NO MORE WAITING FOR TRIALS: M.D. Anderson, AstraZeneca forge master contracts to speed preclinical, clinical research

HOUSTON—Seeking new ways to improve both information sharing and hasten preclinical and clinical research of promising new cancer drugs, M.D. Anderson Cancer Center and AstraZeneca in early January announced the creation of master agreements governing the terms of research that should help shave months off the time between when a promising drug is identified and when it is brought to clinical trials.

 

The umbrella agreements signed by the two groups provide "templates" that will make the contracting of research services much faster. "[In the past] one of our scientists would contact a single investigator and start to move through a negotiation process to reach an agreement, where a collaboration could eventually take place," says Kevin Webster, Ph.D., director of cancer and infection drug discovery at AstraZeneca. "This would be repeated every time—not just with M.D. Anderson, but in general—and is pretty inefficient. Whereas with the umbrella agreements, we have a pre-agreed set of terms that are meant to cover any variety of research we want to do together, so we can quickly move through the contracting phases and get to the science. I'm hopeful that we could easily cut half a year off our process." 

 

These renewable, three-year master agreements also include provisions to give M.D. Anderson an earlier peek at promising AstraZeneca oncology programs to facilitate sharing of information from both clinical and preclinical work.

 

"The hope is that if we can work more closely with AstraZeneca and work with their most promising compounds at an earlier stage, we can help identify those biomarkers and identify promising drug combinations," says Dr. Robert Bast, vice president for translational research at M.D. Anderson.  "But it will also allow us to be primed and ready to move those [compounds] as rapidly as possible into intelligent Phase 1 and Phase 2 trials so we can minimize the delays."

 

To aid in the creation of integrated preclinical and clinical work, the two organizations have also agreed to create an alliance management team. Comprising researchers from both M.D. Anderson and AstraZeneca, the team will serve as the conduit for scientists looking to initiate research under the alliance.

 

Initial research under the collaboration will focus on aerodigestive diseases such as lung cancer, head and neck cancers or colorectal cancers. For M.D. Anderson, the scope of the umbrella agreements are the most extensive working relationship to date it has forged with a pharmaceutical company, but comes at a time when it was examining how to be more efficient in the design and execution of clinical trials.

"What we are doing with this agreement is addressing one of the key challenges in drug discovery, and that is how drugs move from the preclinical to the clinical phase," says Webster. "We are looking to further build our knowledge around the compounds in our pipeline and as they are transitioning through that phase into early clinical development," he says. "So we are looking to discover biomarkers of activity, tools that might allow us to select the right tumor type or the right patients to get these compounds and to move them through those early phases more efficiently."