Advanced Regenerative Manufacturing Institute Inc

THIS EDA INVESTMENT SUPPORTS THE BIOFABRICATION CLUSTER, LED BY THE CITY OF MANCHESTER, WITH CREATING A BIOFABRICATION CLUSTER BY ESTABLISHING SOUTHERN NEW HAMPSHIRE AS THE GLOBAL EPICENTER FOR THE PRODUCTION AND DISTRIBUTION OF REGENERATIVE TISSUES AND ORGANS. COALITION PROJECTS INCLUDE DEVELOPING A FACILITY SUITABLE FOR SCALED PRODUCTION OF CELLS, TISSUES, AND ORGANS, CREATING A BUSINESS ACCELERATOR, ESTABLISHING A CLUSTER WORK-AND-LEARN PROGRAM, AND BUILDING PILOT STATIONS FOR A LOGISTICS NETWORK TO BE USED FOR FUTURE ORGAN DISTRIBUTION. ONCE IMPLEMENTED, THE INVESTMENT WILL HELP DEVELOP AND STRENGTHEN REGIONAL INDUSTRY CLUSTERS - ALL WHILE EMBRACING ECONOMIC EQUITY, CREATING GOOD-PAYING JOBS, AND ENHANCING U.S. COMPETITIVENESS GLOBALLY.

PURPOSE: EXPAND CAPACITY OF, AND THEREBY ACCESS TO, CRITICAL ANALYTIC SERVICES, REGULATORY AND QUALITY SERVICES, AUTOMATED MANUFACTURING SERVICES, AND SUPPLY CHAIN SERVICES, ALL OF WHICH WILL SUPPORT COMPANIES IN ADVANCING BIOFABRICATION TECHNOLOGIES TO MARKET. ACTIVITIES TO BE PERFORMED: 1)PURCHASE ANALYTICAL EQUIPMENT AND CONNECT TO SECURE DATA ARCHITECTURE.2)REFINE MERIT-BASED REVIEW PROCEDURES TO PRIORITIZE ANALYTIC DEMAND QUEUE; EXPAND CLIENT ENGAGEMENT; ENHANCE RESOURCE PROJECTION, SCHEDULING, AND COMMERCIAL ONBOARDING PROCEDURES TO OPTIMIZE EFFICIENCY; HIRE/PROMOTE/ONBOARD STAFF.3)REFINE MERIT-BASED REVIEW PROCEDURES TO PRIORITIZE REGULATORY AND QUALITY DEMAND QUEUE; EXPAND CLIENT ENGAGEMENT; REFINE PHASE-APPROPRIATE TEMPLATES AND PROCEDURES; HIRE/PROMOTE/ONBOARD STAFF.4)IMPLEMENT ROCKWELL AUTOMATION DIGITAL TECH TRANSFER PROTOCOL.5)REFINE MERIT-BASED REVIEW PROCEDURES TO PRIORITIZE MANUFACTURING AUTOMATION DEMAND QUEUE; EXPAND CLIENT ENGAGEMENT; REFINE PHASE-APPROPRIATE PROCEDURES; HIRE/PROMOTE/ONBOARD STAFF.6)ESTABLISH STANDARD PROTOCOLS WITH NEW HAMPSHIRE MANUFACTURING EXTENSION PARTNERSHIP FOR MAPPING ONBOARDED COMPANY SUPPLY CHAIN RISKS; MAKE KEY SUPPLY CHAIN ELEMENTS AVAILABLE TO ONBOARDED COMPANIES (E.G., STANDARDIZED SOURCE CELLS AND CHEMICALLY DEFINED CELL CULTURE MEDIA).EXPECTED OUTCOMES: DIGITALLY CONNECTED EQUIPMENT AND A PRIORITIZED ANALYTIC SERVICES DEMAND QUEUE. PRIORITIZED REGULATORY AND QUALITY DEMAND QUEUE, WITH MORE COMPANIES APPLYING AND RECEIVING SERVICE. INCREASE SPEED AND RESOURCE EFFICIENCY OF TECH TRANSFER WITH IMPLEMENTED DIGITAL TECH TRANSFER PROTOCOL, PRIORITIZED AUTOMATED MANUFACTURING DEMAND QUEUE, AND PHASE-APPROPRIATE PROCEDURES. CLEARLY DEFINED SUPPLY CHAIN MAPPING PROTOCOLS AND STANDARDIZED SOURCE MATERIALS. ONBOARDED PERSONNEL TO SUPPORT ALL FUNCTIONS.INTENDED BENEFICIARIES: IMPROVED EFFECTIVENESS AND EFFICIENCY OF CRITICAL SOURCES FOR COMPANIES ADVANCING BIOFABRICATION TECHNOLOGIES TO MARKET. STREAMLINED UNDERSTANDING OF AND ACCESS TO SUPPLY CHAIN OPERATORS FOR MANUFACTURERS.SUBRECIPIENT ACTIVITIES: THE RECIPIENT DOES NOT INTEND TO SUBAWARD FUNDS.

