Jonathan Jarrow | Senior Medical Advisor to the Center Director of CDER
F.D.A
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy, chair of the Medical Policy Council, and as deputy director of the Office of Hematology and Oncology Products. He is a Board Certified Urologist and prior to joining the FDA he was in academic medicine for over 20 years. His last academic appointment was Professor of Urology, Pathology, Radiology, and Molecular Biology & Biochemistry at Johns Hopkins University where he worked for over ten years.
Appearances:
Pharma Pricing & Market Access USA Day 1 @ 09:00
Keynote Address: Evidence Generation in the Electronic Era - Leveraging Real World Data
- Learn how the FDA utilizes real world data in regulatory decision-making
- Current barriers to full implementation of a learning healthcare system
- Regulatory hurdles to development of real world evidence
Pharma Pricing & Market Access USA Day 1 @ 15:10
PANEL: Accelerated Approval and Expensive Drugs — A Challenging Combination
- Despite the uncertain evidence of clinical benefit, drugs receiving accelerated approval enter the market as FDA-approved products. Insurers must decide whether and how to pay for them
- How do insurers decide whether to pay for these drugs in light of little evidence?
- Ensuring that confirmatory trials conducted after receiving accelerated approval are performed in a timely fashion and are designed optimally to limit the period of uncertainty about true clinical effect
Organiser
