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Two separate databases—one from a government agency and one from a collaboration between two companies—could expedite oncology research and treatment. Both involve data mining to provide a more targeted approach to accelerate personalized treatment approaches.
A new gene database available through the National Cancer Institute (NCI) could accelerate the development of genomic medicine and targeted treatment methods for cancer. The database, which maps cancer-related genetic variations, is expected to speed up the development of new drugs and help doctors customize therapies.
Everybody will have access to the database through the Cell Miner website, directly through the molecular genetics branch at NCI, so that the public can use and analyze it, according to Dr. Yves Pommier, chief of the NCI's Laboratory of Molecular Pharmacology.
"To date, this is the largest database worldwide, containing 6 billion data points that connect drugs with genomic variants for the whole human genome across cell lines from nine tissues of origin, including breast, ovary, prostate, colon, lung, kidney, brain, blood and skin," he says.
Pommier explains that such databases are needed to connect drug activity with genome data. He adds, "It is challenging to precisely deliver medicines. Using genomics makes it more precise."
The NCI database is designed to ease the challenge of understanding and finding genetic parameters to predict responses to drug therapies, Pommier adds. It creates new connections between known drugs and new genes. On the negative side, such databases are very large and make it challenging to make them accessible to laymen.
"We are trying to design new tools to navigate the data site," he says.
The database differs from others, because it is associated with tools for people who are not bioinformaticians, according to Pommier.
"It is not as difficult to use as other databases if one is not an expert," he says. "Any doctor can use Cell Miner. It includes cancer drugs, drugs in investigations and drugs never tested. It incorporates the whole genome. Some of the information is annotated, but now all data is accessible for all genes. It is unique to make these connections."
A different kind of database is being developed by Life Technologies Corp., a global biotechnology company, and RainTree Oncology Services, a leading community oncology alliance, to help community oncologists gain access to early-phase clinical trials. The collaboration agreement is designed to further the advancement of personalized care for cancer patients by attempting to make the latest advances in molecular testing available to the broader patient market and to develop a streamlined protocol for entering patients into clinical trials for new targeted therapies.
"Efficiently identifying clinical trial candidates for new targeted therapies has presented an obstacle in bringing new drugs to market," says Dr. Jeff Patton, chief medical officer of RainTree and CEO of Tennessee Oncology. "Through our collaboration with Life Technologies, we will be able to tap into new genetic information that, along with our existing data sets, will help guide patients to enroll in clinical trials based on the genetic signatures of their tumors."
According to Ronnie Andrews, president of genetic and medical sciences at Life Technologies, "Our goal is to ensure that patients in the community setting have the same access to advanced technologies, such as genetic sequencing, as patients in the top academic centers. This collaboration also establishes a mechanism for pharmaceutical companies to identify the patients they need for clinical trials to bring new, targeted therapies to market."
While Life Technologies is a technical company involved in genomic medicine, RainTree has phenotypic data. The objective is "to marry the two data sets—the phenotypic and genotypic," Patton says. The clinical trials recruitment database will incorporate RainTree's broad patient data set, enhanced by other data sources, including Life's Compendia analytics engine. The companies will collaborate on matching oncology patients to clinical trials using a next-generation sequencing oncology screening panel, educate private payers and health plans about the benefits of next-generation sequencing and build and market comprehensive product, test and data offerings for clinical research organizations.
Patton explains that the data include a large set owned by RainTree. It will be published publicly and commercialized to pharmaceutical partners with raw data with customized reporting depending on what the customer wants. Customers are diagnostic companies, pharmaceutical companies and managed care companies.
The database will include two kinds of data. True patient registries are "more robust and more likely to be published," according to Dr. Patton. These are patients who have had their genomes followed to determine what has happened through clinical trials. Genotypes can be matched to phenotypes. There will also be retrospective outcomes.
"Not every patient goes into a clinical trial, but the data are important," Patton says. "We can add data sources to current clinical trial data. All patients are eligible for a registry, and we can track outcomes. Current clinical trial evaluations include limited subsets. For the registry the challenge is to have the resources to have informed consent."
Patient data will be housed in a de-identified format in a proprietary database, which will be made available to pharmaceutical companies to recruit Phase I patients, as well as to participating clinical research organizations to support recruitment for later phase trials. Prospective registries will standardize data reporting. The challenges are different for the two data sets.
"We expect to accelerate genotypic testing and drug development," Patton says. "We hope to bring companies together with clinical trial organizations to increase those who are identified and actually enrolled."
Patton concludes, "RainTree has unique patient and phenotype data. It is a data company at heart. Life Technologies has the tools to make it better."