What I'm Working On · Updated Monthly

Now.

A standing snapshot of what is active, updated monthly. The /now page convention comes from Derek Sivers.

Out for a ride in Dallas.

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.
Exosome and mesenchymal stem cell-derived extracellular vesicle products are not approved by the FDA for any indication. References here describe published scientific literature. They do not describe an available treatment.
Now
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.
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
SMU scholarship and grant cohorts
Selection committee work for the Andrew Hillman Scholarship for Entrepreneurs and the Andrew Hillman Grant for Biotech at SMU.

Andrew Jonathan Hillman

Dallas senior paralegal and healthcare compliance expert witness. Not an attorney.