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He Hepati patitis tis C Dia iagn gnosti ostics cs the Bott ottleneck leneck to o Unloc lockin king g a Gl a Glob obal al Mark arket Peter Dailey, FIND Cami Graham, FIND Barbara Bulc, Global Development / FIND Meeting at the

  1. He Hepati patitis tis C Dia iagn gnosti ostics cs – the Bott ottleneck leneck to o Unloc lockin king g a Gl a Glob obal al Mark arket Peter Dailey, FIND Cami Graham, FIND Barbara Bulc, Global Development / FIND Meeting at the Occasion of AASLD 2014 and 13 th HCV DrAG Meeting Boston, November 11, 2014

  2. Sum ummar ary Agend nda: 1. 1. FIND D – an innovati tive e partner er in diagn gnost ostics cs for r limited ed-res resou ource ce set etti tings ngs -- Peter Dailey 2. Hepati titi tis s C diagn gnost ostic c tests ts - strategy egy and visi sion on to address ss glob obal market -- Peter Dailey, Cami Graham 3. 3. New opportu tuni nities ties for cross-sect sector or partners ership ips -- Barbara Bulc 4. 4. Q&A and Disc scussi ssion on Moderated by Veronica Miller, Forum for Collaborative HIV Research 2

  3. Object ectiv ives es Objecti ectives es: DRIVE VE ACCESS ESS What t is pot otent ntial ial of new diagnos nostic tic tests ts to drive ve access ess to care and treatme tment nt of HCV in limited ed-resou esource ce set etti tings ngs, and beyond ond CONV NVERGE PER ERSPEC ECTIVES TIVES Converg erge divers erse perspecti pectives es to enable e new partne nershi ships ps and innovat ation on in suppor port t of HCV diagnosti nostics cs and treatme tment nt CATALYZE YZE COL OLLABOR ABORATIONS TIONS Share re opportuni tuniti ties es for r collaborati oration n with FIND D as a catal alyst st to unlock ck a glob obal market et for HCV diagnosis nosis and treatme tment nt 3

  4. FIND – an inno novativ ative partn tner r in diag agnos nostic tics for limit ited-reso resour urce ce sett etting ings 4

  5. Why y diag iagno nost stics ics mat atter er Diagn agnos osis s equ quals s knowledge: To enable accura rate treatment, to target t hea ealt lthcare e in interventions, and to measu sure e prog ogres ess. s. This is the he basis to: ..... fulfill the patient ’ s right to know and promote health ... eliminate diseases ... prevent antimicrobial resistance ... improve the efficiency of healthcare spending 5

  6. Toward rd a worl rld d wh where re di diagnosi nosis s guide des the way to health for for all pe peopl ple Mission : T urning complex diagnostic challenges into simple solutions to transform lives and overcome diseases of poverty FIND I. Catalyze III. II. Guide use development Accelerate & policy access • Lead dynamic • Lead clinical trials needs definition • Facilitate national • Define evidence • Support program policy and develop- needs for manufacturers ment of rollout plans • Support WHO • Help MoHs identify • Scout technology development gaps, coordinate • Match-make of guidelines solutions, and • Provide specimens deploy experts • Develop QA tools & strategies IV. • Measure and communicate impact of Dx Shape • Shape Dx ecosystem to foster willingness to invest/pay • Lead global discussion on emerging Dx topics agenda PA TIENTS SCIENCE PRODUCTS SOLUTIONS 6

  7. Partnering for the right solutions Swiss Partners FIND FIND WHO, TDR, UNITAID, Global Fund, Stop TB Partnership, GLI, GDF, MMV, R&D, Industry and Academic partners Geneva DNDi, SDC, Swiss TPH, EPFL, Switzerland Canton of Geneva, HUG, and others Implementing partners With partnerships and opportunities growing, we are determined to keep our role simple: ask the right questions, team up for the right answers. That is, after all, the root of diagnostic success. 7

  8. How we are structured FIND Geneva headquarters Global expert network • Hub for all FIND activity Network of experts provides expertise to • Home to leadership, programme, and enable development & access work support staff • IVD industry experts provide developers • Geneva center of global health with 50+ mentorship, support international organization in global helath • Access experts across multiple countries support implementation FIND Country offices / nodes • Currently in India, South Africa, Uganda, and the Dominican Republic with likely expansion pending • Responsible for FIND implementation activities in a country/region, trial support, & coordination with local partners Note: locations of expert network and country offices / nodes are examples only

