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?
- 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?
- 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 am involved in developing?
- How was eligibility for Priority Review Vouchers (PRV) determined?
- 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?
The purpose of the Global Health Primer is three-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, 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. Third, the Primer contains educational information related to neglected diseases included for use by students, healthcare providers, public health workers, and others involved with or interested in 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 multiple resources and are cross-checked for accuracy. Although every attempt is made to validate the information contained in the Global Health Primer, the most current data included rely 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 GHP@emory.edu.
Data update is an ongoing process. As changes to individual products are identified, these changes are made in the Global Health Primer’s database and are reflected immediately in the pipelines and product details of the online Primer. As these updates are a manual process, we are actively seeking updates, comments, suggestions, and corrections to information presented in the Primer. At a minimum, data are updated each quarter of every year. If you have information you would like to share on specific products in development, please contact us at GHP@emory.edu.
Not all neglected diseases are covered in the Global Health Primer, how was the disease list selected?
Neglected diseases are categorized as a single group due to neglect rather than their biological or medical basis. Hence, the term "neglected" has been difficult to define and challenging to gain consensus around even within the global health community. Therefore, we selected 25 diseases from the compiled list of recognized neglected diseases of the WHO, the Bill and Melinda Gates Foundation, NIH, and our 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. We have 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, the Primer highlights opportunities or needs for innovation to minimize these health disparities.
Not all drug targets/technologies and vaccine technologies currently appear in the Global Health Primer, how was the target/technology list selected?
The target/technologies profiled do not always reflect 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 25 neglected diseases profiled. In some cases, 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 and to include additional targets and technologies that are most relevant to these diseases.
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
Every effort is made to validate information presented in the Global Health Primer, and attempts are made to reach out to every product developer individually for confirmation. If developers, funders or researchers do not share this information with the Primer, it cannot be included. 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 GHP@emory.edu.
We rely on information obtained from, and active participation of, those engaged in neglected disease research to identify and profile products in development. We only intend to publish verified information about neglected diseases and products in development or recently approved. Thus, it is possible that some products will not be included in the Primer. If you have information or updates on products in development please contact us at GHP@emory.edu.
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 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.
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. Such information, even if considered “negative” in terms of results, is vital to those who may be using the Primer as a tool to guide future research and development activities.
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 GHP@emory.edu.
We have 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.
Because the Primer is a dynamic, always changing website, a print copy of this information is not possible. The information is updated on a regular basis and a print copy is not able to capture these changes in real time. Therefore, the data are provided as a website with ongoing updates to ensure accuracy and revisions in a timely manner.
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?
The goal of the 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 us at GHP@emory.edu.
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