USAID Update 2014 Bureau for Global Health Christine Malati, PharmD Anthony Boni Lisa Ludeman, MSPH December 16, 2014

Outline Structure of the Global Health Supply Chain Program Updates on PQM and SIAPS

Global Health Supply Chain Program ($10.5 Billion) Quality Assurance Contract ($123m) Business Intelligence and Analytics ($20m) GSA Contract Single-Award Procurement & Technical Assistance IDIQ ($9.5b) With the Following Task Orders: Family Planning HIV/AIDS Malaria MCH Supply Chain Innovation & Research Annual Program Statement ($40m) # of Agreements TBD HIV RTK Procurement IDIQ ($300m)   Small Business Set Aside  Multiple-Award Technical Assistance IDIQ ($500m)  Up To Four Awards, Including one Small Business Set Aside

Single-Award Procurement & Technical Assistance IDIQ 5-year single-award IDIQ 4 task orders (HIV, malaria, family planning and reproductive health, maternal and child health) Global Commodity Procurement and Logistics Systems strengthening Global collaboration 5-year single-award IDIQ Three (3) initial Task Orders upon award of an IDIQ Contract. The three task orders will be for 1) HIV/AIDS, 2) The President’s Malaria Initiative (PMI) and 3) Family Planning. Goal: Improve availability of health commodities and provide supply chain technical assistance   Objective 1: Global Commodity Procurement and Logistics – Improve provision of essential health commodities Functions Health Commodity Procurement – strategic sourcing of quality-assured commodities Logistics- logistics services for commodity delivery Health commodity quality assurance – provide health commodities that meet required quality requirements Data visibility – provide appropriate visibility of data Objective 2: Systems strengthening technical assistance – strengthen in-country supply chain systems Strategic planning – provide strategic planning and design assistance In-country logistics – improve delivery of health commodities to service sites Capacity-building – effective transfer of skills, knowledge, and technology for improved and sustained performance Enabling environments – strengthen enabling environments to improve supply chain performance Objective 3: Global collaboration – strategic engagement to improve long term global supply of health commodities Global strategic engagement – global strategic engagement with partners for planning and implementation. Support global partners to utilize lessons learned and share best practices Global market dynamics – conduct, share, and implement market dynamics research and innovations Advocacy – continued awareness-raising and advocacy to improve availability of health commodities Coordination – effective coordination with all USAID funded supply chain activities and with the IQC

HIV RTK Procurement IDIQ Five year single award IDIQ Procurement of RTKs Logistics Collaboration within the GHSCP and with other international stakeholders Small Business 5 year Single award IDIQ Rapid Test Kits   Primary objective: to ensure the availability of approved HIV Rapid Test Kits (RTKs) using a global procurement strategy. A RTK defined is an assay for diagnosis of infection with HIV-1/2 or type specific diagnosis of HIV-1 and HIV-2, from which test results can be read directly, within 30 minutes of the time the specimen is applied to the device, without calibration or calculations. C.2.1 PROCUREMENT OF APPROVED RTKs a) Commodity Procurement and Subcontract Management. b) Commodity Supplier Performance Management. c) Commodity Procurement Risk Mitigation. C.2.2 LOGISTICS a) Customer Order Fulfillment Procedures b) Insurance c) Freight Forwarding d) Continuous Quality Improvement C.2.3 QUALITY ASSURANCE AND QUALITY CONTROL a) Collaboration with QA Contractor or other USAID Designee b) Managing Product Recalls. C.2.4 METRICS C.2.5 DATA VISIBILITY a) Information Systems Capabilities. b) Data c) Data Standards: d) Data Loss Prevention e) Updates to Information System f) Data Ownership g) Existing Support Tools C.3 COLLABORATION

Quality Assurance Award Goal: Establish and implement a comprehensive QAP for USAID that provides global technical leadership regarding quality issues Quality Assurance Program Quality Control Strategy Technical Leadership Global Collaboration Procurement Sensitive Information

Multiple Award Technical Assistance IDIQ Goal: Improve the long-term availability of health commodities in public and private services Objective 1: Systems Strengthening Technical Assistance – Strengthen in-country supply systems Objective 2: Global Collaboration – strategic engagement to improve the long-term availability of health commodities Goal: Improve the long-term availability of health commodities in public and private services   Objective 1: Systems Strengthening Technical Assistance – Strengthen in-country supply systems Functions: Strategic Planning – provide strategic planning and design assistance In-country logistics – improve delivery of health commodities to service sites Capacity-building – effective transfer of skills, knowledge, and technology for improved and sustained performance Enabling Environments – strengthen enabling environments to improve supply chain performance Objective 2: Global Collaboration – strategic engagement to improve the long-term availability of health commodities Global Strategic Engagement – global strategic engagement with partners for planning and implementation. Support global partners to utilize lessons learned and share best practices Advocacy – continued awareness-raising and advocacy to improve availability of health commodities Coordination – effective coordination with all USAID funded supply chain activities and within the IQC

Multiple Supply Chain Assistance Cooperative Agreements and/or Grants Overall objective: Support research on a focused set of health supply chain systems and related commodity security issues in low and middle income countries. Objective 1. Improve health supply chain systems through transformative changes that use industry best practice; Objective 2. Improve the quantity, reliability, and efficiency of financing for health commodities and supply chain systems; Objective 3. Improve governance and accountability for commodity security.

