Dallas, Texas
Andrew J. Hillman is a Dallas-based serial entrepreneur and biotech executive. His work spans FDA regulatory strategy, regenerative medicine commercialization, healthcare compliance, and expert witness retention across complex biotech and healthcare litigation.
Background
More than two decades building, advising, and commercializing businesses at the intersection of medicine, law, and life sciences.
Work spans FDA regulatory strategy for biologic therapeutics, including the 351(a) BLA pathway and cGMP-compliant manufacturing protocols for advanced cell-derived therapeutics. Commercialization leadership for interventional spine procedures. Strategic architecture for physician-led healthcare ventures.
In parallel, a reputation as a legal compliance expert and expert witness in matters involving Anti-Kickback Statute analysis, HIPAA frameworks, Stark Law, and OIG advisory opinion applications.
Based in Dallas. Advises ventures in regenerative medicine, interventional procedures, and healthcare technology.
Practice Focus
351(a) BLA pathway navigation, Drug Master File preparation, pre-IND strategy, and cGMP compliance for biologic therapeutics including cell-derived extracellular vesicle programs.
Commercialization, distribution, physician education, clinical adoption strategy, and revenue model development for advanced cellular and exosome-based therapeutics.
Anti-Kickback Statute analysis, Stark Law advisory, HIPAA frameworks, OIG opinion applications, and corporate practice of medicine structuring across 50-state environments.
Retained expert services for complex healthcare and biotech litigation. Cross-disciplinary testimony spanning clinical operations, regulatory compliance, commercial damages, and industry standards.
Selected Engagements
Philanthropy
The Andrew Hillman Grant for Biotech is an annual merit-based award recognizing emerging talent in biotechnology, regenerative medicine, and life sciences. Established to support the next generation of researchers, entrepreneurs, and scientists advancing human health.
Recipients are selected on demonstrated innovation, scientific rigor, and the potential for real-world clinical impact. Early-stage support for high-potential individuals produces outsized results for patients and the field.
Selection Criteria
Inquiries
Serious inquiries regarding advisory, regulatory strategy, or expert witness retention.
Available for retained advisory engagements, expert witness consultations, and strategic partnerships in biotech, healthcare, and legal services. Based in Dallas, Texas.