Agenda – 2nd Innovative Regulatory Pathways Summit

  • Day One
  • Day Two

Day One

 Monday, January 28

8:50AM – 9:00AM

Conference Chair Opening Remarks
Brian E. Harvey, M.D., Ph.D., Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE

9:00AM – 9:45AM

Considerations About the Future of Accelerated Drug Development in the U.S.
Brian E. Harvey, M.D., Ph.D., Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE

9:45AM – 10:30AM

A Global Policy Perspective on Harmonization of Regulatory Options for Expedited Drug Development
Camille Jackson, Associate Vice President, Science and Regulatory Advocacy, PHRMA

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Create a Global Regulatory Strategy for Accelerated Drug Development
Michael Fahmy, Senior Director Global Regulatory Affairs, OTSUKA

11:45AM – 12:30PM

Innovative Regulatory Pathways for Infectious Disease and Vaccines
Dr. Long Wang, Director, Global Regulatory Team Leader, Vaccines/Infectious Disease, MERCK

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Alexion Case Study: Experience With Breakthrough Therapy Designation
Martine Zimmermann, Senior Vice President, Global Regulatory Affairs, ALEXION PHARMACEUTICALS, INC.

2:15PM – 3:00PM

Harmonize Manufacturing Readiness Plans With Accelerated Drug Development
Usha Ramesh, Executive Director, CMC Regulatory Affairs, PHARMACYCLICS

3:00PM – 3:30PM

Networking Break

3:30PM – 4:15PM

Breakthrough Therapy Designation: Promoting Efficient Trial Design and Addressing Unmet Clinical Needs
Mark Stewart, Vice President, Science Policy, FRIENDS OF CANCER RESEARCH


Day Two

 Tuesday, January 29

9:15AM – 9:30AM

Conference Chair Opening Remarks
Brian E. Harvey, M.D., Ph.D., Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE

9:30AM – 10:15AM

Sakigake Designation System: A Japanese Strategy for Expedited Drug Development
William K. Sietsema, Ph.D., Executive Director, Global Regulatory Affairs, CALADRIUS BIOSCIENCES

10:15AM – 10:45AM

Networking Break

10:45AM – 11:15AM

A Comparative Review of the Global Options for Accelerated Drug Development
Lawrence Liberti, Executive Director, CENTRE FOR INNOVATION IN REGULATORY SCIENCE (CIRS)

11:15AM – 12:00PM

An Overview of Expedited Review Pathways in Several International Markets
Ronald H. Szumigala, Jr., M.S., Director, RAI HQ, Biologics, Oncology, MERCK

12:00PM – 1:00PM

Luncheon