Call for Independent Medical Education (IME) Grant Notification: Medical Affairs, Knowledge Exchange

Transcription

1 DATE of issue: October 1, 2018 Call for Independent Medical Education (IME) Grant Notification: Medical Affairs, Knowledge Exchange Therapeutic Area and Disease: Breast Cancer The Medical Affairs Team at Roche Canada invites members of the medical educational provider community to submit applications for IME grants subject to the terms described below. This Call for IME provides public notice of the availability of funds in a general topic area for activities where recognized scientific or educational needs exist and funding is available. Purpose: As part of its scientific mission, Roche supports grants for IME as a means to enhance the medical community's ability to care for patients. This mission is achieved by supporting quality independent education that addresses evidence-based, valid educational gaps in accordance with the Royal College of Physicians and Surgeons of Canada CPD MOC Program and the spirit of the prevailing Innovative Medicines Canada s guidance. Eligibility Criteria: Appendix A Geographical Scope: Canada (if a Provincial, Territorial or Regional specific proposal is submitted, please include how needs were determined and how the proposed activity will address these needs). Submission Instructions: Providers who meet the eligibility criteria and are interested in submitting a response to this Call for IME may submit their grant request using the Roche grant application form: Appendix B can be accessed at LINK TO FORM Deadline for Submission of Applications: November 12, 2018 (09:00 EST) Award Decision Date/Mechanism: Final approvals and denials of successful applicants will be communicated through no later than November 26, There have been no predetermined approvals. All submissions will be reviewed equally. IME providers should only respond to this Call for Grant if they have read and understand the terms, purpose, therapeutic landscape and educational request identified below. Applicants will be expected to identify independent clinical knowledge gaps that are clinically accurate, relevant and aligned to this Call for IME Grant, which can be referenced. Call for IME Grant Area of Interest Available Funding Metastatic Triple Negative Breast Cancer Roche has a budget of up to $75,000 CDN available for the activity or program (single or multiple linked activities, including live events and/or online education programs and/or accredited printed pieces, intended to address the identified 1/10

2 unmet educational needs for the target audience outlined in this Call for Grant Notification (CGN). Budget submissions should be broken down per activity if more than one approach is proposed. Educational providers may request up to a maximum of $75,000 CDN but are not required to design an IME that utilizes the full available amount. If Provincial, Territorial or Regional specific proposal is submitted, ensure requested funds are reflective of the audience reach. Background Context Triple-negative breast cancer (TNBC), which is characterized by the lack of expression and/or amplification of the targetable receptors for estrogen, progesterone and human growth factor receptor 2 (HER2), accounts for 15% to 20% of all breast cancers 1-3. This breast cancer subtype is an aggressive, heterogeneous disease with high unmet need. Patients with TNBC experience poor clinical outcomes, including earlier and higher relapse rates, compared with other breast cancer subtypes 4-6. In patients that relapse or experience metastatic disease, there is no cure 7. Chemotherapy is the mainstay systemic treatment for TNBC in all settings, and the use of taxanes as first-line treatment for advanced disease is supported by international guidelines, including those of the National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) For patients with metastatic disease, there is a significant unmet medical need due to limited treatment options and short survival after chemotherapy failure 12. Two promising avenues of clinical research in metastatic TNBC are targeted therapies and immunotherapies, including checkpoint inhibitors Educational needs Immunotherapy is an emerging therapeutic approach, which has changed the treatment landscape for many types of cancers, including lung and melanoma 15,16. The immunogenicity characteristics of TNBC, coupled with its high unmet need, make it a potential target for immunotherapy Given the emerging evidence to support the use of immunotherapy in metastatic TNBC 14, there is a need for education to enhance physician knowledge and understanding around these latest advances. According to a recent needs assessment 23, topics related to TNBC were the most compelling, along with novel emerging therapies, including cancer immunotherapies. Medical oncologists also indicated a lack of familiarity relating to the roles of PD-L1 and immunogenicity of breast cancer. This call for an independent medical education grant is specific for metastatic TNBC, which has 2/10

