Bristol-Myers Squibb Independent Medical Education Request for Educational Activity (RFE) Date RFP Code Therapeutic Area Areas of Interest Educational Design Intended Audience Budget Accreditation Geographic Coverage Deadline for Submission May 24, 2018 RFE-18-ONC-103 Oncology Immuno-Oncology and the Management of GU Cancers Comprehensive education initiative that includes a live satellite symposia at the ASCO-Genitourinary (GU) Cancers Symposium (February 14-16, 2019, San Francisco, CA) and web-based, and/or other enduring activities. The activities should measure improvement of learners knowledge, confidence, performance and competency and should achieve at least a Moore s Level 4 impact. Medical/Academic Oncologists, Community Oncologists, Urologists, Post- Doctoral Fellows and Advanced Practitioners in Oncology (NP/PA/PharmD) treating GU cancers. The maximum amount of BMS funding available is $150,000. Single or multi-supported initiatives will be considered. ACCME and others as appropriate to the audience(s) United States and International July 13, 2018 by 5pm EDT 1
Background Recent advances and new approvals in the use of immuno-oncology therapies for genitourinary cancers, especially renal cell carcinoma (RCC) and bladder cancer are rapidly changing the treatment paradigm. However, the fragmented distribution of the rapidly increasing data sets within immunooncology is generating a greater need for data integration for a broad audience in a live setting at a key professional meeting. Since many community oncologists and healthcare professionals working in a multidisciplinary oncology team do not have the opportunity to attend live meetings, it is therefore necessary and important to make the activities correlated with these meetings available as enduring materials through the internet and other delivery formats as well. BMS is seeking applications for a well-designed, interactive and engaging satellite symposia live activity to be held at the 2019 ASCO-GU Cancers Symposium. The activity must include web based/enduring materials. The proposals must be focused on the use of immuno-oncology in GU tumors, focusing on renal cell carcinoma (RCC) and bladder cancer and be current in content at the time of presentation and tailored for the intended audiences. Educational Needs and Professional Practice Gaps The content and/or the format of the CME/CE activity and its related materials must be designed in such a way that it addresses the educational needs of health care professionals and, if appropriate, tools/aids that can help health care practitioners communicate with or better manage their patients. Presentations and content must give a scientifically sound, fair and balanced overview of new and emerging therapeutic options currently available, or in development, to manage these diseases. Through independent needs assessments, BMS has determined health care providers have the following educational needs and professional practice gaps: 1. Need to become aware of current unmet medical needs in GU cancers, primarily in RCC and bladder cancer 2. Limited knowledge and understanding of the mechanisms of action and pathways of immunooncology 3. Lack an understanding of the role for immuno-oncologic mono and combination cancer treatments, including the role of (or lack thereof) biomarkers 4. Difficulty in describing the differences in dosage and scheduling of immuno-oncologic cancer treatments 5. Limited confidence in identifying and effectively managing toxicities of immuno-oncologic cancer treatments 6. Need to better understand the clinical profiles and clinical trial results of currently available and emerging agents based on efficacy, overall survival, rate and durability of response, quality of live and improved safety and tolerability of these agents. 2
Specific Areas of Interest BMS is interested in funding an innovative, interactive, educational activity that addresses the above educational needs and professional practice gaps in GU Cancers. Grant Proposals should include, but not be limited to, the following information: Executive Summary: The Executive Summary should consist of 1-2 pages and highlight the key areas as described below. Needs Assessment/Gaps/Barriers: Needs assessment should be referenced and demonstrate an understanding of the specific gaps and barriers of the target audiences. The needs assessment must be independently developed and validated by the educational provider. Target Audience and Audience Generation: Target audience for educational program must be identified within the proposal. In addition, please describe methods for reaching target audience(s) and any unique recruitment methods that will be utilized. The anticipated or estimated participant reach should also be included, with a breakdown for each modality included in the proposal, as applicable (e.g., number of participants for the live activity, the live webcast, and enduring activity). Learning Objectives: The learning objectives must be written in terms of what the learner will achieve as a result of attending. The objectives must be clearly defined, measurable, and attainable and address the identified gaps and barriers. Educational Design and Methods: Describe the approach used to address knowledge, competence, and performance gaps that underlie identified healthcare gaps. The proposal should include strategies that