PATH
2201 WESTLAKE AVENUE NO 200, SEATTLE, WA 98121 www.path.org

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Organizations Filed Purposes: PATH'S MISSION IS TO ADVANCE HEALTH EQUITY THROUGH INNOVATION AND PARTNERSHIPS. (CONTINUED ON SCHEDULE O)

SEE PART III, LINE 1.

ESSENTIAL MEDICINES: PATH'S ESSENTIAL MEDICINES DIVISION DEVELOPS AND DELIVERS LIFESAVING VACCINES AND DRUGS FOR WOMEN, CHILDREN, AND COMMUNITIES AROUND THE GLOBE. (CONTINUED ON SCHEDULE O)CENTER FOR VACCINE INNOVATION AND ACCESSPATH'S CENTER FOR VACCINE INNOVATION AND ACCESS (CVIA) ALIGNS EXPERTISE ACROSS EVERY STAGE OF VACCINE RESEARCH, DEVELOPMENT, AND INTRODUCTION TO MAKE VACCINES AVAILABLE TO MORE COMMUNITIES, PARTICULARLY IN LOW- AND MIDDLE-INCOME COUNTRIES. OUR PORTFOLIO INCLUDES MORE THAN TWO DOZEN VACCINE PRODUCTS IN DEVELOPMENT OR ALREADY IN USE, WITH AN EMPHASIS ON THE LEADING INFECTIOUS CAUSES OF CHILD DEATH AND DISEASE WORLDWIDE.FOR EXAMPLE, IN 2019 PATH CONTINUED TO PARTNER WITH COUNTRIES TO EXPAND COVERAGE OF JAPANESE ENCEPHALITIS (JE) VACCINATION AND CARRIED OUT A CAMPAIGN TO CELEBRATE PROGRESS TOWARD COMBATING JE. THE GOVERNMENT OF THE PHILIPPINES CONDUCTED JE VACCINATION CAMPAIGNS IN FOUR HIGH-RISK PROVINCES, WHICH PATH SUPPORTED THROUGH PLANNING, VACCINE PROVISION, AND COST-EFFECTIVENESS ANALYSIS. AS PATH'S 16-YEAR GLOBAL JE PARTNERSHIP PREPARED TO CLOSE, WE HOSTED A MEETING WITH KEY STAKEHOLDERS IN HANOI TO DISCUSS AND CAPTURE LESSONS LEARNED FOR COUNTRY VACCINATION PROGRAMS AND INTERNATIONAL VACCINE PARTNERS. PATH DEVELOPED AND LAUNCHED A WEB PAGE, INFOGRAPHIC, AND REPORT OUTLINING THESE LESSONS AND THE STORY OF JE VACCINATION EFFORTS. ALSO IN 2019, WE BEGAN A PIVOTAL, PHASE 3 STUDY OF A POLYVALENT MENINGOCOCCAL MENINGITIS VACCINE. THE VACCINE, DEVELOPED BY SERUM INSTITUTE OF INDIA PVT. LTD., BUILDS ON THE SUCCESS OF MENAFRIVAC, A VACCINE AGAINST MENINGOCOCCAL MENINGITIS SEROGROUP A THAT WAS LICENSED AND INTRODUCED IN 2010. THE POLYVALENT VACCINE TARGETS SEROGROUPS A, C, W, X, AND Y. THE VACCINE IS DESIGNED FOR USE IN AFRICA'S "MENINGITIS BELT" REGION AND, AS THE FIRST VACCINE TO TARGET SEROGROUP X, HAS THE POTENTIAL TO ELIMINATE MENINGITIS EPIDEMICS FROM THIS REGION. TO PREVENT MALARIA, PATH IS ACCELERATING THE DEVELOPMENT OF A WIDE VARIETY OF MALARIA VACCINE CANDIDATES AND APPROACHES. IN 2019, WE WORKED WITH WHO AND OTHER PARTNERS, INCLUDING THE MINISTRIES OF HEALTH IN GHANA, KENYA, AND MALAWI, TO BEGIN PILOT IMPLEMENTATION OF THE RTS,S