NEGLECTED DISEASE R&D SCOPE DOCUMENT

This document sets out the neglected disease research and development (R&D) activities that are included within the scope of the G-FINDER survey as well as the R&D activities that are excluded or partially excluded.

The G-FINDER scope has been defined by an expert international Advisory Committee, in line with the following three criteria:

1. The disease disproportionately affects people in developing countries*

2. There is a need for new products (i.e. there is no existing product, or improved or additional products are needed)

3. There is market failure (i.e. there is insufficient commercial market to attract R&D by private industry) A list of the neglected diseases, products and technologies included in the G-FINDER survey scope is presented in the neglected disease R&D matrix.

*For the purpose of the G-FINDER survey, ‘developing countries’ means low- and middle-income countries (LMICs), as defined by the World Bank.

I. BASIC RESEARCH

II. DRUGS

III. PREVENTIVE VACCINES

IV. THERAPEUTIC VACCINES

V. DIAGNOSTICS

VI. MICROBICIDES

VII. VECTOR CONTROL PRODUCTS

VIII. CAN NOT BE ALLOCATED TO ONE DISEASE

IX. OUT OF SCOPE (EXCLUDED FROM THE SURVEY)



I. BASIC RESEARCH

Studies that increase scientific knowledge and understanding about the disease, disease processes, pathogen or vector, but which is not yet directed towards a specific product

1. NATURAL HISTORY AND EPIDEMIOLOGY

1.1 Basic mechanisms of disease transmission
1.2 Disease prevalence in relation to human genotype, strain variation, and inoculation rates
1.3 Genetic diversity and phylogeny
1.4 Epidemiological research on the roles of human behaviour and effects of specific host genotypes on disease transmission
1.5 Epidemiological research on host genetic factors influencing the prevalence of disease (e.g., sickle cell, HLA type, Rh factor) or the impact of disease in select host genotypes
1.6 Epidemiological research on the distribution of pathogen, vectors and the prevalence of morbidity and mortality due to the disease that is NOT related to specific product development
1.7 Epidemiological research on antigenic variability; population studies of human immunity to the disease
1.8 Epidemiology of drug resistance or evolutionary studies on resistance development for established, existing drugs
1.9 Epidemiological research related to vector behaviour and ecology, and vector control

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2. IMMUNOLOGY OF DISEASE

2.1 Defining signalling pathways of immune function (mechanisms of systemic and/or mucosal immunity)
2.2 Interaction and impact of the signalling pathways with the pathogen
2.3 Development of assays or tools potentially useful for drug, vaccine, or microbicide research & development
2.4 Identification of immune correlates of protection, including in vivo and in vitro studies on the protective immune response (cellular, humoral, and/or mucosal)
2.5 Investigating the immune response to particular antigens; studies of specific antigens or immunogens proposed as vaccine candidates
2.6 Development of animal models to determine immune correlates of protection
2.7 Genetics of the immune response to the disease and effects of antigen polymorphism or genetic diversity on specific vaccine candidates (as recognised from field studies)

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3. BIOLOGY OF DISEASE

3.1 Structure and morphology of different developmental stages
3.2 Host-parasite interactions and biology of pathogen interaction with vector host
3.3 Biology of invasion of host cells (entry mechanisms)
3.4 Localisation of pathogen proteins or antigens
3.5 Development of culture and purification tools to assist in study of the pathogen
3.6 Descriptions of pathogenic species and characterisation of strains or subtypes in animal models (course of infection, susceptibility of different hosts)
3.7 In vitro studies of interactions between the pathogen and other infectious agents (e.g. Epstein-Barr virus)

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4. BIOCHEMISTRY OF THE PATHOGEN

4.1 Metabolism and nutrition
4.2 Protein sequencing, enzymology, and protein and enzyme characterisation (including antigen analysis)
4.3 Signal transduction; translation, processing and export of proteins
4.4 Glycosylation, Glycosylphosphatidylinositol (GPI) anchors, transporters, ion channels, mitochondrial metabolism, and electrophysiology studies
4.5 Influence of pathogen on host-cell biochemistry
4.6 Characterisation of antigen/protein diversity of pathogenic strains and subtypes
4.7 Characterisation of proteins and molecular basis for host-cell invasion
4.8 Analysis & characterisation of drug-resistant strains and studies probing drug resistance mechanism/s or pathways
4.9 Non-specific research on pathogen or host targets to identify potential drug, vaccine, or diagnostic targets (i.e. target identification)

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5. GENETICS OF THE PATHOGEN

5.1 Studies on chromosomes; genomic maps; genetic crosses
5.2 Cloning and sequencing of genes; cDNAs for functional proteins (including drug targets and vaccine candidates)
5.3 Expression of proteins from cloned genes; RNA analyses
5.4 Control and timing of gene expression; post-transcriptional processing
5.5 Analysis and characterisation of genes involved in drug resistance
5.6 Genetics of antigenic variability
5.7 Techniques for the genetic transformation of the pathogen
5.8 Tests for genotyping the pathogen for laboratory use

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6. BIOINFORMATICS AND PROTEOMICS

6.1 Microarray analysis
6.2 Genome annotation - gene predictions
6.3 Comparative genomics, sequence alignment, genome assembly
6.4 Variation, single nucleotide polymorphisms (SNPs)
6.5 Database applications, data mining tools
6.6 Structural and functional genomics
6.7 Structural and functional proteomics
6.8 Proteome analysis, protein structure alignment

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7. PATHOPHYSIOLOGY AND DISEASE SYMPTOMS

7.1 Clinical diagnosis and clinical observations of the disease presentation and pathophysiology in humans and in animals
7.2 The role of nutritional status in determining disease severity and treatment effectiveness
7.3 Histopathology of the disease in humans and in animals
7.4 The mechanisms of pathology of the disease; including, the role of the host immune system, and expression of adhesion molecules
7.5 Development of improved animal models to study disease pathophysiology, to evaluate the biological properties of drugs and microbicides
7.6 Identification of biomarkers for diagnostics or therapeutic monitoring
7.7 Studies of the mechanisms by which particular susceptible/resistant mammalian host genotypes exert their effect
7.8 Research on effects of host co-morbidities and secondary effects of pathogen invasion (e.g., research on anaemia /neurological effects of malaria)
7.9 Interactions between the disease and other relevant concurrent infections, including determining timing and establishment of infection

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8. VECTOR BIOLOGY, BIOCHEMISTRY, AND GENETICS

8.1 Characterisation of vector behaviour and ecology
8.2 Studies of vector susceptibility to infection; studies of parasites and pathogens of vectors (including potential biological control agents)
8.3 Identification of genes responsible for disruption of parasite/virus growth, genetic transformation of vectors, and insect transposable elements
8.4 Target identification of vector sites that may become the subject of in vitro screening or molecular design
8.5 Development of tests for vector identification, taxonomy and systematics, and for the identification of infected vectors
8.6 Studies evaluating resistance development, including the genetics and transmission of pesticide resistance

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II. DRUGS

Research activities and processes necessary to develop and improve new compounds specifically designed to prevent, cure or treat neglected diseases; including drug discovery or design, preclinical and clinical development and other activities essential for successful drug development and uptake.


