Warren Ku

Entrepreneur-in-Residence

Impact- and innovation-driven senior leader with broad scientific and people management experience in pharmaceutical research and development. Extensive experience in developing strategies and managing varied regulatory, investigational, and new technology activities to support drug discovery and development programs to deliver on company productivity and quality goals. Proven ability to:

· Lead in a global matrix environment across multiple disciplines.

· Deliver Investigational New Drug applications, support worldwide product approval submissions, line extensions, and resolve regulatory Chemical Manufacturing and Controls issues impacting development.

· Deliver early safety screening and mechanistic investigations to increase survival of lead chemical matter and development candidates.

· Influence the external environment in regulatory guidance development and revisions and development and promote scientific acceptance of new testing paradigms.

· Deliver digital data science solutions to facilitate preclinical drug development.