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Robert G Ridley - One of the best experts on this subject based on the ideXlab platform.
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advancing drug innovation for Neglected Diseases criteria for lead progression
PLOS Neglected Tropical Diseases, 2009Co-Authors: Solomon Nwaka, Bernadette Ramirez, Reto Brun, Louis Maes, Frank L Douglas, Robert G RidleyAbstract:The current drug R&D pipeline for most Neglected Diseases remains weak, and unlikely to support registration of novel drug classes that meet desired target product profiles in the short term. This calls for sustained investment as well as greater emphasis in the risky upstream drug discovery. Access to technologies, resources, and strong management as well as clear compound progression criteria are factors in the successful implementation of any collaborative drug discovery effort. We discuss how some of these factors have impacted drug discovery for tropical Diseases within the past four decades, and highlight new opportunities and challenges through the virtual North–South drug discovery network as well as the rationale for greater participation of institutions in developing countries in product innovation. A set of criteria designed to facilitate compound progression from screening hits to drug candidate selection is presented to guide ongoing efforts.
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virtual drug discovery and development for Neglected Diseases through public private partnerships
Nature Reviews Drug Discovery, 2003Co-Authors: Solomon Nwaka, Robert G RidleyAbstract:Science a society: Virtual drug discovery and development for Neglected Diseases through public–private partnerships
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Virtual drug discovery and development for Neglected Diseases through public|[ndash]|private partnerships
Nature Reviews Drug Discovery, 2003Co-Authors: Solomon Nwaka, Robert G RidleyAbstract:Science a society: Virtual drug discovery and development for Neglected Diseases through public–private partnerships
Solomon Nwaka - One of the best experts on this subject based on the ideXlab platform.
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Innovative Partnerships for Drug Discovery against Neglected Diseases
PLoS Neglected Tropical Diseases, 2011Co-Authors: Palle Jakobsen, Ming-wei Wang, Solomon NwakaAbstract:There is a compelling scarcity of pharmaceutical agents for efficacious, safe, and affordable treatment of Neglected infectious or tropical Diseases such as malaria, trypanosomiasis, leishmaniasis, dengue, lymphatic filariasis, and soil-transmitted helminths, despite their high prevalence in the developing world. Toxicity of drugs, microbial resistance patterns, and long courses of treatments are among the current challenges in effective management of Neglected Diseases. Lack of commercial market is often outlined as the main factor for the limited number of drugs against Neglected Diseases. In the past 10 years, the product research and development (R&D) pipeline, including vaccines, diagnostics, and drugs, for Neglected Diseases has been supported through product development partnerships (PDPs) and others [1]–[3]. While R&D activities for vaccines and diagnostics for Neglected Diseases are centered on the identification and evaluation of biomarkers, development of new drugs is presently focused on small molecules with little or no ongoing effort for biopharmaceuticals. Small molecule drug discovery and development is a lengthy, risky, and costly process. However, it has been shown that the cost of developing drugs for Neglected Diseases through public–private partnership (PPP) and network models may be significantly less, due to sharing the financial burden between various agencies, including government, philanthropic, and private agencies [3] and adopting rational criteria for lead progression [4]. Discovering leads with the potential to become therapeutics is a critical step in drug development. This involves a strong interplay between various disciplines and expertise in (i) biology, such as target identification and validation, assay development, screening, bioinformatics, and ADME/T (absorption, distribution, metabolism, and excretion/toxicology); and (ii) chemistry, including medicinal chemistry, compound libraries and knowledge management. Compound collections or libraries containing hundreds, thousands, or hundreds of thousands of small molecules or natural substances may be screened against molecular targets or whole cells with variable results. When active hits are identified from successful screens, they undergo extensive characterization and prioritization to rationalize further investment in optimizing them through extensive structure-activity relationship (SAR) analyses. These activities encounter harsh attrition along every step of the discovery value chain, not just at the level of a specific hit or lead, but also during the selection and validation of a molecular target as well as assay development. Because these lead discovery activities are of high risk, they tend not to receive much funding from the normal scientific granting bodies, and so there is less incentive for academia to work in this area [5]. In the absence of a perceived commercial market for drugs against Neglected Diseases, it is critical to devise sustainable approaches to stimulate and fund R&D activities in this field. In spite of the progress made by existing PDPs, there remain major hurdles to the discovery of new chemical entities (NCEs) against Neglected Diseases. An innovation gap has therefore been defined for a range of these Diseases [4]. While some PDPs (e.g., Medicines for Malaria Venture and Drugs for Neglected Diseases Initiative) have done an excellent job in