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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.

Sincerely,
The Co-Chairs

Dayue Chen, PhD
Genentech/Roche, Chair


Christopher Bravery
, PhD
Advanced Biologicals, Chair

Overview

SCIENTIFIC PROGRAM PLANNING COMMITTEE

  • 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

Agenda

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

    9:00
    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

    9:15
    Regulating Gene-Edited Medicinal Products: A European Perspective
    Bristows LLP

    9:40
    Question & Answer Session PICs Annex 2 Draft on ATMPs
    Therapeutic Goods Administration, Australia

    10:05
    Life-Cycle Comparability for Genetically Modified Cells
    AMBR Consulting

    10:30
    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

    11:15
    Personalized Organs That Will Revolutionize Future Medicine

    VERIGRAFT AB

    11:40
    Regenerative Tissue Engineering: Bringing Tissue Repair to Life

    Videregen Limited

    12:05
    A Scaffold-Free Graft for Large Critical Size Bone Defect: Preclinical Evidence, Clinical Proof of Concept and Industrialization Perspective

    NOVADIP Biosciences SA

    12:30
    Q&A, Discussion

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

    LIVE SIMULCAST SESSION WITH PDA USA

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

    14:00
    Welcome and Opening Remarks from US Conference Co-Chair

    Michael N. Blackton, Adaptimmune LLC

    14:15
    Engineered T Cell Therapies: Development, Global Regulatory Approvals, and Future Trends

    Bruce Levine, MD

    14:45
    Industry Representative, invited

    15:15
    Q&A, Discussion

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

    LIVE SIMULCAST SESSION WITH PDA USA

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

    16:30
    Moving Toward Global Regulatory Convergence for Advanced Therapy Medicinal Products

    Peter W. Marks, U.S. FDA

    17:00
    European Regulatory Speaker, invited

    17:30
    Q&A, Discussion

    18:00
    End of Conference Day 1 & Networking Reception

  • Thursday, 25 June 2020

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

    9:00
    Subvisible Particulate Contamination in Cell Therapy Products: Can We Distinguish?
    LONZA

    9:25
    Rapid Adventitious Virus Detection and qPCR Continues to Provide a Well- Established Platform for Testing Products and Raw Materials
    Charles River Laboratories

    9:50
    Manufacturing of an Individualized Immunotherapy for Cancer
    Transgene

    10:15
    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

    11:00
    Towards a System of Intelligence for Cell & Gene Therapy

    Microsoft Research

    11:30
    Flexible Lab and Data Automation for ATMP Development

    Synthace Limited

    12:00
    Challenges & Solutions for Automated Instrument Integration & Computerized System Validation in a GMP Environment for Cell & Gene Therapy

    Oxford Biomedica

    12:30
    Q&A, Discussion

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

    LIVE SIMULCAST SESSION WITH PDA USA

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

    14:30
    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

    15:00
    Qualification of Illumina Next Generation Sequencing to Facilitate Mycoplasma Out-Of-Specification Investigations in Kymriah CAR-T Cell Therapy

    Marthi Pretorius, Novartis

    15:30
    Q&A, Panel Discussion with EU Speakers

    16:00
    End of Live Simulcast & Conference Summary by the EU Co-Chairs

    16:20
    Closing Remarks

    16:30
    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
Novartis
Giulietta Roël
Giulietta Roël
COD.ON
Nicolas Theys
Nicolas Theys
Novadip

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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Brussels, Belgium

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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.

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