ARMI HEALTH TECH HUB PROGRAM FOR BILATERAL HEALTH SECURITY - ARMI HAS BEEN WORKING TO ADVANCE U.S-ISRAELI HEALTH TECHNOLOGY AND HEALTH SECURITY UNDER THE IBX BIOECONOMY EXPANSION PROGRAM DURING THE CURRENT FISCAL YEAR. AS A RESULT OF THAT PROJECT, ARMI HAS ESTABLISHED AN ADVISORY PANEL OF KEY OPINION LEADERS, CONDUCTED AN ALMOST 100-PERSON ROAD MAPPING EFFORT, SURVEYED AND/OR INTERVIEWED MORE THAN 70 START-UP COMPANIES, AND IS HOSTING A BI-LATERAL CONFERENCE TO DISCUSS WAYS TO IMPROVE U.S-ISRAELI HEALTH TECHNOLOGY AND HEALTH SECURITY. ARMI IS PROPOSING THE FOLLOWING TO FURTHER ADVANCE HEALTH SECURITY: 1) CREATE A HEALTH TECH HUB TO IDENTIFY START-UPS, CONDUCT TECHNOLOGY “HEALTH” ASSESSMENTS, CONDUCT “BOOT CAMP” SEMINARS ON QUALITY AND REGULATORY REQUIREMENTS, AND MATCH START-UPS AND TECHNOLOGIES OF MERIT WITH ADVISORS TO BETTER PREPARE AND ENSURE SUCCESS; 2) LEVERAGE THE ADVISORY PANEL AND GOVERNMENT CONNECTIONS THAT HAVE BEEN CREATED TO IDENTIFY KEY HEALTH CARE PROBLEMS/DEFICIENCIES AND PROVIDE THEM TO CREATIVE START-UPS LOOKING FOR A CHALLENGE; TO IDENTIFY OPPORTUNITIES TO IMPROVE QUALITY, REGULATORY, AND REIMBURSEMENT POLICIES; AND TO IDENTIFY OPPORTUNITIES TO IMPROVE HEALTH DATA ARCHITECTURES, DATA SECURITY, AND DATA TECHNOLOGIES/ACCESSIBILITY BETWEEN THE U.S. AND ISRAEL; AND 3) PROVIDE BUSINESS, INTELLECTUAL PROPERTY, REIMBURSEMENT, AND FUNDING EXPERTISE THROUGH THE HEALTH TECH HUB.

THIS EDA INVESTMENT SUPPORTS THE BIOFABRICATION CLUSTER, LED BY THE CITY OF MANCHESTER, WITH CREATING A BIOFABRICATION CLUSTER BY ESTABLISHING SOUTHERN NEW HAMPSHIRE AS THE GLOBAL EPICENTER FOR THE PRODUCTION AND DISTRIBUTION OF REGENERATIVE TISSUES AND ORGANS. COALITION PROJECTS INCLUDE DEVELOPING A FACILITY SUITABLE FOR SCALED PRODUCTION OF CELLS, TISSUES, AND ORGANS, CREATING A BUSINESS ACCELERATOR, ESTABLISHING A CLUSTER WORK-AND-LEARN PROGRAM, AND BUILDING PILOT STATIONS FOR A LOGISTICS NETWORK TO BE USED FOR FUTURE ORGAN DISTRIBUTION. ONCE IMPLEMENTED, THE INVESTMENT WILL HELP DEVELOP AND STRENGTHEN REGIONAL INDUSTRY CLUSTERS - ALL WHILE EMBRACING ECONOMIC EQUITY, CREATING GOOD-PAYING JOBS, AND ENHANCING U.S. COMPETITIVENESS GLOBALLY.

