Oct 24, 2022
Reimagining R&D Webinar Series presenting “Project Optimus: Reimagining Oncology Drug Development with Dose Optimization”
Vivpro Corporation is proud to welcome Dr. Lanre Okusanya to our October session of “Reimagining R&D, Webinar Series.” We’ve partnered with experts and industry leaders to discuss critical pharma and biotech topics. Our goal is to share valuable information and allow the audience to engage with questions while they receive real-time feedback.
Dr. Okusanya is a Clinical Pharmacology leader at the U.S Food and Drug Administration and will share insights on preparing for Project Optimus discussions with the FDA and more.
Session Overview
History and Current status of Project Optimus.
Importance and role of dose optimization for oncology products in regulatory decisions.
Relationship between Model Informed Drug Development and Project Optimus.
Hos sponsors are responding and can prepare for Project Optimus.
How FDA is handling Project Optimus, including guidance documents.
About Dr. Olanrewaju Okusanya, PharmD, MS, BCPS
Deputy Division Director of the Division of Cancer Pharmacology I in the Office of Clinical Pharmacology at the U.S Food and Drug Administration. He received his Pharmacy degree from Texas Southern University, completed a Pharmacy Practice Residency at the University of Pittsburgh, and a Pfizer/University at Buffalo Drug Development Fellowship with a Masters in Pharmacometrics from SUNY Buffalo.
He has been involved in the review and approval of multiple anti-cancer therapies with an emphasis on drugs to treat malignant and non-malignant hematology diseases, including biosimilars, and identifying and addressing regulatory issues that arise in oncology drug development from a clinical pharmacology perspective.
Prior to joining the FDA, his work included leveraging pre-clinical and early human data for dose selection, optimizing dosing regimens for patients, as well as providing translational and investigational PKPD guidance for the development of novel therapeutics.
