CDER Appoints Long-Time Industry Expert as New Deputy Center Director

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is getting a new deputy center director for its Science Operations team, the agency has announced.

The 12 February 2012 announcement was emailed internally to staff and obtained by Regulatory Focus through a reliable source.

The new deputy director, Richard Moscicki (reportedly pronounced mo-shis-ke), previously served as head of clinical development at Genzyme Corporation, which is now owned by Sanofi.  Moscicki had been with Genzyme since 1992, and was SVP of biomedical and regulatory affairs from 1996 until 2011.

Woodcock praised Moscicki, calling him "inclusive in his management style [and] credited with implementing solid business practices to sustain [Genzyme's] long-term operations."

"His medical, academic, clinical, and regulatory knowledge and expertise - coupled with his strong leadership and organizational management qualifications - make him the ideal candidate for this important position," Woodcock said.

Industry Experience Meets Agency Experience

Moscicki joins a team of CDER officials who have been at the agency for decades. Janet Woodcock, director of CDER, joined the agency in 1986. Bob Temple, so-called "dean of drug development" and deputy director of clinical science has been at FDA since 1972. Douglas Throckmorton, deputy director of regulatory programs at CDER, has been at the agency since 1997.

As part of that senior team, he will "share in executive direction of [CDER] operations and provide leadership in overseeing the development, implementation and direction of our programs," Woodcock said.

It is not clear if any FDA staff were removed to make way for Moscicki, or if he is heading up a new section. FDA's organization chart does not list "Science Operations" as an operational area, raising the possibility that he will be forming a cross-office functional area. 

Update: An FDA spokesman just confirmed to Regulatory Focus that this is a "new position," but was not able to provide additional details regarding Moscicki's start date, number of staff, or authority.

A former colleague to Moscicki called the move, "good news for industry." Genzyme is heavily focused on rare diseases, and Moscicki's first-hand industry knowledge of manufacturing difficulties related to the 2011 disruption of Fabrazyme (agalsidase beta), a treatment for Fabry disease, may be of assistance to the center as it continues to grapple with drug shortages throughout the industry.

In addition to working at Genzyme, Moscicki has also taught at Harvard Medical School since 1979, and was previously a staff member at Massachusetts General Hospital.

More: Moscicki on lysosomal diseases on YouTube.