9. DISCOVERY AND PRECLINICAL

Research activities targeted at discovering and optimising investigational compounds and including the processes needed to allow new chemical entities to proceed to human trials; including:

9.1 Target validation, characterisation, & selection
9.2 High throughput screening, lead optimisation
9.3 Development of analytical tests for assaying drugs, including the development of animal models
9.4 Research on drugs from natural products; identification and characterisation of active ingredient
9.5 Research on the effects of drug treatment on immune status
9.6 Measurement of the activity of potential drugs in vitro and in animal models; including safety and efficacy studies necessary to satisfy Investigational New Drug (IND) requirements
9.7 Studies evaluating the activity of new drugs on drug-resistant strains, their effect on genes involved in drug resistance, or their effect on resistance pathways
9.8 Development of tests for drug susceptibility of the pathogen for research purposes
9.9 Drug pharmacokinetic, toxicity and metabolism studies in vitro and in animal models, including bioavailability, adsorption, metabolism, and excretion (ADME) studies
9.10 Chemistry and synthesis of drugs, including process and scale-up manufacture, production of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) batch for toxicology studies; and other Chemistry and Manufacture Control (CMC) activities required to allow new chemical entities to proceed to human trials
9.11 Preparation of Investigational New Drug (IND) application for regulatory submission
9.12 Optimisation and manufacturing of new formulations to support label-extension^ for new patient sub-populations (e.g. infants, pregnant women)

^Label-extensions refer to changes to drugs or their labels after they have been approved. This includes changes in manufacturing, recommended patient population and/or formulation. To change a label, market a new dosage or strength of a drug, or change the way a drug is manufactured, the company must submit a supplemental new drug application (sNDA) to regulatory authorities to obtain marketing approval.


10. CLINICAL DEVELOPMENT

Research activities and processes associated with clinical testing of investigational new drugs so as to demonstrate safety and efficacy in human subjects (as needed for regulatory approval), together with other costs required to support such clinical trials; including:

10.1 Phase I pharmacokinetic, toxicity and metabolism studies in healthy human subjects
10.2 Phase II testing of drugs and drug combinations in human patients to establish safety and efficacy including dose-finding, and proof of principle studies
10.3 Phase III clinical trials for registration purposes
10.4 Regulatory standard clinical trials that support a formal registration for label-extension^ of an existing drug to a new disease or patient group (e.g. paediatric patients, pregnant women or HIV-positive patients)
10.5 Regulatory standard clinical trials that support formal registration for label-extension^ of an existing drug to a new use, such as intermittent preventative therapy and pre-exposure prophylaxis
10.6 Infrastructure and site development costs directly associated with the conduct of clinical trials for drug development in endemic countries (e.g. refurbishment of hospital wing, vehicle purchase, generators, training and community relationship building)
10.7 Further pharmaceutical development to generate the final clinical formulation, dosage form and other Chemistry and Manufacture Control (CMC) activities required for regulatory submission
10.8 Compiling of all non-clinical and clinical data for submission of a New Drug Application (NDA) to regulatory authorities
10.9 Behavioural research during clinical trials relating to risk assessment, factors affecting adherence to protocol, and product acceptability
10.10 Protocol development, investigator meetings, Good Clinical Practice (GCP) monitoring, quality control, data management, analysis and reporting, establishing a Data Safety Monitoring Board (DSMB), and trial audits

^Label-extensions refer to changes to drugs or their labels after they have been approved. This includes changes in manufacturing, recommended patient population and/or formulation. To change a label, market a new dosage or strength of a drug, or change the way a drug is manufactured, the company must submit a supplemental new drug application (sNDA) to regulatory authorities to obtain marketing approval.

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11. PHASE IV / PHARMACOVIGILANCE

Studies relating to the detection, monitoring, evaluation, and prevention of adverse events associated with newly approved drugs so as to bridge the gap between highly controlled clinical trials intended for regulatory approval and the largely uncontrolled use of new drugs by patients. Also includes studies conducted after regulatory approval that assess drug effectiveness in the wider population or which are necessary to support product use in developing countries.

11.1 Pharmacovigilance and post-registration studies of newly registered drugs to assess adverse reactions, toxicology and safety
11.2 Effectiveness studies and head-to-head comparator studies of newly registered drugs (with other therapies or interventions)
11.3 Cost-effectiveness studies of newly registered drugs
11.4 Treatment interactions and population level studies (of newly registered products e.g., pharmaco-epidemiological and resistance studies)
11.5 Behavioural research post-registration of new drugs relating to risk assessment, factors affecting adherence to protocol, provider compliance, and product acceptability
11.6 Case history reports and assessment of long-term prophylaxis using newly registered drugs in communities in endemic areas

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12. BASELINE EPIDEMIOLOGY

Studies evaluating potential trial site populations to confirm disease incidence, prevalence or exposure risk, and which serve as the foundation for determining the optimal collection, analysis, interpretation and presentation of clinical trial data, including:

12.1 Epidemiological studies directly linked to the conduct or support of clinical trials of products in development, in order to assess or validate the epidemiology of disease, disease incidence, or health of target populations at trial sites
12.2 Preliminary studies of morbidity and mortality at potential clinical trial sites, where these studies are directly linked to planned product trials
12.3 Pre-trial activities designed to understand trial site conditions before the commencement of trials and to facilitate engagement


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III. PREVENTIVE VACCINES

Research activities and processes necessary to develop and improve investigational vaccines specifically intended to prevent infection; including vaccine design, preclinical and clinical development and other activities essential for successful vaccine development and uptake


13. DISCOVERY AND PRECLINICAL

Research activities targeted at discovering and optimising investigational vaccines and including the processes necessary to allow a candidate vaccine to proceed to human trials; including:

