Compliance isn’t a checkbox anymore; it’s the engine room shaping strategy, pricing risk, and deciding whether a deal should close. We sit down with Darshan Kulkarni, pharmacist, attorney, professor, and veteran advisor to life sciences companies, to examine how enforcement trends, data ownership, and AI are rewriting the rules for pharma, biotech, and health tech leaders.

We start with Darshan’s unconventional path from sixth-generation pharmacist to regulatory lawyer and educator, then dig into the pressure points every leader feels right now. Why the DOJ and OIG expect compliance to be resourced and at the table. How successor liability can blow up an acquisition if issues aren’t self-identified and disclosed. Why “100% compliant” is not a badge of honor but a signal your program isn’t looking hard enough. And where promotional risk really lives today: not in the TV ad that passed MLR review, but in the hallway conversation where a rep guesses at an off-label question.

From there, we turn to diligence and dealmaking. Darshan breaks down the most common red flags in clinical trial sites, especially physician-ownership rules and formation problems that can make a target effectively unownable. We explore how non-competes, data rights, and state privacy laws collide with federal frameworks, and how to price and structure deals when the risks are real but fixable.

AI and digital health raise the stakes even further. We unpack consent gaps, PHI exposure, IP conflicts, and the difference between public LLMs and truly private deployments. Transparent does not mean public domain, and pushing sensitive data into a public model can make control vanish. The throughline is clear: build controls that find problems early, separate legal advocacy from compliance oversight, and make incentives support the behavior you want.

Reach Darshan here:
darshan@kulkarnilawfirm.com
https://www.kulkarnilawfirm.com/

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