Five talks on offer.
- 01
The 351 vs 361 Decision That Kills Most Exosome Programs
For biotech founders, regulatory counsel, and capital allocators. Why most cell-derived therapeutic programs land on the wrong side of FDA jurisdiction. CMC, manufacturing controls, and the cost of misclassification. 45 minutes plus Q&A.
Exosome and mesenchymal stem cell derived extracellular vesicle products are not approved by the FDA for any indication. The work referenced here describes published scientific literature. It does not describe an available treatment.
- 02
Family Office Capital for FDA-Regulated Science
For LPs, family office principals, biotech operators. Why patient capital fits regulated biotech better than venture timelines. Structuring investment milestones to FDA decision points rather than fundraising rounds.
- 03
Compliance Failures That Precede Enforcement
For healthcare operators, in-house counsel, and CFOs. Documentation patterns and operating signals that show up before federal action. HIPAA, AKS, Stark, OIG, and what thirty years inside FDA-regulated ventures has taught.
- 04
Targeted Osmotic Lysis: Mechanism and Regulatory Pathway
For oncology audiences, clinicians, and biotech investors. The mechanism behind TOL, the
an academic medical foundation partnership, and the regulatory pathway it follows.
Targeted Osmotic Lysis is investigational. It has not been approved by the FDA for any indication and it is not available as a treatment.
- 05
Building Frontier Biotech From Dallas
For Dallas civic, university, and ecosystem audiences. The Dallas biotech network, Methodist, UT Southwestern, and why this is the place to build regulated healthcare today.