collaborating with industry and academic institutions to screen compound libraries against some of the disease pathogens in vitro, many have focused to a large extent on the so-called “low-hanging fruit”, i.e., reformulation or new combination of existing drugs or those developed for other indications (Table 1). To ensure a continued flow of promising candidates into late-stage development, discovery efforts must be maintained in a sustainable manner and with active participation of disease-endemic countries (DECs) [4]–[6]. Table 1 Product development partnerships (PDPs) focusing on drugs. Several pre-competitive approaches have been suggested for overcoming these challenges, including a more coordinated collaboration mechanism involving multidisciplinary networks of investigators and partnerships between industry and public sector in both developed and developing countries [4], [5], [7]; a more open and cooperative model where information and knowledge are freely shared to support innovation [8], [9]; and the establishment of regional networks of RD academic institutions can contribute basic research and understanding of pathogens, genomics, and whole cell assays; while governments and non-governmental organizations can contribute resources such as manpower and finance. A recurring difficulty for all screens against Neglected Diseases is the availability of high-quality compound libraries and the resources to support the prioritization and analysis of any resultant hits [5]. In Figure 1 we describe an innovative partnership that supports drug discovery against Neglected Diseases as well as training of African scientists through collaboration between a public institute (the National Center for Drug Screening, Shanghai [NCDS]), an international agency (the Special Programme for Research and Training in Tropical Diseases [WHO/TDR]), and a multinational biopharmaceutical company (Novo Nordisk [NN]). Figure 1 Examples of public–private partnerships in drug discovery against Neglected Diseases. This collaboration was launched in July 2009 following a contractual agreement of the parties and the initiation of the first high-throughput screening (HTS) campaign (Figure 2). The partnership focuses on hit-to-lead activities against a range of Neglected Diseases, including schistosomiasis and tuberculosis. It should be mentioned that some companies have established in-house research facilities to develop new drugs against Neglected Diseases. For example, Novartis has set up an institute in Singapore focusing on malaria, dengue, and tuberculosis, and AstraZeneca in India is working on tuberculosis. GSK in Spain is now operating as an open laboratory to support drug discovery for Neglected Diseases. While these are all excellent efforts, more efforts and investments are needed to support sustainable health innovation in developing countries. Figure 2 NCDS scientists and African fellows are analyzing the results obtained from a TDR commissioned HTS campaign against a molecular target in tuberculosis (July 2009). Some recent inter-governmental actions have stressed the need to invest in building sustainable capacity for health innovation in the developing world. Of note is the Global Strategy and Plan of Action (GSPOA) on public health, innovation, and intellectual property, which aims to promote new thinking on innovation and access to medicines for Diseases that disproportionately affect developing countries [10]. It also calls for stronger PPPs and North–South and South–South collaborations, as well as the establishment of regional and international networks in support of product innovation in disease-endemic regions. This initiative is best exemplified by the formation of the African Network for Drugs and Diagnostics Innovation (ANDI), which operates under a regional governance and management. ANDI hopes to provide a time-efficient, cost-effective, and inclusive model to meet critical health care challenges in the continent [11]–[13] (Table 2). It is anticipated that leads emerging from the NCDS, NN, and WHO/TDR collaboration could, for example, be further optimized and developed through regional innovation networks in developing regions like ANDI or other partners. Table 2 Brief description of the African Network for Drugs and Diagnostics Innovation (ANDI). A broader interest has been expressed by several stakeholder groups in Asia and some preliminary mapping of innovation centers is under way in China, India, and several Association of Southeast Asian Nations (ASEAN) countries. The Chinese NDI held its first meeting in October 2009 and is in communication with its neighboring counterparts with the goal of creating a pan-Asia network. The collaborative project, described in Table 2, as well as enthusiasm shown by other institutions in China, including the National Institute of Parasitic Diseases of the Chinese Center for Disease Control and Prevention and the Second Military Medical University, have made a significant contribution towards the establishment of the Chinese NDI (Table 3). Cooperation among African, Asian, and South American scientists is a good way to promote South–South collaboration and technology transfer. Table 3 Brief description of the Chinese Network for Drugs and Diagnostics Innovation. In conclusion, we have described a few innovative public–private and North–South partnerships for drug development against Neglected Diseases. Such partnerships are highly relevant in supporting capacity building and establishment of R&D infrastructures in developing countries. The hope is that these and other emerging South–South activities will be scaled up and sustained to support the discovery, development, and delivery of new drugs, diagnostics, vaccines, and medical devices for Diseases that disproportionately affect developing countries.
