MULTIPLE MYELOMA RESEARCH CONSORTIUM INC
383 MAIN AVENUE 5TH FLOOR, NORWALK, CT 06851 www.themmrc.org

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Organizations Filed Purposes: TO CHAMPION COLLABORATION WITH AND INTEGREGATION ACROSS ACADEMIA AND INDUSTRY AND TO FOCUS ON SPEED AND INNOVATION TO BRING THE MOST PROMISING MULTIPLE MYELOMA TREATMENTS TO PATIENTS FASTER.

SITE INVESTMENT GRANTS: THE PURPOSE OF THE SITE INVESTMENT GRANT IS TO ASSIST IN FUNDING A MULTIPLE MYELOMA PROGRAM COORDINATOR IN CONTINUING TO FULFILL ITS OBLIGATIONS AS A CONSORTIUM MEMBER WHICH ARE: 1) PARTICIPATING IN CLINICAL TRIALS CONDUCTED WITHIN THE MMRC CLINICAL TRIAL NETWORK, 2) PROVIDING PATIENT SPECIMENS TO THE MMRC TISSUE BANK, AND 3) ENGAGING WITH THE MMRC LEADERSHIP TEAM TO ADVANCE NEW TREATMENT OPTIONS FOR PATIENTS WITH MULTIPLE MYELOMA.

MMRC TISSUE BANK:THE MMRC TISSUE BANK IS A CENTRALLY LOCATED, STANDARDIZED TISSUE BANK OF HIGHLY ANNOTATED BONE MARROW AND PERIPHERAL BLOOD SAMPLES FROM MYELOMA PATIENTS AND PATIENTS WITH MYELOMA RELATED DISORDERS. HOUSED AT THE MAYO CLINIC, IN SCOTTSDALE, ARIZONA, THE TISSUE BANK IS THE ONLY RESOURCE OF ITS KIND THAT ACCRUES SAMPLES PROVIDED BY MMRC INSTITUTIONS UNDER GOOD LABORATORY PRACTICE (GLP) STANDARD PROCEDURES WITH THE CORRESPONDING CLINICAL DATA. THE BUDGET GRANTED TO THE MAYO SCOTTSDALE FOR THE TISSUE BANK ENABLES THE TISSUE TO BE UNIFORMLY PROCESSED AND STORED IN ADHERENCE WITH GLP STANDARDS AND UNDER THE GOVERNANCE OF MORE THAN 80 STANDARD OPERATING PROCEDURES. THE MMRC HAS ALSO ESTABLISHED A QUALITY ASSURANCE UNIT THAT PERFORMS REGULAR INTERNAL REVIEWS AND ISSUES QUARTERLY QUALITY ASSURANCE REPORTS. THE PAYMENTS TO MAYO SCOTTSDALE REFLECT THE STANDARD COSTS TO SUPPORT THE FULL TIME EMPLOYEES NEEDED TO PERFORM THE PROCESSING ACTIVITIES AS WELL AS VARIABLE CHARGES DEPENDING ON THE ACTUAL NUMBER OF SAMPLES SENT TO BANK TO BE PROCESSED. THE MMRC HAS A SPECIFICALLY DESIGNED TISSUE TRACKING SYSTEM THAT COLLECTS INFORMATION ON THE TISSUE SAMPLES WITH RESPECT TO PROCESSING AND STORAGE AS WELL AS COMPREHENSIVE CLINICAL DATA AND MEDICAL HISTORIES ON THE DE-IDENTIFIED PATIENTS WHO HAVE PROVIDED SAMPLES. ALL DATA IN THE MMRC TISSUE TRACKING SYSTEM IS CONSISTENTLY COLLECTED AND MAINTAINED USING STANDARDIZED PROCESSES THAT ENSURE DATA INTEGRITY. FURTHERMORE, THE DATA IS COLLECTED AND MANAGED IN A MANNER CONSISTENT WITH ALL REGULATORY REQUIREMENTS, INCLUDING THOSE OF THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA) AND IS COMPLIANT WITH OTHER FEDERAL REGULATIONS. THE COSTS ASSOCIATED WITH THE TISSUE TRACKING SYSTEM ARE DISTINCT FROM THE MMRC TISSUE BANK AND INCLUDE A HOSTING SERVICE FOR THE DATABASE, IT SUPPORT, AND MAINTENANCE CONTRACTS FOR THE SOFTWARE THAT SUPPORTS THE TISSUE TRACKING SYSTEM. THIS SPECIFICALLY DESIGNED TISSUE TRACKING SYSTEM ENABLES SCIENTISTS TO PERFORM CUSTOMIZED AND PRE-CONFIGURED QUERIES ON HIGHLY-ANNOTATED TISSUE SAMPLES, COMPREHENSIVE CLINICAL DATA AND MEDICAL HISTORIES; FUNCTIONS THAT ARE ESSENTIAL IN ADVANCING THE MMRC'S PRE-CLINICAL PROJECTS, CLINICAL TRIALS, AND CORRELATIVE STUDIES.

CLINICAL TRIALS:THESE COSTS COVER MMRC SITE EXPENSES TO CONDUCT THE VARIOUS CLINICAL STUDIES THAT THE CONSORTIUM MEMBERS UNDERTAKE EACH YEAR. THESE INCLUDE COSTS FOR OUR CONTRACT RESEARCH ORGANIZATION (CRO) WHICH IS RESPONSIBLE FOR OVERSIGHT OF OUR CLINICAL TRIAL PROCESSES INCLUDING SITE TRAINING, STUDY START UP, REGULATORY COMPLIANCE, DATA COLLECTION, MONITORING AND REPORTING, AND PROJECT MANAGEMENT. THE CRO ALSO ORGANIZES SAFETY REVIEWS AND MAINTAINS METRICS TO ENSURE STUDY MEETS EXPECTED TIMELINE. ALSO INCLUDED IN THESE SITE EXPENSES ARE PAYMENTS FOR TESTS, PROCEDURES, AND STAFF FEES IN SUPPORT OF PATIENTS ENROLLED ON OUR CLINICAL TRIALS.

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