8^th Asian Biologics and Biosimilars Congress August 10-12, 2017 Beijing, China

Dr. Chance has over 25+ years of work experience in the healthcare industry, including over 18 years in regulatory affairs at CRO, CMO, and pharmaceutical/biotechnology companies. She has spearheaded strategic global development for number of biosimilar products and has authored and/or co-authored number of articles on biosimilars. Dr. Chance has provided global regulatory strategy for number of biosimilar products currently in development including biosimilars of Enbrel, Remicade, Herceptin, Rituxin/Mabthera, Humira, Avastin, Aranesp, Epogen, Recombinant Insulins, Forteo and Neupogen/Neulasta. Dr. Chance has authored/co-authored number of articles on biosimilars: • Investment Decisions Based on Biosimilar Programs, Part 1 • An Integrated Approach to Biosimilar Development & Commercialization • Elucidating Biosimilars Characterization • The Biosimilar Landscape: A Systematic Review of Its Current Status • Operational Challenges Associated with Biosimilar Drug Development • A Model for Expeditious Progress to a Phase 3 Trial • Biosimilars in rheumatology: understanding the rigor of their development… & many more…

Biosimilars, Biologics, Biosimilars Characterization, Drug Development

Dr. Iliach, Ph.D. is a Senior Director Global Regulatory Strategy and CMC at the Biosimilar Center of Excellence, QuintilesIMS. She has more than 15 years’ experience in healthcare industry, including the last 10 years in regulatory affairs. Her expertise lies in the development of global regulatory strategy for biosimilars with the focus on overall quality and CMC compliance. She has provided a global regulatory strategy and was involved in CMC development for number of products including biosimilars of Avastin, Herceptin, Humira, MabThera/Rituxan. She has a particular focus and expertise in regulatory and CMC requirements for biosimilars and regularly presents and writes on the topic. She has a PhD in Pharmaceutical Science from St. Petersburg Chemical and Pharmaceutical Academy, Russia. Oxana is also a professor at Seneca College of Applied Arts and Technology, Toronto, Canada and a member of CAPRA (Canadian Association of Professionals in Regulatory Affairs) and RAPS.

Biosimilars and Biologics Product Development, Characterization, Regulatory Intelligence

Dr Fratazzi devised the concept of a Strategic Clinical Innovation Organization (SCIO) and founded the first SCIO –Boston Biotech Clinical Research (BBCR), LLC in 2009, with the objective of actively contributing to innovation in streamlining clinical research and developing strategic clinical regulatory pathways to product approval. Dr. Fratazzi has worked on several Biosimilars’ development with special attention to the major variables that impact costs. As the President of BBCR, LLC, Dr. Fratazzi acts as a consultant to biotech, pharmaceutical medical device companies, and investors on optimum clinical plan development and how to design clinical trials that reduce product development risk. She is a renowned Immunologist with over 15 years of experience in Orphan Petitions in US and EU and phase 1-4 clinical programs, contributed to the registration and approval of 4 successful products.Dr. Candida Fratazzi expertise includes Drug, Device as well as Combination Products. . Recipient of 2013, 2014 and 2015 Best Pharmaceutical Consultant, Cambridge Award, 2015 Cambridge Business Hall of Fame Award,and 2014 Top Ranked US Executives, National Council of American Executives. Act as Member of Advisory Board and Board of Directors in Life-science

Biologics and Biosimilars

Dr Fratazzi devised the concept of a Strategic Clinical Innovation Organization (SCIO) and founded the first SCIO –Boston Biotech Clinical Research (BBCR), LLC in 2009, with the objective of actively contributing to innovation in streamlining clinical research and developing strategic clinical regulatory pathways to product approval. Dr. Fratazzi has worked on several Biosimilars’ development with special attention to the major variables that impact costs. As the President of BBCR, LLC, Dr. Fratazzi acts as a consultant to biotech, pharmaceutical medical device companies, and investors on optimum clinical plan development and how to design clinical trials that reduce product development risk. She is a renowned Immunologist with over 15 years of experience in Orphan Petitions in US and EU and phase 1-4 clinical programs, contributed to the registration and approval of 4 successful products.Dr. Candida Fratazzi expertise includes Drug, Device as well as Combination Products. . Recipient of 2013, 2014 and 2015 Best Pharmaceutical Consultant, Cambridge Award, 2015 Cambridge Business Hall of Fame Award,and 2014 Top Ranked US Executives, National Council of American Executives. Act as Member of Advisory Board and Board of Directors in Life-science

