Dallas, Texas

Andrew J. Hillman

Biotech Executive · FDA Regulatory Strategist · Expert Witness
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30+ Years in FDA-regulated healthcare
351(a) BLA pathway expertise
10+ Ventures co-founded & exited
$1K Annual biotech grant

Operator. Strategist. Builder.

Thirty years inside FDA-regulated healthcare — co-founding, advising, and exiting ventures across biologics, orthopedics, pharmacy, surgical hospitals, clinical laboratory, intraoperative neuromonitoring, and healthcare staffing.

Today my practice focuses on FDA regulatory strategy for regenerative medicine biologics (351(a) BLA pathway, exosome therapeutics), healthcare compliance advisory, and expert witness services in complex regulatory disputes.

Multiple exits to strategic acquirers and private equity. Based in Dallas, Texas. Practicing since 1995.

Built on academic and regulatory record.

Southern Methodist University — Cox School of Business
Business Administration & Management · 1997–2001

Dallas College
Business Administration & Management · 1995–1997

Mensa International · Member 2010
Who's Who of Executives & Professionals · Inducted 1996
Accredited Investor · U.S. Securities and Exchange Commission

Full profile at andrewjhillman.com →

Deep expertise across medicine, law, and strategy.

01

FDA Regulatory Strategy

351(a) BLA pathway navigation, Drug Master File preparation, pre-IND strategy, and cGMP compliance for biologic therapeutics including cell-derived extracellular vesicle programs.

02

Regenerative Medicine

Commercialization, distribution, physician education, clinical adoption strategy, and revenue model development for advanced cellular and exosome-based therapeutics.

03

Healthcare Compliance

Anti-Kickback Statute analysis, Stark Law advisory, HIPAA frameworks, OIG opinion applications, and corporate practice of medicine structuring across 50-state environments.

04

Expert Witness & Advisory

Retained expert services for complex healthcare and biotech litigation. Cross-disciplinary testimony spanning clinical operations, regulatory compliance, commercial damages, and industry standards.

A record across biologics, commercialization, and law.

Giving back to healthcare and the next generation.

Texas Scottish Rite Hospital for Children

Multi-year board service alongside his son, Ashton J. Hillman. Co-leader of the annual KidSwing for Scottish Rite golf tournament with personal matched giving across multiple tournament years.

$178K+

Player fundraising across KidSwing tournament years

Andrew Hillman Grant for Biotech

Annual merit-based award recognizing emerging talent in biotechnology, regenerative medicine, and life sciences. Recipients selected on demonstrated innovation, scientific rigor, and potential for real-world clinical impact.

$1,000

Annual · andrewhillmangrant.com

Andrew Hillman Scholarship for Entrepreneurs

Annual award for aspiring entrepreneurs and business leaders across the United States. Supporting the next generation of innovators and business builders.

andrewhillmanscholarship.com →

Community Volunteering

YMCA soccer coaching · Methodist Health System volunteer · For the Love of the Lake environmental volunteer · The Lamplighter School volunteer staff

In the Record.

Let's connect.

Available for retained advisory engagements, expert witness consultations,

and strategic partnerships in biotech, healthcare, and legal services.

Dallas, Texas · 901 Main Street, Dallas, TX 75202