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 back
• The shift from mega-deals to asset-specific acquisitions
• Why U.S. manufacturing location now affects deal value
• Accelerated approvals and “Buy America” incentives
• Drug pricing risks buyers can no longer ignore
• ASP, inflation rebates, Medicaid rebate cap removal, and 340B pressure
• Political risk in drug pricing and government scrutiny
• China partnerships, data transfer rules, and biosecurity concerns
• Direct-to-patient models and new HIPAA exposure
• Using Sunshine Act and other public data in diligence
• Compliance programs, culture, and successor liability
• Why compliance issues still rarely kill deals
• The emerging role of AI in diligence and enforcement
• The 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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A brief discussion on the various cosmetic ingredients used by cosmetic manufacturers and the concerns FDA has recently found as a result of their own study into the process

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Federal enforcement is changing. Regulators aren’t just going after companies anymore. They’re naming CEOs, CMOs, heads of clinical, quality, and operations in consent decrees and injunctions. Once your name is on that document, it follows you for years and shapes your career.

In this episode we unpack:

• Why enforcement has shifted toward individual accountability
• How repeated compliance failures trigger personal liability
• Data integrity and why it matters more than ever
• Why clinical research and telehealth are now in regulators’ crosshairs
• What personal obligations look like inside a consent decree
• What executives should be doing now to protect themselves

If you lead in an FDA-regulated space, this one matters.

Get show notes and resources at www.kulkarnilawfirm.com

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www.kulkarnilawfirm.com