DNDi Update: Global Partnership Addressing Needs

of Most NeglectedFrom Research to Access

Dr Monique WasunnaKEMRI/Head of DNDi Africa

AEMI meeting Cape Town

December 13-15 2010

DNDi’s HISTORY• 1999

– First meeting in Paris to describe the lack of R&D for neglected diseases (the day MSF received the Nobel Peace Prize)

– MSF commits the Nobel Peace Prize money to the Drugs for Neglected Diseases Working Group

– Jama’s article (01/27/99), “Access to essential drugs in poor countries - A Lost Battle?”, B. Pécoul and all.

• 2001 – DND WG recommends the creation of DNDi

• July 2003– Creation of DNDi (7 founding members

Brazil

India

Kenya

Malaysia

USA

DRC

Japan

Geneva Coordination Team + consultants

7 Founding Partners

• Indian Council for Medical Research (ICMR)

• Kenya Medical Research Institute (KEMRI)

• Malaysian MOH• Oswaldo Cruz Foundation

Brazil• Medecins Sans Frontieres

(MSF)• Institut Pasteur France• WHO/TDR (permanent

observer)

7 worldwide offices

• Non-profit drug research & development (R&D) organization founded in 2003

• Addressing the needs of the most neglected patients

• Harnessing resources from public institutions, private industry and philanthropic entities

A New Model for Drug Development: DNDi created in 2003

VISION • To improve the quality of life and health of

people suffering from neglected diseases- by using an alternative model to develop drugs for these diseases- ensuring equitable access to new and field relevant health tools- not for profit model driven by public sector and partners- build public responsibility and leadership in addressing the needs of these patients

MISSION• To develop new drugs or new

formulations of existing drugs for patients suffering from the most neglected diseases

DNDi’s Main Objectives• Deliver 6 to 8 new treatments

by 2014 for sleeping sickness, Chagas disease, leishmaniasis and malaria

• Establish a robust pipeline for future needs

• Use and strengthen existing capacity in disease-endemic countries

• Raise awareness and advocate for increased public responsibility

7-Year Results• 2 new malaria treatments• 1 new sleeping sickness combination• 1 new visceral leishmaniasis combination

for Africa• Largest pipeline ever for the kinetoplastid

diseases• Clinical research platforms in Africa• On track to deliver new treatments per

business plan

CURRENT STATUS• 4 treatments delivered

- 2007 fixed dose Artesunate/Amodaiaquine (ASAQ) Sanofi Aventis(France)- 2008 ASMQ Farmanguinhos and Cipla- 2009 Nifurtimox/Eflornithine co adminstration (NECT) National Control programmes, MSF/Epicentre, Bayer, Sanofi Aventis, WHO

-2010 SSG+Paromomycin combination RX for VL in EA now recommended by WHO and MOH Sudan has recommended as first line Rx for VL

Challenges to build innovation and research capacities in Africa

• Public leadership to define R&D priorities

• Significant investment with sustainable funding

• Ensure better access to knowledge and promote innovative IP management policies

• Enable more adapted regulatory environment

• Transfer technology and strengthen research capacities in developing countries

By working together in a creative way, south south can bring

innovation to neglected patients!

Thank you

SUDAN: 2 sites (Kassab, Dooka)Univ. of Khartoum Federal Ministry of Health

ETHIOPIA: 2 sites(Gondar, Arba Minch)Addis Ababa Univ.Gondar Univ.Ministry of Health

KENYA: 2 sites (Nairobi, Kimalel)KEMRIMinistry of Health

UGANDA: 1 site (Amudat)• Makerere Univ.• Ministry of Health

MSFI+ solutionsLSH&TMAMC/ SU/ KIT (ASK)IOWH - IndiaIndustry partners

VL

Objectives:

Partners:

LEAP Objectives

• Facilitate clinical testing and registration of new treatments for VL in the region (Ethiopia, Kenya, Sudan and Uganda)

• Evaluate, validate and register improved options that address regional needs for VL

• Provide capacity strengthening for drug evaluation and clinical studies in the region

Infrastructure upgrades

Previous VL Treatment ward Gondar

Current VL Treatment centre and Physiotherapy Dept,

Gondar

LEAP Activities

Renovation and re-equipping of clinical laboratories to high standards

Capacity strengthening

Regional pool of clinical trial expertise

• Serve as forum for members to share their clinical & research experience• Support the review and roll out of VL National Guidelines for member countries

Sharing of experiences between

South-South LEAP scientits

HAT Strengthening Clinical Trial Capacity

PlatformObjectivesTo strengthen clinical trial capacity for sleeping sicknessTo overcome health system challenges for clinical researchTo share information on HAT research progressTo improve HAT clinical trial methodologies

Partners:• National HAT control programs of

most affected endemic countries• DNDi, STI• Research institutes like ITMA, INRB,

CDC, KARI-TRC• NGOs like MSF, Epicentre• FIND, WHO• Regional networks - eg. EANETT,

PABIN, AMANET