THIS EDA INVESTMENT SUPPORTS THE BIOFABRICATION CLUSTER, LED BY THE CITY OF MANCHESTER, WITH CREATING A BIOFABRICATION CLUSTER BY ESTABLISHING SOUTHERN NEW HAMPSHIRE AS THE GLOBAL EPICENTER FOR THE PRODUCTION AND DISTRIBUTION OF REGENERATIVE TISSUES AND ORGANS. COALITION PROJECTS INCLUDE DEVELOPING A FACILITY SUITABLE FOR SCALED PRODUCTION OF CELLS, TISSUES, AND ORGANS, CREATING A BUSINESS ACCELERATOR, ESTABLISHING A CLUSTER WORK-AND-LEARN PROGRAM, AND BUILDING PILOT STATIONS FOR A LOGISTICS NETWORK TO BE USED FOR FUTURE ORGAN DISTRIBUTION. ONCE IMPLEMENTED, THE INVESTMENT WILL HELP DEVELOP AND STRENGTHEN REGIONAL INDUSTRY CLUSTERS - ALL WHILE EMBRACING ECONOMIC EQUITY, CREATING GOOD-PAYING JOBS, AND ENHANCING U.S. COMPETITIVENESS GLOBALLY.

PURPOSE: THE ADVANCED REGENERATIVE MANUFACTURING INITIATIVE (ARMI) WILL LEAD THE CONSORTIUM COORDINATION AND IMPACT ASSESSMENT COMPONENT PROJECT FOR THE REGEN VALLEY TECH HUB TO DELIVER ON POST-AWARD ALIGNMENT IN OPERATIONS AND ENGAGEMENT STRATEGY, WORKFORCE TRAINING, DATA COLLECTION, AND OPPORTUNITIES FOR ENGAGING DISTRESSED POPULATIONS. ACTIVITIES TO BE PERFORMED: 1) ENSURE COMPREHENSIVE POST-AWARD ALIGNMENT AND CODIFY CONSORTIUM OPERATING AND ENGAGEMENT STRATEGY BY UPDATING CHARTER AND HOLDING REGULAR CONSORTIUM UPDATE MEETINGS. 2) BRIDGE THE GAP BETWEEN ACADEMIC TRAINING AND INDUSTRY NEEDS THROUGH THE RISK MITIGATION COMMITTEE MONITORING, ASSESSING, AND REPORTING ON RISK STATUS WHILE ALSO IDENTIFYING TRAINING OPPORTUNITIES FOR CONSORTIUM MEMBERS. 3) CREATE A DATA AND METRICS DISPLAY TO TRACK EACH FUNDED COMPONENT PROJECT AND OVERARCHING NARRATIVE SMART GOALS. 4) INCREASE MARKETING INITIATIVES, ESTABLISH RELATIONSHIPS WITH REGIONAL AND NATIONAL MEDIA, AND CONDUCT BUSINESS ROUNDTABLES AND ORGANIZATIONAL LISTENING SESSIONS TO ALIGN GOALS AND INFORM COMMUNITY. EXPECTED OUTCOMES: IMPROVE ENGAGEMENT WITH CONSORTIUM MEMBERS THROUGH ACTIVITIES AND UPDATE MEETINGS. CREATE A THOROUGH MITIGATION PLAN THAT HIGHLIGHTS WORKFORCE RESPONSIBILITIES AND ACTION ITEMS. ESTABLISH DATA SECURITY PROTOCOLS, DATA DEPLOYMENT, AND METRICS DASHBOARD ALONGSIDE COMMUNITY ENGAGEMENT THROUGH INCREASED MEDIA INTERVENTIONS. INTENDED BENEFICIARIES: REMOVE BARRIERS FOR RESIDENTS TO BENEFIT FROM THE GROWING BIOFABRICATION INDUSTRY THROUGH BETTER JOBS PROVIDING FAMILY-SUSTAINING WAGES. DRIVE CONSORTIUM-WIDE ENGAGEMENT THROUGH TRAINING, POLICY ADOPTION, AND DISPUTE RESOLUTION WHILE ALSO COLLECTING AND ENSURING METRICS, OUTCOMES, AND BROADER IMPACTS ARE FAIRLY DISTRIBUTED AND EFFORTS ARE DRIVING REAL GROWTH FOR THE DISTRESSED COMMUNITY. BUILD A PLATFORM WHERE INDIVIDUAL MEMBERS FEEL EMPOWERED TO HAVE AN IMPACT AND SEE THEIR ACTIVE INVOLVEMENT AS CRITICAL TO REACHING OUR COLLECTIVE VISION. SUBRECIPIENT ACTIVITIES: TRACK TRENDS IN SOCIOECONOMIC WELL-BEING AND COMMUNITY NEEDS ACROSS REGEN VALLEY. HEALTH EQUITY IMPACTS WILL BE ADDED TO THE CONSUMER PRICE INDEX ALONG WITH STANDARD ECONOMIC GROWTH INDICATORS SUCH AS GLOBAL MARKET SHARE AND REGIONAL GROSS DOMESTIC PRODUCT AS DISCUSSED IN THE OVERARCHING NARRATIVE?S OUTCOMES.

