FY19_FBO_Award_Announcement.pdf

Contract Number Amount Obligated Total Estimated Contract Value Awardee Name Awardee Address Awardee Zip Code Description of Requirement

75F40119C10018 $505,858.00 $505,858.00 Uppsala University

UPPSALA UNIVERSITET

S:T OLOFSGATAN 10 A‐B

UPPSALA SWEDEN 06269‐1133

Development of model‐informed bioequivalence evaluation strategies for long‐acting injectable products

75F40119C10021 $1,400,000.00 $1,400,000.00 Icahn School of Medicine at Mount Sinai & Critical Path Institute

ICAHN SCHOOL OF MEDICINE AT

MOUNT SINAI

ONE GUSTAVE L LEVY PL

NEW YORK NY 10032‐3725

PredicTox‐ A Knowledge Environment for Prediction of Drug Induced Adverse Events

75F40119C10054 $599,838.00 $599,838 Regents University of California Los Angeles

REGENTS UNIVERSITY OF CALIFORNIA,

LOS ANGELES

10889 WILSHIRE BLVD STE 700

LOS ANGELES CA 20052‐0042

Strengthening Pharmacovigilance Capacity in the Democratic Republic of Congo: Utilizing archival records to assess rates of maternal vaccionation and birth outcomes of interest throughout Kinshasa

75F40119C10056 $350,000.00 $350,000.00 Elligo Health Research, Inc.

ELLIGO HEALTH RESEARCH, INC.

11612 BEE CAVE RD BLDG 1 STE 150

AUSTIN TX 22042‐1409

Extending the value of common data model harmonization in the generation of clinical evidence from real world data sufficient to support regulatory use

75F40119C10057 $749,805.64 $749,805.64 Digital Infuzion, Inc.

DIGITAL INFUZION, INC.

656 QUINCE ORCHARD RD STE 300

GAITHERSBURG MD 90095‐0001

Integrating EHR RWD for FDA Regulated Submission and Clinical Research

75F40119C10068 $206,498.00 $206,498.00 University of Maryland School of Pharmacy

UNIVERSITY OF MARYLAND

220 ARCH ST RM 02148

BALTIMORE MD 27708‐4677

Batch‐to‐Batch Variability: Exploring Solutions for Generic BE Pathway

75F40119C10079 $306,282.00 $793,400.00 Applied Research Associates, Inc.

APPLIED RESEARCH ASSOCIATES, INC.

4300 SAN MATEO BLVD NE STE A‐220

ALBUQUERQUE NM 22201‐4445

Modifications and Improvements to Hybrid CFD‐PBPK Models for Predication of Nasal Corticosteroid Deposition Absorption and Bioavailability

75F40119C10080 $450,000.00 $450,000.00 Duke University

DUKE UNIVERSITY

2200 W MAIN ST STE 710

DURHAM NC 21218‐2608

Gathering Evidence to Determine whether Modifications are Necessary to the KCCQ to Address Possible Interpretation Differences by Men and Women

75F40119C10081 $959,248.00 $959,248.00 Physical Sciences Inc. & UMass Lowell

PHYSICAL SCIENCES INC.

20 NEW ENGLAND BUSINESS CTR DR

ANDOVER MA 20007‐3835

Single Vial Mass Flow Rate Sensor Assessment of Freeze Drying Heterogeneity

75F40119C10083 $125,000.00 $125,000.00 Clinica Health, Inc. (Inspire)

CLINICAHEALTH, INC

3101 WILSON BLVD STE 220

ARLINGTON VA 92108‐3758

Social Listening for Patient Perspective on Chronic Pain Study‐Option B

75F40119C10084 $1,026,822.00 $1,026,822.00 Johns Hopkins University

JOHNS HOPKINS UNIVERSITY

3400 N CHARLES ST

BALTIMORE MD 27708‐4677

Improving the Efficiency and Rigor of Pharmacovigilance: Visualization of multi‐source information and unsupervised learning to support causal inference and decision‐making

Contract Value Awardee Name Awardee Address Awardee Zip Code Description of Requirement

75F40119C10086 $1,951,894.00 $1,951,894.00 Duke Clinical Research Institute (DCRI) and Amgen

