European Investment Bank
Considerations on the financing of
future TB Vaccine Development
Thomas C. Barrett
TB Vaccines Third Global Forum
Cape Town, South Africa
27 March 2013
The Situation So Far
•
•
So far USD 600m spent and a lot of effort to develop a number of
promising TB vaccine candidates.
Funding has been provided primarily through grant funding, complemented
by some industry funding for individual candidates and a small amount of
equity.
Current Global TB vaccine portfolio:
1 clinical candidate in 2000; 15 candidates tested in clinical trials to date
12 clinical trials currently underway
More than 25 discovery leads and preclinical candidates
Efforts to diversify the portfolio underway
Down selection required to maximize the efficient use of resources and
streamline the preclinical portfolio
Lessons learnt from historical trials offer key insights into the biology of
tuberculosis informing development efforts
Clinical trial capacity and expertise to run large-scale efficacy trials
Improved knowledge around biomarkers and correlates of protection
informing on vaccine design and animal models
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The Opportunity for Global Collaboration
•
This health crisis presents us with an opportunity to collaborate differently
as well as a challenge.
•
We can carry on as we are, spending scarce resources on increasingly
expensive clinical trials on individual vaccine candidates, hoping one will
succeed,
•
…or we can work together, pooling our resources, to make objective
decisions with the aim of getting to our goal of at least one effective TB
vaccine, cost effectively, as soon as possible.
•
The key difference between these approaches is that of partnership
between the public and private sector entities capable of collaborating
together in the common interest. The necessity for partnership is
increasingly evident both from the scale of the medical challenge;
technological risks and uncertainty and the need for prioritization of public
and private sector resources in response to prevailing constraints.
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Invitation to Global Collaboration
•
The IP holders are invited to share their knowledge, learn from the failures
of others and work together to develop the best candidates.
•
The Funders are invited to work together and fund the best candidates.
•
Industry is invited to prepare for the production and distribution of the
successful candidate(s).
•
The Public Health Authorities are invited to support this approach by
demonstrating their commitment to implementing a comprehensive TB
vaccination programme when the successful candidate is launched.
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Overview of Possible Funding Solutions
Average cost/development
stage (can
include
multiple
Average cost/development
stage (can include
multiple
clinical
trials)clinical trials)
$8M
Discovery
$10m
Preclinical
PUSH MECHANISM
GRANTS*
• European Commission
− EDCTP (Phase 2a)
• Netherlands - DGIS
• UK-DFID
• Bill & Melinda Gates Foundation
• NIH
PARMA COST –SHARING
* Top 5 donors listed provide more than 80% of
the funding for TB vaccine R&D globally
Phase 1/2a
$30m
$150m
Phase 2b
Phase 3
PHARMA COST-SHARING
GRANT COST-SHARING
• EDCTP
• Donors channeled through
portfolio manager
STRATEGIC STAGE- BASED
DEBT/EQUITY
• Debt financing with/without
guarantees in the later phases
of development as part of a
well-structured pull
mechanism
• Late-stage equity fund (impact
investors)
Note: The closer to
commercialization the debt is
utilized the lower cost of capital
Dependent of
market strategy
Commercial
PULL MECHANISM
MARKET ENHANCING
MECHANISMS
• Validate the market potential with
key EU MS and other HIC/UMIC
through a pre-AMC like mechanism
utilizing a pre-defined targeted
product profile)
• Debt finance for the commercial
manufacturing scale-up
• Debt finance to governments in
support of comprehensive TB
vaccination programs
• Establish robust, evidence-based
national health economic data to
facilitate vaccine adoption
• WHO and national/regional
regulatory strategies to facilitate
rapid adoption and scale-up
• GAVI & other donors commitment
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Next Proposed Steps
The Collaborative Partner will engage with the wider stakeholder community
to:
 Continue regular exchange with key IP owners/industrial partners (bilateral
meetings and industry roundtables);
 Present the business plan to major donors and funders;
 Engage the broader scientific community to test the assumptions in the
business case;
 Vet various push and pull mechanisms with major IP owners and vaccine
manufacturers to optimize alignment;
 Validate the market among various high- and upper middle-income
countries within the EU and other regional countries;
 Assess year-over-year (YOY) portfolio funding needs and identify
investment strategies to close gaps;
 Refine the business case to include key stakeholder feedback.
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Contacts
Thomas C. Barrett
Director
Advisory Services Department
Tel: +352 4379 87006
Email: t.barrett@eib.org
Shiva Dustdar
Head of RDI Advisory
Advisory Services Department
Tel:+352 4379 87316
Email: s.dustdar@eib.org
John Davis
Head of Division
Project Directorate
Tel: +352 4379 88586
Email: j.davis@eib.org
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