PDA Europe Virtual Conference - Advanced Therapy Medicinal Products

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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

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 [email protected]. Additionally, you may visit the PDA official statement on our website.

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

Agenda

Discover What's Happening Each Day
Wed 24 Jun Thu 25 Jun
Wednesday, 24 June

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

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

Registration

Pricing Options

More information coming soon.

Standard Registration

GovernmentMember Only

€ 349

Health AuthorityMember Only

€ 349

AcademicMember Only

€ 349

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

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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.

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