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

Networking Opportunities

Monday, 24 June 2024

PDA Europe cordially invites you to a special networking evening in Amsterdam with a guided walking tour followed by a delightful dinner!

18:25h Meeting Point: Main Entrance, Amsterdam Marriott Hotel

PDA looks forward to an inspiring evening filled with interesting encounters and engaging conversations.

Standard Registration

Member Price

€ 2.250

GovernmentMember Only

€ 1.080

Health AuthorityMember Only

€ 1.080

Early Career ProfessionalMember Only

€ 1.080

StudentMember Only

€ 1.080

AcademicMember Only

€ 1.080

Non-Member

€ 2.550

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.

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

Sunday, 23 June CEST

15:00 – 18:00 | Registration Open

Studio 3,4,5,6,7

Monday, 24 June CEST

  • Registration Open

    Studio 3,4,5,6,7

  • Welcome and Introduction

    Salon ABC

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

  • Welcome from the Co-Chairs

    Salon ABC

    • 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

    Salon ABC

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

    • 7 Things I Wish I Knew Before Undergoing Gene Therapy

      • Presenter: Jimi Olaghere, Gene Editing Recipient , -

    • 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

    • Plenary Discussion

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

      • Panelist: Jimi Olaghere, Gene Editing Recipient , -

      • Panelist: Veronika Jekerle

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

  • Networking Coffee Break, Poster Session & Exhibition

    Studio 3,4,5,6,7

  • Session 1: Challenges in Manufacturing

    Salon ABC

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

    Manufacturability of ATMP represents one of the most difficult challenges in bringing life-saving/changing productions to patients. Three presentations in this session will describe this universal challenge from different perspectives ranging from novel modality to lifecycle management. Our speakers will share their stories in dealing with this shared challenge across the ATMP space and yet distinctly different from product to product.
    • 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, Associate Director, Global Cell Therapy Sterility Assurance Lead, Bristol Myers Squibb (BMS)

    • 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, Associate Director, Global Cell Therapy Sterility Assurance Lead, Bristol Myers Squibb (BMS)

      • 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

    Studio 3,4,5,6,7

  • Guided Poster Walk

    Studio 3,4,5,6,7

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

    • A Novel Approach to Managing Risks in Aseptic Processing of Cell & Gene Therapies

    • Biodecontamination of Raw Materials in Packaging Production Process

    • CCS for Material Transfer: Best Practice for Packaging and Surface Disinfection

      • Poster Presenter: Bram Van Puymbroeck, Account Manager, STERIS Life Sciences

    • Challenges in the Analysis of a Pharmaceutical Lentiviral Vector by Orthogonal Physical (Nano)particle Characterization Techniques

      • Poster Presenter: Daniela Stadler, PhD, Scientist, Coriolis Pharma Research GmbH

    • Considerations for Cleaning Lipid Nanoparticles (LNPs)9

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

    • Designing a Disinfectant Program for Advanced Therapy Medicinal Product Manufacturing

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

    • Detection of Particulate Matter in Single-Use Systems Applied in the Production of ATMPs

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

    • Development of a Dual Reporter Cargo and Systemic Incorporation of a Highly Flexible, Benchtop Automation System to Facilitate rAAV9-Based Novel Capsid Development and Characterization

      • Poster Presenter: Chakameh Azimpour, PhD, Director - Analytical Development, Capsida Biotherapeutics

    • Harmonizing and Automating the Endotoxin Detection of Cell & Gene Therapy Products with Recombinant Factor C

      • Poster Presenter: Christian Faderl, Project Leader, bioMérieux

    • Influence of Rubber Stoppers on Immunoglobulin Behavior

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

    • Mycoplasma Release Test with Low Volume Protocol: From Sample to Results in Less Than 1 Hour

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

    • Optimization of Electron Microscopical Methods for a Validated Quality Assessment of Adeno-Associated Viruses (AAV)

    • Scalable Single-Use Harvest and Clarification Solutions for Cell and Virus Based ATMPs

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

    • The Myth of the “Non-GMP Space:” The Criticality of Establishing Good Aseptic Practices in the Development Environment

      • Poster Presenter: Amanda Curtis, Microbiology Consultant, ValSource, Inc.

    • Viral Vectors Inside an Isolator - Approaches to Minimize Their Associated Risks

    • Virus Filtration as an Upstream Risk Mitigation Tool in the Manufacturing of Advanced Therapy Medicinal Products

      • Poster Presenter: Michael Lasse, PhD, Global Product Manager, Sartorius

  • Interactive Questionnaire

    Salon ABC

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

  • Session 2: From Development to Commercialization

    Salon ABC

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

    This session will focus on an exciting new development in European cell and gene therapy where academic centers are advancing new ATMPs into clinical practice and towards national compassionate use implementation or European market authorization following an academic, not-for-profit model. This approach can lead to both the rapid introduction of novel therapies to the market or can improve patient accessibility by generating products functionally like commercial products which may currently have limited availability. The speakers will describe their centralized or point-of-care (decentralized) manufacturing methodologies and present an overview of the clinical data obtained to date. The different approaches employed to gain reimbursement for the cellular drug products with the local authorities will be discussed and the possible regulatory path to drug registration will be debated.
    • 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

