FDA Seeking New Talent to Handle Gene Therapy Rise
Agency hopes to attract more seasoned expertise in manufacturing; also looking to add field inspectors.
A top priority this year for dealing with the surge in development of new cell and gene therapies (CGTs) is for the Center for Biologics Evaluation and Research (CBER) to attract hundreds of talented and experienced scientists to the agency. CBER Director Peter Marks recognizes the difficulties in recruiting and retaining staff with limited salary levels and relatively flat funding expected from Congress. While CBER increased staff by 126 new hires last year in its CGT office, it also suffered from “the great retirement” that has plagued FDA overall, plus high demand in industry for employees with the experience and skills also sought by FDA.
CBER’s new super Office of Therapeutic Products (OTP) is up and running, featuring a broader structure and room for additional staff, particularly individuals with experience in biotech manufacturing, statistics, and epidemiology, as well as medical reviewers. A “key need,” Marks explained in a webinar sponsored by the Alliance for a Stronger FDA last week, is to attract more seasoned people, particularly those with expertise in manufacturing, to provide the kind of timely, accurate information that industry needs.1 Such mid-career people with knowledge of manufacturing issues, moreover, are particularly critical for CBER to help train more junior staffers, he explained.
Marks observed that the “new economy,” which permits employees to take new jobs without relocating, has been helpful to FDA in attracting new hires from other areas. But at the same time, this shift enables industry to lure away experienced FDA staffers by offering similar flexibilities. In response, Marks recognizes that FDA has to look beyond salaries and to highlight the diversity and opportunities of the workplace to attract people to FDA.
Meanwhile, FDA’s drug review office is making visible progress in filling empty jobs, reported Patrizia Cavazzoni, director of the Center for Drug Evaluation and Review (CDER), in another Alliance webinar last week.2 A main factor is CDER’s success in reducing attrition in current staff to achieve net gains. Compared to last year, CDER has hired over 270 staffers (vs. 140 the previous year) and lost only 150 employees, compared to a loss of around 180 at this time last year—for a net gain of about 120 staffers through February of this year. Cavazzoni noted important increases in challenging areas such as medical officers, as well as individuals with experience in quantitative sciences.
CDER still has a considerable pay gap in hiring compared to the private sector, Cavazzoni said, acknowledging that “everyone is competing for talent.” Both Marks and Cavazzoni cited the importance of provisions in the 21st Century Cures Act and recently renewed user fee legislation for providing added resources and authority for FDA to offer higher salaries to individuals with needed experience and qualifications. Even so, the agency struggles to compete with the private sector for “really good people,” said Marks.
FDA also needs more field inspectors, in the US and overseas, Cavazzoni noted, as the agency looks to restart foreign inspections and to catch up on the many surveillance inspections that were not done over the past three years. While FDA has sufficient resources in this area, she acknowledged visible attrition in the field force. We “really have to ramp up hiring for investigators,” Cavazzoni observed, particularly for drug products. “So here’s my advertisement,” she said. “if you want to be an investigator at FDA, please come and talk to us because we need more staff.”
Jill Wechsler is ACT's Washington Correspondent and can be reached at jillwechsler7@gmail.com.
References
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
