Icahn School Of Medicine AT Mount Sinai

WTCHP CLINICAL CENTER OF EXCELLENCE

IDENTIFICATION OF BIOMARKERS AND PATHOLOGICAL MECHANISMS VIA LONGITUDINAL ANALYSIS OF NEUROLOGICAL AND CEREBROVASCULAR RESPONSES TO NEUROTOXIC STRESS USING A MULTI-CELLULAR INTEGRATED MODEL OF THE HUMAN BRAIN

TRANSPLANT SURGEONS

OPTION 23C: 0258-A485-4609 OPTION 23D: 0258-A486-4609 THE UNIVERSAL INFLUENZA VACCINE TECHNOLOGY LANDSCAPE IS A UNIQUE, OPEN-ACCESS DATABASE OF INFORMATION ON UNIVERSAL, BROADLY PROTECTIVE, AND NEXT-GENERATION INFLUENZA VACCINES, AS DEFINED IN THE INFLUENZA VACCINES R&D ROADMAP, IN CLINICAL AND PRECLINICAL DEVELOPMENT. AS OF MAY 2024, THE LANDSCAPE PROFILED MORE THAN 200 VACCINE CANDIDATES IN THE R&D PIPELINE IN ACADEMIC, GOVERNMENT, AND INDUSTRY LABORATORIES, INCLUDING COVID-INFLUENZA COMBINATION VACCINES IN CLINICAL DEVELOPMENT, ACROSS SIX DIFFERENT VACCINE PLATFORMS. DATA ON EACH VACCINE CANDIDATE ARE SUMMARIZED BY PHASE, PLATFORM, TECHNICAL APPROACH, GOAL, AND STATUS OF DEVELOPMENT. THE LANDSCAPE IS ONLINE AND OPEN ACCESS, AND THE ENTIRE DATASET CAN BE DOWNLOADED AS A CSV FILE. A SMALL GROUP OF SUBJECT-MATTER EXPERTS IN INFLUENZA VACCINE R&D AND/OR VACCINE DATABASE DEVELOPMENT PROVIDES ADVICE ON THE DEVELOPMENT OF THE LANDSCAPE. THE OBJECTIVE OF THIS PROJECT IS TO CONTINUE DEVELOPING AND MAINTAINING INFORMATION ON THE LANDSCAPE TO INCLUDE AN UP-TO-DATE, COMPREHENSIVE, AND ACCURATE OVERVIEW OF VACCINE CANDIDATES IN PRECLINICAL DEVELOPMENT FOR UNIVERSAL, BROADLY PROTECTIVE, AND NEXT-GENERATION INFLUENZA VACCINES. SPECIFIC ACTIVITIES: 1. COLLECT AND CURATE INFORMATION ON UNIVERSAL, BROADLY PROTECTIVE, AND NEXT-GENERATION INFLUENZA VACCINES TECHNOLOGIES IN PRECLINICAL DEVELOPMENT FROM A WIDE RANGE OF PUBLICLY AVAILABLE SOURCES. CONTINUE RESEARCH ON UNIVERSAL, BROADLY PROTECTIVE, AND NEXT-GENERATION INFLUENZA VACCINE TECHNOLOGIES; MONITOR KEY SOURCES OF INFORMATION FROM THE SCIENTIFIC LITERATURE, PREPRINT SERVERS, AND INDUSTRY WEBSITES AND NEWS SOURCES; AND CROSSCHECK DATA ON VACCINE TECHNOLOGIES IN THE DATABASE. 2. UPLOAD NEW OR REVISED INFORMATION ON THE IVR LANDSCAPE WEBSITE ON A WEEKLY BASIS, FOR DISPLAY IN THE SNAPSHOT GRAPHIC AND DATABASE TABLE, AND MONITOR DATA FOR COMPLETENESS AND ACCURACY. 3. DISSEMINATE INFORMATION ON R&D OF INFLUENZA CANDIDATE VACCINES IN PRECLINICAL DEVELOPMENT VIA PRESENTATIONS AND PUBLICATIONS IN THE PEER-REVIEWED LITERATURE; ENCOURAGE FEEDBACK FROM DEVELOPERS, RESEARCHERS, AND FUNDING ORGANIZATIONS. 4. CONSULT WITH ADVISORY WORKING GROUP MEMBERS FOR GUIDANCE AND REVIEW. COMMUNICATE WITH DEVELOPERS TO VERIFY ACTIVITIES AND ACCURACY OF DATA. 5. MODIFY THE ONLINE DATABASE FORMAT AS NEEDED, WITH SUPPORT FROM CIDRAP€„¢S IT CONSULTANTS, AND IN COMMUNICATION WITH NIAID AND CIVICS-SEM. THE LANDSCAPE WILL PROVIDE A COMPREHENSIVE, UP-TO-DATE RESOURCE ON THE R&D PIPELINE FOR VACCINE CANDIDATES IN PRECLINICAL DEVELOPMENT FOR RESEARCHERS, DEVELOPERS, AND NIAID LEADERSHIP. THE LANDSCAPE SUPPORTS THE NIAID/CIVICS PROGRAM€„¢S GOAL OF ADVANCING INFLUENZA VACCINE SCIENCE AND IDENTIFYING POTENTIAL VACCINE CANDIDATES THAT MAY OFFER BROAD AND LONG-LASTING PROTECTION AGAINST SEASONAL AND PANDEMIC INFLUENZA.

CONDUCT QUALITY CONTROL RELEASE TESTING ON SAMPLES OF TRADITIONAL VACCINES, SPECIFICALLY FOCUSING ON THE FOLLOWING PRODUCTS: NDV MASTER SEED, NDV FINAL PRODUCT, AND NDV BULK HARVEST. PLEASE REFER TO QUOTE NUMBERS R-10151426.1, R-10151430.1, AND R-10151438.1, ATTACHED AND INCORPORATED HEREIN, FOR DETAILED SPECIFICATIONS.

SUBCONTRACTOR SHALL CONTINUE TO ADDRESS UNMET NEEDS IN SARS-COV-2 SEROLOGICAL TESTING AND RESEARCH THROUGH INVESTIGATION OF CHARACTERISTICS OF THE IMMUNE RESPONSE THAT CORRELATE WITH PROTECTION FROM INFECTION OR SEVERE DISEASE, WITH A FOCUS ON CANCER PATIENTS. LONGITUDINAL STUDIES SHALL CONTINUE ONLY IN THE MULTIPLE MYELOMA COHORT; IN HEMATOLOGICAL CANCER TRANSPLANT RECIPIENTS (WITH AND WITHOUT HIV)AND WITH HEALTHY CONTROLS TO ACHIEVE MATCHED TIME POINTS. THIS WORK WILL BE CONDUCTED IN PARTNERSHIP WITH SERONET; INCLUDING THE FNLCR SEROLOGY LABORATORY; AND THE SSC; TO DEVELOP AND PROVIDE REAGENTS AND STANDARDS TO THE SEROLOGY COMMUNITY ONCE GENERATED AND QUALIFIED. TECHNOLOGY DEVELOPMENT INCLUDES CONDUCTING A PILOT TO ADDRESS THE POSSIBILITY OF INCREASED INCIDENCE OF CANCER DUE TO SARS-COV-2 AS WELL AS COLLECTIONS FROM NOVEL VACCINE RECIPIENTS.

DEVELOP AND ADVANCE A DURABLE CROSS-PROTECTIVE ADJUVANTED H5N1 AND H5N2 SUBUNIT VACCINES.