S03E135 The Ever Changing Compliance in Life Sciences with Darshan Kulkarni

Episode notes

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.