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PDA Europe Virtual Conference - Advanced Therapy Medicinal Products

Cell and Gene Therapy - From Promise to Cure

Jun 24 - Jun 25, 2020
Central Europe Standard Time | Online
  • Virtual
  • Conference
  • Online
  • Europe
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

    Module I: Gene-Editing, GMP and Comparability
    10:00-12:00 CEST

    Gene-Editing, GMP and Comparability

    Moderator:
    Christopher Bravery,
    Advanced Biologicals

    New technologies often raise new questions around safety and ethics and how they should be regulated. What are the new legal and ethical issues associated with gene-editing, and how will they impact those developing such products?
    Following on from the new EU Commission guideline on GMP for ATMP, PIC/S have updated their guideline on GMP for biological products to include a section on ATMP. How does this differ, and how might it impact your global development?
    The ability to make process changes is essential over the product life-cycle, and so a key outcome of product development. A key limitation for ATMP is that the structure cannot be determined, how then can we be sure comparability is established following process changes?
    Regulating Gene-Edited Medicinal Products:
    A European Perspective
    Julian Hitchcock,
    Bristows LLP
    Life-Cycle Comparability for Genetically Modified Cells Christiane Niederlaender,
    AMBR Consulting
    Interview: PICs Annex 2 Draft on ATMPs Francesco Cicirello,
    Therapeutic Goods
    Administration, Australia

    Live Q & A, Discussion

     

    Break and Virtual Exhibition
    12:00-13:30 CEST

     

    Module II: Tissue Engineering in the New Decade
    13:30-15:15 CEST

    Personalized Medicines in the New Decade

    Moderator:
    Fabio D'Agostino,
    Claris Ventures

    Would it not be great to have a virtually unlimited supply of human tissues and even organs? Could the well-known drawbacks of organ transplantation (i.e. donor shortage and need of immune-suppressive therapy) be a thing of the past? The short answer is YES. In this session, our speakers will describe the many manufacturing and industrialization hurdles unique to bringing tissue engineered therapies to the market. While clinical adoption is still limited, significant progress has been made from when tissue engineering was first defined in the early 90s.
    Personalized Organs That Will Revolutionize Future Medicine Petter Björquist, VERIGRAFT AB
    Regenerative Tissue Engineering:
    Bringing Tissue Repair to Life
    Steve Bloor,
    Videregen Limited
    A Scaffold-Free Graft for Large Critical Size Bone Defect:
    Preclinical Evidence, Clinical Proof of Concept and Industrialization Perspective
    Philippe Willemsen,
    NOVADIP Biosciences SA

    Live Q & A, Discussion

     

    Virtual Networking Event
    15:15-17:00 CEST

    Meet Your Peers in Our Networking Lounges

  • Thursday, 25 June 2020

    Module III: Technologies for Manufacture and Testing of ATMPs
    10:00-11:30 CEST

    Technologies for Manufacture and Testing of ATMPs

    Moderator:
    Manuel Carrondo, ibet

    Processes for ATMP production are far more complex than for protein biopharmaceuticals. Also, the existing options are still fragile. To improve their robustness and select the best options, analytics are essential as tools for process development. Different process options will need to be tested and shown to work, especially in the situations where process sterility is key - e.g. cell or gene therapies for large viruses (vaccinia, poxvirus) where a final sterile filtration cannot be used. In this session, some key analytics and processes will be presented and discussed with a look at process improvement.
    Subvisible Particulate Contamination in Cell Therapy Products: Can We Distinguish? Ahmad Sediq, LONZA
    Particulate Impurities In Cell-Based Medicinal Products Traced By Flow Imaging Microscopy Combined With Deep Learning For Image Analysis Tim Menzen, Coriolis Pharma
    Rapid Adventitious Virus Detection and qPCR Continues to Provide a Well- Established Platform for Testing Products and Raw Materials Michael J. Hantman, Charles River Laboratories

    Live Q & A, Discussion

     

    Break and Virtual Exhibition
    11:30-13:30 CEST

     

    Module IV: Computer-Aided Biology, Automation & Artificial Intelligence
    13:30-15:00 CEST

    Computer-Aided Biology, Automation & Artificial Intelligence

    Moderator:
    André Raposo, Oxford Biomedica

    Computer-Aided Biology combines tools that augment human capabilities in biological research. It is comprised of two domains: the Digital and the Physical. The Digital, powered by artificial intelligence, includes software for designing and simulating biological systems, as well as methods of collating, connecting, structuring and analyzing experimental data from wet lab experiments. The Physical, enabled by automation, includes systems that allow for the seamless transfer of simulated biological designs into real ‘wet lab’ experiments via abstracted experimental design, logistics simulation and execution. In this session, we will discuss how machine learning is being applied to enhance our knowledge of the biology of cell & gene therapy and which tools are being used to achieve this. Finally, we will explore how complex systems of automation are being implemented in GMP-regulated environments.
    Towards a System of Intelligence for Cell & Gene Therapy Jacob Halatek, Microsoft Research
    Flexible Lab and Data Automation for ATMP Development Markus Gershater, Synthace Limited
    Automated Instrument Integration & Computerized System Validation in a GMP Environment Gareth McCathie, Oxford Biomedica

    Live Q & A, Discussion

     

    Break and Virtual Exhibition
    15:00-16:00 CEST

     

    Module V: The Science of Innovative Therapy Development
    16:00-18:00 CEST

    The Science of Innovative Therapy Development

    Moderator:
    Dayue Chen, Genentech/Roche

    While ATMP such as cell based therapies require new skills and novel technologies to overcome tremendous technical and regulatory challenges, the formula for successful development of these products remains the same: good science, proven clinical efficacy, and demonstrated product safety. The three speakers in this session will share the relevant thoughts, knowledge, data, and perspectives based on their respective experience and practice in the field.
    Engineered T Cell Therapies: Development, Global Regulatory Approvals, and Future Trends Bruce Levine, University of Pennsylvania
    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

    Live Q & A, Discussion

    Conference Summary by the Chairs

    Thank you, Chair Awards, Outlook and Farewell

Highlighted Speakers

Petter Bjorquist
Petter Bjorquist
Verigraft AB
Francesco Cicirello
Francesco Cicirello
Therapeutic Goods Administration
Jacob Halatek
Jacob Halatek
Microsoft Research Cambridge
Gareth McCathie
Gareth McCathie
Oxford Biomedica
Christiane Niederlaender
Christiane Niederlaender
AMBR Consulting Ltd
Marthi  Pretorius
Marthi Pretorius
Novartis
Giulietta Roël
Giulietta Roël
COD.ON
Philippe Willemsen
Philippe Willemsen
Novadip Biosciences
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Registration Fees

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Registration Type Two Day Access One Day Access*
Member, Non-Member, Young Professional, Poster-Presenter € 799 € 449
Govern./Health Authority/Academic € 649 € 349

* To book a one-day access, please contact [email protected].



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