Print Page   |   Contact Us   |   Sign In   |   Register
Community Search
CASSS NorCal Regional Forum Spring 2018: Scientific Program
Share |

 To view the preliminary program click here.


Program Abstract

Strategies on Shortening Process Development
Co-Chairs:  Michelle Frazier, Coherus Biosciences and Bryan Silvey, Kite Pharma, Inc.
The CASSS Northern California Regional Forum is committed to bringing job-relevant education and regulatory trends for biopharmaceuticals to CASSS members through meeting programs. The April forum will focus on strategies for shortening process development. The discussion will include content from other regional, national or international forums organized by CASSS and speakers from industry and FDA. The program will also provide a platform for networking with both peers and regulatory authorities.

The pharmaceutical development process for biological products is labor-intensive and time-consuming for companies and the patients that may ultimately benefit from these products. The advent of breakthrough therapy designations in the US and other global regions has certainly helped to bring important life-changing therapies to patients. However, development of robust manufacturing process for rapid development products often lags behind their rapid clinical programs. The recent entry of several cell and gene therapy products, often under rapid development, can also bring challenges to drug developers and regulators. This forum on rapid pharmaceutical development will provide a practical discussion on lessons learned in traditional breakthrough biologics products as well as cell and gene therapy programs from innovators and regulators alike.



Confirmed Speakers


Alice Chang
Five Prime Therapeutics Inc.


Accelerated Development: Challenges and Opportunities in a Rapidly Evolving World
Kin Tang, Genentech, a Member of the Roche Group

Scientific advancements have led to innovations in biomedical technology, novel therapeutic modalities, clinical study designs and regulatory sciences which present great opportunities for rapid development of innovative new medicines NMEs for patients with unmet medical need. However, this has also presented challenges to CMC scientists who must develop and deliver high quality products made by robust manufacturing processes within a significantly, compressed timeline. This presentation will review points for CMC development and regulatory considerations for accelerated development programs in a global setting.





more Calendar

4/9/2018 » 4/11/2018
HOS 2018

4/16/2018 » 4/17/2018
Bioassays 2018

Featured Members
Stephen E. Hartman, AbbVie Inc.Visit the CASSS News page to get to know Steve Hartman!

Membership Software Powered by YourMembership  ::  Legal