DUKE UNIVERSITY

2200 W MAIN ST STE 710

DURHAM NC 48202‐3450

Evaluating Fitness‐for‐Use of Electronic Health Records in Clinical Research

75F40119C10090 $720,000.00 $720,000.00

University of Colorado School of Medicine and Children's Hospital Colorado

REGENTS OF THE UNIVERSITY OF

COLORADO

13001 E 17TH PLACE F428

AURORA CO 20005‐1003

A Study to Investigate the Combination of Physical Activity and Heart Rate with the Use of Actigraphy Study Endpoint to Facilitate Pediatric Pulmonary Arterial Hypertension Trials and Drug Development

75F40119C10091 $1,293,750.00 $1,293,750.00 National Organization for Rare Disorders (NORD)

NATIONAL ORGANIZATION FOR RARE

DISORDERS

55 KENOSIA AVE 1ST FL

DANBURY CT 85718‐5893

A Systems‐Based Approach to Patient Focused Research and Product Development, Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes

75F40119C10093 $1,744,985.00 $1,744,985.00 Indiana University

TRUSTEES OF INDIANA UNIVERSITY

BRYAN HALL 107 S INDIANA AVENUE

BLOOMINGTON IN 02139‐2947

FDA Quality Management and Pharmaceutical Firm Learning to Reduce Drug Quality Risks

75F40119C10094 $409,358.00 $409,358.00 Setting Scoliosis Straight Foundation

SETTING SCOLIOSIS STRAIGHT

FOUNDATION

2535 CAMINO DEL RIO S STE 325

SAN DIEGO CA 27708‐4677

Adolescent Idiopathic Scoliosis Preference Study of Motion Sparing Spinal Growth Modulation vs Spinal Fusion and Develop of Shared Decision Making Tool

75F40119C10096 $728,117.62 $992,304.63 Akina, Inc.

AKINA, INC.

3495 KENT AVE STE A 200 WEST

LAFAYETTE IN 02138‐5369

New Analytical Methods for Complex Sameness of Injectable, Long‐acting PLGA Formulations

75F40119C10097 $2,591,726.00 $2,591,726.00 Kaiser Permanente Northwest, Center for Health Research

KAISER FOUNDATION HOSPITALS

1800 HARRISON ST FL 16

OAKLAND CA 90095‐0001

Suicide‐Related Risks Associated with Prescription Opioid Deprescribing

75F40119C10098 $3,588,882.00 $5,260,573.00 Wyss Institute for Biological Inspired Engineering at Harvard University

PRESIDENT AND FELLOWS OF

HARVARD CO

1033 MASSACHUSETTS AVE 5TH FL

CAMBRIDGE MA 75312

Human Organ Chips for Radiation Countermeasure Development

75F40119C10099 $2,600,000 $3,910,815.00 University of Pennsylvania, School of Medicine

TRUSTEES OF THE UNIVERSITY OF

PENNSYLVANIA

3451 WALNUT ST STE 440A

PHILADELPHIA PA 92008‐7340

Assessment of the Efficacy of Acute Pain Treatments: An RTC Re‐Analysis

75F40119C10100 $99,999.00 $99,999.00 Medical College of Wisconsin and University of Wisconsin‐Milwaukee

MEDICAL COLLEGE OF WISCONSIN,

INC.

8701 WATERTOWN PLANK RD

MILWAUKEE WI 22203‐1807

Estimation of Treatment in Hematologic Oncology (HO) Trials in the Presence of Subsequent Therapies

75F40119C10101 $1,916,514.00 $1,916,514.00 Columbia University Medical Center

TRUSTEES OF COLUMBIA UNIVERSITY

630 W 168TH ST FL 4

NEW YORK NY 21201‐1531

Neurodevelopmental Outcomes in Infants Receiving Opioid‐replacement Pharmacotherapy for Neonatal Opioid Withdrawal Syndrome (NOWS)

Contract Value Awardee Name Awardee Address Awardee Zip Code Description of Requirement

75F40119C10104 $669,950.00 $669,950.00 University of Maryland School of Pharmacy

UNIVERSITY OF MARYLAND

220 ARCH ST RM 02148

BALTIMORE MD 78238‐5166 Nondestructive Analytics for Vaccines

75F40119C10106 $176,541.00 $545,339.00 Drexel University

DREXEL UNIVERSITY/ BURSAR'S

OFFICE

3141 CHESTNUT ST

PHILADELPHIA PA 47906‐1074

Developing Tools based on Text Analysis and Machine Learning to Enhance PSG Review Efficiency

75F40119C10109 $1,396,759.79 $1,998,901.36 Conceptant, Inc.

