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Pink Sheet – US FDA Cell/Gene Therapy Office ‘Aggressively Recruiting’ Amid Reorg, Senior Staff Departures

Pink Sheet – US FDA Cell/Gene Therapy Office ‘Aggressively Recruiting’ Amid Reorg, Senior Staff Departures

Center for Biologics Evaluation and Research Director Peter Marks wants people to come work at the US Food and Drug Administration, but he also understands if they leave for industry some day.

“I don’t think we should get as crazy about people moving [from] FDA to industry, the back and forth,” Marks said at the recent Prevision Policy/Friends of Cancer Research Biopharma Congress.

“We sometimes get criticized for the idea that they come to FDA only so they can make big salaries in industry. We see people go back and forth because industry isn’t for everyone,” Marks said. “As somebody who was in industry, and back and forth, I can tell you that.”

“I don’t mind it when people go to industry, because a certain number of those will come back.” Rather than criticizing FDA staff for moving to industry, Marks is hopeful that the agency can hire those people back in the future.

Personnel issues are very much top of mind for the CBER director these days, particularly when it comes to staffing the office that handles the center’s burgeoning cell and gene therapy portfolio – an office that recently has seen a number of high-profile departures.

During the week of 20 February, the Office of Tissues and Advanced Therapies officially reorganized into a “super office” called the Office of Therapeutic Products. (See sidebar for related story.)

The new structure is aimed at reducing the strain on office management and providing better oversight for reviewers which, in turn, is expected to lead to more consistent and timely advice for sponsors, and perhaps even fewer clinical holds on investigational new drug applications.

“The super office structure allows us to have a group focused on the manufacturing of gene therapies, a group focused on the manufacturing of cell therapies, a group focused on the manufacturing of everything else, which is the recombinant products and plasma protein products that we have, and then a clinical group that can flex between the different ones,” Marks said.

Opportunity For New Leadership

However, the new super office is moving forward without OTAT’s long-time director. Wilson Bryan will retire after more than 20 years at the agency.  (Also see “FDA’s Cell, Gene Therapy Office Head Wilson Bryan Set To Retire” – Pink Sheet, 30 Jan, 2023.) Bryan’s last official day at the agency is 25 March, although he is on leave until then, he told the Pink Sheet on 27 February.

CBER Deputy Director Celia Witten has been named acting head of OTP while the FDA searches for a permanent director. (Also see “The Risk-Reward Of US FDA Leadership Running Offices Below Them” – Pink Sheet, 9 Feb, 2023.)

In his remarks at the 13 February Biopharma Congress, Bryan said he has been thinking about retiring for some time and would have done so a year or two ago but put it off because of the pandemic. Although Bryan said he stayed on for a few months to try to help with the transformation of OTAT into OTP, “ultimately the reorganization is an opportunity for someone new to come in and new leadership.”

He joins a growing list of former OTAT senior staff who departed the agency in recent months, including:

  • Rachel Anatol, former deputy director of OTAT, who joined the Biotechnology Innovation Organization in December;
  • Seven Bauer, former chief of the Cellular and Tissue Therapy Branch, who joined the Regenerative Medicine Hub in December;
  • Raj Puri, former director of the Division of Cellular and Gene Therapies and former chief of the Tumor Vaccines and Biotechnology Branch, who joined Iovance Biotherapeutics, Inc. in March 2022; and
  • Mercedes Serabian, former chief of Pharmacology/Toxicology Branch 1.

Some of the senior staff who recently left OTAT had 20 or 30 years or more of FDA experience, “and like me they just reached a point where they really just had to move on,” Bryan said.

However, the reorganization is an opportunity for younger leaders in the office, such as Denise Gavin and Kimberly Schultz, who previously headed OTAT’s two gene therapy branches, “to develop and grow with the field,” he said.

In the new OTP structure, Gavin holds the title of Gene Therapy Branch 1 director and is serving as acting director of multiple entities, including the Office of Gene Therapy CMC, Divisions of Gene Therapy 1 and 2, and Gene Therapy Branch 3. Schultz is director of Gene Therapy Branch 4 and acting director of Gene Therapy Branch 5.

‘Aggressively Recruiting’

OTAT is not only reorganizing but also recruiting extensively, thanks to funding for 125 new positions pursuant to the seventh iteration of the Prescription Drug User Fee Act, although Marks cautioned it is going to take a year or two for the new OTP “to get to the right place and staffing.”

“We’re very aggressively recruiting. But it is not easy recruiting, in part, because … just like others, we’ve been a victim of the great retirement. There are people who might have spent a few years more but they were tired out from the pandemic, or they realized because of the pandemic that they decided they would rather move on and do other things with their lives.”

