TAMPA, Fla.—Drug development services provider Covance Inc.,has announced an exclusive alliance and services agreement with M2Gen, thebiotech subsidiary of the Moffitt Cancer Center, to create a powerful newprogram to promote faster patient recruitment for biomarker-driven oncologytrials.
The two organizations will together offer biopharmaceuticalclients the ability to match potential patients for biomarker-driven oncologytrials with the right treatment or clinical trial. This normally challengingprocess will be sped up through the use of M2Gen's Total Cancer Care datawarehouse, a database developed at Moffitt Cancer Center that consists oflongitudinal clinical records on more than 95,000 cancer patients. Covance willbecome the preferred provider for M2Gen for DNA/RNA sequencing, gene expressionanalysis and genotyping analysis services, which will be conducted at theCovance Genomics Lab in Seattle.
"M2Gen and Covance have essentially created a 'one-stopshop' for biomarker-driven clinical trials in oncology with unmatchedgene-based trial design and patient-matching expertise," says Frank Makosiej,executive director of operational strategy and planning and clinicaldevelopment services at Covance.
The key beneficiaries of this service are threefold. First,the matching program benefits patients who are in need of a clinical trial.Patients—and even their doctors—typically have no way to know which clinicaloncology trials are available in real time. Under this program, patients donatesamples to be considered and will have consented to be re-contacted when amatching trial becomes available.
"Patients are usually thrilled to get the call—and so aretheir doctors—if they have the need for a clinical trial," says Dr. WilliamDalton, founder and CEO of M2Gen.
Second, the program should benefit biopharmaceutical clientsby dramatically reducing the timeline for identifying suitable participants forenrollment in clinical trials, and allowing for much quicker enrichment oftrials.
"In one case, in three months we found 37 patients to enrollin a trial—we identified perhaps 10 times that many who were eligible," saysDalton. "This client was able to complete a Phase II trial in 10 months—that'sreally unheard of."
Finally, the program also stands to benefit clients that mayrequire additional information in order to write their trials. Many clients mayhave a biomarker of interest, but don't yet know its prevalence, or may beunsure as to which populations will show it. The service will be able toprovide in-silico trial design, helpingthe sponsor to write their trial.
"Both Covance and M2Gen are working with a number ofbiopharmaceutical companies with strong oncology pipelines who could benefitfrom the services and expertise that our two companies can provide in helpingthem accelerate their drug development plans, make better decisions and identifypatients for the trials more quickly—all to support the goal of bringing newmedicines to patients," says Makosiej.
Currently, physicians at the 18 participating sites that usethe Moffitt Cancer Center's protocol invite new patients to enroll; however,the program is expanding. Future goals include creating a national healthresearch information exchange so that any patient anywhere could enroll in theprogram to be matched quickly to a clinical trial.
M2Gen had been in exclusive partnership with Merck from 2006to 2012 to build the infrastructure of the patient-matching protocol. M2Genreached out to contract research organizations once it had the freedom to do soafter the partnership ended. Covance, which offers its clients a range of drugdevelopment services from discovery through commercialization, saw M2Gen as theideal partner to help to provide its biopharmaceutical clients with solutionsfor their biomarker-driven oncology trials.
Covance is one of the world's largest and most comprehensivedrug development services companies with annual revenues exceeding $2.2 billionand more than 11,750 employees worldwide. Its expertise and capabilities indiscovery, genomics and biomarkers, as well as patient stratification andpredictive modeling, allow it to collaborate with clients through drugdevelopment programs. Headquartered in Princeton, N.J., the company hasconducted more than 130 clinical oncology trials across several tumor types inthe past five years on behalf of biopharmaceutical sponsors.
M2Gen is Moffitt Cancer Center's wholly owned, for-profitsubsidiary. M2Gen's Total Cancer Care data warehouse is one of the largestcancer-focused databases of its kind in the world. The database consists oflongitudinal clinical records on more than 95,000 cancer patients who haveprovided consent to be followed over the course of their lifetime, have theirtumor studied using molecular technologies and be re-contacted for clinicaltrials. More than 33,500 tumor specimens have been collected and generated, andmore than 20,000 molecular data files have been generated by studying thesespecimens.