Funding Full Development of the Emerging Pipeline in Tb - PowerPoint PPT Presentation

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Funding Full Development of the Emerging Pipeline in Tb

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Title: Novartis Commitment to Neglected Diseases NITD Author: herrlipa Last modified by: MSFUser Created Date: 4/7/2008 5:34:10 AM Document presentation format – PowerPoint PPT presentation

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Title: Funding Full Development of the Emerging Pipeline in Tb


1
Funding Full Developmentof the Emerging Pipeline
in Tb
  • Paul L Herrling
  • Head of Corporate ResearchNovartis International
    AG
  • Geneva, 11 April 2008 MSF

2
THE DRUG DISCOVERY PROCESS phases
target validation
PhII-IV
D4
D3
D2
D1
D0
PhI
O
D0 basic science target discovery D1
assay development HTS high throughput
screening D2 HTS ligand finding
proprietary libraries, commercial
libraries D3 lead optimization medicinal
chemistry animal models
D4 final preparation for human testing,
PK,ADME, tox, PhI Proof of concept/mechanism
in man tolerance in human PhII-III dose
finding, efficacy, registration
studies PhIV post marketing studies
3
Historic funding has built a portfolio that is
moving towards clinical trials
Historic funding . . .
has created the pipeline of today
RD Funding Received PDPs (USD M)
PDP Compounds by Disease including industry
447
12
Private Entities 3
Chagas
450
HAT
Malaria
VL
TB
400
Gov 21
VL
HAT
350
9
TB
Chagas
8
Clinical funding needs
Other
300
250
200
5
5
Private Non Profits
76
4
4
150
Malaria
100
1
50
2

1
1
1
0
1999-2007 - by disease
1996-2005
Preclinical D4
Phase 1
Phase 2
Reg
Phase 4
Early stage D0/1
Lead id D2
Lead op D3
Phase 3
Chagas, HAT VL are sourced from DNDi through
2006 Does not include IOWH Some projects have
not been included in graph due to uncertainty of
stage in pipeline Sources DNDi Business Plan,
"Independent Review MMV" DIFID, MMV Annual Report
2006, Focus on Finances MMV.org The New
Landscape of Neglected Disease Drug Development,
Wellcome Trust (2005) "TB DRUGS Where We Are
Today, The Vision For Tomorrow" CEO GATB (Jan
2007) WHO Draft Global plan of action on
public health innovation and intellectual
property (August 2007)
4
THE DRUG DISCOVERY PROCESS phases
target validation
PhII-IV
D4
D3
D2
D1
D0
PhI
O
not financed EXPENSIVE
Existing pipeline, already financed
5

Funding needs drugs - Underestimate
Funding needs for Neglected diseases RD drugs
2008-2017 USD B
Total 10.3
4.4
5.9
100
1.1
Other diseases 2.0
90
0.9
80
0.4
HAT/ VL/ Chagas 0.6
0.2
70
0.4
1.3
Malaria 1.7
60
50
40
2.9
30
3.1
TB 6.0
20
10
0
Discovery
Development
Sources Global plan to stop TB 2006-2015
Tuberculosis research and development a critical
analysis, Treatment Action Group MMV financial
plan DNDi Business plan 2007-2014 The new
landscape of neglected disease drug development,
Wellcome trust How much does it cost to develop
a new drug? Biomedical Industry advisory group
Dalberg interviews and analysis
6
Portfolios are fragmented across players even
in key diseases

54
5
39
16
12
3
3
Public
100
Novartis
Public
90
Public
Public
GSK 1
Public 2
80
Public 24
Sanofi-aventis 5
TDR 1
GSK 1
Pfizer 1
70
TDR 2
  • Fragmentation between Industry Public, and PDPs
    for malaria and TB
  • Fragmentation between public and PDPs for smaller
    diseases

