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Friday, June 18 • 12:00pm - 1:00pm
#523 OD: FDA Oncology Center of Excellence Pilot Programs: Past, Present, and Future

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Component Type: Session
Level: Intermediate

Since 2018, FDA’s Oncology Center of Excellence (OCE) has led the way in transforming the oncology drug review process by piloting several initiatives. The first pilots were the Real Time Oncology Review (RTOR) and Assessment Aid. RTOR focuses on a more efficient review through data and analysis standardization, and presubmission of datasets allowing for early iterative engagement with the applicant aiming to bring treatments to patients earlier. The Assessment Aid presents the sponsor’s position and the FDA assessment in one document allowing the review team to focus on a critical evaluation of the data as well as increasing review efficiency and consistency. Project Orbis, introduced in 2019, provides a framework for concurrent submission and review of products by FDA and international regulators providing for potential earlier access to oncology drugs in other countries. The RTOR and Assessment Aid Pilots have already demonstrated success by shortening the review time and expanding from supplements to original applications. This has created an interest in expanding these pilots across other FDA Centers/Divisions to accelerate the review of products that address unmet medical needs. Project Orbis, although only a little over a year old, began as a pilot with FDA, TGA and Health Canada and due to the success of that first experience quickly expanded to include Swissmedic, Singapore HSA, ANVISA, and MHRA as international collaborators. This session will review each FDA OCE pilot program and present the industry and FDA views highlighting lessons learned and adjustments made by both sponsor and review teams to enable their effective use and suggested modifications for future improvements. Additionally, expansion of the pilots within FDA to other divisions and thoughts from an international regulator’s perspective on their involvement in Project Orbis will be discussed.

Learning Objectives

Describe the different FDA Oncology Pilot programs (Real Time Oncology Review, Project Orbis, and Assessment Aid) with a focus on their origin and purpose; Identify the most effective and efficient ways to employ these pilot programs; Discuss the future potential of these pilot programs across FDA Divisions and inclusion of other countries into Project Orbis.


Robert Kester, MA, MS


FDA Perspective on OCE Review Programs
R. Angelo De Claro

Early Experience with the FDA Real-Time Oncology Review, Assessment Aid, and Project Orbis Pilots
Kathleen Winson, MPH, MS

Project Orbis: MHRA Experience Challenges and Opportunities
Krishna Prasad, DrMed, MD, FRCP

Expanding Real-Time Review Beyond Oncology
Cartier Esham, PhD, MSc

avatar for Robert Kester

Robert Kester

Senior Director, Global Regulatory Affairs, Merck & Co., Inc., United States
Robert Kester is a Senior Director, Global Regulatory Liaison Oncology at Merck & Co. Inc. He has been at Merck for more than eight years and began as a Regulatory Liaison focused on developing Rest of World regulatory strategies before transitioning to his current role in 2016 supporting... Read More →
avatar for R. Angelo De Claro

R. Angelo De Claro

Associate Director, Global Clinical Sciences, OCE; Div Dir, DHM, OOD, CDER, FDA, United States
Dr. de Claro is currently the Associate Director (Acting) for Global Clinical Sciences with US FDA Oncology Center of Excellence (OCE). In this role, he leads OCE efforts to advance cancer drug development and regulatory science across the globe, including direction of Project Orbis... Read More →
avatar for Cartier Esham

Cartier Esham

Chief Scientific Officer, Biotechnology Innovation Organization (BIO), United States
Cartier Esham serves as Executive Vice President for Emerging Companies at the Biotechnology Innovation Organization (BIO). In this role, Dr. Esham manages and directs BIO’s policy development, advocacy, research and educational initiatives for BIO’s emerging companies, which... Read More →
avatar for Krishna Prasad

Krishna Prasad

Deputy Director, Innovative Medicines, HQA/Licensing, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Krishna Prasad is the Deputy Director of Innovative Medicines, HQA at UK Regulatory Agency with management responsibility across multiple therapy areas Dr Prasad’s additional roles include Cardiology consultancy at St. Thomas’ hospital, London. Dr Prasad qualified in 1987 obtaining... Read More →

Kathleen Winson

Executive Group Director, Regulatory, Genentech, A Member of the Roche Group, United States
Kathleen Winson is an Executive Group Director in Regulatory at Genentech/Roche, where she oversees regulatory strategy for the Oncology Lung and GU programs. She has been involved in clinical research for over 24 years accumulating a broad breadth of experience in pharmaceutical... Read More →

Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session