      • Academic Presenter: Eulalia Olesti, PharmD, PhD, Regulatory Affairs Lead, Hospital Clinic Barcelona, IDIBAPS

    • 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, Project Lead Translational TCR Drug Development Senior 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, PharmD, PhD, Regulatory Affairs Lead, Hospital Clinic Barcelona, IDIBAPS

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

  • Networking Coffee Break, Poster Session & Exhibition

    Studio 3,4,5,6,7

  • Session 3: Quality Control

    Salon ABC

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

      • Presenter: Asena Abay, PhD, Senior Scientist, Sanofi

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

      • Panelist: Asena Abay, PhD, Senior Scientist, Sanofi

      • 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

    Studio 3,4,5,6,7

  • Welcome to Day 2

    Salon ABC

    • 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

    Salon ABC

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

    This session will provide an overview and updates on various regulatory expectations for ATMP manufacturing. First, we’ll hear about all the ‘good practices’ needed to manufacture, test, and distribute an ATMP. In addition, there will be updates on 3 draft chapters from the USP covering contamination detection for short shelf-life products using respiration-based, ATP bioluminescence-based, and other rapid microbial methods. Finally, we’ll hear from the EDQM providing an update on two general monographs for gene therapy products which have recently been finalized.
    • 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 to Gene Therapy Texts

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

    • Overview and Future Plans of the USP Rapid Microbiological Methods Subcommittee

      • Presenter: Marsha L. Steed, Founder and CEO / Sr Consultant, Steed MicroBio / JYA

    • 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, Founder and CEO / Sr Consultant, Steed MicroBio / JYA

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

  • Networking Coffee Break, Poster Session & Exhibition

    Studio 3,4,5,6,7

  • Session 5: New Technologies

    Salon ABC

    • 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

    Studio 3,4,5,6,7

  • Interactive Questionnaire

    Salon ABC

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

  • Closing Plenary Part I

    Salon ABC

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

    The Closing Plenary Session will address the regulatory requirements to produce ATMPs and will also include the presentation of the PDA Points to Consider Documents for Viruses. The focus during this session will be on inspections and when hospital exemptions apply as well as discussions/fireside chat with the Swissmedic about their publication of the Q&A document on Annex 1 as well as requirements for the production of ATMPs. At the Industry Experts Discussion, participants' questions will be answered and the resume discussions during the two conference days.
    • Points to Consider for the Development, Classification, Manufacture, Control and Testing of Plasmids and Vectors Used in ATMP Production

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

    • Inspections of ATMP Production Sites and Hospital Exemption Applications

  • Networking Coffee Break, Poster Session & Exhibition

    Studio 3,4,5,6,7

  • Passport Raffle

    Salon ABC

  • Closing Plenary Part II

    Salon ABC

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

    The Closing Plenary Session will address the regulatory requirements to produce ATMPs and will also include the presentation of the PDA Points to Consider Documents for Viruses. The focus during this session will be on inspections and when hospital exemptions apply as well as discussions/fireside chat with the Swissmedic about their publication of the Q&A document on Annex 1 as well as requirements for the production of ATMPs. At the Industry Experts Discussion, participants' questions will be answered and the resume discussions during the two conference days.
    • 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

    • Plenary 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

    Salon ABC

    • 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

    Salon ABC

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

Posters

Biodecontamination of Raw Materials in Packaging Production Process
  • Andrea Weiss

CCS for Material Transfer: Best Practice for Packaging and Surface Disinfection
  • Bram Van Puymbroeck, Account Manager, STERIS Life Sciences

Challenges in the Analysis of a Pharmaceutical Lentiviral Vector by Orthogonal Physical (Nano)particle Characterization Techniques
  • Daniela Stadler, PhD, Scientist, Coriolis Pharma Research GmbH

Considerations for Cleaning Lipid Nanoparticles (LNPs)9
  • James N. Polarine, MA, Senior Technical Service Manager, STERIS Corporation

Designing a Disinfectant Program for Advanced Therapy Medicinal Product Manufacturing
  • James N. Polarine, MA, Senior Technical Service Manager, STERIS Corporation

Detection of Particulate Matter in Single-Use Systems Applied in the Production of ATMPs
  • Klaus R. Wormuth, PhD, Principal Scientist, Sartorius Stedim Biotech

Development of a Dual Reporter Cargo and Systemic Incorporation of a Highly Flexible, Benchtop Automation System to Facilitate rAAV9-Based Novel Capsid Development and Characterization
  • Chakameh Azimpour, PhD, Director - Analytical Development, Capsida Biotherapeutics

Harmonizing and Automating the Endotoxin Detection of Cell & Gene Therapy Products with Recombinant Factor C
  • Christian Faderl, Project Leader, bioMérieux

Influence of Rubber Stoppers on Immunoglobulin Behavior
  • Giorgio Fernando De Avelar Francisco, MSc, R&D project engineer, Aptar Stelmi SAS

Mycoplasma Release Test with Low Volume Protocol: From Sample to Results in Less Than 1 Hour
  • Caroline Kassim Houssenaly, PhD, R&D Biosciences Manager, bioMérieux

Optimization of Electron Microscopical Methods for a Validated Quality Assessment of Adeno-Associated Viruses (AAV)
  • Ashley Layland

Scalable Single-Use Harvest and Clarification Solutions for Cell and Virus Based ATMPs
  • Marc Noverraz, MSc, Process Technology Manager - Separation Technologies, Sartorius

The Myth of the “Non-GMP Space:” The Criticality of Establishing Good Aseptic Practices in the Development Environment
  • Amanda Curtis, Microbiology Consultant, ValSource, Inc.