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advancing drug innovation for Neglected Diseases criteria for lead progression
PLOS Neglected Tropical Diseases, 2009Co-Authors: Solomon Nwaka, Bernadette Ramirez, Reto Brun, Louis Maes, Frank L Douglas, Robert G RidleyAbstract:The current drug R&D pipeline for most Neglected Diseases remains weak, and unlikely to support registration of novel drug classes that meet desired target product profiles in the short term. This calls for sustained investment as well as greater emphasis in the risky upstream drug discovery. Access to technologies, resources, and strong management as well as clear compound progression criteria are factors in the successful implementation of any collaborative drug discovery effort. We discuss how some of these factors have impacted drug discovery for tropical Diseases within the past four decades, and highlight new opportunities and challenges through the virtual North–South drug discovery network as well as the rationale for greater participation of institutions in developing countries in product innovation. A set of criteria designed to facilitate compound progression from screening hits to drug candidate selection is presented to guide ongoing efforts.
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virtual drug discovery and development for Neglected Diseases through public private partnerships
Nature Reviews Drug Discovery, 2003Co-Authors: Solomon Nwaka, Robert G RidleyAbstract:Science a society: Virtual drug discovery and development for Neglected Diseases through public–private partnerships
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Virtual drug discovery and development for Neglected Diseases through public|[ndash]|private partnerships
Nature Reviews Drug Discovery, 2003Co-Authors: Solomon Nwaka, Robert G RidleyAbstract:Science a society: Virtual drug discovery and development for Neglected Diseases through public–private partnerships
Peter J. Hotez - One of the best experts on this subject based on the ideXlab platform.
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The poverty-related Neglected Diseases: Why basic research matters.
Public Library of Science (PLoS), 2017Co-Authors: Peter J. HotezAbstract:Together, malaria and the Neglected tropical Diseases (NTDs) kill more than 800,000 people annually, while creating long-term disability in millions more. International support for mass drug administration, bed nets, and other preventive measures has resulted in huge public health gains, while support for translational research is leading to the development of some new Neglected disease drugs, diagnostics, and vaccines. However, funding for basic science research has not kept up, such that we are missing opportunities to create a more innovative pipeline of control tools for parasitic and related Diseases. There is an urgent need to expand basic science approaches for Neglected Diseases, especially in the areas of systems biology and immunology; ecology, evolution, and mathematical biology; functional and comparative OMICs; gene editing; expanded use of model organisms; and a new single-cell combinatorial indexing RNA sequencing approach. The world's poor deserve access to innovation for Neglected Diseases. It should be considered a fundamental human right
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a handful of antipoverty vaccines exist for Neglected Diseases but the world s poorest billion people need more
Health Affairs, 2011Co-Authors: Peter J. HotezAbstract:So-called Neglected tropical Diseases are the most common infections of the world’s poor. Almost all of the “bottom billion”—the 1.4 billion people who live below the poverty level defined by the World Bank—suffer from one or more Neglected Diseases including hookworm infection, sleeping sickness, or Chagas disease. These Diseases are actually a cause of poverty because of their adverse effects on child growth and development and worker productivity. Vaccines to combat such Diseases have come to be known as “antipoverty vaccines.” Unfortunately, the recent surge in the development and delivery of vaccines to combat the major childhood killers—such as pneumococcal pneumonia and measles—has bypassed Neglected Diseases. Nevertheless, some vaccines for these Neglected Diseases are now entering the clinical pipeline. In this article I describe how some antipoverty vaccine development is proceeding and offer recommendations for stimulating further development such as through pooled funding for innovation, devel...
