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PDA ADVANCED THERAPY MEDICINAL PRODUCTS CONFERENCE 2024
NEXT STEPS IN ATMPS AND BEYOND
24 Jun - 25 Jun 2024 Amsterdam, The Netherlands
Register Now
REGISTRATION OPTIONS
Individual Registration
Register Now
Group Registration
Register Now
Event Information Registration Agenda Presenters Sponsors & Exhibitors Travel
Ask a Question Exhibitor Standard Contract Clause
Add to Calendar
PROGRAM HIGHLIGHTS
Celebrate with us the 15th edition of this format!
The agenda preview has just been published!
Related PDA Letter Article: Next Steps in ATMPs and Beyond authored by our
Co-Chairs, Renske ten Ham, Uni Medical Center Utrecht & Richard Denk, SKAN .
ATTENTION
The conference will take place right before the PDA Virus Conference 2024! Make
the best of your journey and attend two conferences in one week!
Dear Colleagues,
Welcome to the PDA Advanced Therapy Medicinal Products Conference 2024!
Join us on 24-25 June 2024, in Amsterdam, The Netherlands, for an enriching
experience. Organized by the PDA and the Scientific Program Planning Committee,
this conference, themed "Next Steps in AMTPs and Beyond", promises a
comprehensive exploration of the latest developments in advanced therapy
medicinal products.
With thousands of therapies currently in development across hospitals,
start-ups, and pharmaceutical manufacturing portfolios, the common goal is to
successfully bring these therapies to market. However, this journey is laden
with challenges, including regulatory requirements, manufacturing options,
costs, and sustainability concerns. The PDA Advanced Therapy Medicinal Products
Conference has been a steadfast supporter of this path for many years.
Our program will be designed to feature diverse sessions covering cutting-edge
topics, discussions with authorities, and intensive exchanges during
question-and-answer sessions and breaks. Explore system solutions in the
Exhibition area and engage in enlightening poster sessions.
We eagerly anticipate your participation in this gathering of industry leaders
and experts. Amsterdam awaits you for a conference that promises valuable
insights, networking opportunities, and a shared commitment to advancing the
field of advanced therapy medicinal products. See you there!
Sincerely,
The Co-Chairs
Renske ten Ham, Uni Medical Center Utrecht
Richard Denk, SKAN
SCIENTIFIC PROGRAM PLANNING COMMITTEE
* Renske ten Ham, Uni Medical Center Utrecht
* Richard Denk, SKAN
* Manjula Aysola, Merck
* Manuel Carrondo, ibet
* Dayue Chen, Genentech/Roche
* Fabio D’Agostino, Charabio
* Lori Dingledine, Sparktx
* Irving Ford, Adaptimmune Therapeutics
* Markus Haindl, Roche
* Marcel Hoefnagel, MEB
* Ian Johnston, Miltenyi
* Ryan Murray, ValSource
* Josh Eaton, PDA
* Falk Klar, PDA
* Caroline Lynar, PDA, Manager Programs & Events
NETWORKING OPPORTUNITIES
Monday, 24 June 2024
PDA Europe cordially invites you to a special networking evening in Amsterdam
with a guided walking tour followed by a delightful dinner!
18:25h Meeting Point: Main Entrance, Amsterdam Marriott Hotel
PDA looks forward to an inspiring evening filled with interesting encounters and
engaging conversations.
SHARE THIS EVENT:
EVENT LOCATION
Amsterdam Marriott Hotel
Stadhouderskade 12, Amsterdam, The Netherlands Get Directions
RELATED CONTENT
EVENTS
* PDA Virus Conference 2024
* PDA Next Generation Sequencing Workshop 2024
* PDA EU00190 CMC Regulatory Compliance Strategy for ATMPs – CGTPs
CONTACT
PROGRAM INQUIRIES
Caroline Lynar
programs-europe@pda.org
--------------------------------------------------------------------------------
EXHIBITION/SPONSORSHIP INQUIRIES
Christopher Haertig
expo-europe@pda.org
--------------------------------------------------------------------------------
TRAINING COURSE INQUIRIES
training-europe@pda.org
--------------------------------------------------------------------------------
REGISTRATION CUSTOMER CARE
registration-europe@pda.org
STANDARD REGISTRATION
Member Price
€ 2.250
GovernmentMember Only
€ 1.080
Health AuthorityMember Only
€ 1.080
Early Career ProfessionalMember Only
€ 1.080
StudentMember Only
€ 1.080
AcademicMember Only
€ 1.080
Non-Member
€ 2.550
See Qualifying Criteria for Member Types.
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
PDA MEMBERS: Please remember to log in before registering If you come from a
Governmental or Health Authority Institution or from an Academic Organization,
please contact registration-europe@pda.org before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be
informed of this fact at least 4 weeks before the start of the event.
Download Full Agenda
Jump to Date:
Pre-Agenda Day 1 Day 2 Posters
SUNDAY, 23 JUNE CEST
15:00 – 18:00 | Registration Open
Studio 3,4,5,6,7
MONDAY, 24 JUNE CEST
* 08:00 – 17:30
REGISTRATION OPEN
Studio 3,4,5,6,7
* 09:00 – 09:05
WELCOME AND INTRODUCTION
Salon ABC
* Committee Member: Falk Klar, PhD, Parenteral Drug Association
Falk Klar, PhD, Parenteral Drug Association
Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of
experience in Quality Assurance and Compliance in the life science
industry. Falk held positions in pre-clinical research and development in
a medical product company and clinical research in a CRO. He has gained
experience with biopharmaceutical and pharmaceutical products including
monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs
in several positions in quality management. Falk joined PDA Europe in 2015
as Senior Director of Training & Education. Since 2016 he has been
appointed General Manager and Vice President of PDA Europe.
* 09:05 – 09:15
WELCOME FROM THE CO-CHAIRS
Salon ABC
* Co-Chair: Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius
Center, UMC Utrecht
Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius Center,
UMC Utrecht
Renske ten Ham is an assistant professor at the UMC Utrecht in the
Netherlands and specializes in health economics & health technology
assessment (HTA) of regenerative medicines, including gene and cell-based
therapies. Trained as a pharmacist and with an MSc in HTA, she holds a PhD
in Drug Innovation titled: “Development, market authorization and market
access of gene- and cell-based therapies”. Over the years Renske conducted
research at the University of California, San Francisco (UCSF), spend time
at the Dutch Medicines Evaluation Board (CBG-MEB), Dutch National Health
Care Institute (Zorginstituut Nederland) and collaborated with several
research groups, amongst which the Center of Health Economics at the
University of York. At the Julius Center Renske is lead of the
Regenerative Medicines (RM) team within the Health Economic
Evaluation-group. She strives to increase translation of RM and (academic)
gene and cell-based therapies towards implementation in healthcare
services. In doing so her research focusses on payment models, development
cost, (early) economic evaluations and funding/business models. She aims
to contribute to better understanding of the fit between innovative
therapies and existing development frameworks. This is not only relevant
for RM but also for future biomedical innovations.
* Co-Chair: Richard Denk, Senior Consulting Aseptic Processing &
Containment, SKAN AG
Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
Richard Denk is working at the company SKAN AG, headquartered in
Allschwil/Switzerland in the position Senior Consultant Aseptic Processing
& Containment. Richard was member of the PDA Isolator Expert Group and
publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to
Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory
Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator
Group. Richard founded 15 years ago the Containment expert group of the
ISPE D / A / CH. The Containment Group published the Containment Manual
Richard was responsible for in September 2021 Richard has spent more than
30 years with the subject production of aseptic processing and highly
active / highly hazardous substances and has developed the containment
pyramid.
* 09:15 – 11:00
OPENING PLENARY
Salon ABC
* Moderator: Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor,
Julius Center, UMC Utrecht
Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius Center,
UMC Utrecht
Renske ten Ham is an assistant professor at the UMC Utrecht in the
Netherlands and specializes in health economics & health technology
assessment (HTA) of regenerative medicines, including gene and cell-based
therapies. Trained as a pharmacist and with an MSc in HTA, she holds a PhD
in Drug Innovation titled: “Development, market authorization and market
access of gene- and cell-based therapies”. Over the years Renske conducted
research at the University of California, San Francisco (UCSF), spend time
at the Dutch Medicines Evaluation Board (CBG-MEB), Dutch National Health
Care Institute (Zorginstituut Nederland) and collaborated with several
research groups, amongst which the Center of Health Economics at the
University of York. At the Julius Center Renske is lead of the
Regenerative Medicines (RM) team within the Health Economic
Evaluation-group. She strives to increase translation of RM and (academic)
gene and cell-based therapies towards implementation in healthcare
services. In doing so her research focusses on payment models, development
cost, (early) economic evaluations and funding/business models. She aims
to contribute to better understanding of the fit between innovative
therapies and existing development frameworks. This is not only relevant
for RM but also for future biomedical innovations.
* 09:15 – 09:40
7 THINGS I WISH I KNEW BEFORE UNDERGOING GENE THERAPY
* Presenter: Jimi Olaghere, Gene Editing Recipient , -
Jimi Olaghere, Gene Editing Recipient , -
Jimi Olaghere is a CASGEVY™ recipient. Drawing from his personal
experience of living with Sickle Cell Disease for 35 years, Olaghere
has become a staunch advocate for increased accessibility of gene
therapies for SCD patients. His dedication to patient advocacy stems
from a deep-rooted belief in the power of equitable healthcare and the
fundamental right of every individual to access life-changing
treatments. Olaghere's journey took a transformative turn when he
became involved in a groundbreaking clinical trial led by Vertex
Pharmaceutical and CRISPR Therapeutics. His participation in the trial
resulted in a significant achievement - a functional cure for Sickle
Cell Disease. This monumental breakthrough not only transformed
Olaghere's life but also propelled him into the forefront of the
conversation surrounding gene therapy and its potential to
revolutionize healthcare.
* 09:40 – 10:05
EMA’S EXPERIENCE IN THE DEVELOPMENT SUPPORT AND APPROVAL OF GENE THERAPY
MEDICINAL PRODUCTS
* Regulatory Presenter: Veronika Jekerle
Veronika Jekerle
* 10:05 – 10:30
ENHANCING STRATEGIC DECISION-MAKING FOR ATMP DEVELOPMENT &
COMMERCIALIZATION: THE ROLE OF SUPPLY CHAIN BUSINESS INTELLIGENCE
* Presenter: Steffen Schulze, Strategic Analytics & Business Insights
Lead, F. Hoffmann-La Roche
Steffen Schulze, Strategic Analytics & Business Insights Lead, F.
Hoffmann-La Roche
Steffen Schulze is the Strategic Analytics & Business Insights Lead in
Roche's Cell & Gene Therapies division, specializing in quantitative
modeling to assess and integrate data from preclinical stages to
product commercialization in the ATMP field. With a background in
preclinical research, including antibody identification and process
development, Steffen gained technical expertise in commercial
manufacturing as a quality assurance specialist and GMP project
manager. Within Roche, he contributed to cost assessments for a
personalized cancer vaccine and an autologous gene therapy, as well as
preparing the drug product sourcing strategy for an antibody drug
conjugate. Steffen's multidisciplinary expertise bridges scientific,
technical, and economic aspects, supporting Roche's advancements in the
cell and gene therapy field.
* 10:30 – 11:00
PLENARY DISCUSSION
* Moderator: Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor,
Julius Center, UMC Utrecht
Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius
Center, UMC Utrecht
Renske ten Ham is an assistant professor at the UMC Utrecht in the
Netherlands and specializes in health economics & health technology
assessment (HTA) of regenerative medicines, including gene and
cell-based therapies. Trained as a pharmacist and with an MSc in HTA,
she holds a PhD in Drug Innovation titled: “Development, market
authorization and market access of gene- and cell-based therapies”.
Over the years Renske conducted research at the University of
California, San Francisco (UCSF), spend time at the Dutch Medicines
Evaluation Board (CBG-MEB), Dutch National Health Care Institute
(Zorginstituut Nederland) and collaborated with several research
groups, amongst which the Center of Health Economics at the University
of York. At the Julius Center Renske is lead of the Regenerative
Medicines (RM) team within the Health Economic Evaluation-group. She
strives to increase translation of RM and (academic) gene and
cell-based therapies towards implementation in healthcare services. In
doing so her research focusses on payment models, development cost,
(early) economic evaluations and funding/business models. She aims to
contribute to better understanding of the fit between innovative
therapies and existing development frameworks. This is not only
relevant for RM but also for future biomedical innovations.
* Panelist: Jimi Olaghere, Gene Editing Recipient , -
Jimi Olaghere, Gene Editing Recipient , -
Jimi Olaghere is a CASGEVY™ recipient. Drawing from his personal
experience of living with Sickle Cell Disease for 35 years, Olaghere
has become a staunch advocate for increased accessibility of gene
therapies for SCD patients. His dedication to patient advocacy stems
from a deep-rooted belief in the power of equitable healthcare and the
fundamental right of every individual to access life-changing
treatments. Olaghere's journey took a transformative turn when he
became involved in a groundbreaking clinical trial led by Vertex
Pharmaceutical and CRISPR Therapeutics. His participation in the trial
resulted in a significant achievement - a functional cure for Sickle
Cell Disease. This monumental breakthrough not only transformed
Olaghere's life but also propelled him into the forefront of the
conversation surrounding gene therapy and its potential to
revolutionize healthcare.
* Panelist: Veronika Jekerle
Veronika Jekerle
* Panelist: Steffen Schulze, Strategic Analytics & Business Insights
Lead, F. Hoffmann-La Roche
Steffen Schulze, Strategic Analytics & Business Insights Lead, F.
Hoffmann-La Roche
Steffen Schulze is the Strategic Analytics & Business Insights Lead in
Roche's Cell & Gene Therapies division, specializing in quantitative
modeling to assess and integrate data from preclinical stages to
product commercialization in the ATMP field. With a background in
preclinical research, including antibody identification and process
development, Steffen gained technical expertise in commercial
manufacturing as a quality assurance specialist and GMP project
manager. Within Roche, he contributed to cost assessments for a
personalized cancer vaccine and an autologous gene therapy, as well as
preparing the drug product sourcing strategy for an antibody drug
conjugate. Steffen's multidisciplinary expertise bridges scientific,
technical, and economic aspects, supporting Roche's advancements in the
cell and gene therapy field.
* 11:00 – 11:30
NETWORKING COFFEE BREAK, POSTER SESSION & EXHIBITION
Studio 3,4,5,6,7
* 11:30 – 13:00
SESSION 1: CHALLENGES IN MANUFACTURING
Salon ABC
* Moderator: Dayue Chen, PhD, Head of Cell Therapy Technical Development,
Genentech, Inc.
Dayue Chen, PhD, Head of Cell Therapy Technical Development, Genentech,
Inc.
Dayue Chen received his PhD from Baylor College of Medicine and did his
postdoctoral training in Northwestern University. Dr. Chen is currently a
staff scientist and the Head of Cell Therapy and Engineering Development
at Genentech. He is a trained virologist and molecular biologist with
extensive experience in biopharmaceutical industry. He was a research
fellow in the Bioproduct Research and Development Division at Eli Lilly
and Company before joining Genentech in 2019. Dr. Chen has published 40+
research articles in peer reviewed journals and currently serves on the
editorial boards for the PDA Journal of Pharmaceutical Science and
Technology, and the Journal of Biotechnology and Applied Biochemistry. He
is an enthusiastic allurophile (cat lover) and runs two marathon races per
year.
Manufacturability of ATMP represents one of the most difficult challenges in
bringing life-saving/changing products to patients. Three presentations in
this session will describe this universal challenge from different
perspectives ranging from novel modality to lifecycle management. Our
speakers will share their stories in dealing with this shared challenge
across the ATMP space and yet distinctly different from product to product.
* 11:30 – 11:50
THE CHALLENGES OF THE INNOVATIVE EXOSOME-BASED THERAPIES – CASE STUDY
* Presenter: Sandrine Mores, MA, COO , ExoXpert
Sandrine Mores, MA, COO , ExoXpert
Sandrine Mores, is Chief Operating Officer at ExoXpert, a premier CDMO
company specializing in Exosomes GMP manufacturing. Sandrine joined
ExoBiologics as Head of Quality in 2021 and led the set-up of the GMP
manufacturing site of ExoXpert, in parallel to supporting ExoBiologics
in obtaining the first authorisation in the world by EMA to start a
clinical trial in Europe with MSC derived exosomes. With 22 years of
extensive experience in the GMP environment across renowned biotech
firms like Eurogentec, Novasep (now Thermo Fisher Scientific), and
MasTherCell (now Catalent Cell & Gene Therapy), Sandrine's journey
began in Quality Control, before evolving into Strategic Quality and
Operation roles.
