Diagnostics product development projects
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1 Page 0 Diagnostics product development projects Smiljka de Lussigny Technical Officer, HIV UNITAID Copenhagen, 23 September 2013
2 Page About UNITAID HIV diagnostics market UNITAID s current investment in HIV diagnostics
3 Page 2 1 ABOUT UNITAID
4 UNITAID Market Effects Framework for Public Health UNITAID s market impact framework Page 3
5 Page 4 UNITAID s interventions Commodity Birth Line Value Chain R&D IP Issues Market Entry Quality Availability Price Operational Research in country Delivery Country Intervention /- - +
6 Page 5 UNITAID s commitments US$ 1,8 billion; 94 Countries receiving commodities HIV / AIDS 51 recipient countries Malaria 29 recipient countries > US$903 m > US$456 m Tuberculosis 76 recipient countries > US$291 m Cross-cutting programmes: US$ 129 m - WHO PQ of drugs, diagnostics and VMC devices US$ 31 m - Medicines Patent Pool
7 UNITAID s implementers Page 6
8 Page 8 1 Simple, point of care (POC) diagnostics 2 Affordable, adapted paediatric medicine 3 Treatment of HIV/AIDS and co-infections 4 Treatment of malaria (ACT) STRATEGY Six Strategic Objectives 5 Treatment of second-line tuberculosis 6 Preventatives for HIV/AIDS, TB and malaria
9 Page 9 2 HIV DIAGNOSTICS MARKET
10 Page 10 HIV diagnostic and monitoring tools Initial diagnosis of HIV (including Early Infant Diagnosis) Patient staging (CD4 testing) Patient monitoring 2013 WHO guidelines : viral load testing for treatment failure Laboratory-based and point of care
11 Page 11 Demand side Unmet needs: <50% of PLHIV are aware of their serostatus <60% of PLHIV have access to CD4 testing <25% have access to VL testing <26% of the infants born to HIV positive mothers have access to Early Infant Diagnostic (EID) testing. Changes in 2013 WHO guidelines will impact the needs : Increased number of people eligible for ART: total of 25.9 million (9.7 million are now on ART) Preference of VL for monitoring of treatment failure over CD4, When? What?
12 Page 12 Testing coverage far below need Unmet Need for HIV Diagostics Millions Tests Number of Tests performed Additional Tests required CD4 VL EID CD4 and VL coverage data based on country data collected by CHAI in 8 high HIV burden countries in SA. EID data based on kidstat testing numbers. Newer testing volumes were used where available.
13 Testing need increasing with scale up of ART Millions CD4, VL and EID testing need CD4 Staging CD4 monitoring VL monitoring EID Page 13 Based on CHAI ART patient forecast and country guidelines for staging and monitoring. WHO guidelines were used where country guidelines were unavailable. EID data is based on WHO reported number of HIV exposed infants
14 Page 14 Supply side market shortcomings Availability: Limited POC CD4; no POC VL or EID tests available on market. Acceptability: existing tools too complex for all needs of resource limited settings (lab-based), especially remote settings Affordability: Traditional lab testing too expensive (CD4 US$25-90K for instrument; VL US$ K, plus test cost!). Recent POCs less expensive (ranges US$6-25K per device, US$6-12 per test). Quality: absence of information on quality of new POC; slow global and unclear, inconsistent, and costly national QA processes. Delivery: slow and insufficient uptake
15 Page 15
16 Page 16 Market entry barriers for HIV POC Dx Discovery Development Evaluation Registration Market Market entry definition: "completion of the marketing approval steps required to commercialize a product" Most significant market entry barriers: Unclear, absent, and/or inconsistent regulatory pathways to market, register, and use new diagnostics each country has own requirements Slow global QA processes Private funding (venture capital) hard to access
17 Page 17 Implications Delay in market entry of new products Limited competition. First-to-market may capture market share and block market entry of potentially improved and lower cost products in the pipeline Additional costs and resources needed to enter market may increase final price & limit extent of uptake Long term disincentives for continued innovation
18 Page 18 3 UNITAID CURRENT INVESTMENTS IN DX
19 Page 19 UNITAID s HIV Dx approach Development Evaluation Approval Market Landscape Analyses; Market Forums; Partner Coordination to align procurement practices & policies WHO PQ Diagnostics Developers - Market Entry LSHTM MSF CHAI/UNICEF Univ. Bern: CE legend: Secretariat activity Projects
20 Page 20 UNITAID s recent investment CHAI UNICEF Funding 1 year $20 million Phase 2 Dec 2013 Project Aim POINT OF CARE DIAGNOSTICS FOR HIV Prepare the market for accelerated scale-up of POC HIV diagnostics including CD4, VL/EID in 7 countries. MSF 3 years $28.6 million POINT OF CARE DIAGNOSTICS FOR HIV Operational research on introduction of PoC and adapted laboratory-based monitoring to understand how, where and when PoC fits in the mix of laboratory services available in health services in 7 countries. FEI 1 year $2.4 million Phase 2 June 2014 OPEN POLYVALENT PLATFORMS FOR SUSTAINABLE AND QUALITY ACCESS TO VIRAL LOAD Improve access to viral load testing (VLT) and early infant diagnosis (EID) for adults and children living with HIV through the introduction of innovative Open Polyvalent Platforms (OPPs) LSHTM $2.9 million GLOBAL NETWORK TO IMPROVE ACCESS AND QUALITY OF HIV MONITORING Market entry projects $20.7 million envelope MARKET ENTRY Address Developers Market Barriers: 4 developers of CD4, VL and EID POCs
21 Page 21 Closed Platform Extraction Reagents Real time thermocycler OPEN systems: different components can be provided by different suppliers Open Platforms POLYVALENT systems: may be used for multiple diagnostics
22 Page 22 OPP-ERA call for tenders
23 Page 23 Thank you for your attention
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