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A Handful Of ‘Antipoverty’ Vaccines Exist For Neglected Diseases, But The World’s Poorest Billion People Need More
Health Affairs, 2011Co-Authors: Peter J. HotezAbstract:So-called Neglected tropical Diseases are the most common infections of the world’s poor. Almost all of the “bottom billion”—the 1.4 billion people who live below the poverty level defined by the World Bank—suffer from one or more Neglected Diseases including hookworm infection, sleeping sickness, or Chagas disease. These Diseases are actually a cause of poverty because of their adverse effects on child growth and development and worker productivity. Vaccines to combat such Diseases have come to be known as “antipoverty vaccines.” Unfortunately, the recent surge in the development and delivery of vaccines to combat the major childhood killers—such as pneumococcal pneumonia and measles—has bypassed Neglected Diseases. Nevertheless, some vaccines for these Neglected Diseases are now entering the clinical pipeline. In this article I describe how some antipoverty vaccine development is proceeding and offer recommendations for stimulating further development such as through pooled funding for innovation, devel...
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nuclear weapons and Neglected Diseases the ten thousand to one gap
PLOS Neglected Tropical Diseases, 2010Co-Authors: Peter J. HotezAbstract:Together, the world's eight acknowledged nuclear powers—the United States (US), Russia, United Kingdom (UK), France, China, India, Pakistan, and the Democratic People's Republic of Korea (North Korea)—have amassed an arsenal of almost 30,000 nuclear weapons since 1945. In addition, Israel is believed to be a nuclear power while Iran (and possibly Syria as well) is also suspected of developing nuclear weapons. Despite the technological sophistication that has enabled the 11 nuclear weapons states to produce and deliver nuclear bombs, most of these nations simultaneously also suffer from high internal rates of poverty and endemic Neglected Diseases. They include high prevalence rates of Neglected tropical Diseases in India, China, Pakistan, Iran, and Syria, and related Neglected infections of poverty in the US and Europe. Indeed, the 11 nuclear weapons states together account for up to one-half of the global disease burden from all Neglected Diseases. However, for a tiny fraction (less than 1/10,000th) of the costs of producing and maintaining a nuclear arsenal the 11 nuclear powers could eliminate most of their Neglected Diseases and engage in joint Neglected disease research and development efforts that help to reduce international tensions and promote world peace. Shown in Table 1 and Figure 1 are the 11 established and suspected global nuclear powers. Following the development and deployment of the atomic bomb by the US in 1945 (at an estimated cost of US$20 billion), Russia became the second nuclear power in 1949, and in every decade since then at least one new country has joined the nuclear club [1], [2]. In addition three countries, South Africa, Argentina, and Brazil, began active nuclear weapons programs, but subsequently abandoned them by mutual treaty [1]. Today, only the first five nations to produce nuclear weapons,,the US, Russia, UK, France, and China, have signed the nuclear nonproliferation treaty [1]. The costs to maintain these nuclear arsenals are staggering. According to the Brookings Institution, which in 1998 published their US Nuclear Weapons Cost Study Project, the US alone spent $35 billion that year on nuclear weapons technology [2]. Further estimates indicate that the US may have spent more than $5.5 trillion in developing their nuclear arsenal, while France has invested approximately $1.5 trillion [3]. Although the data are unavailable, the costs for other nuclear weapon states are believed to be similar [3]. Therefore it is likely that the 11 nuclear weapons states together have invested at least $10 trillion on weapons production and maintenance. Figure 1 Map of countries with nuclear weapons. Table 1 Estimated number of nuclear weapons by Country, 1945–2008. Despite this massive expenditure, each of the 11 nuclear weapons states, with the possible exception of the U.K., also suffers from high rates of Neglected tropical Diseases (and related Neglected infections of poverty), defined as chronic and debilitating parasitic and other infectious Diseases that occur in association with extreme poverty [4]. In addition to their health effects, the Neglected tropical Diseases also cause poverty through their ability to impair child physical and intellectual development, pregnancy