California Life Sciences Association (CLSA) invites you to join us for our third-year anniversary celebration and open house at our brand-new Events Center and state-of-the-art office space in South San Francisco!

We have partnered with HUB and VWR to introduce all our Northern California members to the CLSA team as well as exhibiting CLSA’s Business Solutions and Member-to-Member program suppliers.

Meet our power purchasing partners and discover how your company can realize up to 80% in savings ranging from lab supplies to employee benefits.  We’ll be taking over our new office location with local beer, wine and food trucks for a casual celebration to thank all of our members.

This seminar provides a view of what to expect when a medical device manufacturer receives notification of an
FDA quality system inspection and suggestions for policies that can expedite inspections with more favorable
outcomes. Having foresight into what topics/questions/records are typically covered during an FDA inspection
helps a manufacturer to be better prepared for expediting the inspection and minimizing the number deficiencies
the investigator may find, i.e.: FDA483 Inspectional Observations. Depending on the device, the inspection can
cover FDA regulation sections §803, 806, 820, and 1000-1040. The seminar will also cover some FDA-483
Inspectional Observations.

Note: We believe this will be a well-attended Round Table. Be sure to reserve your seat soon. There will be a practical limit of 90 attendees. Please register early to ensure admission.

Speakers: Gjalt Huisman, SVP, Strategic Development (Codexis)
Organizers: 
Date: 2019-07-26
Time: 11:30-13:30 Pacific Time
Registration fee (USD): Food: $0.
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: 
Vendor show vendors registered to date: (3)BUCHI Corporation; CoreRx; MicroConstants
Registration: https://www.PBSS.org
Registration deadline:2019-07-25  (it will close sooner if the seating cap is reached)

About the Topic

Over the past 17 years, Codexis has applied its CodeEvolver® protein engineering platform to enable the efficient manufacture of small molecule pharmaceuticals at commercial scale. Recently, learnings from such programs inspired the development of therapeutic enzymes that are stable for function in the upper intestines, or that have been improved for systemic delivery via extension of  serum and lysosomal half-life, and reduced (predicted) immunogenicity. This presentation will highlight technical developments in both areas and provide a perspective on future implementation of this technology in the pharmaceutical industry.

Traditional drug development is often quoted as requiring over $1billion and more than 10 years to bring a new drug to market. Scientists at twoXAR use their proprietary computational drug discovery platform to discover, screen, and prioritize novel drug candidates with potential applications in many disease areas.

Pharma has been lagging behind many other industries in incorporating AI into their processes. More recently however, AI techniques are beginning to be applied across the entire drug discovery and development process, from designing new molecules and performing predictive analytics to supporting clinical trials. Andrew will navigate from the conceptual to the practical applications of AI, illustrating where AI is being used in healthcare, and describing how to leverage the capabilities of AI for significant improvements in drug discovery and development.