TDR 1
60
Sanofi-aventis 1
Pfizer 1
50
Astrazeneca 3
40
MMV 24
DNDi 11
Other 12
DNDi 6
30
DNDi 3
TDR 1
20
IOWH 1
GATB 11
10
Public Only
DNDi 2
IOWH 1
IOWH 1
Industry Only
0
PDPs
TB
Malaria
Chagas
HAT
VL
Other
Dengue
Notes Number of public projects is estimated
based on interviews and research Surface area
does not depict size of projects, which vary
significantly by stage of discovery and
development Source The New Landscape of
Neglected Disease Drug Development, Wellcome
Trust (2005) TB Alliance Portfolio.ppt (October
2007) (www.ifpma.org/clinicaltrials) Industry
RD for Diseases Primarily Affecting Developing
Countries (company response to IFPMA survey)
Working Group on New TB Drugs (Oct 2006)
7
Improved management of the neglected disease
portfolio a key challenge
  • The emerging portfolio of neglected disease
    compounds is fragmented across PDP, industry and
    public entities with limited or no coordination
    and oversight
  • Improved approaches to portfolio management will
    be key to making the case for the expanded
    financing. The techniques and experience of
    pharmaceutical companies will be key in this
    respect
  • Prioritization of funding across diseases is
    going to be necessary, even in a scenario with
    sufficient funding. This is politically sensitive
    area, some donors are hesitant to delegate this
    responsibility
  • The portfolio management challenges are still
    less well recognized among the product
    development partners. However, there is a broad
    support for continuing to work through these
    partnerships

8
FUND FOR NEGLECTED DISEASES RD
Board strategy, diseases, tools Funders
current new ie BMGF, WT etc plus Developed
countries governments as well as Developing world
governments
royalties, milestones

Portfolio management Team Medical, Scientific,
Technical Professionals
(fund only to next go/no go decision)
money for development to next stage
projects and exclusive licenses to neglected
disease
Academia
PPPs
Industry
IP
In case of profits made using data paid by fund
9
Alternative model Neglected Diseases Fund
  • 1. Create a major pool of funds by mechanisms
    similar to Global Fund, GAVI, International
    Finance Facility fed by Governments, both of
    developed and developing world (latter must
    contribute as they are responsible for the health
    of their citizens ), charities (Welcome, BMGF,
    others)
  • - Major problem might not be finding money but
    how to make it efficiently available to entities
    discovering and developing medicines for
    neglected diseases
  • 2. Establish a portfolio management committee
    nominated by funders but fulfilling stringent
    professional criteria. Their task would be to
    evaluate submitted projects and fund the selected
    ones to the next decision point in development
    (phase transitions), monitor the progress and
    make funding decisions for next phases as well
    decide development strategy
  • - This is identical to the process currently used
    in Pharma, the same decision criteria
    (scientific, technical feasibility, medical need,
    target product profile etc.) should be used with
    the exception of commercial viability.

10
  • 3. Companies alone or in conjunction with PPPs
    who want to access these funds would protect
    their IP (see why below) BUT would legally and
    bindingly commit to make their products available
    at cost for poor patients and where no markets
    exist as a condition to obtain funds from the
    pool (exclusive license to fund)
  • 4. Wherever markets allowing returns for these
    products emerge as is eventually to be expected,
    WHOEVER sells the products in these markets will
    commit to pay royalties on those sales back into
    the pool for refinancing if they used Fund
    financed data. The IP protection mentioned above
    is needed to allow this mechanism as it
    incentivises and protects the innovators'
    investment (including the pool entity)
  • This mechanism might address the gray zones
    where the current returns are insufficient today
    for big Pharma to invest, but that do need big
    Pharma contributions

11
Neglected Diseases Fund Model
  • This draft of a model might be sufficiently
    attractive to Pharma companies as some of them
    have already shown their interest to contribute
    to the access to medicines problem. It does not
    threaten the IP protection essential for
    innovation. This model would remove a major
    hurdle to their investment in the RD of
    neglected diseases, short term they would gain in
    reputation by contributing, long term (very) new
    markets may emerge
  • This model might be combined with others such as
    advanced market commitments, for late stage
    developments e.g a vaccine /medicines in late
    Phase 3 clinical trials

12
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