Dr. Francois-Xavier Frapaise, M.D has over 30 years of international drug development experience at major pharmaceutical companies including Sanofi, Bayer, Boehringer, Merck and Abbott; he has hold multiple Clevel positions (CSO,CMO,CEO) in different Pharmacos in the US and Europe. He has extensive experience of biosimilars development (Boehringer-Ingelheim, Pfenex, Merck KGaA) and is currently heading a Biosimilar Consulting Company. 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 and holds an academic position at the Thrombosis Research Center at the Loyola Medical Center in Maywood (IL).

Biosimilars

Dr. Milind Antani, a renowned surgeon turned lawyer, leads the Pharma & Healthcare practice at multi-skilled, research-based international law firm, Nishith Desai Associates where he represents high net-worth clients in matters allied to JVs, M&As, VC and Private Equity investments, Collaborations, Regulatory advice, IP, Licensing and Commercialization. He also leads the Social Sector Practice and represents various global and national foundations in India. Dr. Antani continues as an active participant in helping frame national policies on key impact areas, within the medical field. He has authored and co-authored numerous articles and prestigious publications related to the Pharma and Healthcare industry. Various national as well as international publications such as Digital Health Legal, a Cecil Media Publication in UK continue to reach out to Dr. Antani for insights and have carried his word. A regular speaker at various prominent forums on Pharma, Medical Devices, Med-Tech & eHealth, Biotech, IP, Clinical trials, Healthcare, CSR and Social Impact investments, he is also a visiting faculty at premier institutions in Mumbai and Gujarat including the Institute of Rural Management, Anand (IRMA).

Pharmaceutics and Biotechnology, Regulatory

Dr. Brij. M. Gandhi, M.Sc., Ph.D. is presently CEO and founder of Neo BioMed Services (www.neobiomed.com), providing services and consultancy in health areas and regulatory issues related to biopharmaceuticals, pharmaceuticals, including stem cell and regenerative medicine. Dr. Gandhi had his Masters in Biochemistry from PAU and Ph.D. in Experimental Medicine from the University of Bergan, Norway. He was trained at the Massachusetts Institute of Technology, USA; London School of Hygiene and Tropical Medicine, London; National Institutes of Health, Maryland, USA; Hvidovre Hospital, Copenhagen and University of Bergan, Norway. Dr. Gandhi retired in 2006 as Adviser to the Government of India, Ministry of Science and Technology, Department of Biotechnology, managing promotion and policy related issues in biotechnology related to international collaborations, medical biotechnology, infrastructure development, animals and aquaculture biotechnology. Prior to that, Dr. Gandhi served as Research Scientist at All India Institute of Medical Sciences, New Delhi. Dr. Gandhi continues to serve as Advisor / Director to a number of institutions/pharma and biopharma industries with an experience of about 51 years of active service, as research scientist, science manager, adviser/consultant and has over 155 publications.

Immunology of parasitic, bacterial and viral infections including amoebic diseases; hepatitis; liver diseases, IVD, food and nutritional health issues. CBRNe

Peter H Kalinka is Chairman and Principal Consultant at Longmore 60 Biotech Inc. He possesses in-depth knowledge of drug development and directed numerous development projects including Therapeutic Proteins, Monoclonal Antibodies and Fusion Proteins. His experience in overall development spans cloning, process development, scale-up, (e-coli, CHO, Hybridoma etc.) analytical development, bioassays, pre-clinical, clinical Phases, to manufacturing and regulatory affairs. Working with more than 20 companies worldwide, he has directed all or spearheaded parts of development programs for Biosimilars, Biobetters and Biologics.

Cloning Process development Scale up, (e-coli, CHO, Hybridoma etc.) Analytical development, Bioassays, Pre-clinical, clinical Phases, to manufacturing and Regulatory affairs.