CONCEPTANT INC

7323 ELMWOOD DR

FALLS CHURCH VA 19104‐2816

Advancing Import Operations through Leveraging Cutting Edge Technologies

75F40119C10112 $698,450.00 $698,450.00 National Institute for Pharmaceutical Technology and Education (NIPTE)

NATIONAL INSTITUTE FOR

PHARMACEUTICAL TECHNOLOGY AND

EDUCATION

717 DELAWARE ST SE STE 482

MINNEAPOLIS MN 01810‐1022

Assessment of Smoking and Vaping Risk of Opioids and Commercial Products, and Standardization of Methods to Asses These Properties

75F40119C10113 $232,303.32 $232,303.32 Providence Health Technologies, LLC

PROVIDENCE HEALTH TECHNOLOGIES

LLC

152 WATFORD PARK WAY DR STE 202

CANTON MS 21250‐0001

Small Dispenser Pilot Study Understanding the Impact of the Oncoming Track and Trace Legislation on Small Dispensers

75F40119C10115 $1,275,489.00 $1,930,120.00 University of North Carolina at Chapel Hill

UNIVERSITY OF NORTH CAROLINA AT

CHAPEL HILL

104 AIRPORT DR STE 2200

CHAPEL HILL NC 01890‐3019

Methodological Advances in the Assessment of Uncontrolled Confounding

75F40119C10116 $2,818,267.33 $2,818,267.33 Medical Device Innovation Consortium

MEDICAL DEVICE INNOVATION

CONSORTIUM

1501 WILSON BLVD STE 910

ARLINGTON VA 47405‐7000

Expansion of the Case for Quality Voluntary Improvement Program to Aid Underperforming Medical Device Manufacturing Sites

75F40119C10117 $249,983.00 $249,983.00 American Institutes for Research

AMERICAN INSTITUTES FOR

RESEARCH

1000 THOMAS JEFFERSON ST N W

WASHINGTON DC 22209‐2467

Advance Regulatory Science Related to Clinical Trials of Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

75F40119C10118 $727,875.16 $727,875.16 Mark Herring Associates

MARK HERRING ASSOCIATES INC

2150 DIAMOND ROCK RD

MALVERN PA 02139‐3539

An Exploratory Assessment of Substances Used as Adjunct or Alternatives to Prescription Opioids

75F40119C10120 $210,657.00 $210,657.00 Institute for Safe Medication Practices (ISMP)

INSTITUTE FOR SAFE MEDICATION

PRACTICES

200 LAKESIDE DR STE 200

HORSHAM PA 55414‐2959

Perioperative Medication Safety Self Assessment for Hospitals and Ambulatory Surgical Centers (ASCs) and Targeted Risk‐Reduction Tool Development

75F40119C10121 $5,500,000.00 $5,500,000.00 Dun and Bradstreet and University of St. Gallen

DUN & BRADSTREET, INC.

11710 PLAZA AMERICA DR STE 900

RESTON VA 20190‐4768

Drug Facility and Product Quality Systems Assessment Data and Analytics Research Project

Contract Value Awardee Name Awardee Address Awardee Zip Code Description of Requirement

75F40119C10122 $2,199,139.00 $2,199,139.00 The Charles Stark Draper Laboratory

CHARLES STARK DRAPER

LABORATORY, INC

555 TECHNOLOGY SQ

CAMBRIDGE MA 77030‐4017

Continuous Acoustic Separation for Therapeutic Cell Manufacturing

75F40119C10124 $500,000.00 $500,000.00 American Society of Nephrology

AMERICAN SOCIETY OF NEPHROLOGY

INC

1510 H ST NW

WASHINGTON DC 19341‐2556

Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy (RRT)

