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2010 NIAID Year in Review

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Turning Ideas Into Practice: Translational Research at NIAID

NIAID supports a robust basic science portfolio that pursues fundamental knowledge about the nature and behavior of infectious and immune-mediated diseases. This knowledge, if exploited, can be used to develop new and improved diagnostic, prevention, and treatment strategies that ultimately can improve health and save lives.

Translational studies are a bridge between the laboratory and the clinic. Through translational research, scientists apply the fundamental knowledge gained from basic research toward the development of new or improved clinical products that will reduce disease burden, suffering, and death. NIAID also oversees translational research focused on minimizing the effects of exposure to harmful radiological or chemical substances.

Product Development Steps From Laboratory to Clinic

Translating laboratory advances into clinical tools and strategies is challenging. It begins with a scientific discovery in the lab, and is followed by the following steps:

  • Identification of a potential product
  • Refinement and validation in cell culture and small animal models
  • Efficacy testing in non-human primates
  • Quality production in large quantities for use in clinical trials
  • Testing of the product in clinical trials

Researchers and manufacturers must work with the FDA to ensure that all steps taken provide the information required to move to new stages of development and to prepare for product licensure. The steps may vary slightly depending on the product. Many products fail along the way. For this reason, NIAID maintains a robust translational research program that supports various products at different stages of development—a “pipeline” from the laboratory to final product.

How NIAID Conducts Translational Research

It can take years for a promising laboratory discovery to be used in developing a new vaccine, diagnostic device, or drug. Often, scientists do not know how to navigate the steps involved in product development or lack the resources to move a discovery from the laboratory to the clinic. NIAID helps to shepherd promising discoveries made in laboratories in the United States and abroad through the many challenging and costly steps involved in developing products and obtaining regulatory approval (licensing) for use in clinical practice. NIAID works with academia, industry, government agencies, and non-government partners to provide assistance and bridge gaps to facilitate the development of new and improved drugs, vaccines, and diagnostic tests.

NIAID defines product development according to three categories:

  • Applied research to identify potential products
  • Advanced research to optimize, produce, and test products in animal models
  • Clinical research to evaluate products through clinical trials

As a product moves through each phase of the pipeline, it moves further from being an idea in the lab and closer to being a medical product that can be used to save lives.

FY 2010 Translational Research Budget

In FY 2010, $2.5 billion of NIAID’s $4.5 billion budget (56 percent) supported translational research (Figure 1).
 
  • Of this, $1.5 billion (61 percent) went to identify potential products, and for basic discovery of therapeutics, diagnostics, and vaccines; assay development; screening for potential products in cells and tissues; and animal model refinement/validation (applied research)
  • $523 million (21 percent) was directed to product optimization and piloting, preclinical and investigational new drug application, animal efficacy models for emergency use authorization, and large-scale reagent production and qualification (advanced research).
  • $448 million (18 percent) was used to evaluate promising biomedical research findings in patients in Phase I to Phase III studies (clinical research).

NIAID’s Translational Research Program

Figure 1: NIAID Funding for Translational Research: FY 2010. The total NIAID budget for FY 2010 was $4.5 billion. NIAID’s translational research budget was approximately $2.5 billion, or 56 percent of the overall budget. Credit: NIAID

In FY 2010, NIAID reviewed its translational research activities and projects. This review allowed NIAID to do the following:

  • Identify where NIAID’s activities fall along the product development pipeline
  • Catalog and analyze the challenges and lessons learned during various stages of translational research
  • Identify areas that may benefit from collaboration and partnership

In FY 2010, NIAID funded approximately 2,000 translational research projects: 83 percent applied research, 10 percent advanced research, and 7 percent clinical research. The majority of projects support products in the early developmental stages (applied); the projects are split equally between research conducted and initiated by NIAID (intramural and solicited) and investigator-initiated research (unsolicited). The majority of awards for products in the later stages of development (advanced and clinical) are conducted and initiated by NIAID. (Figure 2)

Lessons From the Review of NIAID Translational Research

A survey of NIAID intramural and extramural staff revealed some common challenges or obstacles that hinder the Institute’s translational research efforts. Identifying these enables the Institute to

  • Identify which challenges affect Institute-wide progress and whether they can be addressed using currently existing practices
  • Determine the changes needed to improve future efforts
  • Allow staff to share best practices

A few examples of the various ways staff and grantees/partners are working together to address translational research challenges are listed below:

  • Limited access/availability of products for clinical testing – When appropriate, NIAID contracts with the private sector to develop and evaluate new drug candidates and clinical trial material.
  • Recruiting and retaining patients for clinical trials – To achieve retention goals and conduct successful trials, NIAID staff and grantees engage and form community partnerships in the areas where trials are being performed.
  • Delays in clinical research due to international regulations or policies – In-country investigators are used to oversee and facilitate regulatory approval.
  • Difficulty engaging or identifying appropriate industry partners – To increase engagement between academia and industry, partnerships are required as part of the grant or contract application process and as a criterion in final funding decisions (when appropriate).
A pie chart displaying NIAID funding for translational research in FY 2010. The pie slices represent the portions of the budget spent on basic and translational research.
Figure 2. Breakdown of FY 2010 Translational Research Projects. The developmental stages for product development extend from identifying a disease target to Phase (Ph.) III clinical trials. In FY 2010 there were a total of 1629 projects funded to support applied research; 210 projects for advanced research; and 135 projects for clinical research (Phase I to Phase III). Projects awarded for applied, advanced, and clinical research are further broken down to show which projects are solicited (light blue), unsolicited or investigator-initiated (light yellow), and intramural (light green) research. Credit: NIAID

Accomplishments

NIAID’s translational research funding in FY 2010 and in prior years made it possible to do the following:

  • File product patents and licenses
  • Identify/characterize the actions of potential products
  • Identify promising drug and vaccine candidates
  • Develop new or improved research tools and models for clinical testing
  • Advance products through stages of development
  • Create partnerships with industry
  • Publish valuable findings in scientific journal articles

The contributions NIAID made through support of translational research programs, research resources, and clinical studies led to many accomplishments; however, much work remains to be done. In support of these efforts, NIAID will continue to identify opportunities to enhance current and new translational research programs to accelerate the speed at which basic scientific discoveries are converted into medical products that can be used in clinics in the United States and abroad.

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Last Updated November 17, 2011

Last Reviewed August 09, 2011