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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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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Everyone’s talking about the new food pyramid like it’s diet advice. I’m here to tell you it’s regulatory policy in disguise. In this episode I break down why this change matters beyond grocery aisles: school meal rules, food labeling, federal purchasing, and how the government quietly reshapes what counts as “healthy.” If you think this is just about fats and grains, think again. This affects prices, marketing claims, and what ends up on kids’ plates. I’m a food and drug lawyer focused on how policy becomes enforcement, and I’ll tell you what you need to know in straight language.

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Episode Description

In this episode, Darshan Kulkarni sits down with former FDA Commissioner Robert Califf for a wide-ranging conversation on FDA authority, politics, guidance, and public trust. From the loss of Chevron deference to the role of FDA as a referee, Dr. Califf explains how regulation really works and why wealth inequality has become the most serious health issue in the United States.

Episode Summary

What does it really take to run the FDA, and how political should the agency be? Former FDA Commissioner Robert Califf reflects on his path to the role, the skills a commissioner actually needs, and why FDA must act as an impartial referee rather than a political actor. The conversation explores guidance versus regulation, the loss of Chevron deference, industry expertise, the revolving door debate, and how social determinants of health shape outcomes far more than medicine alone. A candid, opinionated look at regulation from someone who has seen every side of it.

Key Topics Discussed

• How Dr. Califf became FDA Commissioner twice
• Why FDA should act as a referee, not a combatant
• Guidance documents and how they really function
• Politics, policy, and product level decision making
• Preparing for the loss of Chevron deference
• Wealth inequality as the biggest health problem in the U.S.
• Social determinants of health and FDA’s role
• Generic drugs, tobacco, and public health impact
• Digital health hype versus real-world impact
• The FDA–industry revolving door debate

Why This Episode Matters

As courts, politicians, and industry challenge agency authority, understanding how FDA decision making actually works matters more than ever. This episode explains what regulation can and cannot do, where political pressure becomes dangerous, and why ignoring inequality undermines health outcomes no matter how advanced the science becomes.

Guest

Robert Califf
Former Commissioner, U.S. Food and Drug Administration
Instructor in Medicine, Duke University

Dr. Califf has served twice as FDA Commissioner and brings decades of experience across clinical medicine, academia, industry, and government.

Host

Darshan Kulkarni
Founder, The Kulkarni Law Firm
Host, DarshanTalks

Call to Action

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GLP-1 weight loss programs are everywhere right now, especially in the med spa space. For M&A lawyers and deal teams, that popularity comes with serious regulatory risk.

In this episode, Darshan breaks down why GLP-1 compliance has quietly become a dealbreaker in healthcare acquisitions. What used to be framed as an FDA issue is now actively being enforced by state attorneys general using consumer protection and deceptive trade practice laws.

You’ll hear how the end of the FDA shortage changed what compounding pharmacies are legally allowed to do, why “research grade” GLP-1 products are not a workaround, and how recent enforcement actions in Alabama and Connecticut are reshaping diligence expectations.

This episode walks through the red flags buyers must catch before signing, including opaque supply chains, misleading marketing claims, research washing, and misaligned informed consent. It also explains why missing these issues can lead to asset freezes, injunctions, multi-state investigations, and massive post-closing remediation costs.

If you advise on med spa transactions, private equity healthcare deals, or GLP-1-driven growth strategies, this conversation is essential listening.

For deeper diligence support on GLP-1 programs and healthcare transactions, reach out to the Kulkarni Law Firm.

Subscribe for more conversations at the intersection of M&A, FDA regulation, state enforcement, and healthcare compliance.

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For decades, biotech M&A followed a familiar script. Patents drove value. Molecules closed deals.

That script is breaking.

In today’s precision medicine transactions, the real asset is data. Longitudinal patient records, real-world evidence, and genomic datasets are now central to valuation. But unlike traditional IP, data comes with strings attached. Privacy laws, patient consent, and transfer restrictions can quietly determine whether that data is an asset or a liability.

In this episode of KLF Deep Dive, we explore why clinical data is being treated as the new IP in biotech M&A, how weak consent frameworks can destroy deal value, and what acquirers should be asking during diligence before it’s too late.

If you work in biotech, pharma, corporate development, or private equity, this episode breaks down a risk that is reshaping how deals get priced and structured.

Listen in, and reach out if this issue is sitting inside one of your transactions.

Episode Highlights

• Why patents alone no longer drive biotech valuations
• How precision medicine changed the M&A playbook
• Clinical data as a regulated asset
• Patient consent and data transfer risks
• When valuable datasets become compliance liabilities
• What smart buyers are doing differently in diligence

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Staffing and training are not just operational issues. They are inspection risks. In this episode, we break down what sponsors and regulators actually expect when it comes to site staff training. Competent staff is not enough if training is not documented. We walk through common failure points seen during FDA inspections, including missing GCP documentation, unclear staff roles, and poor escalation processes. We also discuss how structured SOPs, training logs, and clear contracts with coordinators and sub-investigators help demonstrate a real culture of compliance. The goal is simple. When sponsors or the FDA review your site, your records should tell a clear, defensible story.

Key Topics Covered

• GCP training and documentation expectations
• Why undocumented training creates inspection risk
• Common staffing failures seen during FDA inspections
• Training SOPs and staff training logs
• Defining roles and liability in staff contracts
• Managing protocol deviations and escalation paths
• Demonstrating a culture of compliance at the site level

Who This Is For

• Clinical trial sites
• Sponsors and CROs
• Principal Investigators
• Study coordinators
• Clinical operations leaders

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