PDA Advanced Therapy Medicinal Products Conference 2024

Monday, 24 June CEST

• 09:00 – 09:05

  Welcome and Introduction

  • 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

  • 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 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) and National Healthcare Institute (Zorginstituut Nederland) and collaborated with several research groups, amongst which the Center of Health Economics at the University of York, UK. At the Julius Center Renske strives to increase translation of (academic) gene and cell-based therapies towards implementation in healthcare services to facilitate patient access. In doing so her research focusses on payment models, development cost, (early) economic evaluations and business models. She aims to contribute to better understanding of the fit between gene and cell-based therapies and existing development frameworks. This is not only relevant for these transformative therapies 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

  • 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 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) and National Healthcare Institute (Zorginstituut Nederland) and collaborated with several research groups, amongst which the Center of Health Economics at the University of York, UK. At the Julius Center Renske strives to increase translation of (academic) gene and cell-based therapies towards implementation in healthcare services to facilitate patient access. In doing so her research focusses on payment models, development cost, (early) economic evaluations and business models. She aims to contribute to better understanding of the fit between gene and cell-based therapies and existing development frameworks. This is not only relevant for these transformative therapies but also for future biomedical innovations.

  • 09:15 – 09:40

    7 Things I Wish I Knew Before Undergoing Gene Therapy

    • Presenter: Jimi Olaghere

      

      Jimi Olaghere
      

  • 09:40 – 10:05

    EMA’s Experience in the Development Support and Approval of Gene Therapy Medicinal Products

    • Regulatory Presenter: Veronika Jekerle

      

      Veronika Jekerle
      

  • 10:05 – 10:30

    Enhancing Strategic Decision-Making for ATMP Development & Commercialization: The Role of Supply Chain Business Intelligence

    • Presenter: Steffen Schulze, Strategic Analytics & Business Insights Lead, F. Hoffmann-La Roche

      

      Steffen Schulze, Strategic Analytics & Business Insights Lead, F. Hoffmann-La Roche
      

      Steffen Schulze is the Strategic Analytics & Business Insights Lead in Roche's Cell & Gene Therapies division, specializing in quantitative modeling to assess and integrate data from preclinical stages to product commercialization in the ATMP field. With a background in preclinical research, including antibody identification and process development, Steffen gained technical expertise in commercial manufacturing as a quality assurance specialist and GMP project manager. Within Roche, he contributed to cost assessments for a personalized cancer vaccine and an autologous gene therapy, as well as preparing the drug product sourcing strategy for an antibody drug conjugate. Steffen's multidisciplinary expertise bridges scientific, technical, and economic aspects, supporting Roche's advancements in the cell and gene therapy field.

  • 10:30 – 11:00

    Q&A, 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 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) and National Healthcare Institute (Zorginstituut Nederland) and collaborated with several research groups, amongst which the Center of Health Economics at the University of York, UK. At the Julius Center Renske strives to increase translation of (academic) gene and cell-based therapies towards implementation in healthcare services to facilitate patient access. In doing so her research focusses on payment models, development cost, (early) economic evaluations and business models. She aims to contribute to better understanding of the fit between gene and cell-based therapies and existing development frameworks. This is not only relevant for these transformative therapies but also for future biomedical innovations.

    • Panelist: Jimi Olaghere

      

      Jimi Olaghere
      

    • Panelist: Veronika Jekerle

      

      Veronika Jekerle
      

    • Panelist: Steffen Schulze, Strategic Analytics & Business Insights Lead, F. Hoffmann-La Roche

      

      Steffen Schulze, Strategic Analytics & Business Insights Lead, F. Hoffmann-La Roche
      

      Steffen Schulze is the Strategic Analytics & Business Insights Lead in Roche's Cell & Gene Therapies division, specializing in quantitative modeling to assess and integrate data from preclinical stages to product commercialization in the ATMP field. With a background in preclinical research, including antibody identification and process development, Steffen gained technical expertise in commercial manufacturing as a quality assurance specialist and GMP project manager. Within Roche, he contributed to cost assessments for a personalized cancer vaccine and an autologous gene therapy, as well as preparing the drug product sourcing strategy for an antibody drug conjugate. Steffen's multidisciplinary expertise bridges scientific, technical, and economic aspects, supporting Roche's advancements in the cell and gene therapy field.

