BioSketches

Michael Huston

Michael Huston

Michael Huston

 

B.S. Microbiology, Purdue University

MBA, St. Mary's College of California

Regulatory Affairs Certification

Over 30  years of R&D, directing and implementing development of novel  biopharmaceuticals and medical devices. Clinical, regulatory operations,  and market strategies for commercialization.

Project and team  management in all phases of development: Discovery, IND, clinical  trials, NDA/BLA, and commercial launch, including FDA interactions with  several therapeutic divisions.

Risk assessment (technical, regulatory, commercial, timelines and costs; Monte Carlo scenarios) and mitigation planning

Alliance management of development partnerships, domestic and international


Managed multi-million dollar federal research programs in pathogen inactivation and vaccines 


University of California, Santa Cruz 

- Program Chair, Clinical Trials Design and Management Certificate 

- Science of Clinical Trials Design instructor

On-site training in clinical drug development

Marcia Cho

Michael Huston

Michael Huston


B.S. Business, San Francisco State


Over 30 years Human Resources experience.    Positions up to Director  for Cetus Corporation, Lucky Food Stores, Webvan, Clorox,  Chiron/Novartis, & Onyx Pharmaceuticals. 

- Director, Human Resources

- Compensation Analyst

- Executive Compensation planning for recruitment and retention for pre- and post-IPO biotechnology companies