mAb Industry in China : Biosimilars vs Innovative Biologics
24th June 2019 | 4PM China Standard Time, 10AM GMT | Dr. Joe X Zhou, CEO at Genor Biopharma, Walvax Bio Group and Sarah (Xuyu) Wang, Head of Segment Marketing, Biosimilars and Bioconjugations at Sartorius Stedim Biotech |BOOK FREE SEAT
Following patent cliffs for Erbitux, Rituxan, Sandosta_n and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. In this presentation, Joe will be sharing with you his vision of the biosimilars market with a focus on China. He will also discuss key considerations for mAb and biologics therapeutic development, providing a broad overview of challenges and opportunities presenting in the market.
1. Landscape changes of mAb therapeutics
2. New targets and process/manufacturing innovation
3. Key consideration of mAb industry in China
4. Case study: Development strategies of PD-1 mAb as anti-tumor therapeutics in China for global market
Presented by Dr Joe X Zhou, CEO at Genor Biopharma, Walvax Bio Group
Previously, Dr. Zhou was a Scientific Director at Amgen, Thousand Oaks, USA. His over 20-years’ experience of process development, multiple project management capacity in cGMP and non-GMP reproducible purification/production of protein/antibody therapeutics made Dr. Zhou many times as Project Process Team Leader/Project Team Leader/Cross Functional Core Investigation Teams Leaders at Amgen in the past. Dr. Zhou was awarded as 2007 Amgen’s “Excellence in Science and Engineering” for his major achievement and leadership on photo-oxidation on monoclonal antibody yellowing. He has oral presentation over 150 times globally with more than 50 publications and about 20 patents on bioprocess, and selected by Amgen as a visiting professor teaching the GMP Master’s Degree Program at PKU, People’s Republic of CHINA since 2007.
Sponsored by Sartorius Stedim Biotech
Followed by Biosimilar development—how to deal with the similarity challenge
Globally we have more than 1000 biosimilars in the pipeline till the beginning of 2019, Sales of mAb biosimilars is also taking up as popular targets being approved both in Europe and US. With the 3rd wave of the biosimilar coming the challenges is still ahead—how to keep the similarity from the beginning of the development to the manufacturing stage and cover the whole lifecycle? With the evolving cell line development platform, good analytical strategy and QbD implementation better similarity will be achieved step by step.
Presented by Sarah (Xuyu) Wang, Head of Segment Marketing, Biosimilars and Bioconjugations at Sartorius Stedim Biotech
Ms. Wang has more than 20 years working experience in Biotech/Biopharm industry, previously mainly in China and now expanding to global market, she worked in several multinational companies from the supplier side and participated multiple biologics process development projects using cutting edge technologies. Starting from 2015 she and her team initiated single use technology guidance project in China with the representatives from regulatory body and industry opinion leaders, and the guidance was published in 2017 by CFDA. She also facilitated the global communication together with PDA and ISPE to drive the global regulation harmonization. Currently she is leading the Sartorius global marketing team for Biosimilars and Bioconjugations, with this platform Sartorius is supporting clients globally with the total process solution to produce more affordable biosimilars and innovative biologics, and in the end benefit to patients.