Designing Successful Clinical Trials in a Digital & Payor World Registration

Start Date:5/23/2019

Start Time:11:00 AM EDT

Duration:60 minutes

Abstract:

Planning clinical trials requires a keen focus on your development program goal: optimized technical and scientific outcomes to create a smooth path for regulatory approval, payor coverage, and commercial success.

This timely webinar will feature unique insights from Phase 2 & 3 trials, with examples of common issues that can determine success or failure, including seemingly minor trial design factors that can cost or save millions of dollars, and months to years of excess time. Learn from medical and R&D industry thought leaders how to:

Apply artificial intelligence, digital platforms, and automation (aka, “big data”)
Be more precise and accurate in designing a clinical program and trial protocols
Avoid trial rescues and protocol amendments
Select the right investigators, including QA-ing site lists from CROs
Incorporate cost-effectiveness endpoints to ensure timely payor coverage and patient access upon approval

Mastery of these issues and imperatives will minimize frustration and maximize your chance of completing successful clinical trials on time and within or under budget.

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Speakers

Paul Chew, MD

Chief Medical Officer

Phesi

Dr. Paul Chew is a board-certified cardiologist and internist. He has also held leadership positions at Sanofi, Bristol-Myers Squibb, and was formerly global CMO at Paris-based Sanofi and CMO of Omada Health in San Francisco launching the largest randomized clinical trial in digital therapeutics. Dr. Chew is currently on the Board of Trustees for the U.S. Pharmacopeial Convention.

Annalisa Jenkins, MBBS, FRCP

Dr. Annalisa Jenkins chairs or serves on the boards of a number of private and public life sciences companies. Dr. Jenkins previously held R&D leadership roles at Merck Serono and Bristol Myers-Squibb, and was CEO of Dimension Therapeutics. She is Chair of the Court of the London School of Hygiene and Tropical Medicine, on the board of Faster Cures at the Milken Institute, and a committee member of the FDA Science Board.