• 11:00 – 11:30

  Networking Coffee Break, Poster Session & Exhibition
• 11:30 – 13:00

  Session 1: Challenges in Manufacturing

  • 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 and amateur marathoner.

  • 11:30 – 11:50

    The Challenges of the Innovative Exosomes-based Therapies – Case Study

    • Presenter: Sandrine Mores

      

      Sandrine Mores
      

  • 11:50 – 12:10

    ‘Spilling the Tea’ on Leaks in Autologous CAR T Manufacturing

    • Presenter: Rebecca D Jordan, QC Microbiology Specialist, Celgene, Biotechnology Company

      

      Rebecca D Jordan, QC Microbiology Specialist, Celgene, Biotechnology Company
      

      Rebecca Jordan is a Microbiology Specialist at Celgene's West Coast CAR-T manufacturing facility, where she focuses on the multifaceted discipline of contamination control. She has over 10 years’ experience in industry as a QC Microbiologist, where she has supported both large and small manufacturing firms, commercial facility start-up, development through licensure of parenteral drugs, facility and utilities monitoring, APS, CAPA, and quality risk management to name a few. She has also successfully navigated global regulatory audits, developed and implemented aseptic training programs, established EM trend and disinfectant efficacy programs, and consulted on new facility design projects for CAR-T therapy manufacturing. She is a keen investigator whose curiosity and dedication has led to a diverse and rewarding career. She holds a B.S. in Biology from Fitchburg State University.

  • 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 of Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG

      

      Antonio Burazer, Global Head of 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 and amateur marathoner.

    • Panelist: Sandrine Mores

      

      Sandrine Mores
      

    • Panelist: Rebecca D Jordan, QC Microbiology Specialist, Celgene, Biotechnology Company

      

      Rebecca D Jordan, QC Microbiology Specialist, Celgene, Biotechnology Company
      

      Rebecca Jordan is a Microbiology Specialist at Celgene's West Coast CAR-T manufacturing facility, where she focuses on the multifaceted discipline of contamination control. She has over 10 years’ experience in industry as a QC Microbiologist, where she has supported both large and small manufacturing firms, commercial facility start-up, development through licensure of parenteral drugs, facility and utilities monitoring, APS, CAPA, and quality risk management to name a few. She has also successfully navigated global regulatory audits, developed and implemented aseptic training programs, established EM trend and disinfectant efficacy programs, and consulted on new facility design projects for CAR-T therapy manufacturing. She is a keen investigator whose curiosity and dedication has led to a diverse and rewarding career. She holds a B.S. in Biology from Fitchburg State University.

    • 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 of Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG

      

      Antonio Burazer, Global Head of 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
• 13:40 – 14:10

  Guided Poster Walk

  • 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.
• 14:10 – 14:20

  Interactive Questionnaire

  • Moderator: Ian Johnston, PhD, Academic and Industrial Cooperations ManagerSenior Project Manager - Research & Development, Miltenyi Biotec B.V. & Co. KG

    

    Ian Johnston, PhD, Academic and Industrial Cooperations ManagerSenior Project Manager - Research & Development, Miltenyi Biotec B.V. & Co. KG
    

    Dr. Ian 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. 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

  • Moderator: Ian Johnston, PhD, Academic and Industrial Cooperations ManagerSenior Project Manager - Research & Development, Miltenyi Biotec B.V. & Co. KG

    

    Ian Johnston, PhD, Academic and Industrial Cooperations ManagerSenior Project Manager - Research & Development, Miltenyi Biotec B.V. & Co. KG
    

    Dr. Ian 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. 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 – 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

      

      Eulalia Olesti
      

  • 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, Academic and Industrial Cooperations ManagerSenior Project Manager - Research & Development, Miltenyi Biotec B.V. & Co. KG

      

      Ian Johnston, PhD, Academic and Industrial Cooperations ManagerSenior Project Manager - Research & Development, Miltenyi Biotec B.V. & Co. KG
      

      Dr. Ian 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. 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

      

      Eulalia Olesti
      

    • 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
• 16:20 – 17:50

  Session 3: Quality Control

  • Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc.

    

    Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc.
    

    Lori Dingledine is currently working in Quality Control at Spark Therapeutics, responsible for Microbial Control and Compendial Testing. Lori has over 20 years of experience in the gene therapy, biopharmaceutical, and medical device industries in management roles in Quality Control laboratories responsible for analytical, bioanalytical, microbiology, physical testing, and QC inspection.

