When: November 22, 2013
Videos and presentation materials below.
Escalating drug development costs, and a dearth of high-impact innovation, are highly visible problems for the biopharmaceutical industry. Recent legal developments, most notably the U.S. Supreme Court’s June 2013 decision in Federal Trade Commission (FTC) v. Actavis, further alter the incentive landscape. Actavis suggests decreased judicial tolerance for patent litigation settlements in which brand-name drug manufacturers pay generic firms arguing patent invalidity or non-infringement to drop the lawsuit. One possible consequence is a decrease in effective patent term for small molecule drugs.
As the incentive landscape is changing, new R&D strategies are also emerging. For example, efforts are underway to find, and validate clinically, entirely new uses for existing molecules – either molecules that have been abandoned in clinical trials for lack of efficacy or generic molecules. Firms, government funders, and patient groups are also involved in a variety of different precompetitive research collaborations.
Both existing and new innovation models raise the question of how well the current incentive system works for biopharmaceutical development, particularly in the context of small molecules. Should additional or alternative economic incentives, such as targeted public funding or exclusivity terms based on research risk or disease, be considered?
This inaugural conference brought together leading figures from the private sector, government, and academia to address these questions. Morning sessions discussed the existing incentive regime and the impact of FTC v. Actavis. They also addressed how new research models, such as drug “rescue and repurposing” and precompetitive collaborations to validate drug targets, could best invoke the existing array of incentives. The afternoon session discussed how innovation incentives in drug development already differ substantially from innovation incentives in other industries. It also discussed whether additional or alternative incentives are needed.
Moderator: Arti Rai, Duke Law School
- Christine Colvis, National Center for Advancing Translational Sciences, NIH - Slides (PDF)
- Charles Niebylski, National Center for Advancing Translational Sciences, NIH - Slides (PDF)
- Dominique Pahud, Director in Innovation and Networks, Ewing Marion Kauffman Foundation
- Craig Wegner, Executive Director, Translational Sciences, AstraZeneca - Slides (PDF)
- Aled Edwards, University of Toronto, Structural Genomics Consortium - Slides (PDF)
- Pearl Huang, Vice President, Global Head for Discovery Partnerships with Academia, GlaxoSmithKline - Slides (PDF)
- Bernard Munos, Founder, Innothink Center for Research in Biomedical Innovation; Senior Fellow, FasterCures - Slides (PDF)
Moderator: Stephen Johnson, Chief Intellectual Property and Policy Officer, One Mind for Research
- Philip Johnson, Senior Vice President and Chief Intellectual Property Counsel, Johnson & Johnson
- Gail Levine, Vice President and Associate General Counsel, Intellectual Property, Verizon Communications, Inc.
Panel 3, continued:
- David Ridley, Duke Fuqua School of Business - Slides (PDF)
- Aaron Kesselheim, Assistant Professor of Medicine, Harvard Medical School/Brigham and Women's Hospital - Slides (PDF)
- Ben Roin, Harvard Law School - Slides (PDF)
- Brian Caveney, Vice President and Medical Director of Healthcare Consulting, Blue Cross and Blue Shield of North Carolina
- Amy Comstock Rick, Chief Executive Officer, Parkinson’s Action Network - Slides (PDF)