13.1 Studies supporting novel vaccine design, including target validation & candidate optimisation
13.2 Development of animal models to assist in vaccine design and testing
13.3 Evaluation of vaccine technologies (e.g. adjuvants, delivery systems) to improve the immunogenicity of an identified candidate
13.4 Pre-clinical safety and immunogenicity studies with candidate vaccines, including use or development of functional assays
13.5 Pre-clinical animal studies, challenge models and addressing the correlation between in vitro models, animal models and field results
13.6 Studies on the genetics of the immune response to selected antigens as vaccine candidates, optimisation of animal models and correlates to clinical results
13.7 Manufacturing scale-up and consistency of manufacture, including production of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) batches for regulatory toxicology studies and other Chemistry and Manufacture Control (CMC) activities required to allow a candidate vaccine to proceed to human trials
13.8 Research on safety and regulatory considerations (e.g. validation of preclinical assays to permit registration)
13.9 Preparation of an Investigational New Drug (IND) application for regulatory submission
13.10 Optimisation of vaccine candidates for global use (cheaper, more stable, ease of administration, addition of developing country-specific strains)

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14. CLINICAL DEVELOPMENT

Activities and processes associated with clinical testing of investigational vaccines so as to demonstrate safety, immunogenicity and efficacy in human subjects (as needed for regulatory approval), together with other costs required to support such clinical trials, including:

14.1 Phase Ia studies assessing safety, dosing, and immunogenicity in human volunteers; Phase Ib studies assessing safety, dosing, and immunogenicity in clinically exposed or high-risk populations
14.2 Phase IIa challenge studies; Phase II safety and preliminary efficacy studies in exposed populations or those at high-risk of infection
14.3 Phase III expanded efficacy, effectiveness and safety studies required for registration purposes, including implementation, retention and follow-up of volunteers
14.4 Infrastructure and site development costs associated with the conduct of clinical trials for vaccine development in endemic countries (e.g. refurbishment of hospital wing, vehicle purchase, generators, training and community relationship building)
14.5 Further biological/product development to generate the optimal clinical formulation and dosage form, and other Chemistry and Manufacture Control (CMC) activities required for regulatory submission
14.6 Compiling all non-clinical and clinical data to obtain a Biologics License from regulatory authorities
14.7 Behavioural research during clinical trials relating to risk assessment, factors affecting adherence to protocol, and product acceptability
14.8 Protocol development, investigator meetings, Good Clinical Practice (GCP)-monitoring, quality control, data management, analysis and reporting, establishing a Data Safety Monitoring Board (DSMB) and trial audits

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15. PHASE IV / PHARMACOVIGILANCE

Studies relating to the detection, monitoring, evaluation, and prevention of adverse events associated with newly approved vaccines so as to bridge the gap between highly controlled clinical trials intended for regulatory approval and the largely uncontrolled delivery of new vaccines. Also includes studies conducted after regulatory approval that assess vaccine effectiveness in the wider population or which are necessary to support product use in developing countries.

15.1 Pharmacovigilance and post-registration studies of newly registered preventive vaccines to assess adverse reactions, toxicology and safety
15.2 Effectiveness studies and head-to-head comparator studies of newly registered preventive vaccines (with other therapies or interventions)
15.3 Cost-effectiveness studies of newly registered preventive vaccines
15.4 Treatment interactions and population level studies (of newly registered preventive vaccines e.g., pharmaco-epidemiological and resistance studies)
15.5 Behavioural research post-registration of new preventive vaccines relating to risk assessment, factors affecting adherence to protocol, provider compliance, and product acceptability
15.6 Case history reports and assessment of long-term prophylaxis using newly registered preventive vaccines in communities in endemic areas

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16. BASELINE EPIDEMIOLOGY

Studies evaluating potential trial site populations to confirm disease incidence, prevalence or exposure risk, and which serve as the foundation for determining the optimal collection, analysis, interpretation and presentation of clinical trial data, including:

16.1 Epidemiological studies directly linked to the conduct or support of clinical trials of preventive vaccines in development, in order to assess or validate the epidemiology of disease, disease incidence, or health of target populations at trial sites
16.2 Preliminary studies of morbidity and mortality at potential clinical trial sites, where these studies are directly linked to planned preventive vaccines trials
16.3 Pre-trial activities designed to understand trial site conditions before the commencement of trials and to facilitate engagement

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IV. THERAPEUTIC VACCINES

Research activities and processes necessary to develop and improve investigational vaccines specifically intended to treat infection; including vaccine design, preclinical and clinical development, and other activities essential for successful vaccine development and uptake


17. DISCOVERY AND PRECLINICAL

Research activities targeted at discovering and optimising investigational therapeutic vaccines and including the processes necessary to allow a candidate vaccine to proceed to human trials; including:

17.1 Studies supporting novel vaccine design including target validation and candidate optimisation
17.2 Evaluation of vaccine technologies (e.g. adjuvants, delivery systems) to improve the immunogenicity of an identified candidate
17.3 Pre-clinical safety and immunogenicity studies with candidate vaccines, including use or development of functional assays
17.4 Pre-clinical animal studies, challenge models, and studies addressing the correlation between in vitro models, animal models and field results
17.5 Studies on the genetics of the immune response to selected antigens as vaccine candidates, optimisation of animal models and correlates to clinical results
17.6 Manufacturing scale-up and consistency of manufacture, including production of Good Laboratory Practice (GLP)and Good Manufacturing Practice (GMP) batches for regulatory toxicology studies and other Chemistry and Manufacture Control (CMC) activities required to allow a candidate vaccine to proceed to human trials
17.7 Research on safety and regulatory considerations (e.g. validation of preclinical assays to permit registration)
17.8 Preparation of an Investigational New Drug (IND) application for regulatory submission
17.9 Optimisation of vaccine candidates for global use (cheaper, more stable, ease of administration, addition of developing country-specific targets)

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18. CLINICAL DEVELOPMENT

Activities and processes associated with clinical testing of investigational therapeutic vaccines so as to demonstrate safety, immunogenicity, and efficacy in human subjects (as needed for regulatory approval), together with other costs required to support such clinical trials; including:

18.1 Phase Ia studies assessing safety, dosing and immunogenicity in human volunteers; Phase Ib studies assessing safety, dosing and immunogenicity in clinically exposed or high-risk populations
18.2 Phase IIa challenge studies; Phase II safety and preliminary efficacy studies in exposed populations or those at high-risk of infection
18.3 Phase III expanded efficacy, effectiveness and safety studies required for registration purposes, including implementation, retention and follow-up of volunteers
18.4 Infrastructure and site development costs associated with the conduct of clinical trials for vaccine development in endemic countries (e.g. refurbishment of hospital wing, vehicle purchase, generators)
18.5 Further biological/product development to generate the optimal clinical formulation, dosage form and other Chemistry and Manufacture Control (CMC) activities required for regulatory submission
18.6 Behavioural research during clinical trials relating to risk assessment, factors affecting adherence to protocol and product acceptability
18.7 Compiling of all non-clinical and clinical data to obtain a Biologics License from regulatory authorities
18.8 Protocol development, investigator meetings, Good Clinical Practice (GCP)-monitoring, quality control, data management, analysis and reporting, establishing a Data Safety Monitoring Board (DSMB) and trial audits

