PDA Advanced Therapy Medicinal Products Conference 2025

CEST Daylight Time (UTC +2:00)

• 08:00 – 18:00

  Registration Hours

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• 09:00 – 09:05

  Welcome and Introduction

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  • Committee Member:

    

    Falk Klar, PhD
    General Manager, Vice President Europe, Parenteral Drug Association

• 09:05 – 09:15

  Welcome from the Co-Chairs

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  • Co-Chair:

    

    Renske MT ten Ham, PhD, PharmD, MSc
    Assistant Professor, Julius Center, UMC Utrecht

  • Co-Chair:

    

    Ryan Murray, MS
    Senior Consultant, ValSource, Inc.

• 09:15 – 11:15

  Opening Plenary - Past, Present, and Progress: Advancing Cell Therapy Through Innovation and Responsibility

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  • Moderator:

    

    Ryan Murray, MS
    Senior Consultant, ValSource, Inc.

  • 09:15 – 09:40

    How the Past Can Advance the Future

    • Presenter:

      

      Stephen Judd, CEng, FIChemE FIEI
      European Director of Process Technology, Arcadis

  • 09:40 – 10:05

    Future Directions in Cell Therapy Manufacturing and Enablement

    • Presenter:

      

      Tom Bell, PhD
      Partner, L.E.K. Consulting

  • 10:05 – 10:30

    Reclaim the C’s: Feasibility of Recycling Plastic Waste During ATMP Production

    • Academic Presenter:

      

      Nika Gvazava, MD
      PhD student , Lund University

  • 10:30 – 11:15

    Plenary Discussion

    • Moderator:

      

      Ryan Murray, MS
      Senior Consultant, ValSource, Inc.

    • Panelist:

      

      Stephen Judd, CEng, FIChemE FIEI
      European Director of Process Technology, Arcadis

    • Panelist:

      

      Tom Bell, PhD
      Partner, L.E.K. Consulting

    • Panelist:

      

      Nika Gvazava, MD
      PhD student , Lund University

• 11:15 – 11:45

  Networking Coffee Break, Poster Session & Exhibition

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  Take this opportunity to recharge with a coffee and connect with fellow attendees. Use the time to explore the exhibition area, schedule one-on-one meetings with exhibitors, and expand your network. Don’t forget to visit the poster area and engage with the presenters about their exciting research.
• 11:45 – 12:55

  Speed Session 1: Manufacturing

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  • Moderator:

    

    Dayue Chen, PhD
    Distinguished Scientist, Genentech, Inc.

  ATMP manufacturing represents the last leg of a long R&D marathon, which turns raw materials into therapeutic products that treat diseases and save lives. In the ATMP world, true learning usually occurs when manufacturing starts due to process/product complexity and diversity. This session focuses on Quality, Prevention of Cross Contamination, and Aseptic Process & Containment, all critical areas in ATMP manufacturing. In addition, the session will provide an update on the PDA ATMP Advisory Board, outlining the priorities and ongoing activities of the board.

  • 11:45 – 11:55

    Demonstrating Analytical Comparability for Complex Manufacturing Process Changes: Lessons Learned from Technical and Regulatory Perspectives

    • Presenter:

      

      Houman Dehghani, PhD
      Vice President, Cabaletta Bio

  • 11:55 – 12:05

    Quality Considerations in a Decentralized CAR T Manufacturing Model

    • Presenter:

      

      Jason Treese
      Global Head of Quality, Galapagos

  • 12:05 – 12:15

    Preventing Cross-Contamination During Manufacturing of ATMPs

    • Presenter:

      

      Richard Denk
      Senior Consultant Aseptic Processing, SKAN AG

  • 12:15 – 12:25

    PDA ATMP Advisory Board Updates

    • Presenter:

      

      Darius Pillsbury
      Senior Consultant, ValSource, Inc.

  • 12:25 – 12:55

    Q&A Discussion

    • Moderator:

      

      Dayue Chen, PhD
      Distinguished Scientist, Genentech, Inc.

    • Panelist:

      

      Houman Dehghani, PhD
      Vice President, Cabaletta Bio

    • Panelist:

      

      Jason Treese
      Global Head of Quality, Galapagos

    • Panelist:

      

      Richard Denk
      Senior Consultant Aseptic Processing, SKAN AG

    • Panelist:

      

      Darius Pillsbury
      Senior Consultant, ValSource, Inc.

