Bristol-Myers Squibb Independent Medical Education

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1 Bristol-Myers Squibb Independent Medical Education Request for Educational Support (RFE) Date 6/15/18 RFE Requestor Information RFE Code Name: Pavit Singh, PharmD Title: Post-Doctoral Fellow, Independent Medical Education RFE-18-ONC-104 Therapeutic Area Cancer immunotherapy Solid and hematologic tumors Area of Interest The current state of the art clinical research in cancer immunotherapy, particularly in pathways of immune system response, tumor evasion, and the tumor microenvironment Foundational knowledge of immune biology, mechanisms of resistance to checkpoint inhibitors, and novel immuno-oncology agents in development Educational Design Bristol-Myers Squibb is interested in supporting a comprehensive educational initiative that is innovative, engaging, and interactive that leverages current scientific evidence. Intended Audience (may include, but not limited to) Budget/Budget Range The activities should measure improvement of learners knowledge, confidence, and competency, and should achieve at least a Moore s Level 4 objective impact. Community and academic medical oncologists, hematologists, allied health and advanced practitioners (NP, PA, PharmD), and other relevant healthcare professionals involved in immuno-oncology, precision medicine, and treatment decision-making in cancer. The anticipated program is expected to be achieved with a BMS budget of no more than $400,000. Accreditation Geographic Coverage Single and multi-supported initiatives (of any budget) will be considered. ACCME, ANCC, ACPE, and others as appropriate United States

2 Deadline for Submission (Date and Time) Friday July 13, 2018 by 5pm EST Background: Clinical development within immuno-oncology (I-O) is progressing at an unprecedented rate. Due to the immense amount of investigational clinical data available on the role of cancer immunotherapy treatment for various tumor types, interrogation and integration of data is warranted. 1 Educational needs assessments have demonstrated the necessity for providing education in this space for oncologists and the broader cancer care team. Recent scientific developments and success in use of immunotherapy to treat cancer have led to an array of new compounds in clinical development. 2 The number of immuno-oncology (I-O) targets is high and growing, with over 200 target-based areas of development. 3 Furthermore, the number of potential combinations of therapeutic agents directed against these targets and of combinations of such agents with conventional standard of care therapy is even greater. 4 The future of cancer care should thus incorporate realizing the full potential of all current oncology development to address remaining unmet medical needs. 5 This includes learning the fundamentals of cancer pathophysiology, an understanding of the emerging innovative pathways of tumor and immune system interaction, and of the novel therapeutic agents with unique or complementary mechanisms of action targeting multiple mechanisms of resistance and immune evasion. 6 Immunotherapy is proving to be an effective therapeutic approach in a variety of advanced and metastatic cancers. 7 Immuno-oncology therapies have redefined outcomes with durable overall survival across multiple tumor types. However, failure to respond and disease progression remain important challenges with immune checkpoint inhibition. Significant research efforts are underway to characterize mechanisms of resistance to I- O therapy, with a focus on the tumor microenvironment and novel I-O pathways beyond PD-1 and CTLA-4. 8 Based on a rapidly evolving understanding of tumor and immune biology, there are many promising compounds in clinical development with the potential to overcome multiple tumor immune-evasion mechanisms with the goal of prolonging survival for more patients. 9 Investigational compounds with clinical data include next generation immune checkpoint inhibitors (e.g., anti-lag-3), lymphocyte activating pathways (e.g., IL-2), immune regulatory pathways (e.g., IDO, CSF1R antagonists), and innate immune activators (e.g., TLR, STING, and NLRP3 agonists). Ongoing clinical trials are underway to evaluate the potential of these agents across tumor types and lines of therapy in order to broaden the population of patients that can experience benefit from I-O therapy. 10,11 Educational Needs: BMS has identified, through insights from educational needs assessments, literature searches, learning outcomes, and other methods, the need to provide education around

3 the state of the art science of the interaction between cancer and the immune system. The activity(ies) should ensure timely and effective communication of the latest science, clinical trial data, and significant developmental data for current and emerging immunotherapies. Key clinical research will be addressed through the educational program based on scientific evidence and concepts. At the conclusion of the activity, participants should be able to: Understand cancer (tumor) biology and its interaction with the immune system Highlight significant advances and current unmet medical needs associated with immuno-oncology therapies Analyze innate and adaptive resistance mechanisms (e.g., T-cell exhaustion) and understand the potential strategies to overcome it Describe the various investigational immune pathways that may be targeted to directly or indirectly overcome immune-evasion mechanisms employed by tumors Include emerging clinical data where available and demonstrate its connection to the basic science Since many healthcare professionals working in a multidisciplinary oncology team do not have the opportunity to attend live meetings, it is necessary and important to make the activities available through internet/computer-based modalities. Specific Area of Interest: BMS is seeking grant applications for the development and implementation of a welldesigned, innovative, interactive and educational initiative that addresses the educational needs described above. Proposals that incorporate activities that are more interactive, apply multiple methods and exposures, and are focused on outcomes that are considered important by physicians into the design and development of the educational activity will be given higher priority. The content, instructional design and/or the format of the CME/CE activity and its related materials must be current and designed in such a way that it addresses the educational needs of the intended audiences 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 scientific concepts in cancer immunotherapy. References: 1. Sharma P, Allison JP. The future of immune checkpoint therapy. Science. 2015;348(6230): Cave J. Oncology and medical education past, present and future. ecancermedicalscience. 2016;10: PhRMA. List of 2017 Immuno-Oncology Medicines in Development June. 4. Cesano A, Warren S. Bringing the Next Generation of Immuno-Oncology Biomarkers to the Clinic. Biomedicines Feb 6;1(14):1-11.

4 5. Tan PS, et al. Comparative Effectiveness of Immune-Checkpoint Inhibitors for Previously Treated Advanced Non-Small Cell Lung Cancer A Systematic Review and Network Meta-Analysis of 3024 Participants. Lung Cancer. 2018;115: Jenkins RW, Barbie DA, Flaherty KT. Mechanisms of resistance to immune checkpoint inhibitors. British Journal of Cancer : Farkona S, Diamandis EP, Blasutig IM, Cancer immunotherapy: The beginning of the end of cancer? BMC Med. 2016; Taube JM, Klein A, Brahmer JR, et al. Association of PD-1, PD-1 ligands, and other features of the tumor immune microenvironment with response to anti-pd-1 therapy. Clin Cancer Res Oct 1;20 (19): Rizvi NA, Hellmann MD, Snyder A, et al. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science Apr 3;348(6230): Hodi FS et al. Oral presentation at AACR Abstract CT Brahmer J et al. Oral presentation at AACR Abstract CT077 Note: The accredited provider and, if applicable, the medical education provider (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 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: 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, 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

5 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 reach and 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 Levels 4 & 5 are required. Level 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.