Medical Research

Drugs for Neglected Diseases Initiative, North America Inc.

  • New York, NY
  • http://www.dndina.org

Mission Statement

DNDi is an independent, non-profit product development partnership working to research and develop new and improved treatments for neglected diseases such as malaria, leishmaniasis, human African trypanosomiasis (sleeping sickness) and Chagas disease. Acting in the public interest, DNDi will bridge the existing R&D gaps in essential drugs for these diseases by initiating and coordinating drug R&D projects in collaboration with the international research community, the public sector, the pharmaceutical industry, and other relevant partners.

Main Programs

  1. Human African Trypanosomiasis (HAT)
  2. Leishmaniasis
  3. Chagas Disease
  4. Helminth Infections
  5. Paediatric HIV
Service Areas

Self-reported

International

DNDi North America, an affiliate of DNDi, is a registered 501(c)(3) organization in the United States that works to strengthen and expand DNDi's scientific, advocacy, and fundraising efforts in the region.

ruling year

2007

Principal Officer since 2011

Self-reported

Ms Rachel M Cohen

Keywords

Self-reported

Neglected, tropical, diseases, Chagas, Trypanosomiasis, leishmaniasis, malaria, sleeping sickness, drugs

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Also Known As

DNDi North America

EIN

20-8774179

 Number

1016594817

Contact

Cause Area (NTEE Code)

Research Institutes and/or Public Policy Analysis (H05)

IRS Filing Requirement

This organization is required to file an IRS Form 990 or 990-EZ.

Programs + Results

How does this organization make a difference?

Overview

Self-reported by organization

The Drugs for Neglected Diseases initiative (DNDi) is a patient needs driven, not-for-profit research and development (R&D) organization that develops safe, effective and affordable medicines for neglected diseases that afflict millions of the world’s poorest people.  

DNDi focuses on developing new treatments for the most neglected patients suffering from diseases such as sleeping sickness (or human African trypanosomiasis), leishmaniasis, Chagas disease, malaria, specific helminth infections, and paediatric HIV. 

 

The initiative’s primary objective is to deliver 11 to 13 new treatments by 2018 and to establish a strong R&D portfolio for these diseases.

Programs

Self-reported by organization

What are the organization's current programs, how do they measure success, and who do the programs serve?

Program 1

Human African Trypanosomiasis (HAT)

At its inception, DNDi’s short-term strategy was to make better use of existing treatments by combining drugs already in use. In September 2009, DNDi and partners launched the first new treatment for sleeping sickness in 25 years: nifurtimox and eflornithine combination therapy (NECT). NECT was included on the WHO Essential Medicines List in 2009 and is now recommended as first-line treatment for HAT in 12 endemic countries.
As a medium-term strategy, DNDi initiated a proactive compound mining effort to identify existing chemical compounds with potential against kinetoplastid diseases. This resulted in the rediscovery of fexinidazole, which completed Phase I clinical development in 2011. Fexinidazole is now ready to be assessed in a pivotal Phase II/III study in 2012. An agreement was signed in 2009 with Sanofi as the industrial partner for this project.  

In order to build a strong pipeline for long-term drug discovery, DNDi established the HAT Lead Optimization Consortium. The identification of the Oxaborole SCYX-7158 represents the first success of this consortium.  SCYX-7158 successfully progressed through pre-clinical development and at the end of 2011, all necessary documentation was submitted to relevant authorities for the start of Phase I clinical development in early 2012.  Other backup compounds continue to be evaluated by the consortium.

Finally, DNDi supports the HAT Platform that was launched in Kinshasa (DRC) in 2005. The HAT Platform is a clinical research and access-supporting network that brings together key players in the fight against sleeping sickness from Angola, the Central African Republic, Chad, DRC, Republic of the Congo, Sudan, South Sudan, and Uganda.

 

By 2018, DNDi aims to deliver from its HAT-specific portfolio an oral, safe, effective treatment for stage 2 HAT, ideally to be used with the same regimen for stage 1 HAT.

