White Oak BioPharma Solutions is an international consulting firm focused on providing healthcare companies with strategic guidance on development, registration, and commercialization of therapeutic and device products. The company is based on a network of experts that deliver innovative and asset-enhancing solutions across the R&D spectrum, including core functions such as:
Pharmacovigilance and Safety
Manufacturing & CMC
Quality & Compliance
White Oak BioPharma Solutions also advises clients on strategic business development, external/scientific affairs, and legislative issues. Located 30 minutes from the FDA’s White Oak campus in suburban Maryland, the company is conveniently located near government agencies and 3 major airports.
White Oak BioPharma Solutions was founded in 2006 by Libbie Mansell, PhD, MBA, RAC to meet the needs of healthcare companies with high potential molecular assets but limited development resources. Prior to founding White Oak BioPharma Solutions, Dr. Mansell held positions of increasing responsibility in biotech and pharma industries for over 21 years. Her career has spanned both large pharma companies and innovative start-ups and includes executive leadership roles in both domestic and international product development. Dr. Mansell focused on ensuring successful development and registration of product candidates and commercialization of needed medicines, including Relafen, Nimbex, Navelbine, Campath, and Velcade. She currently has additional products under FDA and EMEA review.
Dr. Mansell earned a Ph.D. in Pharmacokinetics and Biopharmaceutics with a graduate-level minor in Applied Statistics from Oregon State University and an M.B.A. in Finance and International Business from New York University's Stern School of Business. She maintains Regulatory Affairs Certification and is active in several scientific and healthcare-related organizations.
White Oak BioPharma Solutions...
...leading the business of product development for our pharma and biotech partners