Public sector-private sector partnership

							Stakeholders meeting for priority medicines
         for Europe and the world
    Role of Public Private Partnerships
             4 October 2004
                Brussels

       Dr. Frans Van den Boom, MBA
         Executive Director Europe
                     Global Problem
   High incidence and prevalence of infectious diseases in
    developing countries
   Enormous impact (life expectancy; economic growth; security
    threat)
   Market mechanism works: no private sector investments in
    absence of a market
   Insufficient product development efforts for poverty related
    diseases
   15 – 20 year delay before products are made available for poorest
    countries
                          •>70 million HIV infections
                          • >28 million AIDS deaths

                                  •0   cured
                  • 14,000 new infections/day, >95% in
                            developing world
                       The world needs an AIDS vaccine

Photos by WHO/UNAIDS
        World Impact
By the year 2050 the world will have

      480 million less people

as a result of the AIDS epidemic…
Opportunities and challenges in global
                health
             New Interest in Global Health
   Window of opportunity
       United Nations: Security council, Commission on Macro Economics and Health, UNGASS,
        Priority Medicines
       Global Fund
       G8
       EC Plan of Action on Poverty Related Diseases
       President’s Bush 18 b initiative
       Increase in # PPP’s
       Increased industrial interest and involvement
       Increased resources (public and private, notably BMGF)
       Increased involvement of developing countries (e.g. EDCTP)
   Health not defined only in technical terms, but also in terms of:
       Economics
       Moral / Humanitarian imperative
       Security issue
       Development issue
   Global Health as well as global health interventions defined as global public goods
       Repositioning of private and public sector
              Challenges in global health
   Too little effort to tackle developing countries problems (90-10 gap, market
    mismatch)
   Lack of infrastructure in developing countries
   Too little involvement of developing countries
   Emphasis very much on treatment
   Insufficient resources
   Competing priorities (bio-terrorism, SARS)
   Sustainability of effort (GAVI, GF, CVF, PPP’s)
   Unease between public and private sector
   Humanitarian imperative vs business imperative
   No global health R&D funding mechanism
   Uncoordinated effort and counterproductive competition (national/regional vs
    global)
   Lack of political will
AIDS vaccines account for less than 1%
of total global spending on health R&D

                            AIDS vaccine R&D
                           US$540-570 million




Total health-related R&D
     US$70 billion+
      Estimated Worldwide HIV Expenditures*
                               (2002 in Millions of Dollars)
                                                   Basic research, therapeutic
                          Prevention
                                                   & other          Research &
                                                                   Development
                                                                     20-25%
   Prevention &
   Care 75-80%                                            Vaccines $540-570 M
                                                          (LDC effort <$40–50M)


                       Care

                              Global Total = $20+ Billion
* Source: IAVI estimates & AIW II
    Global Expenditures on HIV Vaccines
             (Success or Failure?)

                          1994        2002
 Product                 $ 20 M    (?$ 70-90 M)
 Development
 Developing              $ 1-2 M   (?$ 40-50 M)
 Country Specific
 Total                   $ 125 M   $ 540-570 M


Source: IAVI Estimates
               Challenges (continued)
 PD is expensive (~ US$ 800 million)
 Science is complex: high risk investments
 Numerous IP challenges (e.g. Numerous broad
  ‘umbrella’ patents and vaccine component patents;
  Stacking of patent royalties)
 Access issues (Pricing, Financing, Manufacturing, Delivery,
   Acceleration of regulatory consideration, Provision of non
   negligent liability protection )
 Decreased attention for vaccines (global market for
   drugs:            $ 450 billion
   for vaccines:     $ 6 billion)
   Low
                                    Mening A/C
                                                                                  Rotavirus
                                                                                  Pneumo
                                Probable Orphans                 Market Product
                               Low Risk-Low Return             Low Risk-High Return

     Scientific Complexity




                                   Orphan Zone                   Possible Product
                               High Risk-Low Return            High Risk-High Return


                                                 *   Malaria   TB, AIDS

                                                                                  Cancer
                                                                                Therapeutic
                             Hookworm,
                              Schisto
    High


                             Low            Market Attractiveness                    High
                                         (Based on Developed Country Markets)


Source: MVI, Patricia Atkinson Roberts
A modern vaccine is protected by multiple levels of IP
  licensed from multiple partners


                     Platform/
                     process
    DNA seq   Expression    Antigen              Delivery device




                                       vaccine
                Vehicle
                           Adjuvant
              Immunostim