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19. PHASE IV / PHARMACOVIGILANCE

Studies relating to the detection, monitoring, evaluation, and prevention of adverse events associated with newly approved therapeutic vaccines so as to bridge the gap between highly controlled clinical trials intended for regulatory approval and the largely uncontrolled delivery of new therapeutic vaccines. Also includes studies conducted after regulatory approval that assess therapeutic vaccine effectiveness in the wider population or which are necessary to support product use in developing countries.

19.1 Pharmacovigilance and post-registration studies of newly registered therapeutic vaccines to assess adverse reactions, toxicology and safety
19.2 Effectiveness studies and head-to-head comparator studies of newly registered therapeutic vaccines (with other therapies or interventions)
19.3 Cost-effectiveness studies of newly registered therapeutic vaccines
19.4 Treatment interactions and population level studies (of newly registered therapeutic vaccines e.g., pharmaco-epidemiological and resistance studies)
19.5 Behavioural research post-registration of new therapeutic vaccines relating to risk assessment, factors affecting adherence to protocol, provider compliance, and product acceptability
19.6 Case history reports and assessment of long-term prophylaxis using newly registered therapeutic vaccines in communities in endemic areas

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20. BASELINE EPIDEMIOLOGY

Studies evaluating potential trial site populations to confirm disease incidence, prevalence, or exposure risk, and which serve as the foundation for determining the optimal collection, analysis, interpretation, and presentation of clinical trial data; including:

20.1 Epidemiological studies directly linked to the conduct or support of clinical trials to assess or validate the epidemiology of disease, disease incidence or health of target populations at potential trial sites
20.2 Preliminary studies of morbidity & mortality at potential clinical trial sites necessary for product development
20.3 Pre-trial activities designed to understand trial site conditions before the commencement of trials and to facilitate engagement

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V. DIAGNOSTICS

Research activities and processes necessary to develop, optimise, and validate diagnostic tests for use in resource-limited settings (cheaper, faster, more reliable, ease of use in the field); including discovery and design, preclinical and clinical evaluation, and other activities essential for successful deployment for public health use.


21. DISCOVERY AND PRECLINICAL

Research activities targeted at discovering and optimising low-cost, stable, easy-to-use diagnostics for neglected diseases and including the processes necessary to allow a potential product to proceed to clinical evaluation including:

21.1 Validation, characterisation, and selection of targets suitable for diagnostic use
21.2 Validation of new diagnostic markers or biomarkers
21.3 Development and testing of low-cost, stable, easy-to-use diagnostic tests (e.g. simpler microscopy, improved sample collection/preparation, cheaper ELISA assays), including manufacturing design
21.4 New or improved diagnostics for disease staging and therapy decisions
21.5 New or improved diagnostic tools to identify resistant pathogens
21.6 New or improved diagnostics to identify specific target populations
21.7 Tailoring diagnostic tools for developing country use, including improved point-of-care tests (rapid test), local laboratory test, reference laboratory tests and central laboratory tests
21.8 Creation of reference material banks

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22. CLINICAL EVALUATION

Activities and processes associated with clinical evaluation of investigational diagnostic tools so as to demonstrate sensitivity and specificity in human subjects, together with other costs required to support such clinical trials; including:

22.1 Clinical efficacy trials
22.2 Small-scale testing in humans to establish sensitivity and specificity and utility
22.3 Technical evaluation of tests and studies evaluating product performance
22.4 Establishment of product specifications, kit development and quality assurance
22.5 Submission of relevant data to regulatory authorities for approval
22.6 Assessment & validation of trial sites to carry out product trials
22.7 Infrastructure and site development costs directly associated with the conduct of clinical trials for diagnostic development in endemic countries (e.g. refurbishment of hospital wing, vehicle purchase, generators, training and community relationship building)

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23. OPERATIONAL RESEARCH FOR DIAGNOSTICS

Operational procedures and implementation activities associated with novel diagnostic tools, which are necessary to support World Health Organization recommendations for global public health use including:

23.1 Larger-scale demonstration studies (assessing specificity, sensitivity and utility of the diagnostic test in endemic countries)
23.2 Cost-effectiveness studies assessing the diagnostic test
23.3 Identification of pitfalls of the technology and studies of safety measures needed to support the technology
23.4 Studies to determine at what level of the health care system the technology is applicable (e.g. reference labs, regional labs)
23.5 Identification of training needs
23.6 Collecting evidence for expanding the use of a diagnostic tool in different countries
23.7 Development of equipment and customer support documents
23.8 Head-to-head comparator studies (with current gold standard) and in the context of existing diagnostic algorithms
23.9 Behavioural research relating to risk assessment, factors affecting diagnostics use, and user acceptability (patient and provider)
23.10 Epidemiological studies to assess or validate the epidemiology of disease, disease incidence or health of target populations at potential trial sites, and which are directly linked to clinical trials of a new diagnostic

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VI. MICROBICIDES

Research activities and processes necessary to develop and improve topical microbicides specifically intended to prevent HIV transmission; including microbicide discovery or design, preclinical and clinical development, and other activities essential for successful microbicide development and uptake.


