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Vaccine Development & Manufacturing Conference
July 28th 2022 | 10AM - 4PM GMT
BOOK TICKETS

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Hear from the Brightest minds in the global manufacturing sector at the Vaccine
Development & Manufacturing Conference. The event is being held online on July
28th 2022.

The Vaccine Development and Manufacturing Conference tackles the practical
challenges facing the development and manufacturing of vaccines including
COVID-19. This event will equip delegates with the knowledge and contacts to
bring Novel vaccines to market on a global scale.

Experts will delve into topics which will help attendees improve yields, lower
cost, maintain quality, utilize new technologies, manage complex supply chains,
and cut down time in your vaccine manufacturing process.

Key Topics Include:

·Vaccine Policy, Safety, and Risk Development
·Production strategies for COVID-19 vaccines
·Preparing for the next pandemic
·Supply Chain & Logistics
·Formulation, product development, stability, and delivery
·Upstream & Downstream Processing
·Analytical & Quality
·Stability & Formulation
·Vaccine Manufacturing
·Cell & Gene Therapy
·Cell Line Development and Engineering
·Recovery & Purification
·Viral Safety
·Digitalization
·Sustainabilty

SPEAKERS CONFIRMED

VANESSA ELHARRAR

VICE PRESIDENT, VACCINES BUSINESS STRATEGY LEAD - PPD

"PANDEMIC PREPAREDNESS FROM A CRO PERSPECTIVE"

Speaker Bio



I am a motivated, customer-focused Preventive Medicine and Public Health
physician currently serving as Vice President, Vaccines Business Strategy Lead
at PPD with more than 16 years of experience in the clinical research and
pharmaceutical industry. My depth of experience managing clinical trials
consists of leading Phase I-IV Vaccine (SARS-CoV- 2, Influenza, Zika,
Chikungunya, PIV, H7N9, hMPV and HIV prevention clinical development and early
engagement. I have experience in the CRO, government (NIH/NIAID), normative body
(PAHO EPI) and non-profit settings and in public health, epidemiology and Phase
IV planning and execution.


MIC MCGOLDRICK

ASSOCIATE DIRECTOR OF GLOBAL CMC POLICY - MERCK SHARP & DOHME CORPORATION

"HOW TO ACCELERATE THE SUPPLY OF VACCINES TO ALL POPULATIONS WORLDWIDE - A
REGULATORY PERSPECTIVE"

Speaker Bio Synopsis



Mic is currently an Associate Director of Global CMC Policy at Merck Sharp and
Dohme, Corp. His background in the life sciences started with degrees in
Microbiology, Chemistry, and Medical Technology and has experience with Vaccine
and Biologics in the Pharmaceutical field for the last 30 years. For 15 years
Mic worked in Regulatory Affairs on INDs, new product filings, and post approval
submissions globally. For a large portion of this time he led the evaluation of
worldwide guidances and the expansion of vaccines into the Emerging Markets. For
the last six years Mic has been working on CMC Policy for Vaccines and
Biologics, advocating for reliance, harmonization and greater access of vaccines
to patients.





The COVID-19 pandemic has shown itself to be an unprecedented challenge for
vaccines, which are widely recognized as the most important tool to exit this
pandemic. At the same time, it has highlighted some hurdles that need to be
addressed in the system. More precisely in the trade-offs between the need for
regulatory flexibility in the manufacturing and control requirements to enable
rapid availability of large volumes of vaccines vs. the increased stringency and
lack of harmonization in the regulatory environment for vaccines overall. It is
also characterized by a high heterogeneity in terms of review and approval
processes, limiting equitable and timely access. We have witnessed vaccine
scientists, developers, manufacturers and stakeholders work together to deliver
several vaccines in just about a year. As part of this accelerated process, we
have noted challenges relating to several topics, including process validation,
comparability, stability, post-approval-changes, release testing, packaging,
genetically modified organisms and variants. Overarching these are four areas
for accelerating access to vaccines which provide solutions for the regulatory
concerns, which are (1) Science and Risk based approaches, (2) global regulatory
harmonization, (3) use of reliance, work-sharing, and recognition processes and
(4) digitalization. We will discuss solutions for these areas of concern, some
of which are not new and have been highlighted in the past. In recent months, we
have seen some progress globally, but still a lot needs to be done for both
Covid and other life-saving vaccines. Ultimately, quick and wide access to
medicines and vaccines for patients is most important.


DR. PETER NARA

CSO - KEYSTONE BIO INC.

