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Huston Associates, LLC

Scientific & Market Driven Biopharmaceutical Development Planning and Execution
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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


Publications click here

Email: mhuston@HustonAssociates.net


 

Marcia Cho

30 years of human resources experience in biopharmaceutical and consumer goods industries. Specializing in compensation policies and strategies.
 
Former positions up to Director for Cetus Corporation, Lucky Food Stores, Webvan, Clorox, Chiron/Novartis, & Onyx Pharmaceuticals.