outcomes, and worker productivity, while simultaneously promoting conflict and war through their agriculturally and socially destabilizing effects [4], [5]. Although it is common to think of Neglected Diseases as confined to low-income countries in sub-Saharan Africa, Southeast Asia, and Latin America, as shown in Table 2 these infections also exhibit a high prevalence in middle-income countries such as China, India, Pakistan, North Korea, Iran, and Syria, as well as in selected areas of poverty found in the US, Russia, and Eastern Europe [6]. Indeed, with the possible exceptions of the UK, high Neglected disease burdens are present in all of the nuclear weapons states, particularly the helminth infections, leishmaniasis and Chagas disease, toxoplasmosis, and trachoma. Table 2 The major Neglected tropical Diseases or Neglected infection of poverty endemic to countries with nuclear weapons. Helminthic Neglected Infections The four major soil-transmitted helminth infections of humans include ascariasis (roundworm), trichuriasis (whipworm), hookworm infection, and strongyloidiasis (threadworm) [7]. These intestinal worm infections represent the most common Neglected tropical Diseases of humans living in poverty [7], [8]. Of the estimated 800 million ascariasis infections found predominantly in low- and middle-income countries [7], approximately one-third of the cases occur in nuclear weapons states including India (140 million), China (86 million), North Korea (8 million), Pakistan (7 million), and Iran (5 million) [8], [9]. These nations also account for 20% of the world's cases of hookworm infection, which is associated with anemia and extreme poverty resulting from impairments in child development and cognition, maternal morbidity during pregnancy, and diminished agricultural worker productivity [4], [7], [8], [9]. Trichuriasis and strongyloidiasis are endemic to these countries as well, and the US and France have pockets of endemic strongyloidiasis in, respectively, Appalachia and in Region Midi-Pyrenees in the Southwest [10], [11]. In the US and elsewhere, toxocariasis is a soil-transmitted helminth zoonosis associated with larval migrans syndromes, asthma, and developmental delays in up to 3 million African Americans living in poverty [10]. India accounts for roughly one-quarter of the world's 120 million cases of lymphatic filariasis, a disfiguring and stigmatizing vector-borne infection associated with elephantiasis [12], while China accounts for most of the world's food-borne trematode infections, including 13 million cases of clonorchiasis (liver fluke infection associated with liver fibrosis and bile duct cancer) and paragonimiasis (lung fluke infection associated with hemoptysis and other pulmonary disorders) [9], [13], [14]. Clonorchiasis is also endemic to North Korea [15], while a related liver fluke infection known as opisthorchiasis is highly endemic to Russia where an estimated 12.5 million people are at risk of infection, and in some parts of Siberia up to 95% of the population is infected [13], [16]. Up to 169,000 cases of cysticercosis occur among Hispanic Americans in the US [10].
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Eliminating Neglected Diseases in Africa [letter]
The Lancet, 2005Co-Authors: Peter J. Hotez, Simon Brooker, Jeffrey M Bethony, Marco AlbonicoAbstract:We welcome the comments by Alan Fenwick and colleagues who highlight a pro-poor health intervention in Africa based on the use of four drugs (praziquantel albendazole ivermectin and azithromycin) to eliminate schistosomiasis lymphatic filariasis onchocerciasis hookworm ascariasis trichuriasis and trachoma. Clearly advocacy for tackling the “Neglected seven” in Africa is long overdue. However we wish to temper their comments by pointing out that there are more than 500 million cases of soiltransmitted helminth infections in sub-Saharan Africa including 198 million cases of hookworm 173 million of ascariasis and 162 million of trichuriasis. Cure rates for trichuriasis and hookworm with a single dose of benzimidazoles are low especially for highly infected individuals; ivermectin lacks efficacy for treating hookworm; and rapid reinfection can occur after treatment often necessitating up to three retreatments annually. Thus the question is not simply one of treatment but of sustainable treatment and retreatment. Programmes designed to control morbidity and not to eliminate soil-transmitted helminth infections require a long-term commitment and are logistically complex to sustain over the required time period. (excerpt)
Bernard Pécoul - One of the best experts on this subject based on the ideXlab platform.
