Jur Strobos

Dr. Jur Strobos has spent more than 30 years providing legal, regulatory, strategic development, management, and policy advice to life science companies that manufacture, import, or sell medical products (drugs, devices, biologics, cell and gene therapy, human tissues), foods, cosmetics, tobacco regulated by the US Food and Drug Administration (FDA) or comparable international authorities. Dr. Strobos is a medical doctor and a credentialed federal law enforcement officer. He previously served as a legal, regulatory, and policy official in the Commissioner’s Office at FDA.

During his legal practice, Dr. Strobos has had the opportunity to work as a senior executive directly in charge of clinical and regulatory development at 5 start-ups and as the VP Clinical and Regulatory Affairs at a NYSE-traded company. His work as an executive has resulted in approval of 5 new drugs, 2 premarket-approved medical devices, a cell therapy and a biological product. This work – as with his legal work – included strategic policy and evaluation of in-licensing, out licensing, merger/acquisition, and joint development. Dr. Strobos also worked for the Bill and Melinda Gates Foundation to assist and support the approval, by FDA, EMA, and numerous other international regulatory authorities of Pre-Exposure Prophylaxis for HIV. Dr. Strobos started a graduate level course in drug development at the University of California, Berkeley at this time, which he continued to teach until 2017. Dr. Strobos has numerous publications on drug development, clinical trial design, statistics, and pharmacovigilance.

Along with legal and regulatory work, Dr. Strobos also supports and has intimate expertise with mergers and acquisitions, licensing, and joint ventures. He is particularly adept, based on this wide-ranging experience including at FDA, in developing creative solutions to regulatory impediments that could delay marketing authorization on both sides of the Atlantic, and more recently in the Asia Pacific. He can assist with inspectional readiness, compliance agreements, delegation subcontracts with clinical sites, research and manufacturing organizations, Sunshine Act, False Claims Act, promotion, and food safety, among others.

Representative Experience

• Acquisition by Servier of Shire’s oncology practice and creation of a US regulatory program as part of Servier’s entry into the US.
• Obtain re-assignment of a combination product to device regulation only.
• Opening of worldwide expanded access program for Astellas.
• Management of potential General Data Protection breach for worldwide pharma company.
• Secure regulatory approval of proposed labeling for Macrilen®.
• Drafting of Pre-Market Tobacco Master File.
• Prepare regulatory response to FDA Form 483 and potential consent decree for topical sunscreen.
• Prepare response to FDA investigation of alleged foodborne outbreak of l. Monocytogenes.
• Advise on US joint venture for immunological product for psoriasis from Korean company.
• License negotiations with Stanford University.
• Regulatory analysis of medical data informatics and artificial intelligence diagnostic.
• Support recall of infant child seats.
• Analysis of impact of Drug Quality Security Act on state regulation of drug and ephedrine distribution.
• Analysis of safety of proposed ingredients for deodorant and drying agent.