3 the greatest unmet need, as there is no cure and the 5-year overall survival of patients with TNBC metastatic disease is only 11.2% 24. In order to fully embrace the potential of cancer immunotherapies in metastatic TNBC, healthcare providers need sufficient knowledge to be confident using these treatments in clinical practice. Thus, key topics of interest relating to metastatic TNBC include: Disease overview, including current treatment recommendations and the remaining unmet need New and emerging immunotherapy options (including PD-1/PD-L1 inhibitors) and their associated biomarkers How biomarker testing may identify which patients most likely benefit from immunotherapies Safety profile of emerging immunotherapies compared with the current standard of care Ideally, a broad overview of these topics should be covered in the educational activity (or activities). Methods Measures Results Roche is seeking to support an education grant that: 1. Supports clinicians' information and learning needs as outlined, but not limited to, those outlined above. 2. Identifies further clinician baseline knowledge and awareness needs, together with competence gaps. 3. Provides fair and balanced educational initiatives that translate into benefits for patients, their caregivers and healthcare providers. 4. Is aimed at the identified areas and that embraces effective models for delivery and scientific exchange. Roche believes that on the basis of external research that this educational initiative would benefit, but not be limited to Medical Oncologists and Molecular or Clinical Pathologists and the program(s) must be accredited for physicians according to Royal College of Physicians and Surgeons of Canada CPD MOC Program. Roche encourages IME providers to submit grant requests that address specific clinician knowledge, competence, and performance gaps. Consideration will be given to those grant requests intended to demonstrate how the educational initiative(s) would improve patient care by closing gaps and assessing healthcare providers behaviour relative to standards of care and best available evidence. The educational initiative should provide the participants with the latest data to help with the evaluation and utilization of evidence that leads to appropriate decision- 3/10

4 making and enhancement of patient care. The educational provider should therefore show that learners: 1. Have demonstrated understanding of the educational activity; 2. Have demonstrated competence improvement as a result; 3. Will use evidence-based concepts to consider changing behaviour where appropriate or relevant. Discussion Roche encourages IME provider(s) who are awarded approval to: 1. Consider whether or not the educational intervention(s) reduced on average the time taken for the educational audience to adopt information, demonstrating how this was achieved; 2. Demonstrate key findings via outcomes analysis (see Measures and Results sections above); 3. Summarize (through written analysis) their understanding of the outcomes metrics, identifying the association between the intervention and outcomes; 4. Identify any further knowledge gaps and unanticipated barriers and/or activity/outcomes limitations; explain the reason(s) for them, and describe the efforts made to address them as necessary. Additional Considerations All grant submissions should describe how the educational provider plans to determine the extent to which the initiatives have met the stated objectives and closed the identified clinical/educational gap(s) including the qualifications of those involved in the design and analysis of the outcomes. The successful grant recipient will, upon completion of the activity (or activities), be asked to provide documentation attesting to how the funds were used, and must return any unused funds to Roche, along with the requisite activity outcomes/impact report. Terms and Conditions 1. All grant applications received in response to this Call for IME will be reviewed in accordance with all Roche policies. 2. This Call for IME Grant does not commit Roche to award a grant or to pay any costs incurred in the preparation of a response to this request. 3. Roche reserves the right to approve or deny any or all applications received as a result of this request or to cancel, in part or in its entirety, this Call for IME Grant. 4. For compliance reasons, and in fairness to all education providers, all communications about this Call for IME Grant must come exclusively to mississauga.ime_grant@roche.com 5. Failure to follow any instruction within this Call for IME Grant may result in a denial. Transparency 4/10

