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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Authorized by the 21st Century Cures Act, the FDA’s Oncology Center of Excellent (OCE) is the first intra- center institute working across different functional areas of the agency. In the past two years, the OCE has launched more than 10 initiatives, ranging from promoting collaboration in cancer trial design and analysis to providing a consistent review of safety signals across different drug classes. Among these diverse programs, several directly and immediately affect oncological drug development: Project Equity, Project Optimus, and Project Front Runner. Project Equity aims to enhance the diversity of clinical trial participants, while Project Optimus focuses on reframing the dose selection paradigm. Project Front Runner is part of an ongoing effort to reevaluate the accelerated approval pathway. It encourages sponsors to develop a comprehensive strategy to provide expedited access to innovative medicines to patients while minimizing the period of uncertainty before the clinical benefits of these therapeutics can be verified or refuted. Since approximately half of the approvals for cancer were through the accelerated pathway in the past decade, we are witnessing some of the most consequential changes in the oncological regulatory environment.
This workshop will provide an overview of these three programs and discuss their implications for oncological drug development. The goal is to help the audience better navigate the evolving regulatory landscape, which provides both challenges and opportunities.
1/19/2023 — 2/23/2023: Early Bird $150 Member | $175 Nonmember2/24/2023– 3/23/2023: Regular $175 Member | $200 Nonmember
At the conclusion of this workshop, participants should:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Regulatory affairs professionals working on oncology.
Program agenda, March 23, 2023, 12:00 pm – 1:30 pm, ET
12:00 – 12:20 pm Dr. Vaibhav Kumar, CDER/FDA, Project Front Runner
12:20 – 12:40 pm Dr. Mirat Shah, CDER/FDA, Project Optimus
12:40 – 1:00 pm Dr. Jamie Brewer, CDER/FDA, Project Equity
1:00 – 1:30 pm Panel discussion
Vaibhav KumarPhysician, CDER/FDA, Project Frontrunner
Vaibhav Kumar is a medical oncologist and a clinical reviewer in the Division of Oncology 3. He received his M.D. from Imperial College London and gained membership to the Royal College of Physicians of London prior to moving to the US. He completed his internal medicine residency and Master’s in Clinical and Translational Science from Tufts Medical Center.
Prior to joining the FDA in 2021, he completed his hematology and oncology fellowship at University of North Carolina at Chapel Hill. He specializes in the management of patients with gastrointestinal malignancies. His research focus lies in the development and validation of clinical risk prediction tools to personalize patient care. He has first author publications in the Annals of Internal Medicine, JAMA Oncology, Oncologist and Lancet.
Dr. Cara RabikPhysician, CDER/FDA, Project Optimus
Dr. Rabik is a hematologist-oncologist at FDA and liaison for Project Optimus, and clinical reviewer in the Division of Hematologic Malignancies I at the FDA. Areas of expertise: pediatric hematology-oncology, acute lymphoblastic leukemia, acute myeloid leukemia, clinical trial design, translational research.
Dr. Jamie BrewerLead Physician, CDER/FDA, Project Equity
Jamie Brewer, MD, is a medical oncologist and Clinical Team Lead in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Food and Drug Administration (FDA). Dr. Brewer joined the FDA in 2018 and previously served as a clinical reviewer on the Genitourinary Cancer team. Dr. Brewer serves as the Oncology Center of Excellence (OCE) Scientific Liaison for Cancer Disparities for which she actively engages with FDA colleagues and external stakeholders to promote inclusion and representation of diverse patient populations in clinical trials. Dr. Brewer is an active contributor to OCE initiatives such as Project Equity and Project Community. She is also a participant in multiple internal and external scientific working groups. Dr. Brewer completed her medical training at The University of Illinois at Chicago. She completed her residency and a joint fellowship in Medical Oncology and Clinical Pharmacology and Pharmacogenomics at The University of Chicago.
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