PDA Advanced Therapy Medicinal Products Conference 2024

Next Steps in ATMPs and Beyond

Amsterdam, The Netherlands
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Program Highlights

Celebrate with us the 15th edition of this format!

The agenda preview has just been published!

Related PDA Letter Article: Next Steps in ATMPs and Beyond authored by our Co-Chairs, Renske ten Ham, Uni Medical Center Utrecht & Richard Denk, SKAN .

ATTENTION
The conference will take place right before the PDA Virus Conference 2024! Make the best of your journey and attend two conferences in one week!

Dear Colleagues,

Welcome to the PDA Advanced Therapy Medicinal Products Conference 2024!

Join us on 24-25 June 2024, in Amsterdam, The Netherlands, for an enriching experience. Organized by the PDA and the Scientific Program Planning Committee, this conference, themed "Next Steps in AMTPs and Beyond", promises a comprehensive exploration of the latest developments in advanced therapy medicinal products.

With thousands of therapies currently in development across hospitals, start-ups, and pharmaceutical manufacturing portfolios, the common goal is to successfully bring these therapies to market. However, this journey is laden with challenges, including regulatory requirements, manufacturing options, costs, and sustainability concerns. The PDA Advanced Therapy Medicinal Products Conference has been a steadfast supporter of this path for many years.

Our program will be designed to feature diverse sessions covering cutting-edge topics, discussions with authorities, and intensive exchanges during question-and-answer sessions and breaks. Explore system solutions in the Exhibition area and engage in enlightening poster sessions.

We eagerly anticipate your participation in this gathering of industry leaders and experts. Amsterdam awaits you for a conference that promises valuable insights, networking opportunities, and a shared commitment to advancing the field of advanced therapy medicinal products. See you there!

Sincerely,
The Co-Chairs

Renske ten Ham, Uni Medical Center Utrecht
Richard Denk, SKAN

SCIENTIFIC PROGRAM PLANNING COMMITTEE

  • Renske ten Ham, Uni Medical Center Utrecht
  • Richard Denk, SKAN
  • Manjula Aysola, Merck
  • Manuel Carrondo, ibet
  • Dayue Chen, Genentech/Roche
  • Fabio D’Agostino, Charabio
  • Lori Dingledine, Sparktx
  • Irving Ford, Adaptimmune Therapeutics
  • Markus Haindl, Roche
  • Marcel Hoefnagel, MEB
  • Ian Johnston, Miltenyi
  • Ryan Murray, ValSource
  • Josh Eaton, PDA
  • Falk Klar, PDA
  • Caroline Lynar, PDA, Manager Programs & Events

Standard Registration

Member Price

€ 2.250

GovernmentMember Only

€ 1.080

Health AuthorityMember Only

€ 1.080

Early Career ProfessionalMember Only

€ 1.080

StudentMember Only

€ 1.080

AcademicMember Only

€ 1.080

Non-Member

€ 2.550

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Monday, 24 June CEST

  • Registration Open

  • Welcome and Introduction

    • Committee Member: Falk Klar, PhD, Parenteral Drug Association

  • Welcome from the Co-Chairs

    • Co-Chair: Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius Center, UMC Utrecht

    • Co-Chair: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

  • Opening Plenary

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

    • 7 Things I Wish I Knew Before Undergoing Gene Therapy

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

    • 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

    • Q&A, Discussion

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

      • Panelist: Jimi Olaghere

      • Panelist: Veronika Jekerle

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

  • Networking Coffee Break, Poster Session & Exhibition

  • Session 1: Challenges in Manufacturing

    • Moderator: Dayue Chen, PhD, Head of Cell Therapy Technical Development, Genentech, Inc.

    • The Challenges of the Innovative Exosome-based Therapies – Case Study

      • Presenter: Sandrine Mores, MA, COO , ExoXpert

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

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

    • Visual Inspection & Particle Life Cycle Management in CGT Products - Same, Same but Different?

      • Co-Presenter: Roman Mathaes, PhD, CEO, Clear Solutions Laboratories

      • Co-Presenter: Antonio Burazer, Global Head Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG

    • Q&A, Discussion

      • Moderator: Dayue Chen, PhD, Head of Cell Therapy Technical Development, Genentech, Inc.

