New Approaches and Incentives in Drug Development

New Approaches and Incentives in Drug DevelopmentWhen: November 22, 2013
 

Videos and presentation materials below.

 

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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.

Webcasts

 


Conference Organizers

Stuart M. Benjamin
Douglas B. Maggs Professor of Law
Associate Dean for Research

 

Arti K. Rai
Elvin R. Latty Professor of Law

 

with thanks to Stephen Johnson
of One Mind for Research

 

Conference Sponsors

One Mind

 

Kauffman Foundation of Entrepreneurship

 

Duke Law

 

For more information, contact:

Balfour Smith
Program Coordinator
Center for Innovation Policy
Duke University School of Law
210 Science Drive / Box 90360
Durham, NC 27708-0360
U.S.A.
+1.919.613.7003
innovationpolicy@law.duke.edu