Compliance Isn’t a Deal Killer… Until It Is - Interview with Stephanie Trunk

Life sciences M&A is picking up again, but today’s deals look nothing like they did two years ago.

In this episode, Darshan Kulkarni sits down with Stephanie Trunk, Partner at ArentFox Schiff, to unpack what’s really driving renewed deal activity and what buyers are still missing in diligence. From U.S. manufacturing incentives and drug pricing exposure to China risk, DOJ enforcement, compliance culture, and AI, this conversation goes beyond headlines and into deal reality.

If you are buying, selling, or advising life sciences companies, this episode is a must-listen.

Key Topics Discussed

Why life sciences M&A slowed down and why it’s backThe shift from mega-deals to asset-specific acquisitionsWhy U.S. manufacturing location now affects deal valueAccelerated approvals and “Buy America” incentivesDrug pricing risks buyers can no longer ignoreASP, inflation rebates, Medicaid rebate cap removal, and 340B pressurePolitical risk in drug pricing and government scrutinyChina partnerships, data transfer rules, and biosecurity concernsDirect-to-patient models and new HIPAA exposureUsing Sunshine Act and other public data in diligenceCompliance programs, culture, and successor liabilityWhy compliance issues still rarely kill dealsThe emerging role of AI in diligence and enforcementThe IP diligence problem no one wants to solve

Why This Episode Matters

Life sciences deals are no longer just about science and revenue projections. Manufacturing geography, pricing exposure, compliance culture, data security, and enforcement risk now directly shape valuation and post-close outcomes.

Ignoring these issues does not make them go away. It just shifts the risk to the buyer.

Guest

Stephanie Trunk
Partner, ArentFox Schiff
Life Sciences | CMS | OIG | Reimbursement | Fraud & Abuse

Stephanie advises pharmaceutical, biotech, and device companies on regulatory risk, government pricing, and transaction diligence.

📧 stephanie.trunk@afslaw.com

 🔗 ArentFox Schiff Life Sciences Blog

Host

Darshan Kulkarni
Founder, Kulkarni Law Firm
Host, DarshanTalks

📧 darshan@kulkarnilawfirm.com

 🔗 LinkedIn: Darshan Kulkarni

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 Questions or ideas for future episodes? Reach out anytime.

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