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Tuesday, June 26 • 4:15pm - 5:30pm
#280: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-608-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, a panel of experts will share their experience on the breakthroughs -what really works, and the deal breakers -what’s not working yet or was harder than expected. Our aim is to debunk the decentralized trial hype and share lessons learned. The forum will include perspectives from a sponsor, a decentralized trial vendor, a 'site' and if possible, a patient who has participated in a decentralized trial.

Learning Objectives

Discuss key learnings about what's working and not working in decentralized trials; Discuss individual experiences on design and implementation of decentralized trials; Describe the patient and site perspective on participation in decentralized trials.

Chair

Jane E. Myles, MS

Speaker

Panelist
Leonard Sacks, MD

Panelist
Komathi Stem, MS

Panelist
Gerrit Hamre, MA



Speakers
avatar for Gerrit Hamre

Gerrit Hamre

Clinical Project Manager, Clinical Trials Transformation Initiative (CTTI)
Gerrit Hamre manages the development and implementation of CTTI projects. Prior to joining CTTI, he worked in the FDA Office of Legislation, followed by the FDA Center for Drug Evaluation and Research, Office of Policy for Pharmaceutical Quality. Additionally, Gerrit has worked on... Read More →
avatar for Jane Myles

Jane Myles

Head, Operational Intelligence and Innovation, Genentech, A Member of the Roche Group
Jane is the Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation into the way we design and execute trials to get medicines to patients faster. She's worked at Genentech for 17 years in many roles, including line manager... Read More →
LS

Leonard Sacks

Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently... Read More →
KS

Komathi Stem

Founder and Chief Executive Officer, monARC Bionetworks
Komathi Stem, MS is passionate about transforming drug development by rethinking the way clinical trials are designed & executed. As an entrepreneurial systems thinker, she is focused on sparking an ecosystem change that accelerates research through greater collaboration across the... Read More →


Tuesday June 26, 2018 4:15pm - 5:30pm
Room 254AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA