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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.

Chair

Kenneth A. Getz, MBA

Speaker

Panelist
Jane E. Myles, MS

Panelist
Debra Michaels, MS

Panelist
Patrick Cauntay



Speakers
avatar for Kenneth Getz

Kenneth Getz

Director of Sponsored Research Programs and Associate Professor, Center For the Study of Drug Development, Tufts University School of Medicine
Kenneth A. Getz, MBA, is the Director of Sponsored Research and an Associate 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... Read More →
avatar for Debra Michaels

Debra Michaels

Associate Director, Scientific Programs & 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 →
PC

Patrick Cauntay

Assistant Director, Patient Advocacy and Engagement, 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, Operational Intelligence and Innovation, Genentech, A Member of the Roche Group
Jane is the Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation into the way we design and execute trials to get medicines to patients faster. She's worked at Genentech for 17 years in many roles, including line manager... 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