Although precision, or personalized, medicine is still new, the ability to use genomics to customize patient treatment has already led to life-saving advances in patient care.

“Especially in oncology, there are a number of very precise genomic indicators to determine how a particular patient will respond,” says Jonathan Sheldon, global vice president of Oracle Health Sciences. “For example, a particular gene mutation occurs in about 50% of melanoma patients, and those with that mutation are responsive to a particular drug from Roche.”

That kind of high-potential scenario helps explain why President Obama in January announced the landmark Precision Medicine Initiative, a proposed $215 million investment to be spread across four areas.

“While $215 million is a small percentage of the overall investment in biomedical research, it’s important in that the federal government for the first time is unambiguously supporting personalized medicine,” says Edward Abrahams, PhD, president of the Personalized Medicine Coalition, a nonprofit education and advocacy group in Washington DC. “It pushes us into a new era focused on personalized medicine.”

Abrahams and Sheldon will discuss the latest developments in precision medicine at Oracle Industry Connect 2015 in Washington DC on March 25 and 26. The agenda includes several sessions on the topic.

According to Edwards, the real conversation revolves around where the White House wants the money to go. The funding breaks down as follows:

• $130 million to the National Institutes of Health to develop of a national research cohort of a million or more volunteers to provide a large genetic research pool and build a new way of doing research through engaged participants and open, responsible data sharing.
• $70 million to the National Cancer Institute to scale up efforts to identify genomic drivers in cancer and apply that knowledge to the development of more effective approaches to cancer treatment.
• $10 million to the Food and Drug Administration to develop high quality, curated databases necessary to revamp the regulatory structure to support precision medicine while protecting public health.
• $5 million to the Office of the National Coordinator for Health Information Technology (ONC) to support development of interoperability standards and requirements that address privacy and enable secure data exchange across systems.

Three of those projects highlight the increasingly intrinsic nature of technology in precision medicine and the issues that come with that, from the need for responsible data sharing to standards-based interoperability in an infrastructure that complies with regulatory requirements. “These are the building blocks we need to move the agenda forward,” says Edwards.

The systems necessary to support precision medicine widely are not yet in place, says Sheldon. “The pressure will grow exponentially as precision medicine expands from its early niches in major research hospitals and pharmaceutical companies to a more mainstream clinical setting,” he says.

Sheldon points to three critical developments that must happen before we can extract full value from precision medicine:

1. Set the Scalability Bar High

Although the goal is to build a million-strong national research cohort, that’s still a drop in the bucket compared with how fast genomic technologies are being adopted, says Sheldon.  Moreover, as testing costs continue to decrease—what cost $100 million in 2001 is about $1,000 today—and more people can interpret the data, the rate of adoption should further increase, especially at the clinical level. On top of that, Sheldon points out that current cutting-edge genomic techniques are likely just the tip of the iceberg and next-generation techniques will produce even more data per sample. Meanwhile, newer big data technology requires not just genetic data, but also associated clinical, behavioral, physiological, and environmental data. The bottom line, he says, is that “it is critical that the infrastructure we build to support this precision medicine initiative can scale far beyond what we can envisage today.”

2. Adopt Standards—Don’t Just Create Them

In this new era of big science, no single organization has access to all the resources required to truly enable precision medicine. “The proliferation of data formats has been an issue for bioinformatics since its inception, although progress has been made of late,” says Sheldon. Data sharing and the necessary adoption of interoperability standards has rightly been prioritized in Obama’s proposed initiative, but standards creation is only the first step, he says. Also required is widespread acceptance of data standards that can be used at a clinical as well as research level. Additionally, Sheldon points out that genomic data sharing will require revision of privacy regulations like HIPAA in order to support both individual privacy rights and successful scientific collaboration. Fortunately, says Sheldon, “The ONC is very well placed to ensure that the precision medicine community has the opportunity to learn from past experiences in terms of the sharing of electronic health information.”

3. Move to Enterprise-Grade IT Infrastructure Now

As precision medicine evolves from its research roots to an activity that also defines clinical care pathways, the underlying IT platforms must also change to support it. “Many of the analytical approaches used today lack features that are table stakes for enterprise-grade software, such as security and extensive testing as part of a formal documented software development lifecycle,” says Sheldon. These features become even more vital when the software is used to make decisions at the point of care rather than in the research lab. “For example, traceability is an increasingly important issue, not just for ensuring high-quality and replicable research but also for complying with regulations such as CLIA (Clinical Laboratory Improvement Amendments) and new regulatory guidance emerging from the FDA for biomarker applications,” says Sheldon.

