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Push for greater R&D and
innovation in Africa

Solomon Nwaka.
ANDI Director a.i.
EAHIC London, March 26-27, 2013
Presentation to address following question!
• What is the potential & capacity for health product R&D and
innovation in Africa?

• How can we stimulate collaboration between local pharma
industry, academia and public sector?

2
Outline of presentation
• Landscape for product R&D and access for diseases that
disproportionately affect developing countries, esp Africa
• Health product/pharmaceutical R&D in Africa
• ANDI and other initiatives
• Summary & conclusions

3
Global landscape for product R&D and innovation
• PDPs, PPPs & dedicated industry activities
• Academia – screens, genomics, MedChem, ADMET
• Network and consortia based mechanism
• Government or intergovernmental effort
•

Open source & open innovation approaches

• Product access and procurement initiatives
• Funding from government & philanthropy
ANDI is presently the only product R&D coordination
mechanism operating on a pan African basis
4
'Innovation gap' remain: e.g. drugs

Nwaka et al. 2009

5
A global innovation framework for diseases that
'disproportionately affect developing countries'
• Global Strategy and Plan of Action on Public Health, Innovation and Intellectual
Property (GSPoA)
▪ Agreed by ALL countries in World Health Assembly Resolution 61.21
▪ Emphasise country level & regional innovation in developing countries
▪ Financing and coordination mechanisms being discussed
▪ www.who.int/phi
• Designed to promote:
▪ innovation
▪ build capacity
▪ improve access to innovation
▪ mobilize resources

6
Research and pharmaceuticals in Africa
• Africa home to medicines – traditional & herbal remedies
• Growing emphasis on pharmaceutical R&D, manufacture and capacity building
▪ AU Pharmaceutical Manufacturing Plan
▪ AMCOST Cairo Declaration of 2006, 'promote R&D and develop innovation
strategies for wealth creation and economic development'
▪ Algiers declaration on research for health 2008
▪ Globally competitive R&D institutions and SMEs exist
• But existing capacity not coordinated or leveraged to solve African health
challenges
▪ limited intra-African collaboration, limited capacity utilization
• Enhanced intra-African collaboration will boost North South/South South
partnerships
7
Increasing African R&D support but a more holistic
approach needed
• Multilateral Initiative for Malaria
▪ Provided small grants (MIM/TDR) but grant now discontinued
▪ Secretariat transferred to AMANET, Tanzania in 2005, now hosted Univ.
Yaoundé
• EDCTP
▪ Strong African engagement in management and governance (African office)
• Many agencies now fund direct to African institutions
▪ NIH, EU, Wellcome Trust, Gates Foundation, DFID/MRC…….
• Increasing number of African countries establishing research councils
• AU / NEPAD
▪ Direct engagement in fostering research and capacity building
▪ Local product and regulatory activities
ANDI responds to the need for coordination

9
Evolution and background of ANDI

10
ANDI establishment informed by landscape analysis

5
50
66
176

Country
visits

▪
▪
▪
▪
▪

Interviews
outside of
Africa

▪ Group interviews
▪ 1-on-1 interviews
▪ Phone interviews

Data
sources

▪
▪
▪
▪

Interviews
in Africa

▪ 1-on-1 interviews
▪ Focus groups
▪ Plenary sessions

South Africa
Nigeria
Egypt
Kenya
Burkina Faso

> 30,000 papers analyzed
> 1,500 clinical trials analyzed
> 160 African patents analyzed
> 120 pharmaceutical companies surveyed

Note: sources consulted included databases, institutional web pages and reports (foundations, PPPs, pharma companies)
SOURCE: Country visits, interviews

11
Lack of collaboration in Africa…HIV/AIDS research

Only 5% of articles are
in collaboration between
two or more African countries

SOURCE: Thomson Web of Science, UCINET

12
Good news - competency research centers exist

• Cities with 30 or more
articles published in the
2004 - 2008 period
• Total of 90 cities in 27
countries
• 16,647 biomedical articles
led by African authors
included in analysis

Note: Only top 40 cities by research output labeled
SOURCE: Thomson Web of Science

13
Potential downstream partners for product manufacture &
commercialization exist
Pharmaceutical manufacturing
Tunisia
Morocco

