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 Expert  723165

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

Available for your Consulting and Expert Witness Needs

Colorado (CO)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

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.

business development


clinical measurement


clinical medicine


clinical protocol


clinical research


clinical research management


clinical study


corporate strategic planning


drug development




Good Clinical Practice


investigational drug


pharmaceutical industry


pharmaceutical drug


proposal writing


SBIR grant writing


small business


strategic planning

Show Secondary and Basic Areas of Expertise
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;  and Cheyenne, Wyoming.

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

Work History:
Years   Employer   Department   Title   Responsibilities

2005 to







Principal Consultant

2002 to 2005


University of Colorado


Technology Transfer


Director, Technology Transfer for Health Sciences


Managed inventions, licensing, and startup agreements originated at the University of Colorado's Health Sciences Center

1990 to 2001


Biex, inc.



CEO and Director, Founder


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.

1986 to 1990


Expert Associates, Inc.





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.

1980 to 1986


Abbott Laboratories, Inc.



Manager, Regulatory Affairs and clinical research quality assurance


Progressed to Manager of Regulatory Affairs

Career Accomplishments:


Professional Appointments

Board Director of UCAR, Principal Advisor to NIH

Publications and Patents Summary

She has three issued patents, and 16 publications

Selected Publications and Publishers  
 - American Journal Obstetrics & Gynecology  

Consulting Services:
Selected Consulting Examples:
  • 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-outs
  • Advise a venture capital firm regarding due diligence on a medical startup
  • Advise a medical device company on clinical strategy.
Recent Client Requests:
  • Expert FDA medical device strategy expert for consulting on new medical diagnostics and devices.
  • Expert in intota for consulting on on Experimental Design.
  • Clinical test design expert for consulting on Design of Clinical Study.
  • Expert for consulting on Due Dilligence - Clinical Laboratory.
  • Expert in SBIR for consulting on SBIR grant application.
  • Expert in national implant registry for consulting on application of NIH SBIR phale I grant.
  • Packaging validation expert for consulting on document.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
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.
Recent Litigation Client Requests:
  • Clinical test design expert needed for consulting on NIH-funded research on hip protectors.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Country / Region   Summary
Great Britain   She is advising a company on clinical trial strategy

Market Research:
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.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:

She has developed sales training material for medical device and pharmaceutical companies. Also developed training material for physician continuing education classes.

Other Skills and Services

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.


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