• 12:55 – 13:25

  Guided Poster Walk 

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  • Moderator:

    

    Josh Eaton, MS
    Senior Director, Scientific and Regulatory Affairs, PDA

  • 12:55 – 13:25

    Developing a Contamination Control Strategy for ATMP Cleanrooms

    • Poster Presenter:

      

      Renee V. Buthe
      Technical Services Manager, STERIS Corporation

  • 12:55 – 13:25

    Effective Use of Deviron® Detergents for AAV Recovery During Lysis And Viral Inactivation in Gene Therapy Manufacturing

    • Poster Presenter:

      

      Antoine Heron, PhD
      Modality Consultant - Viral Vectors EMEA, Merck

  • 12:55 – 13:25

    Establishing State-of-the-Art CAR T Cell Manufacturing Capabilities in a Not-for-Profit Organization in Sweden

    • Poster Presenter:

      

      Chao Sheng, PhD
      Process Development Manager & Team Lead, CCRM Nordic

  • 12:55 – 13:25

    Flexible aseptic processing under grade A conditions

    • Poster Presenter:

      

      Adrian Keller
      Strategic Product Management, SKAN AG

  • 12:55 – 13:25

    From Breakthrough to Sustainable Success: The Criticality of Contamination Control in ATMP Development

    • Poster Presenter:

      

      Amanda Curtis
      Microbiology Consultant, ValSource, Inc.

  • 12:55 – 13:25

    Improving safety and quality in ATMP production while enhancing the sustainability of cell factories with closed system.

    • Poster Presenter:

      

      Pietro Bosi, MD
      Business Development Manager, IWT srl

  • 12:55 – 13:25

    Maximizing Contamination Control for Classified Areas Through Material Transfer

    • Poster Presenter:

      

      Renee V. Buthe
      Technical Services Manager, STERIS Corporation

  • 12:55 – 13:25

    Navigating the Analytical Landscape: Method Comparison for GMP-Compliant AAV Characterization with TEM

    • Poster Presenter:

      

      Ashley Stephen Layland
      Project Director, neotem Bioanalytics-IIT GmbH

  • 12:55 – 13:25

    Non-Authorised ATMPs in the Czech Republic: Regulatory Pathways and Patient Access

    • Poster Presenter:

      

      Zora Čechová, PharmD, PhD
      Regulatory Specialist, Centre of Excellence CREATIC, Masaryk University

  • 12:55 – 13:25

    Phenotypic detection via continous metabolic monitoring enables sterility testing in under 3 days with calscreener+

    • Poster Presenter:

      

      Wilhelm Paulander, PhD
      Chief Clinical Development Officer, Symcel

  • 12:55 – 13:25

    Scalable Stem Cell-Derived Natural Killer Cell Differentiation in an In Vitro Feeder-Free System

    • Poster Presenter:

      

      Theo Vogiatzoglou
      

  • 12:55 – 13:25

    Standardisation, automation, decentralisation: a Path for personalised medicine manufacture

    • Poster Presenter:

      

      Laureline Mahe, PhD
      Head of Applied Science, Team Consulting

  • 12:55 – 13:25

    User-centred design for effective, automated, cGMP bioprocessing platforms in cell & gene therapies

    • Poster Presenter:

      

      Joseph Conroy, MEng
      Consultant Mechanical Engineer, Team Consulting

• 13:05 – 14:10

  Networking Lunch Break, Poster Session & Exhibition

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  This is your time to network and explore! Connect with colleagues, meet new professionals in the field, and take a closer look at the posters. Visit the exhibition booths, book appointments with exhibitors, and complete your Passport Raffle for a chance to win.
• 14:10 – 16:05

  Session 2: Regulatory Updates

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  • Regulatory Moderator:

    

    Marcel Hoefnagel, PhD
    Senior Assessor Biopharmaceuticals, Medicines Evaluation Board

  In this regulatory session we have three great presentations to share some recent developments in the regulations for cell and gene therapy products. The EMA Guideline for Investigational ATMP in Clinical Trials provides support to developers in their CMC development. Andreea Barbu will highlight the elemental parts of that guideline. Development of ATMP is challenging in itself, but this is sometimes further complicated by (perceived) different regulatory expectations in the different regions. Dolca Rogers will inform us about some of the common challenges in development, but also about the efforts on harmonization between EMA and FDA trying to alleviate impact those differences would have for product development. Ander Izeta will discuss the implications for ATMP of the Regulation on Substances of Human Origin (SoHo) will have. The panel discussion will focus on these topics, but undoubtedly, other related topics will come up.

  • 14:10 – 14:20

    Interactive Questionnaire Session

    • Moderator:

      

      Ryan Murray, MS
      Senior Consultant, ValSource, Inc.

