Molecules at Johnson & Johnson

Currently, Luis is responsible for management of Janssen Supply Chain’s global
Small Molecule Platform. This includes oversight of the global internal and
external network, management of critical strategic partnerships, reliability,
and continuous improvement. His main focus is on orchestrating the end-to-end
supply chain to drive business results and enhance the customer experience.

Throughout his career at J&J of over 20 years, Luis has held positions of
increasing responsibility within Supply Chain across various functions in
Manufacturing, Engineering, New Product Introduction and Strategy
Development/Deployment and Distribution/Logistics. Prior to his current role,
Luis was Vice President of Janssen’s Partnership and External Supply with supply
chain responsibility for Janssen’s external network of ~160 Contract
Manufacturers across Small Molecules, Large Molecules, and New Modalities.
Additionally, he has held multiple roles as Vice President of Supply Chain
within MedTech leading Cardiovascular Care and Specialty Solutions (CSS) and
Ethicon with supply chain end-to-end responsibility of finished goods and
services for the franchises.

In all prior roles, organizations delivered a strong track record of improving
key operational performance and stabilizing product supply while delivering
enhancements in all phases of the business that have been recognized both
internally and externally.

Luis is a strong developer of talent, an advocate for Diversity & Inclusion
while also being a strong supporter of social justice. He is also a member of
the Seton Hall University Transformative Leadership in Disruptive Times Program
Advisory Board. In this role, Luis also shapes the Seton Hall Supply Chain
graduate curriculum and provides mentorship to graduate students regarding the
changing landscape of pharmaceutical supply chain external manufacturing.
Throughout his tenure, he has been known for his active participation and
sponsorship of Employee Relationship Groups (HOLA/Open & Out). Additionally, he
is a Board Member for the Pace Center for Girls which is an innovative
prevention and intervention program focused on providing an opportunity for a
better future through education, counseling, training, and advocacy.

Luis earned his Bachelor of Science degree in Industrial Engineering from Purdue
University and a M.B.A degree from the University of Texas. He is certified as a
Six-Sigma Black Belt, Lean Green Belt and in FPX (Flawless Project Execution).
Additionally, he is an active member of the Institute of Industrial Engineers
(IIE), Society of Manufacturing Engineers (SME), and American Society of Quality
(ASQ).



JENNIFER BAXTER
VP, SMALL MOLECULE SCIENCE AND TECHNOLOGY AT MERCK

Jennifer Baxter has over 20 years of experience in pharmaceutical development
and manufacturing activities. During her tenure at Merck, Jennifer has worked in
research & development, technical support, and strategic planning of small
molecules in roles […]
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JENNIFER BAXTER

VP, Small Molecule Science and Technology at Merck

Jennifer Baxter has over 20 years of experience in pharmaceutical development
and manufacturing activities. During her tenure at Merck, Jennifer has worked in
research & development, technical support, and strategic planning of small
molecules in roles across the human health, animal health, research and
manufacturing divisions. Jennifer is currently the Vice President of Small
Molecule Science and Technology, leading a group of approx. 800 scientists and
engineers located worldwide. The group is responsible for the late-stage
development of Merck’s small molecule pipeline across drug substance, drug
product and packaging for both worldwide and regional products as well as all
technical support for in-line small molecule products and lifecycle management
activities. The group also manages manufacture and supply of late-stage clinical
materials, technology development of new and innovative manufacturing
technologies and provides site based technical support to all of Merck’s small
molecule sites. Jennifer holds BS, MS and PhD degrees in Chemical Engineering
from Rutgers University.



CHRIS HORAN
CHIEF TECHNICAL OPERATIONS OFFICER AT ARTIVA BIOTHERAPEUTICS

Christopher Horan spent nearly 14 years at Genentech, a member of the Roche
Group, where he held several leadership positions across technical operations,
including as Senior Vice President, Global Product and Supply Chain Management
for Roche […]
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CHRIS HORAN

Chief Technical Operations Officer at Artiva Biotherapeutics

Christopher Horan spent nearly 14 years at Genentech, a member of the Roche
Group, where he held several leadership positions across technical operations,
including as Senior Vice President, Global Product and Supply Chain Management
for Roche in Basel, Switzerland. In that role, he led a 480-person team
supplying all of Roche biopharma products worldwide. Mr. Horan joins Artiva from
SanBio, where, as Chief Technical Officer (CTO), he led the process development,
manufacturing, supply, and quality systems for their mesenchymal stem cell
regenerative medicine approach to brain injury in support of a near-term
registration in Japan. Previous to SanBio, he was Chief Technical Operations
Officer at Dermira, where he led all aspects of pharmaceutical sciences,
manufacturing, quality, supply chain, and procurement to launch the company’s
first commercial product. He led the effort to prepare Dermira’s IL-13
monoclonal antibody program for Phase 3 trials and commercial filing and had a
key role in supporting the company’s successful acquisition by Eli Lilly and
Company. Mr. Horan started his career with over a decade of increasing
responsibility in technical operations at Merck & Co. He earned a B.E. in
engineering from the Stevens Institute of Technology in New Jersey.



SPENCER FISK
CHIEF TECHNOLOGY OFFICER AT RESILIENCE INC

Spencer has more than 30 years of experience in Manufacturing and CMC product
development. While at Rubius, Spencer built the technical functions to design
and deliver the RED™M manufacturing platform, including clearance of 4 IND’s
over […]
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SPENCER FISK

Chief Technology Officer at Resilience Inc

Spencer has more than 30 years of experience in Manufacturing and CMC product
development. While at Rubius, Spencer built the technical functions to design
and deliver the RED™M manufacturing platform, including clearance of 4 IND’s
over 4 years.

He also led the acquisition and re-fit of their Red Cell Therapeutics
manufacturing site in Smithfield Rhode Island, where the team transferred and
delivered clinical supplies for their 3 oncology programs. Prior to joining
Rubius, Spencer served as VP & Global Head of Cell & Gene Technical Development
and Manufacturing at Novartis where he led the CMC development and manufacturing
organization to deliver the CAR-T portfolio. Under his leadership, the team
successfully registered and launched the first CAR-T cellular therapy product,
Kymriah, which has demonstrated transformative efficacy in patients with acute
lymphoblastic leukemia. While at Novartis, Spencer also led technical
development teams across the Novartis Biologics portfolio in support of the
commercialization of Cosentyx® and the registration and approval of Erelzi™M?
and Rixathon®.

Prior to Novartis, he led manufacturing and CMC functions in support of
Somavert®, Elonva®, Retavase® and Puregon® while at Merck, formerly Schering
Plough, Organon and Covance. Prior to Merck, Spencer held various process and
technical development and manufacturing roles at Genentech, Genencor and Novo
Nordisk.



KATHY AZUARA
SVP GLOBAL QUALITY AT ULTRAGENYX

Kathy Azuara is the Senior Vice President of Quality Assurance for Ultragenyx
Gene Therapy. She has been with Ultragenyx since 2019. In this role she is
responsible for leading quality strategy for the company’s clinical stage […]
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KATHY AZUARA

SVP Global Quality at Ultragenyx

Kathy Azuara is the Senior Vice President of Quality Assurance for Ultragenyx
Gene Therapy. She has been with Ultragenyx since 2019.

In this role she is responsible for leading quality strategy for the company’s
clinical stage gene therapy portfolio and Europe. She focuses on deploying phase
appropriate quality systems that support rapid development and licensure of
ultra-rare disease products, driving the Ultragenyx “Responsible Quality
Mindset” into every aspect of the business, and building a team that can deliver
clinical supply and evolve to manage the companies first gene therapy regulatory
approvals in the next two years. Kathy was responsible for the design and
startup of the company’s first QC laboratories in Woburn, Massachusetts. She has
also managed the early regulatory discussions, design, and quality aspects of
the company’s first GMP manufacturing facility in Bedford, Massachusetts.

Prior to Ultragenyx, Kathy held roles in Marketing, Manufacturing Strategy,
Quality Control, and Quality Assurance at Baxter, Baxalta, Shire, and Alexion.
She holds a Bachelor of Science degree from the University of Wisconsin –
Madison.



TIM ELLIOTT
EXECUTIVE DIRECTOR, NORTH AMERICA SUPPLY CHAIN OPERATIONS AT MERCK

During a 25 year tenure in the Merck Manufacturing Division (MMD), Tim Elliott
has held positions of increasing responsibility in Technology, Operations, and
Supply Chain Management. In his current role, Tim oversees all aspects of supply
[…]
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TIM ELLIOTT

Executive Director, North America Supply Chain Operations at Merck

During a 25 year tenure in the Merck Manufacturing Division (MMD), Tim Elliott
has held positions of increasing responsibility in Technology, Operations, and
Supply Chain Management. In his current role, Tim oversees all aspects of supply
chain for North America including supply chain planning, new product
introductions, warehousing, and logistics. In addition to his operational
responsibilities, Tim is tasked with leading and enabling transformational
strategic initiatives for MMD.  These include running the business more
efficiently, adoption of new technologies, mitigation of supply risk, reducing
Merck’s carbon footprint through sustainability initiatives, and enabling of
innovative ways of serving Merck’s customers. Tim holds a BS and PhD in Chemical
Engineering from Lehigh University and an MBA from New York University.



RICH KILMER
CEO AT CARGOSENSE

Has been at CargoSense for over 10 years. He is the Co-Founder of CargoSense and
is currently President and CEO. Previously was the President and CEO of
InfoEther until its acquisition by LivingSocial in March 2011. […]
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RICH KILMER

CEO at CargoSense

Has been at CargoSense for over 10 years. He is the Co-Founder of CargoSense and
is currently President and CEO. Previously was the President and CEO of
InfoEther until its acquisition by LivingSocial in March 2011. Rich started his
career in the U.S. Air Force working on computer encryption programming at the
Pentagon.



ANDERS VINTHER
SVP PHARMACEUTICAL DEVELOPMENT & MANUFACTURING AT KRONOS BIO

Anders joined Kronos Bio in June 2021 as Vice President of Quality. Currently he
is the SVP of pharmaceutical development and manufacturing. He brings more than
30 years of experience in the biopharmaceutical industry, from small […]
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ANDERS VINTHER

SVP Pharmaceutical Development & Manufacturing at Kronos Bio

Anders joined Kronos Bio in June 2021 as Vice President of Quality. Currently he
is the SVP of pharmaceutical development and manufacturing. He brings more than
30 years of experience in the biopharmaceutical industry, from small startups of
which he co-founded one to large, global companies. Anders has worked in senior
positions in several companies prior to joining Kronos Bio including Novo
Nordisk, AGC Biologics, Genentech, Roche, Sanofi, Intarcia. His achievements
include quality and cGMP compliance improvements, development and deployment of
quality systems, culture change and employee career development. Throughout his
career, Anders has led various industry-wide initiatives related to quality,
compliance and sustainable drug product supply to patients. Anders received his
M.Sc. and Ph.D. in chemical engineering from The Technical University of
Denmark.



BABITA PAREKH
VP ANALYTICAL SCIENCES AND GLOBAL BIOASSAY STEWARD AT ELI LILLY

Currently, Babita Parekh is the Vice President of Analytical Sciences and Global
Bioassay Steward at Eli Lilly & company. She has obtained an M.S and a Ph.D. in
Microbiology/Biochemistry from the M. S. University of Baroda, […]
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BABITA PAREKH

VP Analytical Sciences and Global Bioassay Steward at Eli Lilly

Currently, Babita Parekh is the Vice President of Analytical Sciences and Global
Bioassay Steward at Eli Lilly & company. She has obtained an M.S and a Ph.D. in
Microbiology/Biochemistry from the M. S. University of Baroda, India. Babita
began her post-doctoral career at United States Department of Agriculture,
Maryland and postdoctoral fellowship at NYU medical Center.

Babita joined Lilly NJ in 1996 and started her career in Quality Control. She
has provided leadership to the BioAnalytical Sciences and is responsible for the
strategic direction and organizational capability. She was involved throughout
the development and regulatory submission/commercialization for four monoclonal
antibodies. Her group is responsible for managing analytical methods through all
phases of product development, for studying correlation between
structure/function, bioassay stewardship and regulatory filing support.



RICK PANICUCCI
SVP CMC AT BRIDGEBIO

Rick has been at BridgeBio for over one year. He currently responsible for the
role of Senior VP of CMC. Prior to BridgeBio he worked at QED Therapeutics,
Origin Biosciences , Novartis, Vertex and Biogen. He […]
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RICK PANICUCCI

SVP CMC at BridgeBio

Rick has been at BridgeBio for over one year. He currently responsible for the
role of Senior VP of CMC. Prior to BridgeBio he worked at QED Therapeutics,
Origin Biosciences , Novartis, Vertex and Biogen. He earned his PhD, Chemistry
at the University of Toronto.



TORI ARENS
VP GM & SITE HEAD AT RESILIENCE, INC.

Tori leads the Resilience RTP gene-therapy manufacturing facility. Tori joined
Resilience from Aerie Pharmaceuticals, where she was VP of Drug Product
Manufacturing, providing end-to-end leadership for the manufacturing and supply
of both commercial and clinical drug […]
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TORI ARENS

VP GM & Site Head at Resilience, Inc.

Tori leads the Resilience RTP gene-therapy manufacturing facility. Tori joined
Resilience from Aerie Pharmaceuticals, where she was VP of Drug Product
Manufacturing, providing end-to-end leadership for the manufacturing and supply
of both commercial and clinical drug products. Previously, Tori also held
leadership roles at Biogen and Eisai.



LAQUISHA E. CRAWFORD
EXECUTIVE DIRECTOR, DEVELOPMENT AND COMMERCIAL BIOLOGICS QUALITY AT GILEAD
SCIENCES

Laquisha E. Crawford is a leader that centers her leadership philosophy around
vision engagement, effective change management, and accountability. Deeply
rooted in her faith, colleagues appreciate her transparent and pragmatic
approach towards problem solving. Laquisha earned […]
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LAQUISHA E. CRAWFORD

Executive Director, Development and Commercial Biologics Quality at Gilead
Sciences

Laquisha E. Crawford is a leader that centers her leadership philosophy around
vision engagement, effective change management, and accountability. Deeply
rooted in her faith, colleagues appreciate her transparent and pragmatic
approach towards problem solving.

Laquisha earned her BS and an MS degree in chemistry from Lincoln University,
PA, and Drexel University, respectively. She is currently completing a doctoral
degree in the University of Southern California’s Organizational Change and
Leadership program, where her doctoral dissertation probes into the lack of
leadership diversity in Europe. Laquisha is a results-driven and award-winning
quality management professional with over 20 years of progressive management
experience in quality assurance and compliance operations within the
pharmaceutical industry. She currently serves as the Executive Director of
Development and Commercial Biologics Quality at Gilead Sciences, Inc. where she
is responsible for the quality and compliance oversight of both Gilead internal
site manufacturing and contract manufacturers producing biological products for
global development and commercial markets. Prior to joining Gilead Sciences,
Inc, she lived and worked in Basel, Switzerland for ~ 8 years where she was most
recently responsible for external manufacturing quality and compliance of
pharmaceutical products as well as the Swissmedic responsible person for Bayer
Pharmaceuticals AG.



KAORU NISHINO
EXECUTIVE DIRECTOR, GLOBAL QUALITY MANAGEMENT SYSTEMS AT BRISTOL-MYERS SQUIBB

Kaoru has been with BMS for almost 2 years. He is responsible for the role of
Executive Director, Global QMS Operational Controls. Prior to BMS he worked at
MyoKardia, Dermira Inc, Ultragenyx Pharmaceutical Inc & Roche […]
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KAORU NISHINO

Executive Director, Global Quality Management Systems at Bristol-Myers Squibb

Kaoru has been with BMS for almost 2 years. He is responsible for the role of
Executive Director, Global QMS Operational Controls. Prior to BMS he worked at
MyoKardia, Dermira Inc, Ultragenyx Pharmaceutical Inc & Roche among others. He
earned his Biochemistry & Molecular Biology degree at University of California,
Berkeley



MURALI MURALIDHARA
CHIEF TECHNICAL & MANUFACTURING OFFICER AT RVAC MEDICINES, BOSTON, US

Murali Muralidhara (Murali), PhD, as the CTMO at RVAC Medicines oversees CMC,
Development, Manufacturing , Supply Chain  of mRNA based vaccines & therapeutics
products and Global IT function. He has over 22 years of technical and […]
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MURALI MURALIDHARA

Chief Technical & Manufacturing Officer at RVAC Medicines, Boston, US

Murali Muralidhara (Murali), PhD, as the CTMO at RVAC Medicines oversees CMC,
Development, Manufacturing , Supply Chain  of mRNA based vaccines & therapeutics
products and Global IT function.

He has over 22 years of technical and leadership experience in Product
Development, Manufacturing, and Commercialization Protein Biologics, Vaccines  &
Gene Therapy products in large & mid-size pharma set-up.  Murali has contributed
to product development/module-3 preparation/investigations/manufacturing and
approval of nine biologic & vaccine products ( Flumist®, Elelyso®, Xiapex®,
Trumenba®, Imfinzi®,  Crysvita®, Reblozyl® , and  Imdojo®  ) and  over 30
INDs/IMPDs for clinical development as an  individual contributor, team leader
and executive manager with his careers at Pfizer Biotherapeutics, AstraZeneca,
Ultragenyx, Acceleron (now Merck)  and GSK Vaccines.

He has deep leadership expertise in organizational design, leading
multi-site/multi-country operations, CDMO operations, Manufacturing foot-print
build-up, talent development & retention, and divestment and value creation.  He
has published 50 research papers & reviews, made over 40 industry podium
presentations and serves on journal editorial boards of Drug Discovery Today,
PDA, mAbs , & Vaccines & Vaccination.



RICHARD D. BRAATZ
EDWIN R. GILLILAND PROFESSOR OF CHEMICAL ENGINEERING AT MIT

Dr. Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical
Engineering at MIT, where he conducts research into advanced biopharmaceutical
manufacturing systems. In this role, he leads process data analytics,
mechanistic modeling, and control […]
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RICHARD D. BRAATZ

Edwin R. Gilliland Professor of Chemical Engineering at MIT

Dr. Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical
Engineering at MIT, where he conducts research into advanced biopharmaceutical
manufacturing systems. In this role, he leads process data analytics,
mechanistic modeling, and control systems for several projects on campus,
including those focused on monoclonal antibody, viral vaccine, and gene therapy
manufacturing. Dr. Braatz received an M.S. and Ph.D. from the California
Institute of Technology and was the Millennium Chair and Professor at the
University of Illinois at Urbana-Champaign and a Visiting Scholar at Harvard
University before moving to MIT.

Dr. Braatz has collaborated with more than 20 companies including Novartis,
Pfizer, Merck, Bristol-Myers Squibb, Biogen, Amgen, Takeda, and Abbott Labs.
Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug
Substance, the AIChE Excellence in Process Development Research Award, the
Technical Innovation Award from the International Society of Automation, and the
IEEE Control Systems Society Transition to Practice Award. He has published over
200 papers and three books, including Fault Detection and Diagnosis in
Industrial Systems. Dr. Braatz is a Fellow of IEEE, IFAC, AIChE, and AAAS and a
member of the U.S. National Academy of Engineering.



