FDABAA-16-00122_Awards.pdf

Contract No Contractor Name Project Title Awarded Amount HHSF223201610018C Stanford University Sequelae and Immunopathology of Ebola Virus Infections $3,661,908 HHSF223201610035C eMocha Mobile Healthcare "CURE (Collaborative Use Repurposing Engine) $103,000.00

HHSF223201610043C WEBMD Health Corp Improving Safe Use of Fluoroquinolones Through Development of an Innovative

Educational Program $488,000.00

HHSF223201610061C University of Georgia Salmonella Serotyping Using Genome Sequencing Data $195,332.42

HHSF223201610070C Johns Hopkins University Development of an Automated and Sustainable Electronic Approach for Data Mining to Evaluate Clinical Outcomes of Patients with Bacterial Infections

$266,010.50

HHSF223201610073C University of Maryland Genome Sequencing of Mosquito Borne Viral Pathogens in Support of FDA Argos $303,283.00

HHSF223201610075C Rocky Mountain Poison and Drug Center Evaluating the Impact of Flow Restrictors on Pediatric Exposures to Liquid Single

Ingredient Acetaminophen $307,622.10

HHSF223201610079C University of Arkansas In Vivo Pharmacological Studies for Abuse Liability Testing $356,123

HHSF223201610081C University of Maryland Generating Highly Curated Whole Genome Sequences for Bacterial Pathogens from the FDA‐CDC Antimicrobial Resistance Isolate Bank $199,985.00

HHSF223201610082C Duke University Bridging Novel Laboratory Animal and Hollow Fiber Infection Models to Evaluate

Central Nervous System Penetration of Drugs in Infants $654,701.00

HHSF223201610083C Duke University Use of Electronic Health Records as Source Data for Clinical Research $1,019,688 HHSF223201610086C LumenData Informatics Master Data Domain Analysis $1,961,580 HHSF223201610087C WEBMD Health Corp Clinical Trial Recruitment Bias Patient Choice Analysis $174,999.95 HHSF223201610091C Akina, Inc. Advanced Analytical Techniques for Mixed Polymer Drug‐Delivery Systems $375,398.00 HHSF223201610093C Neo‐Advent Technologies, LLC Critical Process Parameters for the Preparation of Amphotericin B Liposomes $497,310.00

HHSF223201610098C

Predictive Safety Testing Consortium (PSTC)

Critical Path Institute Informatics Master Data Domain Analysis $787,013.00

HHSF223201610099C University of Florida College of Pharmacy Pharmacokinetic Comparison of Locally Acting Orally Inhaled Drug Products $729,304.00

HHSF223201610100C Icon Clinical Research, Inc Evaluation of the Measurement Properties of a Patient‐Reported Outcome (PRO)

Instrument in Patients with Community‐Acquired Bacterial Pneumonia $1,882,795

HHSF223201610104C Continuus Pharmaceuticals, Inc. Advancement of Integrated Continuous Manufacturing (ICM)Unit Operations $4,400,000

HHSF223201610105C Physical Pharmaceutica LLC Investigation of release rates and factors affecting release rate tests of cyclosporine from ophthalmic emulsions formulations using pulsatile microdialysis

(PMD)

$236,500.00

HHSF223201610110C

Inserm and Université Paris Diderot Team

'Biostatistics Evaluation of Model‐Based BioEquivalence (MBBE) statistical approaches for sparse designs PK studies $198,283.00

HHSF223201610111C Arkansas Research Alliance Scientific and methodological advancements in liquid biopsies to further the development of lung cancer‐based precision medicine $1,225,000

HHSF223201610112C

International Business Machines

Corporation Watson Classification Model for Adverse Event Causality $1,701,950

HHSF223201610113C Applied Research Associates, Inc.

Development of Physiological Models and Software Tools for Health Risk

Evaluation of E‐Cigarettes $892,914

HHSF223201610114C Battelle Memorial Institute PNNL‐ Mass Spectrometry Profiling of Pentosan Polysulfate in Urine $223,057.00

HHSF223201610115C Stanford University Accuracy and Integration of large scale data from genome sequencing and mobile sensors $1,006,847

HHSF223201610121C University of Connecticut Continuous Manufacturing of Liposomes: Materials Understanding and Process

Control $219,991.00

HHSF223201610122C Conceptant, Inc. FDA Population Health and Product Safety Platform $606,701.30

HHSF223201610125C QPS, LLC.

Assessment of the in vitro Percutaneous Absorption, in vitro Rate of Release, and Physicochemical Properties of Selected Commercially Available at Rated Ointment

Formulations $597,340.00

Total $25,272,636

Awards From FDABAA‐16‐00122