The Cancer Letter

The leading source for information on the issues that shape oncology since 1973

Guest Editorial

OCE’s Project 5 in 5 seeks to inspire pragmatic innovation

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print
BYLINE
IN THIS ISSUE
BYLINEDOWNLOAD PDFTABLE OF CONTENTS

If the FDA Oncology Center of Excellence (OCE) began an “innovation challenge” in oncology drug development, what would that look like? 

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe
Byline
Steven C. Cunningham, MD, MLA, FACS
Clinical reviewer, Gastrointestinal Cancers Team, Division of Oncology 3, CDER, FDA
Donna R. Rivera, PharmD, MS
Associate director, Pharmacoepidemiology and Oncology RWE, Oncology Center of Excellence, FDA
Richard Pazdur, MD
Director, Oncology Center of Excellence, FDA
Kelly J. Norsworthy, MD
Associate director, Research Mentorship, Oncology Center of Excellence, FDA
Jennifer Gao, MD
Associate director, Education, Oncology Center of Excellence, FDA
Table of Contents

YOU MAY BE INTERESTED IN

Regulatory News

Cyber-iconoclast Vinay Prasad named head of FDA’s CBER
An oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies

Vinay Prasad, a MAHA-aligned hematologist-oncologist with an avid cyber following, was named director of the FDA Center for Biologics Evaluation and Research, where he will be responsible for the agency’s regulation of vaccines and biologics, including cell and gene therapies.
By Claire Marie Porter
Regulatory News

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Commissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas

In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models. 
By Claire Marie Porter
Byline
Steven C. Cunningham, MD, MLA, FACS
Clinical reviewer, Gastrointestinal Cancers Team, Division of Oncology 3, CDER, FDA
Donna R. Rivera, PharmD, MS
Associate director, Pharmacoepidemiology and Oncology RWE, Oncology Center of Excellence, FDA
Richard Pazdur, MD
Director, Oncology Center of Excellence, FDA
Kelly J. Norsworthy, MD
Associate director, Research Mentorship, Oncology Center of Excellence, FDA
Jennifer Gao, MD
Associate director, Education, Oncology Center of Excellence, FDA
Table of Contents

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login

Site license subscribers:
Log in with your IP | Register a sponsored account