Agenda – Innovative Regulatory Pathways Summit

  • Day One
  • Day Two

Day One

 Monday, January 29, 2018

8:50AM – 9:00AM

Conference Chair Opening Remarks
Alejandro D. Ricart, M.D., Executive Medical Director, Oncology, Early Development Strategy and Innovation, NOVARTIS

9:00AM – 9:45AM

AbbVie’s Experience With Breakthrough Therapy Designation
Andrew Storey, Vice President, Global Regulatory Strategy, ABBVIE

9:45AM – 10:30AM

Breakthrough Therapy Designations in Oncology
Alejandro D. Ricart, M.D., Executive Medical Director, Oncology, Early Development Strategy and Innovation, NOVARTIS

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Case Study: Impact of Breakthrough Therapy Designation on Clinical Trial Design
Joseph A. Sliman, M.D., MPH, Chief Medical Officer, SYNTHETIC BIOLOGICS

11:45AM – 12:30PM

Harmonize Manufacture Readiness Plans With Accelerate Drug Development
Usha Ramesh, Ph.D., PMP, Executive Director, Regulatory Affairs, CMC, PHARMACYCLICS, AN ABBVIE COMPANY

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Sakigake Designation System: A Japanese Strategy for Expedited Drug Development
Colin Vechery, Manager, U.S. Regulatory Affairs–Strategy, BIOGEN

2:15PM – 3:15PM

Panel: Global Regulatory Options for Accelerated Drug Development
Panelists:
Jennifer Dudinak, Pharm.D., Vice President, Global Regulatory Affairs, Head, Pharma Regulatory Therapeutic Team, GLAXOSMITHKLINE
Dr. Henrietta Ukwu, Senior Vice President, Head of Global Regulatory Affairs, OTSUKA PHARMACEUTICAL COMPANIES
Lawrence Liberti, M.Sc., Executive Director, CENTER FOR INNOVATION IN REGULATORY SCIENCE (CIRS)

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Eisai Case Study: Coordinating Global Submissions: How to Reuse Content for Emerging Markets
Sophia A. Kourliouros, Senior Manager, Global Regulatory Operations, EISAI INC.


Day Two

 Monday, January 30, 2018

8:50AM – 9:00AM

Conference Chair Opening Remarks
Alejandro D. Ricart, M.D., Executive Medical Director, Oncology, Early Development Strategy and Innovation, NOVARTIS

9:00AM – 9:45AM

Development and Implementation of Whole-Parasite Malaria Vaccine
Tooba Murshedkar, Senior Director, Regulatory Affairs, SANARIA INC.

9:45AM – 10:30AM

A Public Policy Perspective on Regulatory Policies and Market-Shaping Considerations for Emerging Infectious Diseases
John Billington, Director, U.S. Public Policy, Vaccines, GLAXOSMITHKLINE

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Panel: Expedited Options for Competitive Generic Therapies 
Panelists:
Lisa Parks, R.Ph., Vice President, Sciences and Regulatory Affairs, ASSOCIATION FOR ACCESSIBLE MEDICINES
Nicholas Tantillo, Head, Policy and Regulatory Strategy, SANDOZ INC

11:45AM – 12:30PM

Utilize Patient–Focused Drug Development to Build Clinical Trial Frameworks for Breakthrough Therapy Applications
Mark Stewart, Ph.D., Senior Science Policy Analyst, FRIENDS OF CANCER RESEARCH

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Integrate Patient Advocacy Groups Into Drug Development Programs to Navigate the Expedited Regulatory Options
Brian E. Harvey, M.D., Ph.D., Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE; Former Vice President U.S. Regulatory Strategy, PFIZER 

2:15PM – 3:15PM

Panel: Effective Collaboration Between Drug Developers and Patient Advocates
Moderator:
Brian E. Harvey, M.D., Ph.D., Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE; Former Vice President U.S. Regulatory Strategy, PFIZER 

Panelists:
Jayne C. Gershkowitz, Senior Vice President and Chief Patient Advocate, AMICUS THERAPEUTICS
Ron Bartek, President and Co-Founder, FRIEDREICH'S ATAXIA RESEARCH ALLIANCE (FARA)
Stacy Woeppel, Advocate in Science, SUSAN G. KOMEN

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Utilize Expedited Review Pathways in Precision Medicine
Christopher Adams, CEO, ANDARIX PHARMACEUTICALS

4:30PM – 5:15PM

Implications of Personalized Medicine on Clinical Trial Design and Expedited Review Pathways 
Chitra Edwin, Ph.D., RAC, Senior Vice President of Regulatory Affairs and Compliance, SPOTLIGHT INNOVATION, INC