PDA Advanced Therapy Medicinal Products Conference 2024

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 Role in Bringing Gene Therapy Products to Patients

    • Regulatory Presenter: Veronika Jekerle, PhD, Head of Pharmaceutical Quality, Human Medicines, European Medicines Agency

      

      Veronika Jekerle, PhD, Head of Pharmaceutical Quality, Human Medicines, European Medicines Agency
      

      Veronika Jekerle obtained a pharmacy degree from University of Marburg, Germany (2001) and PhD in Molecular pharmacology, drug discovery from the University of Bonn, Germany and the University of Toronto, Canada. She joined the European Medicines Agency in 2006 and has held various roles including Product Team Lead for Biological medicinal product, Vaccines, ATMPs and Biosimilar applications; Quality Specialist with focus on Advanced Therapies, recombinant proteins including mABs, biosimilars and vaccines, Scientific Secretary to the Biologics Working Party (BWP – 1014 – 2020) and lead of regulatory science activities including prior knowledge flexibility in CMC requirements for PRIME and scientific guidance development of ATMPs, vaccines and Biosimilars. Since March 2020, Veronika is leading the Pharmaceutical Quality Office, responsible for the scientific oversight and management of the pharmaceutical quality of human medicines throughout their life-cycle in the context of the benefit risk assessment.

  • 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, PhD, Head of Pharmaceutical Quality, Human Medicines, European Medicines Agency

      

      Veronika Jekerle, PhD, Head of Pharmaceutical Quality, Human Medicines, European Medicines Agency
      

      Veronika Jekerle obtained a pharmacy degree from University of Marburg, Germany (2001) and PhD in Molecular pharmacology, drug discovery from the University of Bonn, Germany and the University of Toronto, Canada. She joined the European Medicines Agency in 2006 and has held various roles including Product Team Lead for Biological medicinal product, Vaccines, ATMPs and Biosimilar applications; Quality Specialist with focus on Advanced Therapies, recombinant proteins including mABs, biosimilars and vaccines, Scientific Secretary to the Biologics Working Party (BWP – 1014 – 2020) and lead of regulatory science activities including prior knowledge flexibility in CMC requirements for PRIME and scientific guidance development of ATMPs, vaccines and Biosimilars. Since March 2020, Veronika is leading the Pharmaceutical Quality Office, responsible for the scientific oversight and management of the pharmaceutical quality of human medicines throughout their life-cycle in the context of the benefit risk assessment.

    • 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 Facility

    • 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, Mr., Managing Director, Innerspace GmbH

      

      Sebastian Scheler, Mr., 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, Mr., Managing Director, Innerspace GmbH

      

      Sebastian Scheler, Mr., 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
      

      Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with the 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 participated as an expert in the EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure and contributed to the drafting of numerous Guidelines and Monographs on viral safety. Further, he is working on several research projects on virus inactivation and detection of Viruses by Next Generation Sequencing (NGS). Since 2023 he has been 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. Before 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 five years of 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 a teaching graduation (Habilitation) in Medical Virology from the University of 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, PhD, Head of Pharmaceutical Quality, Human Medicines, European Medicines Agency

      

      Veronika Jekerle, PhD, Head of Pharmaceutical Quality, Human Medicines, European Medicines Agency
      

      Veronika Jekerle obtained a pharmacy degree from University of Marburg, Germany (2001) and PhD in Molecular pharmacology, drug discovery from the University of Bonn, Germany and the University of Toronto, Canada. She joined the European Medicines Agency in 2006 and has held various roles including Product Team Lead for Biological medicinal product, Vaccines, ATMPs and Biosimilar applications; Quality Specialist with focus on Advanced Therapies, recombinant proteins including mABs, biosimilars and vaccines, Scientific Secretary to the Biologics Working Party (BWP – 1014 – 2020) and lead of regulatory science activities including prior knowledge flexibility in CMC requirements for PRIME and scientific guidance development of ATMPs, vaccines and Biosimilars. Since March 2020, Veronika is leading the Pharmaceutical Quality Office, responsible for the scientific oversight and management of the pharmaceutical quality of human medicines throughout their life-cycle in the context of the benefit risk assessment.

    • Panelist: Johannes Bluemel, PhD, Head of Virus Safety Section, Paul-Ehrlich-Institut

      

      Johannes Bluemel, PhD, Head of Virus Safety Section, Paul-Ehrlich-Institut
      

      Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with the 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 participated as an expert in the EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure and contributed to the drafting of numerous Guidelines and Monographs on viral safety. Further, he is working on several research projects on virus inactivation and detection of Viruses by Next Generation Sequencing (NGS). Since 2023 he has been 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. Before 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 five years of 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 a teaching graduation (Habilitation) in Medical Virology from the University of 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

• Andrea Weiss

• Bram Van Puymbroeck, Account Manager, STERIS Life Sciences

• Daniela Stadler, PhD, Scientist, Coriolis Pharma Research GmbH

• James N. Polarine, MA, Senior Technical Service Manager, STERIS Corporation

• James N. Polarine, MA, Senior Technical Service Manager, STERIS Corporation

• Klaus R. Wormuth, PhD, Principal Scientist, Sartorius Stedim Biotech

• Chakameh Azimpour, PhD, Director - Analytical Development, Capsida Biotherapeutics

• Christian Faderl, Project Leader, bioMérieux

• Giorgio Fernando De Avelar Francisco, MSc, R&D project engineer, Aptar Stelmi SAS

• Caroline Kassim Houssenaly, PhD, R&D Biosciences Manager, bioMérieux

• Ashley Stephen Layland, Project Director, neotem Bioanalytics-IIT GmbH

• Marc Noverraz, MSc, Process Technology Manager - Separation Technologies, Sartorius

• Amanda Curtis, Microbiology Consultant, ValSource, Inc.

• Maximilian Mittelviefhaus

• Michael Lasse, PhD, Global Product Manager, Sartorius