FDA leaders worry agency will lose out on talent in gene therapy, cancer fields – BioPharma Dive

Posted: October 8, 2019 at 1:46 am

Food and Drug Administration leaders are concerned the agency won't be able to recruit and retain sufficient numbers of experts in fields that have undergone rapid scientific advances, such as cell and gene therapy or oncology.

In cell and gene therapy, the relevant FDA review unit aims to double in size over the next three to five years, competing with biopharmaceutical companies and venture firms for the same talent.

"Sometimes they're competing to actually pick people from our agency that's always fun," Peter Marks, director of the FDA's Center for Biologics Evaluation and Review, said Monday at the Biopharma Congress in Washington. "We're dealing with the issue of a very competitive job market."

Former agency head Scott Gottlieb, speaking at the same event, called recruitment and retention "an unrecognized challenge for the FDA."

In some respects, the FDA finds itself disadvantaged in enticing candidates who are in demand to fill high-paying private sector jobs. Congress acknowledged as much in the 21st Century Cures Act, a law passed in December 2016 that, among many other things, granted the regulator authority to pay some positions annual salaries of up to $400,000.

Marks said that flexibility will partially help address hiring problems, but doesn't see the issue going away, particularly given the anticipated expansion of the FDA's cell and gene therapy unit.

"We'll use that to the maximum, but it's going to continue to be a bit of a challenge," he added.

Other FDA leaders at Monday's event brought up alternative ways they hope to keep talent at the agency.

Gideon Blumenthal, the deputy director of the FDA's Oncology Center of Excellence, said they've shifted to a more academic model for the unit's roughly 100 medical oncologists.

A scientific liaison program encourages those FDA employees to take on more beyond the day-to-day review work. With it, those reviewers can become the agency's point person for a specific topic, such as breast cancer, melanoma or a research topic like health disparities, Blumenthal said.

"This is something we are really trying to push," he added. "We think it'll benefit not only the external community in understanding the FDA and oncology, but it'll help retain and attract the base talent, because not only are they reviewers, but they are really thought leaders in their fields."

In fast-moving fields, the FDA has also had difficulty filling its advisory committees with relevant, non-conflicted experts.

Janet Woodcock, a longtime FDA official and director of the Center for Drug Evaluation and Research, pointed to conflicts of interest policies as a sticking point.

"The ACs just have so many rules and lawyers ... it's really difficult to get people with the greatest expertise," she said Monday.

CBER's Marks agreed, adding that growth in rare disease drug development has made finding the right people more onerous.

"The conflict rules become so difficult that what you end up putting together is something that gets watered down ... to the point that you really can't have a discussion that's actually meaningful."

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FDA leaders worry agency will lose out on talent in gene therapy, cancer fields - BioPharma Dive

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