Two separate databases—one from a government agency and onefrom a collaboration between two companies—could expedite oncology research andtreatment. Both involve data mining to provide a more targeted approach toaccelerate personalized treatment approaches.
A new gene database available through the National CancerInstitute (NCI) could accelerate the development of genomic medicine andtargeted treatment methods for cancer. The database, which maps cancer-relatedgenetic variations, is expected to speed up the development of new drugs andhelp doctors customize therapies.
Everybody will have access to the database through the CellMiner website, directly through the molecular genetics branch at NCI, so thatthe public can use and analyze it, according to Dr. Yves Pommier, chief of theNCI's Laboratory of Molecular Pharmacology.
"To date, this is the largest database worldwide, containing6 billion data points that connect drugs with genomic variants for the wholehuman 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 connectdrug activity with genome data. He adds, "It is challenging to preciselydeliver medicines. Using genomics makes it more precise."
The NCI database is designed to ease the challenge ofunderstanding and finding genetic parameters to predict responses to drugtherapies, Pommier adds. It creates new connections between known drugs and newgenes. On the negative side, such databases are very large and make itchallenging to make them accessible to laymen.
"We are trying to design new tools to navigate the datasite," he says.
The database differs from others, because it is associatedwith tools for people who are not bioinformaticians, according to Pommier.
"It is not as difficult to use as other databases if one isnot an expert," he says. "Any doctor can use Cell Miner. It includes cancerdrugs, drugs in investigations and drugs never tested. It incorporates thewhole genome. Some of the information is annotated, but now all data isaccessible for all genes. It is unique to make these connections."
A different kind of database is being developed by LifeTechnologies Corp., a global biotechnology company, and RainTree OncologyServices, a leading community oncology alliance, to help community oncologistsgain access to early-phase clinical trials. The collaboration agreement isdesigned to further the advancement of personalized care for cancer patients byattempting to make the latest advances in molecular testing available to thebroader patient market and to develop a streamlined protocol for enteringpatients into clinical trials for new targeted therapies.
"Efficiently identifying clinical trial candidates for newtargeted therapies has presented an obstacle in bringing new drugs to market,"says Dr. Jeff Patton, chief medical officer of RainTree and CEO of TennesseeOncology. "Through our collaboration with Life Technologies, we will be able totap into new genetic information that, along with our existing data sets, willhelp guide patients to enroll in clinical trials based on the geneticsignatures of their tumors."
According to Ronnie Andrews, president of genetic andmedical sciences at Life Technologies, "Our goal is to ensure that patients inthe community setting have the same access to advanced technologies, such asgenetic sequencing, as patients in the top academic centers. This collaborationalso establishes a mechanism for pharmaceutical companies to identify thepatients they need for clinical trials to bring new, targeted therapies tomarket."
While Life Technologies is a technical company involved ingenomic medicine, RainTree has phenotypic data. The objective is "to marry thetwo data sets—the phenotypic and genotypic," Patton says. The clinical trialsrecruitment database will incorporate RainTree's broad patient data set,enhanced by other data sources, including Life's Compendia analytics engine. Thecompanies will collaborate on matching oncology patients to clinical trialsusing a next-generation sequencing oncology screening panel, educate privatepayers and health plans about the benefits of next-generation sequencing andbuild and market comprehensive product, test and data offerings for clinicalresearch organizations.
Patton explains that the data include a large set owned byRainTree. It will be published publicly and commercialized to pharmaceuticalpartners with raw data with customized reporting depending on what the customerwants. Customers are diagnostic companies, pharmaceutical companies and managedcare companies.
The database will include two kinds of data. True patientregistries are "more robust and more likely to be published," according to Dr.Patton. These are patients who have had their genomes followed to determinewhat has happened through clinical trials. Genotypes can be matched tophenotypes. There will also be retrospective outcomes.
"Not every patient goes into a clinical trial, but the dataare important," Patton says. "We can add data sources to current clinical trialdata. All patients are eligible for a registry, and we can track outcomes. Currentclinical trial evaluations include limited subsets. For the registry thechallenge is to have the resources to have informed consent."
Patient data will be housed in a de-identified format in aproprietary database, which will be made available to pharmaceutical companiesto recruit Phase I patients, as well as to participating clinical researchorganizations to support recruitment for later phase trials. Prospectiveregistries will standardize data reporting. The challenges are different forthe two data sets.
"We expect to accelerate genotypic testing and drug development,"Patton says. "We hope to bring companies together with clinical trialorganizations to increase those who are identified and actually enrolled."
Patton concludes, "RainTree has unique patient and phenotypedata. It is a data company at heart. Life Technologies has the tools to make itbetter."