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Patient Involvement in Lilly's Alopecia Areata Clinical Development Program

Kathy Wyrwich is the Senior Research Advisor for the Patient-Focused Outcomes Center of Expertise at Eli Lilly and Company. With over two decades of experience conducting research studies in the development, validation, and interpretation of change over time of clinical outcome assessments (COAs), she recently led the development of several new alopecia areata COA measures at Lilly.

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Patient Involvement in Lilly's Alopecia Areata Clinical Development Program

  1. 1. Patient Involvement in Our Alopecia Areata Clinical Development Program Kathy Wyrwich, PhD Patient-Focused Outcomes Center of Expertise NAAF Research Summit December 4, 2018
  2. 2. Our Fundamentals ♦ Our Mission: We make medicines that help people live longer, healthier, more active lives. ♦ Our Vision: We will make a significant contribution to humanity by improving global health in the 21st century. ♦ Our Values: Integrity, excellence, respect for people 2© 2018 Eli Lilly and Company
  3. 3. On-going Program in AA: BRAVE-AA1 A Phase 2/3 Adaptive Study of Baricitinib in Participants With Severe or Very Severe Alopecia Areata
  4. 4. Company Confidential © 2018 Eli Lilly and Company AA Patient Involvement and The Impact at Lilly 1. Patient Interviews – Seeking Understandings • Concept elicitation • Understanding of important concepts and recommendations from patients 2. Lilly’s CoLab Simulation • Our CoLab simulations allow face-to-face input with clinicians, study coordinators, and patients to identify potential challenges in the operations and conduct of a planned trial and find solutions 3. Participation in the NAAF PRO Consortium Partnership • Confirmed key concepts and provided patient insights on an ideal AA treatment
  5. 5. AA Disease Severity and Treatment Experience Representation • Challenge = Recruitment of the spectrum of patients with AA hair loss areas (scalp/eyebrow/eyelash/other) and treatment backgrounds to hear a representative range of key concerns • Success = Hearing strong consistencies across patient voices, while also allowing often-overlooked key patient concerns (e.g., lack of nose hairs and associated day-to-day functional impairments) to be voiced in detail Minority and Education Level Representation • Challenge = Recruitment through specialized AA clinic sites makes finding and recruiting minority or lower education patients difficult • Success = Making new connections with sites following these patient with AA, facilitating their enrollments and participation in the interview process Concurrent Patient Interview Processes • Challenge = Concern about potentially discordant findings • Success = Learning together, and supporting patient input on the key concerns and ideal/meaningful treatment needs Company Confidential © 2018 Eli Lilly and Company Challenges and Successes Achieved Through Our AA Patient Involvement

Kathy Wyrwich is the Senior Research Advisor for the Patient-Focused Outcomes Center of Expertise at Eli Lilly and Company. With over two decades of experience conducting research studies in the development, validation, and interpretation of change over time of clinical outcome assessments (COAs), she recently led the development of several new alopecia areata COA measures at Lilly.

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