A01_Attachment_PWS-P12_Description_of_Surge_CLIN_Estimates_122717.docx

Attachment 12

DESCRIPTION OF SURGE CLIN ESTIMATES

CLIN 0004 Surge HDRL cost is based on expansion of HDRL’s clinical services mission to encompass a full HIV Force Wide test mission inclusive of all Army components. Level of effort is estimated at an additional 14FTEs per year.

CLIN 0005 Surge Laboratory Operations is based on expansion of DLDM’s mission support for a full HIV Force Wide Test mission; and, vaccine, therapeutic, and cure clinical trials for prevalent and/or emerging pathogens of US Military and National interest. The Laboratory Operations Office within DLDM centralizes project coordination, data management and analysis, and quality assurance functions. Level of effort is estimated at an additional 7 FTEs per year.

CLIN 0006 Surge Clinical Evaluation/Translational Research Units level of effort are based on (1) expanded Pre- market clinical trial efforts with commercial partners for FDA licensure of new/novel assays/platforms for detection, screening, confirmatory testing of prevalent and/or emerging pathogens of US Military or National interest; (2) support for develop of new/novel approaches for HIV detection and infection classification under Treatment as Prevention (TasP), Pre Exposure Prophylaxis (PrEP), and HIV cure initiatives; and, (3) development/evaluation of next generation assays/platforms for detection of pathogens of US Military and/or National interest for vaccine, therapeutic, and/or cure clinical trials. Level of effort is estimated at an additional 8 FTEs per year.

CLIN 0008 Surge DETA cost are based on expanded missions aligned with knowledge products development; HIV and HIV transmission dynamics in the U.S. military; HIV/STI/BBP, TTI, and emerging infectious pathogen threat assessment; evaluation of existing prevention programming; identification of targets for preventive intervention; and, to inform policy development e.g. screening, immunization, service delivery/clinical practice guideline development, and prevention services development and evaluation threat assessment, and blood safety. Level of effort is estimated at an additional 8 FTEs per year.

Four optional CLINs [0011, 0012, 0014, and 0015 and the associated outyear CLINS] are proposed for short suspense protocols (Short Suspense Specific Protocol) for an estimate of $1,400,000. Total cost estimate per optional protocol is $350,000. Costs are based on twenty years of historical data/assay develop costs for modification, under short suspense, of currently FDA approved assays or de novo development of nucleic acid detection assays for a prevalent and/or emerging pathogen of interest to the US Military or US Government. A recent 2014-2015 example encompassed development of two assays in support of a US FDA directed safety end point analysis of Vesicular Stomatitis Virus (VSV) viremia in plasma and VSV viral shedding in urine and saliva from volunteers participating in an Institutional Review Board (IRB) approved, Phase I, first in man, safety study for a recombinant Ebola vaccine, rVSV∆G-ZEBOV-GP, conducted at WRAIR and the Vaccine Research Center, National Institutes of Health over a 8 month period. Total project effort for development and screening support for this Phase I study encompassed 5,472 person hours. Supplies including primer/probes, biological materials inclusive of specimen matrices (normal reference urine, blood, salvia), consumables (PCR tubes, plates, strip caps, pipet tips,), plasmid DNA, enzymes, disposables (laboratory coats, gloves, etc), office supplies and courier service for a total of $14,409.00. Total direct cost $335,591. See PWS para 4.2 for the expected research support.