24. DISCOVERY AND PRECLINICAL

Research activities targeted at identifying, optimising, and characterising investigational microbicides and including the processes necessary to allow lead compounds to proceed to human trials including:

24.1 Specific research aimed at discovery of topical applications for microbicide use (e.g. vaginal defence enhancers, surfactants, entry/fusion inhibitors and replication inhibitors)
24.2 Target validation, characterisation and selection
24.3 Preclinical evaluation of microbicide candidates including determination of acceptable formulation and delivery modes
24.4 Studies supporting safety & immunogenicity testing in animal models and looking at in vitro correlates of in vivo protective response
24.5 Developing reagents and standardised methods to assess microbicide-induced immune response in animals and humans
24.6 Optimisation of microbicide candidates, bioprocess development, formulation and mode of delivery of novel prevention tools for broad international use (cheap, easy to produce, stable, easy to administer) including production of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) grade product for regulatory toxicology studies
24.7 Preparation of an Investigational New Drug (IND) application for regulatory submission

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25. CLINICAL DEVELOPMENT

Activities and processes associated with clinical testing of investigational new microbicides to demonstrate safety and efficacy in human subjects (as needed for regulatory approval), together with other costs required to support such clinical trials, including:

25.1 Phase I trials of novel microbicide products aimed at determining early safety and efficacy in healthy human subjects
25.2 Phase II clinical trials that evaluate safety and efficacy of the microbicide in a controlled setting, including dose-finding and proof-of-principle studies
25.3 Phase III trials of novel microbicide products aimed at confirming efficacy and safety in expanded populations
25.4 Infrastructure and site development costs associated with the conduct of clinical trials for microbicide development in endemic countries (e.g., refurbishment of hospital wing, vehicle purchase, generators, training and community relationship building)
25.5 Further microbicide development to generate the final clinical formulation, dosage form and other Chemistry and Manufacture Control (CMC) activities required for regulatory submission
25.6 Compiling of all non-clinical and clinical data for submission of a New Drug Application (NDA) to regulatory authorities
25.7 Behavioural research during clinical trials relating to risk assessment, factors affecting adherence to protocol and product acceptability
25.8 Protocol development, investigator meetings, Good Clinical Practice (GCP)-monitoring, quality control, data management, analysis and reporting, establishing a Data Safety Monitoring Board (DSMB) and trial audits

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26. PHASE IV / PHARMACOVIGILANCE

Studies relating to the detection, monitoring, evaluation, and prevention of adverse events associated with newly approved microbicides so as to bridge the gap between highly controlled clinical trials intended for regulatory approval and the largely uncontrolled delivery of new microbicides. Also includes studies conducted after regulatory approval that assess microbicide effectiveness in the wider population or which are necessary to support product use in developing countries.

26.1 Pharmacovigilance and post-registration studies of newly registered microbicides to assess adverse reactions, toxicology and safety
26.2 Effectiveness studies and head-to-head comparator studies of newly registered microbicides (with other therapies or interventions)
26.3 Cost-effectiveness studies of newly registered microbicides
26.4 Treatment interactions and population level studies (of newly registered preventive microbicides e.g., pharmaco-epidemiological and resistance studies)
26.5 Behavioural research post-registration of new microbicides relating to risk assessment, factors affecting adherence to protocol, provider compliance, and product acceptability
26.6 Case history reports and assessment of long-term prophylaxis using newly registered microbicides in communities in endemic areas

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27. BASELINE EPIDEMIOLOGY

Studies evaluating potential trial site populations to confirm disease incidence, prevalence or exposure risk, and which serve as the foundation for determining the optimal collection, analysis, interpretation and presentation of clinical trial data, including:

27.1 Epidemiological studies directly linked to the conduct or support of clinical trials of microbicides in development, in order to assess or validate the epidemiology of disease, disease incidence, or health of target populations at trial sites
27.2 Preliminary studies of morbidity and mortality at potential clinical trial sites, where these studies are directly linked to planned microbicide trials
27.3 Pre-trial activities designed to understand trial site conditions before the commencement of trials and to facilitate engagement

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VII. VECTOR CONTROL PRODUCTS

Research and development activities and processes necessary to develop and improve vector control approaches intended to prevent infection and block transmission of a neglected disease from vector and/or animal reservoirs to human; including novel pesticides, biological control products and vaccines targeting animal reservoirs.

28. PESTICIDES

This product category ONLY includes chemical pesticides intended for global public health use and which specifically aim to inhibit and kill vectors associated with transmitting neglected diseases.

Baits, traps, predation measures, biological larvicides, habitat control and infrastructure measures are EXCLUDED from this product category.

28.1 Primary and secondary screening and optimisation

Laboratory-based design, synthesis and testing of potential insecticides, chemical larvicides, molluscides, trypanocides etc. and generation of data sufficient to allow developers to proceed field testing, including:

28.1.1 Primary and secondary screens (e.g. in vitro and in vivo screens, chemical screens, whole insect screens)
28.1.2 Target validation and characterisation
28.1.3 Lead optimisation, synthesis optimisation
28.1.4 Early toxicology screens (e.g. acute oral toxicity, eye and skin irritation studies, AMES/mutagenicity studies)
28.1.5 Applied laboratory research and small-scale field trials, including in vitro and glass house efficacy testing
28.1.6 Acute toxicology and ecotoxicology studies (e.g. animal studies, exposure studies, fish and wildlife studies)
28.1.7 Metabolism and stability studies in plants and animals including mode of action, residue analysis and cross-resistance studies
28.1.8 Environmental effect and decomposition studies in soil, water and air

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28.2 Development

Pre-registration activities and processes associated with clinical testing of investigational chemical pesticides so as to generate data sufficient to allow developers to proceed to product roll-out & dissemination and including other costs required to support such clinical trials.

28.2.1 Small-scale efficacy studies, residue plots and field studies necessary for product optimisation and registration
28.2.2 Acute and long-term toxicology and ecotoxicology studies
28.2.3 Metabolic and residual fate studies, crop residue and exposure data
28.2.4 Environmental assessment and environmental chemistry data
28.2.5 Generation of hazard data in humans, domestic animals and non-target plants and animals
28.2.6 Compiling of all laboratory and field data necessary for submission to regulatory authorities
28.2.7 Behavioural research conducted pre-registration relating to risk assessment, factors affecting adherence to protocol, and product acceptability
28.2.8 Manufacturing process development, formulation and scale-up

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28.3 WHOPES Evaluation

Post-registration activities that comprise entomological, safety and epidemiological evaluation (where appropriate) and development of specifications required for application of pesticide products for use in international public health programmes, including:

28.3.1 WHOPES Phase I Laboratory studies (e.g. determining intrinsic insecticidal activity, diagnostic concentration, irritant or excito-repellent properties, cross-resistance to other insecticides, efficacy and residual activity on relevant substrates)
28.3.2 WHOPES Phase II small-scale field trials (e.g. efficacy and persistence under different ecological settings, dosage of application, handling and application, perceived side-effects)
28.3.3 WHOPES Phase III large-scale field trials (e.g. efficacy and residual activity, operational and community acceptance)
28.3.4 Assessment & validation of trial sites directly linked to product trials
28.3.5 Infrastructure and site development costs associated with the conduct of clinical trials for pesticide development in endemic countries (e.g. refurbishment of hospital wing, vehicle purchase, generators, training and community relationship building)
28.3.6 Behavioural research conducted post-registration relating to risk assessment, factors affecting adherence to protocol, provider compliance and product acceptability
28.3.7 Studies that confirm efficacy, improve product uptake or confirm safety (e.g. studies to measure impact, usage levels, contamination potential or storage and disposal needs)
28.3.8 Surveillance studies directly linked to the conduct of field trials for vector control products; including studies that determine prevalence, track distribution, abundance, or significant habits of target vectors or the vector-borne pathogen

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29. BIOLOGICAL CONTROL PRODUCTS

This product category ONLY includes research and development of innovative biological control interventions that specifically aim to kill or control vectors associated with transmitting neglected diseases (e.g. microbial/bacteriological larvicides, sterilisation techniques, and genetic modification measures).