Biologics and Biosimilars

Dr Charu has comprehensive experience in clinical development of healthcare products, and expertise spanning complete clinical product development and post authorization lifecycle management. She has worked in all stages of clinical drug development from Phase 1 through to commercialization. She has over 20 years of experience in healthcare industry including 15 years in the pharmaceutical industry. She has also led clinical development of pharmaceuticals and biosimilars in a variety of therapeutic areas, with primary focus on infectious diseases, diabetes and metabolism, has led cross functional team for global development of a biosimilar product, coordinating discussions and planning, leading up to scientific advise meetings with the EMA, has led evaluation and provided technical inputs for clinical development of several biosimilars including filgrastim, pegfilgrastim, erythropoietin, darbepoetin, teriparatide, interferon β, rituximab, etanercept, adalimumab, trastuzumab and bevacizumab.

Clinical development of healthcare products, Drug development, Biologics and Biosimilars

Raymond A. Huml, MS, DVM, RAC is Vice President, Strategic Drug Development and Head, Global Biosimilars Strategic Planning, at QuintilesIMS. Dr. Huml has written over 60 articles on a variety of subjects and three books. He has more than 27 years of experience in the biopharmaceutical and healthcare industries and holds an MS in biology from East Stroudsburg University, a DVM from the North Carolina State University College of Veterinary Medicine, and has earned the RAC (US) certification.

Drug Development, Global Biosimilars Strategic Planning, Biopharmaceutical and Healthcare

Raymond A. Huml, MS, DVM, RAC is Vice President, Strategic Drug Development and Head, Global Biosimilars Strategic Planning, at QuintilesIMS. Dr. Huml has written over 60 articles on a variety of subjects and three books. He has more than 27 years of experience in the biopharmaceutical and healthcare industries and holds an MS in biology from East Stroudsburg University, a DVM from the North Carolina State University College of Veterinary Medicine, and has earned the RAC (US) certification.

Drug Development, Global Biosimilars Strategic Planning, Biopharmaceutical and Healthcare.

Suzette DiMascio, is President/CEO of the CSI Specialty Group, a globally recognized; WBE Certified Leadership Consulting Firm helping healthcare clients drive sustainable, accelerated growth. Recognized internationally as an industry expert in Specialty Pharmacy, Suzette is a frequent speaker, thought leader & sought after educator on strategic marketplace trends.In 2016, Ms. DiMascio received APPA’s Hall of Fame Award – given as a reflection of her 20 years dedication to the industry.Under Suzette’s leadership, CSI Specialty Group has become known as the Industry’s Most Influential Leader in Specialty Pharmacy Consulting & Talent Acquisition, awarded Consulting Magazine’s Fastest Growing Firms, ranking 5th out of 50, Chosen as one of Goldman Sach’s Top Growing Businesses & awarded Top 50 Women Owned Business by the The Common Wealth Institute.

Biosimilars, Biologics, Pharmacy, Healthcare

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

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

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 Biosimiars 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

Dr. Osama Ibrahim is a highly-experienced Principal Research Scientist with particular expertise in the field of microbiology, molecular biology, food safety, and bioprocessing for both pharmaceutical and food ingredients. He is knowledgeable in microbial testing, microbial screening, culture improvement, molecular biology and fermentation research for antibiotics, enzymes, therapeutic proteins, organic acids and food flavors.Since 1979 he is a member of American Chemical Society, American Society of Microbiology, and Society of Industrial Microbiology.

microbiology, molecular biology, biotechnology, food safety and bioprocessing

James Harris III: CEO: has extensive experience within biotech, pharmaceuticals and medical devices, with small start-ups, mid-sized and large firms. Mr. Harris is the founder of Healthcare Economics LLC,co-founder of AS Biotech AG and participates on the board of directors as well as advisory board for various firms. Prior to this he served as General Manager and Vice President at Dragon Pharmaceuticals, Inc. where he was instrumental in the launch and successful market penetration of rh-Erythropoietin (“EPO") in international markets and is very well experienced in product licensing, business development, market access and reimbursement.

Biosimilars, biotech, pharmaceuticals and medical devices

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 organisation is evolving to service life sciences industry requirements.

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

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 organisation is evolving to service life sciences industry requirements.

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