12^th Asian Biologics and Biosimilars Congress August 20-21, 2018 Tokyo, Japan

Dr. James Yang is the Chief Executive Officer at Abpro, China and also Vice President of the Abpro, USA. Previously he had been associated with Genzyme , Qilu Pharmaceuticals, Sanofi, MedImmune , Astrazeneca, Abbott Laboratories.

Biologics, Protein Purification, GMP, Biosimilars

Dr. Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generic industry. Dr Mikhail is an Expert in Biosimilars. Has been involved in the Global Development and Worldwide regulatory approval of Blockbuster Monoclonal antibodies Medicines. He was involved in shaping the EU Biosimilars Guidelines and their Review, the WHO Guidelines, ICH Guidelines and now in the US-FDA Biosimilars Guidelines. He is a Chartered Expert in Pharmacology-Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr. Mikhail is member of the Expert committee of the Government Federal Institute of Risk Assessment (BfR) Germany and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia (USP)..

Biosimilars, Monoclonal antibodies Medicines, Pharmacology-Toxicology

Divya Chadha Manek is the Head of Business Development (Commercial) for the NIHR Clinical Research Network (CRN). Divya’s role is to maintain strategic relationships with Global and UK life sciences companies. Divya facilitates key discussions between life sciences industry and the Clinical Research Network. Divya provides advice and works collaboratively with companies on how they are able to tap into the Clinical Research Network services to ensure clinical studies are set up quickly and effi ciently so that they recruit to time and target. Divya also leads on ensuring that the Clinical Research Network is abreast of new study delivery innovations to ensure that the organization is evolving to service life sciences industry requirements.

Pharmaceuticals, Biologics, Biosimilars, Clinical Psychology, Clinical Research, Dementia Care

Dr. Lutz Hilbrich holds a Medical Degree from the University In Wuerzburg Germany and an MBA from Stern School of Business at NYU, USA. He is currently the Head of the Biosimilars Platform China for Sanofi and was previously second in command for the Biosimilars Business Unit at Boehriger Ingelheim GmbH, Germany. He is experienced in CMC-, Pre-clinical -and Clinical Development but also in Business Development and Market Access Strategies. Besides serving on the Organizing Committee for Asian Biosimilars 2017, he sits on the Biosimilar Advisory Board of the American Conference Institute (ACI).

Biopharmaceuticals, Biologics, Biosimilars, Clinical trials, Drug development

Global Regulatory Affairs AMESA ME Zone Head

Biologics, Biosimilars, Regulatory Affairs

Mr. Pankaj Chaudhari is Manager in Biotech division of Ipca Laboratories Ltd, Mumbai. A Bioprocess Engineer with more than 10 years of experience in bioprocess development R&D, process scale up in GMP & Global regulatory submissions of Biosimilars. In Ipca, He is actively participating as a Regulatory CMC team by contributing to the regulatory strategy, identifying the critical issues during product development. In his past experience he was a key member in success of Biosimilar in Europe, Canada., India & ROW market.

Biosimilars, Monoclonal Antibodies, Pharmacovigilance, BioDrugs

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.

Biosimilars, Biologics, mAbs, Bioassay

Tucker has advised major biotechnology firms on a broad range of sales and marketing strategy issues related to the biotech industry, with an emphasis on Oncology and Biosimilars. His experience has focused on global quantitative and qualitative primary market research and forecasting. Tucker was one of the founding members of ZS’s Biosimilars Vertical, and he has led over 30 training sessions across North America and Asia on this topic. Tucker holds an M.B.A. with honors from UCLA, and a B.A. with honors in from Stanford University.

Biosimilars, Biologics, Oncology

Dr Asif is currently working as Disease Area Cluster Lead for Biosimilars & Drug Delivery Devices at Pfizer. Currently Pfizer has the largest biosimilars portfolio in the industry. His past experience includes working as Associate vice president PV and Therapeutic Area Head (Rare Diseases) for Sanofi Genzyme, working as Senior Director & Director for vaccines PV at Sanofi Pasteur, working as Medical Consultant for Apotex Inc Canada. Prior to joining industry he had worked as Joint Executive Director for Pakistan Institute of Medical Sciences (PIMS), Registrar of the Post graduate medical institute PIMS and as Deputy Director General, Ministry of Health Pakistan.

Biosimilars & Drug Delivery Devices, pharmacovigilance, clinical development, rare diseases, novel preventive & therapeutic vaccines, monoclonal antibodies, generic and OTC medicines

Mahmoud Balbaa is a Professor of Biochemistry in Faculty of Science at Alexandria University, Egypt. He used to be a Head of the Department of Biochemistry at the same faculty from 2007 to 2009. He obtained his PhD degree from Hokkaido University, Japan in 1988 and worked in the field of protein phosphorylation, enzyme characterization in disease and enzyme inhibition at Faculty of Science, Alexandria University. He worked as a Professor of biochemistry in Beirut Arab University (2009 – 2014) and University of Qatar (2002–2006). In addition, he was a Postdoctoral Fellow of Hokkaido University School of Medicine and Faculty of Medicine, University of Toronto. He published more than 45 papers and serving as a Reviewer in some peer review journals. He is a Member of the Editorial Board of Biochemistry & Physiology: Open access.

Generics, Cancer Biology, Drug Design, Biochemistry

Dr Pierre A Morgon is the Chief Executive Officer of MRGN Advisors and Regional Partner for Switzerland at Mérieux Développement, Chairman of the Board of Virometix, Non-Executive Director to the Board of Theradiag, Non-Executive Director to the Board of Eurocine Vaccines, and Non-Executive Director to the board of Vaccitech.I have over 30 years of experience in the global pharmaceutical and biological industry and in healthcare IT, both at the helm of operations (from business unit head to general manager and CEO) and in marketing and commercial positions (from product marketing at country level to global marketing strategy).

Vaccines, Drugs, Biologics, Generics, Biotechnology, Biosimilars