* 11:50 – 12:10
"SPILLING THE TEA" ON LEAKS IN AUTOLOGOUS CAR T MANUFACTURING
* Presenter: Rebecca D. Jordan, Associate Director, Global Cell Therapy
Sterility Assurance Lead, Bristol Myers Squibb (BMS)
Rebecca D. Jordan, Associate Director, Global Cell Therapy Sterility
Assurance Lead, Bristol Myers Squibb (BMS)
Rebecca Jordan is the PDA Interest Group lead for ATMPs. She is also an
Associate Director, serving as the Global Sterility Assurance Lead for
the BMS Cell Therapy Franchise. She oversees all things contamination
control in manufacturing facilities spanning across the Globe. Rebecca
has over 15 years’ experience in industry, with the past 6 in the Cell
Therapy space. She has supported both large and small manufacturing
sites, new facility design and start-up, and global regulatory
interactions. She has experience with a diverse product portfolio
spanning everything from phase I INDs, veterinary, controlled
substance, to commercial approvals of parenteral and CAR T medicines.
She is a skilled investigator with a curious mind which has led to
engaging diverse endeavors throughout her career. Rebecca holds a B.S.
in Biology from Fitchburg State University. Outside of work, Rebecca is
a military spouse, so she’s had to relocate her career and family
across 4 states so far, including a giant tortoise that has been in her
family for 23 years.
* 12:10 – 12:30
VISUAL INSPECTION & PARTICLE LIFE CYCLE MANAGEMENT IN CGT PRODUCTS - SAME,
SAME BUT DIFFERENT?
* Co-Presenter: Roman Mathaes, PhD, CEO, Clear Solutions Laboratories
Roman Mathaes, PhD, CEO, Clear Solutions Laboratories
Roman Mathaes is the CEO of Clear Solutions Laboratories. Before that,
he was Head of Pharmaceutical Services at Lonza Drug Product Services.
In this role, he was responsible for pre-clinical Drug Product
manufacturing for vials, prefilled syringes, and ampoules. He also
leads the packaging & combination product development department and
the lab automation group. Roman joined Lonza from Roche. He is a
Pharmacist by training and holds a Ph.D. in Pharmaceutical technology
from the University of Munich, as well as an MBA and is a lecturer at
the University of Basel.
* Co-Presenter: Antonio Burazer, Global Head Visual Inspection & Particle
LCM, Takeda Pharmaceuticals International AG
Antonio Burazer, Global Head Visual Inspection & Particle LCM, Takeda
Pharmaceuticals International AG
Antonio Burazer joined Takeda in 2010 where he has overseen visual
inspection and secondary packaging processes at a multi-product
manufacturing facility in Vienna, Austria. In 2019 he transitioned to
Global Quality, taking over responsibility for visual inspection and
particle life cycle management globally for Takeda. He is engaged in
collaborating with experts across the industry and strives for
continuous improvement, guided by the ultimate goal of achieving zero
particles in parenteral products.
* 12:30 – 13:00
Q&A, DISCUSSION
* Moderator: Dayue Chen, PhD, Head of Cell Therapy Technical Development,
Genentech, Inc.
Dayue Chen, PhD, Head of Cell Therapy Technical Development, Genentech,
Inc.
Dayue Chen received his PhD from Baylor College of Medicine and did his
postdoctoral training in Northwestern University. Dr. Chen is currently
a staff scientist and the Head of Cell Therapy and Engineering
Development at Genentech. He is a trained virologist and molecular
biologist with extensive experience in biopharmaceutical industry. He
was a research fellow in the Bioproduct Research and Development
Division at Eli Lilly and Company before joining Genentech in 2019. Dr.
Chen has published 40+ research articles in peer reviewed journals and
currently serves on the editorial boards for the PDA Journal of
Pharmaceutical Science and Technology, and the Journal of Biotechnology
and Applied Biochemistry. He is an enthusiastic allurophile (cat lover)
and runs two marathon races per year.
* Panelist: Sandrine Mores, MA, COO , ExoXpert
Sandrine Mores, MA, COO , ExoXpert
Sandrine Mores, is Chief Operating Officer at ExoXpert, a premier CDMO
company specializing in Exosomes GMP manufacturing. Sandrine joined
ExoBiologics as Head of Quality in 2021 and led the set-up of the GMP
manufacturing site of ExoXpert, in parallel to supporting ExoBiologics
in obtaining the first authorisation in the world by EMA to start a
clinical trial in Europe with MSC derived exosomes. With 22 years of
extensive experience in the GMP environment across renowned biotech
firms like Eurogentec, Novasep (now Thermo Fisher Scientific), and
MasTherCell (now Catalent Cell & Gene Therapy), Sandrine's journey
began in Quality Control, before evolving into Strategic Quality and
Operation roles.
* Panelist: Rebecca D. Jordan, Associate Director, Global Cell Therapy
Sterility Assurance Lead, Bristol Myers Squibb (BMS)
Rebecca D. Jordan, Associate Director, Global Cell Therapy Sterility
Assurance Lead, Bristol Myers Squibb (BMS)
Rebecca Jordan is the PDA Interest Group lead for ATMPs. She is also an
Associate Director, serving as the Global Sterility Assurance Lead for
the BMS Cell Therapy Franchise. She oversees all things contamination
control in manufacturing facilities spanning across the Globe. Rebecca
has over 15 years’ experience in industry, with the past 6 in the Cell
Therapy space. She has supported both large and small manufacturing
sites, new facility design and start-up, and global regulatory
interactions. She has experience with a diverse product portfolio
spanning everything from phase I INDs, veterinary, controlled
substance, to commercial approvals of parenteral and CAR T medicines.
She is a skilled investigator with a curious mind which has led to
engaging diverse endeavors throughout her career. Rebecca holds a B.S.
in Biology from Fitchburg State University. Outside of work, Rebecca is
a military spouse, so she’s had to relocate her career and family
across 4 states so far, including a giant tortoise that has been in her
family for 23 years.
* Panelist: Roman Mathaes, PhD, CEO, Clear Solutions Laboratories
Roman Mathaes, PhD, CEO, Clear Solutions Laboratories
Roman Mathaes is the CEO of Clear Solutions Laboratories. Before that,
he was Head of Pharmaceutical Services at Lonza Drug Product Services.
In this role, he was responsible for pre-clinical Drug Product
manufacturing for vials, prefilled syringes, and ampoules. He also
leads the packaging & combination product development department and
the lab automation group. Roman joined Lonza from Roche. He is a
Pharmacist by training and holds a Ph.D. in Pharmaceutical technology
from the University of Munich, as well as an MBA and is a lecturer at
the University of Basel.
* Panelist: Antonio Burazer, Global Head Visual Inspection & Particle
LCM, Takeda Pharmaceuticals International AG
Antonio Burazer, Global Head Visual Inspection & Particle LCM, Takeda
Pharmaceuticals International AG
Antonio Burazer joined Takeda in 2010 where he has overseen visual
inspection and secondary packaging processes at a multi-product
manufacturing facility in Vienna, Austria. In 2019 he transitioned to
Global Quality, taking over responsibility for visual inspection and
particle life cycle management globally for Takeda. He is engaged in
collaborating with experts across the industry and strives for
continuous improvement, guided by the ultimate goal of achieving zero
particles in parenteral products.
* 13:00 – 14:10
NETWORKING LUNCH BREAK & EXHIBITION
Studio 3,4,5,6,7
* 13:40 – 14:10
GUIDED POSTER WALK
Studio 3,4,5,6,7
* Moderator: Josh Eaton, MS, Senior Director, Scientific and Regulatory
Affairs, PDA
Josh Eaton, MS, Senior Director, Scientific and Regulatory Affairs, PDA
Josh Eaton joined PDA in 2011 as a project manager and is now Senior
Director, Scientific and Regulatory Affairs at PDA. He and his team work
with PDA members to produce Technical Reports, Points to Consider
documents, and feedback on regulatory draft guidance. The S&RA staff also
facilitate the activities of the PDA Technical Advisory Boards and PDA
Interest Groups. Prior to joining PDA, Josh developed and marketed drug
discovery and research reagents and co-founded a small spin-off company
based on those technologies. He earned his Master’s degree in Biochemistry
and Biotechnology in 2005 from Georgetown University.
* 13:40 – 14:10
A NOVEL APPROACH TO MANAGING RISKS IN ASEPTIC PROCESSING OF CELL & GENE
THERAPIES
* 13:40 – 14:10
BIODECONTAMINATION OF RAW MATERIALS IN PACKAGING PRODUCTION PROCESS
* Poster Presenter: Andrea Weiss
Andrea Weiss
* 13:40 – 14:10
CCS FOR MATERIAL TRANSFER: BEST PRACTICE FOR PACKAGING AND SURFACE
DISINFECTION
* Poster Presenter: Bram Van Puymbroeck, Account Manager, STERIS Life
Sciences
Bram Van Puymbroeck, Account Manager, STERIS Life Sciences
I have a strong background in technical sales and marketing. Currently,
I serve as a cGMP Sales Consultant at STERIS, where I specialize in
sterility maintenance products. My role involves assisting
pharmaceutical companies with their Contamination Control Strategy,
providing consultative support, and managing territories for sterility
maintenance products. One of the innovative solutions I work with is
the Purefit sterilization wrapping system. My journey began at Optimus
Instruments, where I spent eight years focusing on (bio)reactor systems
and bioprocess solutions. I've also been actively involved in industry
events, such as the VCCN Contamination Control Congress. My passion
lies in advancing sterility practices within the life sciences field,
and I continue to learn and contribute to the industry through
publications and speaking engagements.
* 13:40 – 14:10
CHALLENGES IN THE ANALYSIS OF A PHARMACEUTICAL LENTIVIRAL VECTOR BY
ORTHOGONAL PHYSICAL (NANO)PARTICLE CHARACTERIZATION TECHNIQUES
* Poster Presenter: Daniela Stadler, PhD, Scientist, Coriolis Pharma
Research GmbH
Daniela Stadler, PhD, Scientist, Coriolis Pharma Research GmbH
Dr. Daniela Stadler is working as scientist at Coriolis Pharma, a
science-driven contract research organization located in Munich,
Germany, for formulation development, lyophilization, and analytics of
biopharmaceuticals. She did her master’s degree in molecular
biotechnology at the Technical University of Munich (TUM) in 2013.
During her PhD (2013-2017) at the Institute of Virology at TUM she
investigated hepatitis B virus DNA modification and degradation
mechanisms induced by cytokines. As postdoctoral researcher at
Helmholtz Zentrum München and TUM, her following studies focused on
antiviral host proteins and drug repurposing against SARS-CoV-2. At
Coriolis Pharma, she is working on the evaluation of particle analysis
and characterization technologies with a focus on biopharmaceuticals.
* 13:40 – 14:10
CONSIDERATIONS FOR CLEANING LIPID NANOPARTICLES (LNPS)9
* Poster Presenter: James N. Polarine, MA, Senior Technical Service
Manager, STERIS Corporation
James N. Polarine, MA, Senior Technical Service Manager, STERIS
Corporation
Mr. Polarine is a senior technical service manager at STERIS
Corporation. He has been with STERIS Corporation for twenty-four years.
His current technical focus is microbial control in cleanrooms and
other critical environments. Mr. Polarine is a 2019 PDA Michael S.
Korczynski Award recipient and the 2024 PDA Service Appreciation Award
recipient. He is active on the prestigious PDA’s Scientific Advisory
Board (SAB). He was a co-author on PDA’s Technical Report #70 on
Cleaning and Disinfection, Technical Report #88 on Microbial
Deviations, and the COVID Points to Consider. Mr. Polarine teaches
industry regulators as well as the pharmaceutical, biotech, ATMP, and
medical device industries at the PDA and the University of Tennessee.
Mr. Polarine currently teaches the cleaning and disinfection course as
part of the PDA Aseptic Processing Course, IEST, and at the University
of Tennessee Parenteral Medications Course. Mr. Polarine is the current
past President for the PDA Missouri Valley Chapter and Vice President
of Membership for the IEST. He is the PDA Chapter Council Vice
Chairperson. Mr. Polarine graduated from the University of Illinois
with a Master of Arts in Biology.
* 13:40 – 14:10
DESIGNING A DISINFECTANT PROGRAM FOR ADVANCED THERAPY MEDICINAL PRODUCT
MANUFACTURING
* Poster Presenter: James N. Polarine, MA, Senior Technical Service
Manager, STERIS Corporation
James N. Polarine, MA, Senior Technical Service Manager, STERIS
Corporation
Mr. Polarine is a senior technical service manager at STERIS
Corporation. He has been with STERIS Corporation for twenty-four years.
His current technical focus is microbial control in cleanrooms and
other critical environments. Mr. Polarine is a 2019 PDA Michael S.
Korczynski Award recipient and the 2024 PDA Service Appreciation Award
recipient. He is active on the prestigious PDA’s Scientific Advisory
Board (SAB). He was a co-author on PDA’s Technical Report #70 on
Cleaning and Disinfection, Technical Report #88 on Microbial
Deviations, and the COVID Points to Consider. Mr. Polarine teaches
industry regulators as well as the pharmaceutical, biotech, ATMP, and
medical device industries at the PDA and the University of Tennessee.
Mr. Polarine currently teaches the cleaning and disinfection course as
part of the PDA Aseptic Processing Course, IEST, and at the University
of Tennessee Parenteral Medications Course. Mr. Polarine is the current
past President for the PDA Missouri Valley Chapter and Vice President
of Membership for the IEST. He is the PDA Chapter Council Vice
Chairperson. Mr. Polarine graduated from the University of Illinois
with a Master of Arts in Biology.
* 13:40 – 14:10
DETECTION OF PARTICULATE MATTER IN SINGLE-USE SYSTEMS APPLIED IN THE
PRODUCTION OF ATMPS
* Poster Presenter: Klaus R. Wormuth, PhD, Principal Scientist, Sartorius
Stedim Biotech
Klaus R. Wormuth, PhD, Principal Scientist, Sartorius Stedim Biotech
Klaus Wormuth has a Ph.D. in Chemical Engineering from the University
of Washington and 36 years of experience in research and development in
a variety of fields, primarily in dispserions, medical devices, and
most recently single-use technologies. He is currently Principal
Scientist for particles topics at Sartorius in Göttingen Germany.
* 13:40 – 14:10
DEVELOPMENT OF A DUAL REPORTER CARGO AND SYSTEMIC INCORPORATION OF A
HIGHLY FLEXIBLE, BENCHTOP AUTOMATION SYSTEM TO FACILITATE RAAV9-BASED
NOVEL CAPSID DEVELOPMENT AND CHARACTERIZATION
* Poster Presenter: Chakameh Azimpour, PhD, Director - Analytical
Development, Capsida Biotherapeutics
Chakameh Azimpour, PhD, Director - Analytical Development, Capsida
Biotherapeutics
Dr. Chakameh Azimpour is an experienced leader with extensive expertise
in regulatory applications, project management, and digital and
continuous improvement. Currently serving as a director, she leads a
high-performing technical team in Analytical Development at Capsida
Biotherapeutics, a pioneering company in gene therapy. Her
responsibilities include providing technical leadership for analytical
development and quality control aspects in portfolio programs, as well
as managing laboratory operations such as method development,
qualification, and transfer to quality control. Additionally, she
ensures compliance with FDA, cGMPs, ICH guidelines, and follows QBD
principles and industry best practices in all analytical and quality
control processes. Beyond her work in the industry, she has also
dedicated more than 12 years to sharing her knowledge, teaching both
theoretical principles and practical skills at academic institutions.
She is currently a board member at Conejo School Foundation, an
independent 501(c)(3) non-profit organization that supports student's
achivement. she holds a Ph.D. in Microbiology/Genetics from the
University of Vienna. During her leisure time, she volunteers, enjoys
reading, cooking and baking, and cherishes moments with family and
friends.
* 13:40 – 14:10
HARMONIZING AND AUTOMATING THE ENDOTOXIN DETECTION OF CELL & GENE THERAPY
PRODUCTS WITH RECOMBINANT FACTOR C
* Poster Presenter: Christian Faderl, Project Leader, bioMérieux
Christian Faderl, Project Leader, bioMérieux
Christian Fader holds a PhD in organic chemistry from the University of
Regensburg. After experiences in the quality management for a pharma
company, he currently serves as Project Leader working in the R&D
Department for endotoxin at bioMérieux. With 7 years experiences in the
endotoxin business, he is responsible for all endotoxin service
projects and is a recognized expert for Low Endotoxin Recovery (LER)
and endotoxin demasking.
