Now.

Currently working on.

• Now

  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.

• Now

  Targeted Osmotic Lysis clinical positioning

  Working with the an academic medical foundation to advance the TOL platform for solid tumors. Non-toxic, non-chemotherapy approach. Clinical and regulatory roadmap on the build.

• Now

  The Hillman Letter publication schedule

  Weekly long-form essays on FDA regulatory strategy, frontier therapeutics, and capital decisions. Subscribe at The Hillman Letter.

• Now

  Expert witness retentions

  Active engagements across FDA, HIPAA, AKS, Stark, and OIG matters. Plaintiff and defense counsel. Dallas and nationwide.

• Now

  SMU scholarship and grant cohorts

  Selection committee work for the Andrew Hillman Scholarship for Entrepreneurs and the Andrew Hillman Grant for Biotech at SMU.