ICASA SATELLITE SYMPOSIUM Tuesday, 1 December 18:30 20:30 Prof. Soudre Room Rainbow Towers Conference Centre. Organized by:
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1 Optimizing Testing and Treatment of HIV-Exposed Infants: Creating Sustainable Markets for Point-of-Care Technologies within National Diagnostic Networks ICASA SATELLITE SYMPOSIUM Tuesday, 1 December 18:30 20:30 Prof. Soudre Room Rainbow Towers Conference Centre Organized by: 0 UNITAID EID Symposium, 1 December 2015
2 Overview of UNITAID investments in early infant diagnosis EID satellite symposium 1 December 2015 Carmen Perez Casas
3 UNITAID's role in the global response is to connect the upstream and the downstream Academia Industry PDPs BMGF Grand Challenges...others... Upstream Regulatory Evidence IP Quality Adaptability Price Market interventions with grantees Governments & Partners Medicines Devices Downstream HIV / AIDS Tuberculosis Malaria 2 UNITAID EID Symposium, 1 December 2015
4 UNITAID s crosscutting approach in diagnostics Development Evaluation Approval Market Landscape Analyses; Consultations; Partner Coordination Developers Market Entry (15M) ( ) Open Polyvalent Platforms (6.4M) ( /2016) WHO PQ Diagnostics (22.6M) ( ) HIV Dept (Dx Adviser) ( ) ERPD with Global Fund LSHTM Regulatory acceleration (4.9M) (07/ /2016) MSF viral load (28M) ( ) CHAI/UNICEF: EID+VL (55M) ( / yr grant extension under consideration) EGPAF: Early infant diagnosis (63M) (08/ /2019) Legend: Secretariat activity Projects PSI self-testing (23M) (09/ /2017) 3 UNITAID EID Symposium, 1 December 2015
5 Key goals of UNITAID investments in EID Public health To increase the number of HIV+ infants whose HIV status is known to facilitate early ART initiation Market shaping To accelerate availability of quality-assured and adapted EID products at lowest possible cost 4 UNITAID EID Symposium, 1 December 2015
6 Programmatic and commodity scope of UNITAID investments in EID Status: Consideration of a 4-yr extension to 2020 Focus: Optimizing VL and EID networks through strengthening conventional/laboratory systems and introduction of POC EID and VL commodities Commodity envelope: 50% of grant value Status: USD 63m, 4 year duration (until mid-2019) Focus: Optimizing EID networks and introduction of POC EID commodities where gaps are. Commodity envelope: ~USD 25m Status: USD 28m, 4 year duration (until end-2016) Focus: Introduction of viral load and POC VL and EID testing; demonstration project with strong operational research focus Commodity envelope: limited in size 5 UNITAID EID Symposium, 1 December 2015
7 Geographical scope of UNITAID investments in EID Countries to be confirmed 6 UNITAID EID Symposium, 1 December 2015
8 Are adequate tools for EID scale-up there? POC EID: Available and in pipeline TaqMan HIV-1 Qual v2.0 Roche DBS CE Mark RealTime Qual HIV-1 Abbott DBS CE Mark (2011) Alere q HIV-1/2 Detect Alere CE Mark ZIVA Cavidi Under development Iquum/Roche Ustar SAMBA II EID DRW Kenya, Uganda Xpert HIV-1 Qual Cepheid CE Mark LYNX HIV p24 NWGHF Lumora Micronics QuantumDx SAMBA I Semi-Q EID DRW Kenya, Uganda DFA * Reported November timeline and sequence may change no specific market launch date; DBS assay CE Mark noted for laboratory products ** In addition, open polyvalent platforms are currently available for HIV VL and EID testing Source: HIV/AIDS Diagnostics Technology Landscape, UNITAID, UNITAID EID Symposium, 1 December 2015
9 Introducing new tools: Key principles National response Systems approach Realistic pace Evidence generation National priorities and plans as a point of departure Dialogue with ministries of health and partners, coordination for alignment and transition Optimizing existing systems and national EID networks: Right product at the right place Laboratory-based system as the backbone (training, QA, data management, etc.) Product availability on the market and in country Country and site preparation Phased approach with initial pilots: understanding how the product works in settings for intended use Public health goods: implementation tools, publications, lessons learnt 8 UNITAID EID Symposium, 1 December 2015
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