Algeria

Libya

Western Sahara

Egypt

Mauritania
Mali

Cape Verde

Sudan

Niger

Senegal

Eritrea

Chad

Gambia
Guinea
Bissau

Burkina
Guinea

Sierra Leone
Liberia

Djibouti
Central African
Republic

Nigeria

Ethiopia

Ivory
Coast

Uganda

Cameroon
Ghana

Benin
Equatorial

Togo

▪ Total of 129 companies
identified
▪ Most companies locate
to Egypt, SA, Nigeria,
Morocco and Algeria
▪ Estimated average sales
for identified companies
of ~USD 90 million/year

Guinea

Somalia

Zaire
Gabon
Congo

Kenya

Rwanda
Burundi
Tanzania

Malawi

Angola

Mozambique

Zambia

Namibia

Zimbabwe
Botswana

South Africa

Madagascar
Swaziland
Lesotho

SOURCE: OneSource, company websites, press searches

14
ANDI mission & vision
Mission Statement

"To promote and sustain African-led health product
innovation to address African public health needs
through the assembly of research networks, and
building of capacity to support human and economic
development"
Vision

"Creating a sustainable platform for R&D innovation
in Africa to address Africa’s own health needs"

15
Governance
• Hosting Agency
▪ Being transitioned out of UNECA

• Board
▪ Co-Chaired
– Minister of Health, Kenya
– Minister of S &T, S Africa
▪ 12 members with >75% from Africa
▪ WHO, AfDB & host agency

• Secretariat
▪ Operates through regional hubs

16
Viable projects exist in Africa- call for projects
implemented

Capacity for innovation exist in Africa but need to be coordinated for optimal result
Covers product R&D, manufacturing, commercialization

17
CoEs implemented through a rigorous process

Capacity for innovation exist in Africa but need to be coordinated for optimal result
Covers product R&D, manufacturing, commercialization
18
Approved CoEs, incl manufacturers
National Institute for Pharmaceutical
Research and Development
University of Ibadan

Institut Pasteur de Tunis
Theodor Bilharz Reseach Institute
Vacsera (2)
Vacsera Manufacturing

University of Lagos

National Center for Research
Joint Clinical Research Center

University of Bamako
Kumasi Center for
Collaborative Research
LaGray Chemical Co. Ltd
Noguchi Memorial Institute
for Medical Research
University of Buea
Institut de recherches médicales et
d'études des plantes médicinales
African Institute of Biomedical
Science and Technology

Makerere University
KEMRI Production Unit
Institute of Primate Research
Kenya Medical Research Institute
Kenya Agricultural Research Institute
Kilimanjaro School of Pharmacy
University of Zambia
University of Mauritius

Stellenbosch University (2)
The Biovac Insttute
University of Cape Town (3)
IThemba Labs
South African Medical Research Council

Botswana Vaccine Institute
Council for Scientific and Industrial Research
IThemba Pharma
University of Witwatersrand (2)
19
CoE mapped around value chain - DRUGS

Product
Value Chain

Research
& Development

Clinical Studies
to Registration

Manufacturing &
Market access

Impact

20
Analysis of CoE reveal most frequent donors of health
innovation in Africa – Nwaka et al. BMC 2012

21
Other challenges for R&D & manufacture in Africa

$$$$$$$$$$$$$$$
Regulation
Infrastructure

22
Many partners needed
• Political leadership and ownership
▪ AU, NEPAD, AfDB, governmental-led governance

• Technical leadership and ownership
▪ Research institutions, Pharma, National agencies
▪ Diaspora
▪ Build on ANDI business plan

• Financial leadership
▪ Governments, development partners, AfDB
Questions addressed!
• The potential & capacity for health product R&D and
innovation exist in Africa
• We need to leverage existing capacity to build more capacity
(concept of capacity utilization)
• Strong political will and support critical

• Collaboration between local pharma industry, academia and
public sector has great potential
• Work on ANDI CoEs show that this can happen
• Encourage research based companies that can collaborate and take
on leads from academia
• Incentives schemes to encourage PPPs and tech transfer
24
>500 people at ANDI Stakeholders Meetings

25
Acknowledgment
• WHO incl. TDR, PHI, AFRO, EMRO
• Economic Commission for Africa (UNECA)
• African Development Bank (AfDB)
• European Commission (EC), also for financial support
• African Union (AU)
• African institutions & scientists
• Nigeria for funding support
• McKinsey & Co
• ANDI STAC and former task force
26

