Having enlisted the best minds in the healthcare industry, Harvard University's Clayton Christensen, the creator of the disruptive innovation theory, is developing an actionable roadmap for how to advance a personalized healthcare paradigm.
The Roadmap for Personalized Health Care, which will be released online later this year, will be based on Christensen's analysis of how disruptive innovation can be harnessed to bring about top-to-bottom changes in the healthcare system. The document will also incorporate recommendations from the Forum on Personalized Health Care, which includes luminaries of the personalized medicine field, as well as data from outside stakeholders, such as PricewaterhouseCoopers and Leavitt Partners.
By developing the Roadmap, the forum leaders hope to "guide the development and utilization of transformative technologies, business models, and value networks that increase the effectiveness of care and reduce costs of healthcare delivery." Specifically, with the Roadmap in hand, healthcare industry players can have a plan for "guiding and influencing the community's efforts in a coordinated manner to maximize returns on effort, encouraging the pooling of resources, and eliminating zero-sum competition," the forum said in a statement.
In an interview with PGx Reporter, Kimball Thomson, executive director of the Forum on Personalized Health Care, discussed the goals of the roadmap, challenges to the implementation of new technologies, and how the forum's activities differ from other personalized medicine collaborations.
Below is an edited transcript of the interview.
How did the Roadmap for Personalized Health Care come about?
The Roadmap for Personalized Health Care was originally envisioned at the Third Annual National Summit on Personalized Healthcare. That was held in October 2010 in Deer Valley, Utah. The first summit was held in 2008, at the request of then HHS Secretary Michael Leavitt. … At this first event there was a fair amount of enthusiasm for it to become an ongoing discussion, so we held the second summit, where we launched the Forum on Personalized Healthcare.
The forum was launched with six initial board members: Harvard Business School Professor Clayton Christensen; Leavitt of Leavitt Partners after he had left HHS; Lee Hood from the Institute for Systems Biology; Duke University Professor and founder of Proventys Ralph Snyderman; Risa Stack of Kleiner Perkins Caufield & Byers; and then me. Since then, we've added to our board Eric Topol, director of Scripps Translational Science Institute; Mara Aspinall, formerly head of Genzyme Genetics and current founder of On-Q-ity; and Steve Burrill of Burrill & Associates.
So within the forum we had a fair number of discussions about what we saw as the need for a fair and actionable primary roadmap that could be used to guide the development and deployment of precision personalized healthcare. Christensen calls this precision healthcare, many call it personalized, Topol calls it individualized, Hood calls it P4 Medicine. We presented this idea [of developing a roadmap] to the other members of the board, and this became the primary focus at the 2010 summit. There we came to the short conclusion that though we have many technological innovations and scientific advances that are capable of precipitating the massive transformation that our healthcare system needs, it seems obvious to all of us that these forces have been stymied fairly consistently. The best way to bring about transformative innovation was to find a way to unleash the power of disruptive innovation.
You described how the leaders of the forum all have their own way of describing personalized healthcare, but you agree on the basic premise. Do you all identify the same barriers to the field and do you have any consensus on how to move the field forward?
One of the first guiding principles for us is [that] what we have now is less of a healthcare system than a sick-care system. A lot of players in the present system make a lot more money when people are sick, not for keeping them well. In the end, there need to be incentives and a system for keeping people well. The barriers to the healthcare of the future that we see are myriad. We see a regulatory and legislative environment that is outdated, Byzantine, and stultifying. The cost of bringing diagnostics and therapies to market through the [Centers for Medicare and Medicaid Services], third-party payor reimbursement, and [the US Food and Drug Administration] approval process are all broken. At the same time, ingrained provider behavior stemming from medical education and conventional clinical approaches, and ingrained patient behavior, have all worked to stymie the potential of these disruptive forces in healthcare. As a result, so many of the promising technologies that are out there, especially in the diagnostics arena, are stuck in neutral. They have little chance of procuring the funding they need to fuel their development and empower meaningful innovation in healthcare delivery.
So as we analyze these barriers, we concluded that some of them are technical, some of them were related to business models and value networks, and some were societal. The key insight that has emerged from our collaborative discussions is that all three barriers need to be addressed simultaneously. Trying to swap the new technologies into the existing healthcare ecosystem has proven and will continue to prove to be a recipe for failure. So we felt that a coordinated effort across all the stakeholders in healthcare is what is needed to move the entire effort forward and hopefully help it harden into an industry.
There are other efforts that have similar aims to the Forum on Personalized Healthcare, in that they say they want to lift barriers and facilitate the adoption of new technologies. How is your effort different?
This is something we've thought about a lot, because we didn't want to add to the noise in the marketplace. We were hoping to increase the signal-to-noise ratio. We feel our approach is different because we view our efforts thorough Christensen's framework of disruptive innovation.
In the healthcare system we see four interrelated primary components of disruption that we hope to put to work … First are the technology enablers, which reduce costs and the intellectual capital to produce meaningful solutions. The second disruptive drivers are innovative business models that enable the cost-effective, accessible delivery of solutions to consumers or the market. The third is the web of value networks [that provide incentives to stakeholders], and all these need to be changed.
Those are the three universal components of disruptive innovation. In healthcare, the fourth disruption is societal infrastructure, including regulation and standards required to facilitate more accessible and affordable healthcare. So we intend to provide both system-level and in-the-trenches reductionist approaches to explore how diagnosis and patient care can be transformed through the interplay of all those elements.
In addition to Clayton's approach, we will be able to tap into the deep, systemic research and data analysis resources of PricewaterhouseCoopers, and their hands-on experience in this space. We're going to be collaborating quite closely with Gerry McDougall, [principal and lead of PwC's personalized medicine and health sciences practice] and also with Leavitt Partners and other key industry groups.