"DEVELOPING A VACCINE FOR ALZHEIMER'S DISEASE-PORPHYROMONAS GINGIVALIS A LEADING
CAUSE OF SYSTEMIC INFLAMMATION"

Speaker Bio Synopsis



Dr. Nara is currently on of the co-founders, the Chief Scientific Officer and
President Business Development for Keystone Bio Inc. in St. Louis, Mo., a
Systemic-Oral Health Biomedical company that is targeting precision microbiome
bio-therapeutics for the elimination of a specific oral bacterial associated
with systemic inflammation. He is also the former co-founder, President,
Chairman and CEO (1997-2017)and now Chairman Emeritus at Biological Mimetics,
Inc. and cofounder of Lantern Pharma Inc. He holds a M.Sc. in
Immuno-pharmacology, a combined Doctor of Veterinary Medicine and Ph.D.
(retro-virology/oncogenesis) from The Ohio State University, 4 year combined
residency in Comparative Pathology and NIH post-doctoral Fellowship at the Armed
Forces Institute of Pathology and a NIH respectively. Dr. Nara currently holds
the Endowed Eugene Lloyd Chair, Professor in Vaccinology, founding Center
Director for the Center for Advanced Host Defense, Immunobiotics, and
Translational Comparative Medicine in the Department of Biomedical Sciences, in
the College of Veterinary Medicine at Iowa State University and also the Chief
Executive Officer, President, Chairman & co-founder of Biological Mimetics,
Inc.,. He is also an distinguished Alumni of The Ohio State University College
of Veterinary Medicine 2014, and an elected Fellow of the American Association
for the Advancement of Science in 2011. His comparative medical research
interests are to more fully understand how early and pre-determined events in
the host innate and acquired immune systems are sculpted and bias the
development of protective long lasting responses against infectious pathogens
and cancer. More importantly he and his team are interested developing new
technologies and strategies to circumvent the non-protective immune responses
for the development of novel classes of immunobiotics and vaccines focused on
the prevention of disease.





The talk will describe progress on the discovery and role of this oral origin
bacteria 's ability to drive chronic low grade systemic vascular and end organ
degeneration and approaches for treating, diagnosing and prevention through
vaccination.


DR. ASHISH SAHAI

DIRECTOR - VIRAL VACCINE PRODUCTION - SERUM INSTITUTE OF INDIA PVT. LTD.

"UPSTREAM & DOWNSTREAM PROCESSING."

Speaker Bio Synopsis



Presently additional director, production (viral vaccines) at Serum Institute of
India Pvt. Ltd., Pune, India. Trained in regulatory affairs at UMASS in Boston,
USA and Chumakov Institute, Moscow, Russia. He is Ex.IITian and virologist with
more than 30 years of rich experience in various departments such as production,
quality assurance, quality control in the Biotechnological industry and Research
Institute. He is specialized in purification of viral vaccines and has developed
WHO approved Oral polio vaccine and Rabies vaccine at SIIPL.

Recent publications:
• Development of competitive inhibition ELISA as an effective potency test to
analyze human rabies vaccines and assessment of the antigenic epitope of rabies
glycoprotein. Journal of Immunological Methods, December 2020.
• Development of Affinity Purified 0.2 Micron Filtered Vero Cell Based Rabies
Vaccine. Archives of Clinical Case Reports, 2020, Volume 1 | Issue 1 | 7. •
Study on Preparation of New Purified Vero Cell Rabies Vaccine Clin Exp Immunol,
2019, Volume 4 | Issue 4| 1 of 2.
• Development of a new Purified Vero cell Rabies vaccine (Rabivax-S) at the
Serum Institute of India Pvt Ltd. Article in Expert Review of Vaccines 16(4) ·
February 2017.
• A randomized non-inferiority clinical study to assess post-exposure
prophylaxis by a new purified Vero cell rabies vaccine (Rabivax-S) administered
by intramuscular and intradermal routes. Volume 34, Issue 40, 14 September 2016,
Pages 4820- 4826.





Viral vaccine contain inactivated viruses or live attenuated viruses.Viral
diseases still cause human deaths in the endemic areas in Asia and Africa.
Upstream processes are processes of vaccine manufacturing in which biological
materials are either obtained from an outside source or inoculated and grown in
culture, under controlled conditions, to manufacture certain types of products.
Downstream processes are those in which the products are harvested, tested,
purified and packaged.Finally with this two processes, a cheap vaccine for human
can be manufactured, that could be used in mass vaccination campaigns, would be
a valuable weapon against viral diseases. Serum institute of India Pvt Ltd has
developed several vaccines such as Rabies, Corona (Covishield), Polio, Measles,
Mumps, Rubella, Rota vaccines.


ARANCHA DE CASTRO

QUALITY OPERATIONS MANAGER - OXFORD BIOMEDICA (UK) LIMITED

"QUALITY ASSURANCE FOR MANUFACTURING OPERATIONS DURING A PANDEMIC"

Speaker Bio Synopsis



Born in Madrid (Spain) in 1973. Moved to Paris (France) 1987 to 1990 with
parents and sister in relation to my father’s job.
Went to University in Madrid (Universidad Complutense de Madrid) 1991-1997 –
Biology Degree, then did a Master Degree in Food Tech.
Started working as Quality Control and Quality Assurance for the food industry
but quickly moved to the Pharmaceutical Industry.
Married in 2005, separated now. 2 Children, a boy that will be 14 in May and a
girl 11.
I moved to the UK with both my kids in August 2018 – living in Oxford since.
Joined OXB in Feb 2020 right before the first lockdown.





Quality Assurance support for Manufacturing Operations requires understanding of
the process and on site support in terms of Quality on the shop floor and
documentation review. To be able to provide this support during a Pandemic is
challenging due to several factors such as: lockdown requirements, sickness
leaves, increased difficulty in recruitment and training of new team members.
During the presentation we will navigate through the challenges faced and do a
lessons learnt on how to maximise efficiencies that can be used under normal
circumstances for the benefit of routine operations, as well as to be better
prepared for future similar challenging situations.


BERNARD JAUCOT

SR. DIRECTOR PSO, CLINICAL SUPPLIES & IRT - PPD

"SUPPLY CHAIN & LOGISTICS – THE CLINICAL TRIAL SUPPLY CHAIN FOR VACCINES –
CHALLENGES, SOLUTIONS"

Speaker Bio Synopsis



Passionate about clinical trial supply chain and clinical trials in general,
Bernard started in a Phase I Clinic, developing analytical methods and combining
both his Chemistry & Pharmaceutical degrees. After that it was 25 years of
anything touching clinical trial supply chain: starting in an IRT department,
then moving to a manufacturing environment, followed by outsourcing, heading a
global clinical supplies unit of a Big Pharma company, 2 years as QA, and
finally started 14 years ago at PPD, now part of Thermo Fisher Scientific. At
PPD, part of Thermo Fisher Scientific, Bernard started on the operational side,
but is now on the support side, ensuring the department is ready for growth,
from an improvement, compliance & resource perspective.





Specific challenges linked to vaccines in the Clinical Trial Supply Chain arena
What was the effect of COVID-19 on our business? What did we learn to benefit
our future vaccines trial supply chains? Trade Compliance


ANDREW LEES

FOUNDER AND SCIENTIFIC DIRECTOR - FINA BIOSOLUTIONS

"GENETICALLY DETOXIFIED DIPHTHERIA AND TETANUS TOXINS (CRM197 AND 8MTT)
EXPRESSED IN AN ENGINEERED E. COLI AND THEIR USE AS CONJUGATE VACCINE CARRIER
PROTEINS"

Speaker Bio Synopsis



Andrew Lees is the founder and scientific director of Fina Biosolutions LLC
(Rockville, MD), a company focused on promoting affordable conjugate vaccines by
making the technology available to emerging market vaccine manufacturers. Among
his contributions in the field, Andrew developed an efficient linking chemistry
which is widely used in conjugate vaccines, a class that includes vaccines for
S. pneumoniae and meningococcal disease. The chemistry has helped to reduce the
cost of these vaccines. Prior to starting Fina Biosolutions in 2006, he was
Director of Vaccine Development at Virion Systems (1993-1999) and Biosynexus
(1999-2006). He was also an associate research professor at the Uniformed
Services University (1993-1999). Andrew is an adjunct professor at the
University of Maryland School of Medicine Center for Vaccine Development, the
Uniformed Services University, Dept. of Medicine and the University of Toledo,
Dept of Chemistry. He has over 70 publications and 25 patents, mainly in the
area of conjugate vaccines. He received his BS in chemistry from Harvey Mudd
College in chemistry (1976) and his Ph.D. in Biophysics from Johns Hopkins
(1984). Honors include the Uniformed Services Meritorious Service Award, Harvey
Mudd College Outstanding Alumni Award and is a Johns Hopkins University
Outstanding Alumni. On graduating from Hopkins, he was on the cover of Baltimore
Magazine as one of “84 people to watch in ‘84” due to his role as a leading
Baltimore area magician.