Business Intelligence & Analytics ($20m) Contract Purpose: to build and maintain as a Software as a Service (SaaS) USAID GH Business Intelligence and Analytics (BI&A) platform and provide technical services for and on behalf of USAID GH Bureau and the supply chain business initiatives. Program Management Data warehouse Data mapping Data migration Knowledge Management Database Business Intelligence and Analytics Purple: 000060 The Federal Supply Schedule (FSS) Task Order (TO) type is a hybrid containing firm fixed-price (FFP); time and material (T&M); and cost-reimbursement (CR) line items as designated in the TO Line Item Number (LIN) structure. 1 year with four 1 year option periods Purpose: to build and maintain as a Software as a Service (SaaS) USAID GH Business Intelligence and Analytics (BI&A) platform and provide technical services for and on behalf of USAID GH Bureau and the supply chain business initiatives.   B.8.5 TASKS Task 1 – Program Management (TOLIN 001, FFP) B.8.5.1.1 SUBTASK 1.1 – COORDINATE A POST AWARD ORIENTATION/PROJECT KICKOFF MEETING B.8.5.1.2 SUBTASK 1.2 PREPARE FINANCIAL REPORTS B.8.5.1.4 SUBTASK 1.4 – CONVENE TECHNICAL STATUS MEETINGS B.8.5.1.3 SUBTASK 1.3 – PREPARE STATUS REPORTS B.8.5.1.5 SUBTASK 1.5 – PREPARE A PROGRAM MANAGEMENT PLAN (PMP) B.8.5.1.6 SUBTASK 1.6 – PREPARE PERFORMANCE MANAGEMENT PLAN (PMP2) REPORTS B.8.5.1.8 SUBTASK 1.8 – PREPARE CONFIGURATION MANAGEMENT PLAN B.8.5.1.7 SUBTASK 1.7 – PREPARE TRIP REPORTS (CMP) B.8.5.1.9 SUBTASK 1.9 – IMPLEMENT TRANSITION OUT PLAN B.8.5.1.10 SUBTASK 1.10 – FINAL REPORT Task 2 – Business Intelligence & Analytics Solution (TOLIN 002, FFP) - Data warehouse solution - Business intelligence and analytics solution - Knowledge management solution - Licensing arrangements Task 3 – Technical Support Services (TOLIN 003, T&M) B.8.5.3.1 SUBTASK 3.1 – DATA WAREHOUSE PLANNING B.8.5.3.2 SUBTASK 3.2 – REQUIREMENTS GATHERING B.8.5.3.4 SUBTASK 3.4 – DATA MIGRATION AND INTEGRATION PLANNING B.8.5.3.3 SUBTASK 3.3 – DATA MAPPING B.8.5.3.5 SUBTASK 3.5 – STANDARD REPORTS B.8.5.3.6 SUBTASK 3.6 – DASHBOARDING B.8.5.3.7 SUBTASK 3.7 – DATA MIGRATING, INTEGRATING, AND HOST ENVIRONMENT ESTABLISHMENT B.8.5.3.9 SUBTASK 3.9 – BUSINESS/DATA ANALYSIS AND ADVISORY B.8.5.3.8 SUBTASK 3.8 – SYSTEM GOVERNANCE AND MASTER DATA MANAGEMENT SUPPORT B.8.5.3.10 SUBTASK 3.10 – USER TRAINING AND WORKSHOPS B.8.5.3.11 SUBTASK 3.11 – SURGE DEVELOPMENT, MODIFICATIONS AND ENHANCEMENT SUPPORT B.8.5.4.1 SUBTASK 4.1 –DATABASE ADMINISTRATION Task 4 – SaaS Hosting, Operations and Maintenance (TOLIN 004, FFP) B.8.5.4.2 SUBTASK 4.2 –BI&A MAINTENANCE B.8.5.4.3 SUBTASK 4.3 – GH SC BI&A HOSTED ENVIRONMENT MAINTENANCE Task 5 - Travel Expenses (TOLIN 005, Cost Reimbursement) Current invoice period Travel Authorization Request identifier, approver name, and approval date Names of persons traveling Number of travel days Dates of travel Number of days per diem charged Per diem rate used Total per diem charged Transportation costs (rental car, air fare, etc) Total charges Indirect Handling Rate (If Applicable). Explanation of variances exceeding 10% of the approved versus actual costs

