Global regulatory strategy
Integrated pathways across FDA, EMA, and other health authorities, from early engagement through pivotal development and registration.
Profile
Connecting scientific detail with practical development decisions.
My work spans regulator, biotechnology leader, standards contributor, and advisor. I spent 15 years at FDA CBER reviewing advanced therapies, including viral and non-viral vectors, genetically modified cells, gene-edited products, and therapeutic vaccines.
I now focus on global regulatory strategy across cancer, rare disease, and autoimmune disease. My approach is to understand the product, identify the evidence that matters, and create a development path that teams can execute.
Areas of focus
Complex products require product-specific strategies.
Cell and gene therapy
Regulatory and scientific strategy for engineered cells, viral and non-viral delivery, gene editing, and therapeutic vaccines.
Manufacturing evolution
Comparability, technology transfer, process validation, and the translation of individualized N-of-1 approaches into reproducible commercial platforms.
Evidence and decisions
Connecting product understanding, clinical evidence, safety, dose, and manufacturing controls to the next consequential development decision.
Experience
Perspective from both sides of the regulatory table.
FDA perspective
Reviewed INDs, master files, and BLAs for advanced therapies. Served as chair and CMC lead for the first submitted CAR-T BLA, contributed to gene-therapy guidance, and supported international harmonization.
Biotechnology leadership
Executive experience defining global regulatory roadmaps, leading multidisciplinary teams, and connecting clinical, manufacturing, quality, and commercial considerations.
Standards and scientific communication
Leadership in advanced-therapy standards and a sustained interest in making complex scientific and regulatory issues clear, rigorous, and usable.
Current interests
RNA engineeringNon-viral cell engineeringDistributed manufacturingOncolytic immunotherapyRegulatory science
Outside work, I spend time cycling around the Washington, D.C. region and restoring older bikes.
Contact
Michael Havert, PhD
Washington, D.C. region