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the drug and vaccine landscape for Neglected Diseases 2000 11 a systematic assessment
The Lancet Global Health, 2013Co-Authors: Belen Pedrique, Claudette Some, Piero Olliaro, Patrice Trouiller, Nathan Ford, Bernard Pécoul, Nathalie Strubwourgaft, Jean-hervé BradolAbstract:Summary Background In 1975–99, only 1·1% of new therapeutic products had been developed for Neglected Diseases. Since then, several public and private initiatives have attempted to mitigate this imbalance. We analysed the research and development pipeline of drugs and vaccines for Neglected Diseases from 2000 to 2011. Methods We searched databases of drug regulatory authorities, WHO, and clinical trial registries for entries made between Jan 1, 2000, and Dec 31, 2011. We defined Neglected Diseases as malaria, tuberculosis, diarrhoeal Diseases, Neglected tropical Diseases (NTDs; WHO definition), and other Diseases of poverty according to common definitions. Findings Of the 850 new therapeutic products registered in 2000–11, 37 (4%) were indicated for Neglected Diseases, comprising 25 products with a new indication or formulation and eight vaccines or biological products. Only four new chemical entities were approved for Neglected Diseases (three for malaria, one for diarrhoeal disease), accounting for 1% of the 336 new chemical entities approved during the study period. Of 148 445 clinical trials registered in Dec 31, 2011, only 2016 (1%) were for Neglected Diseases. Interpretation Our findings show a persistent insufficiency in drug and vaccine development for Neglected Diseases. Nevertheless, these and other data show a slight improvement during the past 12 years in new therapeutics development and registration. However, for many Neglected Diseases, new therapeutic products urgently need to be developed and delivered to improve control and potentially achieve elimination. Funding None.
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The drug and vaccine landscape for Neglected Diseases (2000–11): a systematic assessment
The Lancet Global Health, 2013Co-Authors: Belen Pedrique, Nathalie Strub-wourgaft, Claudette Some, Piero Olliaro, Patrice Trouiller, Nathan Ford, Bernard Pécoul, Jean-hervé BradolAbstract:Summary Background In 1975–99, only 1·1% of new therapeutic products had been developed for Neglected Diseases. Since then, several public and private initiatives have attempted to mitigate this imbalance. We analysed the research and development pipeline of drugs and vaccines for Neglected Diseases from 2000 to 2011. Methods We searched databases of drug regulatory authorities, WHO, and clinical trial registries for entries made between Jan 1, 2000, and Dec 31, 2011. We defined Neglected Diseases as malaria, tuberculosis, diarrhoeal Diseases, Neglected tropical Diseases (NTDs; WHO definition), and other Diseases of poverty according to common definitions. Findings Of the 850 new therapeutic products registered in 2000–11, 37 (4%) were indicated for Neglected Diseases, comprising 25 products with a new indication or formulation and eight vaccines or biological products. Only four new chemical entities were approved for Neglected Diseases (three for malaria, one for diarrhoeal disease), accounting for 1% of the 336 new chemical entities approved during the study period. Of 148 445 clinical trials registered in Dec 31, 2011, only 2016 (1%) were for Neglected Diseases. Interpretation Our findings show a persistent insufficiency in drug and vaccine development for Neglected Diseases. Nevertheless, these and other data show a slight improvement during the past 12 years in new therapeutics development and registration. However, for many Neglected Diseases, new therapeutic products urgently need to be developed and delivered to improve control and potentially achieve elimination. Funding None.
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Interview with Dr Bernard Pécoul, Executive Director of the Drugs for Neglected Diseases Initiative.
Future Medicinal Chemistry, 2009Co-Authors: Bernard PécoulAbstract:A significant number of product-development partnerships have arisen in the past 10 years to tackle Diseases that mainly affect developing countries. With their coherent research and development leadership, they have become key players in identifying gaps and overcoming bottlenecks in order to deliver medicines to those who need them most in the developing world. Dr Bernard Pecoul is the Executive Director of one such partnership, the Drugs for Neglected Diseases Initiative (DNDi). Under his leadership, the DNDi has built the largest and most robust R&D portfolio for three of the most Neglected Diseases. He speaks to Future Medicinal Chemistry about challenges facing Neglected disease R&D and the DNDi’s ongoing work.
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New drugs for Neglected Diseases: from pipeline to patients.
PLoS Medicine, 2004Co-Authors: Bernard PécoulAbstract:The Drugs for Neglected Diseases Initiative is a new, public- sector organization dedicated to drug discovery.
