Incentives for Global Health R&D:
Perspectives from BIO Ventures for Global Health (BVGH)
Open Forum of the CEWG on
Research and Development
6 April 2011
Melinda Moree, PhD
Chief Executive Officer of BVGH
Overview: BVGH and Global Health Incentives
 BVGH works to create an enabling environment for the biopharmaceutical
industry to engage in global health R&D
 Connecting innovators with critical information and resources for R&D:
o Administrator of Pool for Open Innovation against Neglected Tropical Diseases
o Recently launched Global Health Primer connects innovators to key R&D issues
 Assessing and developing R&D incentives:
o Participating in design and advocacy for current incentives (Pneumo Advance
Market Commitment, FDA Priority Review Voucher)
o Developing new milestone-based prizes for global health R&D
 Learning from past models – and advancing new solutions – is critical to
harnessing the power of market-based incentives
What Have We Learned From Incentives?
 Few examples to learn from: Purchase Funds (GAVI & GFATM), AMC, PRV,
Market Consolidation (JE vaccine & MenA vaccine)
 Industry will engage in incentives. Challenging to know if they are
“incentivized” or are participating in good faith efforts by public sector.
 Purchase funds and market consolidation activities focus on improve access
and also to incentivize R&D (indirect benefits).
 Clear, transparent and credible mechanisms are essential to success (AMC vs.
PRV).
 Must know the target of the incentive and propose solutions that fit with their
business model. Talk to industry early and often (AMC vs. PRV).
 The public sector can incentivize the private sector through organizing itself to
be a good partner e.g. JE vaccines
 The details matter. Few incentive mechanisms have companion analytics.
 Different problems call for different solutions. The economics and scientific
challenges posed by the specific innovation gap are critical considerations. No
silver arrow—need a full quiver.
Potential Milestone-Based Prize: POC Fever Diagnostic
 Urgent Need:
o Nearly 3 million children under five die annually from malaria, bacterial pneumonia
o Significant number of these deaths could be avoided with timely, accurate diagnosis
 Dx Funding Situation:
o Critical need for investments in diagnostic R&D for neglected diseases
o Diagnostics receive less than 4% of total neglected disease R&D funds
 Potential Solution:
o Point-of-care diagnostic for differential diagnosis of fever
o Tool could save 350,000 lives annually and help curb antibiotic resistance
 Benefits of BVGH Incentive:
o
o
o
o
Cultivates leading Dx innovators, many of which have signaled interest
Offers opportunity to engage emerging market biotech sectors (India, Brazil)
Provides cost-effective framework for product development and access
Model can be used for additional products in the future
Target Product Profile for Point-of Care Fever Dx




TPP ensures end product is
accurate, inexpensive, portable,
easy to use, durable
Externally validated by 80
leading global health and
industry stakeholders
Rigorous specifications ensure
donors only pay for a product
that is effective in resourcepoor settings
TPP provides ‘minimal’ and
‘optimal’ scenarios for
developers
TPP Highlights
Spec
Optimal
Minimal
Goal of Test
Differential diagnosis of the cause of fever for treatment, including in
children <5
Sensitivity
P. falciparum – 95%
P. vivax – 95%
Streptococcus pneumoniae – 95%
Staphylococcus aureus – 95%
Haemophilus influenzae B – 95%
Supplemental pan-bacterial marker(s)
that, in combination with pathogenspecific markers above, can identify all
bacterial pneumonia with an overall
sensitivity of 95%.
Supplemental pan-viral marker(s) –
Best in class
Tuberculosis – Best in class
HIV – Best in class
P. falciparum – 90%
P. vivax – 90%
Streptococcus pneumoniae –
90%
Staphylococcus aureus – 90%
Haemophilus influenzae B –
90%
Supplemental pan-bacterial
marker(s) that, in
combination with pathogenspecific markers above, can
identify all bacterial
pneumonia with an overall
sensitivity of 90%.
Specificity
Each individual pathogen above, 85%
Each individual pathogen
above, 80%
Specimen /
Sample
One of the following sample types:
blood, saliva, sputum, mouth swab, or
urine
One or more of the following
sample types collected in a
single patient visit: blood,
saliva, sputum, mouth swab,
urine
Time to result
<10 minutes
<30 minutes
Test/Platform
size
Handheld device;
<5 lbs / 100 tests
Portable device;
<10 lbs / 100 tests
$2-5
$2-5
Target ExWorks Price
Targets R&D Stage
A Milestone-Based Prize for Global Health R&D
Point-of Care Fever Diagnostic
Milestone 1: Proof of Concept
o 19 innovators enter; 15 pass
o 1.7 years
Milestone 2: Prototype Development
o 15 innovators enter; 3 pass
o 1.2 years
Milestone 3: Clinical Validation
o 3 innovators enter; 2 pass
o 3.3 years
Milestone 4: Regulatory Approval
o 2 innovators enter; two pass
o 0.3 years
RESULT: 2 POC FEVER DX THAT MEET THE TPP
BROUGHT TO MARKET
= Innovator Company
Figure 13: Size of Milestone Awards
Milestone Payments
$29.2M - 36.5M
Cumulative Time
Optimal TPP Award
$7.3M
Risk Premium
7.4yrs
7.1yrs
(Optional for
Optimal TPP)
Milestone Award
8
7
6
5
$14.6M
4
3.8yrs
3
2
$7.8M
$3.9M
1.7yrs
$14.6M
$3.9M
$3.9M
$3.9M
Milestone 1
Milestone 2
1
$0.3M
Milestone 3
0
Milestone 4
7
Source:
Alternate Pilot Project: New Drugs for Chagas Disease
 Urgent Need:
o 10 million individuals currently infected, 100,000 new cases each year in the Americas
o No drugs currently available to treat chronic infections (i.e. heart/organ damage)
 Funding Situation:
o Limited R&D resources are allocated to Chagas drugs, vaccines and diagnostics
o Total accounts for only 0.4% of total neglected disease R&D funds
 Potential Solution:
o New Chagas drugs need to be developed to treat chronic-stage infection
o Tools could alleviate significant health and economic burden (full impact study needed)
Incentives for Global Health R&D:
Perspectives from BIO Ventures for Global Health (BVGH)
Presented by Melinda Moree
Chief Executive Officer of BVGH
Open Forum of the CEWG on
Research and Development
6 April 2011
Snapshot of Pipeline
213 Products
•
•
•
•
•
61 Discovery (29%)
48 Preclinical (23%)
46 Phase I (22%)
47 Phase II (22%)
11 Phase III (5%)
105 Companies
• 23 Countries
• 41% in U.S.
• 11% Non-US, Non EU