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DarshanTalks Podcast

DarshanTalks Podcast

Di: Darshan Kulkarni
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A proposito di questo titolo

Welcome to DarshanTalks!

We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!

Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.

We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.

© 2026 DarshanTalks Podcast
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  • Compliance Isn’t a Deal Killer… Until It Is - Interview with Stephanie Trunk
    Jan 22 2026

    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

    Subscribe & Connect

    If life sciences compliance, enforcement, or deals matter to your business, subscribe for more conversations like this.
    Questions or ideas for future episodes? Reach out anytime.

    Support the show

    www.kulkarnilawfirm.com

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    26 min
  • Cosmetic ingredients the FDA doesn’t want you to use
    Jan 17 2026

    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

    Support the show

    www.kulkarnilawfirm.com

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    2 min
  • Why Federal Agencies Are Targeting Executives
    Jan 15 2026

    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

    Subscribe for weekly breakdowns of enforcement trends that actually affect you.

    Support the show

    www.kulkarnilawfirm.com

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    8 min
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