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Monday, June 17 • 3:30pm - 4:30pm
#150: Building Trust in New Alternative Methods in Investigational New Drug Applications

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-549-L04-P; CME 1.00; RN 1.00

This forum will discuss practical experiences developing investigational new drug applications (IND) applications with new alternative methods (NAMs). Panelists will share lessons learned on how to build trust in NAMs for regulatory uses.

Learning Objectives

Apply strategies to leverage new alternative methods (NAMs) in IND applications; Evaluate successful case studies; Identify gaps and opportunities to advance the use of NAMs for drug development.

Chair

Rasika Kalamegham, PhD

Speaker

FDA's Perspectives on the Current Use of NAMs in IND Applications
Paul C. Brown, PhD


Speakers
avatar for Paul Brown

Paul Brown

Associate Director for Pharmacology and Toxicology, OND, CDER, FDA, United States
Dr. Brown's responsibilities include development and implementation of guidance and policy related to the nonclinical assessment of human pharmaceuticals. He has been at the FDA since 1996 when he joined the Division of Dermatology and Dental Drug Products as a Pharmacology/Toxicology... 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 →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  06: TranslationalDelivery Tech-PrecMedicine, Forum