Executive Summary

Peter Stein is a familiar face within OND and has been working alongside CDER Director Janet Woodcock on the proposed “modernization” of OND. As a previous recruit from outside FDA, Stein has had time to make the key connections and adjustments to working inside government.

The US FDA’s Center for Drug Evaluation & Research is wrapping up its two-year search for a permanent director of the Office of New Drugs, with an official announcement expected in early December.

While no announcement has been made either internally or outside FDA, the current Office of New Drugs deputy director, Peter Stein, appears poised to become full director.

In many ways, Stein is the obvious choice. As deputy director of OND for the past two years, he is well-tuned to the current structure and leadership within the review offices and divisions – and he has worked closely with CDER Director Janet Woodcock on the design of the proposed reorganization and “modernization” of the Office of New Drugs. (Also see “Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions ” – Pink Sheet, 4 Jun, 2018.)

Woodcock has been leading both the search and OND itself since the retirement of long-time director John Jenkins in January 2017. Woodcock is understood to have interviewed several candidates for the position, eventually narrowing her search down to Stein and an industry executive. In choosing Stein, Woodcock is going with a previous recruit from outside the agency (Merck) who has had time to make the key connections and adjustments to working inside government.

Peter Stein

By many accounts, Stein is thoroughly enjoying his time in government service – a sentiment he himself strongly articulated during a panel discussion on the “New OND” at Prevision Policy’s fourth annual Biopharma Congress on Nov. 14. When asked, Stein declined to comment on whether he would like the top job at OND, but expressed enthusiasm for his current position, and added that he expects to close out his career at FDA. (He also noted that he has no plans to end his career soon.)

In one public sign that an announcement may be imminent, Woodcock’s colleague, Oncology Center of Excellence Director Richard Pazdur, commented twice during the Biopharma Congress and the Friends of Cancer Research annual meeting the day before that that she was “down to one job.”

That, of course, is not quite official yet, but an internal Office of New Drugs town hall, initially scheduled for Nov. 5 but postponed for a date in December, could provide an opportunity for leadership to announce both an update on the modernization process – and, perhaps, the agency’s pick to lead the office.

Tested Early at FDA

Stein is still relatively new at FDA: he joined the agency just two years ago from Merck Research Laboratories, where he was VP for late-stage development, diabetes and endocrinology. The appointment was considered a big win for the agency, which has had trouble attracting and retaining candidates from industry. (Also see “Merck R&D Exec Jumps To US FDA As Office Of New Drugs Deputy Director” – Pink Sheet, 8 Nov, 2016.)

Stein was tested early as deputy director of OND: he was still settling into his job when Jenkins, his direct supervisor, announced his move to the private sector just a few weeks after Stein joined the agency. Jenkins subsequently joined the consulting firm Greenleaf Health. (Also see “Jenkins’ Retirement From US FDA Was Several Years In The Making” – Pink Sheet, 6 Dec, 2016.)

Less than a year later, when Richard Moscicki (CDER deputy director for science operations) left FDA for the Pharmaceutical Research & Manufacturers of America, Stein became the highest ranking CDER official with extensive within industry experience. (Also see “Moscicki, One Of US FDA’s Industry Connections, Moves To PhRMA” – Pink Sheet, 30 Aug, 2017.)

Since then, Pfizer Inc.’s Patrizia Cavazzoni has been named CDER deputy director of operations. (Also see “US FDA Taps Pfizer Executive For CDER Deputy Director Slot” – Pink Sheet, 1 Feb, 2018.)

Stein quickly became the “face” of OND after Jenkins’ departure. He appears frequently at industry conferences, including the last two Biopharma Congress conferences (co-hosted by Prevision Policy and Friends of Cancer Research) to discuss the coming changes to OND. Most recently, he joined a panel of top FDA officials to discuss the future of expanded access at a Reagan-Udall meeting at FDA headquarters in White Oak on Nov. 19.

In public, Stein displays a similar calm, organized demeanor that characterized his predecessor, Jenkins. That is probably a good outward image to portray over the large complicated operation that is OND. His flat, uninflected style, while also warm and avuncular, gives room for the individual division directors within his operation to be outgoing and passionate about the fields they manage.

OND Modernization Is Coming

Naming a permanent OND director will be an important step as the agency prepares to implement its massive reorganization and modernization of the office.

The OND modernization involves a significant expansion in the number of review divisions, as well as process modifications intended to improve consistency and efficiency. The package is still preliminary and needs final sign-off from the Office of Management & Budget and Congress. That process takes time, and final approval is not expected until late summer or early fall 2019. (See org charts for the most recent proposed structures.)

The reorg will also centralize two important functions within OND that previously had been dispersed among the review divisions: product management (expected to be headed by Jennifer Mercier) and pharmacology-toxicology (expected to be headed by Karen Davis-Bruno). Centralizing and elevating those functions are intended to improve consistency among the review divisions, Stein explained at the Biopharma Congress.

OND already has a new Office of New Drug Policy up and running, headed by Keith Flanagan with a staff of 40. In staffing that office, FDA pulled from a number of disciplines across OND, including labeling and guidance development. Having a policy office “right next to us” will help provide consistency in policy decisions, Stein said.

One addition to the leadership of the policy office is expected to be Jim Smith, currently a medical officer in the immediate office of OND. Smith and Stein both have backgrounds in endocrinology; Smith was previously deputy director in the Division of Metabolism and Endocrinology Products.

CDER has internally announced office-level transition heads, with division-level heads expected to be named in January. Based on the proposed organizational chart and the current leaders in each therapeutic category, it would not be surprising to see the following officials leading the transition of their respective offices.

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