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drugs for Neglected Diseases a failure of the market and a public health failure
Tropical Medicine & International Health, 2001Co-Authors: Patrice Trouiller, Piero Olliaro, Els Torreele, Nicholas J White, Susan Foster, Dyann F Wirth, Bernard PécoulAbstract:Infectious Diseases cause the suffering of hundreds of millions of people, especially in tropical and subtropical areas. Effective, affordable and easy-to-use medicines to fight these Diseases are nearly absent. Although science and technology are sufficiently advanced to provide the necessary medicines, very few new drugs are being developed. However, drug discovery is not the major bottleneck. Today's R&D-based pharmaceutical industry is reluctant to invest in the development of drugs to treat the major Diseases of the poor, because return on investment cannot be guaranteed. With national and international politics supporting a free market-based world order, financial opportunities rather than global health needs guide the direction of new drug development. Can we accept that the dearth of effective drugs for Diseases that mainly affect the poor is simply the sad but inevitable consequence of a global market economy? Or is it a massive public health failure, and a failure to direct economic development for the benefit of society? An urgent reorientation of priorities in drug development and health policy is needed. The pharmaceutical industry must contribute to this effort, but national and international policies need to direct the global economy to address the true health needs of society. This requires political will, a strong commitment to prioritize health considerations over economic interests, and the enforcement of regulations and other mechanisms to stimulate essential drug development. New and creative strategies involving both the public and the private sector are needed to ensure that affordable medicines for today's Neglected Diseases are developed. Priority action areas include advocating an essential medicines R&D agenda, capacity-building in and technology transfer to developing countries, elaborating an adapted legal and regulatory framework, prioritizing funding for essential drug development and securing availability, accessibility, distribution and rational use of these drugs.
Piero Olliaro - One of the best experts on this subject based on the ideXlab platform.
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the drug and vaccine landscape for Neglected Diseases 2000 11 a systematic assessment
The Lancet Global Health, 2013Co-Authors: Belen Pedrique, Claudette Some, Piero Olliaro, Patrice Trouiller, Nathan Ford, Bernard Pécoul, Nathalie Strubwourgaft, Jean-hervé BradolAbstract:Summary Background In 1975–99, only 1·1% of new therapeutic products had been developed for Neglected Diseases. Since then, several public and private initiatives have attempted to mitigate this imbalance. We analysed the research and development pipeline of drugs and vaccines for Neglected Diseases from 2000 to 2011. Methods We searched databases of drug regulatory authorities, WHO, and clinical trial registries for entries made between Jan 1, 2000, and Dec 31, 2011. We defined Neglected Diseases as malaria, tuberculosis, diarrhoeal Diseases, Neglected tropical Diseases (NTDs; WHO definition), and other Diseases of poverty according to common definitions. Findings Of the 850 new therapeutic products registered in 2000–11, 37 (4%) were indicated for Neglected Diseases, comprising 25 products with a new indication or formulation and eight vaccines or biological products. Only four new chemical entities were approved for Neglected Diseases (three for malaria, one for diarrhoeal disease), accounting for 1% of the 336 new chemical entities approved during the study period. Of 148 445 clinical trials registered in Dec 31, 2011, only 2016 (1%) were for Neglected Diseases. Interpretation Our findings show a persistent insufficiency in drug and vaccine development for Neglected Diseases. Nevertheless, these and other data show a slight improvement during the past 12 years in new therapeutics development and registration. However, for many Neglected Diseases, new therapeutic products urgently need to be developed and delivered to improve control and potentially achieve elimination. Funding None.
