Riding Moonshot, FDA Will Revamp Its Cancer Practice. To What End?

those involved in oncology medical product development and review across centers to hear their ideas for the OCE and how we can work together to enhance our efforts across the agency.”

Pazdur, who recently lost his wife to ovarian cancer, is keenly aware of the need for new approaches in a coming age of “N of 1 medicine,” said Lippman, referring to cancer treatments pinpointed at ever-smaller patient populations. Lippman knows Pazdur from their days at The University of Texas MD Anderson Cancer Center in Houston, where Pazdur was a top administrator and Lippman was chair of the thoracic and head-and-neck cancer department. More recently, they served together on a National Cancer Institute advisory panel. Lippman said one of Pazdur’s favorite open-ended questions was that, with ever more personalized treatments, how many patients would need to be tested with an experimental drug before it’s considered safe?

The day-long summit in Washington was mirrored by more than 200 gatherings around the country meant to pump up enthusiasm for the initiative—the White House is seeking $1 billion in funding—serve as a backdrop to several announcements, and to gather ideas from participants. Helping, or forcing, researchers to share data from lab experiments and from clinical trials was another big theme. The day also served to highlight pilot programs and partnerships with other government agencies, private companies such as IBM, GlaxoSmithKline, as well as much smaller companies. The goal is to use massive computer power to better understand cancer biology and past treatments, develop new treatments, and make faster diagnoses.

FDA reorganization in the name of urgency and efficiency is an idea with some bipartisan political backing. One piece of the 21st Century Cures Act calls for the FDA to create “intercenter” groups focused on specific disease areas. The moonshot funding is wrapped up in the legislation, which passed the House a year ago but is now fragmented into separate bills. It faces an uphill climb in the Senate, because of funding fights and Congressional summer sessions curtailed by election-year campaigns.

Author: Alex Lash

I've spent nearly all my working life as a journalist. I covered the rise and fall of the dot-com era in the second half of the 1990s, then switched to life sciences in the new millennium. I've written about the strategy, financing and scientific breakthroughs of biotech for The Deal, Elsevier's Start-Up, In Vivo and The Pink Sheet, and Xconomy.