The Evolving Regulatory Landscape in Oncology Drug Development

1.5
RAC Credits
Virtual ProgramsVirtual Programs
Thursday, 23 March 2023 (12:00 PM) - Thursday, 23 March 2023 (1:30 PM) Eastern Time (US & Canada)

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 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 of innovative medicines to patients, while minimizing the period of uncertainty before 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 webcast 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.


Registration Fees & Deadlines

1/19/2023 — 2/23/2023: Early Bird $150 Member | $175 Nonmember
2/24/2023– 3/23/2023: Regular $175 Member | $200 Nonmember


Learning Objectives

At the conclusion of this workshop, participants should:

  • Explain how recent initiatives from the Oncology Center of Excellence affects drug development, especially the accelerated approval pathway.
  • Describe strategies to better navigate the evolving oncological regulatory environment.

Audience Learning Level

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.


Who Should Attend?

Regulatory affairs professionals working on oncology.


Agenda

Program agenda, March 23, 2023, 12:00 am – 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


Speakers:

Vaibhav Kumar

Vaibhav Kumar

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. Mirat Shah
CDER/FDA, Project Optimus

Dr. Jamie Brewer
CDER/FDA, Project Equity

Cancellations

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-help

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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