SIAPS: Recent Accomplishments Advancing a framework and metrics to measure pharmaceutical systems strengthening “Enhancing Health Outcomes for Chronic Diseases in Resource Limited Settings by Improving the Use of Medicines: The Role of Pharmaceutical Care” Improving understanding of the vital role medicines play in Universal Health Coverage Development of an accreditation framework for the establishment of national pharmaceutical continuous education programs in LMICs. SIAPS West Africa Regional Project launches an Early Warning System (EWS) for HIV/AIDS commodities Improving governance capacity for more transparent and accountable pharmaceutical systems Applying knowledge management approaches to improve pharmaceutical management through collaboration with WHO The goal of the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program is to assure the availability of quality-assured pharmaceutical products and effective pharmaceutical services to achieve desired health outcomes SIAPS authored a discussion paper and convened a partners meeting to reach consensus on defining pharmaceutical systems and pharmaceutical systems strengthening. The ultimate objective is to be able to measure the impact of pharmaceutical systems strengthening interventions to inform investment decisions. To address changing health risks, SIAPS published the state of the art paper “Enhancing Health Outcomes for Chronic Diseases in Resource Limited Settings by Improving the Use of Medicines: The Role of Pharmaceutical Care”. The paper provides managers and decision makers with concrete examples of how the introduction and expansion of pharmaceutical care can support the improvement of health outcomes for chronic diseases. SIAPS supported the regional conference “UHC Considerations in Designing Medicines Benefits Policies and Programs” held in September 2014 in Cape Town to help national programs plan and expand financial mechanisms to improve equitable access to medicines and pharmaceutical services. SIAPS developed a framework to establish academic accreditation for pharmacists, technicians and assistants for more consistent nationally recognized education programs to support improved medicines access and higher quality services. Utilizing a participatory approach, SIAPS engaged a variety of stakeholders to develop an early warning system (EWS) to help avoid stock-outs of HIV and AIDS commodities and prevent wastage. The EWS is easily accessible online, built to accommodate a range of users with varying levels of permissions, and features a dashboard that collects and displays regional data in a meaningful and easy-to-interpret way. The dashboard allows the spectrum of stakeholders—from program managers to ministry of health officials to donor agencies—to monitor commodity stock status, anticipate future funding gaps, respond to projected medicine shortages and expiries, and make decisions based on accurate information. As a crosscutting issue, good governance is central to all pharmaceutical management functions; regulation, selection, procurement, distribution and rational use. To help better manage scarce resources, reduce the chances for patient harm, counter corruption and improve health outcomes, SIAPS is completing an e-learning course on key governance interventions. The course will be available globally to support managers and decision makers in addressing pharmaceutical sector governance-related challenges. SIAPS supports the WHO Division of Essential Medicines and Health Products portal with resources to expand the IT platform for improved access to high-value documentation, best practices, and effective solutions for pharmaceutical management to support pharmaceutical systems strengthening.

PQM: Recent Accomplishments Promoting the Quality of Medicines Program extended to September 2019 Two PQM-supported manufacturers in China are the first to be prequalified for Capreomycin Active Pharmaceutical Ingredient (API). PQM supported the first generic producer of Capreomycin to achieve WHO prequalification, thereby helping to reduce the cost of this medicine. PQM  supported the only major producer of Kanamycin to obtain GMP compliance status from the WHO Prequalification Program for the non-sterilized API of Kanamycin. Ghana Food and Drug Authority QC lab receives ISO 17025 accreditation for compendial tests used to assess the quality of essential medicines. With PQM support, the Ethiopian drug regulatory authority (FMHACA) laboratory became the first medical device laboratory in Africa to achieve ISO 17025 accreditation ((testing of male condoms). Monograph developed (specifications, QC tests to perform, and methods) for Dihydroartemisinin-piperaquine phosphate tablets (DHAP), thereby enabling testing of this important FDC antimalarial. The Promoting the Quality of Medicines (PQM) program strengthens medicines regulatory capacity (e.g., medicines quality monitoring and drug quality control labs), supports local manufactures to achieve WHO prequalification to increase the availability of quality assured medicines (particularly 2nd line TB medicines), and contributes to efforts to combat counterfeit and substandard medicines. A major constraint for the treatment or MDR TB is the paucity of quality assured Active Pharmaceutical Ingredients (APIs) for second line TB medicines. Having two companies producing a quality-assured Capreomycin API helps to prevent a supply monopoly and ensures supply security. In order to increase the performance standards of quality control laboratories, PQM introduces quality management systems and supports labs to achieve ISO 17025 accreditation. PQM supported the ISO 17025 accreditation of the first medical device laboratory in Africa, the Food Medicine and Health Care Administration and Control Authority (FMHACA) laboratory in Ethiopia for conducting key tests to assess the quality of male condoms. DHAP is used to treat drug resistant falciparum malaria which is a global problem.

USAID Update 2014 Bureau for Global Health Christine Malati, PharmD Anthony Boni Lisa Ludeman, MSPH December 16, 2014