  • 14:20 – 14:45

    Highlights from the EMA Guideline for Investigational ATMP in Clinical Trial

    • Regulatory Presenter:

      

      Andreea Barbu, PhD
      Senior assessor, The Swedish Medical Product Agency

  • 14:45 – 15:10

    Common Challenges in the Regulatory Path for ATMPs – International Collaboration for More Harmonized Outcomes

    • Regulatory Presenter:

      

      Dolca Rogers, PhD
      Scientific Officer at the Pharmaceutical Quality Office, European Medicines Agency

  • 15:10 – 15:35

    Regulation on Substances of Human Origin (SoHo): Implications for ATMP Development

    • Regulatory Presenter:

      

      Ander Izeta, PhD
      Section Head, Advanced Therapies Unit/Donostia University Hospital/Basque Health Service

  • 15:35 – 16:05

    Q&A Discussion

    • Regulatory Moderator:

      

      Marcel Hoefnagel, PhD
      Senior Assessor Biopharmaceuticals, Medicines Evaluation Board

    • Regulatory Panelist:

      

      Andreea Barbu, PhD
      Senior assessor, The Swedish Medical Product Agency

    • Regulatory Panelist:

      

      Ander Izeta, PhD
      Section Head, Advanced Therapies Unit/Donostia University Hospital/Basque Health Service

    • Regulatory Panelist:

      

      Dolca Rogers, PhD
      Scientific Officer at the Pharmaceutical Quality Office, European Medicines Agency

• 16:05 – 16:35

  Networking Coffee Break, Poster Session & Exhibition

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  Enjoy a relaxed coffee break while diving into the vibrant atmosphere of our exhibition. Schedule meetings with solution providers, participate in the Passport Raffle, and stop by the PDA photo wall to capture a memory with your new connections.
• 16:35 – 18:10

  Session 3: Clinical Perspective

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  • Moderator:

    

    Ian Johnston, PhD
    Scientific Director, Project Lead Translational TCR Drug Development Senior Project Manager - Research & Development , Miltenyi Biotec B.V. & Co. KG

  Would you be willing to consider yourself or a family member as a candidate for treatment with an experimental cell or gene therapy? This session will open with a powerful patient perspective to ground the audience in the ultimate purpose of their daily efforts—advancing and improving the manufacturing of advanced therapy medicinal products (ATMPs). Subsequent presentations will examine the academic development and implementation of cell and gene therapy products, emphasizing how clinical innovation and point-of-care manufacturing are enhancing patient access to these advanced therapeutic modalities.

  • 16:35 – 17:00

    A Patient’s Journey: Life Before, During, and After Gene Therapy

    • Presenter:

      

      Maria-Luiza Prioteasa
      Parent , Patient relative

  • 17:00 – 17:20

    From Lab to Clinic: Point-of-Care Anti-CD19 CAR-T Cell Therapy Induces Remission in Refractory Acquired Hemophilia A

    • Academic Presenter:

      

      Kalin Stoyanov
      Resident, Hanover Medical School (MHH)

  • 17:20 – 17:40

    Steering Innovation to Clinical Success: The Development of a Fully Personalized Dendritic Cell Vaccine for Pediatric High-Risk Solid Tumors

    • Academic Presenter:

      

      Regina Demlova
      Head of CREATIC CoE, Head of Pharmacology Dept., Masaryk University, Faculty of Medicine

  • 17:40 – 18:10

    Q&A Discussion

    • Moderator:

      

      Ian Johnston, PhD
      Scientific Director, Project Lead Translational TCR Drug Development Senior Project Manager - Research & Development , Miltenyi Biotec B.V. & Co. KG

    • Academic Panelist:

      

      Regina Demlova
      Head of CREATIC CoE, Head of Pharmacology Dept., Masaryk University, Faculty of Medicine

    • Academic Panelist:

      

      Kalin Stoyanov
      Resident, Hanover Medical School (MHH)

• 18:10 – 18:10

  End of Conference Day 1 & Networking Event

CEST Daylight Time (UTC +2:00)

• 08:00 – 16:30

  Registration Hours

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• 08:30 – 09:00

  Collaboration or Competition? The Nordic Model in ATMP Innovation

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  • Moderator:

    

    Sarah Callens
    Chief Technology Officer, CCRM Nordic

  • Co-Presenter:

    

    Anna Pasetto, PhD
    Director ACT centre, Oslo University Hospital

  • Co-Presenter:

    

    Fredrik Wessberg, MSc
    CEO, CCRM Nordic

  • Co-Presenter:

    

    Thomas H.R Carlsen, PhD
    CEO, Novo Nordisk Foundation Cellerator

  This breakfast panel brings together leaders from clinical translation organisations in Denmark, Sweden, and Norway to explore how collaboration and competition shape the Nordic advanced therapy ecosystem. With limited regional resources and growing international pressure, we’ll ask where duplication of effort can be reduced, what collaboration models have worked (or failed), and how the Nordics can better coordinate to unlock shared value. Panelists will share how they define success in partnerships, when they choose to collaborate vs. compete, and what they hope Nordic cooperation will look like five years from now.
• 09:05 – 10:30

  Session 4: Quality, Safety, and Efficacy

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  • Moderator:

    

    Ola Adel
    Site Quality Head Aseptics and Cell and Gene Therapy , Novartis

  This session covers product quality, patient safety, and therapeutic efficacy in cell and advanced therapies. Experts will present strategies to enhance manufacturing processes, establish robust control systems, and integrate ethical AI for personalized medicine. Through discussions and case studies, attendees will gain insights into innovative approaches shaping the future of advanced therapies. Mahmoud Asif will begin with insights on particle control strategies for cell therapy manufacturing. Kat Kozyrytska will discuss the application of ethical AI to improve the manufacturability and personalization of ATMPs. Claudia Lee will conclude with case studies on sequencing-based quality control techniques for cell, gene, and mRNA therapies. Expert presentations and discussions will provide attendees with valuable strategies and innovative approaches to advance therapies.

  • 09:05 – 09:25

    Is That a Particle? Establishing a Particle Control Strategy in Cell Therapy

    • Presenter:

      

      Asif Mahmood
      Technical Director - Technology Transfer, Bristol Myers Squibb

  • 09:25 – 09:45

    Improving Manufacturability and Personalizing ATMPs with Ethical AI

    • Presenter:

      

      Kat Kozyrytska, MS
      Founder, Cell Therapy Manufacturability Program

  • 09:45 – 10:00

    Case Studies of Sequencing Based QC for Cell, Gene and mRNA Therapy

    • Presenter:

      

      Claudia Lee, PhD
      VP of R&D, Velvet Therapeutics

  • 10:00 – 10:30

    Q&A Discussion

    • Moderator:

      

      Ola Adel
      Site Quality Head Aseptics and Cell and Gene Therapy , Novartis

    • Panelist:

      

      Asif Mahmood
      Technical Director - Technology Transfer, Bristol Myers Squibb

    • Panelist:

      

      Claudia Lee, PhD
      VP of R&D, Velvet Therapeutics

    • Panelist:

      

      Kat Kozyrytska, MS
      Founder, Cell Therapy Manufacturability Program

• 10:30 – 11:00

  Networking Coffee Break, Poster Session & Exhibition

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  Grab a coffee, mingle with other participants, and make valuable new contacts. Visit the poster presentations, engage with the authors, and take time to explore the exhibition - your chance to meet key industry players and schedule deeper conversations.
• 11:00 – 12:30

  Session 5: Manufacturing Challenges

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  • Moderator:

    

    Richard Denk
    Senior Consulting Aseptic Processing & Containment, SKAN AG

  Manufacturing cell and gene therapies consistently and at scale remains a complex, evolving challenge but one the industry is steadily learning to navigate. In this session, experts from leading biotech companies and supplier organizations will explore how growing regulatory scrutiny is reshaping raw material strategies, highlight emerging innovations improving AAV yields, and share efforts to bring greater clarity to viral safety expectations in cell therapy. Be part of the conversation driving real progress in the manufacturing of living medicines.

  • 11:00 – 11:20

    ATMP Material Classification, Associated Framework for Development of Science & Risk Based Approach

    • Presenter:

      

      Aida Rouzmehr, MS
      Material Science Product Lead, Genentech part of Roche

  • 11:20 – 11:40

    AAV Process Intensification: Focus on Upstream Critical Process Parameters

    • Presenter:

      

      Antoine Heron, PhD
      Modality Consultant - Viral Vectors EMEA, Merck

  • 11:40 – 12:00

    Ensuring Viral Safety of Cell Therapy Products

    • Presenter:

      

      Manjula Aysola, MS
      Senior Regulatory Consultant, MilliporeSigma

  • 12:00 – 12:30

    Q&A Discussion

    • Moderator:

      

      Richard Denk
      Senior Consulting Aseptic Processing & Containment, SKAN AG

    • Panelist:

      

      Aida Rouzmehr, MS
      Material Science Product Lead, Genentech part of Roche

    • Panelist:

      

      Antoine Heron, PhD
      Modality Consultant - Viral Vectors EMEA, Merck

    • Panelist:

      