* 13:40 – 14:10
INFLUENCE OF RUBBER STOPPERS ON IMMUNOGLOBULIN BEHAVIOR
* Poster Presenter: Giorgio Fernando De Avelar Francisco, MSc, R&D
project engineer, Aptar Stelmi SAS
Giorgio Fernando De Avelar Francisco, MSc, R&D project engineer, Aptar
Stelmi SAS
My name is Giorgio and I hold a position of R&D engineer at Aptar
Pharma Injectables and PhD student at Institut de sciences de matériaux
de Mulhouse. I have an undergraduate degree in industrial chemistry
obtained at Federal University of São Paulo, Brazil, with a science
master’s degree obtained in the same university. During my academic
life, I worked in different projects as study of release of ibuprofen
covalently bounded on a functionalized mesoporous silica, synthesis of
superparamagnetic nanoparticles made of iron oxide and mesoporous
silica in a core-shell structure to be used in magnetofection. My PhD
thesis with Aptar Pharma has the goal to understand and evaluate the
interactions between the proteins, present in the drug formulations,
with the surfaces present in the conditioning and administration
devices.
* 13:40 – 14:10
MYCOPLASMA RELEASE TEST WITH LOW VOLUME PROTOCOL: FROM SAMPLE TO RESULTS
IN LESS THAN 1 HOUR
* Poster Presenter: Caroline Kassim Houssenaly, PhD, R&D Biosciences
Manager, bioMérieux
Caroline Kassim Houssenaly, PhD, R&D Biosciences Manager, bioMérieux
Caroline Kassim is Research and Development Manager for Pharma Quality
Control ranges within the bioMérieux. With over 15 years of Industrial
Microbiology, she is focusing on leading the development of new of
Pharma QC solutions & their applications which will continue to answer
unmet needs. Having worked in different technical roles, she is a
technical expert in her field and provide scientific support on both
traditional & rapid alternative microbial methods for pharma
applications.
* 13:40 – 14:10
OPTIMIZATION OF ELECTRON MICROSCOPICAL METHODS FOR A VALIDATED QUALITY
ASSESSMENT OF ADENO-ASSOCIATED VIRUSES (AAV)
* Poster Presenter: Ashley Stephen Layland, Project Director, neotem
Bioanalytics-IIT GmbH
Ashley Stephen Layland, Project Director, neotem Bioanalytics-IIT GmbH
Graduating as a research assistant in 2011, Ashley Stephen Layland
began his career in cell culture technology at Xell AG (which is now
part of Sartorius) where he acquired eight years of experience in
upstream processing and cultivation. Shortly after, from 2012, Ashley
then gained further in-depth experience in quality assurance
management, virology and electron microscopy from Charles River
Laboratories and the Centre for Ultrastructural Diagnostics located at
the University of Bielefeld. Ashley then took the position of project
director at neotem Bioanalytics in 2022 and now leads a GMP-certified
company, applying electron microscopy for the viral safety assessment
of biologics and the characterisation of virus products.
* 13:40 – 14:10
SCALABLE SINGLE-USE HARVEST AND CLARIFICATION SOLUTIONS FOR CELL AND VIRUS
BASED ATMPS
* Poster Presenter: Marc Noverraz, MSc, Process Technology Manager -
Separation Technologies, Sartorius
Marc Noverraz, MSc, Process Technology Manager - Separation
Technologies, Sartorius
Marc Noverraz has been working for Sartorius since 2021, where he is a
Process Technology Manager for Separation Technologies. He earned his
chemical engineering masters degree at EPFL in Lausanne, Switzerland.
Marc held various positions in process development for biopharma
manufacturing, in particular the purification of vaccines and viral
vectors, and was leading a downstream process development group at
Janssen. As of 2021, he has been working as a Process Technology
Manager focusing on downstream processing of new modalities where he
helps to fit Sartorius' technologies into those new processes such as
AAV, lentivirus and mRNA.
* 13:40 – 14:10
THE MYTH OF THE “NON-GMP SPACE:” THE CRITICALITY OF ESTABLISHING GOOD
ASEPTIC PRACTICES IN THE DEVELOPMENT ENVIRONMENT
* Poster Presenter: Amanda Curtis, Microbiology Consultant, ValSource,
Inc.
Amanda Curtis, Microbiology Consultant, ValSource, Inc.
Amanda Curtis is a Microbiology Consultant at ValSource with 15 years
of experience in medical microbiology, pharmaceutical microbiology, and
other regulated industries. She received her bachelor’s degree in
Microbiology from Purdue University. Amanda’s pharmaceutical expertise
is in the field of Advanced Therapy Medicinal Products (ATMPs), with
experience bringing cell and gene therapy products through FDA
Pre-Approval Inspections. She is experienced in complex investigations,
sterility testing, and microbial and contamination control with a focus
on risk-based approaches to environmental monitoring.
* 13:40 – 14:10
VIRAL VECTORS INSIDE AN ISOLATOR - APPROACHES TO MINIMIZE THEIR ASSOCIATED
RISKS
* Poster Presenter: Maximilian Mittelviefhaus
Maximilian Mittelviefhaus
* 13:40 – 14:10
VIRUS FILTRATION AS AN UPSTREAM RISK MITIGATION TOOL IN THE MANUFACTURING
OF ADVANCED THERAPY MEDICINAL PRODUCTS
* Poster Presenter: Michael Lasse, PhD, Global Product Manager, Sartorius
Michael Lasse, PhD, Global Product Manager, Sartorius
Dr. Michael Lasse is a Global Product Manager for Virus Clearance
working at Sartorius in Göttingen. He is a biochemist with strong focus
on protein expression, downstream purification and viral clearance.
After studying cell and molecular biology at the University of Rostock,
he continued his PhD studies in Biochemistry at the University of
Cologne. His research areas include the programmed cell death during
development of neural progenitor cells as well as recombinant protein
expression of apoptosis relevant membrane proteins, development of
chromatographic purification techniques and identification of
post-translational lipid modifications. In 2013 he joined Charles River
Laboratories in Cologne as a Study Director for virus clearance (VC)
studies and later managed a specialized team within the VC operations
group focusing on chromatography, chromatography-related tech transfer
and associated topics like continuous processing. In 2019 he
transitioned into his current position as a Global Product Manager at
Sartorius focussing on technologies for virus inactivation and virus
removal in particular upstream and downstream virus filtration and
associated production setups in commercial manufacturing.
* 14:10 – 14:20
INTERACTIVE QUESTIONNAIRE
Salon ABC
* Moderator: Ian Johnston, PhD, Project Lead Translational TCR Drug
Development Senior Project Manager - Research & Development , Miltenyi
Biotec B.V. & Co. KG
Ian Johnston, PhD, Project Lead Translational TCR Drug Development Senior
Project Manager - Research & Development , Miltenyi Biotec B.V. & Co. KG
Dr. Ian Johnston is Project Lead Translational TCR Drug Development and
Senior Project Manager in the Research & Development Department at
Miltenyi Biotec B.V. & Co. KG. Dr. Johnston is currently project and
development lead responsible for certain TCR T and CAR T cell gene
therapies being prepared for clinical application. Since joining Miltenyi
Biotec in 1999, Dr. Johnston has developed a number of reagents and
procedures to improve the efficiency of genetic modification of primary
cells such as human T and stem cells. A number of these procedures have
been fully automated on a functionally closed cell processing platform –
the CliniMACS® Prodigy. In addition, Dr. Johnston has lead development of
numerous products for magnetic isolation of cells, molecules, organelles
and for use in the field of HIV research. He has been Principle
Investigator on a number of European consortium grants focused on the
genetic modification of stem cells, most recently Cell-PID and SCIDNET.
Prior to joining Miltenyi, he studied Natural Sciences at Cambridge
University where he also completed a PhD studying immunopathological
mechanisms in the CNS supported by the Multiple Sclerosis Society. This
was followed by postdoctoral research at Würzburg University with Prof.
Volker ter Meulen working with recombinant measles virus systems,
supported by two fellowships from the Wellcome Trust and Alexander von
Humboldt Foundation.
* 14:20 – 15:50
SESSION 2: FROM DEVELOPMENT TO COMMERCIALIZATION
Salon ABC
* Moderator: Ian Johnston, PhD, Project Lead Translational TCR Drug
Development Senior Project Manager - Research & Development , Miltenyi
Biotec B.V. & Co. KG
Ian Johnston, PhD, Project Lead Translational TCR Drug Development Senior
Project Manager - Research & Development , Miltenyi Biotec B.V. & Co. KG
Dr. Ian Johnston is Project Lead Translational TCR Drug Development and
Senior Project Manager in the Research & Development Department at
Miltenyi Biotec B.V. & Co. KG. Dr. Johnston is currently project and
development lead responsible for certain TCR T and CAR T cell gene
therapies being prepared for clinical application. Since joining Miltenyi
Biotec in 1999, Dr. Johnston has developed a number of reagents and
procedures to improve the efficiency of genetic modification of primary
cells such as human T and stem cells. A number of these procedures have
been fully automated on a functionally closed cell processing platform –
the CliniMACS® Prodigy. In addition, Dr. Johnston has lead development of
numerous products for magnetic isolation of cells, molecules, organelles
and for use in the field of HIV research. He has been Principle
Investigator on a number of European consortium grants focused on the
genetic modification of stem cells, most recently Cell-PID and SCIDNET.
Prior to joining Miltenyi, he studied Natural Sciences at Cambridge
University where he also completed a PhD studying immunopathological
mechanisms in the CNS supported by the Multiple Sclerosis Society. This
was followed by postdoctoral research at Würzburg University with Prof.
Volker ter Meulen working with recombinant measles virus systems,
supported by two fellowships from the Wellcome Trust and Alexander von
Humboldt Foundation.
This session will focus on an exciting new development in European cell and
gene therapy where academic centers are advancing new ATMPs into clinical
practice and towards national compassionate use implementation or European
market authorization following an academic, not-for-profit model. This
approach can lead to both the rapid introduction of novel therapies to the
market or can improve patient accessibility by generating products
functionally like commercial products which may currently have limited
availability. The speakers will describe their centralized or point-of-care
(decentralized) manufacturing methodologies and present an overview of the
clinical data obtained to date. The different approaches employed to gain
reimbursement for the cellular drug products with the local authorities will
be discussed and the possible regulatory path to drug registration will be
debated.
* 14:20 – 14:40
TREATMENT WITH TUMOR-INFILTRATING LYMPHOCYTES (TILS) FOR PATIENTS WITH
ADVANCED MELANOMA: FROM A RANDOMIZED PHASE 3 TRIAL IN ACADEMIA TOWARDS
MARKETING AUTHORIZATION
* Academic Presenter: Inge Jederma, PhD, Head of Translational Cellular
Therapy, Netherlands Cancer Institute / Antoni van Leeuwenhoek
Inge Jederma, PhD, Head of Translational Cellular Therapy, Netherlands
Cancer Institute / Antoni van Leeuwenhoek
Since June 2020, Dr. Inge Jedema is Head of Translational Cellular
Therapy at the Netherlands Cancer Institute/Antoni van Leeuwenhoek
Hospital in Amsterdam, the Netherlands. In this position she is
responsible for the development and implementation of cellular
immunotherapy strategies in the field of solid oncology. She studied
Biomedical Sciences in Leiden and worked between 1997 and 2020 at the
Department of Hematology of the Leiden University Medical Center (LUMC)
in the Netherlands. After her PhD research she was leading the
Laboratory for Translational Hematology and the diagnostic Laboratory
for Specialized Hematology and was responsible for the development and
implementation of cellular immunotherapy strategies and the application
of ATMPs in clinical trials for patients with hematological
malignancies.
* 14:40 – 15:00
DECENTRALIZING CAR-T PRODUCTION: PROOF OF CONCEPT NETWORK EXPERIENCE WITH
AN ACADEMIC CAR-T
* Academic Presenter: Eulalia Olesti, PharmD, PhD, Regulatory Affairs
Lead, Hospital Clinic Barcelona, IDIBAPS
Eulalia Olesti, PharmD, PhD, Regulatory Affairs Lead, Hospital Clinic
Barcelona, IDIBAPS
Eulalia Olesti, PhD Dr. Eulalia Olesti is a regulatory and scientific
manager at the Clinical Pharmacology Department of the Hospital Clínic
de Barcelona. She possesses extensive expertise in the scientific and
regulatory assessment of Advanced Therapy Medicinal Products (ATMPs)
and has a robust background in clinical research and academia. Her
professional experience includes the assessment of regulatory
strategies and scientific advice on ATMPs, as well as the development
and submission of regulatory documentation for clinical candidates and
authorized drugs. Dr. Olesti earned her PhD in Clinical Pharmacology
from Hospital del Mar in Barcelona and subsequently completed a
post-doctoral fellowship at the University of Geneva. In addition to
her research and regulatory roles, Dr. Olesti has substantial teaching
experience, having taught at both the bachelor's and master's levels at
various national and international universities.
* 15:00 – 15:20
ONE-STEP INSTANT MSC PRODUCT ACCOMPANYING AUTOLOGOUS CHONDRON
TRANSPLANTATION FOR FOCAL ARTICULAR CARTILAGE LESIONS OF THE KNEE:
PRELIMINARY RESULTS OF A CROSS-OVER RANDOMIZED CONTROLLED TRIAL
* Academic Presenter: Jasmijn Korpershoek, MD PhD, Postdoctoral
Researcher, UMC Utrecht
Jasmijn Korpershoek, MD PhD, Postdoctoral Researcher, UMC Utrecht
Jasmijn Korpershoek, MD PhD, works as a postdoctoral researcher at the
University Medical Center (UMC) in Utrecht, the Netherlands, and the
Mayo Clinic in Rochester, USA. Her curiosity and dedication to
improving patient care through translational research have motivated
her to pursue a career in academic research. Jasmijn and her team at
UMC Utrecht are currently working on the IMPACT one-stage cartilage
transplantation, which is a combination ATMP consisting of autologous
recycled cartilage cells with allogeneic MSCs.
* 15:20 – 15:50
Q&A, DISCUSSION
* Moderator: Ian Johnston, PhD, Project Lead Translational TCR Drug
Development Senior Project Manager - Research & Development , Miltenyi
Biotec B.V. & Co. KG
Ian Johnston, PhD, Project Lead Translational TCR Drug Development
Senior Project Manager - Research & Development , Miltenyi Biotec B.V.
& Co. KG
Dr. Ian Johnston is Project Lead Translational TCR Drug Development and
Senior Project Manager in the Research & Development Department at
Miltenyi Biotec B.V. & Co. KG. Dr. Johnston is currently project and
development lead responsible for certain TCR T and CAR T cell gene
therapies being prepared for clinical application. Since joining
Miltenyi Biotec in 1999, Dr. Johnston has developed a number of
reagents and procedures to improve the efficiency of genetic
modification of primary cells such as human T and stem cells. A number
of these procedures have been fully automated on a functionally closed
cell processing platform – the CliniMACS® Prodigy. In addition, Dr.
Johnston has lead development of numerous products for magnetic
isolation of cells, molecules, organelles and for use in the field of
HIV research. He has been Principle Investigator on a number of
European consortium grants focused on the genetic modification of stem
cells, most recently Cell-PID and SCIDNET. Prior to joining Miltenyi,
he studied Natural Sciences at Cambridge University where he also
completed a PhD studying immunopathological mechanisms in the CNS
supported by the Multiple Sclerosis Society. This was followed by
postdoctoral research at Würzburg University with Prof. Volker ter
Meulen working with recombinant measles virus systems, supported by two
fellowships from the Wellcome Trust and Alexander von Humboldt
Foundation.
* Panelist: Inge Jederma, PhD, Head of Translational Cellular Therapy,
Netherlands Cancer Institute / Antoni van Leeuwenhoek
Inge Jederma, PhD, Head of Translational Cellular Therapy, Netherlands
Cancer Institute / Antoni van Leeuwenhoek
Since June 2020, Dr. Inge Jedema is Head of Translational Cellular
Therapy at the Netherlands Cancer Institute/Antoni van Leeuwenhoek
Hospital in Amsterdam, the Netherlands. In this position she is
responsible for the development and implementation of cellular
immunotherapy strategies in the field of solid oncology. She studied
Biomedical Sciences in Leiden and worked between 1997 and 2020 at the
Department of Hematology of the Leiden University Medical Center (LUMC)
in the Netherlands. After her PhD research she was leading the
Laboratory for Translational Hematology and the diagnostic Laboratory
for Specialized Hematology and was responsible for the development and
implementation of cellular immunotherapy strategies and the application
of ATMPs in clinical trials for patients with hematological
malignancies.
