Sanofi Request for Proposals
Auto-immune thrombotic thrombocytopenic purpura (iTTP) is a rare, life-threatening disorder caused by auto-antibodies against ADAMTS13. It is characterized by a severe thrombotic microangiopathy (TMA) that leads to organ failure and is associated with high morbidity and mortality. The mortality rate of the untreated disease is around 90%, and treatment with corticosteroids and therapeutic plasma exchange (PLEX) reduces that rate to around 10%. Although this treatment induces remission, disease relapse remains a common problem. Relapse is estimated to occur in around 30–50% of patients after achieving initial remission.
Due to the rarity of the disease, and the emergency-nature of iTTP, there is a need to raise awareness on the urgency to rapidly diagnose and initiate therapy in patients, particularly for ICU and emergency room physicians. In recent years, knowledge around the pathophysiology of this disease has inspired new efforts to optimize a fast differential diagnosis (e.g., ADAMTS13 testing and surrogate scoring systems) and to prevent early deaths by targeting different axis of the disease, including the incorporation of new therapies (i.e., suppression of autoantibody production, replenishing ADAMTS13, and blocking microvascular thrombosis). Recently, ISTH guidelines on the diagnosis and acute management of TTP have been recently published in an attempt to harmonize clinical practices, as well as the publication of expert statements on the ICU management for iTTP patients with thrombotic thrombocytopenic. However, disease awareness is limited within ICU/ER community, and initial management practice.
REQUEST FOR iTTP IME GRANT PROPOSALS
SANOFI is seeking proposals to close these independently identified healthcare gaps to improve clinician knowledge of timely diagnosis and treatment strategies in iTTP. Proposals can target one or multiple audiences. Specifically, Sanofi will consider programs including, but not limited to, the following:
• IME enduring programs
• Regional and/or Local distribution channels
• Accredited or Non-accredited IME activities
• Single supported and multi-supported activities
• Maximum request not to exceed $75,000
Preference will be given to proposals that recommend appropriately designed interventions that are likely to enhance a learner’s knowledge of the unmet needs and employ proven strategies to overcome knowledge and performance gaps and barriers.
Proposal should include the following information:
• Target Audience and Audience Generation: describe methods for reaching the target audience including description of recruitment and placement strategies to maximize participation.
• Learning Objectives and Content Accuracy: Provide clearly defined and measurable learning objectives framed as expected practice improvements in relation to the identified gaps and barriers.
• Include an overview of program content and explanation of criteria that will guide content selection, considering level of evidence and other variables. Sanofi is committed to the highest standards in ensuring patient safety; the applicant should describe methods to ensure complete, accurate, evidence-based review of key safety data for any therapeutic entities discussed in the activity. Explain how content will be updated, if necessary, throughout the program period, and how accuracy will be ensured.
• Educational Methods: Sanofi supports the ACCME guidance for educational methods to be clearly designed to address the knowledge, competence and/or performance gaps that may underlie an identified healthcare gap. Your proposal should demonstrate an understanding of instructional design as it relates to the gaps in the knowledge, competence, or performance of the targeted audience. Educational methods and design should be based on current literature in CME best practice and consistent with ACCME accreditation criteria, as applicable. Preference will be given to applications that utilize methods that have been shown to result in practice improvements, and/or with data on the effectiveness of other programs of the same type.
• Faculty Recruitment and Development: Provide Information on the expected qualifications of contributors and description of methods to ensure recruitment of course directors and faculty who meet the qualifications. Explain any methods that will be used to ensure that faculty are fully trained in the program expectations and any skills that may be needed to ensure effective delivery of intended education.
• Program Evaluation and Outcomes: Provide a description of the approach to evaluate the reach and quality of program delivery; methods for monitoring individual activities and for ensuring ongoing quality improvements.
Preference will be given to programs with Objectives and Outcomes Plans with objective measures of changes in knowledge, and/or additional measures of improvements in competence, performance, patient health, population health, and/or system improvements, as aligned with the design of the intervention.
• Budget: Include a detailed budget with rationale and breakdown of costs, per unit, and description of each budget line item. In addition, please include any registrations fees paid by the learner, and how the fees will be applied.
• Accreditation: If proposal involves an accredited program, the accreditation must be provided by an appropriate accrediting body and fully compliant with the accrediting body’s criteria and applicable government guidelines and regulations.
• Fair Balance: The proposal should briefly describe methods for ensuring fair and balanced content, identification and resolution of conflict of interest, in alignment with applicable ACCME criteria.
• Communication and Publication Plan: Provide a description of how the provider will keep
Sanofi informed of progress. If applicable, include description of how the results of this educational intervention will be presented, published or disseminated.
Proposals are due May 29 at 12 PM ET. Submission Portal: https://sgrants.envisionpharma.com/vt_sgrants/.