THIS EDA INVESTMENT SUPPORTS THE BIOFABRICATION CLUSTER, LED BY THE CITY OF MANCHESTER, WITH CREATING A BIOFABRICATION CLUSTER BY ESTABLISHING SOUTHERN NEW HAMPSHIRE AS THE GLOBAL EPICENTER FOR THE PRODUCTION AND DISTRIBUTION OF REGENERATIVE TISSUES AND ORGANS. COALITION PROJECTS INCLUDE DEVELOPING A FACILITY SUITABLE FOR SCALED PRODUCTION OF CELLS, TISSUES, AND ORGANS, CREATING A BUSINESS ACCELERATOR, ESTABLISHING A CLUSTER WORK-AND-LEARN PROGRAM, AND BUILDING PILOT STATIONS FOR A LOGISTICS NETWORK TO BE USED FOR FUTURE ORGAN DISTRIBUTION. ONCE IMPLEMENTED, THE INVESTMENT WILL HELP DEVELOP AND STRENGTHEN REGIONAL INDUSTRY CLUSTERS - ALL WHILE EMBRACING ECONOMIC EQUITY, CREATING GOOD-PAYING JOBS, AND ENHANCING U.S. COMPETITIVENESS GLOBALLY.

PURPOSE: THE PURPOSE OF THE BIOFABRICATION STANDARDS RELATED TEST LAB IS TO DEVELOP THE INFRASTRUCTURE TO APPLY A QUALITY-BY-DESIGN APPROACH IN THE BIOFABRICATION INDUSTRY FOR THE STANDARDIZATION OF ASSAY DEVELOPMENT. ACTIVITIES TO BE PERFORMED: THE ACTIVITIES OF THIS PROJECT ARE SPLIT INTO THE ASSAY DEVELOPMENT AND STANDARD DEVELOPMENT COMPONENTS, USING THE GLUCOSE STIMULATED INSULIN SECRETION (GSIS) ASSAY AS THEIR MODEL. UNDER ASSAY DEVELOPMENT, ARMI WILL SIMPLIFY THE GSIS ASSAY, MAKING THE ASSAY COMPATIBLE FOR AUTOMATION. THEY WILL ALSO DETERMINE THE SOURCES OF VARIABILITY THAT AFFECTS THE ACCURACY OF THE MODIFIED ASSAY. UNDER STANDARDS DEVELOPMENT, ARMI WILL LEVERAGE THE PARTICIPATION OF SUBJECT MATTER EXPERTS TO HELP INFORM THE SCOPE AND CONTENT OF A DOCUMENTARY STANDARD AS WELL AS TO DEVELOP AN IMPLEMENTATION TRAINING COURSE FOR THE STANDARD, WHERE TRAINEES WILL BE ABLE TO OBTAIN A MICROCREDENTIAL. ARMI WILL ENGAGE THE BIOFABRICATION ECOSYSTEM IN THEIR PROJECT IN MULTIPLE WAYS. ARMI WILL ENGAGE WITH THE BIOSYSTEMS AND BIOMATERIALS DIVISION AT NIST TO EXCHANGE KNOWLEDGE ON NIST'S WORK ON THE PROTOTYPE CELL ASSAY MEASUREMENT PLATFORM. ADDITIONALLY, THEY WILL ENGAGE BREAKTHROUGH T1D (BREAKTHROUGH TYPE 1 DIABETES) AND