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The Drug Development Paradigm in Oncology: A Workshop

Completed

Topics

Advances in cancer research have led to an increasing number and variety of cancer therapies in the development pipeline, but there are concerns that traditional processes for drug development, evaluation, and regulatory approval could impede or delay the use of promising therapies. The National Cancer Policy Forum, in collaboration with the Forum on Drug Discovery, Development, and Translation, hosted a workshop to discuss challenges with traditional approaches to drug development, opportunities to improve efficiency, and strategies to enhance the information available about a cancer therapy throughout its lifecycle in order to improve its use in clinical practice.

About Past Events

Description

An ad hoc committee will plan and host a 1.5-day public workshop to examine the drug development paradigm for cancer therapy. The workshop will feature invited presentations and panel discussion on topics that may include:

  • Challenges with the traditional phased drug development paradigm in the age of targeted therapies and opportunities for using new approaches to cancer therapy development and regulatory review.
  • Best practices for cancer drug development and review (e.g., trial design, statistical approaches, ethical considerations and informed consent, industry-FDA interactions).
  • Lessons learned from recent expedited drug approval processes.
  • Evidence requirements for cancer therapies before and after regulatory approval, and the mechanisms needed to generate this knowledge (e.g., clinical trials, “real world” experiential data, combination approaches).
  • Examples of international regulatory approaches.

The committee will develop the agenda for the workshop sessions, select and invite speakers and discussants, and moderate the discussions. A summary of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.

Collaborators

Committee

Richard L. Schilsky

Chair

Amy P. Abernethy

Member

Jeff Allen

Member

Kenneth Anderson

Member

Margaret Anderson

Member

Monica M. Bertagnolli

Member

Gideon Blumenthal

Member

Hedvig Hricak

Member

Ronald M. Kline

Member

Amy McKee

Member

Rebecca D. Pentz

Member

Steven Piantadosi

Member

Mace L. Rothenberg

Member

Daniel Sargent

Member

Deborah Schrag

Member

Marc Theoret

Member

Suzanne L. Topalian

Member

Download all bios

Sponsors

American Association for Cancer Research

American Cancer Society

American College of Radiology

American Society for Radiation Oncology

American Society of Clinical Oncology

American Society of Hematology

Association of American Cancer Institutes

AstraZeneca

Bristol Myers Squibb

Cancer Support Community

Centers for Disease Control and Prevention (CDC)

CEO Roundtable on Cancer

Flatiron Health

Helsinn Therapeutics (U.S.), Inc.

LiveSTRONG Foundation

Merck & Co., Inc.

National Comprehensive Cancer Network

National Institutes of Health/National Cancer Institute

Novartis Oncology

Oncology Nursing Society

Pfizer Inc.

Staff

Erin Balogh

Lead

Sharyl Nass

Lead

Rebecca English

Cyndi Trang

Amanda Wagner Gee

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