Life Science Leader Magazine

NOV 2014

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM 32 NOVEMBER 2014 f achieving patient-centricity is biopharma's Holy Grail, I thought I would seek some insight on this topic from the leadership team of a business built on serving patients. Founded in 2004, PatientsLikeMe, a for- profit company built on the principle of patient engagement, has grown from a single online community for ALS patients to a business covering 2,300 health con- ditions gathering real-time data from 300,000 members. In the company's bustling, brownstone headquarters in Cambridge, MA, I was joined by Jamie Heywood, cofounder and chairman; Ben Heywood, cofounder and president; and Martin Coulter, CEO. Together, they shared with me their per- spectives on why biopharma companies struggle when it comes to engaging with patients, as well as what companies can do to become more patient-centered. WHY DOES PHARMA STRUGGLE WHEN SEEKING TO ENGAGE PATIENTS? While being highly regulated or culturally conservative are most likely contributing factors to biopharma's patient-engage- ment struggles, to understand being patient-centered as a strategic solution, the PatientsLikeMe execs suggest you go to the root of the problem — the deeply infused cultural rules of clinical research. "As you're talking to people about how to do clinical research," Jamie Heywood analogizes, "it is as if Moses came down from Mount Sinai with a third tablet that said, 'Thou shalt only do a double-blind placebo-controlled trial and believe only the evidence from that.'" This mental- ity creates a number of problems. "The purpose of blinding a study is to elimi- nate biases," he shares. "Because blinding is the only approach many researchers have ever known, and, therefore, the only evidence which they will ever believe, they are less open to considering new ways of conducting clinical research." For example, PatientsLikeMe has developed an ALS predictive model that Jamie says is so accurate it is conceivable to conduct a clinical trial without a placebo. "It's now been validated in multiple publications," he states. "If you can determine whether a drug makes a difference against pre- diction instead of placebo, this is really neat because you can do what might be an 80- or 100-person trial with just 25 or 30 people. That's dramatic cost savings and you can do more dose ranges for the same money." Jamie believes that being able to conduct a clinical trial against prediction versus placebo could not only be cheaper but also better and faster to market. Though the rules of clinical drug trials are constantly being revised and rewritten, testing against prediction is not considered a viable option. Patients desperate for solutions are willing to try just about anything. As such, they want researchers open to trying new solutions, not ones blinded by their own biases. Although the PatientsLikeMe team admits the present way in which clini- cal trials are conducted is adequate for the purpose of getting a drug approved, they contend it is not at all patient-cen- tered. "Medicine and clinical research are very paternalistic fields that have large- ly regarded patients as subjects which perform best when they are adherent, compliant, unquestioning followers of the rules," says Jamie. This attitude is not conducive to creating a relationship between patient and researcher, and subsequently, patient and biopharma. To achieve patient-centricity requires creating a relationship where the patient is an equal partner similar to your other business partnerships. "In a partnership with a biotech or a clinical research com- pany, you're not sitting there at the end, saying, 'Hey, you patient, help me out here so I can make this medicine that makes your disease better that you may or may not be able to buy from me in the future,'" says Jamie. "That's not a partnership. That's a subject relationship." Another reason why biopharma has struggled with patient engagement is that the industry has relied on one-way communication that often includes only mass media and the healthcare provider. "As that world changes and the physician channel is going away, there's this real- ization of needing to develop a different model for establishing a relationship with patients," says Coulter. "But there's a lack of infrastructure, experience, and under- standing as to how to do this effectively." Ben Heywood adds, "The first instinct The Disappointment Of Clinical Outsourcing Jamie Heywood, the cofounder and chair- man of PatientsLikeMe, is disappointed with how clinical trials are outsourced today. He says that although CROs have done a great job optimizing the processes surrounding trials, the sponsors have done little more than tweak some of the parameters that have always been in place. "We've basi- cally committed to a trial model that was designed 20 years ago, outsourced every- thing according to that model's specifications, and then built an entire optimization system to drive down costs. But during all of this, we've stopped thinking about what a trial is for." Heywood believes patients and diseases need "continuous measurement improve- ment." "Pharma needs to enable continual collection of increasingly meaningful infor- mation about patient experiences. Doing so will help improve measurement and drive better decision making," he says. He also believes pharma should invest accordingly. "If you're not spending significantly to opti- mize how you measure a disease, then don't complain about the billion-dollar price tag of drug development," he comments. Instead, broadly engage as partners with the patient community so you can collaboratively improve measures, target patients more effectively, and ultimately reduce clinical trial costs. M A R T I N C O U LT E R CEO of PatientsLikeMe As that world changes and the physician channel is going away, there's this realization of needing to develop a different model for establishing a relationship with patients. I HOW TO BUILD REAL PATIENT-CENTERED PHARMACEUTICAL COMPANIES By R. Wright

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