Institute of Medicine Committee on Food Allergies Global Burden, Causes, Treatment, Prevention, and Public Policy
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1 Institute of Medicine Committee on Food Allergies Global Burden, Causes, Treatment, Prevention, and Public Policy Mary Jane Marchisotto Senior Vice President, Research, FARE June 22, 2015
2 Presentation Outline FARE Mission, Core Tenets, and Programs Education & Advocacy Highlights FARE Clinical Network (FCN) FARE Investigator in Food Allergy Award Program 2
3 FARE s Mission & Core Tenets FARE s mission is to improve the quality of life and the health of individuals with food allergies, and to provide them hope through the promise of new treatments Our work is organized around three core tenets Life Health Hope 3
4 FARE s Core Tenets Life Health Hope The ability to live a safe productive life with the respect of others on food issues Enhance access to healthcare that provides state of the art diagnostic and treatment Support research that promises and accelerates new therapies that improve the condition 4
5 FARE s Core Tenets & Programs Life Health Hope Education Advocacy Clinical Centers of Excellence FARE Clinical Network Clinical Research Encourage pharma to test drugs for food allergy Develop infrastructure for clinical research and clinical trials Research Awards New Investigators Mid-Career Investigators
6 Education and Advocacy Efforts Schools Professional education around CDC guidelines Expansion of stock epinephrine laws Emergency Medicine Bedside definition of anaphylaxis and incorporation into EMT training curricula and to create discharge toolkits Restaurants Continued expansion and marketing of ServSafe program Colleges and universities Continued expansion and marketing of college program Ongoing work to deepen understanding of allergen preparedness, beyond dining halls Air travel EAACI Patient Organization and International Alliance Committees 6
7 FARE s Core Tenets & Programs Life Health Hope Education Advocacy Clinical Centers of Excellence FARE Clinical Network Clinical Research Encourage pharma to test drugs for food allergy Develop infrastructure for clinical research and clinical trials Research Awards New Investigators Mid-Career Investigators
8 FARE Clinical Network FCN --Background Food Allergy research is at a critical juncture Scientific advances in allergy, immunology and related fields Development and testing of new products and therapies Shift to research and clinical services focused on patients Closing the estimated 18 year gap between evidence of best practices and widespread use in clinical practice Limited number of clinical sites Sharing data to help identify best practices in diagnostic and treatment outcomes and disparities 8
9 FARE Clinical Network FCN FCN member centers will help change the face of food allergy care by raising the quality of care for food allergy patients nationwide reducing discrepancies in care among providers making comprehensive care accessible and available for all patients with food allergies. FCN will help parents, caregivers and patients identify centers that provide clinical and sub-specialty food allergy services of the highest quality are leaders in rapidly applying new evidence-based knowledge FCN centers will accelerate drug development for food allergy by enhancing the ability of food allergy centers to perform crucial late-stage clinical trials help us build national food allergy patient registry and bio-repositories 9
10 FCN: Registry & Related Infrastructure FCN will develop a registry and supporting infrastructure to facilitate clinical research and clinical trials related to food allergy FCN members will provide EHR & other data to the FCN Registry Participating Patients will provide patient reported outcome data Network Provider EHR Data FCN Research Registry Patient Reported Data 10
11 FARE Clinical Network FCN FCN sites completed a comprehensive application documenting qualifications, credentials and facilities operational oversight measures training programs, inter and intra site collaborations community engagement projects patient satisfaction surveys and quality-of-life data Expect to launch FCN with 24 members, numerous others beginning the application process Expect to grow to centers by end 2016, including international centers Provides salary support for Center Director Salary Research Coordinator 11
12 FCN: Stakeholder Engagement & Collaboration FCN will change the face of food allergy care by engaging a broad array of stakeholder perspectives to: Establish priorities for FA clinical research and knowledge and evidence dissemination Facilitate FA clinical trial design and recruitment Facilitate dissemination of FA diagnosis, treatment and management best practices Patient Perspective Family Perspective Payer Perspective Clinical Perspective Change the Face of Food Allergy Care 12
13 FARE Research Support: Investigator in Food Allergy Awards New research grant program launched in late 2014 Multi-million dollar, multi-year program designed to expand the field of food allergy New Investigator Award ($75,000 annually for two years) Supports the development of an academic career for young investigators (MD, PhD, MD/PhD or DO) Mid-Career Award ($150,000 annually for up to five years) Supports established investigators of Assistant Professor or Associate Professor rank (or the equivalent in non-academic research settings) who want to transition to work in food allergy Grant Program advertised in in leading journals NEJM, JACI Received 25 quality proposals from 19 different institutions across the country Proposals were reviewed by a newly constituted RAB which conducted conflictfree evaluations Secured funding for 2 New Investigator Awards 3 Mid-Career Awards 13
14 Thank you Life Health Hope 14
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