Diane M. Beatty, PhD

Managing Director, Regulatory Affairs and Product Development

Diane M. Beatty, PhD, is Managing Director, Regulatory Affairs and Product Development, for the Regulatory Sciences group of Cardinal Health Specialty Solutions. 

Role responsibilities

Dr. Beatty is responsible for managerial, business and technical aspects of the regulatory affairs and product development group, which provides nonclinical, clinical and regulatory affairs consulting services.

Professional experience

Dr. Beatty has more than 20 years of experience in the formulation of scientific and regulatory strategies for pharmaceutical drug, biologic and medical device development programs. Prior to joining Cardinal Health in 1998, she was a product manager at Molecular Probes, Inc., where she led new product introduction from concept to packaged product and served as a technical liaison between company scientists, collaborators and clients. Previously, Dr. Beatty was with the School of Biological Sciences at the University of Missouri-Kansas City (UMKC), where she managed laboratory personnel and research activities in the fields of biochemistry, cell biology, physiology, pharmacology, neuroendocrinology, molecular biology and analytical instrumentation. She is also a regular lecturer at regulatory and pharmaceutical development workshops and seminars.

Therapeutic experience

Dr. Beatty’s therapeutic experience includes analgesia, anti-infection, cardiovascular, dermatology, endocrinology, infectious diseases, neurology, nutraceuticals, oncology, over-the-counter, psychiatry, rheumatology, skeletal, special pathogens and medical device products. She is also an industry expert on orphan drugs and the FDA expedited programs.

Professional affiliations and awards

She received the 2010 UMKC Alumni Achievement Award and is an executive member of the Alumni Association Board. She is also a member of the American Society of Clinical Oncology and the American Society of Hematology.

Education

Dr. Beatty received her doctorate in chemistry/biochemistry and a bachelor’s degree in biology with a minor in chemistry from UMKC.

Areas of Expertise


Orphan drug development and designation

FDA expedited programs

Pharmaceutical product development

Regulatory affairs

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