PASCAL BÉCOTTE
MANAGING DIRECTOR AT RUSSELL REYNOLDS ASSOCIATES

Pascal leads Canadian operations for Russell Reynolds Associates and is also a
member of the firm’s global Executive Committee. He is a key member of the
Healthcare Sector where he advises clients across the globe on […]
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PASCAL BÉCOTTE

Managing Director at Russell Reynolds Associates

Pascal leads Canadian operations for Russell Reynolds Associates and is also a
member of the firm’s global Executive Committee. He is a key member of the
Healthcare Sector where he advises clients across the globe on their overall
talent strategy, particularly with respect to leadership assessment, succession
planning and the recruitment of directors, CEOs and other senior executives.
More specifically Pascal specializes in Biotech and Pharma Technical Operations
including Process Development, Manufacturing, Quality, Engineering and Supply
Chain leadership across modalities.



JOSÉ MANUEL OTERO
CHIEF TECHNICAL OFFICER AT AUREGEN

Jose Manuel recently joined Auregen and is responsible for the role of Chief
Technical Officer. Prior to Auregen he worked at Turnstone Biologics as CTO,
Seres Therapeutics as VP, Bioprocesses Developments & Merck as Director,
Engineering. […]
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JOSÉ MANUEL OTERO

Chief Technical Officer at Auregen

Jose Manuel recently joined Auregen and is responsible for the role of Chief
Technical Officer. Prior to Auregen he worked at Turnstone Biologics as CTO,
Seres Therapeutics as VP, Bioprocesses Developments & Merck as Director,
Engineering. He is currently is still and advisor for Turnstone Biologics and a
principal consultant for the University of Chicago



SARAH MIKSINSKI
EXECUTIVE DIRECTOR AT ASTRAZENECA

Respected and trusted visionary leader with more than 20 years of experience in
regulatory affairs, quality and biopharmaceutical policy.  Highly experienced in
strategic organizational transformation, executive leadership and business
planning.  Mentorship, research and publications support CMC […]
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SARAH MIKSINSKI

Executive Director at AstraZeneca

Respected and trusted visionary leader with more than 20 years of experience in
regulatory affairs, quality and biopharmaceutical policy.  Highly experienced in
strategic organizational transformation, executive leadership and business
planning.  Mentorship, research and publications support CMC benefit risk,
accelerated assessments, patient centricity/CMC, and advanced manufacturing
technologies. Recognized thought leader in global regulatory affairs, and
extensively and visibly networked across biopharmaceutical industry and global
health authorities.



CARL FINAMORE
EXECUTIVE DIRECTOR GENE THERAPY MANUFACTURING AT ULTRAGENYX

Carl is the head of the Manufacturing PMO and Operational Excellence at
Ultragenyx and the Program Director for Ultragenyx’s largest capital project,
the construction and startup of a large-scale Gene Therapy Manufacturing
Facility.  The greenfield facility […]
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CARL FINAMORE

Executive Director Gene Therapy Manufacturing at Ultragenyx

Carl is the head of the Manufacturing PMO and Operational Excellence at
Ultragenyx and the Program Director for Ultragenyx’s largest capital project,
the construction and startup of a large-scale Gene Therapy Manufacturing
Facility.  The greenfield facility brings internal manufacturing capabilities
on-line to support Ultragenyx’s growing pipeline of gene therapies for rare
diseases.  Carl has over 25 year of experience in the pharma, biotech, and med
device industries with previous roles in industry and as a management consultant
at PRTM / PwC where his focus has been on Operational Strategy, Program
Management, Product Development, Continuous Improvement and Lean, Regulatory and
Quality Systems, Manufacturing / CMC, Post-merger Integration, and Operating
Model design.



CHRISTOPHER TEMPLE
VP, OPERATIONS AT ATHERSYS

Christopher Temple serves as Vice President, Operations for Athersys, an
allogeneic cell therapy company for acute indications. Christopher’s current
responsibilities include leading clinical operations for Athersys’ global Phase
3 pivotal study in Ischemic Stroke as well […]
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CHRISTOPHER TEMPLE

VP, Operations at Athersys

Christopher Temple serves as Vice President, Operations for Athersys, an
allogeneic cell therapy company for acute indications. Christopher’s current
responsibilities include leading clinical operations for Athersys’ global Phase
3 pivotal study in Ischemic Stroke as well as process optimization activities
across all of Athersys’ operations.

During his career, Christopher has held operational leadership roles of
increasing scope and responsibilities. He has excelled in leading domestic and
international lean transformations for manufacturing companies across various
industries; focused on improving culture, enhancing efficiency, driving quality,
and bringing value to the customer. Christopher holds a BS in Manufacturing
Engineering from Brigham Young University.



NDIDI RICKERT
ASSOCIATE DIRECTOR, QUALITY CULTURE EXCELLENCE AT ULTRAGENYX

Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of
experience in the Pharmaceutical/Biotechnology Industry. Presently, Ndidi
currently leads Quality Culture Excellence Program at Ultragenyx where she has
worked for over 8 years. […]
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NDIDI RICKERT

Associate Director, Quality Culture Excellence at Ultragenyx

Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of
experience in the Pharmaceutical/Biotechnology Industry. Presently, Ndidi
currently leads Quality Culture Excellence Program at Ultragenyx where she has
worked for over 8 years. Her overall responsibilities focus on the development
and execution of the Quality Culture Excellence Program, where she is
acknowledged for her passion for nurturing a responsible quality mindset across
the organization. She has been recognized as a thought leader in driving
strategy and continuous improvement.

 

After completing her education in the United Kingdom, Ndidi began her career
working for Parexel followed by Merck Sharp & Dohme. She then ventured across
the pond to the United States, spent several years working for Novartis and
Gilead Sciences, and is now settled in the San Francisco Bay Area with her
husband. Her background in Biotechnology and proficiency in Data Management
solidified her proven ability to identify data integrity risks, Quality Risk
Management, Vendor Management, and innovative solutions-driven capabilities.

 

Ndidi is the former leader and steering committee member of the X2 Women in
Biotech and was one of the founding members of the UltraMosaic Employee Resource
Group. In her spare time, Ndidi enjoys creative writing. She intentionally
injects laughter and authenticity into everything she does. She is an advocate
for kindness, and issues impacting women and children.



AARON ALLEN
DIRECTOR, GLOBAL QUALITY EXTERNAL ENGAGEMENT AT MODERNA

Aaron Allen is an experienced Manufacturing Sciences and Technology professional
with more than 25 years of process engineering, manufacturing and MS&T
experience. Mr. Allen has transferred and executed process validation for
multiple vaccines within Novartis and […]
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AARON ALLEN

Director, Global Quality External Engagement at Moderna

Aaron Allen is an experienced Manufacturing Sciences and Technology professional
with more than 25 years of process engineering, manufacturing and MS&T
experience. Mr. Allen has transferred and executed process validation for
multiple vaccines within Novartis and Moderna. He has recently transitioned to a
new role as Global Quality External Engagement.

Mr. Allen’s previous experience includes positions with Diosynth, Biogen, Jacobs
Engineering and Novartis Vaccines. Mr. Allen holds a bachelor’s degree in
Chemical Engineering from the University of California at Santa Barbara.



JULIE GO
EXECUTIVE DIRECTOR, TECHNICAL OPERATIONS - STRATEGY AT SEAGEN

Julie Go has been with Seagen since 2020.  In her current role as Executive
Director, Technical Operations – Strategy and Business Ops, Julie oversees the
Strategic Initiatives, Operational Excellence, Portfolio Management,
Communications and Outreach functions for […]
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JULIE GO

Executive Director, Technical Operations - Strategy at Seagen

Julie Go has been with Seagen since 2020.  In her current role as Executive
Director, Technical Operations – Strategy and Business Ops, Julie oversees the
Strategic Initiatives, Operational Excellence, Portfolio Management,
Communications and Outreach functions for Seagen’s Technical Operations Division
which encompasses Technical Development, Global Commercial Product Supply &
Manufacturing, and Global Quality.

Prior to joining Seagen, Julie was at Gilead Sciences leading the Pharmaceutical
Development and Global Manufacturing Portfolio, Program Management and Systems
function. She oversaw the portfolio program management for 50+ development
pipeline products, 25 commercial products, 30+ Outsourced Manufacturing teams
and the Operational Excellence Initiatives for the CMC area.  During her time at
Gilead, she was part of the successful approval and launch of the HCV Cure
Franchise and 2nd generation HIV products encompassing 14 product approvals in
10 years.   She also supported multiple integrations of acquired companies into
Gilead.

Julie holds a B.S. in Physiology from UCLA and an MBA from the University of
California, Davis.



MARTY SMYTH
SVP, GO-TO-MARKET STRATEGY AT MASTERCONTROL

As the senior vice president of go-to-market strategy, Marty Smyth is
responsible market intelligence, product strategy, and bringing MasterControl
quality and manufacturing products to market globally. He brings 20 years of
technology strategy, marketing, sales, and […]
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MARTY SMYTH

SVP, Go-To-Market Strategy at MasterControl

As the senior vice president of go-to-market strategy, Marty Smyth is
responsible market intelligence, product strategy, and bringing MasterControl
quality and manufacturing products to market globally. He brings 20 years of
technology strategy, marketing, sales, and support experience across high-growth
private SaaS companies as well as Fortune 500 companies.

In previous roles, Marty has driven strategic planning, customer experience, and
go-to-market for technology leaders like Cisco, Panasonic, Verizon, and AT&T. He
is a University of Notre Dame alumnus.



TERESA GORECKI
PRACTICE LEAD AT COMPLIANCE ARCHITECTS LLC

Teresa Gorecki comes to Compliance Architects® from Johnson & Johnson, Janssen
Pharmaceuticals, where she was most recently Vice President, Market Quality.  
At Johnson & Johnson, Teresa was one of J&J’s top Quality professionals, known
for her ability […]
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TERESA GORECKI

Practice Lead at Compliance Architects LLC

Teresa Gorecki comes to Compliance Architects® from Johnson & Johnson, Janssen
Pharmaceuticals, where she was most recently Vice President, Market Quality.  
At Johnson & Johnson, Teresa was one of J&J’s top Quality professionals, known
for her ability to manage inspections and remediate and improve deficient
operations.  Teresa had senior level roles across all three sectors within
Johnson & Johnson:  Pharmaceuticals, Consumer Products and Medical Devices.

Teresa is one of Compliance Architects’® lead subject matter experts, and has
primary responsibility for strategic client engagements.

At Johnson & Johnson, Teresa’s key accomplishments included:

 * Chair of Johnson & Johnson Cross Sector Business Quality Governance Team
   responsible for developing a Governance Model and Organizational Structure to
   develop and oversee an aligned Quality Management System, Processes and
   Procedures across the J&J Enterprise Business/Marketing Company Quality
   Units.
 * Member of J&J Company Leadership Teams/Boards including Regional Management 
   Board for North America; J&J Consumer Healthcare Company (CHC) Board; and
   Neutrogena Management Board.
 * Management of all aspects of Quality Systems, Quality Assurance, and
   Regulatory Compliance with Worldwide Regulatory Authorities including FDA
   (CBER, CDER and CDRH), MHRA,EMA, ANVISA, CFDA, Health Canada, etc.  Extensive
   experience in combination products, pharmaceutical dosage forms for both OTC
   and Rx products; biological (r­ DNA and monoclonal antibody) products and a
   wide range of consumer products (class I and II medical devices, OTC drugs,
   cosmetics and consumer products) in the US and Puerto Rico.
 * Over 20 years’ experience and lead J&J subject matter expert in handling FDA
   inspections (routine, special cause, and PAI) for Cosmetic and Consumer,
   Combination Drug/Device, Pharmaceutical, and Biological products.
 * Extensive experience with new product introduction; product and technology
   transfer, and commissioning of new/re-constructed facilities.
 * Leadership of ERP System (SAP) implementation for Pharmaceutical Sourcing
   Group of the Americas Sites in New Jersey and Puerto Rico. Management of
   large-scale Supply Chain projects for “Demand Pull,” or LEAN Manufacturing.
    Sponsorship of Six Sigma initiatives in Manufacturing and QA, which
   increased quality and compliance and yielded business benefits.

Teresa received her B.S. in Microbiology, with a minor in Chemistry from South
Dakota State University.



JUDITH KOLIWER, PHD
PRINCIPAL CONSULTANT, CELL & GENE THERAPY AT KÖRBER PHARMA SOFTWARE

After her PhD on the genetic background of autism spectrum disorders, Judith was
leading an academic research group, which analyzed the physiological role of
proteins associated with cancer and epilepsy by using lenti and retroviral
transduction […]
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JUDITH KOLIWER, PHD

Principal Consultant, Cell & Gene Therapy at Körber Pharma Software

After her PhD on the genetic background of autism spectrum disorders, Judith was
leading an academic research group, which analyzed the physiological role of
proteins associated with cancer and epilepsy by using lenti and retroviral
transduction for genetic modification of cell cultures. As the leading scientist
for BSL2, she supported the development of all virus-based projects of the
university. In 2019, Judith joined the MES Company Werum IT Solutions GmbH, now
Körber Pharma Software GmbH, where she works as principal consultant for cell
and gene therapy projects. She works closely with cell and gene therapy / ATMP
manufacturers, supporting them in transitioning their manufacturing process from
paper to a digital solution.



ANDY ALASSO
CHIEF PRODUCT AND CUSTOMER SUCCESS OFFICER AT AIZON

Andy Alasso is the Chief Product and Customer Success Officer at Aizon. At Aizon
Andy is responsible for leading product delivery of the Aizon AI Cloud GxP
platform designed to optimize manufacturing in Life Sciences. Prior […]
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ANDY ALASSO

Chief Product and Customer Success Officer at Aizon

Andy Alasso is the Chief Product and Customer Success Officer at Aizon. At Aizon
Andy is responsible for leading product delivery of the Aizon AI Cloud GxP
platform designed to optimize manufacturing in Life Sciences. Prior to Aizon,
Andy was Global Vice President of Product Management within the Oracle Health
Sciences Business Unit. Andy and his team were responsible for defining,
specifying, and facilitating the delivery of 20+ products within Oracle’s
Clinical Research, Pharmacovigilance, and Healthcare portfolios. Prior to his
role at Oracle, Andy led product management for several product portfolios
within Healthcare services company Optum. Prior to Optum, Andy was Director of
Clinical and Regulatory IT at Astra USA (now part of AstraZeneca). Overall Andy
has over 25 years of experience in providing software solutions to the Life
Sciences and Healthcare industries.



KIM FORTE
PRINCIPAL, SCNO AT DELOITTE CONSULTING LLP

Kim is a partner with Deloitte’s Life Sciences Supply Chain and Network
Operations practice. Based in New York, she has over 20 years of consulting
operations experience across the pharmaceutical, biologics and medical device
sectors. Having […]
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KIM FORTE

Principal, SCNO at Deloitte Consulting LLP

Kim is a partner with Deloitte’s Life Sciences Supply Chain and Network
Operations practice. Based in New York, she has over 20 years of consulting
operations experience across the pharmaceutical, biologics and medical device
sectors. Having held leadership positions at Amazon and SAP, she brings smart /
digital manufacturing and plant floor operations, plant engineering, facilities
management, material sourcing, distribution, performance improvement,
operational excellence and market entry operations strategy expertise. Her
current focus at Deloitte is enabling advanced analytics across the end-to-end
global supply chain.



IKNAM GILL
SR. MANAGER, SCNO AT DELOITTE CONSULTING LLP

Iknam is a trusted advisor for Life Science clients ~20 years of deep expertise
in Technical Operations, enabling reliable supply and accessible treatments. As
a leader in Technical Operations, Iknam delivers End-to-end Digital
Transformations involving innovative […]
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IKNAM GILL

Sr. Manager, SCNO at Deloitte Consulting LLP

Iknam is a trusted advisor for Life Science clients ~20 years of deep expertise
in Technical Operations, enabling reliable supply and accessible treatments.

As a leader in Technical Operations, Iknam delivers End-to-end Digital
Transformations involving innovative solutions in manufacturing, quality,
product/process development and lifecycle management. In addition, her focus
includes large Operating and Business Model Transformations that ensure
fit-for-purpose organizations that are transformed to deliver on the execution
of growth-enabling strategies.

Areas of expertise include the following in pharmaceutical and medical device
companies: manufacturing and distribution strategies, operations due diligence, 
competitive intelligence, benchmarking,  process design and continuous
improvements, organizational transformations, quality systems and validation,
product lifecycle management and eQMS software implementation.



AISHWARYA MANTHA
PRODUCT MANAGEMENT LEAD AT DELOITTE CONSULTING LLP

Aish is a Technology Lead at Deloitte Consulting with over 12 years of
experience leading global, cross-functional  teams in design, development and
delivery of technology-powered solutions in Life Sciences, Healthcare, and Oil &
Gas industries. In […]
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AISHWARYA MANTHA

Product Management Lead at Deloitte Consulting LLP

Aish is a Technology Lead at Deloitte Consulting with over 12 years of
experience leading global, cross-functional  teams in design, development and
delivery of technology-powered solutions in Life Sciences, Healthcare, and Oil &
Gas industries. In her current role, Aish leads the development and
implementation of AI/ML-based solutions to provide proactive insights to
Biopharma and MedTech manufacturers to help optimize manufacturing processes and
product quality.

Aish has a strong track record of successfully leading and delivering impactful
AI/ML solutions on time and budget in both corporate and startup environments.
In addition to strong technical skills, Aish is adept at business strategy,
project execution and stakeholder management. Aish is proactive, anticipates
challenges, and strives to deliver the best solutions to enable organizations
gain/extend their competitive edge.



AMY LOVASCO
NEW PRODUCTS INTEGRATION LEAD, EXTERNAL SUPPLY AT PFIZER

As a highly accomplished pharmaceutical manufacturing professional with over 22
years of experience in the biopharma industry, Amy currently manages the
successful integration of new products into Pfizer’s external supply chain. As a
leader at one […]
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AMY LOVASCO

New Products Integration Lead, External Supply at Pfizer

As a highly accomplished pharmaceutical manufacturing professional with over 22
years of experience in the biopharma industry, Amy currently manages the
successful integration of new products into Pfizer’s external supply chain. As a
leader at one of the three sites in the United States responsible for
manufacturing the Pfizer-BioNTech COVID-19 vaccine, Amy led the operational
overhaul at the Andover, Massachusetts facility to rapidly scale up production
during the coronavirus pandemic. With a strong background in project management,
process engineering and optimization, and cross-functional collaboration, Amy
has consistently demonstrated her ability to drive results and deliver
exceptional value to her stakeholders. She holds a Bachelor’s in Engineering and
a Master’s in Biotechnology Engineering from Tufts University.