“We also are dealing with the fact that in this area of cell and gene therapy, when we have well-trained people, they are very valuable to industry. And so we have people who get enticed away by better salaries.” Although the 21st Century Cures Act allowed the agency to increase salaries, those increases have not kept pace with inflation, he said.

Calling Witten a “master recruiter,” Marks said the new super office is not worried about exceeding its hiring budget.

“We know attrition occurs. And we also know that we usually have … under-burn, which is we usually don’t spend all of our money on headcount in any given year. And so if we go above, it won’t be a problem. … But it’s really critical to get staffed up because that’s the only way we’ll get back to giving the kinds of feedback that we would like to give.”

Selling CBER As A Good Place To Work

Given the sometimes significant disparity in salaries between the FDA and industry, Marks was asked how to position CBER as a place where people want to work.

“There are different areas and different ways to attract people,” he said.

For people interested in vaccines, CBER “is a wonderful place to work because in public health the vaccines that we’re working on now – not just for SARS-CoV-2 but whether it be for respiratory syncytial virus or dengue, or any number of other infectious diseases – it’s a very exciting time,” he said.

“And for people who are in infectious diseases, our salaries are very competitive. Infectious disease doctors traditionally get paid about the worst in internal medicine. And so the salaries are competitive, plus the ability to work on these areas is quite exciting.”

The COVID-19 pandemic has been a challenging time for the Office of Vaccines Research and Review, which helped expedite development and emergency authorization of vaccines in record time but faced political pressure in the process and has seen its own upheaval in office leadership.

In the cell and gene therapy space, working at the agency is “like being able to see beneath the hood of … every manufacturer’s car at the same time and know the proprietary secrets for each car at the same time. And though you can’t go out and speak about them, intellectually it’s tremendously interesting.” – FDA’s Peter Marks

Marion Gruber and Philip Krause, OVRR’s director and deputy director, respectively, left in the fall of 2021 amid disagreements with Marks and agency leadership over the speed of COVID-19 vaccine reviews and approvals.  (Also see “US FDA’s Marks Was Frustrated About Slow Completion Of 2021 Comirnaty Review” – Pink Sheet, 24 Jan, 2023.) Marks then headed up OVRR on an acting basis, with Doran Fink serving as acting deputy director. Fink had been deputy director-clinical in the Division of Vaccines and Related Products Applications.

David Kaslow, chief scientific officer of PATH, took over as the new director of OVRR in October 2022. Fink left the agency in December. The agency said it currently is in the process of filling the DVRPA deputy director-clinical and OVRR deputy director positions.

“I think now that some of the temperature has been taken down around some of the controversy of getting these vaccines to people, hopefully that will also take away some of the pressure that was there,” Marks said. “There was a lot of swirl that had to do with politics getting mixed up with science and medicine that did not help.”

In the cell and gene therapy space, working at the agency is “like being able to see beneath the hood of … every manufacturer’s car at the same time and know the proprietary secrets for each car at the same time. And though you can’t go out and speak about them, intellectually it’s tremendously interesting.”

“The fact that you can take the different pieces and actually move things forward more rapidly by helping companies avoid mistakes, without telling them obviously that somebody else has gone down the wrong path, I think that’s what we’re about,” Marks said. “I think it’s a really intellectually stimulating place for people to be.”

Expanded Bandwidth To Decrease Clinical Holds

Marks is optimistic that increased OTP staffing will enable better, more timely interactions between FDA review staff and sponsors in the 30 days after an IND is filed, which could resolve issues without the need for a clinical hold.

There are multiple causes for the high number of clinical holds in the cell and gene therapy space, Marks said.

“There are a lot more clinical trials coming along. There are a number of sponsors that are not well experienced in the cell and gene therapy space,” he said. “We see a variety of different types of INDs that come in … some of which are missing key pieces. And sometimes those can be fixed with interactive discussions during the 30 days, but 30 days is not a lot of time.”

He contrasted the situation of an IND from an inexperienced sponsor that lacks a manufacturing section, from that of a more experienced sponsor with issues that are easier to resolve.

“There are some cases where we have bona fide sponsors who have issues that probably could be resolved with interactive review where we just haven’t had the bandwidth,” Marks said. “Having increased bandwidth would be a good thing. I can’t say that that’s going to fix all of it, but it would reduce this somewhat. And that’s again a goal to get to.”

“The issue is 30 days is not a lot of time. By the time we sometimes figure out what’s going on, it’s close to the end of those 30 days. And so it’s a matter of trying to have that that discussion pretty swiftly. Hopefully we’ll get staffed up so that can happen.”

Derrick Gingery contributed to this story.