Category

Medical Research

Population(s) Served

Adults

Budget

Program 2

Leishmaniasis

DNDi’s short-term approach is to develop new treatments by combining existing drugs and/or shortening treatment duration in order to increase tolerability, reduce burden on health systems, and offer greater affordability, whilst also preventing or delaying emergence of resistance. Another short-term objective is to assess efficacy and safety of existing drugs in other countries and regions to extend their registration and availability to more patients.
 In 2010, DNDi and partners delivered the SSG&PM combination therapy for East Africa that is now recommended as first-line treatment for visceral leishmaniasis (VL) in the region by the WHO Expert Committee on the Control of Leishmaniases. In India, together with its partners, DNDi also conducted a Phase III trial to evaluate the combination of already registered drugs: AmBisome®, miltefosine, and paromomycin. The study showed that the three possible 2-drug combinations were all highly efficacious, and they are now, together with single-dose AmBisome®, recommended by the WHO Expert Committee. Together with OWH and TDR, DNDi will collaborate with the National Control Programs of India and Bangladesh, MSF, the Bihar State Health Society, and the Indian Council for Medical Research to facilitate the introduction of these new treatments for VL in South Asia. In Latin America, DNDi is participating in a study sponsored by the Brazilian Innovation Agency (FINEP) to evaluate the safety and efficacy of Glucantime®, AmBisome®, amphotericin B, and AmBisome® + Glucantime® combination to treat VL patients in Brazil.

 As a medium-term approach, DNDi is looking into new formulations of amphotericin B.

 In order to develop new drugs for the treatment of leishmaniasis, DNDi’s long-term strategy is to bring new candidates into clinical development through its lead optimization program.

 Finally, DNDi supports the Leishmaniasis East Africa Platform that aims to geographically extend all currently available VL drugs to East Africa and to develop new therapies suitable for the region, as well as to build capacity in the region for conducting clinical trials.

 By 2018, DNDi aims to deliver from its VL-specific portfolio an oral, safe, effective, low-cost and short-course treatment, a new treatment for post-kala-azar dermal leishmaniasis (PKDL) that is shorter course and better tolerated than current options, and treatment options for HIV-VL co-infected patients that would limit recurrences

 By 2018, DNDi aims to deliver from its CL-specific portfolio a safe, effective, and shorter-course treatment for cutaneous leishmaniasis.

Category

Medical Research

Population(s) Served

Budget

Program 3

Chagas Disease

DNDi’s short-term goal was to make better use of existing treatments, notably through the development of a paediatric dosage form of benznidazole – a goal which was achieved: This treatment was granted registration by the Brazilian regulatory authorities in December 2011 and  DNDi is working with LAFEPE, the manufacturer, to ensure it is widely accessible to all those in need.
 As a medium-term strategy, DNDi is assessing known compounds already in development against fungal infections, such as the new azole antifungal drug, E1224, active against T. cruzi in adult chronic patients, as well as biomarkers of treatment response.

 As part of its long-term strategy, DNDi continues to identify and engage partners from private and public sectors within the Chagas lead optimization consortium in order to identify, characterize, and advance the development of promising compounds.  In addition, DNDi supports clinical research capabilities through the Chagas Clinical Research Platform, which was launched in 2009.

 By 2018, DNDi aims to deliver from its Chagas-specific portfolio an effective and safe oral treatment for the treatment of chronic Chagas disease, ideally effective also against the acute form of the disease, as well as biomarkers to gain understanding of the disease progression, and ease the development of test-of-cure diagnosis tools that support drug development.

Category

Medical Research

Population(s) Served

Budget

Program 4

Helminth Infections

DNDi's short-term strategy is to reformulate flubendazole, an antihelminthic drug with proven efficacy against gastrointestinal infections of soil-transmitted helminths in animals and humans, into a safe, highly efficacious, and field-adapted macrofilaricidal drug candidate. 
As a medium-term strategy, DNDi will assess additional opportunities through an active screening program, with the goal of selecting one or two candidates emanating from the animal health industry or leads in development in pharmaceutical, biotechnology, and academic laboratories.

By 2015, DNDi aims to deliver from its helminth infections portfolio a new drug candidate available for clinical testing that could be used by mass drug administration programs for filarial infections and/or case management of Onchocerciasis and lymphatic filariasis, especially in Loa loa filariasis co-endemic regions.