OMAR KASSIM
DIRECTOR OF CDMO RELATIONSHIP MANAGEMENT, PHARMSCI R&D AT TAKEDA PHARMACEUTICALS

Kassim is a highly accomplished pharmaceutical professional with extensive
global experience in pharmaceuticals, devices, biologics, and oncology. He
currently manages a global team of CDMO relationship managers at Takeda
Pharmaceuticals, collaborating with internal and external teams […]
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OMAR KASSIM

Director of CDMO Relationship Management, PharmSci R&D at Takeda Pharmaceuticals

Kassim is a highly accomplished pharmaceutical professional with extensive
global experience in pharmaceuticals, devices, biologics, and oncology. He
currently manages a global team of CDMO relationship managers at Takeda
Pharmaceuticals, collaborating with internal and external teams to execute
critical global programs. Omar also oversees supply chain needs, finance impact,
and combination device development strategies at Takeda to meet current and
future needs for Takeda’s development and commercial needs.

Previously, he held management roles across category management, external
network strategy, sales, finance, accounting, and global supply chain strategy
at Astra Zeneca and other life sciences companies bringing several therapies
from development to commercialization. Before migrating to the pharmaceutical
industry, Omar worked in corporate banking with BMO Harris Bank and RBC.

Omar has a bachelor’s in biochemistry and biotechnology from the University of
Waterloo, an MBA from Wilfrid Laurier University, and is a CPA and CMA from the
Chartered Professional Accountants of Canada.



RAVI SAMAVEDAM
CHIEF INNOVATION OFFICER AT AZZUR GROUP

Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience
in the pharmaceutical and biotechnology industries. Before he was appointed
Chief Innovation Officer at Azzur Group, he was President and Chief Operating
Officer […]
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RAVI SAMAVEDAM

Chief Innovation Officer at Azzur Group

Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience
in the pharmaceutical and biotechnology industries. Before he was appointed
Chief Innovation Officer at Azzur Group, he was President and Chief Operating
Officer of Azzur Cleanrooms on Demand™. In 2019, Ravi was the General Manager of
Azzur Boston and has been with the company since 2012. Prior to Azzur, Ravi has
been part of the technical operations and quality/validation departments at
Baxter, Amgen, and Shire. Ravi is an expert in phase-appropriate cGMP
implementation, process validation, supplier management, and technology
transfer.



CHRIS MANSUR
EVP OF CORPORATE DEVELOPMENT AT AZZUR GROUP

Chris Mansur serves as Azzur Group’s Executive Vice President of Corporate
Development and specializes in providing innovative quality and compliant
solutions to the life sciences industry. Throughout his career, Chris has
specialized in the startup of […]
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CHRIS MANSUR

EVP of Corporate Development at Azzur Group

Chris Mansur serves as Azzur Group’s Executive Vice President of Corporate
Development and specializes in providing innovative quality and compliant
solutions to the life sciences industry. Throughout his career, Chris has
specialized in the startup of new and renovated facilities, project management,
commissioning and qualification, computer validation, quality management
systems, and application of QRM principles. He is passionate about the use of
phase appropriate GMPs to help companies solve problems that accelerate their
product’s lifecycle or project timeline. Chris holds a Bachelor of Science
degree in Mechanical Engineering from Worcester Polytechnic Institute.



JOE GOODMAN
VP SOLUTIONS ENGINEERING & CUSTOMER ENGAGEMENT AT SPARTA SYSTEMS, A HONEYWELL
COMPANY

Joe Goodman is the Global Vice President of Solutions Engineering and Customer
Engagement at Honeywell/Sparta Systems where he leads the efforts to
strategically partner with their global clients and prospects to find the
quality system solution […]
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JOE GOODMAN

VP Solutions Engineering & Customer Engagement at Sparta Systems, A Honeywell
Company

Joe Goodman is the Global Vice President of Solutions Engineering and Customer
Engagement at Honeywell/Sparta Systems where he leads the efforts to
strategically partner with their global clients and prospects to find the
quality system solution that best fits their need.  Joe is recognized as a
thought leader in the fields of quality systems, regulatory compliance, and the
implementation of enterprise software across manufacturing.  Prior to joining
Sparta Systems Joe spent more than 7 years at Merrill Lynch as a Six Sigma Black
Belt.  He owes much of his penchant for process and solution design to his time
spent in that role.  Joe also speaks internationally at Compliance and
Manufacturing events.



ADAM PFEIFFER
VP AT PROJECT FARMA

Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role,
Adam drives overall business strategy, aligning with operations, marketing, and
business development groups in growing the firm’s global life sciences
partnerships. With […]
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ADAM PFEIFFER

VP at Project Farma

Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role,
Adam drives overall business strategy, aligning with operations, marketing, and
business development groups in growing the firm’s global life sciences
partnerships.

With 16+ years of life sciences consulting experience, Adam has supported
countless drug manufacturers in bringing life-saving therapies to the market,
with an emphasis on engineering and qualification in the advanced therapy and
large-molecule biologics space. He has a degree in Chemical Engineering from
Colorado State University.



CHARLIE HARPER
VP AT PROJECT FARMA

Charlie is a Vice President at Project Farma and the regional lead for the
Boston and East Coast Region.  He has over 25 years of experience encompassing
gene therapy, microbiome, vaccines, and sterile injectables including four […]
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CHARLIE HARPER

VP at Project Farma

Charlie is a Vice President at Project Farma and the regional lead for the
Boston and East Coast Region.  He has over 25 years of experience encompassing
gene therapy, microbiome, vaccines, and sterile injectables including four
facility startups and the completion of a consent decree workplan.  Charlie has
held positions of increasing management responsibility across technical
operations and CMC including roles in manufacturing, quality, supply chain and
program management.

Prior to Project Farma, Charlie was the VP, Manufacturing and Supply Chain at
Intergalactic Therapeutics, a company focused developing a best-in-class
non-viral gene therapy to overcome the limitations of viral-based gene therapy.
 Prior to Intergalactic, Charlie held progressive roles at Voyager Therapeutics,
Seres Therapeutics, Sanofi/Genzyme, GlobeImmune and Amgen.

Charlie holds an MBA from the University of Denver and a B.S. in Biology from
Baylor University.



KARA PRICE
VP, SITE LEAD AT PFIZER

Dr. Kara Renai Price is the Site Leader of PGS Rocky Mount, North Carolina
facility. Kara joined Pfizer in May 2021 as Rocky Mount’s Integrated
Manufacturing Operations Lead, with responsibility across Filling, Finishing,
R3, Engineering, and […]
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KARA PRICE

VP, Site Lead at Pfizer

Dr. Kara Renai Price is the Site Leader of PGS Rocky Mount, North Carolina
facility. Kara joined Pfizer in May 2021 as Rocky Mount’s Integrated
Manufacturing Operations Lead, with responsibility across Filling, Finishing,
R3, Engineering, and Transformation (including IMEx and Operational Excellence).
Prior to Pfizer, Kara served as site leader for Minaris Regenerative Medicine, a
contract manufacturer, where she was responsible for the research and
development, clinical and commercial manufacturing operations for cell and gene
therapy.

Kara has over 24 years of progressive experience in the pharmaceutical industry,
particularly in aseptic/sterile manufacturing for small and large molecules,
including senior leadership roles within Merck across manufacturing, quality,
engineering, technical services, and strategy, as well as demonstrated
transformational leadership in these organizations. Kara sits on the board of
Eastern University and the International Leadership Association (ILA). She holds
a Bachelors degree in Biology from Hampton University, a Masters degree in Cell
Biology & Biotechnology from University of the Sciences, and a Doctorate in
Organizational Leadership from Eastern University.



DAVID EGE
CHIEF TECHNOLOGY OFFICER, EVP PROCESS DEVELOPMENT, QUALITY & SUPPLY AT SERES
THERAPEUTICS

David Ege is the Executive Vice President and Chief Technology Officer of Seres.
He has 20 years of experience in the pharmaceutical industry, with a focus on
vaccine and biologics manufacturing, facility development and process
optimization. […]
Read more


DAVID EGE

Chief Technology Officer, EVP Process Development, Quality & Supply at Seres
Therapeutics

David Ege is the Executive Vice President and Chief Technology Officer of Seres.
He has 20 years of experience in the pharmaceutical industry, with a focus on
vaccine and biologics manufacturing, facility development and process
optimization. Prior to joining Seres, Dr. Ege had been at Merck since 2003, in a
variety of technical and leadership roles in R&D and manufacturing, in the U.S.
and Switzerland. His most recent role was global lead for digital strategy in
Merck’s Manufacturing Division. From 2015-2019, Dr. Ege served as Executive
Director of Vaccines & Biologics Manufacturing at Merck’s plant in Elkton, VA
where he led bulk manufacturing operations for the Gardasil® and Gardasil9®
cervical cancer vaccines, as well as adjuvants and Cancidas® – a broad-based
anti-fungal medicine made by fermentation. He has contributed to the successful
first-in-class licensure and launch of cervical cancer vaccines, Gardasil®
(2006) and Gardasil9® (2014), and a breakthrough cancer immunotherapy, Keytruda®
(2014). He graduated summa cum laude from Princeton with a BSE in chemical
engineering and earned his Ph.D. in chemical engineering from the University of
Pennsylvania.



AMY DOUCETTE
HEAD OF BUSINESS OPERATIONS AT APG PHARMA

Amy leads the Pharma Automation Product Group Business Operations team (Business
Development, Sales, Pre-Sales, Marketing, Operations and Client Success) that’s
providing SmartFactory Rx® automation solutions.  SmartFactory Rx® is developed
for process manufacturing to harness the power […]
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AMY DOUCETTE

Head of Business Operations at APG Pharma

Amy leads the Pharma Automation Product Group Business Operations team (Business
Development, Sales, Pre-Sales, Marketing, Operations and Client Success) that’s
providing SmartFactory Rx® automation solutions.  SmartFactory Rx® is developed
for process manufacturing to harness the power of data, reduce development time,
and improve productivity to optimize high value manufacturing, while increasing
throughput, decreasing risk, and accelerating time to market for new products. 
Amy earned a Master’s Degree in Biotechnology Engineering from Northeastern
University.



RICK JOHNSTON PHD
HEAD OF MANUFACTURING DATA SCIENCE AT APG PHARMA

Rick is a senior technical leader within Applied Materials’ pharmaceutical
business unit. He has more than 15 years of experience in building software that
solves big data, machine learning, scheduling, forecasting and advanced
analytics problems in […]
Read more


RICK JOHNSTON PHD

Head of Manufacturing Data Science at APG Pharma

Rick is a senior technical leader within Applied Materials’ pharmaceutical
business unit. He has more than 15 years of experience in building software that
solves big data, machine learning, scheduling, forecasting and advanced
analytics problems in pharma. Software built by Dr Johnston is used by more than
90% of the world’s largest pharmaceutical companies. He has a Ph.D. in
operations research and bioinformatics from UC Berkeley.



CRAIG KENNEDY
SVP GLOBAL SUPPLY CHAIN AT MODERNA

Read more


CRAIG KENNEDY

SVP Global Supply Chain at Moderna


BRAD WYNJA
VP OF BUSINESS DEVELOPMENT AT INCOG BIOPHARMA SERVICES

Read more


BRAD WYNJA

VP of Business Development at INCOG BioPharma Services


BRENDAN WALKER
SR. DIRECTOR, DIGITAL SITE LEAD AT MODERNA

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BRENDAN WALKER

Sr. Director, Digital Site Lead at Moderna


2022 SPEAKERS

CARLO DE NOTARISTEFANI
LEAD, MANUFACTURING & SUPPLY CHAIN ADVISOR AT OPERATION WARP SPEED

An international operations executive with global technical, operational, and
P&L experience, Carlo has deep expertise in designing and operating global
supply chains in complex regulatory environments, leading accretive M&A activity
and devising and executing value-creating strategies […]
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CARLO DE NOTARISTEFANI

Lead, Manufacturing & Supply Chain Advisor at Operation Warp Speed

An international operations executive with global technical, operational, and
P&L experience, Carlo has deep expertise in designing and operating global
supply chains in complex regulatory environments, leading accretive M&A activity
and devising and executing value-creating strategies in global markets.

Since May 2020, Carlo has been the lead advisor for Manufacturing and Supply
Chain to Operation Warp Speed/Federal Covid Response, the US government
initiative to support the acceleration of development and supply of Covid-19
vaccines and therapeutics. He has collaborated with the sponsors, suppliers and
CDMOs to ensure the fast scale-up of manufacturing and distribution for the
entire US.

In Carlo’s most recent corporate position, he was Executive Vice President of
Operations at Teva Pharmaceuticals Inc.  In this role he was responsible for all
Manufacturing, Technology and Capital Investments, Supply Chain, Quality and
Compliance and Procurement operations, as well as the global API and CMO
business. Carlo retired from this position in October 2019

Before joining Teva Pharmaceuticals in 2012, Carlo was the President, Technical
Operations and Global Support Functions for Bristol Myers Squibb from 2004 to
2011. At BMS he significantly contributed to their successful transformation to
a focused biopharma company.

Carlo received his Doctorate in Chemical Engineering and graduated Summa Cum
Laude from the University of Naples in Naples, Italy.



MICHAEL KOPCHA
DIRECTOR, OFFICE OF PHARMACEUTICAL QUALITY, CDER AT FDA

Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ),
is a leader in the development of innovative solutions to resolve scientific,
manufacturing, and commercialization issues worldwide – and in standardizing and
harmonizing global processes. With more than […]
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MICHAEL KOPCHA

Director, Office of Pharmaceutical Quality, CDER at FDA

Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ),
is a leader in the development of innovative solutions to resolve scientific,
manufacturing, and commercialization issues worldwide – and in standardizing and
harmonizing global processes. With more than 25 years of pharmaceutical industry
experience, his areas of expertise include formulation and process development,
process validation, technology transfer, off-shoring/outsourcing, and change
management. Dr. Kopcha recently served as vice president, and global research
and development franchise head, for cough, cold, and respiratory products at
Novartis Consumer Health, Inc. in New Jersey. He joined Novartis in 2008 as the
global head for pharmaceutical and analytical development, later serving as
global head for new technologies and product innovation, and vice president and
global head for global product development. At Novartis, Dr. Kopcha led the
creation of a global R&D vision and strategies to drive innovation for the
cough, cold, and respiratory franchise – through development, sourcing,
manufacturing, and supply. He restructured and reorganized global product
development to provide for a category-focused, globalized organization, and is
credited for the creation of a successful strategic off-shoring/outsourcing
program to increase project capacity and efficiency. Before joining
Novartis, Dr. Kopcha served as vice president for pharmaceutical development at
KV Pharmaceutical, Inc. in St. Louis, where he directed and managed analytical
research and development, product development, process development and
technology transfer, stability, drug delivery, project management, and external
alliance. His experience also includes related roles with Schering-Plough, J&J,
and Ivax. Dr. Kopcha earned his doctorate and master’s degrees in pharmaceutical
science, and a bachelor’s degree in pharmacy, from Rutgers University in New
Brunswick, New Jersey. He served as an adjunct assistant professor in the
Department of Pharmaceutics, Ernest Mario School of Pharmacy at Rutgers.



JOANNE T. BECK
CHIEF OPERATING OFFICER AT BOSTON PHARMACEUTICALS

Joanne Beck joined Boston Pharmaceuticals in 2019 from Celgene, where she was
Executive Vice President of Global Pharmaceutical Development and Operations,
and oversaw Product Development, Global Manufacturing Operations, Supply Chain,
Engineering and Quality. Prior to Celgene, […]
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JOANNE T. BECK

Chief Operating Officer at Boston Pharmaceuticals

Joanne Beck joined Boston Pharmaceuticals in 2019 from Celgene, where she was
Executive Vice President of Global Pharmaceutical Development and Operations,
and oversaw Product Development, Global Manufacturing Operations, Supply Chain,
Engineering and Quality. Prior to Celgene, she was SVP of Pharmaceutical
Development at Shire. Prior to Shire she held roles of increasing responsibility
in Process Development at Genentech and Amgen and in Operations at Abbott’s
Pharmaceutical and Vascular Divisions. Beck holds a BA in Chemistry from Lewis
and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University
of Oregon Medical School, and completed a postdoctoral fellowship in the
department of Pharmaceutical Chemistry at the University of California, San
Francisco. Dr. Beck serves on the board of directors for Orchard Therapeutics
and Catabasis Pharmaceuticals.



WOLFRAM CARIUS
EVP PHARMACEUTICALS AT BAYER AG

Prof. Wolfram Carius is the EVP Pharmaceuticals at Bayer AG and is a member of
the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin,
Germany. Prior to joining Bayer, Wolfram was a corporate senior […]
Read more


WOLFRAM CARIUS

EVP Pharmaceuticals at Bayer AG

Prof. Wolfram Carius is the EVP Pharmaceuticals at Bayer AG and is a member of
the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin,
Germany. Prior to joining Bayer, Wolfram was a corporate senior vice president
and member of the global leadership team at Sanofi Genzyme for nearly three
years. Before that, he worked for Boehringer Ingelheim from 1987 to the end of
2013, eventually becoming responsible for that company’s worldwide chemical,
pharmaceutical, and biopharma production network. In his over 30 years in the
pharmaceutical industry he has worked in Asia, South America and Europe. In
2009, the Biberach University of Applied Sciences awarded him the title of
honorary professor in recognition for his long and exceptional service. He also
holds a PhD in pharmaceutical biology and analytical phytochemistry from the
University of Saarland, Germany.



ARLEEN PAULINO
SVP GLOBAL MANUFACTURING AT AMGEN

Arleen Paulino, Senior Vice President, Manufacturing, leads Amgen’s commercial
manufacturing organization. Prior to this role, Paulino served as vice
president, Site Operations at Amgen Singapore Manufacturing from 2016 to 2018,
where she led the team to […]
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ARLEEN PAULINO

SVP Global Manufacturing at Amgen

Arleen Paulino, Senior Vice President, Manufacturing, leads Amgen’s commercial
manufacturing organization. Prior to this role, Paulino served as vice
president, Site Operations at Amgen Singapore Manufacturing from 2016 to 2018,
where she led the team to the successful licensure of Amgen’s first
Next-Generation Biomanufacturing plant.

Paulino joined Amgen in 2002 and over the years has held various positions with
increasing responsibility in Process Engineering and Process Development. She
was also the head of Clinical Operations and Development Supply Chain, where she
was responsible for the end-to-end supply chain for the manufacture and delivery
of clinical product to support Amgen’s global clinical trials.

She began her career in Operations at Genentech and later joined Immunex, where
she held a variety of roles overseeing development and scale-up operations,
contract manufacturing and technology transfer, as well as plant manager for the
cell culture facility.

Paulino holds a Bachelor of Science degree in Biochemistry from Marquette
University.



