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Wednesday, June 26 • 10:30am - 11:30am
#335: Highlights of the Patient Engagement Preparedness, Capabilities, Experience, and Impact (PEPCEI) Study

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-736-L04-P; CME 1.00; IACET 1.00; RN 1.00

Pharmaceutical and biotechnology companies are piloting and adopting a variety of patient centric initiatives across their R&D functions – including development planning, protocol design, study conduct, benefit/risk assessment, regulatory submissions, medical writing and disclosure & transparency. Overall approach and level of adoption in functional areas varies widely within and between companies. DIA, Tufts CSDD, and 20 participating biopharmaceutical companies collaborated to develop a comprehensive process for assessing the adoption and integration of patient centric initiatives within participating company operating areas. Following development and validation of an assessment tool and process, an independent team led by DIA and the Tufts CSDD conducted assessments within participating companies. Data from recently completed assessments will be used to identify leadership areas, to recommend areas where patient centric practices can be strengthened; and to discuss areas where patient-focus in drug development can be expected to drive change in the future. Aggregate measures will be derived from the data and published as benchmarking data for the broader biopharmaceutical community. In this session, experiences and lessons learned with the collaborative development and use of the assessment tool will be discussed by members of the study team and collaborating companies.

Learning Objectives

Describe the role and possible contributions of multiple functions in supporting patient focus in biopharma R&D; Discuss the benefits of cross-functional collaboration in advancing patient involvement in &D; Explain the importance of understanding the internal landscape of patient-centric efforts within one’s company.


Kenneth A. Getz, MBA


Jane E. Myles, MS

Debra Michaels, MS

Patrick Cauntay

avatar for Kenneth Getz

Kenneth Getz

Deputy Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →
avatar for Debra Michaels

Debra Michaels

Associate Director, Scientific Programs and Patient Engagement Lead, DIA
In her content-focused role at DIA, Debra Michaels provides guidance on educational content strategy and development across the DIA Americas portfolio of educational programs as well as subject matter expertise in selected areas. She is the lead for DIA’s Patient Engagement thought... Read More →
avatar for Patrick Cauntay

Patrick Cauntay

Assistant Director, Patient Centric Drug Development, Ionis Pharmaceuticals Inc
Patrick Cauntay is Assistant Director at Ionis Pharmaceuticals. He is responsible for researching and developing local and global advocacy relationships and innovative partnerships that provide a deeper understanding of various diseases from the patient perspective. Bridging antisense... Read More →
avatar for Jane Myles

Jane Myles

Head, Decentralized Trials Implementation, Covance
Jane is driving the global impmenentation of decentralized trials at Covance with a team of tech and trial experts. She is the Founder of JemTech consulting and the former Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation... Read More →

Wednesday June 26, 2019 10:30am - 11:30am
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum