Demand forecasting and market considerations

Transcription

1 Demand forecasting and market considerations New and Innovative Approaches to Laboratory Diagnosis of Zika, Dengue and other Arboviruses Workshop MAY 2 4, 2017 ANNECY

2 Overview Introduction to UNICEF-Supply Division ZIKV Dx Market shaping through Innovation UNICEF procurement process Challenges

3 Executive Director Programme Partnerships Management Field Results Regional Offices Programme Public Partnerships Human Resources Supply Emergency Private Fundraising & Partnerships Finance & Admin Management Communication IT Solutions & Services Data, Research & Policy

4 $3.428 billion in supplies and services 4

5 Critical functions of Supply Division Supply Function 2030 Scale & Equity UNICEF programmes System Strengthening Markets for Children Emergencies Servicedelivery Procurement Services Capacity Building Product Innovation Influencing Markets Efficiency, reliability Sustainability & Ownership Global responsibility & impact Support results for children with an effective, efficient supply operation Help meet UNICEF s Core Commitments for Children in emergencies by providing rapid response to emergency supply and logistics needs Contribute to influencing markets to ensure sustainable access to essentials supplies for children Serve as a centre of expertise and knowledge on essential supplies for children and supply chains and build capacities of national governments Provide procurement services to governments and development partners on strategic-essential supplies Establish policies for supply chain activities Use product innovation to increase results and decrease costs

6 Warehousing and procurement size UNICEF as a procurement agency of choice, including due to strategic focus Emergency (rapid) response procurements remained at between 3-7% of overall procurement over the decade

7 Influencing markets What? Analyze and set targets Availability Quality Affordability Sustainability (including local production) Innovation How? Employ Strategies Pool volumes Convene industry forums Provide Forecast to industry Transparency- publish prices Foster competitive markets Strategic procurement Volume guarantees Bridge financing Collaboration

8 Product development Product Innovation Project Pipeline Identification of bottlenecks Programme inputs Feedback from partners End-user feedback Define and communicate potential solutions User research Target product profile Expression of Interest, Request for Proposals Product development & testing Funding academic research Field trials in UNICEF context Convening partners/advisory committees for feedback Market uptake and scale up Advance purchase commitment Cost-sharing for new products Programme integration

9 Health Emergencies Preparations Initiative (HEPI) Driving the R&D pipeline for health technologies that prevent, diagnose and treat diseases that are a public health threat Linked to Influencing Markets Avoid +10x cost of developing health interventions in real-time response to an emergency Work with WHO, BARDA/USG, Gavi, etc. MEDICAL TECHNOLOGY AVAILABILITY Shading is reflective of medical technologies available to diagnose, prevent, treat. Darker colour are areas with higher risk due to limited/lack of medical technology. Disease Diagnostic Prevention Treatment Ebola/Marburg (v.) SARS/MERS-CoV (v.) Zika (v.) Avian/Pandemic Influenza (v.) Cholera (b.) E: RDTs (4 in 2015), labs-pcr M: ELISA,PCR SARS: Chest x-ray, ELISA, PCR, IFA MERS: PCR RT-PCR (w/in 5 days of symptoms) RDT, PCR, IFA E-M: 4 candidate vaccines under trial for WHO PQ (Merck product under EUAL registration) Rapid dipstick (in pre-qual), PCR Meningitis (b., v.) PCR, Culture Vaccines against groups A, B, C, C135, Y incl. in combination (Sanofi, GSK, BioManghin, Pfizer, others under licensure), WHO PQ Polio & vdpv (v.) Yellow fever (v.) Dengue/Chikungunya (v.) Crimea-Congo Hemorrhagic Fever (v.) Viral culture, Serology, RT- PCR ELISA (conf days after illness) D: RDT, RT-PCR, ELISA CH: PCR, ELISA RT-PCR, ELISA E: 4-5 candidates under study, & serum treatment M: Palliative care MERS: antivirals being studied No cross-protection seen with new Dengue vaccines Flu platform available from seasonal influenza 2 vaccines WHO PQ ORS, IV, antibiotics (when necessary) Antibiotics Multiple vaccines activated/inactivated, oral/injected, salk/sabin, type1-2-3; WHO PQ Vaccines WHO PQ 2 Dengue vaccines being reviewed for WHO PQ (Sanofi-2016; licensed by Brazil; Takeda-2017) Old vaccine used in Bulgaria; candidate vaccines by Erciyes (Turkey) pending FDA review Palliative care Palliative care Serum treatment under study in Turkey (Refik Saydam Health Institute) Ribavirin gives potential interference Antibiotics Lassa Fever (v.) ELISA, RT-PCR Candidate vaccine under study by USAMRIID Leptospirosis (b.) RDT, ELISA, PCR, Culture Doxycycline is prophylaxis Vaccines avail in Cuba & China Plague (b.) RDT, PCR, ELISA, Microscopy Antibiotics Rift Valley fever (v.) PCR, Culture, Microscopy Palliative care West Nile (v.) PCR, ELISA Phase 1 testing Hantavirus PCR, ELISA Phase 2 study of HtVN/PUUV/DNA vaccine is ongoing Hepatitis E (v.) PCR, ELISA Licensed vaccine in China Shigella (b.) PCR, Culture Phase 1 testing for 2 candidate vaccines Seasonal Influenza RDT (A, B detection), RT-PCR Seasonal vaccines WHO PQ (v.) Typhoid Fever (b.) RDT, PCR, ELISA, Culture Two vaccines WHO PQ; Oral % effective (Crucell); Polys % (GSK, Sanofi). Antibiotics 9

