Personalized Medicine for Now and the Future

June 1, 2010
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

Brett J. Davis, Senior Director, Personalized Healthcare, Oracle Health Sciences, will chair the Information Technology track session "Health Information Technology and Personalized Medicine: The Knowledge-driven Health Care Transformation," on Tuesday June 15 from 2 to 3:30 pm.

Q: As session chair, you are bringing together three distinct areas of the research chain (translational/academic; diagnostics/clinical trials; sponsor view). With IT as the backbone, what are the top 5 primary objectives or "takeaways" you hope attendees will get from the dialogue?

A: It is a very exciting yet challenging time for healthcare. I believe many global health and healthcare systems stand at a critical juncture. On one hand, the last 25 years have seen an unprecedented expansion of our scientific knowledge as a result of technology breakthroughs in imaging, genomics, proteomics, diagnostics and other disciplines. However, against this backdrop of remarkable innovation, global healthcare systems are reaching their breaking point. Most developed nations are struggling with skyrocketing costs and inconsistent quality. For example, in the United States, some estimates for unwarranted care range from $250 billion to $325 billion per year. Another example of arguably “wasted” care is that many major classes of drugs only work in 30% to 60% of the population who take them each year.

So, we are faced with an interesting challenge and a vexing paradox. We sit at the precipice of arguably the most exciting time in scientific and clinical innovation that can have a meaningful impact on human health, while at the same time are staring down challenges in our healthcare systems that threaten to bring continued innovation to a halt, and consume many nations’ GDP.

I paint this backdrop because I believe IT-enabled personalized healthcare is the only way we can address these challenges while keeping innovation alive in our healthcare systems. Unfortunately most of the IT systems that are being adopted across the research and care domains today were not designed, developed or implemented with these broader health system challenges in mind.

The reason I felt it was important to get a cross-disciplinary set of leaders from across the healthcare ‘ecosystem’ together on one panel to discuss these issues was to get that broader perspective and connect the dots from across the research and clinical care landscape. If we are to achieve an IT-enabled personalized healthcare paradigm, these “systems” perspectives are going to be essential. The community needs to be thinking about their IT investments in a broader context, specifically with the widespread adoption of Electronic Health Records (EHRs). Specifically I hope attendees leave with an understanding of:

1. The critical need to move towards an IT-enabled personalized healthcare system in the context of the health system challenges globally

2. The specific role healthcare information technology, particularly the secondary use of observational health data, will need to play to achieve the vision of personalized healthcare

3. The market and regulatory factors driving this imperative including the ARRA HITECH legislation, widespread adoption of EHRs, pay for performance, and Comparative Effectiveness Research (CER)

4. The changes that need to be made to enable personalized healthcare; and finally

5. The macro-information technology implications for the pharmaceutical, biotechnology and healthcare markets.

Q: HIT in general is a disparate and fragmented endeavor. And one that is now realizing it needs supportive systems to achieve end goals. What are the current stop gaps to this and how do life/health sciences companies move forward to the end goal of personalized medicine?

A: Most of today’s healthcare IT systems were designed to automate specific workflows in either a research or care setting, and as a result are “fragmented.” The good news is that these “transactional systems” are a necessary yet insufficient step. I say this because it’s the secondary use of the data captured in these systems that will ultimately provide the insights that lead to a value-based, personalized healthcare system.

These transactional systems were typically not designed to share data between systems, and definitely were not designed to aggregate data in analytics environments to mine the information for insights. This is true whether you think about the needs of translational research, comparative effectiveness research, and recruitment of patients for targeted, molecularly-based clinical trials or evidence based medicine to name just a few cases. It’s these supportive integrated, enterprise analytics environments that I believe are going to be truly transformative to healthcare.

So in the short term, we are seeing the stop-gap measures you might expect. The needs of specific end users are driving bespoke investment in one-off data marts and analytics environments in an effort to glean some insights from the transactional systems. This is just leading to the creation of more silos of information.

However, health sciences organizations that realize the importance of these supportive systems, are increasingly investing in enterprise class interoperable analytics platforms. This is true across biopharma, payers, providers as well as academic medical centers. I believe health sciences companies also need to be thinking about these investments in the context of their “trading partners.” In other words, investing in a robust information management architecture recognizing that the ability to share data with other partners will not only lead to greater innovation, but to new business opportunities for collaboration.

Q: As our audience comprises pharma and CROs professionals dedicated to the Phase I through Phase III clinical trials, can you offer insight into how personalized medicine from an IT perspective impacts them directly? And then how this session would address their concerns?

A: The shift toward personalized healthcare has implications for these organizations on multiple fronts, and as a result on their IT environments. Take, for example, the issue of protocol design and patient recruitment for a targeted, personalized medicine clinical trial. Patient recruitment into a trial has always been a potential bottleneck for advancing a trial. However, personalized therapies are making this challenge more acute because patients must now meet more granular criteria in order to ensure the population recruited into the trial is the right one. This has significant IT implications since the design of the personalized protocol and recruitment of the patients becomes next to impossible without the right IT systems to do the granular cohort identification and protocol design.

This is just one example – comparative effective research (CER) and adaptive trials also have huge IT implications in a personalized healthcare context. This session will explore these types of challenges from multiple perspectives, and attendees can expect to learn how they are facing these challenges and the investments they are making as a result.

Q: As Senior Director for Personalized Healthcare at Oracle, what are your goals for the next year? Next three years? Where will IT in this space be then?

A: Personalized healthcare holds the promise to address not just the cost/quality challenges our health systems face by eliminating waste and driving more preventative and targeted interventions. It also can sustain and even accelerate innovative new discoveries to clinical practice.

The IT implications for this new paradigm are significant, particularly the secure exchange of data between systems, as well as the analytics to glean insights from the secondary use of this data. The industry is clearly recognizing this need, and beginning to shift its investments in this direction.

Oracle is committed to continuing to help our health sciences customers thrive in this changing environment, by providing the technology, applications and platforms required. This commitment is illustrated in our recent announcements around Enterprise Healthcare Analytics (EHA), Oracle Clinical Development Analytics (CDA) and our newest release of Healthcare Transaction Base (HTB) to name just a few.