      • Panelist: Sandrine Mores, MA, COO , ExoXpert

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

      • Panelist: Roman Mathaes, PhD, CEO, Clear Solutions Laboratories

      • Panelist: Antonio Burazer, Global Head Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG

  • Networking Lunch Break & Exhibition

  • Guided Poster Walk

    • Moderator: Josh Eaton, MS, Senior Director, Scientific and Regulatory Affairs, PDA

  • Interactive Questionnaire

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

  • 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

    • 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

    • Decentralizing CAR-T Production: Proof of Concept Network Experience with an Academic CAR-T

    • 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

    • Q&A, Discussion

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

      • Panelist: Inge Jederma, PhD, Head of Translational Cellular Therapy, Netherlands Cancer Institute / Antoni van Leeuwenhoek

      • Panelist: Eulalia Olesti

      • Panelist: Jasmijn Korpershoek, MD PhD, Postdoctoral Researcher, UMC Utrecht

  • Networking Coffee Break, Poster Session & Exhibition

  • Session 3: Quality Control

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

    • Addressing the Challenges: Alternative Methods for ATMP Analytics Testing

      • Presenter: Sarah E. Sheridan, PhD, Technical Consultant, Merck

    • Viral Control Strategy for Allogeneic Cell Therapy

    • 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.

    • Q&A, Discussion

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

      • Panelist: Asena Abay

      • Panelist: Sarah E. Sheridan, PhD, Technical Consultant, Merck

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

  • End of Conference Day 1 & Networking Event

Tuesday, 25 June CEST

  • Registration Open

  • Welcome to Day 2

    • Co-Chair: Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius Center, UMC Utrecht

    • Co-Chair: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

  • Session 4: Regulatory Updates

    • Moderator: Manjula Aysola, MS, Senior Regulatory Consultant, MilliporeSigma

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

      • Presenter: Patrick Buschor, Dr., Contracted Qualified Person, PMS - Process Management System

    • European Pharmacopoeia - new approach of the to gene therapy texts

      • Regulatory Presenter: Olga Kolaj-Robin, PhD, Scientific Programme Manager, European Directorate for the Quality of Medicines and HealthCare

    • USP Microbiology Updates on RMM for Short Life Products

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

    • Q&A, Discussion

      • Moderator: Manjula Aysola, MS, Senior Regulatory Consultant, MilliporeSigma

      • Panelist: Patrick Buschor, Dr., Contracted Qualified Person, PMS - Process Management System

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

      • Panelist: Olga Kolaj-Robin, PhD, Scientific Programme Manager, European Directorate for the Quality of Medicines and HealthCare

  • Networking Coffee Break, Poster Session & Exhibition

  • Session 5: New Technologies

    • Moderator: Ryan Murray, MS, Senior Consultant, ValSource, Inc.

    • Decentralized Manufacturing of Autologous ATMPs: How Technology Innovation Fosters Regulatory Compliance

      • Presenter: Ursula Busse, PhD, MBA, Head of Regulatory Affairs, Tigen Pharma

    • Frame-by-Frame: How Digital Process Twins Overcome Barriers to Develop Robust ATMP Manufacturing Processes

      • Presenter: Sebastian Scheler, Managing Director, Innerspace GmbH

    • Q&A, Discussion

      • Moderator: Ryan Murray, MS, Senior Consultant, ValSource, Inc.

      • Panelist: Ursula Busse, PhD, MBA, Head of Regulatory Affairs, Tigen Pharma

      • Panelist: Sebastian Scheler, Managing Director, Innerspace GmbH

  • Networking Lunch Break, Poster Session & Exhibition

  • Interactive Questionnaire

    • Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

  • Closing Plenary Part I

    • Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    • Title to be announced

      • Presenter: Darius Pillsbury, Senior Consultant, ValSource, Inc.

    • Inspections of ATMP Production Sites and Hospital Exemption Applications

  • Networking Coffee Break, Poster Session & Exhibition

  • Passport Raffle

  • Closing Plenary Part II

    • Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    • 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

      • Co-Presenter: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    • Revision of Guideline ICH Q5A(R2) with Relevance for ATMPs

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

    • Closing Panel Discussion

      • Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

      • Panelist: Francois Pinsard, GMDP Inspector ATMP Division, Swissmedic

      • Panelist: Darius Pillsbury, Senior Consultant, ValSource, Inc.

      • Panelist: Christianne Reijnders, PhD, Coordinating/Specialistic Inspector, Health and Youth Care Inspectorate

      • Panelist: Veronika Jekerle

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

      • Panelist: Olga Kolaj-Robin, PhD, Scientific Programme Manager, European Directorate for the Quality of Medicines and HealthCare

  • Co-Chairs Conference Summary

    • Co-Chair: Renske MT ten Ham, PhD, PharmD, MSc, Assistant Professor, Julius Center, UMC Utrecht

    • Co-Chair: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

  • Closing Remarks & Farewell

    • Committee Member: Falk Klar, PhD, Parenteral Drug Association

Posters

Agenda is subject to change.

