8th Annual Blueprint for Breakthrough Forum
Validating Real-World Endpoints for an Evolving Regulatory Landscape 

Thank you to all who attended! Click HERE for access to the meeting whitepaper and check our Engaging Innovation blog soon for a full event recap.

Featuring Keynotes from:
Dr. Ned Sharpless
Acting Commissioner, U.S. FDA
&
Dr. Amy Abernethy
Principal Deputy Commissioner, U.S. FDA

The Ritz-Carlton
1150 22nd St NW
Washington, DC 20037

Wednesday, September 18, 2019
8:30 AM EDT – 3:00 PM EDT

Friends of Cancer Research (Friends) and Alexandria Real Estate Equities, Inc. (Alexandria) are proud to announce the eighth annual Blueprint for Breakthrough forum. Friends and Alexandria will convene stakeholders across academia, government, industry, research and advocacy organizations, and other interested groups with the intent of developing consensus on critical aspects of validating real-world endpoints (rwEndpoints) for an evolving regulatory landscape.

For more information on the project, please click HERE. Scroll through below for the final agenda.

Final Agenda

8:30 AM – Registration and Breakfast

9:00 AM – Welcoming Remarks

• Ellen Sigal, Friends of Cancer Research
• Lynne Zydowsky, Alexandria Real Estate Equities, Inc.

9:05 AM – Morning Keynote Conversation

• Dr. Ned Sharpless, Acting Commissioner, U.S. Food and Drug Administration

9:35 AM – Pilot Project Findings: Evaluating Real-World Endpoints

• Jeff Allen, Friends of Cancer Research

10:00 AM – Panel 1: Operationalizing the Use of Real-World Datasets

• Moderator: Donna Rivera, NCI/SEER
• Larry Kushi, Kaiser Permanente/CRN
• Wendy Rubinstein, ASCO-CancerLinQ
• Mark Walker, Concerto HealthAI
• Ruth Pe Benito, Tempus
• Mary Tran, Syapse
• Sean Khozin, U.S. FDA

Audience Q&A

11:15 AM – Break

11:30 AM – Panel 2: Developing a Validation Framework for Real-World Data

• Moderator: Nick Robert, McKesson
• Aracelis Torres, Flatiron Health
• Joe Henk, OptumLabs
• Elizabeth Lamont, Cota
• Jennifer Christian, IQVIA
• Pallavi Mishra Kalyani, U.S. FDA
• Jacqueline Corrigan-Curay, U.S. FDA

Audience Q&A

12:45 PM – Lunch

1:15 PM – Lunch Keynote Conversation

• Dr. Amy Abernethy, Principal Deputy Commissioner, U.S. Food and Drug Administration

1:45 PM – Panel 3: The Future of Real-World Evidence: Informing Regulatory and Payer Decisions

• Moderator: Kate Rawson, Prevision Policy
• Naomi Aronson, Blue Cross Blue Shield Association
• Kimberly Blackwell, Eli Lilly and Company
• Robert Califf, Duke University School of Medicine
• Christie Mangir, Patient Advocate
• Jeremy Rassen, Aetion
• Janet Woodcock, U.S. FDA

Audience Q&A

3:00 PM – Closing Remarks