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A Proving Ground for P4

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Personalized medicine — the crossroads at which biotechnology, genomics, and medical treatment meet — is a concept that is often touted, though rarely seen in action. As with any radical idea, there needs to be a proving ground before it achieves wider acceptance among professionals and the public. The concept of a healthcare system that can someday provide predictive, preventive, personalized, and participatory medicine, or "P4 medicine" — a term coined by Leroy Hood of the Institute for Systems Biology back in 2003 — is being put to the test.

In early May, The Ohio State University Medical Center and ISB announced a partnership to establish the P4 Medicine Institute, a nonprofit consortium based in Seattle. The new institute's mission is the delivery of a healthcare model with the four-pronged "P" approach, through which patients can be treated proactively throughout their lifetime, instead of the current model of reactive clinical treatment.

While ISB is positioned to bring its biotechnology expertise to the table, OSU's clinical delivery infrastructure, including its own insurance company OSU Health Plan, will give the P4 a chance to try out lots of new ideas in a closed system with roughly 55,000 university employees enrolled in the campus health plan. By creating a matrix of genomics, protein metabolics, and molecular-based diagnostic information tailor-made for each patient, the leaders of the P4 Medicine Institute hope to map out individualized plans for health maintenance, wellness evaluation, and the diagnosis and treatment of illness.

"We're working on trying to come up with an understanding of how the healthcare system can be changed from one that is disease-based care, without an understanding of the real deep, precise biology underlying the health and wellness, to one which really looks at predicting and preventing disease by focusing on wellness in a very personal way," says Clay Marsh, executive director of Ohio State's Center for Personalized Healthcare. "We see the P4 Medicine Institute as a conduit for connecting the best people in the world, for really transforming how we do things. Our goal is to try and connect with the best people and, as a team, really define where the healthcare ecosystem is today — what elements are needed to create a tipping point or create a culture change that will transform medicine — and work as a group to do that."

Putting it together

Part of the new institute's strategy to bring genomics-based healthcare to the clinic is to connect researchers working in biology and medicine with those working in computer science and IT, as well as bringing in thought leaders from the legal, business, and medical device manufacturing sectors. "P4 is really about combining the systems biology-driven innovations and insights into human biology of ISB and the translational research and clinical delivery capabilities of one of the largest academic medical centers in the country," says Frederick Lee, the executive director of the P4 Medicine Institute. "It's really about that pragmatic and tangible bringing together of the things that we are learning about not only human biology itself, but really driving those into how the care is going to be delivered — health, wellness, and disease management — in a real P4 manner."

Lee says that ISB's decision to partner with OSU came only after a serious survey of the academic medical landscape of the United States. "ISB had spent some time evaluating and meeting with a lot of the top academic medical centers in the country, but we found that OSU had really embraced the concepts of personalized healthcare and the leadership was already very open to this approach to medicine as the way to really shine," Lee says. "Back in 2005, OSU established their own personalized healthcare center. They have also been having for the past few years a personalized medicine conference. All of these things were something that we just didn't see at any [of the] other universities."

The P4 Medicine Institute's first project will focus on using novel molecular modalities, including organ-specific proteomics, mRNA analysis, and deep sequencing of genomes in the context of families. They aim to combine that data with more conventional clinical data to establish an individual's base level of health and to determine when he is veering off that baseline into illness. A series of wellness clinics will also be established at OSU from a population base of their employees. The institute will then apply the molecular modalities and technologies from ISB along with the clinical delivery models that they will design together with OSU. "This is really interesting because OSU can and will be a closed-loop system — it's the payor for that large employee base, it's the provider of care, and it's also the patient population itself," says Lee. "We can really rewrite the rules for how care is paid for, provided, and received, and then draw out pragmatic things so that industry partners can develop the technical infrastructure to power this new type of healthcare."

The researchers at OSU have already set about one pilot project focused on wellness, a buzzword that is the cornerstone of any discussion about the P4 concept. The wellness project will include programs in exercise, nutrition, and biorhythms in order to better understand patient needs and how P4 can create "modules" to help the patient achieve optimal health. "We're very interested in looking to stratify people into groups according to exercise, nutrition, stress, sleep, and age, and merge that with genetic data and other molecular profiles so that we can then start to assign a predictive and preventive approach," OSU's Marsh says. "We'd like to give people feedback into how to improve and make changes to their lifestyle."

OSU will also initiate a chronic disease pilot project, which Marsh says will look at ways to build a team of clinicians around chronically ill patients using molecular profiling and other genomic elements to improve their quality of treatment.

Finding partners

Marsh says that one of the biggest challenges facing the P4 Medicine Institute at this early stage is making sure that additional partners are chosen carefully. Because this is still very much an experimental endeavor contained within the confines of the OSU healthcare system, those institutes looking to join in the hopes of making a profit from this new brand of healthcare are barking up the wrong the tree. "We want to produce wins for everyone involved, but we're looking for people who understand the long-term opportunity and also understand that if you're looking for some sort of committed return on an investment in a relatively short period of time, this is probably not the right partnership," he says. "We're spending a huge amount of time to make sure we're assessing the partners that are interested in what we're doing and making sure we have a level of compatibility with them so that we don't have any problems down the road because we failed to expressed our goals to each other clearly. That's a key element that we need to make this run smoothly. "

The Breakdown
Members: The Institute for Systems Biology and The Ohio State University Medical Center
Funding: ISB and OSUMC internal funding, with each institute contributing $500,000 annually for the next two years.

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