VACCINE IN SELECTED AREAS OF THOSE COUNTRIES. WITH OUR PARTNERS, PATH CONTINUED TO ADVANCE RESEARCH INTO WHETHER REDUCING THE DOSE LEVEL OF RTS,S AND DELAYING THE ADMINISTRATION OF DOSES HAS THE POTENTIAL TO FURTHER AID MALARIA ELIMINATION EFFORTS BY STRETCHING LIMITED VACCINE SUPPLIES AND PROTECTING AS MANY PEOPLE AS POSSIBLE. PILOT INTRODUCTION IN KENYA OF THE DELAYED FRACTIONAL-DOSE REGIMEN BEGAN IN 2019. ADDITIONALLY, WORK CONTINUED ON EFFORTS TO IDENTIFY IMMUNE CORRELATES OF PROTECTION FOR MALARIA VACCINES AND ON THE USE OF MONOCLONAL ANTIBODIES TO COMBAT MALARIA.IN 2019, THE DEFEAT DIARRHEAL DISEASE (DEFEATDD) INITIATIVE, HOUSED WITHIN CVIA, CONTINUED ITS ROLE AS A DIGITAL HUB FOR KEY INFORMATION AROUND PREVENTING AND TREATING CHILDHOOD DIARRHEAL DISEASE. IN PARTNERSHIP WITH PATH'S DRUG DEVELOPMENT PROGRAM, DEFEATDD LAUNCHED A CAMPAIGN TO PROMOTE THE ADDITION OF CO-PACKAGED ORAL REHYDRATION SOLUTION (ORS) AND ZINC TO THE WHO ESSENTIAL MEDICINES LIST FOR CHILDREN. DEFEATDD ALSO LAUNCHED A CAMPAIGN FOR WORLD TOILET DAY AROUND THE ROLE OF SANITATION IN HEALTH CARE ALONGSIDE VACCINES, NUTRITION, AND ACCESS TO MEDICINES. THROUGHOUT THE YEAR, DEFEATDD'S CHANNELS HELPED DISSEMINATE POLICY UPDATES AND RESEARCH ON THE PROJECTED HEALTH AND ECONOMIC IMPACTS OF NEW AND EXISTING ENTERIC VACCINES, INCLUDING ROTAVIRUS, CHOLERA, ENTEROTOXIGENIC ESCHERICHIA COLI, SHIGELLA, AND TYPHOID. DEFEATDD ALSO MAINTAINED, UPDATED, AND EXPANDED UPON ITS ONLINE STATE-OF-THE-FIELD REPORT, STOP THE CYCLE OF DIARRHEA. PATH CONDUCTED A PHASE 3 BRIDGING STUDY IN VIETNAM TO COMPARE A NEW LIQUID FORMULATION OF THE ROTAVIRUS VACCINE, ROTAVIN, WITH AN EARLIER LICENSED FROZEN FORMULATION, ROTAVIN-M1. WE CONDUCTED A PHASE 1 STUDY IN THE UNITED STATES TO ASSESS THE SAFETY OF A SUBUNIT SHIGELLA VACCINE CANDIDATE. ADDITIONALLY, PATH HELPED INTRODUCE AND ADVANCE ACCESS TO CURRENTLY AVAILABLE ENTERIC VACCINES, INCLUDING THE RECENTLY WHO-PREQUALIFIED ROTAVAC AND ROTASIIL ROTAVIRUS VACCINES.TO PREVENT TYPHOID, PATH, AS PART OF THE TYPHOID VACCINE ACCELERATION CONSORTIUM, IS WORKING TO ACCELERATE INTRODUCTION OF TYPHOID CONJUGATE VACCINES (TCVS) IN LOW-INCOME COUNTRIES. IN 2019, PATH SUPPORTED COUNTRIES THROUGHOUT THE VACCINE DECISION-MAKING AND INTRODUCTION PROCESS. WITH SUPPORT FROM PATH, PAKISTAN BECAME THE FIRST COUNTRY TO INTRODUCE TCV INTO ITS ROUTINE CHILDHOOD IMMUNIZATION PROGRAM. WE ALSO WORKED WITH THE GOVERNMENTS OF LIBERIA AND ZIMBABWE TO DETERMINE APPROPRIATE TCV