Insight: Preventing a Preclinical Dead End

Oncology preclinical studies are commonly viewed as straightforward investigations run exclusively by researchers.  Tasked with finding molecules that stop cell growth, researchers often operate independently without true integration with the preclinical, regulatory and clinical teams.

Dr. Mike McGarry, a preclinical research scientist with 35 years of experience generating high quality animal-based data, advocates for a more synergistic approach.  In an upcoming issue of "Peer Perspectives in Oncology," he weighs in on the typical preclinical process and shares insight that can help CMOs extract more useful information that aids drug development and speeds overall progress to phase I.

One of the big issues Dr. McGarry commonly sees is a chasm between a sponsor’s preclinical and clinical teams.

"Preclinical researchers are extremely technical and scientific; they’re focused on microscopic details of various tissue or organ side effects," he explains.  "On the other side, the CMO is pushing to move a drug forward while managing costs to meet the company’s targets.  That forward momentum can create friction with the conservative, tentative nature of the research scientist who is watching the nuances unfold and has perhaps a very different perspective on the trial."

Without close communication and integration, preclinical experimentation can lead to a regulatory brick wall, a scenario no CMO wants to experience.

"I’ve spent most of my career in preclinical experimentation, and it's an expensive funneling process," he continues.  "You start with thousands of compounds and eventually narrow it down to the one that warrants close scrutiny, hopefully making it into clinical study and application. As you’re narrowing the field, the preclinical team also has to focus on the end goal or you can easily end up in a place that has no utility."

For a CMO, the answer is to get more involved in the preclinical process to gain insight, lead the study direction and prevent the silo effect from derailing a promising drug.

"There needs to be ongoing, seamless communication and integration among the clinical, regulatory and pre-clinical teams," he adds. "Communication affects the quality of results to be reported and thus the usefulness of the data.  Each team should be actively involved in feasibility dialogue at each step in the study."

The complete interview is one of several slated to be published this summer.  You can sign up to be notified via email here.