* Panelist: Eulalia Olesti, PharmD, PhD, Regulatory Affairs Lead,
Hospital Clinic Barcelona, IDIBAPS
Eulalia Olesti, PharmD, PhD, Regulatory Affairs Lead, Hospital Clinic
Barcelona, IDIBAPS
Eulalia Olesti, PhD Dr. Eulalia Olesti is a regulatory and scientific
manager at the Clinical Pharmacology Department of the Hospital Clínic
de Barcelona. She possesses extensive expertise in the scientific and
regulatory assessment of Advanced Therapy Medicinal Products (ATMPs)
and has a robust background in clinical research and academia. Her
professional experience includes the assessment of regulatory
strategies and scientific advice on ATMPs, as well as the development
and submission of regulatory documentation for clinical candidates and
authorized drugs. Dr. Olesti earned her PhD in Clinical Pharmacology
from Hospital del Mar in Barcelona and subsequently completed a
post-doctoral fellowship at the University of Geneva. In addition to
her research and regulatory roles, Dr. Olesti has substantial teaching
experience, having taught at both the bachelor's and master's levels at
various national and international universities.
* Panelist: Jasmijn Korpershoek, MD PhD, Postdoctoral Researcher, UMC
Utrecht
Jasmijn Korpershoek, MD PhD, Postdoctoral Researcher, UMC Utrecht
Jasmijn Korpershoek, MD PhD, works as a postdoctoral researcher at the
University Medical Center (UMC) in Utrecht, the Netherlands, and the
Mayo Clinic in Rochester, USA. Her curiosity and dedication to
improving patient care through translational research have motivated
her to pursue a career in academic research. Jasmijn and her team at
UMC Utrecht are currently working on the IMPACT one-stage cartilage
transplantation, which is a combination ATMP consisting of autologous
recycled cartilage cells with allogeneic MSCs.
* 15:50 – 16:20
NETWORKING COFFEE BREAK, POSTER SESSION & EXHIBITION
Studio 3,4,5,6,7
* 16:20 – 17:50
SESSION 3: QUALITY CONTROL
Salon ABC
* Moderator: Ryan Murray, MS, Senior Consultant, ValSource, Inc.
Ryan Murray, MS, Senior Consultant, ValSource, Inc.
Ryan Murray is a quality and manufacturing science Senior Consultant with
ValSource, Inc. He is primarily focused in the areas of quality and
regulatory compliance, facility design and control, technology transfer,
process qualification, and aseptic risk management of both biologics and
advanced therapy medicinal products (ATMPs). Ryan is an active member of
the Parenteral Drug Associationand the International Society for
Pharmaceutical Engineering (ISPE). He has a BS in biomedical science and
MS in biochemistry and biophysics from Texas A&M University.
* 16:20 – 16:40
ADDRESSING THE CHALLENGES: ALTERNATIVE METHODS FOR ATMP ANALYTICS TESTING
* Presenter: Sarah E. Sheridan, PhD, Technical Consultant, Merck
Sarah E. Sheridan, PhD, Technical Consultant, Merck
Dr Sarah Sheridan is a Technical Consultant within Merck KGaA,
providing scientific, technical and regulatory consultancy on Merck
KGaA / BioReliance® Biosafety Testing Services. Drawing on over 22
years of experience in the human and animal health biotech industries,
Dr Sheridan provides biosafety testing consultancy for the company’s
global client base to support pre-clinical to commercial phase
biosafety testing of client manufactured products spanning monoclonal
antibodies to vaccines and novel gene therapies. Dr Sheridan has a
Ph.D. in Virology from the University of Cambridge, UK and a B.Sc.
Honours degree in Life Science.
* 16:40 – 17:00
VIRAL CONTROL STRATEGY FOR ALLOGENEIC CELL THERAPY
* Presenter: Asena Abay, PhD, Senior Scientist, Sanofi
Asena Abay, PhD, Senior Scientist, Sanofi
Asena Abay is a senior scientist in Sanofi’s Cell Therapy Process
Development group. She is working as a Drug Substance lead as well as a
CMC Sub-Team Lead for development of next generation cell therapies.
Asena obtained her Biomedical Engineering degree from Bucknell
University and her PhD for University of Amsterdam. She did her PhD at
the University of Amsterdam as a Marie Curie Fellow, focused biofluidic
and cellular responses to mechanical stresses in bioreactors.
* 17:00 – 17:20
CHALLENGES IN DEVELOPING A CONTAMINATION CONTROL STRATEGY FOR AN ATMP
MANUFACTURING SITE
* Presenter: Arabela X. Cuirolo, PhD, Sterility Assurance Lead, Kite
Pharma EU B.V.
Arabela X. Cuirolo, PhD, Sterility Assurance Lead, Kite Pharma EU B.V.
Arabela is a Pharmacist and a Microbiologist with nearly 10 years of
experience in the industry. She joined the company in 2018, as a QC
Micro Scientist in the start-up face of Kite, fundamentally supporting
the set-up of the EM program (to Establish, validate and sustain EM
program for the site) and the Methods Transfers for her department. She
later led the QC Micro department for about 6 months until she took on
the new challenge as a Sterility Assurance Lead. Within this new role,
she is leading the site Contaminiation Control Strategy while
supporting internally as a SME for new projects related to aseptic
practices.
* 17:20 – 17:50
Q&A, DISCUSSION
* Moderator: Ryan Murray, MS, Senior Consultant, ValSource, Inc.
Ryan Murray, MS, Senior Consultant, ValSource, Inc.
Ryan Murray is a quality and manufacturing science Senior Consultant
with ValSource, Inc. He is primarily focused in the areas of quality
and regulatory compliance, facility design and control, technology
transfer, process qualification, and aseptic risk management of both
biologics and advanced therapy medicinal products (ATMPs). Ryan is an
active member of the Parenteral Drug Associationand the International
Society for Pharmaceutical Engineering (ISPE). He has a BS in
biomedical science and MS in biochemistry and biophysics from Texas A&M
University.
* Panelist: Asena Abay, PhD, Senior Scientist, Sanofi
Asena Abay, PhD, Senior Scientist, Sanofi
Asena Abay is a senior scientist in Sanofi’s Cell Therapy Process
Development group. She is working as a Drug Substance lead as well as a
CMC Sub-Team Lead for development of next generation cell therapies.
Asena obtained her Biomedical Engineering degree from Bucknell
University and her PhD for University of Amsterdam. She did her PhD at
the University of Amsterdam as a Marie Curie Fellow, focused biofluidic
and cellular responses to mechanical stresses in bioreactors.
* Panelist: Sarah E. Sheridan, PhD, Technical Consultant, Merck
Sarah E. Sheridan, PhD, Technical Consultant, Merck
Dr Sarah Sheridan is a Technical Consultant within Merck KGaA,
providing scientific, technical and regulatory consultancy on Merck
KGaA / BioReliance® Biosafety Testing Services. Drawing on over 22
years of experience in the human and animal health biotech industries,
Dr Sheridan provides biosafety testing consultancy for the company’s
global client base to support pre-clinical to commercial phase
biosafety testing of client manufactured products spanning monoclonal
antibodies to vaccines and novel gene therapies. Dr Sheridan has a
Ph.D. in Virology from the University of Cambridge, UK and a B.Sc.
Honours degree in Life Science.
* Panelist: Arabela X. Cuirolo, PhD, Sterility Assurance Lead, Kite
Pharma EU B.V.
Arabela X. Cuirolo, PhD, Sterility Assurance Lead, Kite Pharma EU B.V.
Arabela is a Pharmacist and a Microbiologist with nearly 10 years of
experience in the industry. She joined the company in 2018, as a QC
Micro Scientist in the start-up face of Kite, fundamentally supporting
the set-up of the EM program (to Establish, validate and sustain EM
program for the site) and the Methods Transfers for her department. She
later led the QC Micro department for about 6 months until she took on
the new challenge as a Sterility Assurance Lead. Within this new role,
she is leading the site Contaminiation Control Strategy while
supporting internally as a SME for new projects related to aseptic
practices.
* 17:50 – 22:00
END OF CONFERENCE DAY 1 & NETWORKING EVENT
TUESDAY, 25 JUNE CEST
* 08:00 – 18:00
REGISTRATION OPEN
Studio 3,4,5,6,7
* 08:30 – 08:35
WELCOME TO DAY 2
Salon ABC
* Co-Chair: Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius
Center, UMC Utrecht
Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius Center,
UMC Utrecht
Renske ten Ham is an assistant professor at the UMC Utrecht in the
Netherlands and specializes in health economics & health technology
assessment (HTA) of regenerative medicines, including gene and cell-based
therapies. Trained as a pharmacist and with an MSc in HTA, she holds a PhD
in Drug Innovation titled: “Development, market authorization and market
access of gene- and cell-based therapies”. Over the years Renske conducted
research at the University of California, San Francisco (UCSF), spend time
at the Dutch Medicines Evaluation Board (CBG-MEB), Dutch National Health
Care Institute (Zorginstituut Nederland) and collaborated with several
research groups, amongst which the Center of Health Economics at the
University of York. At the Julius Center Renske is lead of the
Regenerative Medicines (RM) team within the Health Economic
Evaluation-group. She strives to increase translation of RM and (academic)
gene and cell-based therapies towards implementation in healthcare
services. In doing so her research focusses on payment models, development
cost, (early) economic evaluations and funding/business models. She aims
to contribute to better understanding of the fit between innovative
therapies and existing development frameworks. This is not only relevant
for RM but also for future biomedical innovations.
* Co-Chair: Richard Denk, Senior Consulting Aseptic Processing &
Containment, SKAN AG
Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
Richard Denk is working at the company SKAN AG, headquartered in
Allschwil/Switzerland in the position Senior Consultant Aseptic Processing
& Containment. Richard was member of the PDA Isolator Expert Group and
publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to
Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory
Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator
Group. Richard founded 15 years ago the Containment expert group of the
ISPE D / A / CH. The Containment Group published the Containment Manual
Richard was responsible for in September 2021 Richard has spent more than
30 years with the subject production of aseptic processing and highly
active / highly hazardous substances and has developed the containment
pyramid.
* 08:35 – 10:05
SESSION 4: REGULATORY UPDATES
Salon ABC
* Moderator: Manjula Aysola, MS, Senior Regulatory Consultant,
MilliporeSigma
Manjula Aysola, MS, Senior Regulatory Consultant, MilliporeSigma
Manjula Aysola is a Senior Regulatory Consultant supporting the
BioReliance® contract testing services business of MilliporeSigma. She is
an expert on regulatory requirements for manufacturing and quality of
biologics and cell/gene therapeutic products globally. She consults to
ensure BiorReliance® testing services meet global regulatory requirements.
She actively participates in working groups in industry associations such
as BioPhorum on viral detection and clearance topics among others.
Previously, she focused on regulatory requirements for single-use systems
and products for cell/gene therapy manufacturing. She also spent over 10
years as an R&D scientist involved in developing products for biologics
and cell therapy bioprocessing.
This session will provide an overview and updates on various regulatory
expectations for ATMP manufacturing. First, we’ll hear about all the ‘good
practices’ needed to manufacture, test, and distribute an ATMP. In addition,
there will be updates on 3 draft chapters from the USP covering contamination
detection for short shelf-life products using respiration-based, ATP
bioluminescence-based, and other rapid microbial methods. Finally, we’ll hear
from the EDQM providing an update on two general monographs for gene therapy
products which have recently been finalized.
* 08:35 – 08:55
NAVIGATING REGULATORY CHALLENGES: INSIGHTS FROM DEVELOPING ATMPS THROUGH
GMP/GDP/GCP
* Presenter: Patrick Buschor, Dr., Contracted Qualified Person, PMS -
Process Management System
Patrick Buschor, Dr., Contracted Qualified Person, PMS - Process
Management System
I am Dr. Patrick Buschor, a PhD immunologist and consultant in
Regulatory and Quality Affairs. For more than 10 years, I have been
active in the start-up environment at the interface of Manufacturing
(GMP) and clinical development (GCP). I serve as a contracted Qualified
Person and support various ATMP (IMP) projects.
* 08:55 – 09:15
EUROPEAN PHARMACOPOEIA - NEW APPROACH TO GENE THERAPY TEXTS
* Regulatory Presenter: Olga Kolaj-Robin, PhD, Scientific Programme
Manager, European Directorate for the Quality of Medicines and
HealthCare
Olga Kolaj-Robin, PhD, Scientific Programme Manager, European
Directorate for the Quality of Medicines and HealthCare
Olga Kolaj-Robin joined the European Pharmacopoeia Department of the
European Directorate for the Quality of Medicines and Healthcare in
2015 where she works as Scientific Programme Manager coordinating the
work of European Pharmacopoeia Groups of Experts and Working Parties.
In particular, since its reinstatement in 2018 by the European
Pharmacopoeia Commission, she coordinates the activities of Gene
Therapy Products Working Party in charge of elaboration and maintenance
of pharmacopoeial texts in the field of gene therapy. She holds a PhD
in in Protein Biochemistry from University of Limerick (Ireland) and a
MS in Molecular Biotechnology from Gdansk University of Technology
(Poland).
* 09:15 – 09:35
OVERVIEW AND FUTURE PLANS OF THE USP RAPID MICROBIOLOGICAL METHODS
SUBCOMMITTEE
* Presenter: Marsha L. Steed, Founder and CEO / Sr Consultant, Steed
MicroBio / JYA
Marsha L. Steed, Founder and CEO / Sr Consultant, Steed MicroBio / JYA
Marsha Steed has over 30 years of experience as a microbiologist
working in the Pharmaceutical, Biotechnology and Medical Device fields.
Marsha is the Founder and President of Steed MicroBio, LLC which is an
independent microbiology consulting firm and a Senior Microbiology
Associate/Sterility Assurance Expert at Jeff Yuen & Associates, Inc.
consulting firm. Marsha is a globally recognized consultant
specializing in sterility assurance and contamination control matters
in pharmaceutical, biotech and medical device companies. Marsha is a
USP Microbiology Expert Committee member and the chair of the USP
Microbial Control and Sterility Assurance Subcommittee. Marsha studied
Biology at Western New England University in Springfield, MA. Marsha is
active in industry and currently serves on the Parenteral Drug
Association (PDA) ATMP Advisory Board and has previously served on the
PDA Education Advisory Board (EAB); Scientific Advisory Board (SAB) and
has served on numerous PDA Task Forces and meeting planning committees
and has been the chair of the PDA Annual Meeting and PDA Microbiology
Meeting. Marsha is a former notified body ISO inspector.
* 09:35 – 10:05
Q&A, DISCUSSION
* Moderator: Manjula Aysola, MS, Senior Regulatory Consultant,
MilliporeSigma
Manjula Aysola, MS, Senior Regulatory Consultant, MilliporeSigma
Manjula Aysola is a Senior Regulatory Consultant supporting the
BioReliance® contract testing services business of MilliporeSigma. She
is an expert on regulatory requirements for manufacturing and quality
of biologics and cell/gene therapeutic products globally. She consults
to ensure BiorReliance® testing services meet global regulatory
requirements. She actively participates in working groups in industry
associations such as BioPhorum on viral detection and clearance topics
among others. Previously, she focused on regulatory requirements for
single-use systems and products for cell/gene therapy manufacturing.
She also spent over 10 years as an R&D scientist involved in developing
products for biologics and cell therapy bioprocessing.
* Panelist: Patrick Buschor, Dr., Contracted Qualified Person, PMS -
Process Management System
Patrick Buschor, Dr., Contracted Qualified Person, PMS - Process
Management System
I am Dr. Patrick Buschor, a PhD immunologist and consultant in
Regulatory and Quality Affairs. For more than 10 years, I have been
active in the start-up environment at the interface of Manufacturing
(GMP) and clinical development (GCP). I serve as a contracted Qualified
Person and support various ATMP (IMP) projects.
