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Wednesday, June 29 • 10:30am - 11:30am
#322: Real-World Evidence in Drug Development: Creating the Right Environment for Enhanced Pre-Launch Evidence

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-571-L01-P; CME 1.00; IACET 1.00; RN 1.00

Ideally, health technology assessment and other decisions at launch are informed by an understanding of the (added) value of treatments for patients. In this session, we will explore the barriers and enablers for using real-world data in generating effectiveness evidence in R&D.

Learning Objectives

Identify the positive and negative incentives for generating effectiveness evidence in the current environment; Distinguish different study designs and forms of evidence synthesis using real-world data that can provide input to decision makers; Identify potential solutions for addressing current challenges for generating effectiveness evidence in the pre-launch environment.

Chair

Pieter Stolk, PharmD, PhD

Speaker

The Environment for Enhanced Pre-Launch Evidence: An EU Perspective
Chris Chinn, MSc

The Environment for Enhanced Pre-Launch Evidence: A US Perspective
Gregory Daniel



Chair
PS

Pieter Stolk

Project Manager, University Medical Centre Utrecht
Pieter Stolk, PhD, was trained as a pharmacist with a PhD from Utrecht University. Pieter is interested in all aspects of medicines regulation and policy (with a focus on marketing authorisation and HTA of medicines). He has been involved in several EU public private partnerships... Read More →

Speakers
CC

Chris Chinn

Head of Real World Data Strategy and Partnerships, Sanofi
Chris graduated from Oxford University with a degree in Biochemistry. He qualified as a chartered accountant with Ernst & Young in London and completed a MSc in Health Economics at City University, London. He has led health outcomes research teams at Eli Lilly and GSK, and in his... Read More →
avatar for Gregory Daniel

Gregory Daniel

Deputy Director, Duke-Margolis Center for Health Policy, Duke University
Dr. Gregory Daniel is a Clinical Professor in Duke's Fuqua School of Business and Deputy Director in the Duke-Robert J. Margolis Center for Health Policy. Dr. Daniel directs the DC-based office and leads its pharmaceutical and medical device policy portfolio aimed at developing strategies... Read More →
avatar for Gregory Daniel

Gregory Daniel

Deputy Director and Clinical Professor, Duke-Margolis Center For Health Policy
Gregory Daniel, PhD, MPH is the Deputy Director of the Duke-Robert J. Margolis, MD Center for Health Policy and a Clinical Professor in Duke's Fuqua School of Business. He directs the DC-based office of the Center leading its pharmaceutical and medical device policy portfolio, and... Read More →
PS

Pieter Stolk

Program Manager, Escher, the Lygature Platform For Regulatory Innovation
Pieter Stolk, PhD, was trained as a pharmacist with a PhD from Utrecht University. Pieter is interested in all aspects of medicines regulation and policy (with a focus on marketing authorisation and HTA of medicines). He has been involved in several EU public private partnerships... Read More →


Wednesday June 29, 2016 10:30am - 11:30am
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA