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.
- 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.
- Baker & McKenzie, Partner
- Olsson Frank Weeda Terman Matz, Of Counsel
- Greenberg Traurig, Shareholder
- Office of the Commissioner, US Food and Drug Administration Director, Policy Research Staff
- University of California Berkeley, Academic Faculty
HONORS AND AWARDS
- Public Health Service Recognition Award
- Commissioner’s Special Citation
PRO BONO AND COMMUNITY INVOLVEMENT
- Grantee, Bill and Melinda Gates Foundation
- Grantee, Biomedical Advanced Research and Development Authority, US Dept of Health and Human Services
- Grantee, US Department of Defense Biomedical Command
- Board Member, Forman School for Educationally Handicapped Students
RECENT PUBLICATIONS AND SPEECHES
- Author, Chapter 3-13 Application, Review, Approval and Complete Response Letters in Bringing Your Pharmaceutical to Market (Food and Drug Law Institute)
- Speaker, Regulatory Hurdles to Marketing Authorization for Medical Devices (NAMSA 2019)
- Speaker, Overview of Drug Regulation for Course of Drug Regulation (FDLI 2018)
- Speaker, New Initiatives in Bioresearch Monitoring (BiMo) (San Francisco Medical Device Conference (2018)
- Speaker, New Developments in Regulation of Drug Marketing (FDLI 2018)
- Speaker, Marketing and Approval Pathway for Biosimilars (FDLI 2018)
- Speaker, Update on Substandard Products and Distribution Controls (2017)
- Speaker, Medical Device Investigations (Philadelphia MAGI 2017)
- Speaker, Introduction of Director Jeff Shuren (FDLI 2016)
- Speaker, Preparing for Clinical Site Investigations (Las Vegas MAGI 2016)