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PP05-41: How to Establish a Patient Publication Steering Committee for a Global Biopharmaceutical Company: A Feasibility Case Study

Poster Presenter

      Alexandra Moutet

      • Global Head of Patient Engagement
      • UCB


As a Patient Publication Steering Committee (PPSC) is an innovation in industry publication practices, our objectives for this real-world feasibility study were to identify the key roles, governance, and documentation required to establish a PPSC for a global biopharmaceutical company.


To establish a process for UCB’s first PPSC, we collaborated (Nov ‘19-Feb ‘20) with key internal (patient engagement/advocacy, publications, compliance, medical) and external (expert patient partners, publication professionals) stakeholders. We co-created and measured readability of PPSC documents.


Our results show it is feasible for global biopharmaceutical companies to partner with patients at this early, important stage of the publication lifecycle (ie, in publication steering committees [PSCs]). We consulted with internal/external stakeholders required to support, approve and implement a PPSC. This confirmed the need for a PPSC, a compliant process, and plain language (PL) documents. We are using a step-wise process to establish the PPSC. Our PPSC framework is based on UCB’s existing publications SOP which aligns with Good Publication Practice 3 (GPP3) and addresses important compliance considerations (eg, clear selection criteria for patient representatives to join PPSC, a PPSC charter clearly defining roles/responsibilities, inclusion of identified publications in a Strategic Publication Plan). Draft PPSC documents (N=7) for the first meeting have been co-created by patient experts and publication professionals with expertise in PL and patient involvement in publications. For legal reasons, we did not alter UCB’s Confidentiality Agreement (CA) and Authorship Agreement (AA) forms, but did co-create a PL guide to each. These guides were more suitable for patients (CA vs PL-CA: D vs B; Flesch-Kincaid 13.9 vs 9.6; reading time 8:40 vs 3.51 min; speaking time 15.36 vs 6.56 min. AA vs PL-AA: D vs B; Flesch-Kincaid 13.4 vs 8.4; reading time 5.36 vs 4.59; speaking time 10.05 vs 8.59 min). The other documents (PPSC Charter; PPSC Invitation; Publication Process Overview; Patient Author Candidate Matrix; PL Summary of GPP3 guideline) followed PL principles, met readability targets, and were deemed suitable for patients. We are piloting the PPSC in one therapeutic area following UCB’s existing patient engagement principles. We are inviting qualifying members of one of UCB’s existing patient advisory councils to become PPSC members. The first PPSC meeting (May ‘20) will focus on PPSC roles and responsibilities and review of documents.


To our best knowledge, we have conducted the first feasibility study to establish a PPSC for a global biopharmaceutical company. Our results indicate it is feasible for industry sponsors to partner with patients to establish PPSCs. This has implications for changing industry publication practices to enable early, compliant and influential partnership with patients in the publication lifecycle. Patient engagement in publications of industry-sponsored research is relatively new compared with patient engagement in other areas (eg, clinical trials). While pharmaceutical companies have started to involve patient experts later in the publication lifecycle (eg, as authors and co-creators of PL summaries of publications [Pushparajah et al; Ther Innov Regul Sci. 2018;52:474-81]), we are unaware of published reports of patient involvement early in the publication lifecycle (eg, in PSCs). Our interest in establishing a PPSC was driven by: recognition that PSCs are part of GPP for industry-sponsored research; advocacy by patient experts for involvement in publication planning; our recent systematic review identifying the importance of involving patients before publication writing begins; and benefits described for early and non-tokenistic involvement of patients in other advisory groups (eg, Trial Steering Committees). By working collaboratively with internal/external stakeholders, we developed a compliant PPSC process and PL documents. We recognize our study has limitations (eg, only one industry sponsor’s experience, one therapeutic area) but we believe a highly focused approach is prudent for a feasibility study. To conclude, this novel, real-world, ‘how to’ case study indicates it is feasible for a global biopharmaceutical company to partner with patients to establish a PPSC. By sharing our insights, we hope other industry sponsors will consider how to partner with patients to establish PPSCs.