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Wednesday, June 19 • 1:15pm - 2:15pm
#353: ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-656-L04-P; CME 1.00; RN 1.00

Model Informed Drug Development (MIDD) can enhance the efficiency of drug development and regulatory decision-making. The ICH M15 guideline aims to enable the further integration and consistent use of MIDD. This session will cover the draft guideline in greater detail.

Learning Objectives

Discuss the draft guideline and what may be new to drug developers and the regulatory community, including the concept of a risk-based assessment, the value of multidisciplinary team alignment on MIDD strategy, and early alignment with regulators; Identify current approaches, best practices, and future opportunities to enhance development and decision-making.

Chair

Erin Greene, JD

Speaker

Industry Perspective
Malidi Ahamadi

Industry Perspective
Mark C. Peterson, PhD


Speakers
avatar for Erin Greene

Erin Greene

US Lead, Global Regulatory Policy and Innovation, Takeda, United States
Experienced leader in Global Regulatory Policy and Intelligence with a demonstrated history of working in the pharmaceutical and healthcare industries. Graduated from American University, Washington College of Law with an emphasis on FDA regulation and health law and policy.
MA

Malidi Ahamadi

US Head, Modeling and Simulation, Sanofi, United States
MP

Mark Peterson

Senior Director, Modeling and Simulation, Vertex Pharmaceuticals, United States
Dr. Mark C. Peterson works at Vertex Pharmaceuticals as a Senior Director in Clinical & Quantitative Pharmacology. Prior to that, he was at Pfizer (9 years), Biogen (2 years) and Amgen (8 years). Dr. Peterson received a Bachelor of Sciences in Pharmacy (1992) and a Doctorate in Pharmaceutical... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session