Compliance Isn’t a Deal Killer… Until It Is скачать в хорошем качестве

Compliance Isn’t a Deal Killer… Until It Is

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