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  1. Oncology Center of Excellence

OCE Programs and Projects Overview

OCE Vision:  We seek to create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer. OCE Mission:  The mission of the Oncology Center of Excellence is to achieve patient-centered regulatory decision making through innovation and collaboration.

OCE Programs

Immuno-oncology Therapeutics Program brings together existing expertise within FDA to promote development of new therapeutics that focus on harnessing the immune system to engage new, more efficacious treatment paradigms for patients with cancer.

OCE Scientific Collaborative supports FDA oncology staff who participate in applied regulatory science research projects and collaborations with FDA and external experts. 

Oncology Cell and Gene Therapy Program focuses on clinical evaluations for, and helps to expedite development of, transformative cancer therapies based on cutting-edge technologies with curative potential.

Oncology Labeling Program provides an integrated cross-center approach to advance clinically meaningful, data-driven, and scientifically accurate drug information for healthcare practitioners and patients with cancer.

Oncology Real World Evidence Program aims to engage in evidence development modernization through scientific collaboration and policy development to advance the appropriate fit-for-purpose application of RWD to generate RWE for regulatory purposes.

Oncology Regulatory Affairs provides an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review.

Patient-Focused Drug Development Program fosters collaboration between FDA Centers and external stakeholders involved in patient outcomes research in cancer populations.

Pediatric Oncology Program promotes the development of safe and effective new drugs and biologics to treat cancer in children.

Precision Oncology Program is coordinating and integrating efforts across the centers to catalyze regulatory science research and development to apply new methodologies to deliver the promise of precision oncology for new and better drugs, diagnostics, and biologics to reduce the burden of cancer.

Rare Cancers Program promotes the development of safe and effective new drugs and biologics to treat patients with rare cancers.


OCE Projects

Project 5 in 5 crowdsourcing 5 clinically relevant questions for 5 pragmatic trials.

Project Asha is a collaboration to increase cancer clinical trial access in India.

Project ASIATICA (ASian amerIcans, nATive hawaIian, and other paCific islAnders) aims to bring focus and awareness to Asian Americans, Native Hawaiians, and Other Pacific Islander (AA & NHPI) patients with cancer. 

Project Catalyst provides guidance and educational resources that help support informed anticancer therapy development to expedite the availability of directed and novel cancer treatments to the public, working primarily with small pharmaceutical companies and academic life science incubators and accelerators.

Project Community is a public health outreach initiative established for patients living with cancer, survivors, advocates, families, and people living in underserved urban and rural communities who are at greater cancer risk.

Project Confirm is an initiative to promote the transparency of outcomes related to accelerated approval for oncology indications.

Project Endpoint works to advance the use of endpoints in oncology drug development.

Project Equity is a public health initiative to ensure that the data submitted to the FDA for approval of oncology medical products adequately reflects the demographic representation of patients for whom the medical products are intended.

Project Facilitate is a single point of contact call and information center created to help oncology healthcare providers or regulatory professionals submit an Expanded Access Request for an individual patient with cancer through FDA's Expanded Access Program.

Project FrontRunner aims to encourage drug companies to consider the most appropriate line of treatment setting when developing new cancer therapies, such as in earlier clinical settings.

Project Livin’ Label is an educational initiative that aims to foster broad understanding of the associated oncology product label and increase awareness of recent oncology drug FDA approvals in the cancer community.

Project Optimus is an initiative to reform the dosage optimization and dosage selection paradigm in oncology drug development.

Project Orbis provides a framework for concurrent submission and review of oncology products among international partners.

Project Patient Voice is an online platform for patients and caregivers along with their healthcare providers to look at patient-reported symptom data collected from cancer clinical trials.

Project Point/Counterpoint provides a new version of the Oncologic Drugs Advisory Committee (ODAC) briefing document that combines the company’s and the FDA’s positions in a single document.

Project Pragmatica seeks to introduce functional efficiencies and enhance patient centricity by integrating aspects of clinical trials with real-world routine clinical practice through appropriate use of pragmatic design elements. 

Project Renewal is a public health initiative that aims to update the prescribing information (i.e., labeling) for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date

Project Significant (Statistics in Cancer Trials) promotes collaboration and engagement among diverse stake holders to further the design and analysis of cancer clinical trials with the goal to advance cancer therapies.

Project Silver is a public health initiative to increase representation of older adults (65 years and older) in cancer clinical trials with the goal of improving their treatment, care, and outcome through evidence base data.

Project Socrates provides educational opportunities for hematology/oncology fellows, basic and translational scientists, junior faculty, and others interested in learning more about regulatory science and drug development. 


OCE Projects Under Development

Project Beyond Breakthrough seeks to identify and institute best practices to expedite development of breakthrough therapy-designated drugs and biological products.  

Learn more about these two projects in OCE's 2022 Annual Report.


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