Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 8th Asian Biologics and Biosimilars Congress Beijing, China.

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Day 1 :

Keynote Forum

Kamali Chance

Vice President, Quintiles, IMS, USA

Keynote: FDA/EMA current thinking on totality of evidence for development of biosimilars
Asian Biosimilars International Conference Keynote Speaker Kamali Chance photo
Biography:

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…

Abstract:

The regulatory landscape for the development of biosimilars in the US and EU is dynamic as many of the guidance issued by European Medicines Agency (EMA) have recently undergone revisions and the FDA has issued number of revised guidelines for quality and scientific considerations as well as updated questions and answers documents that lend much needed clarity. FDA has also issued final guidelines for nonproprietary naming of biological products as well as draft interchangeability guidance. This session is designed to provide current status of biosimilar guidelines in the US and EU. The focus will be to identify major updates in order to help sponsors navigate through the complex requirements for the regulatory approval of biosimilars in the US and EU.

Keynote Forum

Jianguo Yang

President / CEO, Abpro China, USA

Keynote: Strategic partnership for China biologics
Asian Biosimilars International Conference Keynote Speaker Jianguo Yang photo
Biography:

Dr. Jianguo Yang, is the Vice President of Abpro, USA and the CEO of Abpro, China. He was the principal scientist , leads late stage biologics commercial projects at Genzyme/ Sanofi. Prior to Genzyme, he worked on early, late stage and commercial biologic drug development in MedImmune /Astrazeneca and Abbott labs , respectively . With over 16-year bio-pharm industry experience, and achieved world record high mammalian cell line productivity, he is an international recognized expert in biologics development, and frequently invited keynote speaker / chairperson / scientific advisor for international conferences, a member of Editor and Advisor Board for Bioprocess International Journal, reviewer for scientific and professional Journals, and authored numerous publications and patent applications. He holds both M.S. and Ph.D. degrees in molecular cell biology and biotechnology from Illinois Institute of Technology.

Abstract:

Biologic drugs on the market now have been results of some partnership from RD to commercialization. Increasing complexity of biologic drug development requires more collaborations or partnerships in biopharma industry. This presentation will review current status of biologic drugs market and articulate landscape and importance of strategic partnerships in biologic research and development, and future trends.

Keynote Forum

Raymond Huml

Vice Precident, Quintiles IMS, USA

Keynote: Biosimilars: Accelerating early clinical development
Asian Biosimilars International Conference Keynote Speaker Raymond Huml photo
Biography:

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.

Abstract:

This presentation will discuss how early clinical development with biosimilars is paramount to later development and registration success. It will provide an overview of ECD services successfully used for implementing Phase-I biosimilar trials in Asia Pacific as well as the West (e.g., US and EU) for global registrations. It will present an overview of site selection and feasibility data using a Next Generation approach driven by IMS legacy data to aid recruitment especially in tough areas to recruit patients for biosimilar trials such as the US and Europe. Finally, a model to accelerated biosimilar development will be presented that has been successfully used by one of the world’s largest providers of pharmaceutical services.