LINZELL HARRIS
SVP GLOBAL SUPPLY CHAIN AND STRATEGY AT ASTRAZENECA

Linzell Harris is senior vice president of Global Supply Chain and Strategy for
AstraZeneca, with overall responsibility for the development and execution of
the end to end supply chain platform and product supply strategies. In addition,
[…]
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LINZELL HARRIS

SVP Global Supply Chain and Strategy at AstraZeneca

Linzell Harris is senior vice president of Global Supply Chain and Strategy for
AstraZeneca, with overall responsibility for the development and execution of
the end to end supply chain platform and product supply strategies. In addition,
he is responsible for ensuring the strategic development of network designs and
supply chain capabilities supporting the global AZ operational network.

Reporting into the EVP of Operations and Information Technology, Linzell is a
member of the Global Operations Senior Leadership Team.

Linzell has more than 30 years of diverse general management and global
operations experience in the consumer product goods, pharmaceutical and luxury
goods industries.

Prior to joining AstraZeneca, Linzell held the role of Senior Vice President,
Global Supply Chain for TEVA Pharmaceuticals – supporting the company’s
comprehensive global supply network for generic and specialty pharmaceuticals. 
Before TEVA, he served as Head of Global Operations for Godiva Chocolatier and
as a member of Godiva’s Executive Leadership team reporting to the CEO and
President.

Additionally, Linzell has worked in Senior Management roles at Johnson and
Johnson, Pfizer, Warner Lambert and Baxter Healthcare. He began his working
career as a Supply Corp officer in the US Navy.

Linzell earned a BS in Mathematics from the US Naval Academy in Annapolis, MD
with graduate studies at Villanova University. He has completed executive
studies at Michigan State, Columbia and Harvard Universities.



BRENDAN O’CALLAGHAN
EVP, GLOBAL INDUSTRIAL AFFAIRS AT SANOFI

Brendan O’Callaghan leads an international network of manufacturing and
distribution sites. His ambition is to enable successful commercialization of
Sanofi’s diverse pipeline, to build world-class standards of manufacturing and
supply chain excellence and to future proof […]
Read more


BRENDAN O’CALLAGHAN

EVP, Global Industrial Affairs at Sanofi

Brendan O’Callaghan leads an international network of manufacturing and
distribution sites. His ambition is to enable successful commercialization of
Sanofi’s diverse pipeline, to build world-class standards of manufacturing and
supply chain excellence and to future proof Sanofi’s manufacturing network,
leveraging the latest digital, process and technology solutions, to ensure the
continued reliable supply of essential, high-quality medicines to patients
worldwide.

Brendan joined Sanofi in 2015 and was previously our Global Head of Biologics
and Industrial Affairs head of the Specialty Care portfolio. He has played a key
role in supporting our transformation to a fully integrated BioPharma company
and advancing the digital transformation of our manufacturing network, notably
the Framingham site in the US, which was awarded the prestigious International
Society for Pharmaceutical Engineering Factory of the Future and Facility of the
Year Awards in 2020.

Prior to Sanofi, Brendan worked at Schering-Plough before moving to Merck / MSD
as Head of Biologics and later Vice President of its Europe, Middle East and
Africa Operations.

Brendan graduated in chemical engineering from the University College of Dublin,
where he currently serves as an honorary adjunct Professor of Chemical and
Biochemical Engineering.



GER CARMODY
SVP, GLOBAL PHARMACEUTICAL OPERATIONS AT MERCK

Ger Carmody is responsible for global pharmaceutical and packaging operations
comprising approximately 4000 colleagues and internal 9 manufacturing sites. 
His organization supplies drug substance and drug product for Merck’s small
molecule portfolio, leads the late stage […]
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GER CARMODY

SVP, Global Pharmaceutical Operations at Merck

Ger Carmody is responsible for global pharmaceutical and packaging operations
comprising approximately 4000 colleagues and internal 9 manufacturing sites. 
His organization supplies drug substance and drug product for Merck’s small
molecule portfolio, leads the late stage development and commercialization of
the small molecule pipeline as well as packages the entire human health
portfolio. Ger has worked with Merck for almost 30 years, working in Europe,
Asia and the US primarily in operations, technical and operational excellence
roles. As well as ensuring safe, compliant supply of high quality products,
current focus areas include increasing productivity through operational
excellence and digital, positioning for an evolving pipeline and environmental
sustainability. Ger is from Ireland, is currently based in Pennsylvania and
graduated as a chemical engineer from University College Dublin.



DEREK ADAMS
CHIEF OPERATING OFFICER AT PLATELETBIO

Derek Adams is PlateletBio’s Chief Operating Officer. Derek has spent the past
four years as Chief Technology and Manufacturing Officer at bluebird bio, a
leading lentiviral gene therapy company, overseeing pharmaceutical sciences and
quality functions: process […]
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DEREK ADAMS

Chief Operating Officer at PlateletBio

Derek Adams is PlateletBio’s Chief Operating Officer. Derek has spent the past
four years as Chief Technology and Manufacturing Officer at bluebird bio, a
leading lentiviral gene therapy company, overseeing pharmaceutical sciences and
quality functions: process and analytical development, vector manufacturing,
patient operations, global supply chain, quality assurance and quality control.
Prior to that, Derek was Senior Vice President of Chemistry, Manufacturing and
Controls at Evelo Biosciences, establishing the process development function and
supply chain for clinical studies. For over a decade prior to Evelo, he held
senior leadership roles of increasing responsibility in process development and
manufacturing at Alexion Pharmaceuticals, where he led process development,
analytical sciences, global technical services and clinical supply within global
operations and helped to more than double the size of the clinical manufacturing
network. Derek started his manufacturing career with Merck & Co, Inc. as a
Process Engineer for vaccine production technologies. He earned a Ph.D. in
Chemical Engineering from the University of Minnesota and a B.S. in Chemical
Engineering with High Distinction from Worcester Polytechnic Institute (WPI).



BRENDAN HUGHES
SVP GLOBAL MANUFACTURING OPERATIONS AT BRISTOL-MYERS SQUIBB

Brendan is responsible for all of BMS Pharma and Biologics manufacturing from
internal and external sources. He is based in Devens MA. Brendan joined BMS as
Head of CMC Strategy for Biologics in 2012. From 2015-2020 […]
Read more


BRENDAN HUGHES

SVP Global Manufacturing Operations at Bristol-Myers Squibb

Brendan is responsible for all of BMS Pharma and Biologics manufacturing from
internal and external sources. He is based in Devens MA.

Brendan joined BMS as Head of CMC Strategy for Biologics in 2012. From 2015-2020
Brendan led MS&T for the company with responsibility for all technologies used
in manufacturing including biologics, pharma products, parenterals and devices.

Before joining BMS, he led MS&T and Technical Services teams in Wyeth and
Pfizer.

Brendan has worked in the US, Ireland and the UK. He started his career in the
UK working for Wellcome which then became Glaxo-Wellcome and then GSK; roles
included leadership positions in Quality, analytical sciences as well as project
leadership. Brendan came to US in 2001 joining the Biotech Development team in
Wyeth. He later joined the leadership team for the Wyeth Grange Castle biotech
start-up in Ireland from 2003-2010 and returned to US in 2010 to work in Pfizer
Global Manufacturing.

Brendan received his B.Sc and Ph.D in Biochemistry in Ireland and carried out
post-doctoral studies in Oxford UK. He was a member of the ICH Expert Working
Group which drafted the initial Quality Guidelines for biotech products in the
1990s and later for ICH Q11.



JOHN KELLY
VP, QUALITY OPERATIONS AND ENVIRONMENT, HEALTH & SAFETY, PFIZER GLOBAL SUPPLY AT
PFIZER INC.

John F. Kelly is Vice President, Quality Operations and Environment, Health &
Safety, responsible for leading the overall Quality function for Pfizer and for
leading global EHS across the Company.  John is a member of the […]
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JOHN KELLY

VP, Quality Operations and Environment, Health & Safety, Pfizer Global Supply at
Pfizer Inc.

John F. Kelly is Vice President, Quality Operations and Environment, Health &
Safety, responsible for leading the overall Quality function for Pfizer and for
leading global EHS across the Company.  John is a member of the PGS Leadership
Team.  John is a member of the Pfizer PAC Board of Directors and past member of
the Pfizer PAC Steering Committee and is Chairman of the Board of Directors of
Zydus Hospira Oncology Private Limited, a joint venture between Pfizer and Zydus
Cadila.  He is also a member of the Board of Directors of The Patterson Club,
Fairfield, CT, a member of the Board of Trustees of Wakeman Boys & Girls Club, a
member of the Worcester Polytechnic Institute Engineering Dean’s Advisory Board,
and past co-President of the Fairfield College Preparatory School Fathers’ Club.

John joined Pfizer in 1982 as Plant Services Engineer at the Brooklyn, New York
site.  Prior to his current position, he held assignments in New York,
(Technical Services, Plant Network Strategy, Strategy, Transitioning Sites),
Brooklyn, New York (Engineering, Manufacturing), Barceloneta, Puerto Rico
(Manufacturing, Quality Operations) and Vega Baja, Puerto Rico (Site Leader). 
He assumed his current position in 2017.

John holds a B.S. in Chemical Engineering from Worcester Polytechnic Institute
and an M.B.A. in Operations Management from Pace University.

He and his wife, Beth, have three sons: Christopher, Thomas and Andrew.



CHARLES L. COONEY
ROBERT T. HASLAM PROFESSOR OF CHEMICAL ENGINEERING, EMERITUS, AND FACULTY
DIRECTOR, EMERITUS DESHPANDE CENTER FOR TECHNOLOGICAL INNOVATION AT MIT

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and
Biochemical Engineering, Emeritus in the Department of Chemical Engineering at
MIT and founding Faculty Director, Emeritus of the Deshpande Center for
Technological Innovation. […]
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CHARLES L. COONEY

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty
Director, Emeritus Deshpande Center for Technological Innovation at MIT

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and
Biochemical Engineering, Emeritus in the Department of Chemical Engineering at
MIT and founding Faculty Director, Emeritus of the Deshpande Center for
Technological Innovation. He has been involved as founder, advisor or board
member of over 25 companies and currently sits on the Boards of Directors of
Codiak Bioscience, Innovent Biologics (1801.HK), Elektofi, Hovione, LayerBio,
Boyd Technologies, Levitronix Technologies, and is chairman of GreenLight
Bioscience. In addition, he is Trustee Emeritus of Boston Ballet, Advisor
Emeritus of the Boston Symphony Orchestra and Trustee and Treasurer of the
Leventhal Map and Education Center. Other interests include: high altitude
mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro,
Huascaran). and antique map collecting.



AINE HANLY
CHIEF TECHNOLOGY OFFICER AT VIR BIOTECHNOLOGY

Aine Hanly, Ph.D., serves as Chief Technology Officer at Vir Biotechnology,
where she is responsible for overseeing the Company’s technical operations. Her
purview includes product and process development, supply chain, manufacturing,
quality and CMC strategy. Her […]
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AINE HANLY

Chief Technology Officer at Vir Biotechnology

Aine Hanly, Ph.D., serves as Chief Technology Officer at Vir Biotechnology,
where she is responsible for overseeing the Company’s technical operations. Her
purview includes product and process development, supply chain, manufacturing,
quality and CMC strategy. Her career in the biomanufacturing industry, which has
spanned roles in the UK, Ireland and the US, has been dedicated to advancing
innovative solutions to accelerate the delivery of medicines to patients.

Prior to joining Vir, Dr. Hanly served as the Vice President of Process
Development for Amgen, accountable for clinical manufacturing and global supply
of clinical trial materials. During her nearly decade-long tenure, she led teams
enabling the commercialization of Amgen’s pipeline products as well as providing
technical support for ongoing commercial manufacturing operations. Additionally,
as site head at Amgen’s Cambridge facility, Dr. Hanly led the site’s
transformation and staff growth, and together with the research and development
team, greatly increased Amgen’s partnerships and presence within the local
Cambridge ecosystem. She also worked for more than 10 years at Pfizer (formerly,
Wyeth), where she held roles of increasing responsibility in analytical R&D,
process development, quality and product supply strategy.

Dr. Hanly received her bachelor’s degree in biological chemistry and a Ph.D. in
physical organic chemistry, from the University of Ulster, Northern Ireland. She
completed her post-doctoral fellowship at Creighton University School of
Medicine before joining the collaborative research wing at Yale University and
CuraGen Corporation as lead scientist studying gene isolation and subsequent
confirmation using a variety of molecular biology techniques.



GREG TROIANO
CHIEF MANUFACTURING OFFICER AT TRANSLATE BIO, A SANOFI COMPANY

Greg serves as Chief Manufacturing Officer at Translate Bio, a Sanofi Company,
where he is responsible for cGMP Strategic Supply and Operations at Sanofi’s
mRNA Center of Excellence.  Over his 20+ year career in the drug […]
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GREG TROIANO

Chief Manufacturing Officer at Translate Bio, A Sanofi Company

Greg serves as Chief Manufacturing Officer at Translate Bio, a Sanofi Company,
where he is responsible for cGMP Strategic Supply and Operations at Sanofi’s
mRNA Center of Excellence.  Over his 20+ year career in the drug delivery field,
Greg had various roles leading the pharmaceutical development of complex
formulations, including numerous nano- and microparticle based systems.  This
includes leading groups for Formulation Development, Process Development,
Analytical Development, Supply Chain Management, Manufacturing and Facilities at
companies including Pfizer, Seer, BIND Therapeutics, Alkermes, and Guilford
Pharmaceuticals.  He’s brought myriad novel products into the clinic and helped
commercialize five.  Greg received his MSE and BS in Biomedical Engineering from
The Johns Hopkins University and was elected and inducted into the American
Institute for Medical and Biological Engineering (AIMBE) College of Fellows in
2020 for recognition of his accomplishments in drug delivery.



ELAINE SHANNON
HEAD OF ONCOLOGY EXTERNAL SUPPLY SMALL MOLECULE GLOBAL QUALITY AT TAKEDA

Elaine currently holds the role of Global Head of Quality Oncology and External
Supple Small Molecules. Prior to this she was the Global Head of Quality Audits
and Supplier Management. Elaine joined Takeda Pharmaceuticals Global Quality […]
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ELAINE SHANNON

Head of Oncology External Supply Small Molecule Global Quality at Takeda

Elaine currently holds the role of Global Head of Quality Oncology and External
Supple Small Molecules. Prior to this she was the Global Head of Quality Audits
and Supplier Management. Elaine joined Takeda Pharmaceuticals Global Quality
Compliance and Systems group in June 2016 to develop the companies Knowledge
Management processes.

Prior to this, Elaine worked with Teva Pharmaceuticals, responsible for Quality
Compliance with European and Israeli operations.

Elaine has 25 years of experience in the Pharmaceutical Industry. She holds an
MSc in Pharmaceutical Manufacturing Technology.  Elaine has held positions in
Quality Assurance, Compliance, Quality Control and Research and Development.

In her spare time, Elaine enjoys spending time with her husband, 2 kids and 2
dogs especially outdoors. She likes to shop and relaxes with a good book and a
nice glass of wine.



CEDRIC DUBOIS
HEAD OF BIOLOGICS EXTERNAL MANUFACTURING AT SANOFI

Mr. Dubois has 20 years of experience in the biopharmaceutical industry. He
holds a MSc in Industrial Engineering from a French “grande ecole” (ENSAM), a
MSc in Pharmaceutical Engineering from The University of Manchester (UK) and […]
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CEDRIC DUBOIS

Head of Biologics External Manufacturing at Sanofi

Mr. Dubois has 20 years of experience in the biopharmaceutical industry. He
holds a MSc in Industrial Engineering from a French “grande ecole” (ENSAM), a
MSc in Pharmaceutical Engineering from The University of Manchester (UK) and an
MBA from Hong Kong University of Sciences and Technology.

During his career, Mr Dubois has worked in the United States, in China and
Algeria, leading strategic investments and building manufacturing facilities in
these countries during the 1st part of his career, and has now been leading
manufacturing operations for close to 10 years.

Through his professional career, Mr. Dubois has designed, built and managed
vaccines and traditional pharmaceuticals plants. Over the last 3 years, he has
been providing oversight to external partners producing biologics products for
Sanofi.



DANIEL COUTO
CHIEF OPERATING OFFICER AT VEDANTA BIOSCIENCES

Daniel Couto is the Chief Operating Officer of Vedanta Biosciences, a leading
Microbiome company. Mr. Couto is an Operations Management Executive with almost
30 years of experience starting and advancing Biopharmaceutical Development and
Manufacturing organizations to […]
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DANIEL COUTO

Chief Operating Officer at Vedanta Biosciences

Daniel Couto is the Chief Operating Officer of Vedanta Biosciences, a leading
Microbiome company. Mr. Couto is an Operations Management Executive with almost
30 years of experience starting and advancing Biopharmaceutical Development and
Manufacturing organizations to higher levels of capability, growth and
productivity. Mr. Couto has a comprehensive knowledge and hands-on experience
leading organizations through improvement initiatives and developing new
therapeutic modalities. Mr. Couto is the former SVP of Manufacturing and
Operations of ContraFect Corporation, a public company developing new Lysin
enzymes for MRSA infections. His previous employment was with Merck Sharp Dohme
Biologics UK Ltd. (former Avecia Biologics) where he served as Vice President of
Commercial Manufacturing Operations responsible for all late stage and
commercial product. Prior to this he was responsible for 7 World Wide Contract
Manufacturing sites including API/BDS and Final Fill Finish as he served as
Director of Manufacturing for Nuvelo Inc. (San Francisco Bay area). He has been
instrumental in 2 BLA submissions for drug approvals, 2 major Pre-Approval
Inspection (PAI), and several IND submissions. Mr. Couto holds patents for
several novel separation technologies such as Bulk Protein Crystallization,
HPTFF, SMB, and Bacterial formulation and Lyophilization. Prior to this he
served in a number of Sr. Management positions for companies including Genzyme
Transgenics Corp. (GTC Biotherapeutics), Advanced Biosystems Corp., ImmuCell
Corp., and Sepracor Corp. Mr. Couto received his B.S. Degree in Chemical
Engineering with a minor in Economics from Rensselaer Polytechnic Institute.



KERRY HAWITT
SVP HEAD OF QUALITY & COMPLIANCE AT BOSTON PHARMACEUTICALS

Dr Kerry Hawitt is the SVP Quality & Compliance at Boston Pharmaceuticals, a
company that focuses on the transformation of innovative molecules into
differentiated medicines. Kerry leads all aspects of Quality strategy and
execution to applicable […]
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KERRY HAWITT

SVP Head of Quality & Compliance at Boston Pharmaceuticals

Dr Kerry Hawitt is the SVP Quality & Compliance at Boston Pharmaceuticals, a
company that focuses on the transformation of innovative molecules into
differentiated medicines. Kerry leads all aspects of Quality strategy and
execution to applicable global regulations, and is responsible for Compliance
and Risk across the BP enterprise. Over the last 10 years, Kerry has served as
SVP Alexion West Site head and Global Transformation lead, SVP Quality &
Compliance at Portola Pharmaceuticals, and has held several roles at Shire
Pharmaceuticals including Head of Business Operations and VP Global Quality
Systems and Product Quality. Kerry holds two degrees from University of
Manchester, UK, a PhD in Pharmaceutical Microbiology and BSc. Hons., in
Microbiology. Kerry is also a fellow of the International Women Forum Leadership
Program.



