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The Fondation Brocher is an essential player in this vital thinking process: one which will help make us aware of the real challenges in using our resources for maximum impact on the health of the people of the world.

 

 

Professor Daniel Wikler, Harvard University

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The Brocher Foundation is a Swiss non-profit private foundation  recognized of public interest. Your donations are tax deductible according to the regulations in force.

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October 9 - 11, 2019

When drug companies become doctors: consequences and responses

Schedule:

Tuesday, 8 October 2019

19:30 Welcome Reception and Dinner (for 21 participants staying at the Brocher Foundation)

Welcome - Jamie Love and Ellen ‘t Hoen


Wednesday, 9 October 2019

9:00 - 9:10: Welcome and introduction - Thiru Balasubramaniam

9:10 - 13:00 Science and Technology - An overview of cell and gene based treatments

Discussion moderated by Marie-Paule Kieny and James Love

Advanced medical therapies using genes, cells and tissue, introduction to the science and technology

Chimeric antigen receptor T cells (CAR T)
Gene therapies
Clustered regularly interspaced short palindromic repeats (CRISPR)
Etc. (See figure 1 below)

This is an introduction to the science of the new cell and gene therapies. We have a lot of expertise in the room. The session will last all morning on Wednesday, and begin with initial comments from five persons, and then an open discussion with lots of questions and answers in a roundtable format.





Initial Comments: Hannes Braberg, Diane Singhroy, Paul Fehlner, Robert Watson, Tim Hubbard.

10:30 Coffee Break

Discussion continues

13:00 - 14:00 Lunch

14:00 - 18:00 Exploring challenges and solutions to pricing, access and manufacturing cell and gene-based treatments

Introduction to the challenges of manufacturing, pricing and access, broken into two topics, beginning with manufacturing, and section session on pricing and access. Each session will begin with initial comments from persons, and then an open discussion with lots of questions and answers in a roundtable format.

Manufacturing

Discussion moderated by Paolo Foggi

Initial Comments: Paul Fehlner, Renato Massimi, Robert Watson, Marie Paul Kieny


Pricing and Access

Discussion moderated by Ellen ‘t Hoen and Vanessa Lopez

Initial Comments: Gaelle Krikorian, Marcel Van Raaij, Valerie Paris, Paolo Foggi, Richard Sullivan, Vincenzo Pavone, Polly Webster, Gregg Alton, Charles Gore, James Love,


16:00 - 16:30 Coffee break

16:30 - 18:00 Discussion continued

18:00 Drinks

19:30 Group Dinner




Thursday, 10 October 2019

9:00 - 12:30 Legal and Regulatory barriers to providing access to cell and gene-based treatments

DIscussion of legal and regulatory barriers to providing access. Each session will begin with initial comments from persons, and then an open discussion with lots of questions and answers in a roundtable format.

Legal issues - 9:00 - 10:30

Discussion moderated by Thiru Balasubramaniam

Initial Comments: Esther van Zimmeren, Julian Cockbain, Gregg Alton, James Love,

10:30 - 11:00 Coffee break

Regulatory issues - 11:00 - 12:30

Discussion moderated by Yannis Natsis

Initial Comments: Emer Cooke, Marcel Van Raaij


12:30 - 14:00 Lunch and Group Photo


14:00 - 18:00 Normative Proposals, Research Questions, Next Steps

The afternoon session on Thursday will be shaped by the earlier discussions, to ensure that we address topics that need more discussion, and talk about work going forward.

Discussion co-moderated by Ellen ‘t Hoen and Mariângela Simão


16:00 - 16:30 Coffee break

Discussion continued

19:30 Dinner

Place:

Brocher Foundation

Organizers:

This workshop will bring together biomedical, legal, trade, human rights, and public health experts to examine the implications of Article 27.3(a) of the WTO TRIPS Agreement on the patentability of gene and cell-based therapies including those involving CAR T, CRISPR and other technologies when treatment can be described as a service or a medical procedure, rather than a product. The workshop will explore if certain gene and cell-based treatments are, in fact, exempt from patentability when a country has an exception that mirrors Article 27.3(a) of the TRIPS Agreement. Experts will also discuss non-patent approaches to providing incentives to invest in innovations that delink R&D costs from prices and monopolies on the medical technologies for such treatments, for example innovation inducement prize funds and market entry rewards.