  • 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 held a number of scientific and operational positions at Merck KGaA including set-up and operations management of the UK in vivo testing facility and Scientific Director for Virology and In Vivo testing services. 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: Cheryl E Essex, MSc, Head of Contamination Control, R&D Global Quality, Sanofi

      

      Cheryl E Essex, MSc, Head of Contamination Control, R&D Global Quality, Sanofi
      

      Ms. Essex is a recognized global expert in microbial contamination control at Sanofi and she co-led the PDA author team for Technical Report 90 on Contamination Control Strategy. Ms. Essex has 20 years’ experience in Quality focused on Microbiological Contamination Control at large pharmaceutical companies, contract manufacturers, and emerging biotechnology working in mammalian, microbial and human cell systems. Ms. Essex’s undergraduate education focused on Biology & Microbiology and she holds graduate degrees in Bioengineering & Stem Cell Medicine.

  • 17:00 – 17:20

    Challenges in Developing a Contamination Control Strategy for an ATMP Manufacturing Site

    • Presenter: Arabela X. Cuirolo, PhD, Sterility Assurance Lead, Kite Pharma EU B.V.

      

      Arabela X. Cuirolo, PhD, Sterility Assurance Lead, Kite Pharma EU B.V.
      

      Arabela is a Pharmacist and a Microbiologist with nearly 10 years of experience in the industry. She joined the company in 2018, as a QC Micro Scientist in the start-up face of Kite, fundamentally supporting the set-up of the EM program (to Establish, validate and sustain EM program for the site) and the Methods Transfers for her department. She later led the QC Micro department for about 6 months until she took on the new challenge as a Sterility Assurance Lead. Within this new role, she is leading the site Contaminiation Control Strategy while supporting internally as a SME for new projects related to aseptic practices.

  • 17:20 – 17:50

    Q&A, Discussion

    • Moderator: Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc.

      

      Lori Dingledine, QC Lead- Microbial Control and Compendial Testing, Spark Therapeutics, Inc.
      

      Lori Dingledine is currently working in Quality Control at Spark Therapeutics, responsible for Microbial Control and Compendial Testing. Lori has over 20 years of experience in the gene therapy, biopharmaceutical, and medical device industries in management roles in Quality Control laboratories responsible for analytical, bioanalytical, microbiology, physical testing, and QC inspection.

    • Panelist: Cheryl E Essex, MSc, Head of Contamination Control, R&D Global Quality, Sanofi

      

      Cheryl E Essex, MSc, Head of Contamination Control, R&D Global Quality, Sanofi
      

      Ms. Essex is a recognized global expert in microbial contamination control at Sanofi and she co-led the PDA author team for Technical Report 90 on Contamination Control Strategy. Ms. Essex has 20 years’ experience in Quality focused on Microbiological Contamination Control at large pharmaceutical companies, contract manufacturers, and emerging biotechnology working in mammalian, microbial and human cell systems. Ms. Essex’s undergraduate education focused on Biology & Microbiology and she holds graduate degrees in Bioengineering & Stem Cell Medicine.

    • 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 held a number of scientific and operational positions at Merck KGaA including set-up and operations management of the UK in vivo testing facility and Scientific Director for Virology and In Vivo testing services. 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

• 08:30 – 08:35

  Welcome to Day 2

  • 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 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) and National Healthcare Institute (Zorginstituut Nederland) and collaborated with several research groups, amongst which the Center of Health Economics at the University of York, UK. At the Julius Center Renske strives to increase translation of (academic) gene and cell-based therapies towards implementation in healthcare services to facilitate patient access. In doing so her research focusses on payment models, development cost, (early) economic evaluations and business models. She aims to contribute to better understanding of the fit between gene and cell-based therapies and existing development frameworks. This is not only relevant for these transformative therapies 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

  • 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.

