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Tuesday, October 29 • 9:45am - 10:30am
Getting Real: The Changing Tide on Real-World Evidence in Drug Development

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  • Consider how regulators are recognizing the need for a more flexible framework for evaluating treatments, helped along by the 21st Century Cures Act
  • Explore the growing ability to tap real-world data sources and analyze them using everything from the latest data-crunching technologies to natural language processing and artificial intelligence
  • Hear how companies are using RWE to identify biomarkers that can be used to select clinical trial patients, tapping patient records to help design and optimize trial protocols, and help identify optimal trial sites
  • Understand how RWE requires the right talent and technology in order to reduce trial duration and costs, tap new marketing and payer insights including long-term safety and outcomes, and the challenges of deploying it internally or with partners

avatar for Danny Wiederkehr

Danny Wiederkehr

Senior Director, Global Health Economics and Outcomes Research Team Lead, PFIZER
avatar for Jennifer Lamppa, Ph.D.

Jennifer Lamppa, Ph.D.

Director, Real World Data Science, PAREXEL
Jennifer Lamppa is a Director of Data Sciences and Data Stewardship within Parexel’s Scientific Data Organization, a group focused on the identification and study of real-world healthcare data (RWD). Prior to joining Parexel, she worked at Health Advances, a healthcare strategy... Read More →
avatar for Jennifer Graff, Pharm.D.

Jennifer Graff, Pharm.D.

Vice President, Comparative Effectiveness Research, NATIONAL PHARMACEUTICAL COUNCIL
Jennifer Graff, PharmD, is vice president of comparative effectiveness research at the National Pharmaceutical Council (NPC). Since joining NPC in 2009, she has lead research and policy initiatives to advance the use of high-quality evidence to inform health care decision-making.Prior... Read More →
avatar for Kay Larholt, Sc.D.

Kay Larholt, Sc.D.

Director of Integrated Knowledge Solutions, NEWDIGS, Center for Biomedical Innovation, MASSACHUSETTS INSTITUTE OF TECHNOLOGY
Kay M. Larholt ScD is Director of Integrated Knowledge Solutions, NEWDIGS at MIT Center for Biomedical Innovation.  Dr. Larholt is a seasoned statistical professional with 30 years of experience in the Pharmaceutical, Biotechnology, and Medical Device industry. She has global experience... Read More →
avatar for David Thompson, Ph.D.

David Thompson, Ph.D.

Senior Vice President, Real World Research, SYNEOS HEALTH
Dave is a health economist by training with 25+ years of experience conducting real-world research and consulting for clients in the biopharmaceutical sector. His work has been global in nature, with extensive experience in North American & European markets as well as the emerging... Read More →
avatar for Carly Helfand

Carly Helfand


Tuesday October 29, 2019 9:45am - 10:30am PDT