We have developed a novel E. coli expression system, which we call the Gor/Met
strain. Gor/Met E. coli has an oxidative cytoplasm and can express
disulfide-bonded proteins as intracellular, soluble, properly-folded proteins.
In addition to the oxidative cytoplasm, the strain has been engineered to
efficiently cleave the N-terminal methionine found on cytoplasmic E. coli
proteins. To create an oxidative cytoplasm, we deleted the gor gene in BL21 E.
coli, resulting in an oxidative cytoplasm. We used the gor- strain to produce
the conjugate vaccine carrier protein CRM197 in a fermenter. CRM197 was
expressed as a soluble, properly folded protein in the cytoplasm and no
inclusion bodies were formed. We developed a simple purification process that
resulted in 2 g of purified protein per liter fermentation broth. FinaBio’s
CRM197 (marketed as EcoCRM®) has been extensively compared to CRM197 obtained
from multiple manufacturers (Hickey et al., J Pharm Sci. 107, 1806, 2018). It
was found to have the correct disulfide bonding. EcoCRM® is being used for
several conjugate vaccines in development targeting S. pneumoniae, Group B
Strep, malaria and vaccines for drugs of abuse. Clinical grade EcoCRM® is
available now. To further improve the strain, the deleted gor gene was replaced
with a methionine peptidase with the same tac promoter as the plasmid containing
the recombinant protein gene. Induction induced co-expression of the methionine
amino peptidase along with the heterologous recombinant protein on the plasmid.
Gor/Met E. coli achieves can grow to high cell densities in a fermenter, unlike
comparable strains, making it commercially viable for recombinant protein
expression. Remarkably, Gor/Met can grow to >300g/L in fed-batch fermentation.
We have initially used the Gor/Met strain to produce a unique, genetically
detoxified tetanus toxin (8MTT, Przedpelski et al. mBio Aug 11;11(4):e01668-20).
8MTT is purified at >0.5 g/L fermentation and was found by mass spec analysis to
have extremely low levels of N-terminal methionine, showing that the amino acid
was efficiently cleaved by the peptidase. 8MTT was found to be comparable to
tetanus toxoid as a carrier protein. Gor/Met E. coli was used to express CRM197,
tetanus toxin heavy chain fragment C and human IL-10. This work shows the
potential of the Gor/Met E. coli to be a commercially viable production strain
for producing high yields of disulfide-bonded proteins, with their native
sequence. Among these are carrier proteins such as CRM197 and a new genetically
detoxified tetanus toxin, along with many therapeutic proteins of interest. The
availability of affordable conjugate vaccine carrier proteins produced in a
low-cost expression system makes the development of conjugate vaccines more
feasible. The variety of applications including vaccines for malaria, S.
pneumonia, Covid and other infectious diseases as well as vaccines for areas as
diverse as drugs of abuse, cancer and cholesterol control.


DARREN NOLEN

ASSOCIATE DIRECTOR - QA CAPITAL PROJECTS IN EUROPE - LONZA

"OPERATIONAL READINESS FOR LOGISTICS AND SUPPLY CHAINS IN MRNA VACCINE
MANUFACTURING"

Speaker Bio Synopsis



Darren Nolen, P.E., is starting his third decade in the industry. Combining
engineering and operational expertise with a QA perspective, he has worked in
large and small molecule pharma, API and sterile fill, medical devices, in vitro
diagnostics, blood products, and human tissues. Recently he was the QA
Operational Readiness lead ensuring buffer supply to the Lonza-Moderna mRNA
project in Visp, Switzerland. He is currently the Associate Director of QA
Operational Readiness for Logistics and Utility systems for the Visp Ibex
Biopark.





The transition away from traditional “big tanks – lots`a pipes” manufacturing to
single-use facilities has introduced new flexibility in our operations. It has
also introduced new challenges and risks that must be managed for successful
project execution. This talk will highlight the potential failures as well as
the strategies and tools to navigate this new manufacturing paradigm.