  • 08:35 – 08:55

    Navigating Regulatory Challenges: Insights from Developing ATMPs through GMP/GDP/GCP

    • Co-Presenter: Patrick Buschor

      

      Patrick Buschor
      

  • 08:55 – 09:15

    New Approach of the European Pharmacopoeia to Gene Therapy Products

    • Regulatory Presenter: Olga Kolaj-Robin

      

      Olga Kolaj-Robin
      

  • 09:15 – 09:35

    USP Microbiology Updates on RMM for Short Life Products

    • Presenter: Marsha L Steed, Head of Corporate Microbial Control and Viral Safety, Resilience

      

      Marsha L Steed, Head of Corporate Microbial Control and Viral Safety, Resilience
      

      Marsha Steed has over 30 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha is currently the Head of Corporate Microbial Control & Sterility Assurance for Resilience. In this role, Marsha leads the global sterility assurance team which oversees the Resilience contamination control strategy for the manufacturing sites. Marsha’s team leads efforts to implement modern microbial methods across the Resilience network.
      
      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

      

      Patrick Buschor
      

    • Panelist: Marsha L Steed, Head of Corporate Microbial Control and Viral Safety, Resilience

      

      Marsha L Steed, Head of Corporate Microbial Control and Viral Safety, Resilience
      

      Marsha Steed has over 30 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha is currently the Head of Corporate Microbial Control & Sterility Assurance for Resilience. In this role, Marsha leads the global sterility assurance team which oversees the Resilience contamination control strategy for the manufacturing sites. Marsha’s team leads efforts to implement modern microbial methods across the Resilience network.
      
      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

      

      Olga Kolaj-Robin
      

• 10:05 – 10:35

  Networking Coffee Break, Poster Session & Exhibition
• 10:35 – 11:45

  Session 5: New Technologies

  • 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

    How AI Can Transform ATMP Development

    • Presenter: Michael N Blackton, MBA, Founder and CEO, Blackfin Biopharm Advisors

      

      Michael N Blackton, MBA, Founder and CEO, Blackfin Biopharm Advisors
      

      Michael is a seasoned professional with over 30 years in the biopharmaceutical industry, joining the Parenteral Drug Association (PDA) in 1996. Currently, as the founder and principal of Blackfin Biopharm Advisory, he leads a consultancy dedicated to advancing therapies to market. Throughout his career, Michael has worked in Quality, Operations, and Manufacturing, showcasing expertise in monoclonal antibodies, small molecules, medical devices, and advanced therapies. His notable roles include serving as Senior Vice President of Cell Therapy Manufacturing at Nurix and Global Head of Quality at Adaptimmune. Michael's biotech journey began at IDEC Pharmaceuticals, where he developed downstream processing methodologies for Rituxan. He has contributed significantly to Eli Lilly, Millennium Pharmaceuticals, and Biomarin. In addition to his corporate achievements, Michael has been actively engaged with the PDA, serving as a past Board Member, where he co-founded and serves as past chair of the ATMP Advisory Board. He co-founded the ATMP Interest Group and contributed to several PDA Technical Reports, white papers, and regulatory comment requests. Michael's leadership and contributions underscore his commitment to advancing the biopharmaceutical industry.

  • 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: Michael N Blackton, MBA, Founder and CEO, Blackfin Biopharm Advisors

      

      Michael N Blackton, MBA, Founder and CEO, Blackfin Biopharm Advisors
      

      Michael is a seasoned professional with over 30 years in the biopharmaceutical industry, joining the Parenteral Drug Association (PDA) in 1996. Currently, as the founder and principal of Blackfin Biopharm Advisory, he leads a consultancy dedicated to advancing therapies to market. Throughout his career, Michael has worked in Quality, Operations, and Manufacturing, showcasing expertise in monoclonal antibodies, small molecules, medical devices, and advanced therapies. His notable roles include serving as Senior Vice President of Cell Therapy Manufacturing at Nurix and Global Head of Quality at Adaptimmune. Michael's biotech journey began at IDEC Pharmaceuticals, where he developed downstream processing methodologies for Rituxan. He has contributed significantly to Eli Lilly, Millennium Pharmaceuticals, and Biomarin. In addition to his corporate achievements, Michael has been actively engaged with the PDA, serving as a past Board Member, where he co-founded and serves as past chair of the ATMP Advisory Board. He co-founded the ATMP Interest Group and contributed to several PDA Technical Reports, white papers, and regulatory comment requests. Michael's leadership and contributions underscore his commitment to advancing the biopharmaceutical industry.

• 11:45 – 12:45

  Networking Lunch Break, Poster Session & Exhibition
• 12:45 – 12:55

  Interactive Questionnaire

  • 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

  • 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 – 13:10

    Title to be announced

    • 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

      

      Christianne Reijnders
      

• 13:35 – 14:05

  Networking Coffee Break, Poster Session & Exhibition
• 14:05 – 14:10

  Passport Raffle
• 14:10 – 15:45

  Closing Plenary Part II

  • 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.