Viral Vectors Inside an Isolator - Approaches to Minimize Their Associated Risks
  • Maximilian Mittelviefhaus

Virus Filtration as an Upstream Risk Mitigation Tool in the Manufacturing of Advanced Therapy Medicinal Products
  • Michael Lasse, PhD, Global Product Manager, Sartorius

Agenda is subject to change.

Presenters

  • Asena Abay, PhD

    Senior Scientist, Sanofi

    Panelist
    Presenter
    Read Bio
  • Manjula Aysola, MS

    Senior Regulatory Consultant, MilliporeSigma

    Moderator
    Read Bio
  • Chakameh Azimpour, PhD

    Director - Analytical Development, Capsida Biotherapeutics

    Poster 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
  • Amanda Curtis

    Microbiology Consultant, ValSource, Inc.

    Poster Presenter
    Read Bio
  • Giorgio Fernando De Avelar Francisco, MSc

    R&D project engineer, Aptar Stelmi SAS

    Poster Presenter
    Read Bio
  • Richard Denk

    Senior Consulting Aseptic Processing & Containment, SKAN AG

    Co-Chair
    Co-Presenter
    Moderator
    Read Bio
  • Josh Eaton, MS

    Senior Director, Scientific and Regulatory Affairs, PDA

    Moderator
    Read Bio
  • Christian Faderl

    Project Leader, bioMérieux

    Poster 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

    Project Lead Translational TCR Drug Development Senior Project Manager - Research & Development , Miltenyi Biotec B.V. & Co. KG

    Moderator
    Read Bio
  • Rebecca D. Jordan

    Associate Director, Global Cell Therapy Sterility Assurance Lead, Bristol Myers Squibb (BMS)

    Panelist
    Presenter
    Read Bio
  • Caroline Kassim Houssenaly, PhD

    R&D Biosciences Manager, bioMérieux

    Poster 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
  • Michael Lasse, PhD

    Global Product Manager, Sartorius

    Poster Presenter
    Read Bio
  • Ashley Layland

    Poster Presenter
  • Roman Mathaes, PhD

    CEO, Clear Solutions Laboratories

    Co-Presenter
    Panelist
    Read Bio
  • Maximilian Mittelviefhaus

    Poster Presenter
  • Sandrine Mores, MA

    COO , ExoXpert

    Panelist
    Presenter
    Read Bio
  • Ryan Murray, MS

    Senior Consultant, ValSource, Inc.

    Moderator
    Read Bio
  • Marc Noverraz, MSc

    Process Technology Manager - Separation Technologies, Sartorius

    Poster Presenter
    Read Bio
  • Jimi Olaghere

    Gene Editing Recipient , -

    Panelist
    Presenter
    Read Bio
  • Eulalia Olesti, PharmD, PhD

    Regulatory Affairs Lead, Hospital Clinic Barcelona, IDIBAPS

    Academic Presenter
    Panelist
    Read Bio
  • Darius Pillsbury

    Senior Consultant, ValSource, Inc.

    Panelist
    Presenter
    Read Bio
  • Francois Pinsard

    GMDP Inspector ATMP Division, Swissmedic

    Panelist
    Read Bio
  • James N. Polarine, MA

    Senior Technical Service Manager, STERIS Corporation

    Poster Presenter
    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
  • Daniela Stadler, PhD

    Scientist, Coriolis Pharma Research GmbH

    Poster Presenter
    Read Bio
  • Marsha L. Steed

    Founder and CEO / Sr Consultant, Steed MicroBio / JYA

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

    Assistant Professor, Julius Center, UMC Utrecht

    Co-Chair
    Moderator
    Read Bio
  • Bram Van Puymbroeck

    Account Manager, STERIS Life Sciences

    Poster Presenter
    Read Bio
  • Andrea Weiss

    Poster Presenter
  • Klaus R. Wormuth, PhD

    Principal Scientist, Sartorius Stedim Biotech

    Poster Presenter
    Read Bio

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  • 1st class 112,90€ (seat reservation incl.)
  • 2nd class 77,90€

Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.

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Area Attractions

Experience a well-deserved escape at the hotel in Netherlands, Amsterdam. The Amsterdam Marriott Hotel is surrounded by stunning canals and exquisite architecture boasting an unparalleled city centre location across from the Leidseplein, just moments from Amsterdam's iconic attractions. Walk to the Anne Frank House, the Van Gogh Museum, Rijksmuseum and Vondelpark as well as upscale shopping, fine dining and entertainment destinations.