R&D PIPELINE TRACKER

Policy Cures Research’s R&D pipeline tracker contains a comprehensive list of product and technology candidates in the development pipeline for global health priority issues. It currently reflects the pipeline as of August 2019.

The pipeline tracker presents data collected as part of a project supported by the WHO-TDR and Duke University, and owes a significant debt to prior R&D pipeline mapping work undertaken by Policy Cures, published in 2015, available at www.pipeline.policycures.org, and summarised here.

Our unique database with product candidates and technologies for global health issues can be freely accessed through the R&D pipeline tracker.

Our analysis and reports based on this data can be found here.

In line with Policy Cures Research’s mission, our pipeline tracker provides information on product candidates for diseases and issues that disproportionately affect people in low- and middle-income countries, such as tuberculosis, malaria and sleeping sickness. It covers all product categories including drugs, vaccines, diagnostics and vector control products, and all stages of research, from early-stage R&D through to product registration.

This tracker allows global health actors to efficiently allocate funding by identifying gaps or overlaps in the R&D pipeline. It also helps mobilise funds by highlighting the progress made when money is invested in R&D.

The scope of the R&D pipeline mirrors the scope of the G-FINDER neglected diseases project. It includes pathogens and health issues only if they meet all three of the following criteria:

  1. Does the disease or health issue disproportionately affect populations in low- and middle-income countries?
  2. Is there is a need for new products (i.e. there is no existing product, or improved or additional products are needed)? and
  3. Is there is market failure (i.e. there is insufficient commercial market to attract R&D investment by private industry)?

The product types included in the R&D pipeline tracker are: drugs, vaccines, biologics, diagnostics and vector control products. However, in line with the G-FINDER scope, not all product types were included for all areas – product/pathogen combinations for which there is a viable commercial market, such as dengue vaccines, are excluded from both the G-FINDER scope and the R&D pipeline tracker. Medical devices and general or supportive therapies (e.g. oral hydration or nutritional supplements) are not captured by the pipeline tracker.

The R&D pipeline tracker includes candidates at all stages of development – from discovery through to registration. For drugs, biologics and vaccines, development was broken down into discovery, pre-clinical studies, and clinical trials (which was further divided into Phase I, Phase II and Phase III trials). Diagnostics and vector control products follow different regulatory pathways and the development stage for these products was broken down into: concept and research; feasibility and planning; design and development; and clinical validation and launch readiness. Screening programmes are excluded as these were not considered to represent discrete pipeline candidates. Candidates were no longer considered to be part of the R&D pipeline – and therefore were excluded from this analysis – once granted regulatory approval by a stringent regulatory authority, or if their development had been placed on hold indefinitely.

Please see here for further details on the specific diseases and related product areas within the scope of the R&D pipeline tracker.

Policy Cures Research undertook a global review of candidate products for neglected diseases in order to capture a snapshot of the R&D pipeline as of August 31, 2019. This followed a previously published review of the R&D pipeline as of August 31, 2017.

At every update, Policy Cures Research reviews and cross-references all major sources of available data on the R&D pipeline for neglected diseases, such as the WHO ‘rainbow tables’; the WHO Initiative for Vaccine Research (IVR), which includes background documents prepared for the WHO Product Development for Vaccines Advisory Committee and Strategic Advisory Group of Experts (SAGE) on immunisations; WHO Vector Control Advisory Group (VCAG) reports; WHO R&D roadmaps; WHO vaccine pipeline tracker; WHO prequalification database; Unitaid landscape and technical reports; clinical trial portals including the US NIH-curated clinical trials database, Chinese clinical trial registry, Indian CTRP and WHO ICTRP; the US NIH’s AIDS info database; disease-specific pipeline updates prepared by HIV Vaccines Trials Network and the Treatment Action Group; publicly available company and product development partnership R&D portfolios; journal publications; clinical trial registration portals; and university, government, and non-profit organisation websites.

Candidates were only included if an authoritative source could confirm they were still in active development. The following sources were considered to be authoritative:

  • The recently updated website of the candidate developer
  • Recent reports from international organisations such as WHO and Unitaid
  • Clinical trial portals
  • Correspondence with product developers
  • Correspondence with experts in the field, including the Foundation for Innovative New Diagnostics (FIND); the Innovative Vector Control Consortium (IVCC); the International AIDS Vaccine Initiative (IAVI); Netherlands Leprosy Relief (NLR); Program for Appropriate Technology in Health (PATH); the Sabin Vaccine Institute; and the US National Institute of Allergy and Infectious Diseases (NIAID).

Although the R&D pipeline tracker provides the most complete analysis and up-to-date summary of the global R&D pipeline for neglected diseases, some limitations apply:

  • The data currently presented is accurate as at August 2019 and represents a snapshot of the research and development pipeline at that single point in time. Since the pipeline is constantly changing, any changes that became publicly known after this date have not yet been captured.
  • Our research was limited to publicly available sources and relied on confirmation from the above-listed authoritative sources. Where Policy Cures Research could not confirm the status of a candidate, it was excluded from the active candidate list.

The lack of publicly available information on some products under development means that the count and development phase of active candidates may not be fully accurate. There is little information available on discovery and pre-clinical candidates due to: the lack of dedicated public registries mirroring those available for clinical trial candidates; limited sharing of proprietary data by companies; and the potential for termination of discovery efforts prior to publication.