Kim Parthum
Vice President, GRA
Principal Consultant
Kimberly Parthum, PhD, is a seasoned regulatory leader with a proven track record of successful regulatory interactions and product approvals over her 20-year career in life sciences. She possesses deep expertise in developing and executing global regulatory strategies for all phases of development, registration, and life cycle management of drugs, biologics, regenerative medicines, and gene editing products. Her experience spans a wide array of therapeutic areas, including psychiatry, neurology, pulmonary, oncology, and rare disease.
Prior to joining BBd, Kim held several leadership positions in regulatory affairs at Sumitomo Pharma America (formerly Sunovion). As the Head of Strategic Office 1, the regulatory strategic group responsible for central nervous system (CNS) and regenerative medicine products, she was responsible for more than 15 assets from early development to commercialization and managed a team of 7 regulatory strategists.
As the Global Regulatory Lead for multiple assets, including Aptiom®, Xopenex HFA®, and the company’s lead development program for Ulotaront, Kim successfully guided teams through health authority interactions, preparation of regulatory submissions including INDs, CTAs, NDAs, a successful application for Breakthrough Therapy Designation, label negotiations, NDA approvals, and renegotiation of pediatric post-marketing requirements.
Kim is a skilled leader of teams and manager of individuals and is committed to mentoring and developing regulatory professionals and fostering collaborative environments that drive organizational success.
Kim holds a PhD in Chemistry from the University of New Hampshire.
