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?

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

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

5

'Innovation gap' remain: e.g. drugs

Nwaka et al. 2009

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

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

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

10

Evolution and background of ANDI

11

ANDI establishment informed by landscape analysis

SOURCE: Country visits, interviews

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

5▪ South Africa▪ Nigeria▪ Egypt▪ Kenya ▪ Burkina Faso

Countryvisits

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

Interviews outside of Africa

66▪ > 30,000 papers analyzed▪ > 1,500 clinical trials analyzed▪ > 160 African patents analyzed▪ > 120 pharmaceutical companies surveyed

Data sources

176▪ 1-on-1 interviews▪ Focus groups▪ Plenary sessions

Interviews in Africa

12

Lack of collaboration in Africa…HIV/AIDS research

SOURCE: Thomson Web of Science, UCINET

Only 5% of articles are in collaboration between

two or more African countries

13

Good news - competency research centers exist

SOURCE: Thomson Web of Science

Note: Only top 40 cities by research output labeled

• 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

14SOURCE: OneSource, company websites, press searches

▪ 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

Libya

Tunisia

Algeria

Morocco

Western Sahara

Guinea Bissau

Mauritania

Egypt

Chad

NigerEritrea

Sudan

Central African RepublicNigeria

MaliSenegal

Liberia

Togo

Cameroon

EthiopiaSomalia

DjiboutiGambia

Sierra Leone

Guinea

Ivory Coast

Benin

Zaire

Uganda

GabonKenya

Burkina

Ghana Equatorial

GuineaCongo

Rwanda

Tanzania

MozambiqueAngola

Zambia

Burundi

Malawi

MadagascarBotswana

ZimbabweNamibia

South AfricaLesotho

Swaziland

Cape Verde

Pharmaceutical manufacturing

Potential downstream partners for product manufacture & commercialization exist

15

Mission Statement

Vision

"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"

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

ANDI mission & vision

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

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

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

1919

Approved CoEs, incl manufacturers

IThemba PharmaUniversity of Witwatersrand (2)

University of Cape Town (3)IThemba Labs

South African Medical Research Council

Council for Scientific and Industrial Research

University of Buea

Institut de recherches médicales et d'études des plantes médicinales

Institut Pasteur de Tunis

Joint Clinical Research Center

National Center for Research

National Institute for PharmaceuticalResearch and Development

Noguchi Memorial Institutefor Medical Research

Theodor Bilharz Reseach InstituteVacsera (2)

University of Bamako

University of Ibadan

University of Lagos

Stellenbosch University (2)

University of Mauritius

University of ZambiaAfrican Institute of BiomedicalScience and Technology

Institute of Primate ResearchKenya Medical Research InstituteKenya Agricultural Research Institute

Kumasi Center for Collaborative Research

Makerere University

KEMRI Production Unit

Kilimanjaro School of Pharmacy

Vacsera Manufacturing

Botswana Vaccine InstituteThe Biovac Insttute

LaGray Chemical Co. Ltd

20

ProductValue Chain

Research& Development

Manufacturing &Market access

Clinical Studiesto Registration

Impact

CoE mapped around value chain - DRUGS

21

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

22

Other challenges for R&D & manufacture in Africa

$$$$$$$$$$$$$$$

Regulation

Infrastructure

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

25

>500 people at ANDI Stakeholders Meetings

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