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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?
In this episode, we are joined by Chris Voss, top FBI negotiator, CEO and Author of Never Split The Difference: Negotiating As If Your Life Depended On It. Using his many years of experience in high-stakes negotiations, Chris will share proven negotiation strategies that you can apply in your job search. We are also joined by Mansi Khanna, PhD, Regulatory Writer at Synchrogenix, who will discuss the regulatory writer career track and how other PhDs can pursue this career.
Jim Nasr is Vice President of Technology and Innovation at Synchrogenix where he spearheads strategy and implementation of emerging technologies such as large scale blockchain and machine learning in healthcare and the life sciences. He previously served as Chief Software Architect for the CDC, the Centers for Disease Control and Prevention. In this episode Jim walks us through the critical requirements of data interoperability and how designing for machine to machine data transfer is the most critical of architectural decisions. See acast.com/privacy for privacy and opt-out information.
Listen to Jim Nasr, VP of Synchrogenix, a Certara company, talk about Open Pharma, technology, micropayments and the future of healthcare. Visit OpenPharma.IO for more information on the project and watch Jim's presentation at the 2018 developer event Hedera18: https://youtu.be/1uS2706lO3A
Joining us on the topic of Transparency is Mr. Darshan Kulkarni. Darshan is the VP of Regulatory Strategy & Policy at Synchrogenix, a globally recognized organization that provides regulatory and communications strategy, science, and other solutions to life sciences organizations. There aren’t too many individuals who are as well educated as Darshan. He holds his Doctor of Pharmacy degree from the University of Sciences in Philadelphia and both his Law Degree and Masters in Pharmaceutical Quality Assurance and Regulatory Affairs from Temple University. Darshan, a practitioner of pharmacy for almost 20 years, is often called upon to be a Keynote Speaker at several major conferences across the US. He has also written several text book chapters used today in the areas of pharmacy compounding, drug advertising, medical devices and drug reimbursement. Some key points we cover during this episode: 1. How do you define transparency? 2. Is transparency a burden? 3. Is there truly a need for transparency?
Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist. It is an instance of the wider phenomenon of telemedicine, as implemented in the field of pharmacy. Darshan Kulkarni, host of the Gavel & Pestle Podcast and VP Regulatory Strategy & Policy with Synchrogenix interviews Timothy Youkhana President with Scaled Enterprise Solutions about telepharmacy opportunities for pharmacy business. Telepharmacy services include drug therapy monitoring, patient counseling, prior authorization and refill authorization for prescription drugs, and monitoring of formulary compliance with the aid of teleconferencing or videoconferencing. Remote dispensing of medications by automated packaging and labeling systems can also be thought of as an instance of telepharmacy. Telepharmacy services can be delivered at retail pharmacy sites or through hospitals, nursing homes, or other medical care facilities. The term can also refer to the use of videoconferencing in pharmacy for other purposes, such as providing education, training, and management services to pharmacists and pharmacy staff remotely. ABOUT --Scaled Enterprise Solutions https://ses.healthcare/about/ See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices
Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist. It is an instance of the wider phenomenon of telemedicine, as implemented in the field of pharmacy. Darshan Kulkarni, host of the Gavel & Pestle Podcast and VP Regulatory Strategy & Policy with Synchrogenix interviews Timothy Youkhana President with Scaled Enterprise Solutions about telepharmacy opportunities for pharmacy business. Telepharmacy services include drug therapy monitoring, patient counseling, prior authorization and refill authorization for prescription drugs, and monitoring of formulary compliance with the aid of teleconferencing or videoconferencing. Remote dispensing of medications by automated packaging and labeling systems can also be thought of as an instance of telepharmacy. Telepharmacy services can be delivered at retail pharmacy sites or through hospitals, nursing homes, or other medical care facilities. The term can also refer to the use of videoconferencing in pharmacy for other purposes, such as providing education, training, and management services to pharmacists and pharmacy staff remotely. ABOUT --Scaled Enterprise Solutions https://ses.healthcare/about/ See omnystudio.com/listener for privacy information.