Panel 1 White Paper  Panel 2 White Paper  Panel 3 White Paper

Friends of Cancer Research (Friends) was proud to host our Annual Meeting to address critical issues in the development of new oncology drugs. This meeting brought together leaders in cancer drug development, federal health and regulatory agencies, academic research, the private sector, and patient advocates for focused discussions on key issues surrounding the development and regulation of cancer drugs and therapies. This meeting featured panels and experts that proposed unique approaches toward the following vital topics in drug development:

• Identifying and Establishing the Role of Circulating Tumor DNA in Cancer Drug Development
• Augmenting Randomized Confirmatory Trials for Breakthrough Therapies with Historical Clinical Trials Data
• Real-time Oncology Review: Streamlining Data Submissions and Ensuring Data Quality

AGENDA

9:00 AM – Registration and Breakfast

9:30 AM – Welcome

• Ellen Sigal, Chairperson & Founder, Friends of Cancer Research
• Jeff Allen, President & CEO, Friends of Cancer Research

9:35 AM – Breakfast Keynote

• Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis, U.S. FDA

10:00 AM – Panel 1: Augmenting Randomized Confirmatory Trials for Breakthrough Therapies with Historical Clinical Trials Data
Panel 1 Slides

Moderator: Elizabeth Stuart, Johns Hopkins University

Presentations:

• Landscape analysis and topic introduction: Elizabeth Stuart, Johns Hopkins University
• Case study 1: Ruthanna Davi, Medidata
• Case study 2: Pallavi Mishra-Kalyani, Mathematical Statistician, U.S. FDA

Panelists:

• Andrea Ferris, LUNGevity Foundation
• Antoine Yver, Daiichi Sankyo
• Joohee Sul, U.S. FDA
• Pallavi Mishra-Kalyani, Mathematical Statistician, U.S. FDA
• Rajeshwari Sridhara, U.S. FDA
• Ruthanna Davi, Medidata Solutions

11:45 AM – Lunch

12:30 PM – Lunch Conversation with the Oncology Center of Excellence (OCE)

Moderator: Rick Pazdur, Director, OCE, U.S. FDA

• Gideon Blumenthal, U.S. FDA
• Amy McKee, U.S. FDA

1:15 PM – Panel 2: Identifying and Establishing the Role of Circulating Tumor DNA in Cancer Drug Development
Panel 2 Slides

Moderator: Geoffrey Oxnard, Dana Farber Cancer Institute

Panelists:

• Darya Chudova, Guardant
• David Shames, Genentech
• Jamie Holloway, Patient Advocate
• Jean-Charles Soria, AstraZeneca/MedImmune
• Julia Beaver, U.S. FDA
• Reena Philip, U.S. FDA

3:00 PM – Break

3:15 PM – Afternoon Keynote

• Janet Woodcock, Director, Center for Drug Evaluation and Research, U.S. FDA

3:25 PM – Panel 3: Real-time Oncology Review: Streamlining Data Submissions and Ensuring Data Quality
Panel 3 Slides

Moderator: Michael McCaughan, Prevision Policy

Presentation:
RTOR Pilot and Case Studies: Qi Liu, U.S. FDA (10 minutes)

Panelists:

• Giuseppe Randazzo, U.S. FDA
• Jennifer Gao, U.S. FDA
• Jiten Rana, Novartis
• Jonathan Cheng, Merck
• Karen Jones, Genentech
• Katherine Couvillon, Patient Advocate

5:00 PM – Closing Remarks

• Jeff Allen, Friends of Cancer Research

RECEPTION TO FOLLOW