Presenters

  • Asena Abay

    Panelist
    Presenter
  • Manjula Aysola, MS

    Senior Regulatory Consultant, MilliporeSigma

    Moderator
    Read Bio
  • Michael N Blackton, MBA

    Founder and CEO, Blackfin Biopharm Advisors

    Panelist
    Presenter
    Read Bio
  • Johannes Bluemel, PhD

    Head of Virus Safety Section, Paul-Ehrlich-Institut

    Panelist
    Regulatory Presenter
    Read Bio
  • Antonio Burazer

    Global Head Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG

    Co-Presenter
    Panelist
    Read Bio
  • Patrick Buschor, Dr.

    Contracted Qualified Person, PMS - Process Management System

    Co-Presenter
    Panelist
    Presenter
    Read Bio
  • Ursula Busse, PhD, MBA

    Head of Regulatory Affairs, Tigen Pharma

    Panelist
    Presenter
    Read Bio
  • Dayue Chen, PhD

    Head of Cell Therapy Technical Development, Genentech, Inc.

    Moderator
    Read Bio
  • Arabela X. Cuirolo, PhD

    Sterility Assurance Lead, Kite Pharma EU B.V.

    Panelist
    Presenter
    Read Bio
  • Richard Denk

    Senior Consulting Aseptic Processing & Containment, SKAN AG

    Co-Chair
    Co-Presenter
    Moderator
    Read Bio
  • Lori Dingledine

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

    Moderator
    Read Bio
  • Josh Eaton, MS

    Senior Director, Scientific and Regulatory Affairs, PDA

    Moderator
    Read Bio
  • Cheryl E Essex, MSc

    Head of Contamination Control, R&D Global Quality, Sanofi

    Panelist
    Presenter
    Read Bio
  • Inge Jederma, PhD

    Head of Translational Cellular Therapy, Netherlands Cancer Institute / Antoni van Leeuwenhoek

    Academic Presenter
    Panelist
    Read Bio
  • Veronika Jekerle

    Panelist
    Regulatory Presenter
  • Ian Johnston, PhD

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

    Moderator
    Read Bio
  • Rebecca D Jordan

    QC Microbiology Specialist, Celgene, Biotechnology Company

    Panelist
    Presenter
    Read Bio
  • Falk Klar, PhD

    Parenteral Drug Association

    Committee Member
    Read Bio
  • Olga Kolaj-Robin, PhD

    Scientific Programme Manager, European Directorate for the Quality of Medicines and HealthCare

    Panelist
    Regulatory Presenter
    Read Bio
  • Jasmijn Korpershoek, MD PhD

    Postdoctoral Researcher, UMC Utrecht

    Academic Presenter
    Panelist
    Read Bio
  • Roman Mathaes, PhD

    CEO, Clear Solutions Laboratories

    Co-Presenter
    Panelist
    Read Bio
  • Sandrine Mores, MA

    COO , ExoXpert

    Panelist
    Presenter
    Read Bio
  • Ryan Murray, MS

    Senior Consultant, ValSource, Inc.

    Moderator
    Read Bio
  • Jimi Olaghere

    Panelist
    Presenter
  • Eulalia Olesti

    Academic Presenter
    Panelist
  • Darius Pillsbury

    Senior Consultant, ValSource, Inc.

    Panelist
    Presenter
    Read Bio
  • Francois Pinsard

    GMDP Inspector ATMP Division, Swissmedic

    Panelist
    Read Bio
  • Christianne Reijnders, PhD

    Coordinating/Specialistic Inspector, Health and Youth Care Inspectorate

    Panelist
    Regulatory Presenter
  • Sebastian Scheler

    Managing Director, Innerspace GmbH

    Panelist
    Presenter
    Read Bio
  • Steffen Schulze

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

    Panelist
    Presenter
    Read Bio
  • Sarah E. Sheridan, PhD

    Technical Consultant, Merck

    Panelist
    Presenter
    Read Bio
  • Marsha L Steed

    Head of Corporate Microbial Control and Viral Safety, Resilience

    Panelist
    Presenter
    Read Bio
  • Renske MT ten Ham, PhD, PharmD, MSc

    Assistant Professor, Julius Center, UMC Utrecht

    Co-Chair
    Moderator
    Read Bio

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