* Panelist: Marsha L. Steed, Founder and CEO / Sr Consultant, Steed
MicroBio / JYA
Marsha L. Steed, Founder and CEO / Sr Consultant, Steed MicroBio / JYA
Marsha Steed has over 30 years of experience as a microbiologist
working in the Pharmaceutical, Biotechnology and Medical Device fields.
Marsha is the Founder and President of Steed MicroBio, LLC which is an
independent microbiology consulting firm and a Senior Microbiology
Associate/Sterility Assurance Expert at Jeff Yuen & Associates, Inc.
consulting firm. Marsha is a globally recognized consultant
specializing in sterility assurance and contamination control matters
in pharmaceutical, biotech and medical device companies. Marsha is a
USP Microbiology Expert Committee member and the chair of the USP
Microbial Control and Sterility Assurance Subcommittee. Marsha studied
Biology at Western New England University in Springfield, MA. Marsha is
active in industry and currently serves on the Parenteral Drug
Association (PDA) ATMP Advisory Board and has previously served on the
PDA Education Advisory Board (EAB); Scientific Advisory Board (SAB) and
has served on numerous PDA Task Forces and meeting planning committees
and has been the chair of the PDA Annual Meeting and PDA Microbiology
Meeting. Marsha is a former notified body ISO inspector.
* Panelist: Olga Kolaj-Robin, PhD, Scientific Programme Manager, European
Directorate for the Quality of Medicines and HealthCare
Olga Kolaj-Robin, PhD, Scientific Programme Manager, European
Directorate for the Quality of Medicines and HealthCare
Olga Kolaj-Robin joined the European Pharmacopoeia Department of the
European Directorate for the Quality of Medicines and Healthcare in
2015 where she works as Scientific Programme Manager coordinating the
work of European Pharmacopoeia Groups of Experts and Working Parties.
In particular, since its reinstatement in 2018 by the European
Pharmacopoeia Commission, she coordinates the activities of Gene
Therapy Products Working Party in charge of elaboration and maintenance
of pharmacopoeial texts in the field of gene therapy. She holds a PhD
in in Protein Biochemistry from University of Limerick (Ireland) and a
MS in Molecular Biotechnology from Gdansk University of Technology
(Poland).
* 10:05 – 10:35
NETWORKING COFFEE BREAK, POSTER SESSION & EXHIBITION
Studio 3,4,5,6,7
* 10:35 – 11:45
SESSION 5: NEW TECHNOLOGIES
Salon ABC
* Moderator: Ryan Murray, MS, Senior Consultant, ValSource, Inc.
Ryan Murray, MS, Senior Consultant, ValSource, Inc.
Ryan Murray is a quality and manufacturing science Senior Consultant with
ValSource, Inc. He is primarily focused in the areas of quality and
regulatory compliance, facility design and control, technology transfer,
process qualification, and aseptic risk management of both biologics and
advanced therapy medicinal products (ATMPs). Ryan is an active member of
the Parenteral Drug Associationand the International Society for
Pharmaceutical Engineering (ISPE). He has a BS in biomedical science and
MS in biochemistry and biophysics from Texas A&M University.
* 10:35 – 10:55
DECENTRALIZED MANUFACTURING OF AUTOLOGOUS ATMPS: HOW TECHNOLOGY INNOVATION
FOSTERS REGULATORY COMPLIANCE
* Presenter: Ursula Busse, PhD, MBA, Head of Regulatory Affairs, Tigen
Pharma
Ursula Busse, PhD, MBA, Head of Regulatory Affairs, Tigen Pharma
Ursula is currently leading Regulatory Affairs for Tigen Pharma, a
Swiss biotech company developing autologous T-cell therapies against
cancer. Ursula joined Tigen from Boehringer-Ingelheim, where she was
Head of Regulatory Intelligence & Policy. Prior to that, Ursula worked
at Novartis as Global Head of Quality Intelligence & External Affairs,
a role she assumed after a few years as Head of Project Office,
Biopharmaceutical Operations, and Project Leader in CMC Regulatory
Affairs for biotech products. Before joining Novartis in 2006, Ursula
worked for startup biotech companies in Canada, in R&D, Quality
Assurance and CMC Regulatory Affairs. Ursula can look back on over 20
years of volunteer engagement in several industry associations (PDA,
DIA, ISPE, EFPIA) and served on PDA’s Board of Directors from 2012 to
2017. She holds a PhD in Cellular and Molecular Biology from Laval
University (Québec, Canada), coupled with an MBA she earned with
honours.
* 10:55 – 11:15
FRAME-BY-FRAME: HOW DIGITAL PROCESS TWINS OVERCOME BARRIERS TO DEVELOP
ROBUST ATMP MANUFACTURING PROCESSES
* Presenter: Sebastian Scheler, Managing Director, Innerspace GmbH
Sebastian Scheler, Managing Director, Innerspace GmbH
I am passionate about pushing the boundaries of advanced risk
assessment technologies to unlock new possibilities for designing and
managing manufacturing processes in pharma. I spearhead a dynamic team
of life science professionals and software developers. The core focus
of my professional work lies in Frame-by-Frame Risk Profiling—an
innovative, automated approach to risk assessment. This cutting-edge
technology facilitates process improvement, process automation,
autogenerated SOPs, and immersive training curricula, empowering
organizations to achieve unparalleled levels of efficiency, compliance
and safety in drug manufacturing. With a profound background in
psychology, I have always been captivated by the intersection of human
behavior and technology. My passion for Virtual Reality has culminated
in pioneering VR simulator methodologies that push the boundaries of
experiential learning, training, and behavior measurement systems.
Beyond my leadership at Innerspace, I also serve as trainer for PDA
training courses and further development of the PDA/Innerspace official
partnership focusing on refining training course delivery and design.
* 11:15 – 11:45
Q&A, DISCUSSION
* Moderator: Ryan Murray, MS, Senior Consultant, ValSource, Inc.
Ryan Murray, MS, Senior Consultant, ValSource, Inc.
Ryan Murray is a quality and manufacturing science Senior Consultant
with ValSource, Inc. He is primarily focused in the areas of quality
and regulatory compliance, facility design and control, technology
transfer, process qualification, and aseptic risk management of both
biologics and advanced therapy medicinal products (ATMPs). Ryan is an
active member of the Parenteral Drug Associationand the International
Society for Pharmaceutical Engineering (ISPE). He has a BS in
biomedical science and MS in biochemistry and biophysics from Texas A&M
University.
* Panelist: Ursula Busse, PhD, MBA, Head of Regulatory Affairs, Tigen
Pharma
Ursula Busse, PhD, MBA, Head of Regulatory Affairs, Tigen Pharma
Ursula is currently leading Regulatory Affairs for Tigen Pharma, a
Swiss biotech company developing autologous T-cell therapies against
cancer. Ursula joined Tigen from Boehringer-Ingelheim, where she was
Head of Regulatory Intelligence & Policy. Prior to that, Ursula worked
at Novartis as Global Head of Quality Intelligence & External Affairs,
a role she assumed after a few years as Head of Project Office,
Biopharmaceutical Operations, and Project Leader in CMC Regulatory
Affairs for biotech products. Before joining Novartis in 2006, Ursula
worked for startup biotech companies in Canada, in R&D, Quality
Assurance and CMC Regulatory Affairs. Ursula can look back on over 20
years of volunteer engagement in several industry associations (PDA,
DIA, ISPE, EFPIA) and served on PDA’s Board of Directors from 2012 to
2017. She holds a PhD in Cellular and Molecular Biology from Laval
University (Québec, Canada), coupled with an MBA she earned with
honours.
* Panelist: Sebastian Scheler, Managing Director, Innerspace GmbH
Sebastian Scheler, Managing Director, Innerspace GmbH
I am passionate about pushing the boundaries of advanced risk
assessment technologies to unlock new possibilities for designing and
managing manufacturing processes in pharma. I spearhead a dynamic team
of life science professionals and software developers. The core focus
of my professional work lies in Frame-by-Frame Risk Profiling—an
innovative, automated approach to risk assessment. This cutting-edge
technology facilitates process improvement, process automation,
autogenerated SOPs, and immersive training curricula, empowering
organizations to achieve unparalleled levels of efficiency, compliance
and safety in drug manufacturing. With a profound background in
psychology, I have always been captivated by the intersection of human
behavior and technology. My passion for Virtual Reality has culminated
in pioneering VR simulator methodologies that push the boundaries of
experiential learning, training, and behavior measurement systems.
Beyond my leadership at Innerspace, I also serve as trainer for PDA
training courses and further development of the PDA/Innerspace official
partnership focusing on refining training course delivery and design.
* 11:45 – 12:45
NETWORKING LUNCH BREAK, POSTER SESSION & EXHIBITION
Studio 3,4,5,6,7
* 12:45 – 12:55
INTERACTIVE QUESTIONNAIRE
Salon ABC
* Moderator: Richard Denk, Senior Consulting Aseptic Processing &
Containment, SKAN AG
Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
Richard Denk is working at the company SKAN AG, headquartered in
Allschwil/Switzerland in the position Senior Consultant Aseptic Processing
& Containment. Richard was member of the PDA Isolator Expert Group and
publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to
Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory
Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator
Group. Richard founded 15 years ago the Containment expert group of the
ISPE D / A / CH. The Containment Group published the Containment Manual
Richard was responsible for in September 2021 Richard has spent more than
30 years with the subject production of aseptic processing and highly
active / highly hazardous substances and has developed the containment
pyramid.
* 12:55 – 13:35
CLOSING PLENARY PART I
Salon ABC
* Moderator: Richard Denk, Senior Consulting Aseptic Processing &
Containment, SKAN AG
Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
Richard Denk is working at the company SKAN AG, headquartered in
Allschwil/Switzerland in the position Senior Consultant Aseptic Processing
& Containment. Richard was member of the PDA Isolator Expert Group and
publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to
Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory
Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator
Group. Richard founded 15 years ago the Containment expert group of the
ISPE D / A / CH. The Containment Group published the Containment Manual
Richard was responsible for in September 2021 Richard has spent more than
30 years with the subject production of aseptic processing and highly
active / highly hazardous substances and has developed the containment
pyramid.
The Closing Plenary Session will address the regulatory requirements to
produce ATMPs and will also include the presentation of the PDA Points to
Consider Documents for Viruses. The focus during this session will be on
inspections and when hospital exemptions apply as well as
discussions/fireside chat with the Swissmedic about their publication of the
Q&A document on Annex 1 as well as requirements for the production of ATMPs.
At the Industry Experts Discussion, participants' questions will be answered
and the resume discussions during the two conference days.
* 12:55 – 13:10
POINTS TO CONSIDER FOR THE DEVELOPMENT, CLASSIFICATION, MANUFACTURE,
CONTROL AND TESTING OF PLASMIDS AND VECTORS USED IN ATMP PRODUCTION
* Presenter: Darius Pillsbury, Senior Consultant, ValSource, Inc.
Darius Pillsbury, Senior Consultant, ValSource, Inc.
Darius Pillsbury is a senior consultant at ValSource. He holds a
Bachelor of Science in Chemical Engineering from Tufts University and
has more than 20 years of experience working within the
Biotech/Pharmaceutical industry. Darius worked on the development and
validation of manufacturing processes in the Manufacturing Science and
Technology group at ImClone Systems and Eli Lilly. He subsequently
worked as the Director of Validation at the rare disease company,
Ultragenyx, and as the Director of Quality Lifecycle Management at the
cell therapy company, Adaptimmune. Darius has extensive experience in
the establishment and implementation of science-driven and risk-based
Control Strategies as a part of the overall process validation
lifecycle approach. Darius is a member of the PDA ATMP Advisory Board
and leads the PDA Cell & Gene Therapy Interest Group. Darius has many
additional contributions to PDA including as an author of the PDA
Technical Report 60-2 and in the current revision to TR60 Process
Validation Lifecycle Approach, as well as a contributor to the PDA
Annex 1 commenting team and the working groups for the standards for
both the Cryopreservation of Cells for Use in Cell Therapies and
Regenerative Medicine and Apheresis Cell Collection.
* 13:10 – 13:35
INSPECTIONS OF ATMP PRODUCTION SITES AND HOSPITAL EXEMPTION APPLICATIONS
* Regulatory Presenter: Christianne Reijnders, PhD,
Coordinating/Specialistic Inspector, Health and Youth Care Inspectorate
Christianne Reijnders, PhD, Coordinating/Specialistic Inspector, Health
and Youth Care Inspectorate
* 13:35 – 14:05
NETWORKING COFFEE BREAK, POSTER SESSION & EXHIBITION
Studio 3,4,5,6,7
* 14:05 – 14:10
PASSPORT RAFFLE
Salon ABC
* 14:10 – 15:45
CLOSING PLENARY PART II
Salon ABC
* Moderator: Richard Denk, Senior Consulting Aseptic Processing &
Containment, SKAN AG
Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
Richard Denk is working at the company SKAN AG, headquartered in
Allschwil/Switzerland in the position Senior Consultant Aseptic Processing
& Containment. Richard was member of the PDA Isolator Expert Group and
publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to
Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory
Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator
Group. Richard founded 15 years ago the Containment expert group of the
ISPE D / A / CH. The Containment Group published the Containment Manual
Richard was responsible for in September 2021 Richard has spent more than
30 years with the subject production of aseptic processing and highly
active / highly hazardous substances and has developed the containment
pyramid.
The Closing Plenary Session will address the regulatory requirements to
produce ATMPs and will also include the presentation of the PDA Points to
Consider Documents for Viruses. The focus during this session will be on
inspections and when hospital exemptions apply as well as
discussions/fireside chat with the Swissmedic about their publication of the
Q&A document on Annex 1 as well as requirements for the production of ATMPs.
At the Industry Experts Discussion, participants' questions will be answered
and the resume discussions during the two conference days.
* 14:10 – 14:35
FIRESIDE CHAT: SWISSMEDIC Q&A DOCUMENT ON EU GMP ANNEX 1 AND REQUIREMENTS
FOR ATMPS
* Regulatory Co-Presenter: Francois Pinsard, GMDP Inspector ATMP
Division, Swissmedic
Francois Pinsard, GMDP Inspector ATMP Division, Swissmedic
My name is François Pinsard, GMDP Inspector in the division ATMP of
Swissmedic, the Swiss agency for therapeutic products. I studied
biology and did my master in microbiology with a lot of interess in
medical biology After working in the Quality Management for a few
years, I did a Post-Grade diploma in Quality Management and Audit I
have now more than 10 year experience in the inspection of
pharmaceutical companies.
* Co-Presenter: Richard Denk, Senior Consulting Aseptic Processing &
Containment, SKAN AG
Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN
AG
Richard Denk is working at the company SKAN AG, headquartered in
Allschwil/Switzerland in the position Senior Consultant Aseptic
Processing & Containment. Richard was member of the PDA Isolator Expert
Group and publisher of the PDA Paper “Isolator Surfaces and
Contamination Risk to Personnel and Patient”. Furthermore, Richard is
Member of the PDA Advisory Board for ATMPs, Richard is Member of the
ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago
the Containment expert group of the ISPE D / A / CH. The Containment
Group published the Containment Manual Richard was responsible for in
September 2021 Richard has spent more than 30 years with the subject
production of aseptic processing and highly active / highly hazardous
substances and has developed the containment pyramid.
* 14:35 – 15:00
REVISION OF GUIDELINE ICH Q5A(R2) WITH RELEVANCE FOR ATMPS
* Regulatory Presenter: Johannes Bluemel, PhD, Head of Virus Safety
Section, Paul-Ehrlich-Institut
Johannes Bluemel, PhD, Head of Virus Safety Section,
Paul-Ehrlich-Institut
SPEAKER BIOGRAPHY Johannes Blümel, Ph. D. Head of Virus Safety Section
Paul-Ehrlich-Institut Federal institute for Vaccines and Biomedicines
Paul-Ehrlich-Straße 51-59 63225 Langen, Germany Phone: +49 6103 773800
Fax: +49 6103 771285 E-mai: Johannes.Bluemel@pei.de Dr. Johannes Blümel
is leading the virus safety section at the Paul-Ehrlich-Institut,
Langen. He is dealing with assessment of virus safety and TSE safety of
blood products, recombinant DNA products such as monoclonal antibodies,
and advanced therapy medicinal products (ATMPs) for clinical trials and
marketing authorization. He participates as expert in EMA-Biologics
Working Party (BWP) and EDQM TSE-certification procedure and
contributed in drafting of numerous Guidelines and Monographs on viral
safety. Further, he is working in several research projects on virus
inactivation and detection of Viruses by Next Generation Sequencing
(NGS). Since 2023 he is chairing the group on blood-associated
pathogens for the national advisory board “Arbeitskeis Blut” in Germany
as well as the Ph. Eur. Working Party on High Throughput Sequencing
(HTS), in charge of elaborating a general chapter on HTS for the
detection of viral extraneous agents. Prior to joining the
Paul-Ehrlich-Institut in 1998, Dr. Blümel worked at the University
Hospital, University of Bonn (1993-1998). He performed basic research
on virus replication and received a five years training in medical
virology and virus diagnostics (Fachvirologe). Dr. Blümel completed his
Diploma Study in Biology (molecular genetics, microbiology, biophysics
and physical chemistry) in 1991 at the University of Freiburg, Germany.
