Even though IDRI is a nonprofit, our product pipeline could rival that of large pharmaceutical companies or biotechs as we have diagnostics on the market, vaccines in clinical trials and drugs being discovered and developed. Our ultimate goal is to help people lead healthy, productive lives.
To make a new product to aid in the fight against infectious diseases, the first step is to understand the basic causes of disease at the level of genes, proteins and cells and how that disease interacts with the human host. This informs the process of developing a new solution.
An example of the vital discovery work IDRI does can be found within our TB Drug Discovery program where IDRI tests compounds – often shared with us by major pharmas through the Eli Lilly TB Drug Discovery Initiative and the TB Drug Accelerator – that could become drugs.
Harnessing the power of robotics and computation, IDRI scientists use high-throughput screening to test compounds to identify any that might be promising. From there lead compounds are selected for further study and optimized. By changing the structure of a compound, scientists can give it different properties making it safer and/or more effective. To date, IDRI has tested more than 500,000 compounds, feeding a pipeline of new drugs for tuberculosis.
Before moving into human trials, drugs and vaccines must go through extensive evaluation. This area of research includes both exploratory studies and hypothesis-testing studies, with various designs, in lab tests as well as animal studies. Preclinical studies provide detailed information on dosing and toxicity levels, so that researchers can review their findings and decide if the drug or vaccine should be tested in humans.
IDRI has conducted a variety of preclinical studies for its vaccine candidates including identification of relevant antigens, adjuvant formulation, creation of the vaccine concept, toxicity studies, testing of vaccine safety, immunogenicity and efficacy and manufacturing of the vaccine components adhering to Good Manufacturing Practice (GMP) standards.
Through the years, IDRI has amassed a great deal of expertise in clinical trials, having conducted 11 trials for a leishmaniasis vaccine, three trials for a tuberculosis vaccine and one trial for a pandemic influenza vaccine. Clinical trials are conducted in human volunteers, starting with a small number of people in the early phases and moving to large numbers in the final stages. These studies answer questions about a product’s safety, immunogenicity and protective efficacy, while following a pre-defined set of rules and regulations adhering to Good Clinical Practice (GCP) and International Code of Harmonization (ICH).
During the design of an early phase clinical trial, the researchers file an investigational new drug application (IND) with the U.S. Food and Drug Administration (for investigational products being tested in the U.S. or other national regulatory authorities for products tested outside of the U.S.), detailing what is being proposed for human testing. Regulatory review and approval is critically important at this point, as is ethical review, which focuses on protecting the safety and welfare of the participants.
From there, the clinical trials move into four stages of testing, with each phase building on the information received from the previous one.
Phase 1 involves a small number of healthy adult volunteers to assess whether the vaccine/drug is safe in humans and what immune response it evokes at different dose levels.
In Phase 2, the number of volunteers is increased and the best tolerated and most immunogenic doses of the vaccine/drug is given to people who have characteristics similar to the target population the new vaccine is being created to protect/cure.
Phase 3 clinical trials are conducted on a large scale with hundreds or even thousands of volunteers and the optimal dose and regimen selected based on results of previous phase trials. If the vaccine retains safety and efficacy over a defined period in the target population, application can be made to regulatory authorities for a license to register and market the product for human use.
Many vaccines undergo Phase 4, which includes ongoing safety reporting after the vaccine is approved and licensed.
IDRI currently has a TB vaccine candidate in clinical trials; this infographic shows its progress.
IDRI’s Clinical Team is composed of experts with years of experience. The team is responsible for working with our external clinical trial partners, developing clinical trial protocols, preparing and managing regulatory submissions, conducting site assessment visits, coordinating, monitoring and overseeing Phase 1 and Phase 2 clinical trials conducted in Africa, India, South America and the U.S.