13^th International Conference on Biosimilars and Biologics March 18-19, 2019 Holiday Inn Amsterdam - Arena Towers

Professor Sarfaraz K. Niazi, Ph.D., FRSB, FPAMS, FACB, SI, Executive Chairman, Karyo Biologics and PharmSci, is a globally recognized pioneer of the pharmaceutical and biopharmaceutical industry, with 50+ books, 100+ research papers, 100+ patents, several approved CPs to FDA, dozens of crafted regulatory guidance, and the experience of taking many pharmaceuticals and biosimilars through regulatory approval across globe, raising hundreds of millions of dollars. He has now embarked on a global effort, in collaboration with regulatory agencies, to revolutionize the the current archaic approval process for generics and biosimilars, making it more relevant on contemporary scientific concepts—all with a goal to enhance accessibility to safer medicines. These concepts include a thermodynamic approach to compare products and a clinical approach to allow substitution without unnecessary human testing. He is an in inductee into Entrepreneur Hall of Fame, and the Forbes Magazine, Chicago Tribune and many other publications calling him “the most interesting man in the world changing healthcare.” He serves on the faculty of several major universities and is a fellow of several most prestigious learned societies.

Biosimilars and Biologics

Dr. Yashwant Pathak completed his education M.S., Ph.D. in Pharmaceutical Technology from India and EMBA and MS Conflict Management from Sullivan University, USA. He is Professor and Associate Dean for Faculty Affairs College of Pharmacy, University of South Florida. Tampa, Florida. With extensive experience in academia and industry, he has over 150 publications research papers, abstracts, chapters and reviews, edited over 25 books. Some of his titles include Nutraceuticals and health: Handbook of Metallo-nutraceuticals, nanotechnology in Nutraceuticals: production to consumption, and the recent most is Nutrigenomics and Nutraceuticals: clinical relevance and disease prevention. His areas of research include drug delivery systems, nanotechnology applications in pharmacy and Nutraceuticals. He is a series editor for Nutraceuticals basic research and clinical applications published by CRC Press. He has travelled extensively over 80 countries and is actively involved with many Pharmacy colleges in different countries.

Drug delivery systems, Nanotechnology applications in Pharmacy and Nutraceuticals

Dr. Francois-Xavier Frapaise, M.D has over 30 years of international drug development, strategic planning and marketing experience at major pharmaceutical companies including Sanofi, Bayer, Boehringer, Merck and Abbott; he has hold multiple C-level positions (CSO,CMO,CEO) in different Pharmacos in the US and Europe. He is currently heading Clinical Development, Medical Affairs and Pharmacovigilance at Merck KGaA Biosimilars Division; he has extensive experience of biosimilars development (Boehringer-Ingelheim, Pfenex); He has been the CSO and SVP of Optimer, has served as the CEO of Asphelia Pharmaceuticals, Inc.VP R&D and Corporate Officer of TAP , CMO of Ocera Therapeutics, VP of Scientific Affairs at Abbott International , Head of Medical Affairs at Bayer Europe, Medical Director at Bayer France, VP of R&D at Delagrange, Head of Anti-thrombotics Strategic Marketing at Sanofi, Medical Director at Choay. Dr. Frapaise holds an M.D. degree from Faculté de Médecine Paris and is a INSEAD alumni. Dr. Frapaise holds an academic position at the Thrombosis Research Center at the Loyola Medical Center in Maywood (IL).

Drug development & strategic planning

Dr. Saharan has MS in Life Sciences (JNU); Ph.D in medicine (WVU) & Post Doc. (Stanford University).He has several International Publications / Presentations including in Top Scientific Journal Nature from the age of 21. Nominated for several Global Awards including by New Drug Discovery Programme of Department of Science & Technology (GoI) funded US$ 3 million grant and the best US Scientist Award at age 22 years by AAAS, Washington DC. Dr. Pawan Saharan has been CSO & CEO for large MNC & founder of Biomix Network Inc. USA & India. He has global experience in running healthcare industry, including the Pharmaceuticals MNCs and hospitals at the top management level in USA & India.

Biosimilars Business

Rodica Olteanu is a Dermatologist and Medical Director of Colentina Clinical Hospital, Bucharest, Romania. She has received her PhD on lupus research in 2007, in collaboration with Hamburg University. She is involved in autoimmunity and immunogenicity of biologics and biosimilars and published more than 100 papers in lupus and psoriasis. She is Alumni EADV Club rewarded, winner of many international grants, Member in EADV Project Committee, AAD, GRAPPA, EuSCLE, SRD, ILDS Member and Member in Editorial Board of SRD and LAJPPA. She has completed her educational training by participating at Master Class on Psoriasis- Barcelona, Center for Excellence in Psoriasis-Vienna, Pearls in Lisbon and Bucharest-as Invited Speaker and also at Harvard. She supports the idea of a collaborative work group of specialists in different areas for autoimmune diseases also with patient’s participation and she intent to create an Autoimmune Diseases Center in Colentina Hospital.

Biosimilars, Biologics

Kurt R Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the Co-Founder and Primary Author of Hyman, Phelps & McNamara’s FDA law blog, he often leads the response to new rules and regulations, sharing his interpretation with the broader legal community. He has co-authored and contributed to several text books, including “Generic and Innovator Drugs: A Guide to FDA Approval Requirement’s”; “Pharmaceutical, Biotechnology, and Chemical Inventions”; “Fundamentals of US Regulatory Affairs” and “FDLI’s Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives”.

Biosimilars & Pharmacies