Paul Gesellchen, Ph.D., RAC

Dr. Paul Gesellchen is currently an independent consultant in all aspects of non-CM&C regulatory affairs (2006 to 2011).  His most recent full-time job function was as Vice President of Regulatory Affairs at Targanta Therapeutics Corporation (2006 to 2008) where he guided the regulatory strategy for submission of FDA and EMEA marketing applications for a proposed new injectable antibiotic for complicated skin and skin structure infections.

Prior to this period, Dr. Gesellchen worked at Eli Lilly and Company for 29 years (1977 to 2006), spending his final 16 years in the Regulatory Affairs Department and retiring in 2006 as Senior Scientific Director of Regulatory Affairs.  In his regulatory affairs function he was the liaison between Lilly and the FDA for new drug candidates, primarily in the endocrine therapeutic area (growth, diabetes, and osteoporosis).

Dr. Gesellchen received a BS in Chemistry from the University of Nebraska (1970) followed by a PhD in Pharmaceutical Chemistry from the University of Wisconsin (1977).  He held a postdoctoral position in the Biochemistry Department of the Indiana University Medical School (1976 to 1977).

He has made numerous presentations on regulatory affairs topics at Lilly and Targanta as well as at national DIA meetings.  Paul is a member of DIA, RAPS, ACS, is a life member of Sigma Xi, and has been Regulatory Affairs Certified for over 12 years.

CORE COMPETENCIES

• All aspects of non-CM&C Regulatory Affairs
• Interpretation of FDA policy and guidance,
• Regulatory strategy for US IND and NDA applications,
• Planning and strategy development for FDA meetings (e.g., Pre-IND, EOP2, and Pre-NDA meetings),
• Detailed review of regulatory documents (protocols, final reports, cover letters, etc),
• US label development (e.g., physician and patient package inserts, cartons, and vials),
• Planning and strategy for FDA Advisory Committee meetings,
• US promotional marketing materials process and review,
• Some experience with EU marketing authorization submissions and strategy,
• Primary therapeutic area experience: Endocrine, Infectious Disease, Oncology.