Preclinical Trials: A Nuanced Study Process to Get Into the Clinic Faster

Preclinical Trials: A Nuanced Approach to Get Into the Clinic Faster A Q&A with Dr. Mike McGarry, who describes a nuanced preclinical process that can help a Chief Medical Officer get into the clinic faster. This approach hinges on a strategic, well-defined rodent model, quality data, and ongoing integration between the preclinical, regulatory and clinical teams.

Welcome ,[object Object],[object Object]

Preclinical Trials: A Nuanced Approach to Get Into the Clinic Faster ,[object Object],[object Object]

About Dr. Mike McGarry, VP of Preclinical Studies ,[object Object],[object Object]

Mike, when a sponsor initiates a new preclinical study, what are the most important factors for a Chief Medical Officer to understand/ evaluate during this step in the drug development process? ,[object Object],[object Object],[object Object]

How rigorous is the regulatory assessment at the preclinical stage? ,[object Object],[object Object]

How common is it for a company to hit a regulatory wall at this stage? ,[object Object],[object Object]

How can a CMO work with the preclinical team to gain a better understanding of these complexities? ,[object Object],[object Object]

So the sooner you bridge any gaps between preclinical and clinical, the better? ,[object Object],[object Object]

It sounds as if preclinical and clinical teams often operate independently in their own silos. True? ,[object Object]

Can you discuss the typical preclinical process and the questions a CMO should be asking during this phase? ,[object Object],[object Object],[object Object]

Can you discuss the typical preclinical process and the questions a CMO should be asking during this phase? [continued] ,[object Object],[object Object],[object Object]

Are there any additional requirements unique to oncology preclinical trials? ,[object Object]

What’s the typical time frame for a preclinical study? ,[object Object],[object Object]

You have over three decades’ experience conducting animal studies. How important is depth of experience on the part of the preclinical investigator? ,[object Object],[object Object],[object Object]

What would you look for in an outside preclinical team? ,[object Object]

Can you discuss GLPs for preclinical work - are they always required? ,[object Object],[object Object]

Many groups have pushed for the elimination of animal-based studies. Is that a likely scenario down the road? ,[object Object],[object Object]

Can computational toxicology diminish the reliance on animal models in the future? ,[object Object]

How might personalized medicine affect preclinical work? ,[object Object]

So the animal model is here to stay? ,[object Object]

About “Peer Perspectives in Oncology” ,[object Object],[object Object]

About Medelis ,[object Object],[object Object]

Preclinical Trials: A Nuanced Study Process to Get Into the Clinic Faster

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Preclinical Trials: A Nuanced Study Process to Get Into the Clinic Faster