He received his Ph.D. degree at the Department of Virology, University
of Freiburg, Germany (1993). In 2010 he received teaching graduation
(Habilitation) in Medical Virology from the University Frankfurt.
* 15:00 – 15:45
PLENARY DISCUSSION
* Moderator: Richard Denk, Senior Consulting Aseptic Processing &
Containment, SKAN AG
Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN
AG
Richard Denk is working at the company SKAN AG, headquartered in
Allschwil/Switzerland in the position Senior Consultant Aseptic
Processing & Containment. Richard was member of the PDA Isolator Expert
Group and publisher of the PDA Paper “Isolator Surfaces and
Contamination Risk to Personnel and Patient”. Furthermore, Richard is
Member of the PDA Advisory Board for ATMPs, Richard is Member of the
ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago
the Containment expert group of the ISPE D / A / CH. The Containment
Group published the Containment Manual Richard was responsible for in
September 2021 Richard has spent more than 30 years with the subject
production of aseptic processing and highly active / highly hazardous
substances and has developed the containment pyramid.
* Panelist: Francois Pinsard, GMDP Inspector ATMP Division, Swissmedic
Francois Pinsard, GMDP Inspector ATMP Division, Swissmedic
My name is François Pinsard, GMDP Inspector in the division ATMP of
Swissmedic, the Swiss agency for therapeutic products. I studied
biology and did my master in microbiology with a lot of interess in
medical biology After working in the Quality Management for a few
years, I did a Post-Grade diploma in Quality Management and Audit I
have now more than 10 year experience in the inspection of
pharmaceutical companies.
* Panelist: Darius Pillsbury, Senior Consultant, ValSource, Inc.
Darius Pillsbury, Senior Consultant, ValSource, Inc.
Darius Pillsbury is a senior consultant at ValSource. He holds a
Bachelor of Science in Chemical Engineering from Tufts University and
has more than 20 years of experience working within the
Biotech/Pharmaceutical industry. Darius worked on the development and
validation of manufacturing processes in the Manufacturing Science and
Technology group at ImClone Systems and Eli Lilly. He subsequently
worked as the Director of Validation at the rare disease company,
Ultragenyx, and as the Director of Quality Lifecycle Management at the
cell therapy company, Adaptimmune. Darius has extensive experience in
the establishment and implementation of science-driven and risk-based
Control Strategies as a part of the overall process validation
lifecycle approach. Darius is a member of the PDA ATMP Advisory Board
and leads the PDA Cell & Gene Therapy Interest Group. Darius has many
additional contributions to PDA including as an author of the PDA
Technical Report 60-2 and in the current revision to TR60 Process
Validation Lifecycle Approach, as well as a contributor to the PDA
Annex 1 commenting team and the working groups for the standards for
both the Cryopreservation of Cells for Use in Cell Therapies and
Regenerative Medicine and Apheresis Cell Collection.
* Panelist: Christianne Reijnders, PhD, Coordinating/Specialistic
Inspector, Health and Youth Care Inspectorate
Christianne Reijnders, PhD, Coordinating/Specialistic Inspector, Health
and Youth Care Inspectorate
* Panelist: Veronika Jekerle
Veronika Jekerle
* Panelist: Johannes Bluemel, PhD, Head of Virus Safety Section,
Paul-Ehrlich-Institut
Johannes Bluemel, PhD, Head of Virus Safety Section,
Paul-Ehrlich-Institut
SPEAKER BIOGRAPHY Johannes Blümel, Ph. D. Head of Virus Safety Section
Paul-Ehrlich-Institut Federal institute for Vaccines and Biomedicines
Paul-Ehrlich-Straße 51-59 63225 Langen, Germany Phone: +49 6103 773800
Fax: +49 6103 771285 E-mai: Johannes.Bluemel@pei.de Dr. Johannes Blümel
is leading the virus safety section at the Paul-Ehrlich-Institut,
Langen. He is dealing with assessment of virus safety and TSE safety of
blood products, recombinant DNA products such as monoclonal antibodies,
and advanced therapy medicinal products (ATMPs) for clinical trials and
marketing authorization. He participates as expert in EMA-Biologics
Working Party (BWP) and EDQM TSE-certification procedure and
contributed in drafting of numerous Guidelines and Monographs on viral
safety. Further, he is working in several research projects on virus
inactivation and detection of Viruses by Next Generation Sequencing
(NGS). Since 2023 he is chairing the group on blood-associated
pathogens for the national advisory board “Arbeitskeis Blut” in Germany
as well as the Ph. Eur. Working Party on High Throughput Sequencing
(HTS), in charge of elaborating a general chapter on HTS for the
detection of viral extraneous agents. Prior to joining the
Paul-Ehrlich-Institut in 1998, Dr. Blümel worked at the University
Hospital, University of Bonn (1993-1998). He performed basic research
on virus replication and received a five years training in medical
virology and virus diagnostics (Fachvirologe). Dr. Blümel completed his
Diploma Study in Biology (molecular genetics, microbiology, biophysics
and physical chemistry) in 1991 at the University of Freiburg, Germany.
He received his Ph.D. degree at the Department of Virology, University
of Freiburg, Germany (1993). In 2010 he received teaching graduation
(Habilitation) in Medical Virology from the University Frankfurt.
* Panelist: Olga Kolaj-Robin, PhD, Scientific Programme Manager, European
Directorate for the Quality of Medicines and HealthCare
Olga Kolaj-Robin, PhD, Scientific Programme Manager, European
Directorate for the Quality of Medicines and HealthCare
Olga Kolaj-Robin joined the European Pharmacopoeia Department of the
European Directorate for the Quality of Medicines and Healthcare in
2015 where she works as Scientific Programme Manager coordinating the
work of European Pharmacopoeia Groups of Experts and Working Parties.
In particular, since its reinstatement in 2018 by the European
Pharmacopoeia Commission, she coordinates the activities of Gene
Therapy Products Working Party in charge of elaboration and maintenance
of pharmacopoeial texts in the field of gene therapy. She holds a PhD
in in Protein Biochemistry from University of Limerick (Ireland) and a
MS in Molecular Biotechnology from Gdansk University of Technology
(Poland).
* 15:45 – 16:00
CO-CHAIRS CONFERENCE SUMMARY
Salon ABC
* Co-Chair: Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius
Center, UMC Utrecht
Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius Center,
UMC Utrecht
Renske ten Ham is an assistant professor at the UMC Utrecht in the
Netherlands and specializes in health economics & health technology
assessment (HTA) of regenerative medicines, including gene and cell-based
therapies. Trained as a pharmacist and with an MSc in HTA, she holds a PhD
in Drug Innovation titled: “Development, market authorization and market
access of gene- and cell-based therapies”. Over the years Renske conducted
research at the University of California, San Francisco (UCSF), spend time
at the Dutch Medicines Evaluation Board (CBG-MEB), Dutch National Health
Care Institute (Zorginstituut Nederland) and collaborated with several
research groups, amongst which the Center of Health Economics at the
University of York. At the Julius Center Renske is lead of the
Regenerative Medicines (RM) team within the Health Economic
Evaluation-group. She strives to increase translation of RM and (academic)
gene and cell-based therapies towards implementation in healthcare
services. In doing so her research focusses on payment models, development
cost, (early) economic evaluations and funding/business models. She aims
to contribute to better understanding of the fit between innovative
therapies and existing development frameworks. This is not only relevant
for RM but also for future biomedical innovations.
* Co-Chair: Richard Denk, Senior Consulting Aseptic Processing &
Containment, SKAN AG
Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
Richard Denk is working at the company SKAN AG, headquartered in
Allschwil/Switzerland in the position Senior Consultant Aseptic Processing
& Containment. Richard was member of the PDA Isolator Expert Group and
publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to
Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory
Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator
Group. Richard founded 15 years ago the Containment expert group of the
ISPE D / A / CH. The Containment Group published the Containment Manual
Richard was responsible for in September 2021 Richard has spent more than
30 years with the subject production of aseptic processing and highly
active / highly hazardous substances and has developed the containment
pyramid.
* 16:00 – 16:05
CLOSING REMARKS & FAREWELL
Salon ABC
* Committee Member: Falk Klar, PhD, Parenteral Drug Association
Falk Klar, PhD, Parenteral Drug Association
Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of
experience in Quality Assurance and Compliance in the life science
industry. Falk held positions in pre-clinical research and development in
a medical product company and clinical research in a CRO. He has gained
experience with biopharmaceutical and pharmaceutical products including
monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs
in several positions in quality management. Falk joined PDA Europe in 2015
as Senior Director of Training & Education. Since 2016 he has been
appointed General Manager and Vice President of PDA Europe.
POSTERS
Biodecontamination of Raw Materials in Packaging Production Process
* Andrea Weiss
CCS for Material Transfer: Best Practice for Packaging and Surface Disinfection
* Bram Van Puymbroeck, Account Manager, STERIS Life Sciences
Challenges in the Analysis of a Pharmaceutical Lentiviral Vector by Orthogonal
Physical (Nano)particle Characterization Techniques
* Daniela Stadler, PhD, Scientist, Coriolis Pharma Research GmbH
Considerations for Cleaning Lipid Nanoparticles (LNPs)9
* James N. Polarine, MA, Senior Technical Service Manager, STERIS Corporation
Designing a Disinfectant Program for Advanced Therapy Medicinal Product
Manufacturing
* James N. Polarine, MA, Senior Technical Service Manager, STERIS Corporation
Detection of Particulate Matter in Single-Use Systems Applied in the Production
of ATMPs
* Klaus R. Wormuth, PhD, Principal Scientist, Sartorius Stedim Biotech
Development of a Dual Reporter Cargo and Systemic Incorporation of a Highly
Flexible, Benchtop Automation System to Facilitate rAAV9-Based Novel Capsid
Development and Characterization
* Chakameh Azimpour, PhD, Director - Analytical Development, Capsida
Biotherapeutics
Harmonizing and Automating the Endotoxin Detection of Cell & Gene Therapy
Products with Recombinant Factor C
* Christian Faderl, Project Leader, bioMérieux
Influence of Rubber Stoppers on Immunoglobulin Behavior
* Giorgio Fernando De Avelar Francisco, MSc, R&D project engineer, Aptar Stelmi
SAS
Mycoplasma Release Test with Low Volume Protocol: From Sample to Results in Less
Than 1 Hour
* Caroline Kassim Houssenaly, PhD, R&D Biosciences Manager, bioMérieux
Optimization of Electron Microscopical Methods for a Validated Quality
Assessment of Adeno-Associated Viruses (AAV)
* Ashley Stephen Layland, Project Director, neotem Bioanalytics-IIT GmbH
Scalable Single-Use Harvest and Clarification Solutions for Cell and Virus Based
ATMPs
* Marc Noverraz, MSc, Process Technology Manager - Separation Technologies,
Sartorius
The Myth of the “Non-GMP Space:” The Criticality of Establishing Good Aseptic
Practices in the Development Environment
* Amanda Curtis, Microbiology Consultant, ValSource, Inc.
Viral Vectors Inside an Isolator - Approaches to Minimize Their Associated Risks
* Maximilian Mittelviefhaus
Virus Filtration as an Upstream Risk Mitigation Tool in the Manufacturing of
Advanced Therapy Medicinal Products
* Michael Lasse, PhD, Global Product Manager, Sartorius
Agenda is subject to change.
PRESENTERS
* ASENA ABAY, PHD
Senior Scientist, Sanofi
Panelist
Presenter
Read Bio
ASENA ABAY, PHD
Sanofi
Asena Abay is a senior scientist in Sanofi’s Cell Therapy Process Development
group. She is working as a Drug Substance lead as well as a CMC Sub-Team Lead
for development of next generation cell therapies. Asena obtained her
Biomedical Engineering degree from Bucknell University and her PhD for
University of Amsterdam. She did her PhD at the University of Amsterdam as a
Marie Curie Fellow, focused biofluidic and cellular responses to mechanical
stresses in bioreactors.
* MANJULA AYSOLA, MS
Senior Regulatory Consultant, MilliporeSigma
Moderator
Read Bio
MANJULA AYSOLA, MS
MilliporeSigma
Manjula Aysola is a Senior Regulatory Consultant supporting the BioReliance®
contract testing services business of MilliporeSigma. She is an expert on
regulatory requirements for manufacturing and quality of biologics and
cell/gene therapeutic products globally. She consults to ensure BiorReliance®
testing services meet global regulatory requirements. She actively
participates in working groups in industry associations such as BioPhorum on
viral detection and clearance topics among others. Previously, she focused on
regulatory requirements for single-use systems and products for cell/gene
therapy manufacturing. She also spent over 10 years as an R&D scientist
involved in developing products for biologics and cell therapy bioprocessing.
* CHAKAMEH AZIMPOUR, PHD
Director - Analytical Development, Capsida Biotherapeutics
Poster Presenter
Read Bio
CHAKAMEH AZIMPOUR, PHD
Capsida Biotherapeutics
Dr. Chakameh Azimpour is an experienced leader with extensive expertise in
regulatory applications, project management, and digital and continuous
improvement. Currently serving as a director, she leads a high-performing
technical team in Analytical Development at Capsida Biotherapeutics, a
pioneering company in gene therapy. Her responsibilities include providing
technical leadership for analytical development and quality control aspects
in portfolio programs, as well as managing laboratory operations such as
method development, qualification, and transfer to quality control.
Additionally, she ensures compliance with FDA, cGMPs, ICH guidelines, and
follows QBD principles and industry best practices in all analytical and
quality control processes. Beyond her work in the industry, she has also
dedicated more than 12 years to sharing her knowledge, teaching both
theoretical principles and practical skills at academic institutions. She is
currently a board member at Conejo School Foundation, an independent
501(c)(3) non-profit organization that supports student's achivement. she
holds a Ph.D. in Microbiology/Genetics from the University of Vienna. During
her leisure time, she volunteers, enjoys reading, cooking and baking, and
cherishes moments with family and friends.
* JOHANNES BLUEMEL, PHD
Head of Virus Safety Section, Paul-Ehrlich-Institut
Panelist
Regulatory Presenter
Read Bio
JOHANNES BLUEMEL, PHD
Paul-Ehrlich-Institut
SPEAKER BIOGRAPHY Johannes Blümel, Ph. D. Head of Virus Safety Section
Paul-Ehrlich-Institut Federal institute for Vaccines and Biomedicines
Paul-Ehrlich-Straße 51-59 63225 Langen, Germany Phone: +49 6103 773800 Fax:
+49 6103 771285 E-mai: Johannes.Bluemel@pei.de Dr. Johannes Blümel is leading
the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing
with assessment of virus safety and TSE safety of blood products, recombinant
DNA products such as monoclonal antibodies, and advanced therapy medicinal
products (ATMPs) for clinical trials and marketing authorization. He
participates as expert in EMA-Biologics Working Party (BWP) and EDQM
TSE-certification procedure and contributed in drafting of numerous
Guidelines and Monographs on viral safety. Further, he is working in several
research projects on virus inactivation and detection of Viruses by Next
Generation Sequencing (NGS). Since 2023 he is chairing the group on
blood-associated pathogens for the national advisory board “Arbeitskeis Blut”
in Germany as well as the Ph. Eur. Working Party on High Throughput
Sequencing (HTS), in charge of elaborating a general chapter on HTS for the
detection of viral extraneous agents. Prior to joining the
Paul-Ehrlich-Institut in 1998, Dr. Blümel worked at the University Hospital,
University of Bonn (1993-1998). He performed basic research on virus
replication and received a five years training in medical virology and virus
diagnostics (Fachvirologe). Dr. Blümel completed his Diploma Study in Biology
(molecular genetics, microbiology, biophysics and physical chemistry) in 1991
at the University of Freiburg, Germany. He received his Ph.D. degree at the
Department of Virology, University of Freiburg, Germany (1993). In 2010 he
received teaching graduation (Habilitation) in Medical Virology from the
University Frankfurt.
