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EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM 34 NOVEMBER 2014 TRANSFORMING TO PATIENT-CENTERED REQUIRES TRANSFORMATIVE LEADERSHIP Jamie Heywood believes truly transforma- tive businesses were not necessarily built on the idea of being a business. "They were built on a mission that became a business," he attests. "Google did not have a revenue model when it was invented and began to understand how to measure the Web. There were other search engines operat- ing on more traditional heuristics about how to understand things. The parallel to adopting a patient-centered approach at your company is looking at the actual patient experience as essentially the deter- ministic value of healthcare delivery or drug development." While he believes the Framingham Heart Study and the Nurse's Health Study to be excellent examples of this concept in action, it's not broadly accepted. "We've seen, depressingly, exam- ples where we've delivered transformative levels of value to one franchise team, and that team has tried to bring that same value to other parts of the organization. But the organization goes through the same resistance curve because it just rep- licates the problem in a different silo. Convincing the pharmaceutical busi- in clinical trials as an inflection point. Though he believes these devices will save therapeutic development companies hun- dreds of millions of dollars in the future, the benefits and savings will go to only those leaders willing to invest in under- standing which of these technologies, and in which contexts, matter. "Leaders need to be willing to invest in these and other inflection points." Ben says transitioning a new concept, such as patient engage- ment, from the innovation group to opera- tions is challenging. "Demonstrating the value and getting operational buy-in is possible as long as the budget to pay for it is coming from innovation," he states. "What we have seen is the traditional approach of easing it into the operating budget with the initiative being partially funded by both groups." While this some- times works during the transition, it often fails when operations has full financial responsibility. He suggests if adopting a patient-centered strategy, be sure to con- sider how to fund it, including creating transition budgets and teams to help the initiative move successfully from an inno- vative experiment to an operational best practice. only want to share conclusions and not the data from which they were derived. The challenge is not only creating a will- ingness to exchange data but also making that data digestible for patients. "This requires organizations to be able to figure out not only what's important to patients, but also how to present the findings in terms that resonate with them," says Coulter. "That's a skill the life sciences industry needs to develop." An additional challenge is the tradi- tional lengthy cycle times of research projects. "Patient-engagement research projects with six-month answer cycles are often overdesigned to produce pre- cise answers," says Jamie. He suggests if you want to start operating your business where you're making decisions in days and weeks instead of bi-annually, retrain your operational directors and vice presi- dents to seek outside resources which can help operationalize a real-time engage- ment model and stop overdesigning ques- tions. While adopting a patient-centered approach may make sense, expect resis- tance at various levels. For example, implementing a patient-engagement approach across a company's therapeu- tic portfolio (e.g., oncology) might meet resistance from individuals responsible for a single asset (i.e., experimental treat- ment) within the therapeutic category, especially if input adds new information that they fear could add risk to the asset's success. A further challenge is operat- ing in the clinical research world as it exists while trying to think about, and invest in, how you want it to look in the future. "Essentially, there is no funding, no model, and no mechanism for continually improving the measurement of disease via patient engagement," Jamie says. "At some point in the future, devices around us will monitor enough of our lives that the idea of surveys will be gone. While Jawbone [wrist band fitness activity tracker] as a tool for measuring mobility in multiple sclerosis patients as a changed measure- ment methodology in a trial is not vali- dated and ready today, at some point it will be." Jamie refers to the time period between now and eventual validation of personal activity tracking devices for use Patient-Centered Requires Big-Picture Thinking Idiopathic pulmonary fibrosis, IPF, is about to receive a big cash infusion. "There are now six companies specializing in IPF that are either in or going toward a phase 3 program," says PatientsLikeMe chairman and cofounder Jamie Heywood. A rough number of $200 mil- lion each equates to $1.2 billion in spending. One of the problems Heywood envisions is that these six companies are spending more money than they should. Unlike diseases such as ALS, which has an extremely strong clinical trial network, IPF does not. "It doesn't have a network of clinics," he says. "It doesn't have an outcome measure that is accepted or used by the FDA to approve a drug. The current measure, forced vital capacity, doesn't really match the decline of the disease — and the vast majority of IPF patients do not participate in clinical research." Heywood believes these are all fixable problems. "You can build an open clinical research network that is patient-cen- tered and recruit most of the people with the disease. You can educate patients and devel- op the measures, deploy them clinically, and validate." Instead of operating in isolation, these companies should do some big-picture thinking about how to best help the patient, and he believes all will benefit. "Imagine if the companies pooled $50 million toward solving the various problems around conducting IPF research," he ponders. "Suddenly, you could take a $1.2-billion cost and halve it." Heywood feels that becoming truly patient- centered requires biopharma to take on big- picture collaborative thinking. "This type of approach would result in getting faster and better signal detection, a better regulatory response, and a far better patient experi- ence," he attests. "Further, because you're integrating trial level measurement into the care process, you can eliminate most phase 4s; risk management is automatic, and as an added benefit you get real-world compara- tive effectiveness." HOW TO BUILD REAL PATIENT-CENTERED PHARMACEUTICAL COMPANIES By R. Wright