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.

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

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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. 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. 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