636348-a47d59d7-6766-4573-81a5-6a25216e62dc
Position
Principal Attorney
Company
Kulkarni Law Firm
Location
Philadelphia Pennsylvania UNITED STATES
Bio

Dr. Kulkarni is Principal Attorney at the Kulkarni Law Firm where he is responsible to help guide policy development and engagement strategies using various methodologies including, but not limited to patient centricity, transparency initiatives, artificial intelligence, blockchain, big data etc.

 

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 over 15 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.

 

Additionally, as Vice President of a global consulting organization, he consulted on global clinical trial transparency and disclosure activities including issues involving EudraCT, Policy 43, Policy 70, clinicaltrials.gov, Health Canada and others. He regularly works with issues relating to a variety of local, state, federal and international agencies

 

Dr. Kulkarni has over 20 years of experience as a clinician having worked in numerous healthcare settings including retail, hospital, long term care, hospice, and others including working as the only unblinded participant in clinical research, setting up investigational drug pharmacies etc.

 

He lectures and teaches extensively globally on various issues relating to the life sciences, including Johns Hopkins University, Thomas Jefferson University Medical School, Temple Law School, Temple Pharmacy School, Drexel University, University of Florida, University of Southern California. 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. He regularly gives keynote talks at various events including DIA, American Association of Legal Nurse Consultants (AALNC), and others.

 

Dr. Kulkarni serves on various Editorial and Advisory Boards, including FDANews, Applied Clinical Trials, APPA and https://www.pharma-mkting.com/.

 

He serves in the American Bar Association where he is currently the chair of the Life Sciences section and participates and was formerly Vice Chair in the Healthcare Fraud Section, and Distance Learning Sections. 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 chapters on (1) Medical Devices, (2) Drug Advertising, (3) Drug Compounding, and (4) pharmaceutical reimbursement for the Second, Third, Fourth, and Fifth Editions of Pharmaceutical and Medical Device Law - Regulation of Research, Development, and Marketing, Second Edition – an American Bar Association’s flagship textbook.

He is also the author for the chapter for FDA-Regulated research for the Society of Corporate Compliance and Ethics Health Care Compliance Association.