PIROUZ DAFTARIAN

DIRECTOR OF SCIENTIFIC ENGAGEMENT - CROWN BIOSCIENCE

"IND-GUIDED METRICS OF CANCER VACCINE EFFICACY"

Speaker Bio Synopsis



Pirouz Daftarian has over 25 years of experience in academia and biopharma, in
cancer immunology, vaccines and inflammation. He joined Crown Bioscience / JSR
Life Sciences in 2017 and led the developing applications for IO products and
identifying VOC / pain points. Prior to JSR, pirouz was a Senior Scientist at
NGM Biopharmaceutical and that, he was an Asst. Professor also acted as the
Director of Biological Modifiers and Hybridoma Core Facility, U. Miami, Miller
School of Medicine. Prior to U of Miami, Pirouz was the head scientist at IMV
Inc. Pirouz has authored ~ 80 peer reviewed papers, has served as a reviewer of
DOD, NIH, NCI, is a reviewer for several journals, and acted as a consultant
pharma and biotech companies. He completed his Ph.D at Faculty of Medicine,
Ottawa U; Postdoctoral work at UBC and the City of Hope National Medical Center.





Immune evasion by tumors results in tumor poor immunogenicity, tolerance, the
expression of co-inhibitory molecules, mutations, poor antigen presentation,
heavily suppressed microenvironment, T cell exhaustion / dysfunction. Other
barriers of tumor deposits that immunotherapies and vaccines face are
high-pressured, TME with hypoxia, acidity, and nutrient deficiency . Vaccines
and immunotherapies aim to address and deactivate such evading mechanisms.
Different physiologically relevant in vitro and in vivo preclinical models are
required for a realistic vaccine efficacy. I will discuss, syngeneic, and
transgenic, humanized mouse models; in vitro vaccination of PBMC, patient
delivered tumor organoids populated with immune cells, 3D Ex Vivo Patient
Tissues, RNA Seq on TILs, MHC guided analysis of anti-tumor immunity, and T cell
clonality and TCR sequencing. To address the combinatorial approach, I will
discuss assays to identify active immune-potentiating agents. I will also give
examples of studies conducted at crown Biosciences.


MICHAEL DURWIN

DIRECTOR OF SOCIAL MEDIA INTELLIGENCE & COMMUNITIES - ICON

"VACCINE HESITANCY DRIVERS IN AMERICA"

Speaker Bio Synopsis



Michael Durwin is a 26-year veteran of social media strategy and research. With
experience across a dozen industries both on the agency and brand side, he
brings a holistic view of the many use cases for social intelligence. He has
worked with brands ranging from HBO to the country of Germany, and has helped
launch the first Kindle, the first brand on YouTube, predicted the 2016 U.S.
election in 2015, and tracked “a new flu-like virus in China” using social
listening. He currently works as the Director of Social Intelligence &
Communities at ICON out of their Boston office where his team uses social
intelligence to better understand the patient voice in all aspects of their
lives, to create awareness of the opportunities for clinical trial
participation, to provide SAEM (Social Adverse Event Monitoring), to support
clients and partners with a variety of social media-related services and manages
several dozen patient communities. The social intelligence team has been
publishing a monthly Covid report for 2 years and created a public dashboard to
track vaccine hesitancy conversations. Michael lives in the suburbs of Boston
with his wife and three children.





Vaccine hesitancy is a hot topic across media and social media channels. While
there are many reasons given for vaccine hesitancy related to mRNA, the vaccine
development timeline, doubts that the global pandemic is as bad as it’s being
reported or is even real. But vaccine hesitancy dates back to the very first
vaccine for small pox in Middle Ages England. Drivers for vaccine hesitancy were
in place long before the pandemic. Months prior to the announcement that there
was a potential vaccine 36% of Americans reported that they would refuse to
vaccinate. Michael Durwin and the ICON Social Intelligence and Communities team
has been tracking anti-vaccine social commentary since mid-2019 and have a
unique perspective on the drivers of vaccine hesitancy straight from the
unfiltered mouths of those refusing vaccines, voting against town officials who
suggest any kind of vaccine mandate, and pushing back in all 50 states on
vaccination mandates for public school children.


MICHAEL MILLER

HEALTH CARE & LIFE SCIENCES CONSULTANT & ADVISOR - HEALTHPOLCOM

"PROMOTING VACCINES AND COMBATTING MISINFORMATION: THE ROLES FOR VACCINE
COMPANIES"

