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2021 ATMPs-1988x680

2021 PDA Advanced Therapy Medicinal Products Conference

ATMP Heterogeneity: Can we gain deeper insights through an integrated utilisation of quality, preclinical and clinical data?

Jun 23 - Jun 24, 2021
Central Europe Standard Time | Online
  • Virtual
  • Conference
  • Online
  • Europe

Overview

Dear Colleagues,

In the name of the Program Planning Committee, we would like to warmly invite you to join us for the 2021 PDA Advanced Therapy Medicinal Products Conference, to be held online on 23-24 June!

The PDA will be hosting its 13th two-day event that aims to support all stakeholders in the development and commercialization of novel and effective cell and gene and tissue therapies.

The phenomenal success of CAR-T for leukaemias has led to a proliferation of new immunotherapy approaches utilising all types of immune effector cells. One obvious limitation is that these have so far primarily been autologous products, with associated high costs and manufacturing challenges at scale.  A noticeable shift is occurring with more developers exploring allogeneic approaches yet sourcing larger volumes of leukocytes from one individual remains a barrier. One solution might be induced pluripotent stem cells (iPSC) since these could in principle be banked and supply the whole product lifecycle, thus bringing cell-based medicines a step closer to the biotech model.

This year’s theme hopes to bring discussion to bear on the importance of understanding product heterogeneity and how we can characterise this and bring together quality, nonclinical and clinical data. Understanding the critical quality attributes (CQA) is an essential element to developing a commercial manufacturing process, yet confirming those requires sufficient clinical efficacy data. For cell-based medicines in particular, cellular and/or phenotypic heterogeneity represent a significant challenge for product characterization. How can this be better understood? Are developers too focussed on the name we give to a group of cells and overlooking the role of sub-sets? How can product characteristics be linked to clinical efficacy? 

The conference will be a Virtual Event with an online platform allowing for remote participation and presentation! Ample opportunities for interaction between attendees and live Q&A sessions will provide an engaging and fruitful experience!

Sincerely,
The Chairs,

Dayue Chen, PhD, Genentech/Roche
Christopher Bravery, PhD, Advanced Biologicals

SCIENTIFIC PROGRAM PLANNING COMMITTEE

  • Dayue Chen, Genentech/Roche - Chair
  • Christopher Bravery, Advanced Biologicals - Chair
  • Manuel Carrondo, ibet
  • Francesco Cicirello, EVELO BIOSCIENCES
  • Richard Denk, SKAN
  • Marco Fadda, Comecer
  • Fabio D’Agostino, Claris Ventures
  • Andre Raposo, Oxford BioMedica
  • Irving Ford, Bristol-Myers Squibb
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Sylvia Becker, PDA Europe, Senior Manager Programs & Events

Agenda

  • Day 1
  • Day 2
  • Wednesday, 23 June 2021

    Module I: European Updates on Development & Regulations
    11:00-13:45 CEST

    Conference Portal Opens:
    Virtual Exhibition and Poster Session

    Welcome & Introductions Falk Klar, PDA Europe
    Welcome from the Chairs Christopher Bravery, Advanced Biologicals
    Dayue Chen, Genentech/Roche

    Live Session Introduction:
    Session 1: European Updates on Development & Regulations

    Moderators:
    Christopher Bravery, Advanced Biologicals
    Dayue Chen, Genentech/Roche

    ATMPs: Update on the Activities of the European Pharmacopoeia Olga Kolaj-Robin, EDQM
    Microbial Safety for Different ATMP Classes: Old and New Concepts Oleg Krut, Paul-Ehrlich-Institut
    PIC/S Annex 2 Revision & EMA Q&A Christina Meissner, AGES; the Austrian Agency for Health and Food Safety,
    Francesco Cicirello, former GMP Inspector, TGA

    Live Q & A, Discussion


    Break, Virtual Exhibition & Poster Session

    14:00-15:00 CEST

    Module II: Manufacturing of Gene and Cell-Based Therapies in the 21st Century
    15:00-18:00 CEST

    Live Session Introduction:
    Manufacturing of Gene and Cell-Based Therapies in the 21st Century

    Moderators:
    Christopher Bravery, Advanced Biologicals
    Marco Fadda, Comecer

    Development, Market Authorization and Market Access of Gene and Cell-Based Therapies Renske ten Ham, University Medical Center Utrecht
    Capacity and Cost Constraints When Manufacturing ATMPs Tania Pereira, Univercells Technologies
    Virus Control Framework for the Manufacture of Biopharmaceuticals and Viral Vectored Gene Therapy Products Anne Stokes, GSK

