Season 2, Episode 11: Parsing the Biotech Enigma with Darshan Kulkarni

Notes To My (Legal) Self

Darshan is the Principal Attorney of the Kulkarni Law Firm, and focuses his practice on

providing life science, healthcare and healthtech companies with comprehensive regulatory advice. Darshan has worked at multiple Venture Capital backed in-house positions, and started multiple legal departments including at Embedded Healthcare, LLC where he served as General Counsel and Chief Compliance Officer and as Corporate Counsel for Nostrum Pharmaceuticals where he was responsible for and oversaw multiple legal and compliance matters including issues relating to advertising, clinical research, and creating and reviewing a variety of agreements including NDAs, MSAs, CDAs, employment agreements, and licensing agreements.

He has created multiple compliance programs including addressing issues relating to the False Claims Act, Anti-Kickback Law, HIPAA, HITRUST issues etc.

Most recently, he has also served as Vice President of Regulatory Strategy and Policy at Synchrogenix, another Venture Capital backed global consulting company.

He has spent over 20 years counseling clients on regulatory issues, and has served as a pharmacist for over a decade.Darshan has also written several book chapters on regulatory compliance for various publications on behalf of the American Bar Association where he is Chair of the Life Sciences Interest Group.

In this episode, we discuss parsing the biotech enigma. Why is there a boom in biotech right now? What is patient centricity and does it matter in the biosciences? Is transparency the cure to the lack of trust in the biosciences? What is biohacking and is it the future of bioscience?