Managing Clinical Trials

New VP of Preclinical Studies to lead new oncology preclinical research services

We’re pleased to officially announce that Mike McGarry, Ph.D. has joined Medelis as VP of Preclinical Studies.  Dr. McGarry will lead a new service offering to provide preclinical study design, management and execution for our biotech and pharmaceutical clients around the world.

"Adding preclinical services allows us to provide a complete offering for biotech and pharmaceutical companies developing oncology drugs," said Medelis’ Chairman and CEO Bob Bosserman.

"We can deliver a full spectrum of services that allow our client sponsors to outsource more of their technical development work, with concomitant savings in time and money, without sacrificing a clear strategic plan for their drug candidates," he continued.  "For our clients, getting to the right result, with a minimum of risk and at a reasonable cost, is the key deliverable at every stage in the development process."

"The value for Chief Medical Officers is that we can work to bridge their preclinical study design and execution with their clinical team," said Dr. McGarry. "We can help CMOs avoid regulatory obstacles and delays, but more importantly, this well-coordinated process can yield stronger drug candidates for phase I clinical trials."

Under Dr. McGarry’s leadership, Medelis will design and execute oncology preclinical studies using specialized oncology research models while handling technical writing, laboratory services, toxicology consulting and regulatory submissions.  The company will work with clients to develop precise animal-based, IACUC-approved protocols, selecting the most suitable contract lab to perform the research.  Medelis will oversee all study execution and interpretation of results.

Medelis’ preclinical research offerings include:

• Feasibility Studies – exploratory, with several tumor lines
• Proof of Principle – definitive, demonstrative experiments
• Model development
• Efficacy of therapy in a defined animal model
• Endpoints

Links to more information:  Preclinical research services, Mike McGarry bio. 

We also invite you to download our recent Insider Abstract, "Preclinical Trials:  A Nuanced Approach to Get Into the Clinic Faster," an in-depth interview with Dr. McGarry.

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

Medelis 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.