    16:00
    Coffee Break, Exhibition & Scientific Poster Session

    CDMO Best-Practice Experience Raquel Fortunato, Genibet
    Hospital Exemption in Practice Manel Juan, Centro de Díagnóstico Biomédico, University Hospital Barcelona

    Live Q & A, Discussion

     

    Virtual Exhibition, Scientific Poster Session
    17:30-18:30 CEST

    Agenda is subject to change without notice.
  • Thursday, 24 June 2021

    Module III: Manufacturing Engineering Control for ATMPs
    11:00-13:30 CEST

    Conference Portal Opens:
    Virtual Exhibition and Poster Session

    Live Session Introduction:
    Manufacturing Engineering Control for ATMPs

    Moderators:
    Francesco Cicirello, EVELO BIOSCIENCES
    Richard Denk, SKAN

    PDA Points to Consider for Manufacturing of ATMPs Richard Denk, on behalf of the PDA Advisory Board on ATMPs
    Flexible Universal CAR-T Manufacturing in Isolators – Closing the Process from Upstream through Aseptic Filling Silvia Aldi, SKAN
    Development of a Scaffold-Free Autologous Cell-Based Product as a New Candidate for Treatment of Congenital Pseudoarthrosis of the Tibia Control Nicolas Theys, Novadip Biosciences

    Live Q & A, Discussion


    Break, Virtual Exhibition & Poster Session

    13:30-14:30 CEST

    Module IV: Manufacturing Sterility Assurance and Control for ATMPs
    14:30-16:30 CEST

    Live Session Introduction:
    Manufacturing Sterility Assurance and Control for ATMPs

    Moderators:
    Dayue Chen, Roche/Genentech
    Marco Fadda, Comecer

    Viral Contamination in the Manufacture of Biologics and its Implications for Emerging Products Paul W. Barone, Massachusetts Institute of Technology
    Measures to Prevent Potential Viral Contamination for ATMPs Kathryn Remington, Merck KGaA
    Live: Highlights and Key Learnings of the PDA Virus Conference Thomas R. Kreil, Takeda
    Johannes Bluemel, Paul-Ehrlich-Institut

    Live Q & A, Discussion


    Break, Virtual Exhibition & Poster Session

    16:00-16:30 CEST

    Module V: Novel Therapeutic Approaches Using Cell & Gene Therapy
    16:30-18:30 CEST

    Live Session Introduction:
    Novel Therapeutic Approaches Using Cell & Gene Therapy

    Moderators:
    Manuel Carrondo, ibet
    Fabio D’Agostino, Claris Ventures

    Sterile Processing & Key CMC Considerations: Novel Viral and Cell Therapy Modalities for the Treatment of Cancer José Manuel Otero, Turnstone Biologics
    To Viral or to Non-Viral, That is the Question Stefano Baila, Anemocyte
    Next Generation Cell-Engineering Michael Maguire, Avectas

    Closing Panel Discussion: Future Outlook

    Conference Summary by the Chairs

    Dayue Chen, Genentech/Roche
    Christopher Bravery, Advanced Biologicals

    Thank you, Chair Awards, Outlook and Farewell

    Falk Klar, PDA Europe
    Agenda is subject to change without notice.

Highlighted Speakers

Silvia Aldi
Silvia Aldi
SKAN
Stefano Baila
Stefano Baila
Anemocyte
Johannes Blümel
Johannes Blümel
Paul-Ehrlich-Institut
Francesco Cicirello
Francesco Cicirello
EVELO BIOSCIENCES
Manel Juan
Manel Juan
Centro de Díagnóstico Biomédico, University Hospital Barcelona
Tania Pereira
Tania Pereira
Univercells Technologies
Anne Stokes
Anne Stokes
GSK
Renske ten Ham
Renske ten Ham
University Medical Center Utrecht

Registration Fees

Register Now
Early Registration
Registration Type Price before 25 APR 2021
Member €1.595
Non-Member €1.895
Govern./Health Authority/Academic/
Young Professional (Member)
€600
Regular Registration
Registration Type Price after 25 APR 2021
Member €2.690
Non-Member €2.990
Govern./Health Authority/Academic
Young Professional (Member)
€1.140

Package Prices to book both the Virus and ATMPs Conference

All fees given in Euro, excluding VAT – please contact [email protected] to register for the package offer.

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