Oncology clinical research scientist recommends a nuanced preclinical study process to speed drug development

Mike McGarry, VP of Preclinical StudiesMedelis has just published the third issue of "Peer Perspectives in Oncology," our free Q&A series focused on issues that face Chief Medical Officers today: rising costs, optimum patient accrual, targeted therapeutics, patient safety, FDA regulations, efficacy, budgets, and timelines.

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

Dr. McGarry, VP of Preclinical Studies at Medelis, is a preclinical research scientist with 35 years of experience generating high quality animal-based data.  In the interview, he provides a detailed inside look at the issues that can speed or derail the oncology preclinical phase:

  • Critical factors for a CMO to understand and evaluate during this step in the drug development process
  • Regulatory assessments and how to avoid hitting a preclinical wall
  • The nuances and complexities of animal models, tumor selection, and other variables
  • How to keep the preclinical, regulatory and clinical teams involved in feasibility dialogue
  • The typical preclinical process and the questions a CMO should be asking at each step
  • Additional requirements unique to oncology preclinical trials
  • What to look for in an outside preclinical team.

The abstract is free, and you can download it here.  You can also download the first two issues in the series, "The Complete Phase 1b:  A Proven Approach to Getting to Phase II Faster," an interview with Dr. Dan Von Hoff, and "Patient Safety in Clinical Trials," a discussion with Dr. James Gourzis.