Demand forecasting and market considerations - · PDF file•Target product profile •Expression of Interest, ... (Sanofi, GSK, BioManghin, Pfizer, ... Uses scale-up matrix to determine

Demand forecasting and

market considerations

New and Innovative Approaches to Laboratory Diagnosis of Zika, Dengue

and other Arboviruses Workshop MAY 2 – 4, 2017 ANNECY

Overview

• Introduction to UNICEF-Supply Division

• ZIKV Dx Market shaping through Innovation

– UNICEF procurement process

• Challenges

Executive Director

Programme

Programme

Emergency

Partnerships

Public Partnerships

Private Fundraising & Partnerships

Communication

Data, Research & Policy

Management

Human Resources

Finance & Admin

Management

IT Solutions & Services

Field Results

Supply

Regional Offices

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$3.428 billion in supplies and services

Critical functions of Supply Division

• 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

Supply Function 2030 Scale & Equity

UNICEF programmes System Strengthening Markets for Children

Emer-

gencies

Service-

delivery

Procure-

ment

Services

Capacity

Building

Product

Inno-

vation

Influencing

Markets

Efficiency, reliability Sustainability & Ownership Global responsibility & impact

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

Influencing markets

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

What?

Analyze and set targets

• Availability• Quality• Affordability• Sustainability (including local production)

• Innovation

Product development

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

Product Innovation Project Pipeline

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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.) E: RDTs (4 in 2015), labs-PCR M: ELISA,PCR

E-M: 4 candidate vaccines under trial for WHO PQ (Merck product – under EUAL registration)

E: 4-5 candidates under study, & serum treatment M: Palliative care

SARS/MERS-CoV (v.) SARS: Chest x-ray, ELISA, PCR, IFA MERS: PCR

MERS: antivirals being studied

Zika (v.) RT-PCR (w/in 5 days of symptoms)

No cross-protection seen with new Dengue vaccines

Avian/Pandemic Influenza (v.)

RDT, PCR, IFA Flu platform available from seasonal influenza

Cholera (b.) Rapid dipstick (in pre-qual), PCR

2 vaccines WHO PQ ORS, IV, antibiotics (when necessary)

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

Antibiotics

Polio & vDPV (v.) Viral culture, Serology, RT-PCR

Multiple vaccines activated/inactivated, oral/injected,

salk/sabin, type1-2-3; WHO PQ

Yellow fever (v.) ELISA (conf. 6-10 days after illness)

Vaccines WHO PQ Palliative care

Dengue/Chikungunya (v.)

D: RDT, RT-PCR, ELISA CH: PCR, ELISA

2 Dengue vaccines being reviewed for WHO PQ (Sanofi-2016; licensed by Brazil; Takeda-2017)

Palliative care

Crimea-Congo Hemorrhagic Fever (v.)

RT-PCR, ELISA Old vaccine used in Bulgaria; candidate vaccines by Erciyes (Turkey) pending FDA review

Serum treatment under study in Turkey (Refik Saydam Health Institute)

Lassa Fever (v.) ELISA, RT-PCR Candidate vaccine under study by USAMRIID

Ribavirin gives potential interference

Leptospirosis (b.) RDT, ELISA, PCR, Culture Doxycycline is prophylaxis Vaccines avail in Cuba & China

Antibiotics

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 (v.)

RDT (A, B detection), RT-PCR Seasonal vaccines WHO PQ

Typhoid Fever (b.) RDT, PCR, ELISA, Culture Two vaccines WHO PQ; Oral- 62-77% effective (Crucell); Polys- 50-80% (GSK,

Sanofi).

Antibiotics

• 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.

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

UNICEF Procurement Process - GENERAL

• Requirement Definition

• Sourcing/Invitee list

• Solicitation Documents

• Submissions

• Evaluation

• Adjudication & Internal Approvals

• Contract Finalization and Issuance

• Contract Management

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• 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

ZIKV Dx: Requirement definition

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

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ZIKV Dx: Demand Forecasting model assumptions

Forecasting model: Base case targeting 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

1. Clinically diagnosed cases Microcephaly 1% GBS 0.5%

2. Travelers from area with ongoing Zika transmission 0.5%

BASE CASE

Combination of Target Groups 1 + Additional targets

+ Stockpile 2%

+ Wastage rate 5%

ZIKV Dx: Demand Forecasting model Country inclusion/exclusion

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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.

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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

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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 2017

- APC to accelerate and de-risk suppliers’ entry into the market improved commercial terms for UNICEF and global community

ZIKV Dx: Timeline

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Date Activity

19 December 2016 1st Procurement Reference Group (PRG) Webinar

9th February 2017 1st Request For Proposal (RFP) Issuance

7th March 2017 1st RFP closing date

7th June 2017 Initial 1st call-for-offers discussion with PRG

End June 2017 Initial awards to suppliers

July-September Field evaluation of first round Dx

Mid May 2017 2nd RFP pre-meeting with PRG

August 2017 2nd RFP Issuance

September 2017 2nd call-for-offers discussion with PRG

October 2017 2nd call for offers awards to suppliers

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

Thank You!