Expert Details

Expert in Medical Device, Diagnostic, and Pharmaceutical Clinical Trial Design and Strategy

Expert ID: 723165 Colorado, USA

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Expert has over 25 years experience in commercializing medical products. Her experience includes management at Abbott Labs in clinical research and regulatory affairs and as a CEO of a venture capital backed medical diagnotic company. Expert has raised venture money and obtained SBIR grant, and executed licenses. Currently, she is an advisor to NIH on commercializing medical products, as well as a consultant to medical startups. In particular she is helping companies with clinical and FDA strategy and raising venture capital. Expert also conducted successful FDA audits and was a certified quality engineer.

Prinicipal advisor to National Institute of Health. Advise a portfolio of SBIR grantee companies in clinical/regulatory strategy, and raising venture capital.Advise a medical startup company on their development plan including clinical and basic science trials.Advise UCAR on their technology spin-outsAdvise a venture capital firm regarding due diligence on a medical startupAdvise a medical device company on clinical strategy.

Expert may consult nationally and internationally, and is also local to the following cities: Denver, Colorado - Colorado Springs, Colorado - Aurora, Colorado - Fort Collins, Colorado - Arvada, Colorado - Westminster, Colorado - Boulder, Colorado - Greeley, Colorado - Longmont, Colorado - Cheyenne, Wyoming

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Education

Year Degree Subject Institution
Year: 1980 Degree: PhD Subject: Physiology Institution: Tufts School of Medicine
Year: 1974 Degree: BS Subject: Zoology Institution: University of New Hampshire

Work History

Years Employer Title Department Responsibilities
Years: 2005 to Present Employer: Undisclosed Title: Principal Department: Responsibilities: Principal Consultant
Years: 2002 to 2005 Employer: University of Colorado Title: Director, Technology Transfer for Health Sciences Department: Technology Transfer Responsibilities: Managed inventions, licensing, and startup agreements originated at the University of Colorado's Health Sciences Center
Years: 1990 to 2001 Employer: Biex, inc. Title: CEO and Director, Founder Department: Responsibilities: Founded Venture Capital-backed medical diagnostics company. Obtained FDA approval, partnered with major pharma and developed market for labor prediction diagnostic. Company sold to Adeza, Inc.
Years: 1986 to 1990 Employer: Dullien Associates, Inc. Title: Principal Department: Responsibilities: In charge of project work; addressed needs of both major pharma and recent start-ups. Medical consulting in various areas, including clinical study set-up, regulatory issues, sales training, medical writing and pharmacokinetic data auditing.
Years: 1980 to 1986 Employer: Abbott Laboratories, Inc. Title: Manager, Regulatory Affairs and clinical research quality assurance Department: Responsibilities: Progressed to Manager of Regulatory Affairs

International Experience

Years Country / Region Summary
Years: to Present Country / Region: Great Britain Summary: She is advising a company on clinical trial strategy

Career Accomplishments

Licenses / Certifications
Ph.D
Professional Appointments
Board Director of UCAR, Principal Advisor to NIH
Publications and Patents Summary
She has three issued patents, and 16 publications

Additional Experience

Expert Witness Experience
She has experience being an expert witness for Fortune 100 company in the area of FDA approved product label. Represented Abbott Labs in depostions and hearings.
Training / Seminars
She has developed sales training material for medical device and pharmaceutical companies. Also developed training material for physician continuing education classes.
Marketing Experience
She was an executive for a venture capital backed company that launched a new medical device. She is also currently a consultant to startup medical companies entering the market as well as an advisor to NIH commercializaton program. Also a Board Director to UCAR of the National Center of Atmospheric Sciences to help launch new products and services.
Other Relevant Experience
Raised over 50 million in venture capital funding. Assisted companies in obtaining SBIR grants. Experience includes being a CEO of a venture capital backed company as well as a Board Director.

Fields of Expertise

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