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Tuesday, June 18 • 8:00am - 9:00am
#210: Digital Biomarkers as Clinical Endpoints: The Road to Regulatory Acceptability

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-565-L04-P; CME 1.00; RN 1.00

This forum will review the current regulatory paradigms for the use of digital biomarkers as endpoints in clinical trials in the US and EU. A panel of experts will discuss validation pathways and compare regulatory approaches between regions.

Learning Objectives

Describe the V3 process (verification, analytical validation, clinical validation) for validating digital health technologies as fit-for-purpose in a clinical trial; Identify validation pathways in the US and EU; Discuss outstanding challenges to the use of digital health technologies for remote data capture in clinical trials.

Chair

Lina AlJuburi, PharmD, MSc

Speaker

Enhancing Clinical Research in Europe: Navigating the Regulatory Landscape
Max Wegner, PharmD, RPh

Panelist
Anindita Saha

Industry Perspective
Steve Berman, MPH

Industry Update
Gul Erdemli, MD, PhD


Speakers
avatar for Lina AlJuburi

Lina AlJuburi

Head, Global Regulatory Science and Policy - North America, Sanofi, United States
A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →
avatar for Steve Berman

Steve Berman

Deputy Vice President, Science and Regulatory Affairs, BIO, United States
Steve Berman serves as Deputy VP of Science and Regulatory Strategy for the Biotechnology Innovation Organization (BIO). Steve joined BIO after serving as a Director, Translational Regulatory Affairs, at AstraZeneca. Steve joined AZ after eight years at FDA, working in both CDER and... Read More →
avatar for Gul Erdemli

Gul Erdemli

Global Program Regulatory Director, Novartis Pharmaceuticals Corporation, United States
Gül Erdemli is a Global Program Regulatory Director at Novartis Regulatory Affairs Early Development. She is a drug development leader with more than 15 years industry experience from target identification to clinical development. She has an MD degree from Hacettepe University, Medical... Read More →
avatar for Anindita Saha

Anindita Saha

Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States
Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations... Read More →
avatar for Max Wegner

Max Wegner

Head Regulatory Affairs, Bayer AG, Germany
After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum