Life Science Leader Magazine

JAN 2015

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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23 LIFESCIENCELEADER.COM JANUARY 2015 Innovative diagnostics and research solutions for discovery, clinic and bioprocess. Learn more at metabolon.com. Achieve better models, candidates & markers with metabolomics. the company. "It was an 'aha' moment for me," she recounts. "Patients volunteer for our clinical trials, travel many miles, spend hours devoting themselves, and are committed to the work we do. At the end of the trial, we say 'bye-bye,' often with- out as much as a thank you." To rectify this rather nonpatient-centric approach, a member of the Pfizer team tested the notion of establishing a platform that would thank clinical trial volunteers, as well as provide them the opportunity to get summary results from the trial. "In this way, they understood what their hard work and commitment had won in terms of advancing science around the disease," Lewis-Hall attests. In addition, by provid- ing a platform to stay connected to Pfizer, patients naturally began to take a more active and engaged role in the field of drug development. Now known as Pfizer Link, Lewis-Hall describes this online commu- nity as a key patient-centric engagement tool and a "clinical trial alumni associa- tion" for people who have graduated from a Pfizer clinical trial. Participants are given access to current information on diseases and conditions of interest, including suggestions and tools for disease man- agement, opportunities to participate in future clinical trials, and registries. As for patient-centric lessons learned, Lewis-Hall references collaborations such as the $58 million agreement between Pfizer and the Cystic Fibrosis (CF) Foundation to discover new treat- ments for people with the most common mutation of CF (Delta F508), and Lung- MAP, a lung cancer master protocol trial. "These are full-on meta-collaborations," she affirms. "Lung-MAP includes the NIH through the NCI [National Cancer Institute], the FDA, Friends of Cancer Research, and five companies [Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca's global biologics R&D; arm, MedImmune]. It's also fully integrated to include patient input from beginning to end." Lewis-Hall believes these meta- collaborations demonstrate that patient- centricity is not an activity for biopharma companies seeking a competitive advan- tage, but a presage of a new norm for how industry and regulators can and should operate. "The FDA has fielded a series of patient-centric public meetings, and the EMA [European Medicines Agency] has pilots to include patient input to the CHMP [Committee for Medicinal Products for Human Use] on benefits vs. risks," she states. Capture Your Existing Patient-Centric Best Practices If you are like Pfizer, you have devel- oped and implemented patient-centric initiatives guided by patients. But how are you capturing these best practices so you can replicate them? "We saw various leadership-championed initiatives growing throughout Pfizer as best practices," Lewis-Hall testifies. "But in a place this

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