Transcript Draw-down fund: the concept

Funding neglected disease drug R&D:
The Industry R&D Facilitation Fund
(IRFF)
Dr M Moran
[email protected]
Pharmaceutical R&D Policy Project
The George Institute for International Health
March 2006
Neglected disease R&D: An active field
• 63 neglected disease drug
projects (end 2004)
• Translates into 8-9 new
neglected disease drugs
by 2010
• 3 new neglected disease
drugs registered since
2000
The main players
• This R&D activity involves public groups, Public-Private Partnerships, big
and small companies, Contract Research Organisations and academics
• The bulk of R&D activity is driven by PPPs who now conduct 75% of all
projects
• It is happening outside government policies and incentives and largely
without government funding
Performance metrics (1)
• Health value:
Public-private partnering delivered the highest health value products
12 of the 13 neglected disease products under the industry-alone model had a low
overall health value to developing country patients
3 of the 8 “partnered” products developed between 1975 and 2004 had a major
health impact e.g. halved global burden of river blindness in 10 years
•Levels of breakthrough innovation:
 8% of industry finished products before PPPs
 63% of projects now conducted by Industry under the partnered approach
 Half of all PPP projects
• R&D cost:
The PPP approach is significantly cheaper than industry-alone approaches e.g.
under $12 million from lab bench through to Phase I trials for synthetic peroxide AND
$35 million to registration
Performance metrics (2)
Drug development timelines
Industry
PPPs
MMV projects
DNDi projects
TDR projects
TB Alliance projects
Correlates of success
Our analysis shows that:
•
The correlates of successful drug R&D are:
 A sole focus on neglected disease drug development
 Early public involvement
 Early industry involvement
 Management with an industrial mindset and experience
 Adequate funding
•
The PPP framework performs best because overall it most closely matches
these correlates
(Public + Industry + Neglected Disease focus)
•
•
But within this framework PPPs performance varies corresponding
to how closely they match the correlates of success
The two key factors in performance variability were:
–
Level of funding
–
Level of industry input
A solution to these gaps: the IRFF
•
Based on this information, we designed an incentive to:
– Support the best framework (PPPs)
– Address the two key gaps within this framework
• Funding
• Industry input
Industry R&D Facilitation Fund
•
a proposed long-term public fund to specifically fund industry involvement
in PPPs
•
Industry incentive NOT a direct PPP funding mechanism
IRFF: A simple 2 - step process
How it works:
IRFF
1. PPPs contract industry
deals as they do now
PPPs
PPPs
Their funds are depleted
restricting their ability to
sign up new projects
2. The IRFF subsequently
reimburses PPPs for
payments they have
already made to industry
(80%?)
MNCs
CROs
SMEs
IRFF impact
IRFF
IRFF
Increased cash flow allows
PPPs to:
 Do more deals with
industry
 Be more viable long-term
company partners
PPPs
A stronger and more efficient
R&D framework
CROs
MNCs
MNCs
SMEs
CROs
SMEs
CROs
DC
SMEs
Academic
Translation
The cost of the IRFF
• Average US $7 million/year per OECD country to subsidise industry input into all
PPP neglected disease drug R&D to 2015
• Average <$140 million/year until 2010 – plateaus at average $200 million/year
•IRFF would cover up to half of total PPP costs (industry R&D component)
Why the IRFF (1)?
•
Funds and strengthens an active successful model rather than
setting up another new approach
•
The proposal is:
– Based on real-life data, projects, budgets and business
models
– Developed in close consultation with industry and PPPs as
to their needs
• “Jam today not jam tomorrow” for industry
• Addresses funding and performance gaps for PPPs
Why the IRFF (2)?
•
Addresses government needs:
– Feasible amounts
– Simple
– Reduces public risk
– Rapid developing country health returns for the public
investment
– Maximises value for government funding
• Funds the most effective approach (PPPs)
• Further improves performance within this approach
– Provides independent centralised information for donors
– Supports academic translation (and potential spin-offs)
– Widely supported by stakeholders
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