The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, upped its funding recipients from two institutions to three, signing contracts with Ohioan contract research organisation Clinical Research Management, Duke University, and DynPort Vaccine Company in Maryland.
Under the Phase I Clinical Trial Units for Therapeutics programme, the institutions can receive a share of up to $90m to help fund clinical trials during a 10-year contract with NIAID.
The money supports the safety assessment of drug candidates against infectious diseases from viruses, bacteria, pathogens and fungi, including emerging diseases and “biodefense” pathogens designated a priority by NIAID. HIV investigations are excluded.
This safety work can include first-in-human human trials for small molecule and mAbs, corrected QT interval (QTc) trials, and drug-drug interaction studies, as well as assay development, and analysis of bioanalytical samples.
The awards programme began in 2008 and has funded Phase I trials of influenza anti-viral therapies and treatments for MRSA and multi-drug resistant tuberculosis. It recently financed early trials of an anti-viral fusion protein against flu, including H5N1 avian flu – a drug which has since begun Phase II study.
An NIAID programme expert told us the three contract recipients will now be eligible for funding via “task order awards” by applying for subcontracts for specific trials.
Criteria for awarding the money are a “bone fide need to purchase something”, public health significance, and appropriateness and feasibility of the study design, NIAID told us.
The studies to be undertaken by Clinical Research Management, Duke and DynPort are currently undecided as the programme falls under an Indefinite Delivery Indefinite Quantity (IDIQ) contract, meaning the government’s specific needs are unknown at the time it is signed.
“Once a need is determined and concept approved, an RTOP [Request for Task Order Proposal] is drafted and shared with the three grantee organizations. Once proposals are assessed in coordination with the evaluation criteria of the RTOP, a specific award can be made,” said NIAID.