Frequently Asked Questions
What is the purpose of the Global Health Primer?
What data sources were consulted for the Global Health Primer?
How often is the Primer updated?
Disease & Target/Technology Profiles
Not all neglected diseases are covered in the Global Health Primer, how was the disease list selected?
Not all drug targets/technologies and vaccine technologies currently appear in the Global Health Primer, how was the target/technology list selected?
Why are no diagnostics technologies presented as target/technology profiles?
Neglected Disease Pipeline
How are products in development for neglected diseases identified?
Why doesn’t my neglected disease product appear in the Primer?
Why are product development pipelines presented differently for diagnostics?
For diagnostics pipelines, how are developers selected for inclusion?
For diagnostics pipelines, how are technology designations made?
What does “on hold” mean for a product in development?
Can I make a correction or change to a product I’m involved in developing?
Product Development Details
How did BVGH determine if a product is PRV eligible?
How were clinical trials selected for a product in development?
How were publications selected for a product in development?
How can I request a print copy of the Global Health Primer?
If I would like to get involved in neglected disease product development, but don’t know where to start, where can I get more help/guidance?
How should I cite the Global Health Primer?
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The purpose of the Global Health Primer is two-fold. First, the Primer is intended to be a source of compiled information on neglected diseases focusing on the drugs, vaccines, and diagnostics in use or in development to manage them. Second, and perhaps more importantly, the Primer is intended to highlight opportunities for innovators from the biotechnology and pharmaceutical industries, academia, and global health community to come together for new product development to prevent, diagnose, and treat neglected diseases.
The Global Health Primer is written using a variety of sources. Disease information and control strategies are obtained from biological and medical reference texts, scientific literature, and public reports and websites such as those provided by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), product development partnerships, and multilateral organizations. Products in development for neglected diseases were identified using the sources listed below. Although every attempt is made to validate the information contained in the Global Health Primer, the success of this resource relies on input from those actively involved in neglected disease research and development. If you have corrections, changes, or additions for the Global Health Primer, please contact us at firstname.lastname@example.org.
The Primer is formally updated once per quarter for release in April, July, October, and January. However, as changes to individual products are identified, these changes are made in BVGH’s database and are reflected immediately in the pipelines and product details of the online Primer. As these updates are a manual process, BVGH is actively seeking updates, comments, suggestions, and corrections to information presented in the Primer. If you have information you would like to share on specific products in development, please contact us at email@example.com.
Neglected diseases are categorized as a single group due to neglect rather than their biological or medical basis. Therefore, The term "neglected" has been difficult to define and challenging to gain consensus around even within the global health community. Therefore, BVGH selected 15 diseases from the compiled list of recognized neglected diseases of the WHO, the Bill and Melinda Gates Foundation, NIH, and BVGH internal analysis. Many of these neglected diseases are those where new innovation is needed. Other neglected diseases on these lists include those where tools for elimination or eradication exist and have been extensively implemented. For many of the excluded diseases, roll out of exiting tools and technologies, improving access, and gaining political will are priorities over new innovation. We hope to expand the Primer to include these additional neglected diseases in the future to highlight opportunities for innovation that complement these existing programs and activities. BVGH has also included several diseases in the Primer that are not traditionally included on neglected disease lists, such as several causative agents of pneumonia and diarrhea. For these diseases, neglect is categorized more by a health disparity whereby technologies and tools such as drugs, vaccines, and diagnostics exist but are not practical, affordable, or accessible for use in resource poor settings. For these diseases, the Primer highlights opportunities or needs for innovation to minimize these health disparities.
The target/technologies profiled are not intended to be a comprehensive list of all possible targets or technologies that are relevant to neglected diseases. The target/technology profiles presented in the Primer were identified through analysis of the product pipelines for the 15 neglected diseases profiled. Only targets and technologies relevant to multiple neglected diseases were included. The goal is to expand these target/technology profiles in future versions of the Primer.
While diagnostic technologies are also important for neglected disease R&D, these technologies were recently profiled in detail in BVGH’s publication The Diagnostics Innovation Map 2010. For more information on diagnostics that are in use or in development for neglected diseases as well as information on current diagnostic needs, please refer to individual disease profiles.
Products in development for neglected diseases are identified through a variety of sources, including:
- Product development partnership websites and reports
- Interviews with disease experts and organizations actively involved in neglected disease product development
- Searches of public databases of press releases, scientific literature, and clinical trials
- Attending scientific and global health focused meetings
Although BVGH makes every effort to validate information presented in the Global Health Primer, we are unable to reach out to every product developer individually for confirmation. Additionally, products for which information is not publicaly available may be excluded or presented with only minimal information. If you have information on products in development currently presented in the Primer or on products that have not been captured in the Primer, please contact us at firstname.lastname@example.org.