10 UNICEF Procurement Process - GENERAL Requirement Definition Sourcing/Invitee list Solicitation Documents Submissions Evaluation Adjudication & Internal Approvals Contract Finalization and Issuance Contract Management 11

11 ZIKV Dx: Requirement definition Accurate laboratory testing is key for differential diagnosis in areas of simultaneous transmission of different arboviruses with similar clinical presentations (endemic/epidemic) Need of novel diagnostic assays can distinguish Ab response elicited by ZIKV from that of related Arboviruses Testing at Point-Of-Care enable efficient integrated in surveillance and screening country plans

12 ZIKV Dx: Demand Forecasting model Applies 5-year time horizon for ramp-up incorporating population growth effects Countries were classified in terms of likelihood to have a preparedness plan in place and ready to enroll the RDT/POC in country as: Likely, Probable and Possible according to the information we have from countries so far. Large Population - Less Likely category Uses scale-up matrix to determine incremental country introduction timing determined by likelihood of having a preparedness plan in place Need for two types of tests Serology and NAT 13

13 ZIKV Dx: Demand Forecasting model assumptions Target Group 1 Pregnant women and sexual partner 2 tests 35% coverage of target group (based on HIV RDT initial coverage rate) Additional targets Forecasting model: 1. Clinically diagnosed cases Microcephaly 1% GBS 0.5% Base case targeting assumptions 2. Travelers from area with ongoing Zika transmission 0.5% BASE CASE Combination of Target Groups 1 + Additional targets + Stockpile 2% + Wastage rate 5% 14

14 ZIKV Dx: Demand Forecasting model Country inclusion/exclusion African countries Countries located in West Africa sub region adjacent to those currently reporting, having the Aedes vector and facing the Latin American coast: Benin, Burkina Faso, Cameroon, Cape Verde, Equatorial Guinea, Gambia, Ghana, Guinea, Guinea-Bissau, Gabon, Ivory Coast, Niger, Nigeria, Senegal, Sierra Leone and Togo. Remaining countries in Africa within the vector belt presence: Angola, Democratic Republic of Congo, Madagascar, Mozambique, Zambia, Zimbabwe, and Tanzania. Other countries Cambodia; Papua New Guinea; Philippines; Bangladesh; Nepal; Sri Lanka, Viet Nam and Indonesia. 15

15 ZIKV Dx: Procurement Goals Goal: ensure access and availability of affordable, quality assured, diagnostic testing at point of care (POC) ZIKV products by supporting the development of novel devices, creating a healthy and stable market two novel products by 31 December following appropriate regulatory approval. Secure access to affordable prices Novel financing mechanism: use of an Advance Purchase Commitment (APC). demand and scale up is informed and driven by integration of ZIKV diagnostics into countries testing algorithms driving the market towards novel diagnostic assays capable of distinguishing ZIKV infection from that of related flaviviruses 16

16 ZIKV Dx: APC UNICEF has been working with USAID to put together an Advance Purchase Commitment (APC): - UNICEF has secured $10 million to guarantee funded off-take starting in APC to accelerate and de-risk suppliers entry into the market improved commercial terms for UNICEF and global community 17

17 ZIKV Dx: Timeline Date Activity 19 December st Procurement Reference Group (PRG) Webinar 9 th February st Request For Proposal (RFP) Issuance 7 th March st RFP closing date 7 th June 2017 Initial 1st call-for-offers discussion with PRG End June 2017 July-September Mid May 2017 August 2017 September 2017 October 2017 Initial awards to suppliers Field evaluation of first round Dx 2 nd RFP pre-meeting with PRG 2 nd RFP Issuance 2 nd call-for-offers discussion with PRG 2 nd call for offers awards to suppliers 18

18 ZIKV Dx: Innovation challenges Immediate need Real time innovation Regulatory requirements QMS New IVDR regulation END of PHEIC impact on EUAL QA/: Lot to lot variation Validations of developers claims National lab capacity Field evaluations Prevalence and incidence (epidemic vs endemic geographic circulation) Species and strain variability Ab Assays with differential diagnosis Sensitivity and specificity POC vs near medium complexity test (definition of enduser) Patient characteristics Availability of specimen banks for test development and validation (well characterized reference panels) Sustainability of business model for manufacturer

19 Thank You!