Description

Online registration ends at 3:00 PM on Tuesday, March 24th; however, onsite registration will be available starting at 3:30 PM on March 25th.

Denali Therapeutics made a strategic decision to bring clinical biomanufacturing in-house to accelerate development of therapies for neurodegenerative disease while increasing flexibility and supply chain control. This presentation will share how Denali leveraged an integrated design-build model to quickly and efficiently plan, design, and deliver its first GMP clinical manufacturing facility. 

In 21 months and under budget, the Amelia Earhart site opened in 2025, and a year later, the team has already achieved 9 runs and counting. In this presentation, Denali’s VP of Clinical Manufacturing and CRB’s Lead Project Architect will walk you through key design and execution strategies that supported the project’s success. Topics include the use of a ballroom-style cleanroom, single-source systems, future-ready planning, a specialized partner incentive structure, and streamlined decision-making at every stage. Attendees will gain insight into how even biopharma startups can enable in‑house manufacturing while maintaining compliance, flexibility, and speed in a highly dynamic clinical environment.

Looking to engage with professionals in the life science community? Sponsorship includes complimentary event tickets, verbal recognition during welcome remarks, and logo placement on the event webpage and marketing materials! It's a great opportunity to connect with the Bay Area life sciences community while supporting this industry event.
Headline Sponsor – $1,000
Food & Beverage Sponsor – $550

PRESENTERS

Leah Frautschy, Vice President, Clinical Manufacturing and Salt Lake City Site Head at Denali Therapeutics
Leah Frautschy is the Vice President, Clinical Manufacturing and Salt Lake City Site Head at Denali.  She is responsible for leading Denali’s clinical manufacturing site in Salt Lake City, UT. Leah has over 30 years of experience in process development, manufacturing, facility engineering and senior leadership roles at Genentech and Denali.  Her broad background includes initiatives in quality improvement and extensive health authority interactions.  Her most recent role before joining Denali was the Senior Director of Engineering for the Genentech Clinical Supply Center facility in South San Francisco - a Facility which went on to win the ISPE Overall Facility of the Year Award in 2023. Leah holds a Master of Engineering in Professional Practice degree from University of Wisconsin, Madison and a Bachelor of Chemical Engineering degree from the University of Minnesota, Twin Cities. 

Abigail Jones, AIA, LEED AP BD+C, Project Architect at CRB
Abigail has over 10 years of architectural experience, regularly leading complex projects and managing multidisciplinary teams from concept through construction. Her focus is in the biopharma space, with experience spanning academic R&D facilities to large corporate biotech manufacturing campuses.  Her project highlights include a 100,000-square-foot academic research facility, a site-agnostic, a 400,000-square-foot core and shell facility with clinical manufacturing and support spaces, and a GMP clinical trial facility using a fully integrated design-build method.