Dr. Raju obtained a doctorate (Ph.D.) in Chemistry from the University of Mysore, Mysore, INDIA. Dr. Raju also holds a Masters in Chemistry from the University of Mysore. Currently Dr. Raju is a Senior Director and Head of Global Bioassay & Quality at Medimmune. Prior to Medimmune Dr. Raju was with Janssen for 12 years and Genentech for 6 years. He has published more than 40 scientific publications including several book chapters and is named inventor of several issued U.S and worldwide patents. Dr. Raju is currently serving as the Editorial Board member for several industry leading journals including mAbs.

Drug Discovery, Protein Chemistry, Biotechnology, Chromatography, Immunology, Biomarkers, Cell based Assays

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. Brij. M. Gandhi is the Chief Executive Officer and founder of Neo BioMed Services (www.neobiomed.com), a company which provides services and consultancy in health related areas. The Company with a branch office in Cleveland, UK (www.neobiomed.co.uk) serves as the focal point for providing services and solutions to the healthcare community in Europe. His basic skills and experiences is in areas of Management; Research and Development; Policy and Strategic Planning; Market Strategy; Technology Transfer; Sales; Biodefence Strategies; Institutional Development and Regulatory Issues related to biopharmaceuticals, pharmaceuticals, herbals and food safety, biosafety and biosecurity and healthcare areas including stem cell and regenerative medicine. Dr. Gandhi retired in 2006 as Adviser to the Government of India, Ministry of Science and Technology, Department of Biotechnology, after serving for over 18 years in various capacities 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 had been a Research Scientist at the All India Institute of Medical Sciences, New Delhi for about twenty years. Dr. Gandhi continues to serve as Advisor / Director to a number of institutions/pharma and biopharma industries including MNCs and has an experience of over 49 years of active service, as research scientist, science manager, adviser/consultant with over 155 publications. Dr.Gandhi also as Director of a Mumbai based Stem Cell Company has been involved in medical practice for 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; and University of Bergan, Norway.

Immunology and diagnostics for parasitic, bacterial and viral infections especially amoebic diseases; viral diseases including hepatitis viruses; liver diseases; stem cells and regenerative medicine; food and nutritional health issues.

Dr. Peter 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.

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

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 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.

Pharmaceutical, Life Sciences, Healthcare, Social Sector, Intellectual Property and Medical Devices.

Candida is a Founder and President of BBCR consulting. Leveraging extensive experience leading early clinical development and developing regulatory strategy, BBCR consulting is a valuable asset for a company requiring advisory related to life science product development; specifically, pipeline and clinical plan assessments, clinical trials, GTM strategy, safety, or biomarker. BBCR team areas of expertise include rare diseases, immune-oncology, immunology, inflammation, risk-benefit management, regulatory compliance, and FDA issues. BBCR team is a specialized in Orphan, Autoimmune, Oncology, and CNS indications for innovator, biosimilar, and repurposing products. BBCR team has contributed innovative clinical regulatory strategies and trial design for products, directed regulatory compliance across international government entities for drug, device, and combination products. BBCR team leads evidence-based trial strategies, cost-effective solutions, reduces risks and facilitate patient centricity, recruitment and retention Candida is an accomplished Senior Executive MD with more than 25 years of success spanning biotechnology, pharmaceuticals, and device. She led market approval for five major products, improved endpoint achievability, and designed Natural History studies and registry protocols. An industry leader, she is a sought-after speaker presenting at international industry summits. Candida attained her MD and an higher degree in Immunology and trained at The Johns Hopkins University and The Harvard University.

• Biosimilars: Clinical Plan and regulatory strategy • Rare disease: Clinical Plan and regulatory strategy • Safety and Pharmacovigilance • Regulatory submissions (IND, IMPD, etc) • Clinical Hold Resolution • Re-analysis data for failed clinical trial • Patient registry • Natural History study rare disease