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.
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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.