By Deb Borfitz
October 5, 2009 | A few short months after naming Merck & Co. as a customer and development partner, Microsoft has attracted a sizable following to its life sciences platform intent on helping scientists design better drugs, sponsors better interpret clinical trial results, and physicians better match treatments to patients.
Aiding the successful launch of Amalga Life Sciences are a dozen other early adopters, including major pharmaceutical and biotechnology companies as well as two of the nation’s top cancer research centers (Fred Hutchinson and Moffitt), reports Jim Karkanias, senior director of applied research and technology for Microsoft Health Solutions Group. The first-of-its-kind product acts like a global positioning system, helping scientists and their staff navigate through all forms of data at the conceptual level—be it what a dollar means or what a molecule is doing—using a comfortable and familiar Microsoft Office interface.
Amalga Life Sciences is an extension of the Microsoft Amalga family of health enterprise products introduced in February 2008. The idea is to “add value” to existing clinical and operational information systems, including electronic data capture, electronic medical records, and patient recruitment databases, Karkanias says. “A wealth of data exists in databases and IT systems. But without a way to…access [and] make sense of the information, it adds little to no value to an organization. Amalga Life Sciences is designed to easily show contexts and relationships, so that data becomes knowledge that can actually be used.”
With minimal training, even relatively computer illiterate users can discover relationships between different pieces of data that would otherwise not be readily apparent, says Karkanias. The technology also gives organizations the wherewithal to manage and redesign processes to increase productivity, improve decision-making, and reduce errors.
Components of Rosetta Biosoftware, acquired from Merck in June, will be incorporated into the service-oriented, standards-based software over the next two years, adds Karkanias. This will give Amalga Life Sciences the ability to interface with the machinery of genomic science and further understanding of how various drugs impact DNA and proteins in the body and, ultimately, direct researchers to “biomarker needles in the haystack.” Thereafter, the software could be used to create what-if scenarios using the identified biomarkers in different population groups.
H. Lee Moffitt Cancer Center & Research Institute is using Microsoft’s Amalga Unified Intelligence System as part of its Total Cancer Care Survivorship Initiative, which follows patients post-treatment to reduce recurrence of cancer and quickly respond if it does. Test recommendations will become more personalized as researchers identify new best treatment practices gleaned from queries of an Oracle-based data warehouse, says Karkanias. The initiative, in conjunction with a growing cancer registry, is also projected to significantly shorten the process of identifying and recruiting patients for clinical trials based on their molecular traits.
In addition, the collaboration between the Fred Hutchinson Cancer Research Center and Microsoft “will drive the progress and development of an innovative software platform for life science researchers, addressing the challenges faced today in collecting, analyzing, interpreting, and sharing complex data from a wide range of diseases and experiments,” says Karkanias. The collaboration will bring together the world-class domain expertise of the cancer center’s scientists and the power of Microsoft technologies to “integrate, visualize, and generate novel hypotheses from cancer research data.”
Connectivity with HealthVault, Microsoft’s two-year-old personal health application platform for consumers to store and maintain health and fitness information online, gives Amalga Life Sciences several potentially game-changing capabilities, says Karkanias. For starters, it could further the cause of personalized medicine by providing physicians with easy access to their patient’s molecular makeup. Through a patient’s HealthVault account, for example, a physician might discover the patient has the BRCA1 gene, combined with a family history of breast cancer. “This information alone, which is normally very difficult for a physician to identify, can change the course of treatment to one that’s more effective for the patient.”
Microsoft is partnering with Scripps Research, Affymetrix, and direct-to-consumer genetic testing company Navigenics in a research study that will assess the behavioral impact of personal genetic testing on consumers, says Karkanias. Those who opt into the study can learn about their genetic predisposition to more than 20 medical conditions that may be changed by lifestyle choices, and import the data into their personal HealthVault account.
A trial-sponsoring company need only write an application specific to HealthVault to initiate a patient recruitment campaign targeting those that meet a study’s inclusion and exclusion criteria—and promote compliance with the protocol once they’re enrolled, says Karkanias. Through TrialX (from Applied Informatics), HealthVault users can already opt to be matched to relevant clinical trials based on their personal health information. But the potency of HealthVault as a recruitment resource will be highly dependent not only on the platform’s popularity, but on consumer reception to its varied connectivity options.
Microsoft declined to say how many consumers have thus far established HealthVault accounts. But Karkanias notes the company has “designed HealthVault with privacy in mind, putting consumers in control of their health information. Consumers and health care providers will only share data if they trust their privacy will be protected.” Clinical trial sponsors, for now, seem to be taking a wait-and-see attitude.
Microsoft sees the potential for HealthVault to effectively reduce the cost of conducting clinical trials, making “new and different trials possible,” says Karkanias. “Companies can have trials with small measurements across large groups of patients since they’ll have a large population from which to draw. That’s a complete paradigm shift.”
Next-generation clinical research techniques, such as adaptive clinical trials, could also get a much-needed boost. “If researchers have lots of knowledge about what’s going on in a trial at the molecular level of detail for each patient, they can more accurately adjust the trial to reduce risk and cost in a statistically valid way as it goes along,” says Karkanias.
Microsoft is currently talking with all the top pharmaceutical companies about “deep partnering” opportunities with HealthVault, says Karkanias, and the feedback to date has been “extremely positive.” It remains to be seen how far Amalga Life Sciences will reach its hand into the actual administration of clinical trials. Microsoft will most likely opt to complement rather than compete against clinical trial management systems, he says.