ensure reinforcement of learning through use of multiple educational interventions and include practice resources and tools, as applicable. Communication and Publication Plan: Provide a description of how the provider will communicate the progress and outcomes of the educational program to the supporter. It is highly recommended to describe how the results of the activity will be presented, published, or disseminated. Innovation: Describe how this project is innovative and engages the learners to improve knowledge, competence and/or performance. Further describe how this project might build on existing work, pilot projects or ongoing projects developed either by your institution or other institutions related to this topic. Program Evaluation and Outcomes Reporting: Description of the approach to evaluate the quality of the educational program. Describe methods used for determining the impact of the educational program on closing identified healthcare gaps. o Please refer to Guidance for Outcomes Report (on the BMS grants website) for a detailed explanation of preferred outcomes reporting methods and timelines. o Remember that knowledge, performance and competency based outcome measures according to Moore s Level 4 is required. Level 5 or 6 outcomes are highly favored and recommended when possible. Budget: Detailed budget with rationale of expenses, including breakdown of costs, content cost per activity, out-of-pocket cost per activity, and management cost per activity. 3
Note: The accredited provider and, if applicable, the medical education partner (MEP) or other third party executing the activities, are expected to comply with current ethical codes and regulations. They must have a conflict-of-interest policy in place to identify and resolve all conflicts of interest from all contributors and staff involved in developing the content of the activity prior to delivery of the program, and must have a separate company providing/accrediting independent medical education if they are also performing promotional activities. If your organization wishes to submit an educational grant request, please use the online application available on the Bristol-Myers Squibb Independent Medical Education website. http://www.bms.com/responsibility/grantsandgiving References 1. Hsieh JJ, Purdue MP, Signoretti S., et al. Renal cell carcinoma. Nature Rev Disease Primers 2017; 3:17009. 2. Moore DE, Green JS, and Gallis HA. (2009) Achieving Desired Results and Improved Outcomes: Integrating Planning and Assessment Throughout Learning Activities. JCEHP, 29(1):1-15. 3. Rini, BI, McDermott, DF, Hammers, H., et al. Society for Immunotherapy of Cancer Consensus Statement on Immunotherapy for the Treatment of Renal Cell Carcinoma. Journal for Immuno-Therapy of Cancer. 4:81. 2016. 4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ) for Bladder Cancer V.3.2018. National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed April 11, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. 5. NCCN Drugs and Biologics Compendium (NCCN Compendium ). National Comprehensive Cancer Network, Inc 2018. All rights reserved. Accessed April 23, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. 6. Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal Cell Carcinoma. N Engl J Med 2018: 378:1277-1290. 7. Hammers HJ, Plimack ER, Infante JR, et al. Safety and Efficacy of Nivolumab in Combination with Ipilimumab in Metastatic Renal Cell Carcinoma: the CheckMate 016 Study. JClinOncol. 2017.DOI: 10.1200/JCO.2016.72.1985. 8. Motzer RJ, Powles T, Atkins MB, et al. IMmotion151: A randomized phase III study of atezolizumab plus bevacizumab vs sunitinib in untreated metastatic renal cell carcinoma. 2018 Genitourinary Cancers Symposium. Abstract 578. Presented February 10, 2018. 9. Sharma P, Retz M, Siefker-Radtke A, et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a Multi centre, single-arm, phase 2 trial. Lancet Oncol 2017: 18:312-22. 10. Sharma P, Callahan M, Calvo M, etal. Efficacy and safety of nivolumab plus ipilimumab in previously treated metastatic urothelial carcinoma. J Clin Onco. 34:15_supp (May 2016) 4501-4501. 11. Rosenberg JE, Hoffman-Censits J, Powles T, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet 2016;387(10031):1909-20. 12. Powles T, Duran I, van der Heijden MS, et al. Atezolizumab versus chemotherapy in patients with platinumtreated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet 2018;391(10122):748-57. 13. Bellmunt J, de Wit R, Vaughn DJ, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med 2017;376(11):1015-26. 14. Massard C, Gordon MS, Sharma S, et al. Safety and Efficacy of Durvalumab (MEDI4736), an Anti Programmed Cell Death Ligand-1 Immune Checkpoint Inhibitor, in Patients With Advanced Urothelial 4
Bladder Cancer. J Clin Oncol 2016;34(26): 3119-25. 15. Apolo AB, Infante JR, Balmanoukian A, Patel MR, Wang D, Kelly K, et al. Avelumab, an anti-programmed death-ligand 1 antibody, in patients with refractory metastatic urothelial carcinoma: results from a multicenter, phase Ib study. J Clin Oncol Off J Am Soc Clin Oncol. 2017;35: 2117 24. 16. Postow MA, Sidlow R, Hellmann MD. Immune-related adverse events associated with immune checkpoint blockade. N Engl J Med 2018. 378:158-68. 17. Brahmer JR, Lacchetti C, Schneider BJ, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 2018; DOI: 10.1200/JCO.2017.77.6385. 5