FDA has recruited another industry executive for a top leadership position, this one in the Center for Drug Evaluation and Research.

Richard Moscicki, Genzyme Corp. senior VP and head of clinical development, has been named CDER deputy center director for science operations.

CDER Director Janet Woodcock announced the hiring in a memo to staff released Feb. 12. The agency would not release his start date.

In the newly created position, Moscicki “will share in executive direction of center operations and provide leadership in overseeing the development, implementation and direction” of agency programs, Woodcock said in the memo.

Moscicki (pronounced Mo-shis-ke, according to the memo) becomes the third deputy center director alongside Deputy Director for Clinical Science Robert Temple and Deputy Director for Regulatory Programs Douglas Throckmorton.

Moscicki began at Genzyme in 1992 as medical director. He was named chief medical officer and senior vice president of biomedical and regulatory affairs in 1996, which he held until 2011. While with the company, Moscicki handled global regulatory and pharmacovigilance issues, along with clinical research and medical affairs, according to the memo.

He worked on Genzyme’s drug Campath (alemtuzumab), which was originally approved in 2001 and now is being phased out in the oncology setting Also see "Genzyme Reports Interim Data From Troubled Campath Study" - Pink Sheet, 14 September, 2006.. The product, now known as Lemtrada, was submitted to FDA in 2012 for use in multiple sclerosis ([A#14130207004]).

Woodcock also said among his strengths as a candidate for the position was his medical, academic, clinical and regulatory knowledge.

Moscicki also attended Northwestern University Medical School and is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He remains on the Massachusetts General Hospital staff, where he completed a four-year fellowship in immunology and immunopathology, as well as the Harvard Medical School faculty, according to the memo.

Moscicki’s experience with clinical development should help FDA as it implements changes to the accelerated approval pathway, the new breakthrough therapy designation and other programs intended to help speed clinical trials and development programs.

The FDA Safety and Innovation Act, which was enacted in 2012, reauthorized the prescription drug user fee and other programs and also mandated the accelerated approval changes and created the breakthrough designation.

Breakthrough, in particular, is designed to streamline the development of candidates showing a dramatic improvement over existing therapies in early testing. Products with the designation could see early senior agency leadership involvement and abbreviated clinical trials Also see "Industry Wants A Breakthrough Therapy, Even Without All The Standards" - Pink Sheet, 29 October, 2012..

Moscicki should have some influence as FDA creates the regulations governing the designation.

The first designations went to Vertex Pharmaceuticals Inc.’s cystic fibrosis therapy Kalydeco Also see "FDA’s First Breakthrough Designations Continue Vertex Kalydeco’s Regulatory Successes" - Pink Sheet, 7 January, 2013..

Recent Leadership Posts Filled With Industry Veterans

Moscicki also continues a recent trend of FDA filling top leadership positions with outside industry officials, rather than long-time regulators or academics.

After Stephen Spielberg announced he would leave his position as deputy commissioner for medical products and tobacco, Commissioner Margaret Hamburg promoted Leona Brenner-Gati to take over the position on an acting basis.

Brenner-Gati joined the agency in late September 2012 after spending much of her career in the private sector, including 17 years at Johnson & Johnson.

Spielberg also had an industry background upon joining the agency Also see "Spielberg’s Replacement At FDA Also Will Have Strong Industry Ties" - Pink Sheet, 23 January, 2013..

In addition, Gregory Geba was named director of the Office of Generic Drugs in July 2012. He was a former executive at Sanofi US and several other companies Also see "FDA Office Of Generic Drugs Director Has Brand Industry Background" - Pink Sheet, 13 July, 2012..

Industry Perspective Needed At FDA?

The trend may represent an FDA desire to bring in leaders that have experience managing large numbers of employees and first-hand knowledge of industry needs.

Woodcock specifically mentioned the agency’s growth to more than 4,000 employees, as well as Moscicki’s reputation for having an “inclusive” management style, in the memo.

She also said in the memo that Moscicki is credited with implementing “solid business practices to sustain the company’s long-term operations.”

CDER is growing rapidly, in part through the creation of new user fee programs for biosimilars and generic drugs.

Geba was hired on the cusp of an OGD growth spurt, thanks to enactment of the generic drug user fee program. The office is expected to add 950 new staff members through fiscal year 2015 to handle the GDUFA commitments Also see "GDUFA Self-Identification Woes Can’t Deflate Industry, FDA Enthusiasm" - Pink Sheet, 17 December, 2012..

Editor’s note: This story was updated to correct an error about the status of Lemtrada.

CDER Taps Genzyme Exec As Deputy Director For Science Operations

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