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Stimulate health product R&D collaboration in Africa

  • 1. Push for greater R&D and innovation in Africa Solomon Nwaka. ANDI Director a.i. EAHIC London, March 26-27, 2013
  • 2. Presentation to address following question! • What is the potential & capacity for health product R&D and innovation in Africa? • How can we stimulate collaboration between local pharma industry, academia and public sector? 2
  • 3. Outline of presentation • Landscape for product R&D and access for diseases that disproportionately affect developing countries, esp Africa • Health product/pharmaceutical R&D in Africa • ANDI and other initiatives • Summary & conclusions 3
  • 4. Global landscape for product R&D and innovation • PDPs, PPPs & dedicated industry activities • Academia – screens, genomics, MedChem, ADMET • Network and consortia based mechanism • Government or intergovernmental effort • Open source & open innovation approaches • Product access and procurement initiatives • Funding from government & philanthropy ANDI is presently the only product R&D coordination mechanism operating on a pan African basis 4
  • 5. 'Innovation gap' remain: e.g. drugs Nwaka et al. 2009 5
  • 6. A global innovation framework for diseases that 'disproportionately affect developing countries' • Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPoA) ▪ Agreed by ALL countries in World Health Assembly Resolution 61.21 ▪ Emphasise country level & regional innovation in developing countries ▪ Financing and coordination mechanisms being discussed ▪ www.who.int/phi • Designed to promote: ▪ innovation ▪ build capacity ▪ improve access to innovation ▪ mobilize resources 6
  • 7. Research and pharmaceuticals in Africa • Africa home to medicines – traditional & herbal remedies • Growing emphasis on pharmaceutical R&D, manufacture and capacity building ▪ AU Pharmaceutical Manufacturing Plan ▪ AMCOST Cairo Declaration of 2006, 'promote R&D and develop innovation strategies for wealth creation and economic development' ▪ Algiers declaration on research for health 2008 ▪ Globally competitive R&D institutions and SMEs exist • But existing capacity not coordinated or leveraged to solve African health challenges ▪ limited intra-African collaboration, limited capacity utilization • Enhanced intra-African collaboration will boost North South/South South partnerships 7
  • 8. Increasing African R&D support but a more holistic approach needed • Multilateral Initiative for Malaria ▪ Provided small grants (MIM/TDR) but grant now discontinued ▪ Secretariat transferred to AMANET, Tanzania in 2005, now hosted Univ. Yaoundé • EDCTP ▪ Strong African engagement in management and governance (African office) • Many agencies now fund direct to African institutions ▪ NIH, EU, Wellcome Trust, Gates Foundation, DFID/MRC……. • Increasing number of African countries establishing research councils • AU / NEPAD ▪ Direct engagement in fostering research and capacity building ▪ Local product and regulatory activities
  • 9. ANDI responds to the need for coordination 9
  • 11. ANDI establishment informed by landscape analysis 5 50 66 176 Country visits ▪ ▪ ▪ ▪ ▪ Interviews outside of Africa ▪ Group interviews ▪ 1-on-1 interviews ▪ Phone interviews Data sources ▪ ▪ ▪ ▪ Interviews in Africa ▪ 1-on-1 interviews ▪ Focus groups ▪ Plenary sessions South Africa Nigeria Egypt Kenya Burkina Faso > 30,000 papers analyzed > 1,500 clinical trials analyzed > 160 African patents analyzed > 120 pharmaceutical companies surveyed Note: sources consulted included databases, institutional web pages and reports (foundations, PPPs, pharma companies) SOURCE: Country visits, interviews 11
  • 12. Lack of collaboration in Africa…HIV/AIDS research Only 5% of articles are in collaboration between two or more African countries SOURCE: Thomson Web of Science, UCINET 12
  • 13. Good news - competency research centers exist • Cities with 30 or more articles published in the 2004 - 2008 period • Total of 90 cities in 27 countries • 16,647 biomedical articles led by African authors included in analysis Note: Only top 40 cities by research output labeled SOURCE: Thomson Web of Science 13
