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Abstract

Abuse of opioids and other prescription controlled substances is a recognized nation-wide problem in United States and around the globe. Emerging FDA guidelines are setting up the ground rules for related evaluation and product labeling. As these documents point out, science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. This presentation will focus on the overview of the existing and novel formulation approaches to enable tamper-resistant properties to include approaches involving physical/chemical barriers, agonist/antagonist combinations, aversion, delivery, and prodrug. Neither of the approaches can provide absolute protection and eliminate all the illicit options. So the question is, if there are clear pathways is assessing suitability of an appropriate technology for a given drug candidate or product and evaluating their readiness to be deployed. Up to date only a handful of tamper-resistant technological solution advanced far enough to be implemented into the market product. This number will certainly increase in near future as nascent and established tamper-resistant formulations will be further tested in clinical trials and interrogated by FDA.

Biography

Alex Nivorozhkin is an Entrepreneur and a Team builder in life sciences’ arena with vast experience and track record in an early technology transfer and development. He was a Co-founding Member of Boston BioCom, LLC, a biopharma company funded by the seed investment from Pfizer, Neo-Advent Technologies LLC, Amorsa Therapeutics, an emerging company developing new medications and formulation approaches for treatment of the refractory pain, and other ventures. He gained substantial experience in the commercial aspects of drug discovery and development at Epix Medical and Inotek Pharmaceuticals where he served as the company’s Head of Medicinal Chemistry. He was as a Senior Program Manager at the Center of Integration of Medicine and Innovative Technologies (CIMIT) at Massachusetts General Hospital, Draper Laboratory and MIT aimed at developing new medical devices; and a Scientific Programs Officer at Sheldon and Miriam Adelson Medical Research Foundation. He is a Co-inventor of several drug candidates that have advanced to clinical trials and late pre-clinical studies in the United States, has co-authored over 60 scientific publications in different areas of chemistry, chemical biology, and material sciences and holds more than 20 patents. He received a PhD in Physical Organic Chemistry from Rostov University and conducted the Postdoctoral research at the University Paris-Sud, France, and the Department of Chemistry and Chemical Biology, Harvard University. He is a Member of the American Chemical Society, Controlled Release Society, American Association of the Pharmaceutical Sciences and other professional organizations, active on the conference circle and serves as a co-chair of the Formulation and Drug Delivery Committee of the Massachusetts Biotechnology Council.

Email: aln@neo-adventtec.com