Life Sciences – In Focus: Real-World Evidence: Global Regulatory Landscape and Innovation

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Real-World Evidence: Global Regulatory Landscape
and Innovation

February 28, 2024 at 4:00 PM (GMT) | 8:00 AM (PST) - Register now!

Life Sciences - In Focus: EPISODE 2
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Special Guests

Estelle Frappé

Former Director RWE MD&D, Aetion 

Solution-focused and resourceful consulting executive with 10+ years of demonstrated experience in Real World Evidence (RWE). Proven track record of Business Development in RWE and MedTech. Estelle leverages her clinical research background and sales experience to build a foundation for incorporating strategic RWE needs for Medical Device companies. To ensure that the RWE has the required impact for Medical Device and IVD projects, Estelle focuses on developing innovative and disruptive strategies.

Estelle is also a RAPS member.

Dan Stephens, Ph.D.

Global Advocacy – Real World Evidence, Patient Science & Early Feasibility, Boston Scientific

Dan Stephens, a Fellow on the Boston Scientific Global Advocacy Team, holds a doctoral degree in cardiovascular physiology from the University of Texas Health Science Center San Antonio. With twenty-four years of experience in the implantable medical device industry, he focuses on real-world evidence, patient science, and clinical trial policy and strategy. His work in retrospective analysis of clinical trial datasets began in 2003, and he has since been involved in various projects, collaborative community working groups, and advisory committees, including those with the AdvaMed Trade Association and the FDA.

Heather M. Colvin, MPP

Director MD Regulatory Affairs Evidence and Outcomes Policy, Johnson & Johnson

Heather M. Colvin works to advance the adoption of innovative evidence approaches including real-world evidence, the science of patient input, and improving diversity and inclusion in clinical evidence.  Prior to joining Johnson & Johnson, she worked at the Duke-Margolis Center for Health Policy, the Brookings Institution, the Institute of Medicine (now the National Academy of Medicine), HHS’ Office of Global Health Affairs and the National Committee for Quality Assurance. She holds a Master of Public Policy from Georgetown University and a Bachelor of Arts in Cultural Anthropology from George Mason University.

Host

Karen Tkaczyk Ph.D.

Director of Sales – Life Sciences, Vistatec

Karen is a highly respected professional in the field of scientific translation and language services. She has a Ph.D. in Organic Chemistry and is a certified translator (French to English). She has combined that expertise to build an unusual career. Karen is recognized for her contributions to various publications and organizations, and her unique perspective has solidified her reputation as a thought leader in the field.