Life Science Leader Magazine Supplements

CRO Guide 2016

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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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2016 12 ROUNDTABLE leaders It appears patient-centricity/patient voice will continue to be a hot topic in 2016 and beyond. Where does your company currently stand in regard to implementing patient-centric practices? Can you share a few success stories? Roslyn Schneider: The "success story" here at Pfizer is a clear commitment across functions and levels of leadership to advance patient-centricity in a manner that's beneficial to the patient commu- nity. There are serious, disciplined, and often complementary efforts under way to embed patient-centered approaches into our plans and operations and to apply the resources we need to imple- ment our thinking. In addition to the formation of the Office of Global Patient Affairs, we've had patient-centered roles and teams focusing on innovation, advo- cacy, and policy across our organization. There are additional new roles and work streams to build on relationships that support change. Other examples are seen in the inclu- sion of a patient expert on Pfizer's exter- nal bioethics advisory panel, another on an external review panel that reviews Pfizer's independent grants for learning and change. We have included patients and advocates as members of multidisci- plinary advisory boards in several areas of Pfizer and engaged them earlier in the process to better inform decision making. Kathy Vandebelt: Lilly is focused on mak- ing clinical trials an accessible health- care option for patients and their health- care providers. Our clinical innovation and clinical development staff continue to learn more from patients about what they need to better participate in clinical research. Put another way, we want to embrace this notion of evolving along the continuum of "to-for-with" as it pertains to our relationship with patients and how we aim to collaborate with them. In 2016, we are expanding Lilly TrialGuide (, an enduring web presence that helps patients find information about clinical research and trials that may be appropri- ate care options for them. We are involv- ing patients in the design of protocols through a collaborative effort with the Lilly clinical research staff, investigators, and study coordinators. We are showing our appreciation for patients who con- tribute to clinical research and are now providing them with layman summaries of the results at the end of the study. We believe this helps patients understand their contribution. Beverly Harrison: At Janssen, we thought- fully and systematically place the patient voice at the core of how we operate by implementing programs that address patients' self-expressed needs. A variety of programs are under way to achieve this, including — amongst other pro- grams — transforming how we evalu- ate patient requests for compassionate use, enhancing the patient experience in the clinical trial setting, committing to transparency of the resulting data, and creating an internal infrastructure to guide employees in the capture and implementation of the patient voice. Within the clinical trials realm, an active program we have underway is called "Patient Voice in Trial Design." The ultimate goal of this program is for every Janssen trial we design, the patient voice will be just as loud as the many other voices that we have histori- cally sought to guide design decisions, such as key opinion leader physicians. This program involves gaining real world experience with a variety of methods for seeking, listening to, and incorporating the patient voice into clinical trial design and operational planning. To do this, we are in the process of building a "living" toolkit that we can deliver to the orga- nization to provide the know-how and necessary infrastructure. In parallel, we continue to explore novel methods that can be added to the toolkit and to main- tain a repository of patient insights for future reference. Tina Shah: Patient-centered care is a concept that is becoming increasingly important in our health system, and we are targeting ways to streamline the care we deliver in various settings (e.g., ICU, inpatient, outpatient) to revolve around the patient. One effective area of patient- centered innovation has been with our patients who have Chronic Obstructive Pulmonary Disease (COPD), a disease that causes trouble breathing. COPD is a condition now subject to the Medicare Hospital Readmissions Penalty, which seeks to improve patient-centered care by penalizing hospitals for excess read- missions. Our hospital developed a comprehensive care program led by a nurse practitioner that aligned care and implemented evidence-based practices for COPD patients in the inpatient and postdischarge settings. Two critical components of our patient-centered program are: 1) empowering patients through inhaler and disease education; and 2) ensuring continuity with a fol- low-up visit with our nurse practitioner within one week and a 24-hour patient access line that is also staffed by the same nurse practitioner. Our preliminary results have demonstrated a significant reduction in all-cause 30-day readmis- sions. At the same time, our patients tell us they love the teaching and feel more knowledgeable about their disease, but have helped us to uncover areas for improvement, such as ensuring that we schedule appointments that fit with their schedules and that we make sure they have all the needed prescriptions in hand before leaving the hospital. Are CROs able to play a role in protocol design or bringing patient perspectives to the table? Harrison: CROs can play a very important role in our quest to obtain patient By E. Miseta PATIENT-CENTRICITY ROUNDTABLE: SPONSORS, SITES, AND CROs MUST WORK TOGETHER TO HEAR THE PATIENT

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