2nd Priority Review Voucher Summit -

2nd Priority Review Voucher Summit
October 26 - 27, 2017
Boston, MA

Understand the FDA's Priority Review Voucher Programs and Discuss the Challenges With Respect to Valuation, Market Access and the Regulatory Landscape

Agenda – 2nd Priority Review Voucher Summit



DAY ONE

 THURSDAY, OCTOBER 26, 2017 // MAIN CONFERENCE, DAY ONE

8:30AM – 8:45AM

Chairperson’s Opening Remarks


David Ridley, Ph.D., Faculty Director, Health Sector Management, Fuqua School of Business, DUKE UNIVERSITY

8:45AM – 10:45AM

Industry Views on How the Mechanics and Operations of the PRV Program Work


Please note this session will be 2 hours long

Khyati Roberts, Senior Director, Regulatory and Policy Intelligence, ABBVIE
Scott V. McGoohan, J.D., Director, U.S. Regulatory Policy and Intelligence, VERTEX PHARMACEUTICALS
Andrew Robertson, Ph.D., J.D., AVP, Head of Regulatory Science and Policy, North America, SANOFI U.S.
Phyllis Arthur, Managing Director, Infectious Diseases and Diagnostics Policy, BIOTECHNOLOGY INNOVATION ORGANIZATION (BIO)

10:45AM – 11:15AM

Networking Break


11:15AM – 12:00PM

The Current Market for Priority Review Vouchers


David Ridley, Ph.D., Faculty Director, Health Sector Management, Fuqua School of Business, DUKE UNIVERSITY

12:00PM – 12:45PM

An Update on the Potential Impact of Legislative Expansion on the Value of Priority Review Vouchers


Andrew Robertson, Ph.D., J.D., AVP, Head of Regulatory Science and Policy, North America, SANOFI U.S.

12:45PM – 1:45PM

Luncheon


1:45PM – 2:45PM

Anatomy of a PRV Deal: A New Drug for the Treatment of Hookworm Infection


Scott Requadt, J.D., MBA, Managing Director, CLARUS
Glenn Rockman, Partner, GLOBAL HEALTH INVESTMENT FUND (GHIF)
David Shoultz, Ph.D., M.S., MBA, Global Program Leader, Drug Development, PATH
Ed Yoshida, J.D., Deputy General Counsel and Director, Legal Affairs, PATH

2:45PM – 3:15PM

Company Practices: Developing Access Plans for Low- and Middle-Income Countries


Clarke B. Cole, Researcher, ACCESS TO MEDICINE FOUNDATION

3:15PM – 4:00PM

Networking Break


4:00PM – 5:00PM

Panel: Discuss the Calls for “Access” Changes to the PRV Program Including:


Jeffrey Moe, Ph.D., Professor of the Practice of Global Health, DUKE GLOBAL HEALTH INSTITUTE
Clarke B. Cole, Researcher, ACCESS TO MEDICINE FOUNDATION


DAY TWO

 FRIDAY, OCTOBER 27, 2017 // MAIN CONFERENCE, DAY TWO

8:00AM – 9:00AM

Continental Breakfast


9:00AM – 9:15AM

Chairperson’s Recap of Day One


David Ridley, Ph.D., Faculty Director, Health Sector Management, Fuqua School of Business, DUKE UNIVERSITY

9:15AM – 10:00AM

Case Study: Leverage Innovative Regulatory Pathways to Expedite Development of Drugs for Rare Pediatric Diseases


Beatrice M. Biebuyck, J.D., MBA, RAC, Head, Global Regulatory Policy and Intelligence, ALEXION PHARMACEUTICALS

10:00AM – 10:45AM

Case Study: How Rare Disease Foundations and Parents Can Help Provide Information Needed for Achieving a PRV


Timothy J. Miller, Ph.D., President and CEO, ABEONA THERAPEUTICS
Michelle Berg, Vice President, Patient Advocacy, ABEONA THERAPEUTICS

10:45AM – 11:15AM

Networking Break


11:15AM – 12:00PM

PDP and Non-Profit Models of Collaboration With Industry Partners


If you are interested in leading this session, please contact Zohaib Sheikh at zsheikh@exlevents.com.

12:00PM – 1:15PM

Luncheon


1:15PM – 2:00PM

Priority Review Vouchers for Medical Countermeasures: Ensuring National Preparedness Through Incentivization


Patrick Lucy, Interim CEO, President and Secretary, and Chief Business Officer, PFENEX

2:00PM – 2:45PM

TPOXX®: A Case Study in Medical Countermeasure Development and Stockpiling


Phillip L. Gomez, Ph.D., CEO, SIGA TECHNOLOGIES, INC

2:45PM – 3:00PM

Chairperson’s Closing Remarks


David Ridley, Ph.D., Faculty Director, Health Sector Management, Fuqua School of Business, DUKE UNIVERSITY


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