Bristol-Myers Squibb Independent Medical Education

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1 Bristol-Myers Squibb Independent Medical Education Request for Educational Support (RFE) Date August 10, 2017 RFE Requestor Information RFE Code Name: Maria Deutsch, MS, PharmD, RPh Title: IME Specialist, Oncology RFE-17-ONC-120 Therapeutic Area Cancer immunotherapy Immune checkpoint inhibitors Solid tumors and hematologic tumors Area of Interest Current and future role of biomarkers in predicting pan-tumor response to immunotherapy in cancer Biomarkers role in guiding cancer treatment Biology/foundational knowledge of tumor mutational burden Educational Design BMS IME is interested in supporting two comprehensive, innovative, educational initiatives (Note: Educational providers may submit grants that cover one or both initiatives) #1 Live Satellite Symposium at the 2018 ASCO-SITC Clinical Immuno-Oncology Symposium (Jan 25-27, 2018) With live simulcast during the live meeting Plus web-based enduring activity leveraging the medical content from the live meeting #2 On-line web-based activity to be launched 4Q 2017 Knowledge, performance and competency based outcome measures according to Moore s Levels 4 is required; Level 5 outcomes are highly favored

2 Intended Audience (may include, but not limited to) Budget/Budget Range Medical oncologists, Oncology pathologists, clinical/biomedical researchers (and other healthcare professionals interested in personalized medicine and/or biomarker research) The two educational initiatives outlined above are expected to be achieved with a BMS budget of no more than $425,000. Geographic Coverage Deadline for Submission (Date and Time) Single and multi-supported initiatives will be considered. United States September 22, 2017 by 5pm EST Background: Medical oncologists, oncology pathologists, clinical/biomedical researchers, and other healthcare professionals interested in personalized medicine and/or biomarker research contribute to cancer diagnosis, prognosis and treatment through knowledge gained by the laboratory application of the biologic, chemical and physical sciences. The future of cancer care incorporates advanced technology with many forms of testing, including genomic sequencing, molecular diagnostics, liquid biopsies, and image analytics. This presents an increasingly complicated framework within which practicing pathologists, in order to diagnose and recommend the best treatment strategies, must be comfortable with emerging clinical research/results utilizing such evolving technology. The advances in pathology and the increased role of molecular analysis and personalized medicine has brought about new challenges in the continuum of care. Immuno-therapeutics and immune-oncology are rapidly developing areas. The characterization of a tumor s immune profile is essential when classifying a tumor for personalized medicine. Therefore, there is increasing pressure by the oncology community to quantify and validate relevant biomarkers and to understand their role in therapeutic approaches to cancer treatment. For example, Tumor Mutation Burden (TMB) is a next generation sequencing (NGS)-based biomarker that has demonstrated potential for predicting response to immuno-oncology (IO) agents. The novelty of the TMB biomarker presents a need to educate on its entire spectrum before we can meaningfully translate it into clinical practice. Due to the large amount of clinical data available in the role of the biomarkers in guiding cancer immunotherapy treatment for various tumor types, an integration of the data in a live setting for a broad audience at a key professional meeting is warranted.

3 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 correlated with these meetings available through internet/computer-based modalities as well. Educational Needs: This activity will ensure timely and effective communication of the latest science, clinical trial data, and biomarker data for current and emerging immunotherapies. Understand the utility of NGS and comprehensive gene panels in identifying potential biomarkers of novel immuno-oncology (IO) therapeutics and/or predictors of response to IO, including tumor mutation burden Recognize the potential utility of NGS in characterizing the tumor microenvironment Identify some of the current NGS technology platforms and comprehensive gene panels used in IO research today, including advantages and potential limitations. Specific Area of Interest BMS is interested in funding an innovative, interactive, educational activity that addresses the above educational needs. References 1. Bauml JM, Cohen RB, Aggarwal C. Immunotherapy for head and neck cancer: latest developments and clinical potential. Ther Adv Med Oncol May;8(3): Chalmers ZR, Connelly CF, Fabrizio D, et al. Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden. Genome Medicine Gatalica Z, Vanderwalde AM, Rose I, et al. Distribution of PD-L1 expression in diverse cancer types: Experience with over 10,000 cases [ASCO abstract 11548]. J Clin Oncol. 2016;34 (suppl). 4. George TJ, Frampton GM, Sun J, et al. Tumor mutational burden as a potential biomarker for PD1/PD-L1 therapy in colorectal cancer [ASCO abstract 3587]. J Clin Oncol. 2016;34(suppl). 5 Johnson DB, Frampton GM, Rioth MJ et al. Targeted Next Generation Sequencing Identifies Markers of Response to PD-1 Blockade. Cancer Immunology Research Kerr KM1, Nicolson MC. Non-Small Cell Lung Cancer, PD-L1, and the Pathologist. Arch Pathol Lab Med Mar; 140(3): doi: /arpa SA.

4 7. Patel SP, Kurzrock R. PD-L1 expression as a predictive biomarker in cancer immunotherapy. Mol Cancer Ther Apr; 14 (4): 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): Spencer KR, Wang J, Silk AW, Ganesan S, Kaufman HL, Mehnert JM. Biomarkers for immunotherapy: current developments and challenges. Am Soc Clin Oncol Educ Book. 2016;35:e 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): Ung C, Kockx MM. Challenges & perspectives of immunotherapy biomarkers & the HistoOncoImmune methodology. Expert Rev Precis Med Drug Dev Feb 9;1(1): Accessed October 6, Thakur MK1, Gadgeel SM Predictive and Prognostic Biomarkers in Non-Small Cell Lung Cancer.Semin Respir Crit Care Med Oct; 37(5): Epub 2016 Oct Zehir A, Benayed R, Shah RH, et a. Mutational landscape of metastatic cancer revealed from prospective clinical sequencing of 10,000 patients. Nature Medicine 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 or prevent this disease. 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

5 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 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.