Dr. Kulkarni is Principal Attorney at the Kulkarni Law Firm and is responsible to help guide policy development and engagement strategies using various methodologies including, but not limited to clinical trial transparency, and patient centricity using technologies like artificial intelligence, blockchain, big data etc. He is also asked to help with regulatory strategy development, clinical trial contract negotiation and responding to titled and untitled letters.
He has multiple patent filings to his name and owns various forms of intellectual property rights including copyrights, trademarks etc.
He is routinely called on because of his almost 20 years of experiences working on the legal and regulatory requirements associated the Food Drugs and Cosmetics Act, state and federal versions of the Anti-Kickback Law, Civil Monetary Penalties Act, False Claims Act, Sunshine Act, HIPAA, 21st Century Cures Act etc.
He regularly works with issues relating to a variety of local, state, federal and international agencies including, but not limited to the United States (US) Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Drug Enforcement Administration (DEA), United States Department of Justice (DOJ) and International Conference on Harmonization (ICH).
Dr. Kulkarni has over 20 years of experience as a clinician having worked in numerous pharmacy settings including retail, hospital, long term care, hospice and others.
He lectures and teaches extensively globally on various issues relating to the life sciences including in academic settings like Johns Hopkins University, Thomas Jefferson University Medical School, Temple Law School and Temple pharmacy school, Drexel University, University of Florida, University of Southern California etc. He is currently Visiting Professor at the University of the Sciences, in their Biomedical Writing Program, where he has taught for over 10 years and received an Outstanding Adjunct Teaching Award and is Visiting Professor at the Children’s Hospital of Colorado. He regularly gives keynote talks at various events including DIA, and AALNC and others.
Dr. Kulkarni serves on various Editorial and Advisory Boards including for FDANews and Applied Clinical Trials. He serves in the American Bar Association where he participates and is actively involved in the Healthcare Fraud Section, Life Sciences Section, and Distance Learning Section. He is a former board member of the National Bar Association’s Health Law Section.
Most recently, Dr. Kulkarni has written several articles, and chapters for textbooks including the chapter on Medical Devices, Drug Advertising, Drug Compounding, and pharmaceutical reimbursement for the Second, Third, Fourth and upcoming Fifth Edition of Pharmaceutical and Medical Device Law – Regulation of Research, Development, and Marketing, Second Edition – the American Bar Association’s flagship textbook for pharmaceutical and medical device law. He is currently working to submit his chapter on FDA Regulated Research for the latest edition of the Research Compliance Professional’s Handbook.