THE STANDARDS COORDINATING BODY TO OPTIMIZE THE DEVELOPMENT AND STANDARDIZATION OF THE GSIS ASSAY. EXPECTED OUTCOMES: THE MAIN OUTCOME OF THIS PROJECT IS TO PROVIDE A SIMPLIFIED, STANDARDIZED GSIS ASSAY THAT WILL ALLOW FOR AN IMPROVEMENT IN REPEATABILITY AND REPRODUCIBILITY OF THE GSIS ASSAY, A PROTOCOL IN WHICH COULD BE EXTRAPOLATED TO OTHER CELL AND TISSUE BASED ASSAYS AS WELL. INTENDED BENEFICIARIES: THE RESULTS FROM THIS GRANT WILL BENEFIT RESEARCHERS, PATIENTS, AND CLINICIANS WHO RELY ON SIMILAR CELL AND TISSUE-BASED ASSAYS. SUBRECIPIENT ACTIVITIES: THE RECIPIENT DOES NOT INTEND TO SUBAWARD FUNDS.

ARMI RESPONSE: TECHNOLOGY ROADMAPPING FOR PANDEMIC RESPONSE AND RECOVERY

CONFERENCE: FACILITATING ADVANCED TISSUE MANUFACTURING -THE NSF-ARMI|BIOFABUSA WORKSHOP: FACILITATING ADVANCED TISSUE MANUFACTURING, WILL BE HELD IN MANCHESTER, NH DURING THE SUMMER OF 2023. THE WORKSHOP FOCUSES ON STATE-OF-THE-ART TISSUE FABRICATION TECHNOLOGY AND IDENTIFIES GRAND CHALLENGES AND OPPORTUNITIES FOR FUTURE WORK IN THIS FIELD. THE WORKSHOP ADDRESSES THE MISSION OF NSF, WHICH HAS BEEN INCREASINGLY COMMITTED TO INTEGRATING THE ENGINEERING SCIENCES WITH THE LIFE SCIENCES, ENCOURAGING RESEARCH AND DEVELOPMENT IN MULTIDISCIPLINARY AREAS, EDUCATING THE NEXT GENERATION OF YOUNG SCIENTISTS, AND TRANSLATING CUTTING EDGE SCIENCE TO SOLUTIONS FOR CURRENT AND FUTURE CHALLENGES. THE WORKSHOP WILL FOCUS ON CONVERTING MANUAL PROCESSES FOR TISSUE MANUFACTURING TO PROTOCOLS THAT CAN BE IMPLEMENTED IN FULLY AUTOMATED AND CLOSED TISSUE MANUFACTURING ENVIRONMENT. IT WILL PROVIDE A FORUM FOR INDUSTRIAL PRACTITIONERS AND ACADEMIC RESEARCHERS IN THE TISSUE MANUFACTURING SPACE TO INTERACT AND CREATE PRODUCTIVE NETWORKS. IT WILL ALSO PROVIDE A DEMONSTRATION OF THE INTEGRATED DESIGN-BUILD-TEST-LEARN (DBTL) CAPABILITIES OF THE ARMI/BIOFABUSA TISSUE MANUFACTURING FACILITY, AS WELL AS AN EXPLANATION OF HOW THOSE FACILITIES MIGHT BE ACCESSED. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.