Currently working on.
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The 351(a) BLA pathway for mesenchymal exosomes
Pre-IND submission preparation, CMC documentation strategy, and INTERACT meeting positioning for Wharton's jelly mesenchymal stem cell exosome biologics on the FDA biologics pathway.
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Targeted Osmotic Lysis clinical positioning
Working with an academic medical foundation to advance the TOL platform. TOL is investigational. It has not been approved by the FDA for any indication and it is not available as a treatment.
- Exosome and mesenchymal stem cell-derived extracellular vesicle products are not approved by the FDA for any indication. References here describe investment focus and published scientific literature. They do not describe an available treatment. Targeted Osmotic Lysis is investigational. It is not approved by the FDA for any indication, it has not been shown to be safe or effective in humans, and it is not available as a treatment. No clinical trial of it is registered on ClinicalTrials.gov.
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The Hillman Letter publication schedule
Weekly long-form essays on FDA regulatory strategy, frontier therapeutics, and capital decisions. Subscribe at The Hillman Letter.
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Expert witness retentions
Active engagements across FDA, HIPAA, AKS, Stark, and OIG matters. Plaintiff and defense counsel. Dallas and nationwide.
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SMU scholarship and grant cohorts
Selection committee work for the Andrew Hillman Scholarship for Entrepreneurs and the Andrew Hillman Grant for Biotech at SMU.