  • 14. Potential downstream partners for product manufacture & commercialization exist Pharmaceutical manufacturing Tunisia Morocco Algeria Libya Western Sahara Egypt Mauritania Mali Cape Verde Sudan Niger Senegal Eritrea Chad Gambia Guinea Bissau Burkina Guinea Sierra Leone Liberia Djibouti Central African Republic Nigeria Ethiopia Ivory Coast Uganda Cameroon Ghana Benin Equatorial Togo ▪ Total of 129 companies identified ▪ Most companies locate to Egypt, SA, Nigeria, Morocco and Algeria ▪ Estimated average sales for identified companies of ~USD 90 million/year Guinea Somalia Zaire Gabon Congo Kenya Rwanda Burundi Tanzania Malawi Angola Mozambique Zambia Namibia Zimbabwe Botswana South Africa Madagascar Swaziland Lesotho SOURCE: OneSource, company websites, press searches 14
  • 15. ANDI mission & vision Mission Statement "To promote and sustain African-led health product innovation to address African public health needs through the assembly of research networks, and building of capacity to support human and economic development" Vision "Creating a sustainable platform for R&D innovation in Africa to address Africa’s own health needs" 15
  • 16. Governance • Hosting Agency ▪ Being transitioned out of UNECA • Board ▪ Co-Chaired – Minister of Health, Kenya – Minister of S &T, S Africa ▪ 12 members with >75% from Africa ▪ WHO, AfDB & host agency • Secretariat ▪ Operates through regional hubs 16
  • 17. Viable projects exist in Africa- call for projects implemented Capacity for innovation exist in Africa but need to be coordinated for optimal result Covers product R&D, manufacturing, commercialization 17
  • 18. CoEs implemented through a rigorous process Capacity for innovation exist in Africa but need to be coordinated for optimal result Covers product R&D, manufacturing, commercialization 18
  • 19. Approved CoEs, incl manufacturers National Institute for Pharmaceutical Research and Development University of Ibadan Institut Pasteur de Tunis Theodor Bilharz Reseach Institute Vacsera (2) Vacsera Manufacturing University of Lagos National Center for Research Joint Clinical Research Center University of Bamako Kumasi Center for Collaborative Research LaGray Chemical Co. Ltd Noguchi Memorial Institute for Medical Research University of Buea Institut de recherches médicales et d'études des plantes médicinales African Institute of Biomedical Science and Technology Makerere University KEMRI Production Unit Institute of Primate Research Kenya Medical Research Institute Kenya Agricultural Research Institute Kilimanjaro School of Pharmacy University of Zambia University of Mauritius Stellenbosch University (2) The Biovac Insttute University of Cape Town (3) IThemba Labs South African Medical Research Council Botswana Vaccine Institute Council for Scientific and Industrial Research IThemba Pharma University of Witwatersrand (2) 19
  • 20. CoE mapped around value chain - DRUGS Product Value Chain Research & Development Clinical Studies to Registration Manufacturing & Market access Impact 20
  • 21. Analysis of CoE reveal most frequent donors of health innovation in Africa – Nwaka et al. BMC 2012 21
  • 22. Other challenges for R&D & manufacture in Africa $$$$$$$$$$$$$$$ Regulation Infrastructure 22
  • 23. Many partners needed • Political leadership and ownership ▪ AU, NEPAD, AfDB, governmental-led governance • Technical leadership and ownership ▪ Research institutions, Pharma, National agencies ▪ Diaspora ▪ Build on ANDI business plan • Financial leadership ▪ Governments, development partners, AfDB
  • 24. Questions addressed! • The potential & capacity for health product R&D and innovation exist in Africa • We need to leverage existing capacity to build more capacity (concept of capacity utilization) • Strong political will and support critical • Collaboration between local pharma industry, academia and public sector has great potential • Work on ANDI CoEs show that this can happen • Encourage research based companies that can collaborate and take on leads from academia • Incentives schemes to encourage PPPs and tech transfer 24
  • 25. >500 people at ANDI Stakeholders Meetings 25
  • 26. Acknowledgment • WHO incl. TDR, PHI, AFRO, EMRO • Economic Commission for Africa (UNECA) • African Development Bank (AfDB) • European Commission (EC), also for financial support • African Union (AU) • African institutions & scientists • Nigeria for funding support • McKinsey & Co • ANDI STAC and former task force 26