INTRODUCTION STRATEGIES, SUCCESSFULLY APPLY FOR GAVI FINANCING, AND PREPARE FOR TCV INTRODUCTION. PATH CONTINUED TO CALL ATTENTION TO TYPHOID AND THE NEED FOR INTEGRATED SOLUTIONS THROUGH A RANGE OF ADVOCACY AND COMMUNICATIONS ACTIVITIES. PATH CONTINUED TO ADVANCE PRECLINICAL DEVELOPMENT OF A VACCINE AGAINST GROUP B STREPTOCOCCUS, THE LEADING CAUSE OF BACTERIAL SEPSIS AND MENINGITIS IN YOUNG INFANTS WORLDWIDE. PATH IS SUPPORTING INVENTPRISE, A BIOTECHNOLOGY COMPANY, AS IT WORKS TO DEVELOP A MULTIVALENT, CONJUGATE VACCINE FOR LOW- AND MIDDLE-INCOME COUNTRIES. THE INTENDED RECIPIENTS ARE PREGNANT WOMEN-PART OF A STRATEGY THAT BOOSTS IMMUNITY AGAINST THE BACTERIUM AND TRANSFERS PROTECTIVE ANTIBODIES TO THE DEVELOPING BABY. ALSO IN 2019, PATH CONTINUED TO COORDINATE A CONSORTIUM OF NINE INDEPENDENT RESEARCH INSTITUTIONS TO ANALYZE EVIDENCE ON THE POTENTIAL FOR SINGLE-DOSE HPV VACCINATION. ALTHOUGH MANY COUNTRIES HAVE INTRODUCED HPV VACCINES INTO THEIR NATIONAL IMMUNIZATION SCHEDULES, SOME HAVE DELAYED INTRODUCTION BECAUSE OF FINANCIAL, LOGISTICAL, OR OTHER BARRIERS. FOR THESE COUNTRIES, A SINGLE-DOSE REGIMEN COULD ACCELERATE INTRODUCTION. PATH PROVIDES TECHNICAL ASSISTANCE TO GAVI-ELIGIBLE COUNTRIES IN PLANNING, IMPLEMENTING, AND EVALUATING NATIONAL HPV VACCINATION PROGRAMS AIMED AT VACCINATING YOUNG WOMEN. IN 2019, OUR GLOBAL TEAM AND PARTNERS ASSISTED THE GAMBIA, KENYA, AND THE SOLOMON ISLANDS WITH NATIONAL INTRODUCTIONS.

TECHNOLOGY, ANALYTICS, AND MARKET INNOVATION: PATH'S TECHNOLOGY, ANALYTICS, AND MARKET INNOVATION (TAMI) DIVISION IS AN INTEGRATED GLOBAL PLATFORM FOR END-TO-END ADVANCEMENT OF HIGH-IMPACT MEDICAL DEVICES, HEALTH TECHNOLOGIES, DIAGNOSTICS, AND IN-COUNTRY "IMPACT LABS" THAT ADDRESS GLOBAL, REGIONAL, AND COUNTRY HEALTH NEEDS. TAMI ALSO MANAGES PATH'S WORK IN MARKET DYNAMICS AND DIGITAL AND DATA EXCELLENCE.(CONTINUED ON SCHEDULE O)MEDICAL DEVICES AND HEALTH TECHNOLOGIES:THE MEDICAL DEVICES AND HEALTH TECHNOLOGIES PROGRAM WITHIN TAMI IS PATH'S INNOVATIVE PRODUCT DEVELOPMENT ARM. THE PROGRAM WORKS WITH PUBLIC- AND PRIVATE-SECTOR PARTNERS AROUND THE WORLD TO DEVELOP, TEST, REFINE, INTRODUCE, AND SCALE AFFORDABLE TECHNOLOGIES TO IMPROVE THE HEALTH OF PEOPLE IN LOW- AND MIDDLE-INCOME COUNTRIES.IN 2019, THE PROGRAM REACHED SEVERAL KEY MILESTONES; FOR EXAMPLE, THE ELLAVI UTERINE BALLOON TAMPONADE, A MEDICAL PRODUCT ADVANCED BY PATH TO MANAGE POSTPARTUM HEMORRHAGE, RECEIVED A CE MARK, AND THE FIRST SOLAR-POWERED "ENERGY HARVESTING