      Manjula Aysola, MS
      Senior Regulatory Consultant, MilliporeSigma

• 12:30 – 13:30

  Networking Lunch Break, Poster Session & Exhibition

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  Make the most of your break by combining food and conversation! Stroll through the exhibition, talk to poster presenters about their work, and take part in the Passport Raffle. Stop by the PDA photo wall and create a lasting memory with your peers.
• 13:30 – 14:35

  Closing Plenary - Turning Challenges Into Change: Charting the Future of ATMPs

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  • Moderator:

    

    Renske MT ten Ham, PhD, PharmD, MSc
    Assistant Professor, Julius Center, UMC Utrecht

  The closing plenary explores key challenges and future directions in ATMP-development. An interactive fireside chat will delve into centralized vs. decentralized manufacturing and the regulatory considerations shaping each model. Followed by a talk addressing the “valley of despair” in drug development—why many ATMPs stall and what’s needed to overcome this gap. Featuring expert perspectives and practical insights, this session aims to reframe barriers as drivers of change and collaboration across the ATMP ecosystem.

  • 13:30 – 14:00

    Fireside Chat on Centralized vs. Decentralized ATMP Manufacturing

    • Regulatory Presenter:

      

      Roberto Conocchia, MD
      GMP Technical Lead, European Medicine Agency

    • Regulatory Presenter:

      

      Marcel Hoefnagel, PhD
      Senior Assessor Biopharmaceuticals, Medicines Evaluation Board

    • Presenter:

      

      Richard Denk
      Senior Consultant Aseptic Processing, SKAN AG

  • 14:00 – 14:20

    Moving Drug Discovery Through the Valley of Despair: From Struggles to Solutions

    • Presenter:

      

      Orit Gamburg, BPharm MSc MBA
      RA & QA Consultant, Project Manager, GSAP

  • 14:20 – 14:35

    Q&A, Discussion

    • Moderator:

      

      Renske MT ten Ham, PhD, PharmD, MSc
      Assistant Professor, Julius Center, UMC Utrecht

    • Regulatory Panelist:

      

      Roberto Conocchia, MD
      GMP Technical Lead, European Medicine Agency

    • Panelist:

      

      Orit Gamburg, BPharm MSc MBA
      RA & QA Consultant, Project Manager, GSAP

• 14:35 – 15:05

  Networking Coffee Break, Poster Session & Exhibition

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  Fuel up with coffee while building your professional network. Use this time to schedule meetings with exhibitors, view the posters and chat with the presenters, and complete your Passport Raffle. And don’t miss the PDA photo wall to snap a fun keepsake!
• 15:05 – 15:10

  Raffle Card Announcement

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• 15:10 – 15:15

  Best Poster Presentation

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• 15:15 – 16:20

  Interactive Round Table Session

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  • Moderator:

    

    Renske MT ten Ham, PhD, PharmD, MSc
    Assistant Professor, Julius Center, UMC Utrecht

  In this dynamic session, we’ll dive into the two hottest topics, as voted by the PDA social media community! The audience will explore: Regulatory strategies for accelerated ATMP approvals & Manufacturing innovation, scalability, and cost reduction. Join the conversation, share your perspective, and collaborate on actionable ideas. Key insights and outcomes will be captured and presented afterward!
• 16:20 – 16:30

  Co-Chairs Conference Summary

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  • Co-Chair:

    

    Renske MT ten Ham, PhD, PharmD, MSc
    Assistant Professor, Julius Center, UMC Utrecht

  • Co-Chair:

    

    Ryan Murray, MS
    Senior Consultant, ValSource, Inc.

• 16:30 – 16:35

  Closing Remarks & Farewell

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  • Committee Member:

    

    Falk Klar, PhD
    General Manager, Vice President Europe, Parenteral Drug Association

• 16:35 – 16:35

  End of Conference

Posters

• Renee V. Buthe, Technical Services Manager, STERIS Corporation

• Antoine Heron, PhD, Modality Consultant - Viral Vectors EMEA, Merck

• Chao Sheng, PhD, Process Development Manager & Team Lead, CCRM Nordic

• Adrian Keller, Strategic Product Management, SKAN AG

• Amanda Curtis, Microbiology Consultant, ValSource, Inc.

• Pietro Bosi, MD, Business Development Manager, IWT srl

• Renee V. Buthe, Technical Services Manager, STERIS Corporation

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

• Zora Čechová, PharmD, PhD, Regulatory Specialist, Centre of Excellence CREATIC, Masaryk University

• Wilhelm Paulander, PhD, Chief Clinical Development Officer, Symcel

• Theo Vogiatzoglou

• Laureline Mahe, PhD, Head of Applied Science, Team Consulting

• Joseph Conroy, MEng, Consultant Mechanical Engineer, Team Consulting