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Thursday, June 20 • 8:00am - 9:00am
#405: The FDA's Commitment to Patient-Centric Research: Key Themes from Decentralized Trial Draft Guidance

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-681-L04-P; CME 1.00; RN 1.00

This interactive forum will explore the key themes and industry feedback from the decentralized trials alliance members’ response to the FDA draft guidance on decentralized clinical trials.

Learning Objectives

Examine how the FDA draft guidance reflects a commitment to patient-centric decentralized clinical trials; Identify key themes and industry feedback provided in the alliance's response to the draft guidance; Discuss the next steps needed to enable adoption of decentralized trials under the draft framework.

Chair

Rasika Kalamegham, PhD

Speaker

Collaboration Perspective
Jane Elizabeth Myles, MSc

FDA Perspective
M. Khair ElZarrad, PhD, MPH

Industry Perspective
Dylan Bechtle, MS


Speakers
DB

Dylan Bechtle

Associate Director, Regulatory Policy Lead- US, Johnson & Johnson Innovative Medicine, United States
Dylan is an Associate Director in Johnson and Johnson Innovative Medicine's Global Regulatory Policy and Intelligence (GRPI) group. Dylan leads J&J’s regulatory policy efforts around clinical trial diversity. He is interested in the intersection of novel clinical methodologies (e.g... Read More →
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Director, Office of Medical Policy, CDER, FDA, United States
Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
RK

Rasika Kalamegham

Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy at Genentech. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy. She plays an active role in many trade... Read More →
avatar for Jane Myles

Jane Myles

Program Director, Decentralized Trials and Research Alliance (DTRA), United States
Jane has over 25 years of experience improving clinical trials and patient experiences. She has focused on driving innovation in trial design and execution to accelerate getting medicines to patients. Jane transitioned from molecule focus to portfolio focus about 14 years ago, first... Read More →

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Forum |   09: Regulatory, Forum