CONTROL" VACCINE REFRIGERATORS, FOR WHICH PATH HAS BEEN CONDUCTING IN-COUNTRY ASSESSMENTS, PASSED PREQUALIFICATION TESTING IN SENEGAL FOR WHO PERFORMANCE, QUALITY, AND SAFETY APPROVAL. (ENERGY HARVESTING CONTROL ALLOWS EXTRA SOLAR POWER TO BE USED FOR OTHER PURPOSES AT A HEALTH FACILITY.) IN ADDITION, WE TRANSFERRED A FORMULATION AND LYOPHILIZATION PROCEDURE TO DERMBIONT FOR A TOPICAL GEL FORMULATION OF JANTHINOBACTERIUM LIVIDUM BACTERIA FOR TREATING FUNGAL INFECTIONS.PATH ALSO WORKED IN 2019 TO EVALUATE AND ADVANCE DEVICES FOR LONG-TERM ANTIRETROVIRAL DELIVERY OF PREP AND HIV TREATMENT. THESE DEVICES INCLUDE MICROARRAY PATCHES FOR TRANSDERMAL DELIVERY. STAFF PRODUCED 17 JOURNAL ARTICLES AND REPORTS ON RESEARCH FINDINGS, INCLUDING 2 FOR INACTIVATED POLIOVIRUS VACCINE: ONE EVALUATING THE TECHNICAL PRODUCT ATTRIBUTES OF AN ORAL ENTERIC VACCINE CURRENTLY UNDER DEVELOPMENT FOR INFANTS, THE OTHER EVALUATING THE COST PER CHILD VACCINATED WITH FULL VERSUS FRACTIONAL-DOSE VACCINE.DIAGNOSTICS:PATH ADVANCES EQUITABLE AND SUSTAINABLE ACCESS TO QUALITY-ASSURED, PURPOSE-DRIVEN DIAGNOSTICS FOR BETTER TESTING AND TREATMENT OF DISEASES IN LOW-RESOURCE SETTINGS.IN 2019, OUR PIONEERING WORK IN DIAGNOSTICS INCLUDED QUALIFYING, VALIDATING, EVALUATING, AND COMMERCIALIZING TESTS, REFERENCE ASSAYS, AND TOOLS; CONDUCTING PERFORMANCE EVALUATIONS AND CLINICAL TRIALS TO INFORM PATIENT CARE; AND PUBLISHING 20 PEER-REVIEWED JOURNAL ARTICLES.IN PARTNERSHIP WITH PATH'S MALARIA AND NEGLECTED TROPICAL DISEASES PROGRAM, THE DIAGNOSTICS TEAM INITIATED SIX CLINICAL STUDIES FOR POINT-OF-CARE TESTS FOR GLUCOSE-6-PHOSPHATE DEHYDROGENASE (G6PD) DEFICIENCY, A CONDITION THAT CAN COMPLICATE TREATMENT OF PLASMODIUM VIVAX MALARIA. BY THE END OF 2019, WE HAD COMPLETED ENROLLMENT IN FIVE OF THE STUDIES. PATH ALSO SUPPORTED COMMERCIALIZATION OF THE QUANSYS Q-PLEX HUMAN MALARIA ARRAY, WHICH CAN BE USED FOR MALARIA RESEARCH AND SURVEILLANCE. ADDITIONALLY, WE EVALUATED THE PERFORMANCE OF SEVERAL MALARIA RAPID DIAGNOSTIC TESTS, WHICH CAN NOW PROCEED TO CLINICAL EVALUATIONS. THE DIAGNOSTICS TEAM ALSO ESTABLISHED A COMMUNITY OF PRACTICE FOR G6PD OPERATIONAL RESEARCH AND HOSTED THREE INFORMATION-SHARING WEBINARS. IN PARTNERSHIP WITH THE UNIVERSITY OF WASHINGTON, PATH DEVELOPED AND COMMERCIALIZED A BAG-MEDIATED FILTRATION SYSTEM FOR THE ENVIRONMENTAL SURVEILLANCE OF WILD POLIOVIRUS IN SEWAGE. THIS SYSTEM SIMPLIFIES COLLECTION OF THE MATERIAL TO BE TESTED. IN 2019, THE DIAGNOSTICS TEAM CELEBRATED THE LAUNCH OF AN ENZYME-LINKED IMMUNOSORBENT ASSAY KIT THAT WE HELPED DEVELOP AND EVALUATE TO DETECT EXPOSURE TO ONCHOCERCA VOLVULUS, THE PARASITE THAT CAUSES ONCHOCERCIASIS (RIVER BLINDNESS). THE KIT SUPPORTS SEROLOGICAL SURVEILLANCE FOR RIVER BLINDNESS IN CONTROL AND ELIMINATION PROGRAMS IN AFRICA.PATH DIAGNOSTICS ALSO QUALIFIED AND VALIDATED A REFERENCE ASSAY FOR LIPOARABINOMANNAN (LAM), A VIRULENCE FACTOR ASSOCIATED WITH TB. THIS REFERENCE ASSAY IS NOW AVAILABLE FOR THE TB DIAGNOSTIC COMMUNITY TO INDEPENDENTLY EVALUATE EMERGING DIAGNOSTIC LATERAL FLOW ASSAYS FOR THE DETECTION OF URINARY LAM. FURTHER, PATH COMPLETED A FIELD PERFORMANCE EVALUATION STUDY OF A NEW PREECLAMPSIA TEST WITH PARTNERS IN GHANA. AN AFRICAN-BASED MANUFACTURER LAUNCHED THE PRODUCT IN LATE 2019. IT IS NOW BEING USED TO INFORM PATIENT CARE. FINALLY, IN COLLABORATION WITH A PRIVATE-SECTOR PARTNER, PATH WORKED TO DEVELOP A SEROTYPE-SPECIFIC URINE ANTIGEN DETECTION ASSAY ON A PLATFORM SUITABLE FOR USE IN LOW- AND MIDDLE-INCOME COUNTRIES. THE ASSAY PROVIDES HIGH-PERFORMANCE DETECTION ACROSS AN EXPANDED PANEL OF COMMON PNEUMOCOCCAL CONJUGATED VACCINE SEROTYPES. THIS ENHANCED CAPACITY INCREASES ITS UTILITY AS A TOOL FOR BOTH CLINICAL AND EPIDEMIOLOGIC STUDIES TO SUPPORT DEVELOPMENT OF A PNEUMONIA VACCINE.IMPACT LABS:PATH'S IMPACT LABS IN INDIA AND SOUTH AFRICA HELP ADVANCE THE MOST PROMISING HEALTH TECHNOLOGIES. THESE COUNTRIES HAVE RICH INNOVATION ECOSYSTEMS WITH UNIVERSITIES, PRIVATE-SECTOR FIRMS, AND A GROWING NUMBER OF ENTREPRENEURS FOCUSED ON DEVELOPING PRODUCTS AND SERVICES THAT MAKE HEALTH CARE MORE AFFORDABLE, ACCESSIBLE, AND EFFECTIVE.THE INDIA IMPACT LAB, A PARTNERSHIP WITH TATA TRUSTS AND THE INDIAN INSTITUTE OF TECHNOLOGY DELHI, IS A PLATFORM TO ENABLE LATE-STAGE MEDICAL TECHNOLOGY (MEDTECH) INNOVATIONS TO ACHIEVE MARKET ENTRY, ADOPTION, AND SCALE. THE IMPACT LAB ALSO PARTNERS WITH TOP INDIAN TECHNOLOGY AND BUSINESS INCUBATORS IN THE LIFE SCIENCE AND HEALTH CARE INDUSTRIES TO FURTHER DEVELOP THE INNOVATION ECOSYSTEM. IN 2019, THE IMPACT LAB BEGAN ENGAGEMENT WITH TEN SELECTED MEDTECH START-UPS UNDER THE QUEST FOR HEALTHCARE INNOVATIONS PROGRAM, A JOINT INITIATIVE WITH SOCIAL ALPHA. THE PROGRAM FEATURES A SYSTEMATIC, COHORT-BASED ENGAGEMENT MODEL, PROVIDING THE SELECTED START-UPS WITH CONTEXTUAL SUPPORT, GUIDANCE, AND MENTORSHIP IN PRODUCT DEVELOPMENT, CLINICAL EVIDENCE GENERATION, REGULATIONS, QUALITY MANAGEMENT, MARKET UNDERSTANDING, AND PROCUREMENT