Speaker Bio Synopsis



Dr. Miller is a health care and life sciences policy, communications, and
subject matter expert who has been helping organizations to improve their
programs and innovations for more than 30 years. Working with a wide variety of
organizations he plans, develops and manages projects focused on expanding
affordability and access to better care, and improving clinical and economic
outcomes. He has worked with large and small companies, entrepreneurs,
government organizations, and patient advocacy and clinician groups. He has
written and presented widely about how policy, advocacy and communications
intersect to improve health care through private and government programs - and
particularly how legislative, regulatory and budgetary actions effect health
care delivery, access and affordability. In the public health and prevention
sphere, he has worked on a variety of challenges related to vaccines, ranging
from improving maternal and pediatric vaccine usage, to vaccine resistance and
misinformation – including serving on the Board of Directors of Why We Vax
during the height of the COVID-19 pandemic. With Why We Vax, he served as the
vice-chair of their Communications and Policy Committee and continues to
facilitate their Scientific Advisory Board.
Dr. Miller graduated magna cum laude from Williams College with a B.A. in
chemistry, and received his M.D. from the Yale University School of Medicine.
Dr. Miller has volunteered in Bread for the City’s free medical clinic in
Washington DC, served on their Board of Directors, and chaired their Fundraising
Committee. He has also assisted Bread for the City’s CEO with major speaking
engagements and strategic planning activities. He was the Secretary of the
Williams College DC and Boston Regional Alumni Associations, was a founding
co-chairs of the Yale Life Sciences Alumni Association’s Boston Chapter, was the
longstanding honorary “Team Physician” for the political satire troupe the
Capitol Steps, and many years ago became an Eagle Scout.





Companies working in the vaccine space need to be very concerned about
misinformation undermining vaccine confidence and acceptance. Therefore, part of
their role in the health care ecosystem include actively communicating with the
public, as well as with policy makers since the axiom “Vaccines don’t save
lives, vaccinations save lives” continues to be true. For companies to
productively support public health goals and measures that are aligned with
their own business objectives, they need to understand the sources of
misinformation, which often have demographic and geographic specificity.
Industry support and initiatives then needs to be aligned with and
collaboratively produced with various stakeholders, including clinicians,
patient advocates, public health agencies, and perhaps most importantly, local
influencers connected to specific communities. While much of the focus on
vaccine misinformation is now related to COVID vaccines, hesitancy and mistrust
appears to have extended to other vaccines, which creates a worrisome situation
for prevention of future infectious disease outbreaks.


BECKY JONES-PHILLIPS

SENIOR BUSINESS DEVELOPMENT MANAGER - IICON, LIVERPOOL SCHOOL OF TROPICAL
MEDICINE

"INFECTION INNOVATION CONSORTIUM: EXPEDITING VACCINE DEVELOPMENT"

Speaker Bio Synopsis



Dr Becky Jones-Phillips Senior Business Development Manager Becky leads
commercial business development for iiCON’s UKRI Strength In Places programme.
She establishes new commercial and strategic relationships for translational
research and in promoting the research agenda of LSTM to external audiences.
With a PhD in infectious disease immunology, she has over 10 years’ experience
in national business development strategy and implementation in the
immunodiagnostics sector. She brings significant experience and expertise in
commercial negotiations and industry engagement through innovative business
development strategy and dynamic market landscaping.





iiCON is super-charging industry innovation in vaccine development with agile
end-to-end clinical trials and innovative platforms for preclinical vaccine
development. Leveraging the world-leading expertise of Liverpool School of
Tropical Medicine (LSTM) and iiCON industry and academic partners, this
all-in-one solution covers each stage of the vaccine development journey from
our expertise and innovation in preclinical models, such as organoid and
Organ-on-a-chip technology to the clinical trial journey from study protocol
design to downstream analysis. iiCON’s offering is unique in offering industry
partners support through the journey of vaccine development, ultimately
expediting vaccines into the clinic and improving public health impacts.


BRIAN DEAN ABRAMSON

ADJUNCT PROFESSOR OF VACCINE LAW - FLORIDA INTERNATIONAL UNIVERSITY - COLLEGE OF
LAW

"LEGAL RESPONSES TO ANTI-VACCINE MISINFORMATION DIRECTED TOWARDS DEVELOPERS AND
MANUFACTURERS."

Speaker Bio Synopsis



Brian Dean Abramson is a leading expert on vaccine law, teaching the subject as
adjunct professor of vaccine law at the Florida International University College
of Law. He is the primary author of Vaccine, Vaccination, and Immunization Law,
the most comprehensive treatise written with respect to this field of law,
published by Bloomberg Law in cooperation with the American Health Law
Association in November 2018, and regularly updated thereafter. A second print
edition was published in February 2022.

Brian previously worked for Bloomberg Law, for whom he authored the vaccine
injury claims chapter of Matthew H. Solomson’s Court of Federal Claims:
Jurisdiction, Practice, and Procedure, and for whom he wrote extensively in the
fields of health and international privacy law.