[I've divided] our goals for the roadmap into six primary groups, but they can be mixed and matched and we really see this as an iterative process. The first is to try to accelerate the emergence of disruptive innovation in healthcare. This can be done by developing a broad multi-stakeholder approach that addresses all the four elements of disruption. Second is to provide coordination and orchestration of stakeholder efforts at the scientific and technical level, and at the commercial and industrial ecosystem, and at the larger societal level. Third, this we want to create an ongoing forum within the key groups and … foster ongoing interaction on these fronts based on emerging technologies.
Fourth is to attract the support of key influencers from the private and public sectors, including elected officials and regulators, and work with them to develop enlightened, informed, and highly coordinated legislative and regulatory approaches. A fifth goal is to highlight personalized medicine best practices and approaches and increase their dissemination. This will include pilot projects that will help nail best practices before we scale them. There is often a temptation to scale systems before you really get them right. And our sixth goal is to conduct vigorous educational outreach campaigns, especially those that engage consumers.
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You said earlier that people are profiting right now from a sick-care system. So even if you made a compelling argument to stakeholders for implementing your roadmap, why should they?
I don't think everybody wants to. That's so much of the reason that we are doing this. There has been tremendous resistance [to personalized medicine]. People in organizations don't like to be disrupted. That is why we feel we are going to need a really deep and collaborative effort to do this. We're going to have to pull a lot of people who have not been collaborating together, and we're also going to have to convince a lot of people that not only is this where things should head, but that this is where things are heading.
We really hope that this living online document, which we are calling the Roadmap, will help orchestrate this movement, because it's going to require the best efforts of the best minds really working in a unified fashion.
Some of the people you're talking to are legislators on Capitol Hill. Can you talk about your efforts to advance personalized medicine through congressional channels? Who are you talking to and who do you need to win over?
The legislation that Aspinall and others are working on with Senator Orrin Hatch (R- Utah) and other stakeholders had its origins in the first summit meeting in 2008 [Hatch is crafting a bill, expected to be introduced this year, that would create a new FDA division called the Center for Advanced Diagnostics Evaluation & Research — Ed.] Hatch is working across the aisle trying to make that work. Because of the presence of these myriad regulations and the unintended consequences of the current healthcare system, we believe it is going to be necessary to engineer solutions that remove the obstacles for the free market to get freer and for disruptive innovation to take hold … For that we need serious collaboration in Congress.
We are now engaged in active collaborations with members of Congress on both sides of the aisle. They want to see the development of this roadmap, because it's going to give them bipartisan support to develop collaborative legislation. Sen. Hatch has said that this is something that needs to transcend politics. Hopefully the roadmap will show that this needs to be a bipartisan issue, and legislators can rise above the vitriolic environment that's handcuffing some of the efforts before Congress right now.
Sen. Hatch has been very supportive [of the forum's efforts], as has been former Senator from Utah Bob Bennett, and Congressman Tim Murphy on the Republican. Sen. Ron Wyden (D-Ore.), Congressman Jim Matheson (D-Utah), and former congressmen Joe Kennedy (D-Mass.) and Patrick Kennedy (D-RI), have also been helpful to all of us, particularly Christensen and Leavitt.
There now have been a number of bills introduced on personalized medicine. Once the Hatch bill is introduced, is there going to be an effort to align some of the proposals in the various bills that have been floating out there?
That is an iterative process. I don't want to speak for Sen. Hatch, but I know he is working to get bipartisan support, and I imagine it will weave pieces in from other legislation that's been out there.
You discussed the current difficult mood in Washington, and currently there are other priorities, particularly in the area of healthcare reform, that Congress is still tousling with. Do you think that these other priorities could overshadow legislative efforts in the personalized medicine space? When would the Hatch bill have a fair shot at being heard on the floor?
That is something we're actively exploring … We hope to be able to provide good guidance on these and other matters. We've seen some serious gainsmanship in healthcare. I think there's a lot coming from both sides, it's fair to say. There is an effort to find people who have the commitment and skill to rise above that.
When forum member Steven Burrill talks about healthcare reform it's clear that he doesn't believe that many areas of the healthcare reform law square with what needs to happen to incentivize the adoption of personalized medicine. Do the leaders of the forum have a sense of the elements of the healthcare reform that need to be altered and those that meld well with your aims?
There is definitely not unanimity between members of the forum on healthcare reform. It's fair to say that some of the members are major supporters of healthcare reform, and some are major opponents of that particular law. But the things we're focusing on at the forum are things that need to change no matter what shape healthcare reform ends up in … There are a lot of things we're working to figure out and a lot of things internally about which we're trying to build consensus. One of the guiding principles is that whatever is going to impede the implementation of disruptive innovation is something that we need to address.
When will the initial roadmap be released, and how do you plan to disseminate it to stakeholders and how do you intend to incorporate stakeholder input into the document?
Christensen and I are leading this effort and we have an initial team that will draft the roadmap. The team includes me, Frederick Lee of P4 Medicine, and Steven King of Innovo Strategy who helped develop the International Technology Roadmap for Semiconductors, on which the Roadmap on Personalized Health Care will be based in part. Obviously, this has different realities and complications. But the idea is to create something actionable.
Early in the fourth quarter of 2011 is when the first version of the Roadmap will be released publicly online. From then on it will be an ongoing, iterative process and we will continue to curate that with the guidance of the forum and with input from the board … In this process, we plan to get input from a lot of stakeholders, including the Personalized Medicine Coalition, David Ewing Duncan [director of the Center of Life Science Policy at the University of California, Berkeley], and the Kauffman Foundation, for example.
It's going to be an evolving document?
We have no illusions that the results of this roadmap won't be hard fought. But this project holds immense potential on investment and benefits for humankind.