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Covance, M2Gen play matchmaker
TAMPA, Fla.—Drug development services provider Covance Inc., has announced an exclusive alliance and services agreement with M2Gen, the biotech subsidiary of the Moffitt Cancer Center, to create a powerful new program to promote faster patient recruitment for biomarker-driven oncology trials.
The two organizations will together offer biopharmaceutical clients the ability to match potential patients for biomarker-driven oncology trials with the right treatment or clinical trial. This normally challenging process will be sped up through the use of M2Gen's Total Cancer Care data warehouse, a database developed at Moffitt Cancer Center that consists of longitudinal clinical records on more than 95,000 cancer patients. Covance will become the preferred provider for M2Gen for DNA/RNA sequencing, gene expression analysis and genotyping analysis services, which will be conducted at the Covance Genomics Lab in Seattle.
"M2Gen and Covance have essentially created a 'one-stop shop' for biomarker-driven clinical trials in oncology with unmatched gene-based trial design and patient-matching expertise," says Frank Makosiej, executive director of operational strategy and planning and clinical development 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 clinical oncology trials are available in real time. Under this program, patients donate samples to be considered and will have consented to be re- contacted when a matching trial becomes available.
"Patients are usually thrilled to get the call—and so are their doctors—if they have the need for a clinical trial," says Dr. William Dalton, founder and CEO of M2Gen.
Second, the program should benefit biopharmaceutical clients by dramatically reducing the timeline for identifying suitable participants for enrollment in clinical trials, and allowing for much quicker enrichment of trials.
"In one case, in three months we found 37 patients to enroll in a trial—we identified perhaps 10 times that many who were eligible," says Dalton. "This client was able to complete a Phase II trial in 10 months—that's really unheard of."
Finally, the program also stands to benefit clients that may require additional information in order to write their trials. Many clients may have a biomarker of interest, but don't yet know its prevalence, or may be unsure as to which populations will show it. The service will be able to provide in-silico trial design, helping the sponsor to write their trial.
"Both Covance and M2Gen are working with a number of biopharmaceutical companies with strong oncology pipelines who could benefit from the services and expertise that our two companies can provide in helping them accelerate their drug development plans, make better decisions and identify patients for the trials more quickly—all to support the goal of bringing new medicines to patients," says Makosiej.
Currently, physicians at the 18 participating sites that use the Moffitt Cancer Center's protocol invite new patients to enroll; however, the program is expanding. Future goals include creating a national health research information exchange so that any patient anywhere could enroll in the program to be matched quickly to a clinical trial.
M2Gen had been in exclusive partnership with Merck from 2006 to 2012 to build the infrastructure of the patient-matching protocol. M2Gen reached out to contract research organizations once it had the freedom to do so after the partnership ended. Covance, which offers its clients a range of drug development services from discovery through commercialization, saw M2Gen as the ideal partner to help to provide its biopharmaceutical clients with solutions for their biomarker-driven oncology trials.
Covance is one of the world's largest and most comprehensive drug development services companies with annual revenues exceeding $2.2 billion and more than 11,750 employees worldwide. Its expertise and capabilities in discovery, genomics and biomarkers, as well as patient stratification and predictive modeling, allow it to collaborate with clients through drug development programs. Headquartered in Princeton, N.J., the company has conducted more than 130 clinical oncology trials across several tumor types in the past five years on behalf of biopharmaceutical sponsors.
M2Gen is Moffitt Cancer Center's wholly owned, for-profit subsidiary. M2Gen's Total Cancer Care data warehouse is one of the largest cancer-focused databases of its kind in the world. The database consists of longitudinal clinical records on more than 95,000 cancer patients who have provided consent to be followed over the course of their lifetime, have their tumor studied using molecular technologies and be re-contacted for clinical trials. More than 33,500 tumor specimens have been collected and generated, and more than 20,000 molecular data files have been generated by studying these specimens.