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Monday, June 25 • 3:00pm - 4:15pm
#151: Using Real World Evidence for Regulatory Support: Time to Embrace the Future

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-548-L04-P; CME 1.25; IACET 1.25; RN 1.25

As mandated under the 21st Century Cures Act, in December 2018, the FDA is scheduled to issue a draft framework and guidance for evaluating real world evidence (RWE) to help support the approval of a new indication for an already approved drug, and to help support or satisfy post approval study requirements. This session will examine the latest FDA thinking and global experience in terms of decision support for label expansions and other regulatory decisions.

Learning Objectives

Describe the latest FDA thinking about the use of real world evidence (RWE) for regulatory decision making as a supplement to or in lieu of traditional RCT; Apply this knowledge to product development to generate the RWE most likely to be used by regulators; Recognize how to get better ROI from RWE by understanding the differential roles of clinical and surrogate outcomes.

Chair

Nancy Dreyer

Speaker

Lessons from Approval of a Drug to Treat Metastatic Merkel Cell Carcinoma
Tarek Hammad

FDA Perspective
Tamy Kim, PharmD

Rethinking the Process for Post-Market Requirements
Andrew Robertson, JD, PhD


Speakers
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer & SVP, IQVIA, United States
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA Real World Solutions and Adjunct Professor of Epidemiology at Univ of N Carolina at Chapel Hill. She leads the IQVIA Center for Advanced Evidence Generation and is a fellow of both the International Society for Pharmacoepidemiology... Read More →
avatar for Tarek Hammad

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme
Dr. Hammad joined Sanofi-Genzyme, in 2019, as a Therapeutic Area Strategy Lead in the Global Pharmacovigilance group. Prior to this, he served as the Head of Signal Detection and Benefit-Risk Assessment in Merck KGaA/EMD Serono. Previously, he was an Executive Director of Pharmacoepidemiology... Read More →
avatar for Tamy Kim

Tamy Kim

Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER, FDA
Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →
avatar for Andrew Robertson

Andrew Robertson

Global Head of Strategy, and Business Transformation, Digital and Data Sciences, Sanofi
Andrew Robertson is the Global Head of Strategy and Transformation for Sanofi-R&D Digital & Data Sciences. Andrew has more than 14 years of collective experience working in life sciences, policy and law, and has authored multiple peer-reviewed articles on topics pertaining to health... Read More →

Monday June 25, 2018 3:00pm - 4:15pm EDT
Room 205AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session