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Tuesday, June 18 • 10:00am - 11:00am
#223: Challenges in Exceeding the Quality of Existing Endpoints and Approaches Using Digital Tools

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-574-L04-P; CME 1.00; RN 1.00

This forum will discuss how novel technologies provide the means to measure new endpoints and can assess existing endpoints in new ways. Regulatory models are needed to encourage the acceptance of these novel approaches.

Learning Objectives

Identify a clear understanding of regulatory frameworks surrounding digital endpoints; Describe the challenges that may arise when a new tool can measure endpoints more effectively than existing tools; Discuss how to build regulator confidence in novel endpoints and tools.

Chair

Rob Berlin, JD, MPH

Speaker

FDA Perspective
Jeffrey Nahum Siegel, DrMed, MD

Industry Perspective
Julie Tai, PhD

Industry Perspective
Lauren Oliva, PharmD, RPh

Industry Perspective
Rasika Kalamegham, PhD

EMA Update
Steffen Thirstrup, MD, PhD


Speakers
avatar for Rob Berlin

Rob Berlin

Head, US Regulatory Policy, GlaxoSmithKline, United States
Rob Berlin is Head of U.S. Regulatory Policy at GlaxoSmithKline (GSK). Rob leads a team focused on driving U.S. regulatory policy, advocacy, and intelligence activities, to ensure optimal advancement and lifecycle management of GSK’s product portfolio. Rob came to GSK from the FDA... 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 Lauren Oliva

Lauren Oliva

US Lead, Global Regulatory Policy, Biogen, United States
Lauren Oliva is US lead for Global Regulatory Policy at Biogen. She oversees the development and execution of R&D’s policy roadmap to advance Biogen’s neuroscience and rare disease portfolio. She is passionate about patient centric drug development and the impact of multi-stakeholder... Read More →
avatar for Jeffrey Siegel

Jeffrey Siegel

Director, Office of Drug Evaluation Sciences, OND, CDER, FDA, United States
Jeffrey Siegel is the Director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research... Read More →
JT

Julie Tai

Director, GRA, Precision Medicine and Digital Health, GlaxoSmithKline, United States
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Forum