Biological control interventions comprise the use of natural enemies or "engineered" products to manage vector populations either through the introduction of natural parasites, pathogens or predators of the target, or via the introduction of modified vector species to compete with natural sources.

Baits, traps, predation measures, habitat control, chemical pesticides, and infrastructure measures are excluded from this product category.

30. VACCINES TARGETING ANIMAL RESERVOIRS

This product category ONLY includes research and development of veterinary vaccines specifically designed to prevent animal to human transmission of neglected diseases. Vaccines developed and used solely for veterinary purposes are excluded from this product category.

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VIII. CANNOT BE ALLOCATED TO ONE DISEASE



31 CORE FUNDING OF A MULTI-DISEASE R&D ORGANISATION

This category applies to organisations that have disbursed core funding or non-earmarked funding to an organisation that researches and develops products for multiple neglected diseases and, where it is unknown how the funding has been allocated within the recipient organisation.

Example:

i. Core funding has been allocated to an organisation that researches tuberculosis, Buruli ulcer and leprosy but the donor does not know how much has been allocated to each disease

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32. ADJUVANTS AND IMMUNOMODULATORS

Adjuvants and immunomodulators are compounds or structures that aim to improve, modulate or potentiate the immune response. These include compounds such as CpG oligonucleotides, lipopolysaccharide derivatives, Toll-like receptor agonists, chemokines and cytokines.

This category has strict restrictions:

32.1 ONLY includes funding for R&D which meets the following conditions:
a) It is conducted by public, philanthropic or not-for-profit entities
b) It is research that is not directed towards a specific disease or product
c) It is aimed at developing safer, cheaper, more immunogenic adjuvants and immunomodulators suitable for use in developing country products
d) The resulting research findings or leads MUST be accessible to organisations developing pharmaceutical or biological products for neglected diseases


If the adjuvant or immunomodulator is being developed as part of a specific product, this investment is included under the relevant disease and product category (e.g. adjuvant R&D as part of a malaria vaccine construct is included under malaria vaccines)

Examples of R&D for adjuvants and immunomodulators INCLUDED in the survey scope:

i. Understanding the innate or adaptive immune response, e.g. studies of Toll-like receptors for the purpose of adjuvant discovery
ii. Strategies for targeting the cellular immune response to improve the quality of known adjuvants
iii. Developing a systematic approach to adjuvant discovery (e.g. predictive in vitro assays)
iv. High throughput screening to identify potential adjuvants

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33. DELIVERY TECHNOLOGIES AND DEVICES

Delivery technologies and devices comprise mucosal delivery tools, vaccine carrier systems, and alternative delivery technologies that facilitate the successful delivery of pharmaceutical or biological products in a resource-limited setting (e.g. dendritic cell systems, emulsions, novel viral vectors, sprays, patches and needle-free devices).

This category has strict restrictions:

33.1 ONLY includes funding for R&D which meets the following conditions:
a) It is conducted by public, philanthropic or not-for-profit entities
b) It is research that is not directed towards a specific disease or product
c) It is research aimed at developing cheaper, faster, more user friendly delivery technologies and devices, intended for use in resource-limited settings.

Examples of R&D for delivery technologies and devices INCLUDED in the survey scope:

i Development of an intra-nasal vaccine delivery platform or the development of a plant-based sub-unit vaccine delivery system
ii Discovery and optimisation of mechanisms for controlled release

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34. GENERAL DIAGNOSTIC PLATFORMS

This category has strict restrictions.

34.1 ONLY includes funding for R&D which meets the following conditions:
a) It is conducted by public, philanthropic or not-for-profit entities
b) It is research that is not directed towards a specific disease or product
c) It is research aimed at developing cheaper, faster, more user friendly diagnostic platforms or technologies, intended for use in resource-limited settings.

 

Examples of R&D for general diagnostic platforms INCLUDED in the survey scope:

i Simplification of a diagnostic approach to reduce costs e.g. lateral flow tests for malaria
ii Re-designing tests/ equipment to use cheap, standard reagents
iii Work to make standard tests cheaper and simpler, e.g. simpler ELISA assays; simpler Nucleic Acid Amplification tests; simpler DSTs


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35. UNSPECIFIED R&D

The unspecified R&D category is for funding disbursed or received for research and development efforts that simultaneously focus on two or more neglected diseases, and which therefore cannot be apportioned to the specific disease categories.

Examples of unspecified R&D:

i Research into the interaction between HIV and tuberculosis
  - If research is part of the normal development path of a product for a specific disease (e.g. testing new TB drugs in special populations such as AIDS patients), it is included under the specific disease and product category where the product will be used (e.g. TB drugs)
ii Development of a diagnostic to differentiate between different causes of fever (e.g. between malaria and meningitis)
iii Development of a multi-disease diagnostic (e.g. the test can identify tuberculosis, malaria or sleeping sickness depending on the reagents used)
iv Development of a multi-disease vaccine (e.g. a combination pneumonia/meningitis vaccine)

 

 


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IX. OUT OF SCOPE (EXCLUDED FROM THE SURVEY)

36. GENERAL EXCLUSIONS


The G-FINDER survey only captures investments that support pharmaceutical R&D where products aimed at preventing, treating or curing neglected diseases for patients in developing countries either do not already exist, or are inappropriate for developing country contexts.

The following categories are therefore EXCLUDED from the survey:

36.1 Non-pharmaceutical tools

36.1.1 Adult male circumcision, cervical barriers, HSV-2 prevention, untreated bednets, traps, water sanitation tools


36.2 General supportive, nutritional and symptomatic therapies

36.2.1 Oral rehydration therapy
36.2.2 Micronutrient supplementation, vitamins
36.2.3 Anti-pyretics, painkillers


36.3 Products developed and used for veterinary purposes

36.4 In-kind contributions

36.4.1 In-kind R&D contributions are excluded from the survey due to the difficulty in quantifying their value; however a sample of these contributions is highlighted in G-FINDER reporting. Typical in-kind contributions would include training of developing country scientists, sharing of expertise or access to compounds


36.5 Additional exclusions for private sector investment

36.5.1 Industry overhead costs, capital costs and opportunity costs are excluded, due to the difficulty of quantifying these and allocating them to the neglected disease investment. However, the published report will acknowledge the role of these in contributing to costs.

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37. NON-PRODUCT R&D EXCLUSIONS

The intention of the G-FINDER survey is to capture investments into neglected disease product development as accurately as possible.

The following R&D activities are therefore EXCLUDED from the survey:

37.1 Clinical studies not linked to development of a NEW product

37.1.1 Protocol studies and clinical trials using established, available products (not linked to formal label-extension trials of new products).
37.1.2 Epidemiological surveillance and monitoring studies that are not directly linked to product development. For example, routine DSS (Demographic Surveillance System) activities.


37.2 Health services and access research

37.2.1 Any clinical study not linked to development of a product - disease management, studies of community attitudes, knowledge and practice in relation to neglected disease treatment and control programs
37.2.2 Health care service studies in relation to delivery of neglected disease treatment and control measures
37.2.3 Design of treatment and control programs appropriate to local prevailing conditions
37.2.4 Implementation and evaluation of large-scale neglected disease treatment and control programs operated through health care services, government ministries, non-governmental organizations (NGOs), etc.
37.2.5 Roll-out of proven vector control products (e.g. traps and nets, DDT)
37.2.6 Advocacy, community education and policy activities related to use, access, or roll-out of new products


37.3 Operational Programme Assessment

37.3.1 Reviews on the status of neglected disease product development
37.3.2 Studies on the economic impact of neglected disease morbidity and mortality on communities
37.3.3 Studies on the economics of neglected disease prevention and control measures
37.3.4 Mathematical modelling of the disease (e.g. transmission, immune response)
37.3.5 Fostering collaboration between academia, industry, government agencies, and NGOs.



37.4 General Capacity Building (human & infrastructure)

Capacity building activities are excluded unless they are DIRECTLY linked to development of a new neglected disease product.

The following capacity building activities are therefore excluded:

37.4.1 Building academic research capacity; improving existing academic capacity (except where directly linked to development of a specific product)
37.4.2 Providing training opportunities; strengthening R&D institutional capacity; developing and maintaining personnel (except where directly linked to development of a specific product)
37.4.3 Major infrastructure development (e.g. design, construction and validation of large-scale manufacturing facilities)

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38. SELECTED DISEASE AND PRODUCT RESTRICTIONS

Diseases where commercial incentives for R&D already exist; (including diseases prevalent in both high-income and developing countries, where product R&D already occurs in response to high-income country markets) are EXCLUDED from this survey.

38.1 Basic research

RESTRICTIONS: Basic research is RESTRICTED for the following diseases:

38.1.1 HIV/AIDS

ONLY includes basic research that is related to preventive vaccines (e.g. immunological responses to potential antigens) and microbicides (e.g. mechanism of mucosal transmission), or basic research that is explicitly targeted at developing country needs.
38.1.2 Bacterial pneumonia & meningitidis

ONLY includes basic research related to the natural history, epidemiology, biochemistry, and genetics of S. pneumoniae and/or N. meningitides in developing country contexts (e.g. epidemiological research on serotype/serogroup distribution in developing countries; impact of age, HIV status, and malnutrition on disease prevention strategies; impact of the nasopharyngeal microbiome on disease transmission dynamics)


EXCLUSIONS: Basic research is EXCLUDED for diseases that have a commercial market, based on the assumption that investments into basic research are driven by commercial markets. Basic research is therefore excluded for the following diseases:

38.1.3 Diarrhoea caused by Enterotoxigenic E.coli (ETEC), Enteroaggregative E.coli (E.AggEC), Giardia or rotavirus
38.1.4 Trachoma
38.1.5 Rheumatic fever
38.1.6 Cryptococcal meningitis
38.1.7 Hepatitis C (HCV) genotypes 4, 5, 6
38.1.8 Leptospirosis



38.2 Drugs

RESTRICTIONS: R&D for drugs is RESTRICTED for the following diseases:

38.2.1 HIV/AIDS

ONLY includes developing country-specific costs for label-extension^ clinical trials of new drugs and reformulations for developing country use (e.g. paediatric or slow-release formulations; fixed dose combinations; low dose drug formulations for prophylaxis; long-acting injectables for treatment or prophylaxis) or preclinical research targeted at developing such products.
38.2.2 Diarrhoea caused by cholera, shigella, cryptosporidium and multiple diarrhoeal diseases

ONLY includes pharmacological interventions that target the pathogen. Supportive therapies (e.g. zinc treatment, oral rehydration therapy, or other fluid and nutritional supplements) are EXCLUDED
38.2.3 Hepatitis C genotypes 4, 5, 6

ONLY includes developing country specific research and/or research that has been designed specifically for genotypes 4, 5 or 6 (e.g. a clinical trial that includes developing country cohorts)

^Label-extensions refer to changes to drugs or their labels after they have been approved. This includes changes in manufacturing, recommended patient population and/or formulation. To change a label, market a new dosage or strength of a drug, or change the way a drug is manufactured, the Company must submit a supplemental new drug application (sNDA) to regulatory authorities to obtain marketing approval.

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EXCLUSIONS: R&D for drugs is EXCLUDED for the following diseases:

38.2.4 Bacterial pneumonia & meningitis
38.2.5 Diarrhoea caused by Enterotoxigenic E.coli (ETEC), Enteroaggregative E.coli (E.AggEC), Giardia or rotavirus
38.2.6 Trachoma
38.2.7 Rheumatic fever
38.2.8 Leptospirosis



38.3 Preventive Vaccines

RESTRICTED R&D for preventive vaccines for the following diseases:

38.3.1 Bacterial pneumonia caused by S. pneumoniae

ONLY includes R&D on vaccines being developed specifically for developing country needs, or in support of registration of suitable vaccines in developing countries. Such a vaccine must at a minimum:
a) be designed for use in infants less than two years of age;
b) provide broad coverage across all S. pneumoniae serotypes, or focused protection against strains prevalent in developing countries (at minimum serotypes 1, 5, and 14); and
c) involve low-cost whole cell, non-conjugate, or combination conjugate-non-conjugate technologies.
For multi-valent vaccines covering both high-income country and developing country strains, only developing country-specific costs are included; for example, for trials, registration, and Phase IV / pharmacovigilance studies in the target developing countries)
38.3.2 Bacterial meningitis caused by N. meningitidis