                           Excipient

  Source: Martin Friede, WHO
PPP as mechanism to address problems:
        Necessity of new mechanisms
 Market Issue: Private Industry doesn’t have the
  incentives; but needs to be included as they have all of
  the skills
 Public sector is best at funding “R” rather than ”D” and
  is often national in its outlook
 UN agencies do not have the flexibility/agility to
  rapidly move with different corporate partners
 Response has to be global: engaging the world’s best
  scientists, companies, testing sites
   Global Product Development Public
      Private Partnerships in Health
 Partnerships seen as the way to overcome market
  and government failure
 Interest in experimenting with partnership
  strategies and mechanisms that might overcome
  these failures to produce global public goods
 Global advocacy has resulted in more € from
  public sector and legislative proposals to
  promote R&D (tax incentives)
  The Road to an AIDS Vaccine




        iavi
                                                                International
       Pilot                                    Phase           clinical trials
       manufacturing                            I/II            infrastructure

Vaccine Design                Regulatory                Process
                              affairs, QA, QC           development        Scale-up
                       Project                                             manufacturing
                       management
             Product Development PPP’s
   Multi-candidate/portfolio approach
   Focus on translational research: translate basic research discoveries into
    products that can be tested in humans
   Bring industrial expertise into the public sector and small biotech (QA/QC;
    regulatory expertise; process development and manufacturing; project
    management; GLCP; GMP; data management; IP management; business rigor
    to cancel struggling projects early)
   Primary objective: public health rather than commercial goal
   Want to get there as fast as possible, without compromising safety
   Not tied to any one company: interface with other organisations in the R-D-A
    continuum
   Have a global perspective
   Work with developing countries and build sustainable capacity
   Focus on product development, manufacturing and access
      Industrial involvement in IAVI
                programme
 Targeted Genetics (rAAV)
 Bioption (SFV)
 Therion (MVA)
 IDT (MVA)
 Berna (salmonella)
 Cobra (DNA)
 Crucell (Adeno)
                      IAVI R&D Team
Project Management       GSK, CSL, Aventis,


Business Develop. &      Hale & Dorr, Holland & Knight, Merck,
Strategic Planning

Research & Design        NIH, Scripps, Penn, Cornell, Oxford, Harvard

                         Wyeth, Connaught, GSK, Merck
Development & Mfg.

Medical Affairs          Aviron, Aventis, Chiron,VaxGen, Merck


Regulatory Affairs       FDA, EMEA, WHO, Biologics Consulting,
                         GSK, Wyeth, Genetics Institute
                       Mechanism Proven

   7 Vaccine Development Partnerships
   5 vaccines into the clinic in five years (5x5)
   Clinical trials in 9 countries
   Quality across all sites: network of accredited labs
   Development of sustained capacity in the South
   Prioritise and stop programmes on basis of data
   Full participation of affected communities and DC’s
   Developing countries can deliver excellent work
   Strong support for AIDS vaccines from 8 OECD governments
   Increased political leadership in North and South
   All was done with small amounts of money

                    Optimising strategies
   Long-term commitment to a systematic problem-solving agenda
       Redundancy of similar candidates needs to give way to cooperative
        selection of better candidates
       Attack basic issues in vaccine research through cooperative approaches
       Creative mechanisms linking basic research scientists with vaccine
        designers - Multidisciplinary involvement
       Increase resource intensity to quickly get generally useful clinical data
   Frame of reference in order to make resource allocation decisions
    (e.g. public health impact, absence of market, scientific
    complexity, availability of other effective preventive
    interventions): Priority Medicines report, Copenhagen Summit
   Full involvement of developing countries
                        Implications
   Effort has to be programmatic (e.g. Malaria Vaccine Initiative,
    International AIDS Vaccine Initiative)
   Create mechanisms that facilitate global health R&D
   If the rules don’t allow for it, change the rules
   Willingness to pool resources and knowledge and stimulate
    global co-ordination (NIH, ANRS, MRC, DG Research, Global
    Vaccine Enterprise etc.)
   IP should not be a barrier for vaccine R&D and delivery to
    developing countries
   Industry willing to share technologies if roadmap for effective
    vaccine is designed
   A vaccine that is not used is meaningless: think through access
    issues now!
             Implications for Europe
   Accept differentiation between solving a global health problem
    and strengthen European competitiveness
   Accept the fact that PD PPP’s are adding value
   Act accordingly - Create mechanism for translational research
    that also would be accessible to global PD PPP’s as well
   Take responsibility in closing US $ 1,2 – 2.2 billion gap by 2007
   The time is right now: Technology Platforms for Innovative
    Medicines and Chemistry; 7th framework, EDCTP, 3% target
   Create a better European infrastructure through structural funds
    (and not through funds for development cooperation)
   Consortia and consensus  quality, evidence, effectiveness and
    efficiency
   Make more money available: long term programmes
      Preliminary Estimates 2002: Funding by Sector

Estimated Total Spending: $540 – $570 million
                             Public Sector:
                 Biotech        Europe        Public Sector:
                                               Other/ non-
           Pharma 7%              6%
                                               Europe/U.S.
             14%
                                                   3%
   Foundations/
   Private donor
        1%
                                                Public Sector:
 Public Sector:                                   U.S. NIH
  Other U.S.                                         59%
      8%
The best time to plant a tree
   was twenty years ago.
   The next best time is
   today

   African saying