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Accelerating biosimilar/biobetter development in Asia-A CRO/CMO perspective
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Journal of Bioanalysis & Biomedicine

ISSN: 1948-593X

Open Access

Accelerating biosimilar/biobetter development in Asia-A CRO/CMO perspective


2nd International Conference and Exhibition on Biowaivers & Biosimilars

September 23-25, 2013 Hilton Raleigh-Durham Airport at RTP, NC, USA

Shude Yan

Accepted Abstracts: J Bioanal Biomed

Abstract :

With an increasing number of "blockbuster" level biopharmaceutical patents about to expire, and with strong government support of the sector, China presents a huge market for biosimilars. However, the competition will also be equally harsh. How to differentiate your product will be major challenge, so biobetters with a clear advantage from a spectrum of generics will become new opportunities of the future. Furthermore, the timing to enter the market will be critical for the commercial success of the drug, thus it may be a good idea to directly develop a second generation drug when similar drugs against the same target are still waiting to be approved. In recently years, China is gradually closing the technology gap with the developed nations in biologics drug development. In Shanghai, we have developed a platform to rapidly generate biobetters or second generation drugs with fully human sequence, higher affinity, and potentially better PK and other drug properties. We have also achieved high-efficiency cell line engineering, as well as large scale production of biologics including ADC (antibody drug conjugate). This provides a general platform to help biopharma accelerate the development of biosimilar, biobetter or innovator drugs in China and abroad.

Biography :

Shude Yan received his Ph.D. in the field of Protein Engineering from University of Rocheter Medical Center in 2004. He then joined UCSF for postdoc training and subsequently worked as research scientist in developing therapeutic antibodies for a major Biodefense project lead by professor James Marks. In 2011, he joined Shanghai ChemPartner to set up a fully human antibody discovery and optimization platform, in helping global clients accelerate the development of innovator, biosimilar, as well as next generation therapeutic antibodies.

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Citations: 3099

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