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2020 ATMPS

2020 PDA Europe Advanced Therapy Medicinal Products

Jun 24 - Jun 25, 2020
Brussels, Belgium

Cell and Gene Therapy - From Promise to Cure

  • Conference
  • Europe

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Program Highlights

Dear Colleague,

In the name of the Program Planning Committee, welcome to this 2020 PDA global conference that will include live simulcasts of select sessions for both the European and the US audience!

For the 12th time, PDA Europe will be hosting this two-day event that aims to support all stakeholders in the development and bringing to the market of novel and effective cell and gene therapies, as well as tissue-engineered products.

The rise of tissue engineering at the turn of the century led health authorities around the world to consider the need for specific legislation to clarify how they would be regulated. The EU first defined cell and gene therapy products as medicines in 2003 (Directive 2003/63/EC), but did not specifically address tissue engineering. This perceived gap was filled through Regulation (EC) 1394/2007 which defined tissue engineering by function not structure and required all ATMPs to be approved by the European Medicines Agency (EMA).

Today, with fifteen ATMPs approved, there is a real sense that ATMP approvals are building momentum, especially immunotherapies such as CAR-T. Yet already, the use of viral transduction of cells may give way to new technologies such as gene editing, bringing new scientific, legal, and ethical challenges. Having been the catalyst for new regulation, how has tissue engineering evolved since the turn of the century, and are the challenges being met?

These questions and other issues common to all personalized therapies and medicinal products such as comparability, particulates, advancements in automation, and development of commercial manufacturing strategies will be covered by our panel of international speakers.

The Co-Chairs

Dayue Chen, PhD
Genentech/Roche, Chair

Christopher Bravery
, PhD
Advanced Biologicals, Chair



  • Dayue Chen, Genentech/Roche, Chair
  • Christopher Bravery, Advanced Biologicals, Chair
  • Manuel Carrondo, ibet
  • Richard Denk, Skan
  • Fabio D’Agostino, Claris Ventures
  • Marco Fadda, Comecer
  • Rui Andre Raposo, Oxford BioMedica
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Sylvia Becker, Senior Manager Programs & Events, PDA Europe


  • Day 1
  • Day 2
  • Wednesday, 24 June 2020

    Welcome and Introduction

    Falk Klar, PDA Europe

    Conference Chairs
    Dayue Chen, Genentech
    Christopher Bravery, Advanced Biologicals

    Opening Plenary: Regulating Gene-Edited Medicinal Products: European Updates
    Moderator: Christopher Bravery, Advanced Biologicals

    Regulating Gene-Edited Medicinal Products: A European Perspective
    Bristows LLP

    Question & Answer Session PICs Annex 2 Draft on ATMPs
    Therapeutic Goods Administration, Australia

    Life-Cycle Comparability for Genetically Modified Cells
    AMBR Consulting

    Q&A, Discussion

    10:45 - 11:15
    Coffee Break, Poster Session & Exhibition

    Session 1: Tissue & Organ Engineering in the New Decade
    Moderator: Fabio D'Agostino,
    Claris Ventures

    Personalized Organs That Will Revolutionize Future Medicine


    Regenerative Tissue Engineering: Bringing Tissue Repair to Life

    Videregen Limited

    A Scaffold-Free Graft for Large Critical Size Bone Defect: Preclinical Evidence, Clinical Proof of Concept and Industrialization Perspective

    NOVADIP Biosciences SA

    Q&A, Discussion

    12:45 - 14:00
    Lunch Break, Poster Session & Exhibition


    Session 2: Promise Fulfilled: How Innovative Therapies are Transforming Lives
    EU Moderator: Dayue Chen,
    US Moderator: Michael N. Blackton, Adaptimmune LLC

    Welcome and Opening Remarks from US Conference Co-Chair

    Michael N. Blackton, Adaptimmune LLC

    Engineered T Cell Therapies: Development, Global Regulatory Approvals, and Future Trends

    Bruce Levine, MD

    Industry Representative, invited

    Q&A, Discussion

    15:45 - 16:30
    Coffee Break, Poster Session & Exhibition


    Session 3: Regulating a Harmonized Plan of Attack to Progress Cell and Gene Therapies
    EU Moderator: Richard Denk,
    US Moderator: Irving Ford, Bristol-Myers Squibb

    Moving Toward Global Regulatory Convergence for Advanced Therapy Medicinal Products

    Peter W. Marks, U.S. FDA

    European Regulatory Speaker, invited

    Q&A, Discussion

    End of Conference Day 1 & Networking Reception

  • Thursday, 25 June 2020

    Session 4: Technologies for Manufacture and Testing of ATMPs
    Moderator: Manuel Carrondo
    , ibet

    Subvisible Particulate Contamination in Cell Therapy Products: Can We Distinguish?

    Rapid Adventitious Virus Detection and qPCR Continues to Provide a Well- Established Platform for Testing Products and Raw Materials
    Charles River Laboratories

    Manufacturing of an Individualized Immunotherapy for Cancer

    Q&A, Discussion

    10:30 - 11:00
    Coffee Break, Poster Session & Exhibition

    Session 5: Computer-Aided Biology, Automation & Artificial Intelligence
    Moderator: André Raposo,
    Oxford Biomedica

    Towards a System of Intelligence for Cell & Gene Therapy

    Microsoft Research

    Flexible Lab and Data Automation for ATMP Development

    Synthace Limited

    Challenges & Solutions for Automated Instrument Integration & Computerized System Validation in a GMP Environment for Cell & Gene Therapy

    Oxford Biomedica

    Q&A, Discussion

    13:00 - 14:30
    Lunch Break, Poster Session & Exhibition


    Session 6: Closing Plenary Europe: EU Research and Development Highlights
    EU Moderator: Dayue Chen,
    US Moderator: Shane D. Killian, Janssen R&D Quality & Compliance

    Using Clinical Data for Manufacturing Design and Release Criteria to Improve the Quality of a Cell-Based ATMP for Cartilage Repair

    Giulietta Roël, CO.DON

    Qualification of Illumina Next Generation Sequencing to Facilitate Mycoplasma Out-Of-Specification Investigations in Kymriah CAR-T Cell Therapy

    Marthi Pretorius, Novartis

    Q&A, Panel Discussion with EU Speakers

    End of Live Simulcast & Conference Summary by the EU Co-Chairs

    Closing Remarks

    End of Conference and Farewell Coffee

Highlighted Speakers

Petter Bjorquist
Petter Bjorquist
Verigraft AB
Jacob Halatek
Jacob Halatek
Microsoft Research Cambridge
Michael J Hantman
Michael J Hantman
Charles River Laboratories
Julian Hitchcock
Julian Hitchcock
Bristows LLP
Christiane Niederlaender
Christiane Niederlaender
AMBR Consulting Ltd
Marthi  Pretorius
Marthi Pretorius
Giulietta Roël
Giulietta Roël
Nicolas Theys
Nicolas Theys

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

Got a Question? We have answers

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PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Brussels, Belgium

How to Get Here

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Registration Fees

Early Registration
Registration Type Price by 19 April
Member €1.595
Non-member €1.895
Govern./Health Authority/Academic €700
Young Professional (Member) €700

All fees given in Euro and excluding VAT (21%)

Regular Registration
Registration Type Price after 19 April
Member €1.795
Non-member €2.095
Govern./Health Authority/Academic €900
Young Professional (Member) €900

All fees given in Euro and excluding VAT (21%)

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.


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