ONLY includes R&D on vaccines specifically for developing-country registration. Such a vaccine must, at a minimum:
a) provide coverage against N. meningitidis serotype A;
b) be a conjugate vaccine;
c) be designed for use in infants less than two years of age; and
d) be designed to cost less than one US dollar per dose
For multi-valent vaccines covering high-income country and developing country strains, only developing country-specific costs are included; for example, for trials, registration and Phase IV / pharmacovigilance studies in the target developing countries.
38.3.3 Diarrhoea caused by rotavirus

ONLY includes developing country-specific R&D, including clinical trials, registration and Phase IV / pharmacovigilance studies in the target developing countries

 

EXCLUSIONS: R&D for preventive vaccines is EXCLUDED for the following diseases:

38.3.4 Diarrhoea caused by Giardia
38.3.5 Roundworm (ascariasis)
38.3.6 Whipworm
38.3.7 Tapeworm (Cysticercosis/Taeniasis)
38.3.8 Lymphatic filariasis (elephantiasis)
38.3.9 Leprosy
38.3.10 Dengue
38.3.11 Cryptococcal meningitis
38.3.12 Leptospirosis


38.4 Diagnostics

R&D for diagnostics is RESTRICTED to the development of cheap, stable, easy-to-use diagnostics suited to resource-limited settings.

RESTRICTIONS: R&D for diagnostics is RESTRICTED for the following disease:

38.4.1
Leptospirosis

ONLY includes R&D on diagnostics suited to resource-limited settings. Such a diagnostic must at a minimum:
a) detect the disease during the septicemic or early acute phase of disease;
b) be accurate, easy to interpret, with little or no processing and give the results within 1-2 hours; and
c) be cheap, stable, easy-to use (i.e. should not require specific equipment and/or laboratory and highly trained staff)

 

EXCLUSIONS: R&D for diagnostics is EXCLUDED for the following diseases:

38.4.2 Diarrhoea caused by rotavirus
38.4.3 Roundworm (ascariasis)
38.4.4 Hookworm
38.4.5 Whipworm
38.4.6 Tapeworm (Cysticercosis/Taeniasis)
38.4.7 Rheumatic fever
38.4.8 Cryptococcal meningitis



38.5 Microbicides

EXCLUSIONS: Some R&D for microbicides is EXCLUDED

38.5.1 Applications that may have high-income country markets or be useful for other STIs (e.g. mucosal delivery technology, adjuvants) are EXCLUDED


38.6 Vaccines (Therapeutic)


RESTRICTIONS: R&D for therapeutic vaccines is RESTRICTED for the following diseases:

38.6.1 HIV/AIDS

ONLY includes R&D on therapeutic vaccines (e.g. broadly neutralising antibodies (bNAbs) being developed specifically for developing country needs, or in support of registration of therapeutic HIV vaccines in developing countries


EXCLUSIONS: R&D for therapeutic vaccines is EXCLUDED for the following diseases:

38.6.2 Malaria
38.6.3 Bacterial pneumonia and meningitis (S.pneumoniae and N.meningitidis)
38.6.4 Diarrhoeal diseases (rotavirus, cholera, Shigella, Enterotoxigenic E.coli [ETEC], Cryptosporidium, Enteroaggregative E.coli [E.AggEC], Giardia and multiple diarrhoeal diseases)
38.6.5 Sleeping sickness
38.6.6 Buruli ulcer
38.6.7 Dengue
38.6.8 Helminth infections (Schistosomiasis [bilharziasis], Lymphatic filarisis, Onchocerciasis [river blindness], Hookworm [anclostomiasis and necatoriasis], Tapeworm [cysticercosis and taeniasis], Strongylodiasis and other intestinal roundworms, Whipworm [trichuriasis] and Roundworm [ascariasis])
38.6.9 Leprosy
38.6.10 Rheumatic fever
38.6.11 Trachoma
38.6.12 Salmonella infections
38.6.13 Cryptococcal meningitis
38.6.14 Hepatitis C genotypes 4, 5, 6
38.6.15 Leptospirosis



38.7 Vector Control Products

38.7.1 Pesticides

This product category ONLY includes chemical pesticides intended for global public health use and which specifically aim to inhibit and kill vectors associated with transmitting poverty-related diseases.
Baits, traps, predation measures, biological larvicides, habitat control and infrastructure measures are EXCLUDED from this product category.
38.7.2 Biological Control Products

This product category ONLY includes research and development of innovative biological control interventions that specifically aim to kill or control vectors associated with transmitting poverty-related diseases (e.g. microbial/bacteriological larvicides, sterilisation techniques, and genetic modification measures)

Baits, traps, predation measures, habitat control, chemical pesticides, and infrastructure measures are EXCLUDED from this product category.
38.7.3 Vaccines targeting animal reservoirs

This product category ONLY includes research and development of veterinary vaccines specifically designed to prevent animal to human transmission of neglected diseases.
Vaccines developed and used solely for veterinary purposes are EXCLUDED from this product category.



38.8 Cannot be allocated to one disease

RESTRICTIONS: R&D that cannot be allocated to one disease is RESTRICTED for the following categories:

38.8.1 Adjuvants and immunomodulators

ONLY includes funding for R&D which meets the following conditions:
a) It is conducted by public, philanthropic or not-for-profit entities (i.e. private sector investment into adjuvants and immunomodulators is EXCLUDED)
b) It is research that is not directed towards a specific disease or product
c) It is research aimed at developing safer, cheaper, more immunogenic adjuvants and immunomodulators. d) The resulting research findings or leads must be accessible to organisations developing pharmaceutical or biological products intended to treat or prevent neglected diseases
38.8.2 Delivery technologies and devices

ONLY includes funding for R&D which meets the following conditions:
a) It is conducted by public, philanthropic or not-for-profit entities (i.e. private sector investment into delivery technologies and devices is EXCLUDED)
b) It is research that is not directed towards a specific disease or product
c) It is research aimed at developing cheaper, faster, more user friendly delivery technologies and devices, intended for use in resource-limited settings
38.8.3 General diagnostic platforms

ONLY includes funding for R&D which meets the following conditions:
a) It is conducted by public, philanthropic or not-for-profit entities (i.e. private sector investment into adjuvants and immunomodulators is EXCLUDED)
b) It is research that is not directed towards a specific disease or product
c) It is research aimed at developing cheaper, faster, more user friendly diagnostic platforms or technologies, intended for use in resource-limited settings





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