* ANTONIO BURAZER
Global Head Visual Inspection & Particle LCM, Takeda Pharmaceuticals
International AG
Co-Presenter
Panelist
Read Bio
ANTONIO BURAZER
Takeda Pharmaceuticals International AG
Antonio Burazer joined Takeda in 2010 where he has overseen visual inspection
and secondary packaging processes at a multi-product manufacturing facility
in Vienna, Austria. In 2019 he transitioned to Global Quality, taking over
responsibility for visual inspection and particle life cycle management
globally for Takeda. He is engaged in collaborating with experts across the
industry and strives for continuous improvement, guided by the ultimate goal
of achieving zero particles in parenteral products.
* PATRICK BUSCHOR, DR.
Contracted Qualified Person, PMS - Process Management System
Co-Presenter
Panelist
Presenter
Read Bio
PATRICK BUSCHOR, DR.
PMS - Process Management System
I am Dr. Patrick Buschor, a PhD immunologist and consultant in Regulatory and
Quality Affairs. For more than 10 years, I have been active in the start-up
environment at the interface of Manufacturing (GMP) and clinical development
(GCP). I serve as a contracted Qualified Person and support various ATMP
(IMP) projects.
* URSULA BUSSE, PHD, MBA
Head of Regulatory Affairs, Tigen Pharma
Panelist
Presenter
Read Bio
URSULA BUSSE, PHD, MBA
Tigen Pharma
Ursula is currently leading Regulatory Affairs for Tigen Pharma, a Swiss
biotech company developing autologous T-cell therapies against cancer. Ursula
joined Tigen from Boehringer-Ingelheim, where she was Head of Regulatory
Intelligence & Policy. Prior to that, Ursula worked at Novartis as Global
Head of Quality Intelligence & External Affairs, a role she assumed after a
few years as Head of Project Office, Biopharmaceutical Operations, and
Project Leader in CMC Regulatory Affairs for biotech products. Before joining
Novartis in 2006, Ursula worked for startup biotech companies in Canada, in
R&D, Quality Assurance and CMC Regulatory Affairs. Ursula can look back on
over 20 years of volunteer engagement in several industry associations (PDA,
DIA, ISPE, EFPIA) and served on PDA’s Board of Directors from 2012 to 2017.
She holds a PhD in Cellular and Molecular Biology from Laval University
(Québec, Canada), coupled with an MBA she earned with honours.
* DAYUE CHEN, PHD
Head of Cell Therapy Technical Development, Genentech, Inc.
Moderator
Read Bio
DAYUE CHEN, PHD
Genentech, Inc.
Dayue Chen received his PhD from Baylor College of Medicine and did his
postdoctoral training in Northwestern University. Dr. Chen is currently a
staff scientist and the Head of Cell Therapy and Engineering Development at
Genentech. He is a trained virologist and molecular biologist with extensive
experience in biopharmaceutical industry. He was a research fellow in the
Bioproduct Research and Development Division at Eli Lilly and Company before
joining Genentech in 2019. Dr. Chen has published 40+ research articles in
peer reviewed journals and currently serves on the editorial boards for the
PDA Journal of Pharmaceutical Science and Technology, and the Journal of
Biotechnology and Applied Biochemistry. He is an enthusiastic allurophile
(cat lover) and runs two marathon races per year.
* ARABELA X. CUIROLO, PHD
Sterility Assurance Lead, Kite Pharma EU B.V.
Panelist
Presenter
Read Bio
ARABELA X. CUIROLO, PHD
Kite Pharma EU B.V.
Arabela is a Pharmacist and a Microbiologist with nearly 10 years of
experience in the industry. She joined the company in 2018, as a QC Micro
Scientist in the start-up face of Kite, fundamentally supporting the set-up
of the EM program (to Establish, validate and sustain EM program for the
site) and the Methods Transfers for her department. She later led the QC
Micro department for about 6 months until she took on the new challenge as a
Sterility Assurance Lead. Within this new role, she is leading the site
Contaminiation Control Strategy while supporting internally as a SME for new
projects related to aseptic practices.
* AMANDA CURTIS
Microbiology Consultant, ValSource, Inc.
Poster Presenter
Read Bio
AMANDA CURTIS
ValSource, Inc.
Amanda Curtis is a Microbiology Consultant at ValSource with 15 years of
experience in medical microbiology, pharmaceutical microbiology, and other
regulated industries. She received her bachelor’s degree in Microbiology from
Purdue University. Amanda’s pharmaceutical expertise is in the field of
Advanced Therapy Medicinal Products (ATMPs), with experience bringing cell
and gene therapy products through FDA Pre-Approval Inspections. She is
experienced in complex investigations, sterility testing, and microbial and
contamination control with a focus on risk-based approaches to environmental
monitoring.
* GIORGIO FERNANDO DE AVELAR FRANCISCO, MSC
R&D project engineer, Aptar Stelmi SAS
Poster Presenter
Read Bio
GIORGIO FERNANDO DE AVELAR FRANCISCO, MSC
Aptar Stelmi SAS
My name is Giorgio and I hold a position of R&D engineer at Aptar Pharma
Injectables and PhD student at Institut de sciences de matériaux de Mulhouse.
I have an undergraduate degree in industrial chemistry obtained at Federal
University of São Paulo, Brazil, with a science master’s degree obtained in
the same university. During my academic life, I worked in different projects
as study of release of ibuprofen covalently bounded on a functionalized
mesoporous silica, synthesis of superparamagnetic nanoparticles made of iron
oxide and mesoporous silica in a core-shell structure to be used in
magnetofection. My PhD thesis with Aptar Pharma has the goal to understand
and evaluate the interactions between the proteins, present in the drug
formulations, with the surfaces present in the conditioning and
administration devices.
* RICHARD DENK
Senior Consulting Aseptic Processing & Containment, SKAN AG
Co-Chair
Co-Presenter
Moderator
Read Bio
RICHARD DENK
SKAN AG
Richard Denk is working at the company SKAN AG, headquartered in
Allschwil/Switzerland in the position Senior Consultant Aseptic Processing &
Containment. Richard was member of the PDA Isolator Expert Group and
publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to
Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory
Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator
Group. Richard founded 15 years ago the Containment expert group of the ISPE
D / A / CH. The Containment Group published the Containment Manual Richard
was responsible for in September 2021 Richard has spent more than 30 years
with the subject production of aseptic processing and highly active / highly
hazardous substances and has developed the containment pyramid.
* JOSH EATON, MS
Senior Director, Scientific and Regulatory Affairs, PDA
Moderator
Read Bio
JOSH EATON, MS
PDA
Josh Eaton joined PDA in 2011 as a project manager and is now Senior
Director, Scientific and Regulatory Affairs at PDA. He and his team work with
PDA members to produce Technical Reports, Points to Consider documents, and
feedback on regulatory draft guidance. The S&RA staff also facilitate the
activities of the PDA Technical Advisory Boards and PDA Interest Groups.
Prior to joining PDA, Josh developed and marketed drug discovery and research
reagents and co-founded a small spin-off company based on those technologies.
He earned his Master’s degree in Biochemistry and Biotechnology in 2005 from
Georgetown University.
* CHRISTIAN FADERL
Project Leader, bioMérieux
Poster Presenter
Read Bio
CHRISTIAN FADERL
bioMérieux
Christian Fader holds a PhD in organic chemistry from the University of
Regensburg. After experiences in the quality management for a pharma company,
he currently serves as Project Leader working in the R&D Department for
endotoxin at bioMérieux. With 7 years experiences in the endotoxin business,
he is responsible for all endotoxin service projects and is a recognized
expert for Low Endotoxin Recovery (LER) and endotoxin demasking.
* INGE JEDERMA, PHD
Head of Translational Cellular Therapy, Netherlands Cancer Institute / Antoni
van Leeuwenhoek
Academic Presenter
Panelist
Read Bio
INGE JEDERMA, PHD
Netherlands Cancer Institute / Antoni van Leeuwenhoek
Since June 2020, Dr. Inge Jedema is Head of Translational Cellular Therapy at
the Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital in
Amsterdam, the Netherlands. In this position she is responsible for the
development and implementation of cellular immunotherapy strategies in the
field of solid oncology. She studied Biomedical Sciences in Leiden and worked
between 1997 and 2020 at the Department of Hematology of the Leiden
University Medical Center (LUMC) in the Netherlands. After her PhD research
she was leading the Laboratory for Translational Hematology and the
diagnostic Laboratory for Specialized Hematology and was responsible for the
development and implementation of cellular immunotherapy strategies and the
application of ATMPs in clinical trials for patients with hematological
malignancies.
* VERONIKA JEKERLE
Panelist
Regulatory Presenter
* IAN JOHNSTON, PHD
Project Lead Translational TCR Drug Development Senior Project Manager -
Research & Development , Miltenyi Biotec B.V. & Co. KG
Moderator
Read Bio
IAN JOHNSTON, PHD
Miltenyi Biotec B.V. & Co. KG
Dr. Ian Johnston is Project Lead Translational TCR Drug Development and
Senior Project Manager in the Research & Development Department at Miltenyi
Biotec B.V. & Co. KG. Dr. Johnston is currently project and development lead
responsible for certain TCR T and CAR T cell gene therapies being prepared
for clinical application. Since joining Miltenyi Biotec in 1999, Dr. Johnston
has developed a number of reagents and procedures to improve the efficiency
of genetic modification of primary cells such as human T and stem cells. A
number of these procedures have been fully automated on a functionally closed
cell processing platform – the CliniMACS® Prodigy. In addition, Dr. Johnston
has lead development of numerous products for magnetic isolation of cells,
molecules, organelles and for use in the field of HIV research. He has been
Principle Investigator on a number of European consortium grants focused on
the genetic modification of stem cells, most recently Cell-PID and SCIDNET.
Prior to joining Miltenyi, he studied Natural Sciences at Cambridge
University where he also completed a PhD studying immunopathological
mechanisms in the CNS supported by the Multiple Sclerosis Society. This was
followed by postdoctoral research at Würzburg University with Prof. Volker
ter Meulen working with recombinant measles virus systems, supported by two
fellowships from the Wellcome Trust and Alexander von Humboldt Foundation.
* REBECCA D. JORDAN
Associate Director, Global Cell Therapy Sterility Assurance Lead, Bristol
Myers Squibb (BMS)
Panelist
Presenter
Read Bio
REBECCA D. JORDAN
Bristol Myers Squibb (BMS)
Rebecca Jordan is the PDA Interest Group lead for ATMPs. She is also an
Associate Director, serving as the Global Sterility Assurance Lead for the
BMS Cell Therapy Franchise. She oversees all things contamination control in
manufacturing facilities spanning across the Globe. Rebecca has over 15
years’ experience in industry, with the past 6 in the Cell Therapy space. She
has supported both large and small manufacturing sites, new facility design
and start-up, and global regulatory interactions. She has experience with a
diverse product portfolio spanning everything from phase I INDs, veterinary,
controlled substance, to commercial approvals of parenteral and CAR T
medicines. She is a skilled investigator with a curious mind which has led to
engaging diverse endeavors throughout her career. Rebecca holds a B.S. in
Biology from Fitchburg State University. Outside of work, Rebecca is a
military spouse, so she’s had to relocate her career and family across 4
states so far, including a giant tortoise that has been in her family for 23
years.
* CAROLINE KASSIM HOUSSENALY, PHD
R&D Biosciences Manager, bioMérieux
Poster Presenter
Read Bio
CAROLINE KASSIM HOUSSENALY, PHD
bioMérieux
Caroline Kassim is Research and Development Manager for Pharma Quality
Control ranges within the bioMérieux. With over 15 years of Industrial
Microbiology, she is focusing on leading the development of new of Pharma QC
solutions & their applications which will continue to answer unmet needs.
Having worked in different technical roles, she is a technical expert in her
field and provide scientific support on both traditional & rapid alternative
microbial methods for pharma applications.
* FALK KLAR, PHD
Parenteral Drug Association
Committee Member
Read Bio
FALK KLAR, PHD
Parenteral Drug Association
Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of
experience in Quality Assurance and Compliance in the life science industry.
Falk held positions in pre-clinical research and development in a medical
product company and clinical research in a CRO. He has gained experience with
biopharmaceutical and pharmaceutical products including monoclonal
antibodies, vaccines, parenteral, narcotics, and animal drugs in several
positions in quality management. Falk joined PDA Europe in 2015 as Senior
Director of Training & Education. Since 2016 he has been appointed General
Manager and Vice President of PDA Europe.
* OLGA KOLAJ-ROBIN, PHD
Scientific Programme Manager, European Directorate for the Quality of
Medicines and HealthCare
Panelist
Regulatory Presenter
Read Bio
OLGA KOLAJ-ROBIN, PHD
European Directorate for the Quality of Medicines and HealthCare
Olga Kolaj-Robin joined the European Pharmacopoeia Department of the European
Directorate for the Quality of Medicines and Healthcare in 2015 where she
works as Scientific Programme Manager coordinating the work of European
Pharmacopoeia Groups of Experts and Working Parties. In particular, since its
reinstatement in 2018 by the European Pharmacopoeia Commission, she
coordinates the activities of Gene Therapy Products Working Party in charge
of elaboration and maintenance of pharmacopoeial texts in the field of gene
therapy. She holds a PhD in in Protein Biochemistry from University of
Limerick (Ireland) and a MS in Molecular Biotechnology from Gdansk University
of Technology (Poland).
* JASMIJN KORPERSHOEK, MD PHD
Postdoctoral Researcher, UMC Utrecht
Academic Presenter
Panelist
Read Bio
JASMIJN KORPERSHOEK, MD PHD
UMC Utrecht
Jasmijn Korpershoek, MD PhD, works as a postdoctoral researcher at the
University Medical Center (UMC) in Utrecht, the Netherlands, and the Mayo
Clinic in Rochester, USA. Her curiosity and dedication to improving patient
care through translational research have motivated her to pursue a career in
academic research. Jasmijn and her team at UMC Utrecht are currently working
on the IMPACT one-stage cartilage transplantation, which is a combination
ATMP consisting of autologous recycled cartilage cells with allogeneic MSCs.
* MICHAEL LASSE, PHD
Global Product Manager, Sartorius
Poster Presenter
Read Bio
MICHAEL LASSE, PHD
Sartorius
Dr. Michael Lasse is a Global Product Manager for Virus Clearance working at
Sartorius in Göttingen. He is a biochemist with strong focus on protein
expression, downstream purification and viral clearance. After studying cell
and molecular biology at the University of Rostock, he continued his PhD
studies in Biochemistry at the University of Cologne. His research areas
include the programmed cell death during development of neural progenitor
cells as well as recombinant protein expression of apoptosis relevant
membrane proteins, development of chromatographic purification techniques and
identification of post-translational lipid modifications. In 2013 he joined
Charles River Laboratories in Cologne as a Study Director for virus clearance
(VC) studies and later managed a specialized team within the VC operations
group focusing on chromatography, chromatography-related tech transfer and
associated topics like continuous processing. In 2019 he transitioned into
his current position as a Global Product Manager at Sartorius focussing on
technologies for virus inactivation and virus removal in particular upstream
and downstream virus filtration and associated production setups in
commercial manufacturing.
* ASHLEY STEPHEN LAYLAND
Project Director, neotem Bioanalytics-IIT GmbH
Poster Presenter
Read Bio
ASHLEY STEPHEN LAYLAND
neotem Bioanalytics-IIT GmbH
Graduating as a research assistant in 2011, Ashley Stephen Layland began his
career in cell culture technology at Xell AG (which is now part of Sartorius)
where he acquired eight years of experience in upstream processing and
cultivation. Shortly after, from 2012, Ashley then gained further in-depth
experience in quality assurance management, virology and electron microscopy
from Charles River Laboratories and the Centre for Ultrastructural
Diagnostics located at the University of Bielefeld. Ashley then took the
position of project director at neotem Bioanalytics in 2022 and now leads a
GMP-certified company, applying electron microscopy for the viral safety
assessment of biologics and the characterisation of virus products.