It’s become increasingly clear that medicine will survive and thrive based on how well it can analyze complex data. Making technology a central tenet of the Precision Medicine Initiative is an important step, experts say, and the time to start is now.

For more on precision medicine, check out Oracle Industry Connect 2015 in Washington DC, on March 25 and 26. 

Source: iStockphoto

Like many good stories in my life, this one starts with large quantities of beer.

Most people know me as a cloud computing, enterprise technology, and social media guy in my role as senior vice president of product development at Oracle ORCL +0.57%. But I got my start in beer. My first job was at Miller Brewing Company, where I worked mostly in marketing and brand management—and guzzled a good deal of beer. It was the perfect job to have right after college.

Ironically, perhaps, I left Miller in the late 1990s to help build the biggest brand in healthcare, WebMD, as its first chief marketing officer. We were attempting to usher in an era of patient empowerment, to enhance doctor-patient interaction, using information and the fast-growing consumer internet.

For the next decade and a half little changed in healthcare. But now it seems we’re entering a period many are calling a digital health revolution, and I agree—mostly. With smart cloud computing and hundreds of new connected consumer devices, we’re witnessing a leap forward in digital health application adoption. I’m confident that this trend is going to keep accelerating for years to come.

A few weeks ago I had an opportunity to revisit my WebMD roots by attending the 33rd Annual JP Morgan Healthcare Conference in San Francisco. I quickly learned why people are saying we’re in the midst of a revolution.

Source: iStockphoto

At the same time, some of the issues being discussed at the conference were similar to those we faced at WebMD. That is, a healthcare industry largely comprised of proprietary systems and the urgent need for greater interoperability and data fluidity.

When I was at WebMD I had a Nokia 3310 cell phone—cutting-edge stuff at the time. That cell phone was loaded up with my contacts and other data. Unfortunately, if I changed cell phone providers, I lost all my contacts, usage information, even my cell phone number. In other words, my cell phone provider held my data hostage.

That’s analogous to where we are today in healthcare. Despite all the technological advances in smartphones, my medical records are still controlled, by and large, by my doctor. For instance, if I need to visit an emergency room on a business trip, there’s no easy way to access my medical records electronically. The industry and patients agree that this has to change, and we have the technological innovation at hand to clear this hurdle.

One of the persistent issues in health IT is the promulgation of standards concerning how data is handled so that innovation can occur. With the adoption of new standards like Blue Button, C-CDA, and Fast Healthcare Interoperability Resources, we’re making good strides. But we need to demand wider adoption because the pace of innovation in healthcare will live or die by it.

Here’s another example borrowed from past experience. In 2001, I became CEO of N2 Broadband, which created the technology behind video-on-demand. Yup, next time you watch HBO On Demand, you owe some small debt of gratitude to me.

When we started N2 Broadband, the vendors’ systems were all proprietary (similar to what today’s electronic medical records vendors face). You got everything from a single vendor, and the costs were substantial. At N2 Broadband, we created, with our cable partners, a set of standards that everyone could use. There was some kicking and screaming but because clients were pushing for it, we made it happen. The effect was that the market opened up from three vendors to about 25 vendors, and the cost for a video-on-demand system dropped in three years from $1,000 per video stream to about $50 per stream. We saw innovation in hardware and software, and the service became ubiquitous across the cable market. That’s what standards adoption can do for an industry.

In healthcare, too, we see companies that embrace standards succeeding, and I believe that innovation will be driven by the prevalence of large ecosystems that also support standards. There is important movement on this front, such as emergence of the CommonWell Health Alliance, a non-profit organization formed by several leading EMR vendors to facilitate data exchange and interoperability.

At the JP Morgan conference, I loved hearing about Athenahealth’s “More Disruption Please” program, which reminded me of what we did at N2 Broadband. I’m excited to see new disruptive and much needed services like telemedicine built into your phone, allowing secure access to your family’s health records wherever you go.

To help drive this change myself, I recently became a board member and investor in a company that’s focused on a data platform that integrates clinical electronic medical records data with patient-created data like glucose readings and heart rates—helping to put the consumer in control.

The market needs innovation, and emerging standards initiatives like Fast Healthcare Interoperability Resources and healthdata.gov are