Baylor College Of Medicine

ON-SITE LIVER AND KIDNEY TRANSPLANT SERVICES AT HOUSTON VA EXERCISE OPTION YEAR 2

NHLBI TRANS-OMICS FOR PRECISION MEDICINE (TOPMED) FOR THE CENTRALIZED OMICS RESOURCE (CORE) - 2026 TASK ORDER

AGREEMENT: $6,746,364 AMD 1: $0 AMD 2: $0 AMD 3: $6,597,318 AMD 4: $8,331,980 AMD 5: $0 AMD 6: $1,000 TASK 5 WILL PROVIDE TARGETED AND NON-TARGETED METABOLITE PROFILING FOR PLASMA OR SERUM SAMPLES FROM INDIVIDUALS INCLUDED IN DESIGNATED NHLBI TRANS-OMICS FOR PRECISION MEDICINE (TOPMED) PROGRAM PROJECT STUDIES. DR. BOERWINKLE AND THE UTHEALTH GROUP WILL: €¢ WORK COLLABORATIVELY WITH DR. GIBBS AND THE BCM HGSC ON DATA INTEGRATION, DATA FORMATS, QUALITY CONTROL AND QUALITY ASSURANCE, AND OTHER ISSUES DESIGNATED BY NHLBI. €¢ WORK COLLABORATIVELY WITH METABOLON AND THE BCM HGSC TO GENERATE A MANUAL OF OPERATIONS (MOO) PROVIDING DETAILED STANDARD OPERATING PROCEDURES FOR ALL STEPS IN THE WORKFLOW. €¢ OVERSEE THE GENERATION OF METABOLITE PROFILE DATA BY METABOLON, INC., ENSURING THAT ALL WORK PRODUCT CONFORMS TO THE SPECIFICATIONS IN THE CONTRACT STATEMENT OF WORK (SEE ATTACHMENT 2A NOTICE OF AWARD WITHIN THIS AGREEMENT), INCLUDING, BUT NOT LIMITED TO, METHODS AND PROTOCOLS, DATA QUALITY, AND DATA CLASSIFICATION. €¢ OVERSEE THE SECURE TRANSMISSION OF PROJECT DATA TO THE PROJECT STUDIES, THE TOPMED DATA COORDINATING CENTER (DCC) AND/OR THE TOPMED INFORMATICS RESEARCH CENTER (IRC). €¢ CONTRIBUTE TO CONTRACT REPORTING REQUIREMENTS AND OTHER AD HOC REQUESTS FROM THE TOPMED PROGRAM. €¢ PROVIDE BCM HGSC NECESSARY INFORMATION FOR PROJECT INVOICING, IN A FORMAT TO BE COLLABORATIVELY DETERMINED BY BCM HGSC AND UTHEALTH.

"1. ENSURE THE STUDY MEETS ALL THE ETHICAL OBLIGATIONS AND APPROVALS. 2. TRAIN THE RESEARCH STAFF TO CARRY OUT THE STUDY, INCLUDING ORGANOID MODELS AND METABOLOMICS ANALYSES. 3. ENSURE THAT THE COLLECTION OF THE ‘OMICS DATA MEETS THE HIGHEST STANDARD, TO OPTIMIZE THE CHANCES THAT THE MOST RELIABLE DATA ARE COLLECTED. 4. MONITOR THE TIMELY CONDUCT OF THE STUDY INCLUDING DATA COLLECTION AND ENTRY, QUALITY CHECK, AND ANALYSIS AND REPORTING THE RESULTS. 5. WORK CLOSELY WITH DR. VUNJAK-NOVAKOVIC AND HER TEAM IN THE INTERPRETATION AND DISSEMINATION OF THE FINDINGS AS WELL AS THE PREPARATION OF REPORTS AND ORIGINAL MANUSCRIPTS."