5 As a matter of corporate responsibility, Roche reserves the right to publicly disclose, for example via reports published on its website, financial support provided in the form of grants or other contributions to third-party organizations. In such case Roche will report information such as the name of the grantee, a brief description of the program/project, and the amount of the grant award. References 1. Kohler BA, et al. J Natl Cancer Institute (2015); 107(6):djv Wolff AC et al. J Clin Oncol (2013); 31(31): Hammond ME et al. J Clin Oncol (2010); 28(16): denbrok WD et al. Breast Cancer Res Treat (2017); 161: Malorni L et al. Breast Cancer Res Treat (2012); 136(3): Dent R et al. Breast Cancer Res Treat (2009): 115: Egger SJ et al. Cochrane Database of Systematic Reviews 2017, Issue Senkus E et al. Ann Oncol (2015); 26 (Supplement 5):v8-v30 9. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology Breast Cancer. Volume March 20, Denduluri N et al. J Clin Oncol (2016); 34(20): Cardoso F et al. Ann Oncol (2017); 28: Bajaj P et al. Ann Oncol (2017); 28(5): mdx Targeted therapies in Phase III development for TNBC include: (a) the AKT inhibitor ipatasertib in combination with chemotherapy as first-line treatment for mtnbc (ClinicalTrials.gov ID, NCT ); (b) the PARP inhibitor talazoparib for BRCA-mutant advanced breast cancer (ClinicalTrials.gov, NCT ); (c) the antibody drug conjugate sacituzumab govitecan for relapsed or refractory TNBC (ClinicalTrials.gov ID, NCT ), which was granted US FDA Fast Track designation for treatment of patients with TNBC; and (d) bicalutamide for treatment of androgen receptor positive mtnbc (ClinicalTrials.gov ID, NCT ). 14. Immunotherapy agents in Phase III development for TNBC include the checkpoint inhibitors TECENTRIQ and pembrolizumab as monotherapy and in combination with chemotherapy for early and advanced TNBC (ClinicalTrials.gov IDs, NCT , NCT , NCT and NCT ), avelumab monotherapy for high-risk early TNBC (ClinicalTrials.gov ID, NCT ) and the tumour endothelial targeting agent EndoTAG-1 with chemotherapy as first-line treatment for visceral mtnbc (ClinicalTrials.gov ID, NCT ). 15. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology Non-small cell lung cancer. Version Dummer R et al. Ann Oncol (2015); 26(Supplement 5):v Wang, Y et al. Nature (2014); 512: Lehmann, BD et al. J Clin Invest (2011) Jul;121(7): Cimino-Mathews, A et al. Hum Pathol (2013); Oct;44(10): Loi, S et al. Ann Oncol (2014); 2014 Aug;25(8): Chen DS and Mellman I. Immunity (2013); Jul 25;39(1): Mittendorf, EA et al. Cancer Immunol Res 2014; Apr;2(4): /10

6 23. Assessing the knowledge gap in breast cancer: A medical knowledge gap evaluation created for Roche in December Howlader N et al., Cancer Epidemiol Biomarkers Prev Jun;27(6): /10

7 Appendix A Eligibility Criteria for Independent Medical Education (IME) Grant Recipients Roche Grant for Independent Medical Education (IME) to Healthcare-Related Entities can only be provided for the purpose of supporting healthcare-related education and must always ultimately benefit patients and/or public health. IME is generally defined as a healthcare-related educational activity for HCPs initiated and organized independently from Roche by an IME Provider such as a hospital, academic center, society or association, or medical education company, and where Roche has no influence on the content of the program. The IME Provider must be an independent third party that has full control over the development and selection of all aspects of the activity, including content, presenters, moderators and audience. Roche is not providing Grants for IME to the following: 1. Individual HCPs or individual patients or organisations owned or controlled by individual HCPs 2. Small business associations of HCPs, e.g. private physician offices, private group practices, small private hospitals (comprising, as a general rule, less than 10 HCPs) 3. Not-for-profit foundations formed by a small number of HCPs (as a general rule less than 50 HCPs) In order to be eligible, the funding must not be used: 1. To improperly induce or to reward the prescription, recommendation, purchase, order, supply, use, administration, sale or lease of a Roche Product or Service; 2. For the purpose of Pre-approval or Off-label Promotion of a Roche Product; 3. To inappropriately influence regulatory, pricing, formulary or reimbursement decisions; 4. To influence the content of Clinical Practice Guidelines; 5. For relationship building purposes. 6. For standalone entertainment or social events Firewall requirements for IME Providers The IME Provider must be an independent third party that does not provide strategic and promotional or marketing related services to Roche or the IME Provider must certify that a proper firewall exists between the related promotional and IME services. Provision for an independent activity or event specific Grant 1. Grants are provided for a specific activity or event that may not be organized nor influenced in any way by Roche. Additionally, Roche cannot receive any direct benefit in return when providing a Grant. 2. The specific activity or event must be described in the application form link and the description must be sufficiently complete in order for Roche to be able to evaluate whether or not to provide the support. a. It should usually contain at least the following information: 7/10