Category

Medical Research

Population(s) Served

Budget

Program 5

Paediatric HIV

In 2010, DNDi was called on by various organizations, including Médecins Sans Frontières and the international drug-purchase organization UNITAID, to apply its expertise to the development of paediatric HIV drugs. DNDi’s position was published as a Perspective in the New England Journal of Medicine in August 2011.

DNDi is pursuing two objectives to address the needs of HIV-infected Children.  This first is to develop a first-line, all-in-one formulation containing a boosted PI (lopinavir/ritonavir) and two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), suitable for infants and young children.  The second is to develop a stand-alone ritonavir booster formulation that can be added to any PI-based paediatric ARV regimen and can be used to counteract the negative drug-drug interactions between PIs and rifampicin-containing TB treatments.

 

In order to reach these objectives, DNDi has set up exploratory activities to investigate a number of options in terms of formulations of the PIs, ritonavirboosted lopinavir (LPV/r). These include sprinkles, pro-drugs, nanoparticles, and nanodispersion. As part of its formulation work, DNDi will explore the feasibility of LPV/r sprinkles, in a sachet in association with NRTIs.

 

In order to address the needs of HIV-TB co-infected children, DNDi is committed to developing a formulation of ritonavir for super-boosting LPV/r at a 1:1 ratio. This strategy will be further investigated during a clinical study involving sites in South Africa.

 

Finally, DNDi is establishing an HIV platform that will facilitate its clinical research program in the long-term. 

By 2015, DNDi aims to deliver from its paediatric HIV portfolio one new all-in-one solid paediatric formulation and one new treatment for HIV-TB co-infected children based on superboosting.

Category

Medical Research

Population(s) Served

People Living with HIV or AIDS - PLWHA

Infants/Babies (under age 5)

Budget

Service Areas

Self-reported

International

DNDi North America, an affiliate of DNDi, is a registered 501(c)(3) organization in the United States that works to strengthen and expand DNDi's scientific, advocacy, and fundraising efforts in the region.

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Financials

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DRUGS FOR NEGLECTED DISEASES INITIATIVE NORTH AMERICA INC
Fiscal year: Jan 01-Dec 31
Yes, financials were audited by an independent accountant.

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Operations

The people, governance practices, and partners that make the organization tick.

Drugs for Neglected Diseases Initiative, North America Inc.

Leadership

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Principal Officer

Ms Rachel M Cohen

BIO

Rachel Cohen joined Drugs for Neglected Diseases initiative (DNDi) as the Regional Executive Director of DNDi North America in January 2011. Cohen has been working in the global health and humanitarian field for more than 15 years, primarily with Doctors Without Borders/Médecins Sans Frontières (MSF). Most recently, she served as Head of Mission for MSF in South Africa and Lesotho, where she oversaw numerous medical programs, primarily focused on HIV/AIDS and tuberculosis treatment in rural and peri-urban settings, primary health care for Zimbabwean refugees, asylum-seekers, and migrants, and emergency care for survivors of sexual violence. Before working for MSF in the field, Cohen held numerous positions with MSF in New York, including US Director for MSF's Campaign for Access to Essential Medicines, where she directed policy advocacy activities related to drug pricing, intellectual property, and medical innovation for neglected diseases. Prior to joining MSF, she was the Director of Foundation & Corporate Giving at Housing Works, the largest minority-controlled AIDS service organization in the US, and before that, served as the Program Coordinator for the US+Cuba Medical Project, where she directed medical aid programs and carried out educational and advocacy initiatives about the impact of US foreign policy on the health of the Cuban population. Cohen now serves on the Board of Directors of MSF's Operational Center in Brussels. She earned a Master of Public Policy with a Certificate in Health and Health Policy from Princeton University's Woodrow Wilson School of Public and International Affairs.

Governance

BOARD CHAIR

Bennett Shapiro MD

Partner, PureTech Ventures; former Executive Vice President, Merck

BOARD LEADERSHIP PRACTICES

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BOARD ORIENTATION & EDUCATION

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CEO OVERSIGHT

Has the board conducted a formal, written assessment of the chief executive within the past year?


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ETHICS & TRANSPARENCY

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BOARD COMPOSITION

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BOARD PERFORMANCE

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