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BVGH relies on public information and active participation of those engaged in neglected disease research to identify and profile products in development. If you have information or updates on products in development please contact us at email@example.com.
Product development for diagnostics is not segmented into the same clinical phases as drugs and diagnostics. Individual diagnostic products are also sometimes difficult to capture. For instance, there are hundreds of lateral flow rapid diagnostic tests for malaria in use and/or in development. What is more significant than an individual product in development is the extent to which a particular diagnostic format or technology has been used or validated for a disease. Therefore, diagnostics in development are discussed in terms of relevant technology types in the text of the disease profiles.
For diagnostics pipelines, how are developers selected for inclusion?
For some general diagnostic techniques and for products where numerous highly similar products are in simultaneous development by different organizations, all of the developers are listed under a single product name.
In order to better highlight the diversity of underlying diagnostic technologies in development for each neglected disease, each diagnostic is categorized as nucleic acid-based, cell-based, immunoassay, rapid diagnostic test (RDT), or emerging technology.
- Nucleic acid-based tests are all DNA or RNA based tests, such as PCR, RT-PCR, microarray, or isothermal amplification-based diagnostics.
- Cell-based are all whole cell based assays, including microcopy, cell culture, and flow-cytometry. Immunoassay are antibody or antigen based assays, including western blots and ELISAs. Immunoassays in the form of simple agglutination or lateral-flow type devices are characterized as RDTs rather than immunoassays for the purposes of the Global Health Primer.
- As RDTs can encompass several underlying technology types, for the purposes of the diagnostics pipelines, if a test is fast and can be used without laboratory infrastructure it is designated as an RDT rather than its underlying technology type.
- Emerging technologies are newer technologies that do not fit into the more traditional categories listed above. More information on emerging technologies can be found in the BVGH report: The Diagnostics Innovation Map: Medical Diagnostics for the Unmet Needs of the Developing World.
For the purposes of the Global Health Primer, on hold is used to refer to any product that is no longer in active development for a neglected disease. This includes products that have failed to meet clinical endpoints as well as products that may be on hold due to financial or scientific challenges that need to be addressed before progressing. Products recently discontinued for development are also included, however on hold products are not a comprehensive or historical list of all products that have been discontinued for neglected disease development. The intent of this designation is to provide a mechanism to capture negative data and information from stalled or discontinued programs that may inform and improve future product development.
Yes, we are actively seeking additional information, updates, and corrections for products included in the Primer. If you have information you would like to share on a product you are involved in developing, please contact us at firstname.lastname@example.org.
BVGH has designated products as PRV eligible if they meet the current basic eligibility criteria outlined by the FDA. Designation of a product as PRV eligible is in no way an official designation recognized by the FDA but rather a guide for those interested in learning which products should seek additional information on obtaining a PRV through direct consultation with the FDA. For more information on the criteria used to determine PRV eligibility please click here.
Clinical trials include clinical trial record locator numbers at ClinicalTrials.gov. Trials listed include completed and ongoing trials for the product name and any known synonyms. Only clinical trials for neglected disease indications are included. If you have additional information on clinical trials for a product please contact us at email@example.com.
Publications include record locator numbers from PubMed.gov. Publications are identified by searching for clinical trial record locator numbers identified on ClinicalTrials.gov as well as product names and synonyms. Publications referring to neglected disease applications of a product are included, however the publications presented are not intended to be a comprehensive list. If you have additional information on publications for a product please contact us at firstname.lastname@example.org.
To obtain a print copy of the Global Health Primer, please send your contact details and complete mailing address to email@example.com or write to:
BVGH: Global Health Primer
221 Main St
San Francisco, CA 94105
The goal of the BVGH Global Health Primer is to highlight opportunities for collaboration among key innovators from academia, biotech and pharmaceutical companies, policy makers, and the global health community for the common goal of driving new research and development for neglected diseases. If you or your organization have materials, technologies, or know-how with potential application to neglected disease drug, vaccine, or diagnostic R&D, or you would like to explore additional opportunities to get involved, please contact BVGH at firstname.lastname@example.org.
When citing, please use:
"Global Health Primer," (last updated: August 15, 2012), BIO Ventures for Global Health, accessed <<today's date>>, http://www.bvgh.org/GlobalHealthPrimer.aspx
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