Brian was a law clerk for the Honorable Pauline Newman of the U.S. Court of
Appeals for the Federal Circuit, where he took an exceptional interest in the
court’s vaccine injury docket. Prior to this, he interned with the Honorable
Susan G. Braden of the U.S. Court of Federal Claims, and practiced intellectual
property law with the firm of Lott & Friedland in Coral Gables, Florida.

He received an MA in Comparative Sociology from Florida International
University, followed by his JD, summa cum laude, from the Florida International
University College of Law, and an LLM in intellectual property law with highest
honors from the George Washington University Law School.





The COVID-19 pandemic, combined with a growing cottage industry of
misinformation, has fueled the antivaccine movement to the most substantial
levels seen in over a century. Much of the ire of this movement is directed
towards the developers, manufacturers, and distributors of vaccines, which are
depicted as evil corporations, driven by greed to bribe or trick government
agencies into approving poisonous and ineffective vaccines, and to mandate their
use. Ironically, some of this rhetoric comes from people trying to market their
own unscientific and unapproved miracle cures. This presentation will discuss
the sources and drivers of antivaccine misinformation, including intentionally
divisive conduct by internet trolls, and legal efforts that have been proposed
or taken in response to such activities


MATTHEW COLEMAN

SENIOR SCIENTIST & LAWRENCE LIVERMORE NATIONAL LABORATORY ADJUNCT PROFESSOR -
DEPARTMENT OF RADIATION ONCOLOGY AT U.C. DAVIS

"UTILIZING CELL-FREE APPROACHES FOR PRODUCTION AND CHARACTERIZATION OF
CHLAMYDIAL VACCINE DEVELOPMENT."

Speaker Bio Synopsis



r. Coleman is a senior biomedical staff scientist at Lawrence Livermore National
Laboratory and an adjunct professor in the department of radiation oncology at
University of California Davis School of Medicine and. He received his Ph.D. in
molecular biochemistry and cellular biology from Boston University. Dr. Coleman
has authored over 150 publications in peer-reviewed journals, published
proceedings and book chapters covering a diverse breadth of molecular and
cellular biology and biochemistry. He has over 20 year’s experience
characterizing genomic responses of genotoxic stressors such as ionizing
radiation. Dr. Coleman is also very active in the development of advance
biochemical techniques using nanoparticles made of apolipoproteins and
phospholipids called nanolipoproitein particles (NLPs). NLPs closely mimic the
cellular membrane bilayer, and represent an ideal platform for characterizing
membrane proteins involved in signal transduction. NLPs are also proving useful
for drug delivery, immuno-modulation and in vivo imaging in the treatment of
cancer.





Chlamydia is a prevalent sexually transmitted infection that infects over 100
million people worldwide. Chlamydia strains express a major outer membrane
protein (MOMP) that is an effective vaccine antigen. However, approaches to
produce a functional recombinant MOMP protein are limited due to poor
solubility, low yield, and misfolding. We will present a cell-free
co-translation method to make functional MOMP within a nanolipoprotein particle.
Our approach solubilizes membrane-bound proteins for biochemical, biophysical
characterization and antigen generation.


STEVEN FERGUSON

SPECIAL ADVISOR - NIH OFFICE OF TECHNOLOGY TRANSFER

Speaker Bio



Steven M. Ferguson currently serves as Special Advisor at the NIH Office of
Technology Transfer where he has worked since 1990. The biomedical technology
transfer program at NIH is one of the world’s largest with a portfolio that
includes about 1700 active licenses with aggregate sales greater than $6B per
year that is based upon research that has also generated 34 FDA-approved drugs &
vaccines.

A former chemist at the National Cancer Institute and biotech industry product
manager, Mr. Ferguson holds Master's Degrees in Business Administration (George
Washington University) and Chemistry (University of Cincinnati) as well as
Bachelor’s Degree in Chemistry (Case Western Reserve University).

A registered Patent Agent and a Certified Licensing Professional (CLP), Mr.
Ferguson is faculty and Technology Transfer Department Chair at the Foundation
for Advanced Education in the Sciences (FAES) Graduate School at NIH and the
Biotechnology Industry Organization “BIO Boot Camp”. He also serves as a
business reviewer or advisory board member for the US-India Science & Technology
Endowment Fund, Maryland Industrial Partnerships, Maryland Innovation
Initiative, Virginia Bio-Life Science Gap Fund, the Journal of Commercial
Biotechnology and the DOD Congressionally-Directed Medical Research Program.

