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EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM JANUARY 2015 24 what kinds of symptoms people experi- ence when withdrawing from nicotine. "These were included as part of the supportive prescribing information, and are two examples of responding to what patients say they care about when con- sidering their options," she says. Questions To Ask When Becoming Patient-Centric If your goal is to make your organiza- tion more patient-centric, Lewis-Hall suggests asking the following questions: "How do you take the desire on the part of patients to be able to tell you what's important to them? How do you identify or develop tools to collect this informa- tion? How do you ensure their validity or go about validating? How do you utilize the tools? How do you communicate the information back to patients, while sys- tematically teaching the different teams working across other areas in your orga- nization?" She adds that the key to being patient- centric isn't just finding and using patient-centric tools, but understanding when they are appropriate to deploy. Ruminate on the following example: "We had some special challenges in a sickle- cell disease study," she states. "This is an emergency-room-based study where patients have to be in crisis. It's a unique population, many of whom have been ill all their lives and are experiencing agonizing pain." In trying to figure out how to meet these patients' needs while creating a manageable study, Pfizer deployed tools not often used in the clinical setting, such as ethnography and medical anthropology. "We worked with the physicians, patients, and advo- cates so they all better understood and articulated the patient's journey," Lewis- Hall shares. How Patient-Centric Are You? You are probably curious about what metrics Pfizer uses to measure the success or failure of its patient-centric best practices. Lewis-Hall says the first important metric is reach, which is measured by determining which of the company's programs are deploying size and with so much going on, we realized continued success meant put- ting some structure around it." In 2014, Pfizer created the office of global patient affairs. Headed by Roslyn Schneider, M.D., this group is charged with col- lecting, synthesizing, developing, and implementing a framework to better involve patients across all of Pfizer. This framework (i.e., structure) is designed to build "capabilities, systems, process- es, and platforms for sharing in order to make this a part of everyone's day," Lewis-Hall says. To better understand the type of information this group is trying to cap- ture, Lewis-Hall shares two examples, the first of which is related to Xeljanz (tofacitinib), the company's compound for rheumatoid arthritis. Xeljanz origi- nally received FDA approval for rheuma- toid arthritis in November 2012. A year later, the FDA approved a supplemental new drug application (sNDA) including additional patient-reported outcomes data. Says Lewis-Hall, " We worked to include things that are not usually part of a clinical trial." As examples, she lists the eight domains (i.e., vitality, role physical, role emotional, physical function, bodily pain, social function, mental health, and general health) of the Medical Outcomes Study Short-Form (36-Item) Health Survey (SF-36) used on the Xeljanz sNDA that now appear in the label. "That's a soup-to-nuts example of listening to patients about what's impor- tant to them, including it in clinical trials, collecting and analyzing the data, and then sharing it back with the patient community." For the second example, Lewis-Hall references Pfizer's fieldwork on under- standing smoking cessation. "What are the differences between smokers and patients who'd like to quit?" she asks. "How do you define someone who's ready to quit or who's not? How do you under- stand what drives the urge to smoke?" To better understand these questions, the Chantix (varenicline) team used validated scales and a brief question- naire that clarified smoking urges. They also used a withdrawal scale explaining PFIZER: PUTTING THE PATIENT AT THE CENTER OF ITS DRUG DEVELOPMENT UNIVERSE By R. Wright Try Nontraditional Research Approaches Patients often struggle to communicate via surveys and focus groups as to what is really important to them. This makes creating patient-centric initiatives difficult. To better capture the true user experience, Pfizer's consumer health group (makers of products such as ChapStick, Robitussin, and Advil) employs a rather unique tool. "We have a model home in the U.S. where we do research," explains Pfizer's chief medical officer, Dr. Freda Lewis-Hall. This tool helps Pfizer employees better understand what actually happens when company products get into the hands of consumers. While it's not often used in the pharma space, Lewis-Hall thinks the concept of observing user experience may have some applicability. For example, in Europe Pfizer has a similar dedicated user-experience observational space. "We've been bringing patients and caregivers in, giving them some medical software, and through observation, seeking to better understand their experience." Another patient-experience mechanism involves the recently signed research agreement between Pfizer and the personal genetics company, 23andMe. "We hope to enroll thousands of patients who have inflammatory bowel disease [IBD]," Lewis-Hall states. By studying genetic factors and severity of symptoms over the course of illness, as well as responsiveness to therapy, Pfizer employees anticipate gaining a deeper understanding of individual IBD patient variability. "This is an example of leveraging technology so we can better characterize patient disease subgroups, helping us to think about what patients might best benefit from one intervention versus another," she says. Lewis-Hall believes that if you want to better understand the patient, you need to be willing to try some nontraditional research approaches.