  • 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

    Title to be announced

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

      

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

      SPEAKER BIOGRAPHY Johannes Blümel, Ph. D. Head of Virus Safety Section Paul-Ehrlich-Institut Federal institute for Vaccines and Biomedicines Paul-Ehrlich-Straße 51-59 63225 Langen, Germany Phone: +49 6103 773800 Fax: +49 6103 771285 E-mai: [email protected] Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with assessment of virus safety and TSE safety of blood products, recombinant DNA products such as monoclonal antibodies, and advanced therapy medicinal products (ATMPs) for clinical trials and marketing authorization. He participates as expert in EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure and contributed in drafting of numerous Guidelines and Monographs on viral safety. Further, he is working in several research projects on virus inactivation and detection of Viruses by Next Generation Sequencing (NGS). Since 2023 he is chairing the group on blood-associated pathogens for the national advisory board “Arbeitskeis Blut” in Germany as well as the Ph. Eur. Working Party on High Throughput Sequencing (HTS), in charge of elaborating a general chapter on HTS for the detection of viral extraneous agents. Prior to joining the Paul-Ehrlich-Institut in 1998, Dr. Blümel worked at the University Hospital, University of Bonn (1993-1998). He performed basic research on virus replication and received a five years training in medical virology and virus diagnostics (Fachvirologe). Dr. Blümel completed his Diploma Study in Biology (molecular genetics, microbiology, biophysics and physical chemistry) in 1991 at the University of Freiburg, Germany. He received his Ph.D. degree at the Department of Virology, University of Freiburg, Germany (1993). In 2010 he received teaching graduation (Habilitation) in Medical Virology from the University Frankfurt.

  • 15:00 – 15:45

    Closing Panel 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

      

      Christianne Reijnders
      

    • Panelist: Veronika Jekerle

      

      Veronika Jekerle
      

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

      

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

      SPEAKER BIOGRAPHY Johannes Blümel, Ph. D. Head of Virus Safety Section Paul-Ehrlich-Institut Federal institute for Vaccines and Biomedicines Paul-Ehrlich-Straße 51-59 63225 Langen, Germany Phone: +49 6103 773800 Fax: +49 6103 771285 E-mai: [email protected] Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with assessment of virus safety and TSE safety of blood products, recombinant DNA products such as monoclonal antibodies, and advanced therapy medicinal products (ATMPs) for clinical trials and marketing authorization. He participates as expert in EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure and contributed in drafting of numerous Guidelines and Monographs on viral safety. Further, he is working in several research projects on virus inactivation and detection of Viruses by Next Generation Sequencing (NGS). Since 2023 he is chairing the group on blood-associated pathogens for the national advisory board “Arbeitskeis Blut” in Germany as well as the Ph. Eur. Working Party on High Throughput Sequencing (HTS), in charge of elaborating a general chapter on HTS for the detection of viral extraneous agents. Prior to joining the Paul-Ehrlich-Institut in 1998, Dr. Blümel worked at the University Hospital, University of Bonn (1993-1998). He performed basic research on virus replication and received a five years training in medical virology and virus diagnostics (Fachvirologe). Dr. Blümel completed his Diploma Study in Biology (molecular genetics, microbiology, biophysics and physical chemistry) in 1991 at the University of Freiburg, Germany. He received his Ph.D. degree at the Department of Virology, University of Freiburg, Germany (1993). In 2010 he received teaching graduation (Habilitation) in Medical Virology from the University Frankfurt.

    • Panelist: Olga Kolaj-Robin

      

      Olga Kolaj-Robin
      

• 15:45 – 16:00

  Co-Chairs Conference Summary

  • 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 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) and National Healthcare Institute (Zorginstituut Nederland) and collaborated with several research groups, amongst which the Center of Health Economics at the University of York, UK. At the Julius Center Renske strives to increase translation of (academic) gene and cell-based therapies towards implementation in healthcare services to facilitate patient access. In doing so her research focusses on payment models, development cost, (early) economic evaluations and business models. She aims to contribute to better understanding of the fit between gene and cell-based therapies and existing development frameworks. This is not only relevant for these transformative therapies 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

  • 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.

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