Compliance Isn’t a Deal Killer… Until It Is

Описание: Life sciences M&A is picking up again, but the rules have changed.
In this episode, Darshan Kulkarni speaks with Stephanie Trunk, Partner at ArentFox Schiff, about why deals are returning and why buyers are now focusing on U.S. manufacturing, pricing exposure, China risk, compliance programs, and DOJ enforcement in ways they weren’t just two years ago.
We cover how drug pricing rules, Medicaid rebates, Sunshine Act data, biosecurity laws, direct-to-patient models, and AI are reshaping due diligence and deal value. This is a practical conversation for pharma, biotech, device companies, investors, and advisors navigating today’s M&A environment.

Guest: Stephanie Trunk, Partner, ArentFox Schiff
Focus: Life sciences, CMS, OIG, reimbursement, fraud and abuse

Chapters / Timestamps
00:00 Intro and global life sciences context
00:37 Meet Stephanie Trunk and her practice focus
00:52 Why life sciences M&A slowed down
01:04 Why deal activity is picking up again
01:58 Shift from mega deals to asset-specific acquisitions
02:38 Buying U.S.-based manufacturing assets
02:52 Smaller companies vs global supply chains
03:28 Single-drug companies and strategic exits
04:32 Why early-phase biotech models may not survive
05:16 Buying established assets vs building pipelines
05:39 Accelerated approvals for U.S. manufacturing
05:46 Government shutdown context and deal impact
06:17 New M&A risks companies didn’t face two years ago
06:24 Country of origin, API sourcing, and pill manufacturing
07:36 Onshoring, Buy America, and deal valuation
07:44 Pricing risk in due diligence finally matters
08:05 ASP, inflation rebates, Medicaid cap removal
08:49 Drug pricing pressure and political risk
09:44 China partnerships and DOJ data rules
10:16 Biosecurity Act and IP exposure
11:16 Chinese manufacturing in a global economy
11:35 Direct-to-patient models and patient data risk
12:12 HIPAA exposure and patient relationships
12:36 Sunshine Act data mining by DOJ
13:00 Public data vs data room disclosures
14:12 Using public sources to validate compliance
15:59 Compliance programs and successor liability
16:11 DOJ enforcement and self-disclosure strategy
17:49 Cultural compliance vs paper programs
19:44 Why compliance still rarely kills deals
20:08 Pricing diligence vs compliance diligence
20:42 FDA enforcement priorities and AI use
21:22 Can AI help with due diligence?
22:07 Government use of AI in enforcement
23:15 IP diligence pet peeve: patents vs real value
24:00 Mapping IP to FDA approvals and products
24:29 What buyers are really paying for
25:06 How to reach Stephanie Trunk
25:22 How to reach Darshan and closing remarks