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# ‘Fabulous’ Science is ‘Not Enough’: Woodcock
- URL: https://www.fdaweb.com/fabulous-science-is-not-enough-woodcock/
- Published: 2019-09-11T12:00:00.000Z
- Updated: 2026-09-15T01:49:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144973

CDER director **Janet Woodcock** told 150 researchers at the Breakthroughs in Medicine conference 9/6 that there is a need for major reforms in scientists’ relationships with regulators, doctors, and one another. And without a wide-ranging overhaul, she cautioned, lab successes won’t make it to the patients who need them most. “I don’t want to bum everyone out,” she said. “The science is fabulous, but that’s not enough.”

Woodcock said the goal is not to improve knowledge and not to gain FDA approval. “The goal is to improve human health,” she declared. “Is the guy living under the bridge going to get a $2 million CAR-T cell curative therapy? If that guy can’t get the drug, then we’ve failed.”

She noted that the current structure of academic research discourages collaboration and it is necessary to reconsider grant review processes, promotion criteria, and even the concept of tenure.

And, she said, the process of creating and commercializing a drug has been hindered by corporate secrecy. When science is valuable and not to be shared, she said, drug trials are fragmented and costly. And important clinical questions go unanswered if they don’t have obvious commercial gain.

The most significant concern she addressed was patient access. Woodcock said that while other industries focus on making their products cheaper, in the pharmaceutical industry high failure rates and expensive clinical trials have led to drugs far beyond the financial reach of those in need.

She urged the researchers to leverage big data, such as electronic health records, to study things such as cardiovascular illness, addiction, and antimicrobial resistance with efficient, universal protocols. And she encouraged them to incorporate practicing doctors in the research process.

“You can’t just develop breakthroughs and then throw them over the wall to practitioners,” she said. “We need the whole system to evolve and change if we’re going to do what we set out to do — help every patient feel better and live longer.”