KATHLEEN MUNSTER
SVP, ENABLING FUNCTIONS (QUALITY, FACILITIES, & IT) AT 2SEVENTY BIO

Kathleen Munster is SVP, Enabling Functions (Quality, Facilities, and IT) at
2seventy bio.  2seventy bio is a cell and gene therapy company focused on the
research, development, and commercialization of transformative treatments for
cancer.  Kathleen joined […]
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KATHLEEN MUNSTER

SVP, Enabling Functions (Quality, Facilities, & IT) at 2seventy bio

Kathleen Munster is SVP, Enabling Functions (Quality, Facilities, and IT) at
2seventy bio.  2seventy bio is a cell and gene therapy company focused on the
research, development, and commercialization of transformative treatments for
cancer.  Kathleen joined bluebird bio in October 2020 and transitioned to
oncology spin-off 2seventy bio in November 2021.  She has over 20 years of
experience in clinical and commercial manufacturing in site-based and global
roles spanning multiple product types and biopharma companies.  She has
expertise in Health Authority inspection management and has supported numerous
product approvals/launches.  Prior to bluebird/2seventy, Kathleen was
responsible for a global network of sites as VP, Biologics, Cell & Gene Therapy
Quality at Catalent Pharma Solutions. Before this, she led Quality at the
Devens, MA site for Bristol-Myers Squibb after holding a number of leadership
roles in Quality, IT, and Supply Chain during her tenure at BMS.  Kathleen
started her career at Merck & Co., Inc. and holds degrees in Chemistry and
German from Lafayette College and an MBA from Rutgers University.



KEN KENT
SVP, CHEMICAL DEVELOPMENT AND MANUFACTURING OPERATIONS AT GILEAD

Ken is the Senior Vice President of Chemical Development and Manufacturing
Operations. He is responsible for Gilead’s entire drug substance supply and
oversees process R&D functions in Foster City and Edmonton, as well as internal
and […]
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KEN KENT

SVP, Chemical Development and Manufacturing Operations at Gilead

Ken is the Senior Vice President of Chemical Development and Manufacturing
Operations. He is responsible for Gilead’s entire drug substance supply and
oversees process R&D functions in Foster City and Edmonton, as well as internal
and outsourced manufacturing.

He played a critical role leading CDMO in sourcing ingredients and scaling up
production of remdesivir drug substance, to speed up and increase production.
Ken has contributed to the development and commercialization of more than 25
approved products while growing his career from developing new synthetic routes
as a process chemist to increasing leadership responsibilities in
cross-functional roles. He has built and led teams with a reputation for
innovation, quality and safety while also fostering inclusion and career
development. He joined Gilead in 1988, he is a member of the American Chemical
Society and has published over 10 papers and patents on the research he has
conducted at Gilead.



KIM BURSON
HEAD OF QUALITY ASSURANCE AND QUALITY CONTROL AT DENALI THERAPEUTICS

Kim K. Burson, Ph.D. is the Head of Quality Assurance and Quality Control at
Denali Therapeutics located in South San Francisco, CA.  Kim received her Ph.D.
in Chemistry at Stanford University.  She has over 25 years […]
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KIM BURSON

Head of Quality Assurance and Quality Control at Denali Therapeutics

Kim K. Burson, Ph.D. is the Head of Quality Assurance and Quality Control at
Denali Therapeutics located in South San Francisco, CA.  Kim received her Ph.D.
in Chemistry at Stanford University.  She has over 25 years of experience in the
pharmaceutical, biotechnology and medical device industries with in-house and
virtual manufacturing and testing.  Kim’s global background includes both
clinical and commercial products and tenure at Genentech, Roche in Switzerland,
Millennium Pharmaceuticals and two medical device companies.  Kim’s areas of
expertise include Quality Control and Quality Assurance, global inspection
management (FDA, EMA, ISO and ROW), internal and external auditing and
development and implementation of global Pharmaceutical Quality Systems.



DANNIELLE APPELHANS
CHIEF OPERATING OFFICER AT RUBIUS THERAPEUTICS

Dannielle Appelhans is the Chief Operating Officer at Rubius Therapeutics,
joining in August 2021. She brings experience in gene therapy, strategy,
manufacturing, supply chain and operations. As COO, she oversees corporate
strategy, technical development, and operations […]
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DANNIELLE APPELHANS

Chief Operating Officer at Rubius Therapeutics

Dannielle Appelhans is the Chief Operating Officer at Rubius Therapeutics,
joining in August 2021. She brings experience in gene therapy, strategy,
manufacturing, supply chain and operations. As COO, she oversees corporate
strategy, technical development, and operations for Rubius.

Dannielle joined from Novartis Gene Therapies, where she served as Senior Vice
President of Technical Operations and Chief Technical Officer, and oversaw
late-stage development, clinical and commercial manufacturing, supply chain and
all supporting operational functions for the gene therapy unit and AAV
portfolio. Before that role, she served as Senior Vice President, Global Head of
Supply Chain Management for Novartis and was responsible for end-to-end supply
chain of all Novartis divisions worldwide, across 60-plus plants in more than
120 countries to ensure $50 billion in sales. Since 2014, Dannielle held
positions of increasing responsibility in global supply chain, strategy and
operational excellence across several divisions within Novartis. Before joining
Novartis, Dannielle was a senior engagement manager at McKinsey & Company,
working in the pharmaceutical operations practice. Earlier in her career she
held roles of increasing responsibility at Eli Lilly and Company.

Dannielle has an MBA from MIT Sloan School of Management, a Master of Science
from Massachusetts Institute of Technology and a Bachelor of Science from the
University of Michigan in mechanical engineering.



LAURENT BOER
VP & GENERAL MANAGER, ALLSTON SITE AT RESILIENCE

Laurent Boer is vice-president and general manager of the Allston Landing and
interim Chief Manufacturing Officer for Resilience. He has been on the site
since 2017 and led the divestment of the site from Sanofi-Genzyme to […]
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LAURENT BOER

VP & General Manager, Allston Site at Resilience

Laurent Boer is vice-president and general manager of the Allston Landing and
interim Chief Manufacturing Officer for Resilience. He has been on the site
since 2017 and led the divestment of the site from Sanofi-Genzyme to Resilience.
Prior to the role in Allston, he led the Northborough Operations Center of
Sanofi from a brown field site to a world class center for Raw Materials
Management as well as Label & Packaging hub for rare diseases with global
distribution responsibilities. Before his arrival in Genzyme in 2011, Laurent
was VP Global Supply Chain for UCB in Brussels, Belgium. From 2002 to 2007 he
had roles in the global Supply Chain of Biogen (-Idec). And surprise, surprise-
Laurent worked 10 years at United Parcel Service in sortation automation and
industrial engineering (still having brown blood). He started his career in The
Netherlands as Operations Research Consultant in Quantitative Modeling.

His Alma Mater is the Erasmus University in Rotterdam where he obtained a
Masters of Science in Econometrics.

Laurent and his family moved 3 times to the USA and moved back 2 times to Europe
but after the 3rd relocation to the USA became US Citizen (‘one of my better
decisions”).

My motto: Do you dare looking in the mirror every night and ask yourself, “What
did I do for a patient today?”



MICHELE C. D’ALESSANDRO
RETIRED CIO OF MANUFACTURING IT AT MERCK

An Information Technology professional for more than 28 years, Michele C.
D’Alessandro is most recently Vice President and CIO of Manufacturing IT at
Merck. In this role, she provided strategic leadership, oversight and delivery
of information […]
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MICHELE C. D’ALESSANDRO

Retired CIO of Manufacturing IT at Merck

An Information Technology professional for more than 28 years, Michele C.
D’Alessandro is most recently Vice President and CIO of Manufacturing IT at
Merck. In this role, she provided strategic leadership, oversight and delivery
of information technology and digital solutions for the Merck Manufacturing
Division. A change agent with proven track-record of delivering high-impact
projects producing outstanding business results broadly across Pharmaceutical
Supply Chain and Manufacturing, Michele and her team were nationally recognized
in the areas of technical innovation, including next generation data and
analytics platforms; supply chain transformation; and resiliency
/modernization/digitization in manufacturing plants. In Nov 2017, Michele was
awarded a Gold Stevie® Award for Women in Business in the Life Sciences and
Healthcare Transformation category. She was named to Bold’s Business Top 20 of
Chief Information Officers in 2019. She currently runs her own consultancy
business, providing advisory services with an emphasis on IT Transformation and
Women in STEM.



GREG SUKAY
VP MANUFACTURING & PROCESS TECHNOLOGIES AT ARCUTIS BIOTHERAPEUTICS

Greg Sukay serves as Arcutis Vice President of Manufacturing and Process
Technologies where he leads a group of engineers and scientists in developing
and manufacturing their pipeline of novel human therapeutics.  Mr. Sukay has
worked in […]
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GREG SUKAY

VP Manufacturing & Process Technologies at Arcutis Biotherapeutics

Greg Sukay serves as Arcutis Vice President of Manufacturing and Process
Technologies where he leads a group of engineers and scientists in developing
and manufacturing their pipeline of novel human therapeutics.  Mr. Sukay has
worked in the biopharmaceutical industry for over twenty-five years in drug
development and technical operations.  Prior to joining Arcutis, Mr. Sukay was
at Amgen where he held various positions in the US and Asia within Process
Development, Clinical and Commercial Manufacturing, as well as Contract
Manufacturing.  Prior to joining Arcutis, Mr. Sukay led Amgen’s Contract
Development and Manufacturing Organization, responsible for the development and
manufacture of multiple clinical and commercial synthetic and biologic drug
products across a global CDMO landscape.  Mr. Sukay started his pharmaceutical
career at Roche as a Process Engineer supporting a pipeline of synthetic
molecules.  Greg earned his BS, Chemical Engineering from Purdue University.



CELIA XUE
EXECUTIVE DIRECTOR INTEGRATED PRODUCT STRATEGY-CELL THERAPY SUPPLY CHAIN AT
BRISTOL-MYERS SQUIBB

Celia Xue is currently the Executive Director of Integrated Product Strategy for
Cell Therapy Supply Chain at BMS. She leads a team of strategic product leaders
and product launch leaders, responsible for maximizing the value of […]
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CELIA XUE

Executive Director Integrated Product Strategy-Cell Therapy Supply Chain at
Bristol-Myers Squibb

Celia Xue is currently the Executive Director of Integrated Product Strategy for
Cell Therapy Supply Chain at BMS. She leads a team of strategic product leaders
and product launch leaders, responsible for maximizing the value of Cell Therapy
commercial portfolio. Within her tenure with BMS, she also led a team to
champion the BMS clinical supply chain digitization strategy and transformation.

Prior to joining BMS, Celia was with Kite, a Gilead Company. During her time
there, she led a large operational readiness team to successfully launch one of
the first automated greenfield Cell Therapy manufacturing site. Celia spent more
than 10 years with Deloitte Consulting, Biogen, and Novartis. She specialized in
life sciences M&A strategy, operations strategy, portfolio management, and
technology transfers.

Celia holds an MBA degree from UCLA Anderson School of Management, a MS degree
in Chemical Engineering from the University of Colorado, Boulder, and a BS
degree in Chemical Engineering from the University of Nevada, Reno.



MARK BUTCHKO
ASSOCIATE VP, GLOBAL QUALITY LABORATORIES AT LILLY

Mark A. Butchko, Ph.D. is currently Associate Vice President for Eli Lilly and
Company in Indianapolis, IN. He is responsible for leading Lilly’s Global
Quality Laboratories organization to provide analytical method stewardship,
specialized analytical services, and […]
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MARK BUTCHKO

Associate VP, Global Quality Laboratories at Lilly

Mark A. Butchko, Ph.D. is currently Associate Vice President for Eli Lilly and
Company in Indianapolis, IN. He is responsible for leading Lilly’s Global
Quality Laboratories organization to provide analytical method stewardship,
specialized analytical services, and laboratory informatics support.  Mark has
22 years of experience in the pharmaceutical industry, joining Lilly in 2000 as
a Senior Organic Chemist to develop and optimize manufacturing routes for
Lilly’s Active Pharmaceutical Ingredients (API’s).  He subsequently served as
Manager of Lilly’s Technical Services organization (supporting day-to-day cGMP
commercial manufacturing activities), and then as Director/Senior Director of
Lilly’s Product Research and Development Quality Assurance organization
(providing Quality oversight for internal and external cGMP activities
associated with Lilly’s clinical development pipeline).  He received his Ph.D.
in Chemistry from the University of Notre Dame (Notre Dame, IN), and his B.S.
Degree in Chemistry from King’s College (Wilkes-Barre, PA).



RAJIV PANWAR
SR. DIRECTOR, CMC, TECH OPS AND SUPPLY CHAIN AT DISC MEDICINE

Dr. Panwar holds MS and PhD degrees in interdisciplinary pharmaceutical sciences
from Northeastern University, Boston, where his work was focused on use of
antibodies and antibody drug conjugates (ADCs) for molecular imaging and cancer
therapy. After […]
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RAJIV PANWAR

Sr. Director, CMC, Tech Ops and Supply Chain at Disc Medicine

Dr. Panwar holds MS and PhD degrees in interdisciplinary pharmaceutical sciences
from Northeastern University, Boston, where his work was focused on use of
antibodies and antibody drug conjugates (ADCs) for molecular imaging and cancer
therapy. After graduation, he spent his career at Akrivis Technologies, Eleven
Biotherapeutics, Magenta Therapeutics and more recently Disc Medicine, where he
is the head of CMC and Supply Chain Operations.



GEORGE SKILLIN
HEAD OF ENGINEERING, EHS & FACILITIES MANAGEMENT AT SPARK THERAPEUTICS

George currently has responsibility for all Spark Therapeutics Engineering, EHS,
and Facility Management areas where he manages a group of roughly 60+
professionals driving our Engineering and Capital Management efforts, EHS
Programs and Compliance,   George has […]
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GEORGE SKILLIN

Head of Engineering, EHS & Facilities Management at Spark Therapeutics

George currently has responsibility for all Spark Therapeutics Engineering, EHS,
and Facility Management areas where he manages a group of roughly 60+
professionals driving our Engineering and Capital Management efforts, EHS
Programs and Compliance,   George has been in the Life Sciences Industry for
over 30 years, working for Merck, Wyeth, Pfizer, WuXi Biologics and Spark
Therapeutics after starting his career with Eastman Kodak.  George has deep
technical experience in all areas of Life Sciences Manufacturing and Supply
Chain, and deep integrated systems experience as well.

George received his BS in Chemical Engineering at the University of Maine and
his MBA in Finance from the William E. Simon School of Management at the
University of Rochester.  George also serves as a Board Member for the ISPE
Boston Chapter and is a Member of the PDA.



JOSEPH O’BRIEN
HEAD OF ENGINEERING OPERATIONS - SCIENTIFIC & MANUFACTURING FACILITIES AT SPARK
THERAPEUTICS

Joe is currently the Head of Spark Engineering Operations, and has
responsibility for Facilities Engineering, Maintenance, Equipment Validation and
Computer System Validation in the Scientific and Manufacturing Facilities. Joe
has over 20 years’ experience in the […]
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JOSEPH O’BRIEN

Head of Engineering Operations - Scientific & Manufacturing Facilities at Spark
Therapeutics

Joe is currently the Head of Spark Engineering Operations, and has
responsibility for Facilities Engineering, Maintenance, Equipment Validation and
Computer System Validation in the Scientific and Manufacturing Facilities. Joe
has over 20 years’ experience in the Life Science Industry with Wyeth, Pfizer,
and Spark Therapeutics. Joe started his career in the maintenance and facilities
field in high-speed manufacturing with Hewlett Packard, before focusing on
process automation, working on projects in the brewery, dairy, and life science
industries.

Joe received his BE in Electrical/Electronic Engineering and his Masters in
Engineering Management (MIE) from University College Dublin (Ireland).



DAVID BOTTARI
QA CONTRACT MANUFACTURING LEAD AT SPARK THERAPEUTICS

Director of External Quality Assurance with over 17 years of quality related
experience in commercial/clinical manufacturing and packaging of pharmaceutical
and biotech products. Extensive knowledge and experience in the development and
implementation of quality systems as […]
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DAVID BOTTARI

QA Contract Manufacturing Lead at Spark Therapeutics

Director of External Quality Assurance with over 17 years of quality related
experience in commercial/clinical manufacturing and packaging of pharmaceutical
and biotech products. Extensive knowledge and experience in the development and
implementation of quality systems as well as multi-phase clinical and commercial
product disposition. Subject Matter Expert for the management and oversight of
contract manufacturing facilities, laboratories, vendors, and suppliers. As QA
Contract Manufacturing Lead at Spark Therapeutics I provided quality oversight
of the launch and continuous commercial production of the first in vivo gene
therapy approved in the US, now approved and distributed in over 40 countries
worldwide.



JENNIFER MCGEE
SUPPLY CHAIN STRATEGY DIRECTOR AT GSK

Jennifer is a Specialty Medicine Supply Chain and Strategy Senior Director at
GlaxoSmithKline (GSK).  Her scope of responsibility includes biopharmaceutical,
small molecule and oligonucleotide products from early development through
commercial supply.  Her primary focus is ensuring […]
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JENNIFER MCGEE

Supply Chain Strategy Director at GSK

Jennifer is a Specialty Medicine Supply Chain and Strategy Senior Director at
GlaxoSmithKline (GSK).  Her scope of responsibility includes biopharmaceutical,
small molecule and oligonucleotide products from early development through
commercial supply.  Her primary focus is ensuring robust supply chain strategies
are in place to deliver new product launches and continued commercial growth for
established products.  Her personal passion is ensuring people at the end of the
GSK supply chain have the medicine they need to live their best life.  Over
Jennifer’s 20+ year career in the pharmaceutical industry, she has held
operational roles in manufacturing and quality of increasing responsibility
across GSK’s internal and external network.  She consistently delivers business
results through her collaborative, energizing leadership style and is always
ready for new career challenges.  Jennifer received her BS at Ursinus College
and MS at Temple University.  She is based in the Philadelphia area.