He has published extensively in the field of technology transfer and has also
received the AUTM President’s Award (AUTM Band), the AUTM Volunteer Service
Award, the NIH Director’s Award, the FAES Instruction Award, four “Deal of
Distinction” awards and the Frank Barnes Mentoring Award from the Licensing
Executive Society, six Federal Laboratory Consortium Awards, and fifteen NIH
Merit Awards in recognition of his service and activities in technology
transfer.


ANUBHAW SINGH

MANAGER - SERUM INSTITUTE OF INDIA LIMITED

"BUILDING BUSINESS BY VACCINE TECHNOLOGY LICENSING & TRANSFER"

Speaker Bio Synopsis



I possess a unique blend of industrial experiences exclusively in vaccines since
2005. Handled many vaccine projects from applied research, clinical trials batch
manufacturing, high volume commercial production of several vaccines with
packaging and export. Worked in Various department namely - Applied research,
production, developmental QA, EXPORT & International Business Development.
Handled Vaccine Project feasibility evaluation- like chikungunya, Nipah, Ebola,
Zika, Hep A, HIV, etc., Technology licensing & transfer through international
business development. Exposure of Biosafety Label lab-2 & 3+. Have hands-on
experience in process development & validation, cGMP, Plant Set Up from
greenfield, Production, and regulatory documentation, Product Cost calculation,
Resource management for commercialization & global launch planning, Involved in
pricing strategy, technology licensing & supply agreement for various stages of
vaccine – i.e. Finished Vaccine, unlabelled Bulk vaccine vials, Ready to fill,
Ready to blend, Mono antigen bulk production, etc. I have also touched upon
global epidemiology study, Participated in several internal discussions on WHO
TRS requirements, GAVI road Map, UNICEF recommendation on supply, white paper on
market research, SAGE recommendation, National Vaccine Policy & several
pharmacopeia’s like IP, USP, EU, USP, Clinical trial protocol summary & report,
Vendor Audit, CAPA, scientific journal review and Patent understanding. Compiled
regulatory registration Dossier for many countries.





The Talk will revolve around the Technology transfer in vaccines and give a
360-degree view. Starting from Defining the word Technology & Know-How in
vaccine science, intangible material transfer, Licensing, Types of Technology
transfer & timelines, Technology transfer Guidelines, Business advantages &
disadvantages & Transfer Mechanism & strategies. Some examples of successful &
failed tech transfers etc.


PAUL KEOWN

PROFESSOR OF MEDICINE. DIRECTOR, IMMUNE SCIENCES - THE UNIVERSITY OF BRITISH
COLUMBIA

"STRUCTURAL BIOLOGY, MOLECULAR MECHANISMS AND VACCINE STRATEGIES IN COMPLEX
IMMUNE DISEASE"

Speaker Bio Synopsis



Paul Keown (UBC Medicine), a specialist in immunology and transplantation, is a
Professor in UBC’s Department of Medicine, a practicing physician at Vancouver
General Hospital and has served as Executive Director of the BC Transplantation
Program and President of the Canadian Transplantation Society. He is currently
the Head of the Division of Nephrology and the Lead for Genome Canada Transplant
Consortium (2018-2024).

Dr. Paul Keown received his training in medicine, immunobiology and
transplantation at the universities of Manchester, Paris and Western Ontario,
his research doctorates in medicine and science from the University of
Manchester, and his MBA from Simon Fraser University. During his decades long
career his principal research activities have focused particularly on the immune
response in transplantation and autoimmune disease, and extend from molecular
genetics to healthcare economics.

Over his career Dr. Keown has contributed to the fields of immunopharmagology,
immunogenetics and immunotherapeutics with 400 visiting professorships, plenary
addresses, or invited lectures, over 350 published abstracts and over 300
scientific manuscripts, editorials and book chapters.





I will focus on the structural biology of immunogenic targets and recognition
elements in complex diseases like stem cell and organ transplantation, on the
molecular mechanisms of rejection and tolerance, and on the use of vaccines to
prevent viral infection and to induce tolerance.


RITU CHAKRAVARTI

ASSISTANT PROFESSOR - UNIVERSITY OF TOLEDO

"CHALLENGES IN VACCINES DEVELOPMENT FOR AUTOIMMUNE DISEASES"

Speaker Bio Synopsis



Experienced Assistant Professor with a demonstrated history of research and
teaching.





We have developed prophylactic vaccines for inflammatory arthritis. The talk
will detail the strengths and challenges associated with making this treatment
reach to clinical trials.




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