8 i. Background of the request including objectives and expected result of the event / activity ii. Description of why the event / activity is necessary (unmet educational need) iii. Intended audience of the event / activity iv. Whether or not other companies have been invited to support the event / activity v. In case of live event additionally: Proposed agenda and description of the planned location. vi. Requested amount of support, including cost breakdown for event / activity; 3. Grant requests that contain unacceptable budget line items will be ineligible such as: a. Funding for healthcare professional partners or guests. b. Faculty lodging and/or expense reimbursement out of proportion with the number of days that the faculty is presenting c. Gifts/prizes for faculty or attendees d. Request for food only e. Funding for faculty dinners not related to content review f. Honoraria or costs not according to Fair Market value FMV and the applicable local laws, regulations and industry codes, in the country where the attending HCP has his/her primary practice g. Lavish venues and venues that detract from the educational activity as the primary purpose. 4. Grants are provided for a fixed period of time and cannot be self-renewing General 1. The organization will provide an official receipt and full cost reconciliation upon request that meets applicable accounting standards. 2. If a Grant is approved, the organization must enter into a written agreement with Roche Appendix B Roche Grant Application Form (Google form) LINK NOTE: This form must be submitted in its entirety by November 12 th, 2018 All communications about this Call for IME must be directed exclusively to mississauga.ime_grant@roche.com 1) Address 2) Name (given, surname) Provide your first and last name. 3) IME Provider Name Provide the name of your organization. 8/10

9 4) Background Provide a summary of the educational need, which should include: (1) the nature and severity of the clinical gap in the specifically identified area, and (2) a summary of the baseline knowledge / competence / performance gaps for the potential grant's identified educational audience(s). 5) Methods Provide a brief and concise description of the educational initiative, including all educational formats / interventions recommended for the potential grant submission. 6) Measures Provide a brief description of the tools and/or strategies for measuring the educational impact that will be incorporated into the proposed grant. 7) Results Provide a brief and concise description of any knowledge, competence, and/or performance changes expected for the learner after participating in this education. 8) Will the activity (activities) be accredited? The activity must be accredited. Provide name of accrediting body. Proposed activities within Grant application must be reviewed and approved for accreditation in accordance with the Maintenance of Certification (MOC) Program by the Royal College of Physicians and Surgeon of Canada. 9) Will you be working with a third party to develop/accredit the activity (activities)? Provide name of third party below Additional Information: Submit additional supporting documentation and details of the proposal to mississauga.ime_grant@roche.com Type of activity: face-to-face [live or virtual event(s)] /online activity /accredited printed piece/ blended learning curriculum Activity start date Intended audience of the event/activity (activities), anticipated number of participants If Provincial, Territorial or Regional specific proposal is submitted, please include how regional needs were determined and how activity will address. 9/10

10 Requested amount of support, including a detailed cost and resource breakdown (e.g. content development, logistics, distribution, number of IME Provider staff involved, pass through costs etc.) for the event/activity Whether or not the IME Provider has been in contact with other companies to support/sponsor the same event/activity 10/10