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Wednesday, June 30 • 10:00am - 11:00am
#320 SL: Model Informed Drug Development (MIDD) Pilot Program: Experience and Impact Over First Three Years

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-610-L04-P; CME 1.00; IACET 1.00; RN 1.00

We will share experience with Model Informed Drug Development (MIDD) Pilot Program over the past three years from the perspective of FDA and pharma industry experts including a discussion of key learnings, best practices, and impact on the development and regulatory strategy.

Learning Objectives

Summarize experience with the Model Informed Drug Development (MIDD) Pilot Program over the past three years from FDA and pharma industry perspective; Evaluate detailed MIDD case studies from experts in the field including key learnings and impact on the development and regulatory strategy; Discuss best practices for the future.

Chair

Bonnie Brennan, PharmD

Speaker

Experience and Impact of Model-Informed Drug Development (MIDD) Pilot Program: FDA Perspective
Rajanikanth Madabushi, PhD

Prediction of Cytokine Release and Active Dose of a CD3-CD28-CD38 Trispecific Antibody for Multiple Myeloma: Utilization of a Systems Pharmacology Platform for Multispecific T Cell Engagers
Spyros Stamatelos, PhD

Industry Update
Patrick Smith, PharmD


Speakers
BB

Bonnie Brennan

Senior Director, Clinical Pharmacology Lead, Bayer, United States
Bonnie received a BS and PharmD from Rutgers University in 2003 and completed a post-doc fellowship in clinical pharmacology at Roche, after which she joined the department. She has been responsible for leading the clinical pharmacology strategy in the Infectious Diseases and Oncology... Read More →
avatar for Rajanikanth Madabushi

Rajanikanth Madabushi

Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER, FDA, United States
Dr. Madabushi has 10 years of regulatory review experience as Pharmacometrics Review and as Team Leader in the Office of Clinical Pharmacology. He was predominantly involved in the application of quantitative clinical pharmacology approaches for regulatory decision making and addressing... Read More →
PS

Patrick Smith

Senior Vice President, Integrated Drug Development, Certara, United States
SS

Spyros Stamatelos

Group Leader, Sanofi, United States
Spyros Stamatelos, PhD, is a Group Leader within the digital data sciences organization at Sanofi, with a focus on developing QSP models for oncology and immuno-oncology (I/O) applications. Dr. Stamatelos’s group focuses on multiscale QSP model development for solid tumors and hematologic... Read More →

Wednesday June 30, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session |   09: Regulatory, Session