MANEL LUIS
INTERIM PHARMA OPERATIONS LEAD, EXECUTIVE DIRECTOR, STRATEGY AND BUSINESS
OPERATIONS | GLOBAL MANUFACTURING OPERATIONS, GLOBAL PRODUCT DEVELOPMENT AND
SUPPLY AT BRISTOL-MYERS SQUIBB

Manel Luis leads Strategy and Business Operations for Global Manufacturing
Operations at BMS since 2020. This includes Network Strategies, Governance and
Forums, and facilitation and representation of GMO in strategic and Enterprise
level initiatives. Since June […]
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MANEL LUIS

Interim Pharma Operations Lead, Executive Director, Strategy and Business
Operations | Global Manufacturing Operations, Global Product Development and
Supply at Bristol-Myers Squibb

Manel Luis leads Strategy and Business Operations for Global Manufacturing
Operations at BMS since 2020. This includes Network Strategies, Governance and
Forums, and facilitation and representation of GMO in strategic and Enterprise
level initiatives. Since June 2021, Manel is the Interim Lead for the Pharma
Network Operations including Oral Solid Dose 4 sites in Switzerland, China and
Japan managing their General Managers with P&L and Talent development
accountability as well as overall site performance and daily issue resolution.
He’s currently based in Princeton, NJ.

Prior to his experience in Manufacturing, Manel took a number of roles in Global
Supply Chain, including the BMS Supply Chain Lead role for the company in the
Integration with Celgene; Strategic Product Leader for E2E Technical Operations
responsibility for 2 biologics products (one commercial and one to be launched)
and Global Logistics Strategy Lead for BMS.

Before moving to the US, Manel lead the BMS Market Logistics Organization for
Europe, Middle East, Africa and India from Paris, France including the
management of internal warehouses and external partners in the region. In
addition to his experience at BMS, Manel worked at Pfizer for 9 years in
different roles in Global Logistics and Supply in Belgium and Italy and for
Kearny as a consultant for the Pharmaceutical industry from his native Spain.

He holds an Industrial Engineer degree from Universitat Jaume I in Castellon and
an MBA from ESADE Business School Barcelona.



HEATHER NUNN
PROCESS DEVELOPMENT PRINCIPAL SCIENTIST AT AMGEN

Heather Nunn, Process Development Principal Scientist, oversees pivotal
biologics drug substance development at Amgen where she is responsible for the
commercialization of late-stage molecules. Additionally, Heather leads
regulatory strategy, data integrity and compliance, lab operations and […]
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HEATHER NUNN

Process Development Principal Scientist at Amgen

Heather Nunn, Process Development Principal Scientist, oversees pivotal
biologics drug substance development at Amgen where she is responsible for the
commercialization of late-stage molecules. Additionally, Heather leads
regulatory strategy, data integrity and compliance, lab operations and
high-throughput strategy for the organization.

Over her 20-year career at Amgen Heather held various positions with increasing
responsibilities in Process Development. She led a drug substance program from
design to commercial launch, designed and managed the next generation labs in
Cambridge, performed and led bioprocessing and cell line development activities
in Seattle, and supported the start-up of two commercial manufacturing
facilities in Rhode Island.

Heather holds a Bachelor of Science in Biology from Willamette University and a
Masters of Pharmaceutical Bioengineering from the University of Washington.



JACK GARVEY
CEO AT COMPLIANCE ARCHITECTS LLC

Jack Garvey is the Founder and Chief Executive Officer of Compliance Architects,
a leading consulting and advisory firm specializing in innovative quality and
compliance solutions for FDA-regulated manufacturers. Jack possesses over 30
years of hands-on technical, […]
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JACK GARVEY

CEO at Compliance Architects LLC

Jack Garvey is the Founder and Chief Executive Officer of Compliance Architects,
a leading consulting and advisory firm specializing in innovative quality and
compliance solutions for FDA-regulated manufacturers. Jack possesses over 30
years of hands-on technical, operational, quality, regulatory and legal
experience at top-performing life science companies including Johnson & Johnson,
C.R. Bard, Ciba-Geigy, BASF Corporation and Ayerst Laboratories. As both a
chemical engineer and practicing attorney, Jack possesses the legal, regulatory,
quality and compliance expertise that allows him to excel at the complex
interplay of science, law and business.



MICHAEL WEISENBECK
VP AT KÖRBER PHARMA SOFTWARE

Mike Weisenbeck is the VP of Sales at Körber, for the Pharma Business Area. For
over fifteen years, Mike has been helping companies improve their operational
efficiency by utilizing technology’s such as ERP, PLM, IoT and […]
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MICHAEL WEISENBECK

VP at Körber Pharma Software

Mike Weisenbeck is the VP of Sales at Körber, for the Pharma Business Area. For
over fifteen years, Mike has been helping companies improve their operational
efficiency by utilizing technology’s such as ERP, PLM, IoT and MES.

At Körber, software solutions deliver the difference that add value in the
pharmaceutical, biotech, and cell & gene industries. Mike and his team are
working with drug manufacturers to digitize their pharmaceutical, biotech, and
cell & gene therapy companies to control and monitor their production digitally.
This allows companies to boost their efficiency, lower the fault rate, and
reduce production costs. Körber‘s Werum PAS-X MES Suite is recognized as the
world’s leading Manufacturing Execution System for pharma, biotech and cell &
gene.



JAIME VELEZ
CO-FOUNDER AT OPERATIONS & QUALITY SYSTEMS IMPROVEMENT EXPERTS (OQSIE)

Jaime is the co-founder of Operations & Quality Systems Improvement Experts
(OQSIE), a management and technical consulting company focused on supporting
manufacturing, supply chain, and quality systems improvement initiatives at Life
Science companies. Over the last […]
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JAIME VELEZ

Co-Founder at Operations & Quality Systems Improvement Experts (OQSIE)

Jaime is the co-founder of Operations & Quality Systems Improvement Experts
(OQSIE), a management and technical consulting company focused on supporting
manufacturing, supply chain, and quality systems improvement initiatives at Life
Science companies.

Over the last 20 years he has supported more than one hundred consulting
engagements with Life Science companies delivering significant productivity
improvements.  Started his consulting career at McKinsey & Company’s Pharma
Operations practice, has led major improvement initiatives with J&J, Teva,
Novartis, Abbott, and Pfizer among others.  He co-founded OQSIE in 2013.

He holds a bachelor’s degree in Industrial Engineering from Stanford University,
where he was a three-time NCCA All-American water polo player.



STEVE MCCARTHY
VP OF DIGITAL INNOVATION AT SPARTA SYSTEMS, A HONEYWELL COMPANY

Steve McCarthy serves as an industry evangelist and customer advocate for
Sparta, working closely with customers to help them define and execute their
quality management transformations. He leads Sparta’s strategic
thought-leadership and customer coalition programs, partnering […]
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STEVE MCCARTHY

VP of Digital Innovation at Sparta Systems, A Honeywell Company

Steve McCarthy serves as an industry evangelist and customer advocate for
Sparta, working closely with customers to help them define and execute their
quality management transformations. He leads Sparta’s strategic
thought-leadership and customer coalition programs, partnering with industry,
regulators and analysts to shape the future of quality management in
life-sciences. Steve has nearly three decades of experience as a quality and
supply chain leader within the healthcare industry. Prior to joining Sparta, he
held several high-profile positions within Johnson & Johnson, the most recent of
which was as VP of Quality Systems Shared Services for their Pharmaceuticals,
Medical Devices and Consumer sectors. There he implemented several complex
quality system and process transformations across the enterprise. His earlier
career was spent in virology research at the University Hospital St. Thomas’ in
London. Steve holds a BSc in Medical & Industrial Biology from Cardiff
University in Wales, UK.



MICHALLE ADKINS
DIRECTOR, LIFE SCIENCES CONSULTING AT EMERSON AUTOMATION SOLUTIONS

Michalle Adkins, Director Life Sciences Consulting, has been with Emerson for 16
years. Prior to Emerson, she worked for Merck & Co., Inc for 13 years in
instrumentation, automation, manufacturing automation support, computer
validation, manufacturing, and […]
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MICHALLE ADKINS

Director, Life Sciences Consulting at Emerson Automation Solutions

Michalle Adkins, Director Life Sciences Consulting, has been with Emerson for 16
years. Prior to Emerson, she worked for Merck & Co., Inc for 13 years in
instrumentation, automation, manufacturing automation support, computer
validation, manufacturing, and scheduling and planning.

Ms. Adkins has a B.S. in Chemical Engineering and an M.E. in Industrial
Engineering from The Pennsylvania State University as well as a Six Sigma Black
Belt Master’s Certificate from Villanova University. She has been a speaker at
several conferences including Interphex, IFPAC, CBI MES, FDA Quality Systems and
Six Sigma, ISPE Puerto Rico, and Emerson Exchange.



ERNESTO GEMOETS
EXECUTIVE DIRECTOR, LIFE SCIENCES AT JLL

Ernesto Gemoets brings over twenty years of manufacturing facilities management
experience in the areas of strategic planning, operational excellence, quality
assurance, supply chain management, problem solving/analysis and engineering of
process improvements with companies like Treehouse Foods […]
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ERNESTO GEMOETS

Executive Director, Life Sciences at JLL

Ernesto Gemoets brings over twenty years of manufacturing facilities management
experience in the areas of strategic planning, operational excellence, quality
assurance, supply chain management, problem solving/analysis and engineering of
process improvements with companies like Treehouse Foods and Kraft. As Executive
Director at JLL, Ernesto focuses on helping scaling and mid-tier bio pharma
companies grow and achieve their purpose. Ernesto received his Bachelor of
Science in Chemical Engineering from The University of Texas in Austin. He lives
in Chicago with his wife and two children. His hobbies include classic cars and
attending car shows with his family.



BRIAN CURRAN
SVP OF STRATEGIC GROWTH AT MASTERCONTROL

Brian Curran joined MasterControl in 2002 to direct and expand MasterControl’s
product development efforts. He has more than 25 years of experience leading the
direction for enterprise and entrepreneurial software development companies.
Curran began his career […]
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BRIAN CURRAN

SVP of Strategic Growth at MasterControl

Brian Curran joined MasterControl in 2002 to direct and expand MasterControl’s
product development efforts. He has more than 25 years of experience leading the
direction for enterprise and entrepreneurial software development companies.

Curran began his career with IBM, where he spent five years leading consulting
engagements with Fortune 500 companies such as MCI, BellSouth, and many others.
After this, he held several director and vice president level product management
and marketing positions for entrepreneurial software development companies in
the telecommunications and web analytics sector.

Curran has an MBA with an emphasis in information systems.



SIMONA MILLS
DIRECTOR OF PRODUCT LIFECYCLE MANAGEMENT AT PROPHARMA GROUP

Simona Mills, PMP is the Director of Product Lifecycle Management at ProPharma
Group. Simona has a broad range of biotech experience, with over 20 years in
Quality, Compliance, Validation, Engineering, Regulatory, and Program
Management. She is […]
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SIMONA MILLS

Director of Product Lifecycle Management at ProPharma Group

Simona Mills, PMP is the Director of Product Lifecycle Management at ProPharma
Group. Simona has a broad range of biotech experience, with over 20 years in
Quality, Compliance, Validation, Engineering, Regulatory, and Program
Management. She is a proven leader who has helped influence and mentor both
colleagues and clients to recognize and adhere to compliant strategies,
effective project management, and techniques leading to improved knowledge and
understanding. Customer-focused and results-driven, Simona has additional
experience in facility construction/start-up, Inspection Readiness and Technical
Transfers. She studied Chemical Engineering at The Ohio State University and is
an avid football fan.



SHAWN CAIN
SVP OF DEVELOPMENT AND MANUFACTURING AT PCI PHARMA SERVICES

Shawn has over thirty years of experience in combining process engineering with
project management to direct the development and manufacture of sterile
pharmaceuticals, cell-based biologics, and medical devices. Most recently he was
at Organogenesis, Inc., specializing […]
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SHAWN CAIN

SVP of Development and Manufacturing at PCI Pharma Services

Shawn has over thirty years of experience in combining process engineering with
project management to direct the development and manufacture of sterile
pharmaceuticals, cell-based biologics, and medical devices. Most recently he was
at Organogenesis, Inc., specializing in bio-active wound healing. Mr. Cain was
also the Director of Operations for another pharmaceutical CDMO, Formatech, Inc.
Prior to that, he was Interim President and Chief Executive Officer of Arbios
Systems, Inc. Mr. Cain was also the Vice President of Operations for Circe
Biomedical, Inc., where he led the development of the bioartificial liver
technology.



ANDY ALASSO
SVP, PRODUCT MANAGEMENT AT AIZON

Andy Alasso is the SVP of Product Management at Aizon. At Aizon, Andy is
responsible for leading product delivery of the Aizon AI Cloud GxP platform
designed to optimize manufacturing in Life Sciences. Prior to Aizon, […]
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ANDY ALASSO

SVP, Product Management at Aizon

Andy Alasso is the SVP of Product Management at Aizon. At Aizon, Andy is
responsible for leading product delivery of the Aizon AI Cloud GxP platform
designed to optimize manufacturing in Life Sciences. Prior to Aizon, Andy was
Global Vice President of Product Management within the Oracle Health Sciences
Business Unit. Andy and his team were responsible for defining, specifying, and
facilitating the delivery of 20+ products within Oracle’s Clinical Research,
Pharmacovigilance, and Healthcare portfolios. Overall, Andy has over 25 years of
experience in providing software solutions to the Life Sciences and Healthcare
industries.



CHRIS MANSUR
PRESIDENT, AZZUR CONSULTING AT AZZUR GROUP

Chris Mansur currently serves as the President of Azzur Group’s Consulting
division, which specializes in providing innovative quality and compliance
solutions to the life sciences industry. Throughout his career, Chris has
specialized in new and renovated […]
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CHRIS MANSUR

President, Azzur Consulting at Azzur Group

Chris Mansur currently serves as the President of Azzur Group’s Consulting
division, which specializes in providing innovative quality and compliance
solutions to the life sciences industry. Throughout his career, Chris has
specialized in new and renovated facility startups, project management,
commissioning and qualification, computer validation, implementation of quality
systems, and application of quality risk management principles. He is passionate
about use of phase-appropriate GMPs to help companies solve problems that
accelerate their product’s lifecycle or project timeline. Chris holds a bachelor
of science degree in Mechanical Engineering from Worcester Polytechnic
Institute.



SARA SHERIFF
VP OF INTEGRATION/ENGINEERING OPERATIONS SERVICES OPTIMIZATION LEADER AT THERMO
FISHER SCIENTIFIC

Sara is a dynamic leader and change agent of Operations/Supply Chain Excellence
and Business Process/Digital Transformation. Sara joined Thermo Fisher in 2019
as VP of Integration and has led various initiatives, most recently Engineering
Operation Services […]
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SARA SHERIFF

VP of Integration/Engineering Operations Services Optimization Leader at Thermo
Fisher Scientific

Sara is a dynamic leader and change agent of Operations/Supply Chain Excellence
and Business Process/Digital Transformation. Sara joined Thermo Fisher in 2019
as VP of Integration and has led various initiatives, most recently Engineering
Operation Services optimization. In her previous roles, Sara developed and
implemented key strategies driving operational success, strategic alignment, and
integration across all major organizational functions. She brings hands-on
experience in direct industry and management consulting to lead to lead rapid
post-merger integration and delivery of scalable solutions to facilitate complex
transformation and optimize next-generation digital operations platforms. Sara’s
global manufacturing and service experience extends across industries, including
energy, aviation/aerospace, building automation controls, consumer goods,
communication, and information technology, which enables her to providing unique
insights to pharma manufacturing and services.



PASCAL BÉCOTTE
MANAGING DIRECTOR AT RUSSELL REYNOLDS ASSOCIATES

Pascal leads Canadian operations for Russell Reynolds Associates and is also a
member of the firm’s global Executive Committee. He is a key member of the
Healthcare Sector where he advises clients across the globe on […]
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PASCAL BÉCOTTE

Managing Director at Russell Reynolds Associates

Pascal leads Canadian operations for Russell Reynolds Associates and is also a
member of the firm’s global Executive Committee. He is a key member of the
Healthcare Sector where he advises clients across the globe on their overall
talent strategy, particularly with respect to leadership assessment, succession
planning and the recruitment of directors, CEOs and other senior executives.
More specifically Pascal specializes in Biotech and Pharma Technical Operations
including Process Development, Manufacturing, Quality, Engineering and Supply
Chain leadership across modalities.



2020 SPEAKERS

SANAT CHATTOPADHYAY
EVP & PRESIDENT, MERCK MANUFACTURING DIVISION AT MERCK

Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and
supply operations supporting annual global sales revenues exceeding $47 billion.
Merck is known as MSD outside of the U.S. and Canada. Sanat oversees a network
of 50 […]
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SANAT CHATTOPADHYAY

EVP & President, Merck Manufacturing Division at Merck

Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and
supply operations supporting annual global sales revenues exceeding $47 billion.
Merck is known as MSD outside of the U.S. and Canada.

Sanat oversees a network of 50 pharmaceuticals, vaccines, biologics/therapeutic
proteins and animal health manufacturing, commercialization and distribution
sites with approximately 20,000 staff in over 20 countries around the world
producing annually 17.5 billion tablets, 700M injectables, 1 billion packs, and
90 billion animal health vaccines doses in 22,000 product finishes. He also
serves on Merck’s Executive Committee.

In his current role, he has successfully launched a new strategy for the
manufacturing and supply organization, restructured the organization into four
independent, interconnected business units, and further integrated supply
planning and operations across the company.

He has a 30-year track record of success in commercialization, manufacturing and
supply chain excellence in therapeutic proteins, vaccines and pharmaceuticals
for Hoechst, Aventis, Wyeth and Merck.

Before joining Merck in November 2009, Sanat worked for Wyeth Pharmaceuticals as
Senior Vice President, New Products & Process Development. A graduate Chemical
Engineer and a post-graduate Industrial Engineer from India, Sanat started his
career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership
assignments in 5 countries across 3 continents, rising to the level of Senior
Vice President, Product Development & Supply at Aventis where he led global
supply chain, including new product commercialization, technology and
engineering.

Outside Merck, Sanat serves on the Board of Directors of Hilleman Laboratories,
an equal joint-venture partnership formed between Merck and the Wellcome Trust,
a global charitable foundation dedicated to human and animal health.  He is also
a member of the Advisory Board of the USA-India Chamber of Commerce.



AZITA SALEKI-GERHARDT
EVP, OPERATIONS AT ABBVIE

Dr. Azita Saleki-Gerhardt is Executive Vice President, Operations, at AbbVie,
leading a team of scientific, engineering, business, quality, supply chain,
security, purchasing and manufacturing professionals responsible for supply and
distribution of all AbbVie products, as well […]
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AZITA SALEKI-GERHARDT

EVP, Operations at Abbvie

Dr. Azita Saleki-Gerhardt is Executive Vice President, Operations, at AbbVie,
leading a team of scientific, engineering, business, quality, supply chain,
security, purchasing and manufacturing professionals responsible for supply and
distribution of all AbbVie products, as well as a number of corporate services.

Dr. Saleki-Gerhardt joined Abbott in 1993 as a research scientist. She has
worked in key leadership positions of increasing responsibility across a broad
range of areas, including science and technology, manufacturing and quality
assurance. Following AbbVie’s separation from Abbott, Dr. Saleki-Gerhardt was
appointed head of AbbVie Operations.

