PDA Europe Virtual Conference - Advanced Therapy Medicinal Products
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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
Note COVID-19 situation up-date 02nd April 2020:
PDA is closely monitoring the Corona virus situation. Travel restrictions have been widely implemented in European countries and globally in the last couple of days which will prevent our members, volunteers, presenters, attendees and exhibitors from attending PDA Europe Advanced Therapy Medicinal Products, planned for 24-25 June 2020 in Brussels, Belgium.
We consider the safety and health of attendees and staff as subject of utmost importance. Taking all factors into consideration, PDA Europe has decided to present this year’s Advanced Therapy Medicinal Products Conference as a virtual conference.
All participants will be given the opportunity to connect to the presentations from different locations using online conferencing technology, including an interactive component between speakers and the audience.
At this time no action is required on your part. We will contact you prior to the event giving you all relevant information. Please know you will have the ability to request a credit or full refund if you find you are not satisfied with this alternative.
If you have any immediate questions or requests, please contact info-europe@pda.org. Additionally, you may visit the PDA official statement on our website.
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
Contact
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More information coming soon.
Standard Registration
GovernmentMember Only
€ 349
Health AuthorityMember Only
€ 349
AcademicMember Only
€ 349
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.
Day 1
Wednesday, 24 June 2020
Module I: Gene-Editing, GMP and Comparability
10:00-12:00 CEST
Gene-Editing, GMP and Comparability |
Moderator: |
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: |
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 |
Day 2
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: |
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: |
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: |
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 |
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Conference Summary by the Chairs |
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Thank you, Chair Awards, Outlook and Farewell |
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