The University of California San Francisco Catalyst Program: An Innovative Approach to Supporting Collaborative Academic Drug Discovery

Abstract

The University of California San Francisco (UCSF) Catalyst program is an innovative technology translation mechanism, which supports the development of therapeutics, devices, diagnostics and digital health applications from academic research.The development of therapeutics is considered to be the most challenging area with highest risk of failure, costs and longest timelines. It is widely recognized that there is often a significant knowledge, expertise and capability gap between bench research in an academic environment and the requirements for successful development of therapeutics to achieve licensing or further investment. This includes the development of robust and appropriate target validation datasets, product profiles, hit discovery, compound optimization (i.e. medicinal chemistry, pharmacokinetics, pharmacology, formulation), candidate profile, regulatory documentation & development/regulatory and commercial strategy etc. The majority of academic centers do not have access to in‐house expertise and capabilities in these areas.The UCSF Catalyst program identifies high‐potential projects, links them to the key expertise and capabilities (industry expert advisors, CROs, collaborators) required by the project and funds key activities, with the goal to securing the next stage of investment. The UCSF Catalyst has assembled more than 200 Catalyst Advisors, who are experts from all sectors of the biomedical industry who review projects and and provide consultation and mentorship for projects with the highest product and commercialization potential based on assessment criteria that prioritize unmet need, innovation, develop‐ability, commercial potential and intellectual property. The Catalyst advisors serve as mentors and technical consultants to innovators whose projects are selected to receive funding, which ensures efficient and effective use of limited capital and increases the likelihood that the projects deliver viable and commercializable solutions. The catalyst program also supports the development of academic‐industry collaborations.In 11 cycles, over 5 years, to date Catalyst has supported over 40 therapeutics projects (~50:50 Small molecule: Biological). The majority of projects are in the early target validation through to hit discovery and initial optimization phases. The most frequently required support is with regard to expertise in target validation requirements, support for in vitro or in vivo proof of principle studies, identification and supply of suitable tool compounds, hit identification, competitive landscape and development strategy. In later stage projects, Catalyst advisors have been actively involved in regulatory discussions and the preparation of INDs.Since its initiation 6 years ago, projects supported by the Catalyst program (all tracks) have resulted in more than ten new start‐up companies and many disclosures or patents. Catalyst's return on investment has been greater than ten ‐fold. Many of the therapeutics projects have received significant follow‐on funding and have made significant progress towards clinical assessment. The Catalyst mechanism is a successful approach to enabling the translation of novel therapeutics from the academic bench to the clinic and product development.Support or Funding InformationThe UCSF Clinical and Translational Science Institute (CTSI) is part of the Clinical and Translational Science Award (CTSA) program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) (Grant Number UL1 TR000004)