* ROMAN MATHAES, PHD
CEO, Clear Solutions Laboratories
Co-Presenter
Panelist
Read Bio
ROMAN MATHAES, PHD
Clear Solutions Laboratories
Roman Mathaes is the CEO of Clear Solutions Laboratories. Before that, he was
Head of Pharmaceutical Services at Lonza Drug Product Services. In this role,
he was responsible for pre-clinical Drug Product manufacturing for vials,
prefilled syringes, and ampoules. He also leads the packaging & combination
product development department and the lab automation group. Roman joined
Lonza from Roche. He is a Pharmacist by training and holds a Ph.D. in
Pharmaceutical technology from the University of Munich, as well as an MBA
and is a lecturer at the University of Basel.
* MAXIMILIAN MITTELVIEFHAUS
Poster Presenter
* SANDRINE MORES, MA
COO , ExoXpert
Panelist
Presenter
Read Bio
SANDRINE MORES, MA
ExoXpert
Sandrine Mores, is Chief Operating Officer at ExoXpert, a premier CDMO
company specializing in Exosomes GMP manufacturing. Sandrine joined
ExoBiologics as Head of Quality in 2021 and led the set-up of the GMP
manufacturing site of ExoXpert, in parallel to supporting ExoBiologics in
obtaining the first authorisation in the world by EMA to start a clinical
trial in Europe with MSC derived exosomes. With 22 years of extensive
experience in the GMP environment across renowned biotech firms like
Eurogentec, Novasep (now Thermo Fisher Scientific), and MasTherCell (now
Catalent Cell & Gene Therapy), Sandrine's journey began in Quality Control,
before evolving into Strategic Quality and Operation roles.
* RYAN MURRAY, MS
Senior Consultant, ValSource, Inc.
Moderator
Read Bio
RYAN MURRAY, MS
ValSource, Inc.
Ryan Murray is a quality and manufacturing science Senior Consultant with
ValSource, Inc. He is primarily focused in the areas of quality and
regulatory compliance, facility design and control, technology transfer,
process qualification, and aseptic risk management of both biologics and
advanced therapy medicinal products (ATMPs). Ryan is an active member of the
Parenteral Drug Associationand the International Society for Pharmaceutical
Engineering (ISPE). He has a BS in biomedical science and MS in biochemistry
and biophysics from Texas A&M University.
* MARC NOVERRAZ, MSC
Process Technology Manager - Separation Technologies, Sartorius
Poster Presenter
Read Bio
MARC NOVERRAZ, MSC
Sartorius
Marc Noverraz has been working for Sartorius since 2021, where he is a
Process Technology Manager for Separation Technologies. He earned his
chemical engineering masters degree at EPFL in Lausanne, Switzerland. Marc
held various positions in process development for biopharma manufacturing, in
particular the purification of vaccines and viral vectors, and was leading a
downstream process development group at Janssen. As of 2021, he has been
working as a Process Technology Manager focusing on downstream processing of
new modalities where he helps to fit Sartorius' technologies into those new
processes such as AAV, lentivirus and mRNA.
* JIMI OLAGHERE
Gene Editing Recipient , -
Panelist
Presenter
Read Bio
JIMI OLAGHERE
-
Jimi Olaghere is a CASGEVY™ recipient. Drawing from his personal experience
of living with Sickle Cell Disease for 35 years, Olaghere has become a
staunch advocate for increased accessibility of gene therapies for SCD
patients. His dedication to patient advocacy stems from a deep-rooted belief
in the power of equitable healthcare and the fundamental right of every
individual to access life-changing treatments. Olaghere's journey took a
transformative turn when he became involved in a groundbreaking clinical
trial led by Vertex Pharmaceutical and CRISPR Therapeutics. His participation
in the trial resulted in a significant achievement - a functional cure for
Sickle Cell Disease. This monumental breakthrough not only transformed
Olaghere's life but also propelled him into the forefront of the conversation
surrounding gene therapy and its potential to revolutionize healthcare.
* EULALIA OLESTI, PHARMD, PHD
Regulatory Affairs Lead, Hospital Clinic Barcelona, IDIBAPS
Academic Presenter
Panelist
Read Bio
EULALIA OLESTI, PHARMD, PHD
Hospital Clinic Barcelona, IDIBAPS
Eulalia Olesti, PhD Dr. Eulalia Olesti is a regulatory and scientific manager
at the Clinical Pharmacology Department of the Hospital Clínic de Barcelona.
She possesses extensive expertise in the scientific and regulatory assessment
of Advanced Therapy Medicinal Products (ATMPs) and has a robust background in
clinical research and academia. Her professional experience includes the
assessment of regulatory strategies and scientific advice on ATMPs, as well
as the development and submission of regulatory documentation for clinical
candidates and authorized drugs. Dr. Olesti earned her PhD in Clinical
Pharmacology from Hospital del Mar in Barcelona and subsequently completed a
post-doctoral fellowship at the University of Geneva. In addition to her
research and regulatory roles, Dr. Olesti has substantial teaching
experience, having taught at both the bachelor's and master's levels at
various national and international universities.
* DARIUS PILLSBURY
Senior Consultant, ValSource, Inc.
Panelist
Presenter
Read Bio
DARIUS PILLSBURY
ValSource, Inc.
Darius Pillsbury is a senior consultant at ValSource. He holds a Bachelor of
Science in Chemical Engineering from Tufts University and has more than 20
years of experience working within the Biotech/Pharmaceutical industry.
Darius worked on the development and validation of manufacturing processes in
the Manufacturing Science and Technology group at ImClone Systems and Eli
Lilly. He subsequently worked as the Director of Validation at the rare
disease company, Ultragenyx, and as the Director of Quality Lifecycle
Management at the cell therapy company, Adaptimmune. Darius has extensive
experience in the establishment and implementation of science-driven and
risk-based Control Strategies as a part of the overall process validation
lifecycle approach. Darius is a member of the PDA ATMP Advisory Board and
leads the PDA Cell & Gene Therapy Interest Group. Darius has many additional
contributions to PDA including as an author of the PDA Technical Report 60-2
and in the current revision to TR60 Process Validation Lifecycle Approach, as
well as a contributor to the PDA Annex 1 commenting team and the working
groups for the standards for both the Cryopreservation of Cells for Use in
Cell Therapies and Regenerative Medicine and Apheresis Cell Collection.
* FRANCOIS PINSARD
GMDP Inspector ATMP Division, Swissmedic
Panelist
Read Bio
FRANCOIS PINSARD
Swissmedic
My name is François Pinsard, GMDP Inspector in the division ATMP of
Swissmedic, the Swiss agency for therapeutic products. I studied biology and
did my master in microbiology with a lot of interess in medical biology After
working in the Quality Management for a few years, I did a Post-Grade diploma
in Quality Management and Audit I have now more than 10 year experience in
the inspection of pharmaceutical companies.
* JAMES N. POLARINE, MA
Senior Technical Service Manager, STERIS Corporation
Poster Presenter
Read Bio
JAMES N. POLARINE, MA
STERIS Corporation
Mr. Polarine is a senior technical service manager at STERIS Corporation. He
has been with STERIS Corporation for twenty-four years. His current technical
focus is microbial control in cleanrooms and other critical environments. Mr.
Polarine is a 2019 PDA Michael S. Korczynski Award recipient and the 2024 PDA
Service Appreciation Award recipient. He is active on the prestigious PDA’s
Scientific Advisory Board (SAB). He was a co-author on PDA’s Technical Report
#70 on Cleaning and Disinfection, Technical Report #88 on Microbial
Deviations, and the COVID Points to Consider. Mr. Polarine teaches industry
regulators as well as the pharmaceutical, biotech, ATMP, and medical device
industries at the PDA and the University of Tennessee. Mr. Polarine currently
teaches the cleaning and disinfection course as part of the PDA Aseptic
Processing Course, IEST, and at the University of Tennessee Parenteral
Medications Course. Mr. Polarine is the current past President for the PDA
Missouri Valley Chapter and Vice President of Membership for the IEST. He is
the PDA Chapter Council Vice Chairperson. Mr. Polarine graduated from the
University of Illinois with a Master of Arts in Biology.
* CHRISTIANNE REIJNDERS, PHD
Coordinating/Specialistic Inspector, Health and Youth Care Inspectorate
Panelist
Regulatory Presenter
* SEBASTIAN SCHELER
Managing Director, Innerspace GmbH
Panelist
Presenter
Read Bio
SEBASTIAN SCHELER
Innerspace GmbH
I am passionate about pushing the boundaries of advanced risk assessment
technologies to unlock new possibilities for designing and managing
manufacturing processes in pharma. I spearhead a dynamic team of life science
professionals and software developers. The core focus of my professional work
lies in Frame-by-Frame Risk Profiling—an innovative, automated approach to
risk assessment. This cutting-edge technology facilitates process
improvement, process automation, autogenerated SOPs, and immersive training
curricula, empowering organizations to achieve unparalleled levels of
efficiency, compliance and safety in drug manufacturing. With a profound
background in psychology, I have always been captivated by the intersection
of human behavior and technology. My passion for Virtual Reality has
culminated in pioneering VR simulator methodologies that push the boundaries
of experiential learning, training, and behavior measurement systems. Beyond
my leadership at Innerspace, I also serve as trainer for PDA training courses
and further development of the PDA/Innerspace official partnership focusing
on refining training course delivery and design.
* STEFFEN SCHULZE
Strategic Analytics & Business Insights Lead, F. Hoffmann-La Roche
Panelist
Presenter
Read Bio
STEFFEN SCHULZE
F. Hoffmann-La Roche
Steffen Schulze is the Strategic Analytics & Business Insights Lead in
Roche's Cell & Gene Therapies division, specializing in quantitative modeling
to assess and integrate data from preclinical stages to product
commercialization in the ATMP field. With a background in preclinical
research, including antibody identification and process development, Steffen
gained technical expertise in commercial manufacturing as a quality assurance
specialist and GMP project manager. Within Roche, he contributed to cost
assessments for a personalized cancer vaccine and an autologous gene therapy,
as well as preparing the drug product sourcing strategy for an antibody drug
conjugate. Steffen's multidisciplinary expertise bridges scientific,
technical, and economic aspects, supporting Roche's advancements in the cell
and gene therapy field.
* SARAH E. SHERIDAN, PHD
Technical Consultant, Merck
Panelist
Presenter
Read Bio
SARAH E. SHERIDAN, PHD
Merck
Dr Sarah Sheridan is a Technical Consultant within Merck KGaA, providing
scientific, technical and regulatory consultancy on Merck KGaA / BioReliance®
Biosafety Testing Services. Drawing on over 22 years of experience in the
human and animal health biotech industries, Dr Sheridan provides biosafety
testing consultancy for the company’s global client base to support
pre-clinical to commercial phase biosafety testing of client manufactured
products spanning monoclonal antibodies to vaccines and novel gene therapies.
Dr Sheridan has a Ph.D. in Virology from the University of Cambridge, UK and
a B.Sc. Honours degree in Life Science.
* DANIELA STADLER, PHD
Scientist, Coriolis Pharma Research GmbH
Poster Presenter
Read Bio
DANIELA STADLER, PHD
Coriolis Pharma Research GmbH
Dr. Daniela Stadler is working as scientist at Coriolis Pharma, a
science-driven contract research organization located in Munich, Germany, for
formulation development, lyophilization, and analytics of biopharmaceuticals.
She did her master’s degree in molecular biotechnology at the Technical
University of Munich (TUM) in 2013. During her PhD (2013-2017) at the
Institute of Virology at TUM she investigated hepatitis B virus DNA
modification and degradation mechanisms induced by cytokines. As postdoctoral
researcher at Helmholtz Zentrum München and TUM, her following studies
focused on antiviral host proteins and drug repurposing against SARS-CoV-2.
At Coriolis Pharma, she is working on the evaluation of particle analysis and
characterization technologies with a focus on biopharmaceuticals.
* MARSHA L. STEED
Founder and CEO / Sr Consultant, Steed MicroBio / JYA
Panelist
Presenter
Read Bio
MARSHA L. STEED
Steed MicroBio / JYA
Marsha Steed has over 30 years of experience as a microbiologist working in
the Pharmaceutical, Biotechnology and Medical Device fields. Marsha is the
Founder and President of Steed MicroBio, LLC which is an independent
microbiology consulting firm and a Senior Microbiology Associate/Sterility
Assurance Expert at Jeff Yuen & Associates, Inc. consulting firm. Marsha is a
globally recognized consultant specializing in sterility assurance and
contamination control matters in pharmaceutical, biotech and medical device
companies. Marsha is a USP Microbiology Expert Committee member and the chair
of the USP Microbial Control and Sterility Assurance Subcommittee. Marsha
studied Biology at Western New England University in Springfield, MA. Marsha
is active in industry and currently serves on the Parenteral Drug Association
(PDA) ATMP Advisory Board and has previously served on the PDA Education
Advisory Board (EAB); Scientific Advisory Board (SAB) and has served on
numerous PDA Task Forces and meeting planning committees and has been the
chair of the PDA Annual Meeting and PDA Microbiology Meeting. Marsha is a
former notified body ISO inspector.
* RENSKE MT TEN HAM, PHD, PHARMD, MSC
Assistant Professor, Julius Center, UMC Utrecht
Co-Chair
Moderator
Read Bio
RENSKE MT TEN HAM, PHD, PHARMD, MSC
Julius Center, UMC Utrecht
Renske ten Ham is an assistant professor at the UMC Utrecht in the
Netherlands and specializes in health economics & health technology
assessment (HTA) of regenerative medicines, including gene and cell-based
therapies. Trained as a pharmacist and with an MSc in HTA, she holds a PhD in
Drug Innovation titled: “Development, market authorization and market access
of gene- and cell-based therapies”. Over the years Renske conducted research
at the University of California, San Francisco (UCSF), spend time at the
Dutch Medicines Evaluation Board (CBG-MEB), Dutch National Health Care
Institute (Zorginstituut Nederland) and collaborated with several research
groups, amongst which the Center of Health Economics at the University of
York. At the Julius Center Renske is lead of the Regenerative Medicines (RM)
team within the Health Economic Evaluation-group. She strives to increase
translation of RM and (academic) gene and cell-based therapies towards
implementation in healthcare services. In doing so her research focusses on
payment models, development cost, (early) economic evaluations and
funding/business models. She aims to contribute to better understanding of
the fit between innovative therapies and existing development frameworks.
This is not only relevant for RM but also for future biomedical innovations.
* BRAM VAN PUYMBROECK
Account Manager, STERIS Life Sciences
Poster Presenter
Read Bio
BRAM VAN PUYMBROECK
STERIS Life Sciences
I have a strong background in technical sales and marketing. Currently, I
serve as a cGMP Sales Consultant at STERIS, where I specialize in sterility
maintenance products. My role involves assisting pharmaceutical companies
with their Contamination Control Strategy, providing consultative support,
and managing territories for sterility maintenance products. One of the
innovative solutions I work with is the Purefit sterilization wrapping
system. My journey began at Optimus Instruments, where I spent eight years
focusing on (bio)reactor systems and bioprocess solutions. I've also been
actively involved in industry events, such as the VCCN Contamination Control
Congress. My passion lies in advancing sterility practices within the life
sciences field, and I continue to learn and contribute to the industry
through publications and speaking engagements.
* ANDREA WEISS
Poster Presenter
* KLAUS R. WORMUTH, PHD
Principal Scientist, Sartorius Stedim Biotech
Poster Presenter
Read Bio
KLAUS R. WORMUTH, PHD
Sartorius Stedim Biotech
Klaus Wormuth has a Ph.D. in Chemical Engineering from the University of
Washington and 36 years of experience in research and development in a
variety of fields, primarily in dispserions, medical devices, and most
recently single-use technologies. He is currently Principal Scientist for
particles topics at Sartorius in Göttingen Germany.
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AMSTERDAM MARRIOTT HOTEL
Stadhouderskade 12
Amsterdam, The Netherlands , The Netherlands
Make a Reservation Online
PDA recommends the reservation at the following hotel
Amsterdam Marriott Hotel
Stadhouderskade 12
1054 ES Amsterdam
The Netherlands
PDA Europe has reserved a limited number of rooms by 11 April 2024.
Please note that this special rate is subject to availability, as there is a
city fair during this time.
Book your room at the PDA Group Rate via the above-mentioned reservation button.
HOW TO GET HERE
By Air
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will bring you to it. It takes around 20 minutes by car and 35 minutes by train.
By Car On site parking is not available.
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Experience a well-deserved escape at the hotel in Netherlands, Amsterdam. The
Amsterdam Marriott Hotel is surrounded by stunning canals and exquisite
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Frank House, the Van Gogh Museum, Rijksmuseum and Vondelpark as well as upscale
shopping, fine dining and entertainment destinations.
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