Todd Phillips, PharmD, RAC

Principal Scientist, Regulatory Affairs and Product Development

Todd Phillips, PharmD, RAC, is Principal Scientist, Regulatory Affairs and Product Development for Cardinal Health Regulatory Sciences.

Role responsibilities

Dr. Phillips provides strategic development and regulatory consulting services to a variety of drug and biological product manufacturers. He manages the preparation of New Drug Application (NDA) submissions and leads project teams participating in FDA meetings (pre-Investigational New Drug [pre-IND], end-of-phase 2 [EOP2] and pre-NDA). Dr. Phillips also manages the preparation of product development and gap analysis reports and prepares regulatory documents, including Orphan Drug Designation Requests.

Professional experience

Dr. Phillips has more than 12 years of experience in regulatory affairs, drug development, clinical project management and product marketing. His experience has been gained as a regulatory project manager at FDA, in varying positions in the pharmaceutical industry with Novartis Pharmaceuticals and Quintiles and from working in consulting environments.

Therapeutic experience

Dr. Phillips’ therapeutic experience includes gastroenterology, infectious disease, oncology, medical imaging, dermatology, women’s health, endocrinology, neurology, arthritis and rare diseases.

Professional affiliations

Dr. Phillips is a member of the Regulatory Affairs Professionals Society (RAPS).

Education

Dr. Phillips received a doctorate in pharmacy from the University of Missouri–Kansas City. Upon graduation, Dr. Phillips completed a two-year clinical research and marketing fellowship at Novartis Pharmaceuticals (Rutgers University).

Areas of Expertise


Orphan drug development and designation

FDA expedited programs

Regulatory affairs

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