  9. Signif ific icant ant pro rogress ess achieved ed in the last st 10 y years TB Sleeping sickness Malaria Patients can now get drug The development of a Joint FIND-WHO efforts to susceptibility testing rapid diagnostic test has assure the quality of rapid in 2 hours at a district helped make disease tests have increased the hospital. This used to take elimination a reality . % of quality products in up to 120 days and was only use from 15% to 75%. available at national reference labs. 9

  10. FIND’s new Support for Success programme eases the way to u uptak ake for pro romising ising pro roducts cts

  11. FIND’s unique global biorepository and feasibility studies • The FIND biorepository currently counts over 60,000 aliquots among sputum, serum, EDTA plasma, P800 plasma and urine. • Samples have been provided to more than 40 developers all over the world • Also serving as the main provider of specimens for the BMGF TB Biomarkers Discovery project • Technical feasibility and proof-of concept studies for the assessment of new TB diagnostic technologies are integrated into collections

  12. Diagnostic trials are a centerpiece of every step in the value chain Adop opti tion on Scaling ling up & into to global al conti tinu nued ed adoption ion Registrat tratio ion polic icy into to nation ional al polic icy Eva valuat luation ion Demons onstr trati ation on Acces ess • Test accuracy racy • Comparat arativ ive e effec ecti tiven enes ess • Test and resour urce e (patient ient importa tant nt outcomes es, , case utiliz lizati ation on • Ease of use detec ecti tion on); ; • Patient ient impac act • Surrogat ogate patien ent t • Cost of diagn gnos osti tic proces ess and impor orta tant nt outcom omes es • Epidem demiologic iological impac act treatm tmen ent, t, incl. l. for patien ients ts • Basic cost- • Econom nomic ic impact • Operati ation onal al requir uirem emen ents for comparis risons ons implem lemen entat tatio ion n (infra frastruct ructure re • Health th system impact and human) n) • Provide an open platform and ensure adequate firewalls to avoid conflicts of interest • Combining specimen banks and strong trial infrastructure to streamline the pathway • Trial design, planning and coordination optimized to inform policy review 12

  13. FIND’s Access team accelerates uptake through a multi-pronged approach 1 Ensure that holistic solutions tailored to specific country needs are in place 2 Support development of country Countr ntry y implementation adopti tion plans for solutions 3 Strengthen Political Strong lab / health Process & country capabilities commitment systems managerial efficiency to implement and capture benefit of solutions

  14. From tests to comprehensive diagnostic solutions Training packages Connectivity Quality and IT assurance Easy to use diagnostic Support and supply chain Impact measurement Policy & Regulatory guidance 14

  15. Hepati titis tis C diagnos nostic ic tests ts - Strategy gy and vision on to addre ress ss globa bal l mark rket 15

  16. Sta State of the HCV disease ease 8% 170-250M Unknown Likely close Actual Actual to zero in Ideal Ideal LMICs Living in LMIC All Hepatitis C chronic Patients who know their On Treatment carriers status • Hepatitis C virus causes an estimated 350,000 deaths/year • The majority of infections and deaths occurs in low/middle-income countries • A large proportion of the burden of infections and also co- infections (with HIV and TB) occurs in vulnerable populations 16 Global Burden of Disease Report AALSD 2013

  17. Today, , HCV infect ectio ion n is severel erely y un under-diagnosed diagnosed <8% of cases diagnosed in MICs, Roots of under-diagnosis include lack even less in LICs of appropriate tools & delivery issues Current diagnostic algorithm is complex • 6 different diagnostic tests needed for a total cost 50 -94% Estimated prevalence of $250-2500 per patient • RDT screening tests are expensive (~$10) and of Cases diagnosed highly variable quality, esp in sub-Saharan Africa 10 NAAT-based Dx tools that are currently needed to MM people confirm infection and & for treatment monitoring can only be performed at centralized labs 48 • Most low-income countries lack capacity to 12 5 conduct viral load testing • Complicates medical management of hepatitis C 5 and blood-banking 4 3 Current treatment regimens are complex and 0 expensive – LMICs 1 unable to implement at scale China Russia US Germany • Injectable IFN-based treatment can cost up to India Brazil France Italy $20k per patient plus costs of monitoring and AEs Lack of reliable data for LMICs. Available data Impossible for low-income countries to suggests a major problem of under-diagnosis diagnose and treat patients at scale 17 1. Low & Middle Income Countries Source: Decision resources; UNITAID: Hepatitis C Medicines and Diagnostics in the Context of HIV/HCV Co-Infection: A Scoping Report (October 2013)

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