How can medtech, life science and biopharma innovators know their product is ready for preclinical testing? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg joined Renovo Biomedical’s Anna Fallon on January 14, 2021 to answer that question. 

“How quickly can you get your feasibility study to look like your GLP study? When you’re doing any level of pre-GLP preclinical studies, you have to maximize the value of the information you are getting. You never want to go into verification and validation testing without knowing the answer to your questions. You always want some data suggesting that you will meet the objectives of your GLP study. If you are going into GLP with an article of faith that you are going to pass, that’s a very expensive experiment.”

Questions addressed:

  • At what points should you plan for a preclinical study during early stages of product development? 
  • Is a pilot study right for your technology? 
  • What exactly does GLP mean?
  • What boxes should you check before starting a good laboratory practices (GLP) preclinical study?
  • When should you engage the FDA to confirm your preclinical testing plan?
  • How should medtech and life science innovators vet preclinical partners?
  • What should you expect from a prospective preclinical partner before you sign a contract?

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About GCMI

GCMI helps verify, validate and accelerate commercialization of new medical technologies that save lives and improve patient care. From our Northyards and 14th Street facilities in midtown Atlanta, we help find the finish line for medtech innovations at any point on the pathway from bench to bedside including pilot, feasibility and GLP preclinical studies.

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