She has been published in a number of scientific publications and has been
awarded several patents related to pharmaceutical sciences.

Dr. Saleki-Gerhardt is a member of the board of directors for Entegris and also
serves on the board of directors at the United Way of Lake County. She is a
member of the Dean’s Advisory Boards for the School of International Studies and
School of Pharmacy at UW-Madison. At AbbVie, she is the executive chair of the
Asian Leadership Employee Resource Group.

Dr. Saleki-Gerhardt earned her bachelor’s, master’s and doctorate degrees in
pharmaceutics from the University of Wisconsin at Madison.



JENS VOGEL
SVP & GLOBAL HEAD OF BIOTECH AT BAYER AG

Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the
Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of
professional and leadership experience in the area of […]
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JENS VOGEL

SVP & Global Head of Biotech at Bayer AG

Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the
Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of
professional and leadership experience in the area of biologics operations,
development and technology management. From 2012 until 2020, he held positions
of increasing responsibility at Boehringer Ingelheim (BI), including as
President and CEO of BI Fremont Inc and member of BI’s Biopharma Executive
Committee. Prior to his years at BI, Dr. Vogel was a member of the Biologics
Development Leadership team at Bayer in Berkeley. Jens holds a PhD in
Biotechnology from University of Braunschweig, Institute of Technology, Germany.



CHARLES L. COONEY (CHAIRPERSON)
ROBERT T. HASLAM PROFESSOR OF CHEMICAL ENGINEERING, EMERITUS, AND FACULTY
DIRECTOR, EMERITUS DESHPANDE CENTER FOR TECHNOLOGICAL INNOVATION AT MIT

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and
Biochemical Engineering, Emeritus in the Department of Chemical Engineering at
MIT and founding Faculty Director, Emeritus of the Deshpande Center for
Technological Innovation. […]
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CHARLES L. COONEY (CHAIRPERSON)

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty
Director, Emeritus Deshpande Center for Technological Innovation at MIT

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and
Biochemical Engineering, Emeritus in the Department of Chemical Engineering at
MIT and founding Faculty Director, Emeritus of the Deshpande Center for
Technological Innovation. He has been involved as founder, advisor or board
member of over 25 companies and currently sits on the Boards of Directors of
Codiak Bioscience, Innovent Biologics (1801.HK), Levitronix Technologies, and is
chairman of GreenLight Bioscience and Mitra RxDx. In addition, he is Trustee
Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and
Trustee of the Leventhal Map Center. Other interests include: high altitude
mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro,
Huascaran). and antique map collecting.



DONNA GULBINSKI
CHIEF QUALITY & REGULATORY AFFAIRS OFFICER AT CIVICA RX

Donna’s expertise spans worldwide operations, quality, and regulatory experience
across vaccine, biological, pharmaceutical and device technologies where she was
an operational leader with a history of delivering exceptional quality,
compliance and business performance. Donna has a […]
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DONNA GULBINSKI

Chief Quality & Regulatory Affairs Officer at Civica Rx

Donna’s expertise spans worldwide operations, quality, and regulatory experience
across vaccine, biological, pharmaceutical and device technologies where she was
an operational leader with a history of delivering exceptional quality,
compliance and business performance. Donna has a 30-year plus career where she
held positions of significant responsibility for Quality and GxP Compliance,
including various roles in drug discovery, operations, quality and regulatory
affairs. Donna is currently the Chief Quality & Regulatory Affairs Officer at
Civica, Inc., a new independent not-for-profit company founded by health care
systems to address critical generic drug shortages caused by market failures.

Donna was previously at Lachman Consultant Services, LLC where she was Vice
President of the Compliance Practice. Prior to that Donna was the Head of
Quality for Bristol-Myers Squibb where she led Quality through 13 NME approvals
with flawless pre-approval inspections, built, qualified and approved several
biologics facilities and led transformational activities in moving from 34 sites
to 12 both from a quality perspective and as the CMC regulatory leader.

Donna’s expertise spans a strong foundation in technical and quality &
compliance including basic research at Merck & Co., Inc. across cardiovascular,
bone biology, HIV, anti-coagulants and multiple drug resistance.



DEREK ADAMS
CHIEF TECHNOLOGY AND MANUFACTURING OFFICER AT BLUEBIRD BIO

Derek Adams joined bluebird bio in March 2017 as Chief Technology and
Manufacturing Officer leading all pharmaceutical sciences that includes process
and analytical development, manufacturing, technical operations, and supply
chain. Prior to joining bluebird, Derek was […]
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DEREK ADAMS

Chief Technology and Manufacturing Officer at bluebird bio

Derek Adams joined bluebird bio in March 2017 as Chief Technology and
Manufacturing Officer leading all pharmaceutical sciences that includes process
and analytical development, manufacturing, technical operations, and supply
chain. Prior to joining bluebird, Derek was the Senior Vice President of CMC at
Evelo Biosciences. At Evelo, Derek established the initial process development
function and supply chain for clinical studies and drove strategy for product
development. Prior to his time at Evelo, he served as Vice President of
Technical and Strategic Product Development at Alexion Pharmaceuticals, where
his responsibilities included developing and supporting all manufacturing
processes globally as well as global clinical supply chain.  His Alexion career
also included roles as Plant Manager for Alexion’s Rhode Island Manufacturing
facility and head of upstream process development.  Derek began his career in
process technical support for live virus vaccine production at Merck & Co, Inc.

Derek holds a Ph.D. in Chemical Engineering from the University of Minnesota and
a B.S. in Chemical Engineering with High Distinction from Worcester Polytechnic
Institute (WPI).



KIMBERLY LOUNDS FOSTER
SVP GLOBAL SUPPLY CHAIN AT BRISTOL-MYERS SQUIBB

Kimberly Lounds Foster is Senior Vice President, Global Supply Chain at
Bristol-Myers Squibb, where she oversees the clinical and commercial supply
chain. Bristol develops and manufactures products on multiple technology
platforms, including small molecules, biologics and […]
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KIMBERLY LOUNDS FOSTER

SVP Global Supply Chain at Bristol-Myers Squibb

Kimberly Lounds Foster is Senior Vice President, Global Supply Chain at
Bristol-Myers Squibb, where she oversees the clinical and commercial supply
chain. Bristol develops and manufactures products on multiple technology
platforms, including small molecules, biologics and cell therapies. Kimberly
joined Bristol through the Celgene acquisition in 2019 after leading Celgene’s
Global Technical Operations organization. Prior to Celgene, Ms. Foster was Head
of Global Supply Chain at Novartis’ Cell & Gene Therapy unit, where she was
responsible for building out the commercial and clinical autologous supply chain
for KYMRIAHTM (tisagenlecleucel), the first FDA approved CAR T cell therapy. Ms.
Foster held various positions at Sandoz a Novartis company where she built the
External Supply Operations functions for the Americas and managed Sandoz US
supply chain for in-line products, new products launches and managed the
warehouse and distributions network. Prior to Sandoz, Ms. Foster held various
roles of increasing responsibilities at Catalent Pharma Solutions, Baxter
Healthcare, Accenture and Merck. Ms. Foster’s diverse experience includes
business development, mergers & acquisitions, management consulting, strategic
planning, process engineering and operational excellence. Ms. Foster holds an
M.B.A from The Wharton School, University of Pennsylvania and a B.S. in Chemical
Engineering from Northwestern University.



PATRICK YANG
VICE CHAIRMAN & CO-FOUNDER AT NATIONAL RESILIENCE, INC.

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives
and technical operations leaders in the industry. From 2017 to 2019, Pat was
executive vice president at Juno Therapeutics, a leading CAR-T biotech company
[…]
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PATRICK YANG

Vice Chairman & Co-Founder at National Resilience, Inc.

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives
and technical operations leaders in the industry.

From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a
leading CAR-T biotech company (now part of BMS) based in Seattle.

Previously, from 2009 to 2013, Pat was Executive Vice President and Global Head
of Technical Operations at F. Hoffman-La Roche based in Basel, Switzerland. In
this role, he was responsible for Roche’s biopharma process research and
development, analytical sciences, engineering, quality, technical regulatory,
supply chain and all manufacturing plants with approximately 15,000 employees
around the world. From 2003 to 2009, Pat was Executive Vice President of Product
Operations at Genentech. He assumed his role as Global Head of the combined
technical operations of Roche and Genentech upon the acquisition of Genentech by
Roche in 2009.

Before Genentech, Pat worked for 11 years at Merck & Company from 1992 to 2003,
based in New Jersey, in various leadership positions including vice president of
Asia Pacific Operations and vice president of Global Supply Chain Management.
Prior to joining Merck in 1992, Pat spent 12 years at General Electric, serving
in research, engineering, technology, and manufacturing leadership roles with
increasing scope of responsibilities.

Pat holds a Bachelor of Science from the National Chiaotung University in
Taiwan, a Master of Science from the University of Cincinnati, and a Ph.D. in
engineering from Ohio State University.

Pat is a member of the Board of Directors of three public companies, Amyris,
Codexis and PharmaEssentia. In addition, he is on the board of several private
companies, including Acepodia, AltruBio, Antheia and Sana Biotechnology.



AL BOYLE
CHIEF TECHNICAL OPERATIONS AND QUALITY OFFICER AT ALNYLAM PHARMACEUTICALS

Al is Chief Technical Operations and Quality Officer for Alnylam
Pharmaceuticals. He leads a global organization responsible for all aspects of
siRNA process and analytical development, clinical and commercial manufacturing,
supply chain operations, engineering, facilities and […]
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AL BOYLE

Chief Technical Operations and Quality Officer at Alnylam Pharmaceuticals

Al is Chief Technical Operations and Quality Officer for Alnylam
Pharmaceuticals. He leads a global organization responsible for all aspects of
siRNA process and analytical development, clinical and commercial manufacturing,
supply chain operations, engineering, facilities and real estate operations, and
quality assurance and quality control oversight for all GxP activities. Prior to
joining Alnylam in 2015, Al worked for a number of global biotechnology,
chemical and pharmaceutical companies including Alexion, Bristol-Myers Squibb,
Hercules, Akzo-Nobel and Celgene. Al holds a PhD in Microbiology from Rutgers
University and BS and MS degrees in Environmental and Forest Biology from The
State University of New York College of Environmental Science and Forestry.



E. MORREY ATKINSON
SVP AND HEAD OF COMMERCIAL MANUFACTURING AND SUPPLY CHAIN AT VERTEX
PHARMACEUTICALS

As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current
responsibilities include defining the commercial manufacturing and supply chain
strategy needs, as well as, designing and building a global organization and
supply network. In […]
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E. MORREY ATKINSON

SVP and Head of Commercial Manufacturing and Supply Chain at Vertex
Pharmaceuticals

As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current
responsibilities include defining the commercial manufacturing and supply chain
strategy needs, as well as, designing and building a global organization and
supply network. In addition, Morrey is responsible for assuring reliable supply
of Vertex’s transformative medicines.

Morrey is a trained laboratory scientist who brings more than 25 years of
experience leading the development and commercial manufacturing of multiple
products at organizations like Eli Lilly and Bristol Myers Squibb. An
accomplished leader and builder of strong scientific, engineering, and
operations teams, Morrey also has prior experience in process development for
cell and gene therapies, including the development and manufacturing of one of
the first gene therapy candidates for cystic fibrosis.



UWE BUECHELER
CORPORATE SVP BIOPHARMACEUTICALS AT BOEHRINGER INGELHEIM

Uwe Buecheler, Ph. D. joint Boehringer Ingelheim (formerly Dr. Karl Thomae GmbH)
in 1991. During his time at Boehringer Ingelheim he held different positions in
Biopharmaceuticals in regulatory affairs, Validation, CMC/GMP documentation and
biological safety. For […]
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UWE BUECHELER

Corporate SVP Biopharmaceuticals at Boehringer Ingelheim

Uwe Buecheler, Ph. D. joint Boehringer Ingelheim (formerly Dr. Karl Thomae GmbH)
in 1991. During his time at Boehringer Ingelheim he held different positions in
Biopharmaceuticals in regulatory affairs, Validation, CMC/GMP documentation and
biological safety. For several years he was leading the Quality Unit as well as
Process Science for Biopharmaceuticals. Starting 2006 he was appointed site head
for the Boehringer Ingelheim site in Biberach, Germany, got member of the board
of the German subsidiary being responsible for the mammalian cell culture
business at the Biberach site Boehringer Ingelheim. Starting October 2010, he
was responsible for global Biopharmaceuticals Operations including sites in
Germany, Austria and US. Since May 2014 he is SVP Biopharmaceuticals responsible
for the entire Biopharma Business Unit at Boehringer Ingelheim including the new
site in Shanghai.

Uwe Buecheler has conducted his Ph. D. in Molecular Biology at the University of
Heidelberg and the Cancer research Center in Heidelberg. Prior joining
Boehringer Ingelheim he worked at Roche (former Boehringer Mannheim site in
Penzberg). He has been awarded Professor h.c. at the University of Ulm and is
member of Advisory boards of University´s and the Society for Biochemistry and
Molecular Biology (GBM). He is Chairman of the Biopharma Cluster South Germany
and is Member of several (Bio-) Pharmaceutical Industry Associations e.g. the
international leadership forum of ISPE.



JON CAMMACK
CHIEF QUALITY AND COMPLIANCE OFFICER AT NEVAKAR

Jon Cammack is the Chief Quality and Compliance Officer at Nevakar, Inc. He
provides strategic direction and oversight of activities that align with
business objectives, and ensures compliance with overall biopharma regulations
and standards. Jon has […]
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JON CAMMACK

Chief Quality and Compliance Officer at Nevakar

Jon Cammack is the Chief Quality and Compliance Officer at Nevakar, Inc. He
provides strategic direction and oversight of activities that align with
business objectives, and ensures compliance with overall biopharma regulations
and standards. Jon has over 25 years of commercial and development experience
with medical products, including leadership roles in large and small
pharma/biotech companies, and as a co-founder of a risk management consulting
company. He has a Ph.D. in Pharmacology, holds advisory board positions, and
also co-chairs the AAMI/ISO Working Group on Combination Products with John
(Barr) Weiner of FDA’s Office of Combination Products.



ANDERS VINTHER
SITE HEAD & VP GLOBAL QUALITY AT INTARCIA THERAPEUTICS

Anders Vinther serves as Site Head (Hayward) and VP Global Quality at Intarcia
Therapeutics. He joined Intarcia in 2018 as VP Global Quality and Engagement,
previous to this Anders was the Chief Quality Officer at Sanofi […]
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ANDERS VINTHER

Site Head & VP Global Quality at Intarcia Therapeutics

Anders Vinther serves as Site Head (Hayward) and VP Global Quality at Intarcia
Therapeutics. He joined Intarcia in 2018 as VP Global Quality and Engagement,
previous to this Anders was the Chief Quality Officer at Sanofi Pasteur
accountable for cGMP compliance, quality leadership, and the quality of the
company’s vaccines worldwide.

Prior to that he worked for Roche and Genentech most recently as the VP of
Biologics Quality which included operational quality leadership for 10 Biologics
Roche and Genentech manufacturing sites and all outsourced manufacturing for
biologics products. Previous to that role he led the Global Quality System and
Processes organization in Genentech & Roche. In that role areas of
responsibility included developing and overseeing implementation of the
Pharmaceutical Quality System (PQS), Quality Risk Management, Operational
Excellence, Portfolio Management, Computer Systems and Inspection Management.

Previously he was the co-founder and Chief Quality Officer of the contract
manufacturing organization CMC Biologics, where his responsibilities on the
Board of Management included QA, QC, IT, Human Resources and Strategic Planning.

Anders holds a PhD in Chemical Engineering from the Technical University of
Denmark and has 20+ years of business and biopharmaceutical experience,
including research and development, quality assurance and control, compliance,
regulatory affairs and senior management.

In PDA, Anders is currently the Immediate Past Chair of the Board of Directors.
Additionally over the past 20 years in PDA he has been Chairman of the Board of
Directors, Treasurer, Board of Directors member, task force and conference
planning committee leader and member, and author of numerous articles.



MICHELE D’ALESSANDRO
VP AND CIO, MANUFACTURING IT AT MERCK

Michele is Vice President and CIO for the Manufacturing Division with Merck.  In
this role, she provides strategic leadership, oversight and delivery of
information technology and digital solutions for the Merck Manufacturing
Division.   A change agent […]
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MICHELE D’ALESSANDRO

VP and CIO, Manufacturing IT at Merck

Michele is Vice President and CIO for the Manufacturing Division with Merck.  In
this role, she provides strategic leadership, oversight and delivery of
information technology and digital solutions for the Merck Manufacturing
Division.   A change agent with proven track-record of delivering high-impact
projects producing outstanding business results broadly across Pharmaceutical
Supply Chain and Manufacturing.

Michele and her team have been nationally recognized for the past 7 years in the
areas of technical innovation, including next generation data and analytics
platforms; supply chain transformation; and resiliency
/modernization/digitization in manufacturing plants.  In Nov 2017, Michele was
awarded a Gold Stevie® Award for Women in Business in the Life Sciences and
Healthcare Transformation category.

Michele holds a Bachelors’ double major degree in Math and Computer Science from
Rutgers University and an M.B.A. in Information Sciences from Rutgers Graduate
School of Management.

Michele serves on the National Association of Manufacturer’s Manufacturing
Leadership Council Board of Governors, and the Big Data Advisory Board for
Rutgers University.



DENNIS NSENKYIRE
VP, STRATEGY & DEPLOYMENT JANSSEN SUPPLY CHAIN AT JOHNSON & JOHNSON

Dennis is responsible for leading a high performing team responsible for
designing, developing, and executing Janssen’s integrated end-to-end supply
chain strategic roadmap in partnership with R&D, Commercial and global
cross-functional teams. Success in his current role […]
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DENNIS NSENKYIRE

VP, Strategy & Deployment Janssen Supply Chain at Johnson & Johnson

Dennis is responsible for leading a high performing team responsible for
designing, developing, and executing Janssen’s integrated end-to-end supply
chain strategic roadmap in partnership with R&D, Commercial and global
cross-functional teams.

Success in his current role is working with Commercial, R&D, and end-to-end
Supply Chain leaders to translate customer/patient value proposition into an
operational strategy and ensure the continual evolution of supply chain
capability through innovation, agility, end-to-end value and people/leadership
development.

Most recently, Dennis served as Vice President, Supply Chain Culture &
Capability Development, where he led the development and implementation of
innovative capabilities to further advance Supply Chain talent, skills,
competencies, and development programs. Prior to that, Dennis held critical
leadership roles responsible for J&J Supply Chain Insights, Strategy and
Business Excellence where he led and shaped the development, deployment and
execution of J&J Supply Chain strategy and strategic innovation programs.

Prior to joining the Supply Chain organization, Dennis led the Commercial
Operations team at Ethicon (J&J Medical Device Sector), responsible for
go-to-market models, sales force design and deployment, commercial analytics,
planning, and operations.

