Inflammation RFP Opportunities

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Application Criteria

Gilead will consider concepts submitted under this Topics of Interest (TOI) program by November 20, 2026. Concepts submitted under Topic 1 must be in countries where seladelpar is commercially available. Concepts submitted under Topic 2 are open to all geographies. Comparative analyses of PBC treatments will not be considered; however, applicants are encouraged to use robust analytical approaches to contextualize outcomes and address evidence gaps.

Topic 1:

PBC is associated with a substantial patient burden that extends beyond biochemical measures of disease activity. Many individuals with PBC experience persistent symptoms, including pruritus and fatigue, that affect quality of life (QoL), highlighting the need for robust, patient-focused evidence describing symptom trajectories and QoL outcomes in routine clinical practice.

This TOI invites investigator-initiated proposals for real-world research characterizing the patient experience among individuals with PBC treated with seladelpar. Proposals may include, but are not limited to, characterizing less frequently evaluated QoL domains (e.g. daily functioning, emotional well-being, sleep, disability, work productivity), the relationship between pruritus and QoL, or the relationship between patient burden and treatment adherence/persistence or antipruritic treatment sparing/refractory pruritus.

Topic 2:

PBC patients with ALP levels between 1.0–1.67×ULN represent a clinically important yet under-characterized population. Heterogeneity in disease biology, comorbidities, symptoms, and other patient characteristics may influence disease progression and long-term outcomes. Existing evidence has identified some predictors of progression, however, these factors may not fully characterize disease risk or patient burden across this population. Additional evidence is needed to identify individuals with PBC at risk of worsening disease and to understand how clinical progression relates to symptoms and quality of life.

This TOI invites investigator-initiated proposals to characterize factors associated with markers of disease progression among individuals with ALP levels between 1.0–1.67×ULN. Proposals may evaluate biochemical measures, sociodemographic characteristics, comorbidities, symptom burden, quality of life impact, treatment patterns, and their relationships to disease trajectories and long-term outcomes.

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