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The drug and vaccine landscape for Neglected Diseases (2000–11): a systematic assessment
The Lancet Global Health, 2013Co-Authors: Belen Pedrique, Nathalie Strub-wourgaft, Claudette Some, Piero Olliaro, Patrice Trouiller, Nathan Ford, Bernard Pécoul, Jean-hervé BradolAbstract:Summary Background In 1975–99, only 1·1% of new therapeutic products had been developed for Neglected Diseases. Since then, several public and private initiatives have attempted to mitigate this imbalance. We analysed the research and development pipeline of drugs and vaccines for Neglected Diseases from 2000 to 2011. Methods We searched databases of drug regulatory authorities, WHO, and clinical trial registries for entries made between Jan 1, 2000, and Dec 31, 2011. We defined Neglected Diseases as malaria, tuberculosis, diarrhoeal Diseases, Neglected tropical Diseases (NTDs; WHO definition), and other Diseases of poverty according to common definitions. Findings Of the 850 new therapeutic products registered in 2000–11, 37 (4%) were indicated for Neglected Diseases, comprising 25 products with a new indication or formulation and eight vaccines or biological products. Only four new chemical entities were approved for Neglected Diseases (three for malaria, one for diarrhoeal disease), accounting for 1% of the 336 new chemical entities approved during the study period. Of 148 445 clinical trials registered in Dec 31, 2011, only 2016 (1%) were for Neglected Diseases. Interpretation Our findings show a persistent insufficiency in drug and vaccine development for Neglected Diseases. Nevertheless, these and other data show a slight improvement during the past 12 years in new therapeutics development and registration. However, for many Neglected Diseases, new therapeutic products urgently need to be developed and delivered to improve control and potentially achieve elimination. Funding None.
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drug development for Neglected Diseases a deficient market and a public health policy failure
The Lancet, 2002Co-Authors: Patrice Trouiller, Piero Olliaro, Els Torreele, James Orbinski, Richard Laing, Nathan FordAbstract:Summary There is a lack of effective, safe, and affordable pharmaceuticals to control infectious Diseases that cause high mortality and morbidity among poor people in the developing world. We analysed outcomes of pharmaceutical research and development over the past 25 years, and reviewed current public and private initiatives aimed at correcting the imbalance in research and development that leaves Diseases that occur predominantly in the developing world largely unaddressed. We compiled data by searches of Medline and databases of the US Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products, and reviewed current public and private initiatives through an analysis of recently published studies. We found that, of 1393 new chemical entities marketed between 1975 and 1999, only 16 were for tropical Diseases and tuberculosis. There is a 13-fold greater chance of a drug being brought to market for central-nervous-system disorders or cancer than for a Neglected disease. The pharmaceutical industry argues that research and development is too costly and risky to invest in low-return Neglected Diseases, and public and private initiatives have tried to overcome this market limitation through incentive packages and public-private partnerships. The lack of drug research and development for "non-profitable" infectious Diseases will require new strategies. No sustainable solution will result for Diseases that predominantly affect poor people in the South without the establishment of an international pharmaceutical policy for all Neglected Diseases. Private-sector research obligations should be explored, and a public-sector not-for-profit research and development capacity promoted.
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drugs for Neglected Diseases a failure of the market and a public health failure
Tropical Medicine & International Health, 2001Co-Authors: Patrice Trouiller, Piero Olliaro, Els Torreele, Nicholas J White, Susan Foster, Dyann F Wirth, Bernard PécoulAbstract:Infectious Diseases cause the suffering of hundreds of millions of people, especially in tropical and subtropical areas. Effective, affordable and easy-to-use medicines to fight these Diseases are nearly absent. Although science and technology are sufficiently advanced to provide the necessary medicines, very few new drugs are being developed. However, drug discovery is not the major bottleneck. Today's R&D-based pharmaceutical industry is reluctant to invest in the development of drugs to treat the major Diseases of the poor, because return on investment cannot be guaranteed. With national and international politics supporting a free market-based world order, financial opportunities rather than global health needs guide the direction of new drug development. Can we accept that the dearth of effective drugs for Diseases that mainly affect the poor is simply the sad but inevitable consequence of a global market economy? Or is it a massive public health failure, and a failure to direct economic development for the benefit of society? An urgent reorientation of priorities in drug development and health policy is needed. The pharmaceutical industry must contribute to this effort, but national and international policies need to direct the global economy to address the true health needs of society. This requires political will, a strong commitment to prioritize health considerations over economic interests, and the enforcement of regulations and other mechanisms to stimulate essential drug development. New and creative strategies involving both the public and the private sector are needed to ensure that affordable medicines for today's Neglected Diseases are developed. Priority action areas include advocating an essential medicines R&D agenda, capacity-building in and technology transfer to developing countries, elaborating an adapted legal and regulatory framework, prioritizing funding for essential drug development and securing availability, accessibility, distribution and rational use of these drugs.