CHANNELS. ACTIVITIES INCLUDED A DEEP AND EXPANSIVE REQUIREMENT MAPPING FOR EACH START-UP AS WELL AS SUPPORT FOR THEIR CLINICAL VALIDATION JOURNEY AND GO-TO-MARKET NEEDS. THE IMPACT LAB CONDUCTED TWO CURATED CONVENINGS FOR THE COHORT: ONE WITH DOMAIN EXPERTS IN CLINICAL AND REGULATORY COMPLIANCE, THE OTHER WITH EXPERTS IN PUBLIC AND PRIVATE MEDICAL DEVICE TECHNOLOGY ASSESSMENT AND PROCUREMENT. ADDITIONALLY, THE IMPACT LAB DELIVERED FIVE FOCUSED KNOWLEDGE PLATFORMS, INCLUDING WORKSHOPS AND ROUNDTABLES FOR THE WIDER MEDTECH ECOSYSTEM. FOR THESE, THE IMPACT LAB ENGAGED WITH EXPERTS FROM NUMEROUS LARGE AND SMALL MEDTECH COMPANIES, PARTNER INCUBATORS, INDUSTRY, AND ACADEMIA, AS WELL AS KEY NATIONAL AND GLOBAL STAKEHOLDERS. THE KNOWLEDGE PLATFORMS COVERED A RANGE OF TOPICS-FROM TESTING AND CALIBRATING MEDICAL DEVICES TO MEDTECH REGULATIONS, LATE-STAGE PRODUCT DEVELOPMENT, AND MARKET ACCESS- AND INCLUDED ROUNDTABLE DISCUSSION OF PERTINENT ISSUES IN TB DETECTION, TREATMENT, AND ADHERENCE TO MEDICATION. THE IMPACT LAB, A CROSS-CUTTING INITIATIVE WITHIN PATH, PROVIDED SUPPORT TO PATH'S PROGRAM VERTICALS, FOR EXAMPLE IN THE DEVELOPMENT OF A MENSTRUAL HEALTH APPLICATION FOR WOMEN IN LOW- AND MIDDLE-INCOME COUNTRIES, DEVELOPMENT OF A TARGET PRODUCT PROFILE FOR MICROARRAY PATCHES FOR RABIES VACCINE DELIVERY, AND OPERATIONAL VALIDATION OF TRUENAT, A MOLECULAR DIAGNOSTIC DEVICE FOR DETECTION OF TB. THROUGH THE SOUTH AFRICA IMPACT LAB, PATH ACCELERATED OUR ASSISTANCE TO THE SOUTH AFRICAN MEDICAL RESEARCH COUNCIL (SAMRC) THROUGH THE JOINT GLOBAL HEALTH INNOVATION ACCELERATOR (GHIA) PARTNERSHIP. GHIA, WHICH IS PRIMARILY FUNDED BY A GRANT FROM THE BILL & MELINDA GATES FOUNDATION TO SAMRC, CONTINUES TO SUPPORT THE DEVELOPMENT AND COMMERCIALIZATION OF MEDICAL TECHNOLOGIES DESIGNED FOR RESOURCE-LIMITED SETTINGS IN SOUTH AFRICA AND BEYOND. IN 2019, PATH HOSTED STAFF FROM SAMRC FOR A WEEKLONG EXCHANGE IN SEATTLE, WASHINGTON. THE FOCUS WAS ON SHARING INTERNAL PATH PROCESSES FOR TECHNOLOGY EVALUATION, PRODUCT DEVELOPMENT, AND GO-TO-MARKET STRATEGIES, AND IDENTIFYING AREAS OF SUPPORT ON CERTAIN GHIA PROJECTS. ADDITIONAL CAPACITY-BUILDING EFFORTS INCLUDED A "BOOTCAMP" SESSION IN CAPE TOWN TO DISCUSS PRODUCT INTRODUCTION TOPICS SUCH AS PROCUREMENT, MARKET SIZING, AND COUNTRY DOWN-SELECTION APPROACHES. TO INCREASE GHIA'S VISIBILITY, PATH AND SAMRC CO-WROTE AND PUBLISHED AN ARTICLE REFLECTING ON THE LAST FIVE YEARS.

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