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Project Optimus – FDA’s New Dose Optimization & Selection Paradigm in Oncology Drug Development
Dr. Brian P. Booth and Dr. Hao Zhu from the Office of Clinical Pharmacology (OCP) at the FDA will present and discuss Project Optimus, an initiative from the Oncology Center of Excellence (OCE) to reform the dose optimization and dose selection paradigm in oncology drug development. Clinical pharmacology strategy and model-based approach supporting Project Optimus will be discussed with the following outline:
• Introduction-Project Optimus
• Why we need to optimize dose for oncology products
• Case studies
• Leveraging what we know
• The Role of Model-Informed Drug Development (MIDD) in Dose Optimization

Panelist(s): Dr. Brian P. Booth, Division of Cancer Pharmacology I and
Dr. Hao Zhu, Division of Pharmacometrics, FDA CDER/Office of Clinical Pharmacology

Moderator: Tom Sun, Vice President, Strategic Consulting Services, Simulations Plus

Host: Arlene Padron, Corporate Marketing Director, Simulations Plus

Sep 7, 2022 08:00 AM in Pacific Time (US and Canada)

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Dr. Brian Booth
Director @Division of Cancer Pharmacology I, Office of Clinical Pharmacology, U.S. FDA.
Dr. Booth obtained a Bachelor of Science in Physiology at McGill University in 1988, and subsequently pursued a Doctorate in Pharmacology and Toxicology at Queen’s University (1993) in Canada. Following a Post-Doctoral Fellowship in the Department of Pharmaceutics at the State University of New York at Buffalo, where he studied the interaction between nitric oxide donors and the neuropeptide calcitonin gene-related peptide, Dr. Booth joined the Office of Clinical Pharmacology and Biopharmaceutics, FDA, in 1998. In 2004, he became the Acting Team Leader in the Division of Oncology Drug Products, after serving as a reviewer/pharmacometrician in this division. In November 2006, Dr. Booth was appointed as Deputy Director of the Division of Clinical Pharmacology V. At the FDA, Dr. Booth has been involved with the clinical pharmacology development of several hundred new oncology drugs, ranging from phase 1 to phase 4. He has authored 81 peer reviewed articles and book chapters.
Dr. Hao Zhu
Acting Director @Division of Pharmacometrics, Office of Clinical Pharmacology, Center of Drug Evaluation and Research, U.S. FDA
Dr. Hao Zhu is the acting director at the Division of Pharmacometrics, Office of Clinical Pharmacology, Center of Drug Evaluation and Research, U.S. Food and Drug Administration. Dr. Zhu received his Ph.D. in pharmaceutical sciences and Masters degree in statistics from the University of Florida. He started his career in modeling and simulation teams at Johnson & Johnson and Bristol-Myers-Squibb. He joined FDA as a pharmacometrics reviewer more than 15 years ago. Dr. Zhu has been a clinical pharmacology team leader for more than 6 years and a QT-IRT scientific lead for 2 years. He also served as the deputy director for the division of pharmacometrics. His division reviews the pharmacometrics related submissions and supports pharmacometrics-related policy development across CDER.
Tom Sun
Vice President, Strategic Consulting Services @Cognigen
Tom Sun is Vice President, Strategic Consulting Services, Cognigen Division at Simulations Plus. Dr. Sun has more than twenty years of pharmaceutical industry experience at Genentech (1998-2002), ALZA/Johnson & Johnson (2002-2004), Amgen (2004-2015), and Janssen (2015-2022). Prior to this current role, Dr. Sun was the Oncology Therapeutic Area Head, Clinical Pharmacology & Pharmacometrics Department and the Licensing & Acquisition Evaluation Head, Quantitative Sciences at Janssen R&D. Dr. Sun received his B.S. in Pharmacy from Taipei Medical University (formerly known as Taipei Medical College) and his Ph.D. in Pharmaceutical Sciences from the University at Buffalo. He is specialized in translational Pharmacokinetic/Pharmacodynamic (PK/PD) research, Clinical Pharmacology, Modeling & Simulations, and product registration for small molecules, biologics, and CAR-T therapies. His recent research focus has been the application of model-based drug development in oncology.
Arlene Padron
Corporate Director of Marketing @Simulations Plus
Arlene Padron is the Corporate Director of Marketing, responsible for marketing programs, brand management, and scientific marketing communications. She joined Simulations Plus in 2011. As a seasoned professional with more than 25 years of sales and marketing experience, Arlene plays a leading role in creating and managing strategies to achieve sustainable, profitable growth and maximize operational excellence. Her greatest strengths are creativity, leadership, and customer-centricity.