As the biopharmaceutical industry increasingly focuses on discovering and delivering targeted, personalized medicines, we have stepped up our personalized medicine services to help sponsors conduct biomarker-driven oncology trials. The stakes are high for our clients as their drugs move through clinical development. Many of the old, well-tested strategies for developing cancer drugs are no longer relevant, and biomarkers are becoming an integral part of the story. More and more, oncology clinical trials are focused on biomarker strategies in which selecting the right patients is critical to a trial’s success.
Partnership with M2Gen®
In February 2013, we teamed up with M2Gen, a subsidiary of the MoffittCancerCenter in Tampa, Florida, to better identify ideal patients for oncology drug trials. M2Gen, a leader in advancing personalized medicine by using high-quality tissue, clinical data, and molecular technology for personalized cancer treatments, maintains a cancer-focused data warehouse for Total Cancer Care®. This data warehouse has highly specific biomarker information on more than 95,000 cancer patients from Moffitt and a consortium of 17 hospitals throughout the United States.
The Covance-M2Gen partnership also allows our genomics lab in Seattle to be M2Gen’s preferred provider for DNA/RNA sequencing, gene expression, analysis, and genotyping services. Overall, this partnership makes a difference in how we partner with sponsors to develop drugs.
M2Gen’s Total Cancer Care Data Warehouse
M2Gen has been building the Total Cancer Care database over the past six years, and of the 95,000 patients in it, more than 35,000 tumor specimens have been collected and more than 20,000 molecular data files have been generated by these specimens. As part of Total Cancer Care, patients opt in through consent to be followed for life and donate tissues not used for clinical purposes for molecular analysis and research. As a result, clinical data are captured and maintained over the cancer patient’s lifetime. This unique approach has resulted in one of the most robust cancer-focused data resources in the world. The proprietary informatics platform supports a clinical trial matching program that can significantly reduce the timeline for identifying suitable patients for enrollment in clinical trials and improve the design of biomarker-driven trials.
Accelerating the Discovery and Delivery of Personalized Medicine
Overall, this new partnership has enhanced our ability to deliver successful clinical trials for our clients. Over the past five years, we have conducted more than 130 trials across several tumor types and expect that with this innovative tool we will accelerate our clients’ drug development programs, facilitate better decision-making, and improve their efforts to develop targeted therapies for cancer patients.
Increasing Clinical Return on Investment and Delivering the Right Patients Faster
Our partnership provides two significant benefits to pharmaceutical companies conducting biomarker-driven oncology trials.
Increasing Clinical ROI. Combining our biomarker and genomic expertise and M2Gen’s longitudinal clinical, molecular and specimen data to stratify patients based on specific markers, match the right patient to the right clinical trials and minimize the risk of recruitment failure.
Delivering the Right Patients Faster. Leveraging our network of oncology investigators and M2Gen’s ability to rapidly filter criteria ensures that clinical trials are up and running quickly, which saves time and avoids costly study delays.
Frank Makosiej, PharmD, is Executive Director, Operations, Planning, and Strategy for Covance.