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Wednesday, June 28 • 10:30am - 11:30am
#324: Dose Optimization in Oncology: How Do we Tackle the Tricky Topic of Combinations?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-623-L04-P; CME 1.00; RN 1.00

FDA’s Project Optimus emphasizes the importance of dose optimization oncology. Often, oncology drugs are studied in combination with other therapies. This session will focus on dose optimization for combinations and challenges still to be addressed.

Learning Objectives

Explain how FDA expectations for dose optimization may be challenging for combinations; Discuss practical approaches for dose optimization in combinations and current challenges; Discuss unanswered questions and next steps for advancing dose optimization in this context.

Chair

Megan Doyle, JD, MPH

Speaker

Approaches to Dose Optimization in Early Phase Studies
Timothy Yap, PhD, FRCP

Panelist
Azher Hussain, PhD

Panelist
Karthik Venkatakrishnan, PhD

Panelist
Amandine Manon, PharmD


Speakers
avatar for Megan Doyle

Megan Doyle

Global Policy Lead, Digital Health, Diagnostics, Oncology, Amgen, United States
Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →
avatar for Azher Hussain

Azher Hussain

Associate Vice President, Pharmacology and Pharmacometrics, Merck & Co., Inc., United States
Azher Hussain is the Head of Quantitative Pharmacology and Pharmacometrics, Immune-oncology group at Merck. Azher has 20 years of experience in pharmaceutical industry primarily in pharmacokinetics, pharmacodynamics, pharmacometrics and metabolism across small and large molecules... Read More →
avatar for Amandine Manon

Amandine Manon

Senior Director, Clinical Pharmacology and Translational Medicine, Certara, France
Amandine Manon joined Certara in 2020. Prior to that, she served as a Clinical pharmacologist in several pharmaceutical companies for 15 years. She has a proven track record in preclinical and clinical PK, clinical pharmacology with a special focus on oncology drug development from... Read More →
avatar for Karthik Venkatakrishnan

Karthik Venkatakrishnan

Vice President, Global Head of Quantitative Pharmacology, EMD Serono, United States
Karthik Venkatakrishnan is Vice President and Global Head of Quantitative Pharmacology at EMD Serono, Inc., Billerica, MA, with accountability for leadership of Clinical Pharmacology, Translational M&S, and Pharmacometrics. Previously, he held roles in Clinical Pharmacology at Pfizer... Read More →
avatar for Timothy Yap

Timothy Yap

Medical Director, The Institute for Applied Cancer Science, University of Texas MD Anderson Cancer Center, United States
Dr. Timothy Yap is a Medical Oncologist and Physician-Scientist based at the University of Texas MD Anderson Cancer Center. He is an Associate Professor in the Department for Investigational Cancer Therapeutics (Phase I Program), and the Department of Thoracic/Head and Neck Medical... Read More →

Wednesday June 28, 2023 10:30am - 11:30am EDT
Room 156 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum |   11: Statistics, Forum