Dennis joined Johnson and Johnson in 2002 at McNeil Consumer and Specialty
Pharmaceuticals, where he held several leadership positions in Process
Excellence and Business Strategy and Insights. Dennis also worked at J&J Vision
Care, where he was responsible for market insights, sales force deployment,
sales force compensation, CRM, territory management, and business analytics.
Prior to Johnson and Johnson, Dennis held various leadership roles in Marketing,

Process Excellence and Engineering at Honeywell International and Therma Tru
Corporation.

Dennis holds a master’s degree in Electrical Engineering from Arizona State
University, an Executive MBA from Drexel University (Lebow College of Business)
and is a Certified Process Excellence Master Blackbelt.



DANIEL COUTO
CHIEF OPERATING OFFICER AT VEDANTA BIOSCIENCES

Daniel Couto is the Chief Operating Officer of Vedanta Biosciences, a leading
Microbiome company. Mr. Couto is an Operations Management Executive with over 25
years of experience starting and advancing Biopharmaceutical Development and
Manufacturing organizations to […]
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DANIEL COUTO

Chief Operating Officer at Vedanta Biosciences

Daniel Couto is the Chief Operating Officer of Vedanta Biosciences, a leading
Microbiome company. Mr. Couto is an Operations Management Executive with over 25
years of experience starting and advancing Biopharmaceutical Development and
Manufacturing organizations to higher levels of capability, growth and
productivity. Mr. Couto has a comprehensive knowledge and hands-on experience
leading organizations through improvement initiatives and developing new
therapeutic modalities. Mr. Couto is the former SVP of Manufacturing and
Operations of ContraFect Corporation, a public company developing new Lysin
enzymes for MRSA infections. His previous employment was with Merck Sharp Dohme
Biologics UK Ltd. (former Avecia Biologics) where he served as Vice President of
Commercial Manufacturing Operations responsible for all late stage and
commercial product. Prior to this he was responsible for 7 World Wide Contract
Manufacturing sites including API/BDS and Final Fill Finish as he served as
Director of Manufacturing for Nuvelo Inc. (San Francisco Bay area). He has been
instrumental in 2 BLA submissions for drug approvals, 2 major Pre-Approval
Inspection (PAI), and several IND submissions. Mr. Couto holds patents for
several novel separation technologies such as Bulk Protein Crystallization,
HPTFF, SMB, and Bacterial formulation and Lyophilization. Prior to this he
served in a number of Sr. Management positions for companies including Genzyme
Transgenics Corp. (GTC Biotherapeutics), Advanced Biosystems Corp., ImmuCell
Corp., and Sepracor Corp. Mr. Couto received his B.S. Degree in Chemical
Engineering with a minor in Economics from Rensselaer Polytechnic Institute.



STEPHEN SCYPINSKI
VP PHARMACEUTICAL TECHNOLOGY AT DAIICHI SANKYO

Dr. Stephen Scypinski received his B.S., M.S. and Ph.D. degrees in Chemistry
from Seton Hall University, South Orange, NJ USA. Involved in pharmaceutical
research and development for over 30 years, Dr. Scypinski has held positions at
[…]
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STEPHEN SCYPINSKI

VP Pharmaceutical Technology at Daiichi Sankyo

Dr. Stephen Scypinski received his B.S., M.S. and Ph.D. degrees in Chemistry
from Seton Hall University, South Orange, NJ USA. Involved in pharmaceutical
research and development for over 30 years, Dr. Scypinski has held positions at
Berlex Laboratories, Hoffmann-La Roche, the R.W. Johnson Pharmaceutical Research
Institute, Eyetech Pharmaceuticals, and Bristol-Myers Squibb Company. He is
presently Vice President, Pharmaceutical Technology for Daiichi Sankyo Inc. His
professional interests encompass the development of pharmaceutical processes and
methods for drug substances and dosage forms, technical transfer, stability,
bioanalytical methodologies, and new technology as applied to the reduction of
cycle time and enhancement of productivity in preclinical and pharmaceutical
development. Dr. Scypinski has extensive experience in both line and matrix
management. He has played a key role in the filing of over fifty global
regulatory submissions for both synthetic small molecule and biologic products.
Dr. Scypinski is also active in the scientific community, having served as
General Chairman of the Eastern Analytical Symposium and Chairman of the
Laboratory Robotics Interest Group of New Jersey. He serves on the President’s
Advisory Councils of Duquesne University College of Pharmacy and the Stevens
Institute of Technology Pharmaceutical Manufacturing & Engineering Program. Dr.
Scypinski is also an adjunct professor at Duquesne University School of
Pharmacy. He is the recipient of many awards, including the New Jersey Institute
of Chemists Honor Scroll Award and the Distinguished Alumnus Award from Seton
Hall University. Dr. Scypinski is the Editor-in-Chief for The Journal of
Pharmaceutical Innovation and is co-editor of the textbook “Handbook of Modern
Pharmaceutical Analysis”, currently in its second edition.



TRACI SEAMAN
VP, HEAD OF GLOBAL QUALITY STRATEGY & BUSINESS OPERATIONS AT TAKEDA

Traci ran her own consulting company for nearly 15 years, focusing on issues
management. She primarily worked with pharma companies with warning letter and
consent decrees. She holds a bachelor’s degree in journalism and an MBA […]
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TRACI SEAMAN

VP, Head of Global Quality Strategy & Business Operations at Takeda

Traci ran her own consulting company for nearly 15 years, focusing on issues
management. She primarily worked with pharma companies with warning letter and
consent decrees. She holds a bachelor’s degree in journalism and an MBA with an
emphasis on Human Resource Management. She is a six sigma green belt and a
certified professional coach. Traci is a believer in servant-based leadership,
and a strong proponent of accountability. She studies the impact of
accountability on company culture.

Traci is married to her husband Jim and they have two (grown now) sons. She
enjoys traveling, sports, reading, DIY and spending time with family.



SHANNON HOLMES
DIRECTOR, PRODUCT DEVELOPMENT QUALITY AT BIOGEN

Shannon is the Director of Product Development Quality at Biogen, based in
Research Triangle Park, NC. She leads a global team responsible for quality
oversight and strategy of all products and devices in clinical development as
[…]
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SHANNON HOLMES

Director, Product Development Quality at Biogen

Shannon is the Director of Product Development Quality at Biogen, based in
Research Triangle Park, NC. She leads a global team responsible for quality
oversight and strategy of all products and devices in clinical development as
well as lifecycle management of commercial programs. Prior to this role, Shannon
was a member of the Regulatory Affairs CMC team at Biogen and led a global team
responsible for early phase and commercial biological products as well as change
management/compliance activities. While at Biogen, Shannon has led successful
submissions for clinical, licensed, and post-marketing regulatory applications
for biological and combination products. Shannon is an active member of the
PhRMA Global Quality and Manufacturing Work Group. Prior to Biogen, Shannon
worked in regulatory roles at Synthon Pharmaceuticals and Merz Pharma supporting
small molecules, biosimilars, and medical devices. Shannon received her PhD in
Chemistry from the University of North Carolina and a BS degree in Chemistry
from Davidson College.



MICHAEL BOYSON
VP, HEAD OF PRODUCT OPERATIONS, ONCOLOGY & SMALL MOLECULE, STRATEGY AND BUSINESS
EXCELLENCE AT TAKEDA

Mike is responsible for global operations strategy, including life-cycle
planning and overall operations value management for Takeda’s oncology portfolio
and select small molecule therapies. Mike joined Takeda Oncology in 2002. Since
that time, he has held […]
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MICHAEL BOYSON

VP, Head of Product Operations, Oncology & Small Molecule, Strategy and Business
Excellence at Takeda

Mike is responsible for global operations strategy, including life-cycle
planning and overall operations value management for Takeda’s oncology portfolio
and select small molecule therapies. Mike joined Takeda Oncology in 2002. Since
that time, he has held various positions in External Manufacturing, Supply,
Quality Operations, and GMP Training. Prior to joining Takeda, Mike was with
Biogen’s Bioassay Development Group. He holds a B.S. in Microbiology from the
University of Massachusetts, Amherst and is a graduate of the General Management
Program at Harvard Business School. In his spare time, Mike enjoys snowboarding,
running, hiking, improving his private pilot skills, and spending time with his
wife and dog.

“The working lesson most important to me is that the power of ethnic, cultural,
racial and gender diversity, plus a diversity of perspective is a critical
success factor for teams.”



SAUL FINK
VP PHARMACEUTICAL DEVELOPMENT AT GOLDFINCH BIO

Saul is Vice President, Pharmaceutical Development at Goldfinch Bio where he
leads teams for small molecule and biological assets to provide CMC strategic
guidance, budgets and all operational activities to establish a supply chain for
clinical […]
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SAUL FINK

VP Pharmaceutical Development at Goldfinch Bio

Saul is Vice President, Pharmaceutical Development at Goldfinch Bio where he
leads teams for small molecule and biological assets to provide CMC strategic
guidance, budgets and all operational activities to establish a supply chain for
clinical supplies.

Saul is a biotech and pharmaceutical R&D leader. He has led CMC teams across
many therapeutic areas for both small molecule and biologic assets. He also led
large, complex strategy & business operations units with emphasis on financial &
resource management, project management, capital facilities & equipment,
tracking/reporting business performance and metrics.

Saul has held key strategy and business operations leadership roles in
pharmaceutical development, translational medicine, discovery, regulatory,
pharmacovigilance, biostats, manufacturing and supply chain. He was a key leader
in R&D and manufacturing M&A transactions and strategic planning.

Saul spent a good part of his career in the pharmaceutical industry with
Bristol-Myers Squibb (BMS). In these roles he worked closely with C-suite and
other senior executives to accelerate strategy execution, business
transformations and operational performance. Saul led a multi-disciplinary,
global integration manufacturing team following the acquisition of Amylin
Pharmaceuticals by BMS and AstraZeneca (AZ). He then participated in the $7B
divestiture of the BMS diabetes portfolio to AZ including the negotiations for
deal close and led the BMS manufacturing transition team. He also drove the
recent R&D transformation across 7 sites.

Saul received his B.S. in Chemistry from Millersville University and Ph.D. in
Chemistry from the University of Houston

Saul has substantial not-for-profit board and local government experience. He is
currently a member and President for the Millersville University Foundation
Board. He formerly served as a councilman for East Brunswick (NJ) township. Saul
is a licensed recreational pilot.



JEAN BENDER
VP PHARMACEUTICAL SCIENCES & TECHNOLOGY AT VISTERRA INC.

Jean Bender is VP, Pharmaceutical Sciences and Technology accountable for
leading all CMC activities for Visterra’s product pipeline. Prior to Visterra,
Jean led the BioProcess Engineering department at Medimmune LLC where she was
responsible for process […]
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JEAN BENDER

VP Pharmaceutical Sciences & Technology at Visterra Inc.

Jean Bender is VP, Pharmaceutical Sciences and Technology accountable for
leading all CMC activities for Visterra’s product pipeline. Prior to Visterra,
Jean led the BioProcess Engineering department at Medimmune LLC where she was
responsible for process development engineering, scale-up and transfer of drug
substance processes. Previously she held roles of increasing responsibility
within Genentech Inc., where she was responsible for tech transfer and licensure
of monoclonal antibody processes within the Genentech/Roche manufacturing
network.

Jean has a MS in Chemical Engineering from UC Berkeley and a BS in Chemical
Engineering from Lehigh University.



BRENDAN HUGHES
SVP GLOBAL MANUFACTURING OPERATIONS AT BRISTOL-MYERS SQUIBB

Brendan is responsible for all of BMS Pharma and Biologics manufacturing from
internal and external sources. He is based in Devens MA. Brendan joined BMS as
Head of CMC Strategy for Biologics in 2012. From 2015-2020 […]
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BRENDAN HUGHES

SVP Global Manufacturing Operations at Bristol-Myers Squibb

Brendan is responsible for all of BMS Pharma and Biologics manufacturing from
internal and external sources. He is based in Devens MA.

Brendan joined BMS as Head of CMC Strategy for Biologics in 2012. From 2015-2020
Brendan led MS&T for the company with responsibility for all technologies used
in manufacturing including biologics, pharma products, parenterals and devices.

Before joining BMS, he led MS&T and Technical Services teams in Wyeth and
Pfizer.

Brendan has worked in the US, Ireland and the UK. He started his career in the
UK working for Wellcome which then became Glaxo-Wellcome and then GSK; roles
included leadership positions in Quality, analytical sciences as well as project
leadership. Brendan came to US in 2001 joining the Biotech Development team in
Wyeth. He later joined the leadership team for the Wyeth Grange Castle biotech
start-up in Ireland from 2003-2010 and returned to US in 2010 to work in Pfizer
Global Manufacturing.

Brendan received his B.Sc and Ph.D in Biochemistry in Ireland and carried out
post-doctoral studies in Oxford UK. He was a member of the ICH Expert Working
Group which drafted the initial Quality Guidelines for biotech products in the
1990s and later for ICH Q11



THOMAS SEEWOESTER
VP EXTERNAL SUPPLY OPERATIONS AT AMGEN

Thomas Seewoester is the Vice President External Supply, an organization that
orchestrates a global operations network of external partners for contract
development and manufacturing, materials, components and devices to extend
Amgen’s capacity and capabilities. Prior to […]
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THOMAS SEEWOESTER

VP External Supply Operations at Amgen

Thomas Seewoester is the Vice President External Supply, an organization that
orchestrates a global operations network of external partners for contract
development and manufacturing, materials, components and devices to extend
Amgen’s capacity and capabilities.

Prior to this role he served as Vice President Site Operations Rhode Island,
Amgen’s largest commercial drug substance manufacturing operation where he also
oversaw the construction of a second next-generation plant.

He joined Amgen in 2001 and has held various positions in Process Development
before gaining further operational experience through leading drug substance
plants, a drug product plant, a device assembly and packaging plant and a small
molecule API plant at Amgen’s California and Rhode Island locations.

Mr Seewoester worked at BASF and Abbott before. He was a postdoctoral fellow and
holds a M.S. and a Ph.D. in Biotechnology from the Institute for Cell Culture
Technology, Germany.



ANDREY J. ZARUR
FOUNDER & CEO AT GREENLIGHT BIOSCIENCES, INC.

Andrey co-founded GreenLight Biosciences in 2008 to develop advanced biological
solutions to overcome some of the biggest challenges faced by the human race,
including sustainable food production, response and preparedness for pandemics,
and global access to […]
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ANDREY J. ZARUR

Founder & CEO at GreenLight Biosciences, Inc.

Andrey co-founded GreenLight Biosciences in 2008 to develop advanced biological
solutions to overcome some of the biggest challenges faced by the human race,
including sustainable food production, response and preparedness for pandemics,
and global access to effective human health.

He is a co-founder and was Chairman of the Board of Solid Biosciences, Inc.
(NASDAQ: SLDB), a gene-therapy company targeting Duchenne Muscular Dystrophy. He
is also co-founder and Chairman of the Board at Lumicell Surgical, an oncology
company delivering advanced imaging solutions to cancer surgery. He has been a
co-founder and senior executive in more than a dozen companies in the healthcare
and clean energy sectors. Prior to starting GreenLight, Andrey was Managing
Partner at Kodiak Venture Partners, an early-stage, technology-driven venture
fund based in Boston.

Dr. Zarur carried out graduate doctoral studies in Chemical and Biomedical
Engineering at the Massachusetts Institute of Technology, and Immunology at
Harvard-MIT. Andrey is a frequent invited speaker at scientific and trade
conferences, has authored a number of landmark peer-reviewed articles in
prestigious scientific journals, holds over 100 provisional and issued patents
and has been regularly quoted in international media on the pandemic and RNA
vaccines, including recent opinion pieces in Fortune and Stat as well as quotes
in the Financial Times, Investors Business Daily, Wired, Business Insider and
CNBC.



PASCAL BÉCOTTE
GLOBAL EXECUTIVE COMMITTEE, GLOBAL SECTOR LEADER – FUNCTIONAL PRACTICES, COUNTRY
MANAGER – CANADA & MANAGING DIRECTOR AT RUSSELL REYNOLDS ASSOCIATES

Dr. Pascal Bécotte leads the firm’s Canadian operations and leads the firm’s
global Corporate Officers practice which includes the Finance, Human Resources,
Operations & Supply Chain, Legal, Regulatory & Compliance and Corporate Affairs
practices. Pascal is […]
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PASCAL BÉCOTTE

Global Executive Committee, Global Sector Leader – Functional Practices, Country
Manager – Canada & Managing Director at Russell Reynolds Associates

Dr. Pascal Bécotte leads the firm’s Canadian operations and leads the firm’s
global Corporate Officers practice which includes the Finance, Human Resources,
Operations & Supply Chain, Legal, Regulatory & Compliance and Corporate Affairs
practices. Pascal is also a member of the firm’s Global Executive Committee as
well as a member of the Healthcare and Industrial teams, where he advises
clients across the globe on their overall talent strategy, particularly with
respect to leadership assessment, succession planning and the recruitment of
directors, CEOs and other senior executives. He splits his time between the
Toronto and New York offices.

Pascal has more than 18 years of executive search experience, most recently with
a leading global executive search firm where he was Managing Partner for the
Montreal office. Immediately prior to joining Russell Reynolds Associates,
Pascal worked for Target, where he was Group Vice President for Stores and
Officers in Canada. Earlier in his career, he was President of a boutique
recruiting and consulting firm specialized in sales and marketing. Pascal began
his career as National Sales Manager for a sportswear manufacturing company.

Pascal received his Bachelor of Engineering Physics degree from the Royal
Military College of Canada and was trained as an aerospace engineer with the
Royal Canadian Air Force. He also earned Master’s and Doctorate degrees in
business administration from Athabasca University in Canada, where he focused
his research and dissertation on CEO succession. Pascal speaks fluent French and
English.



FRANCK CHASSANT
HEAD OF RARE DISEASE, ONCOLOGY AND IMMUNOLOGY CLUSTER (RDOI) AT SANOFI

Since he completed his PharmD degree, Franck has been working in the industry
for 20 years, with roles of growing responsibilities in pharmaceutical, vaccines
and biologic manufacturing operations (drug substance and drug product) as well
as […]
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FRANCK CHASSANT

Head of Rare Disease, Oncology and Immunology Cluster (RDOI) at Sanofi

Since he completed his PharmD degree, Franck has been working in the industry
for 20 years, with roles of growing responsibilities in pharmaceutical, vaccines
and biologic manufacturing operations (drug substance and drug product) as well
as industrial strategy, in France, Canada and the USA.

After leading large industrial and R&D campuses as site head in Swiftwater, PA
and then at Marcy-L’Etoile, France, Franck is now in charge of Rare Disease,
Oncology and Immunology Industrial cluster (5 sites), at Sanofi Speciality Care.

He is based in Boston with his wife and 2 kids.



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