75F40119C10127 $287,731.34 $287,731.34 Absorption Systems LLC

ABSORPTION SYSTEMS LLC

436 CREAMERY WAY STE 600

EXTON PA 32611‐1941

Expanding BCS Class 3 Waivers for Generic Drugs to Non‐Q1/Q2

75F40119C10128 $1,504,919.00 $5,202,186.00 Regents University of California Los Angeles

REGENTS UNIVERSITY OF CALIFORNIA,

LOS ANGELES

10889 WILSHIRE BLVD STE 700

LOS ANGELES CA 87110‐1295

Using Vaccinated and Survivor Populations of Filovirus Diseases to Inform Regulatory Science and Development of Next‐Gen Vaccines and Other Medical Countermeasures

75F40119C10129 $560,773.00 $560,773.00 UT MD Anderson Cancer Center

THE UNIVERSITY OF TEXAS MD

ANDERSON CANCER CENTER

1515 HOLCOMBE BLVD UNIT 207

HOUSTON TX 21201‐1531

Modular Application of Surface Technology for the Generation of Antigen‐Specific T Cells

75F40119C10132 $735,624.00 $735,624.00 University of Maryland Baltimore County

UNIVERSITY OF MARYLAND

BALTIMORE CO

1000 HILLTOP CIR

BALTIMORE MD 21251‐0001

Rapid Method for On‐the‐Spot Bioburden Detection

75F40119C10135 $2,757,771.00 $2,757,771.00 Critical Path Institute

CRITICAL PATH INSTITUTE

1730 E RIVER RD STE 200

TUCSON AZ 20817‐1834

Developing Novel Clinical Outcome Assessments for Pediatric Asthma to Facilitate Innovative Patient‐Focused Drug Development and Aid regulatory Decision Making

75F40119C10136 $719,486.00 $2,235,712.00 The George Washington University

THE GEORGE WASHINGTON

UNIVERSITY

1918 F ST NW

WASHINGTON DC 27599‐5023

BioCompute Database, Specification and BioCompute Object Transfer Mechanism Development

75F40119C10137 $917,653.00 $917,653.00 International Business Machines Corporation

INTERNATIONAL BUSINESS MACHINES

CORP

6710 ROCKLEDGE DRIVE

BETHESDA MD 06810‐7326

Develop Data Standards for Real World Evidence

75F40119C10138 $620,872.97 $1,902,572.16 Accenture Federal Services, LLC

ACCENTURE FEDERAL SERVICES LLC

800 NORTH GLEBE RD #300

ARLINGTON VA 80045‐2571

Laying the Foundation: The Center for Drug Evaluation Research (CDER) Next Generation Submission Capability

75F40119C10139 $447,236.00 $1,788,939.00 Institute of Quantitative Systems Pharmacology

INSTITUTE OF QUANTITATIVE

SYSTEMS PHARMACOLOGY

1815 ASTON AVE STE 107

CARLSBAD CA 19104‐6205

MIDD Approach to Identify Critical Quality Attributes and Specifications for Generic Nanotechnology Products

Contract Value Awardee Name Awardee Address Awardee Zip Code Description of Requirement

75F40119C10141 $16,065.00 $16,065.00 Henry Ford/Wayne State University Program

HENRY FORD HEALTH SYSTEM

1 FORD PLACE

DETROIT MI 78738‐5409

Women's Preferences Regarding Treatments for Symptomatic Uterine Fibroids

75F40119C10147 $914,617.00 $914,617.00 Morgan State University

MORGAN STATE UNIVERSITY

1700 E COLD SPRING LN

BALTIMORE MD 53226‐3548

NMR‐based metabolomics approach for the authentication and assessment of the quality of botanical raw materials

75F40119C10150 $1,000,000.00 $1,000,000.00 ILSI Health and Environmental Sciences Institute

ILSI HEALTH AND ENVIRONMENTAL

SCIENCES INSTITUTE

740 15TH ST NW STE 600

WASHINGTON DC 20878‐1434

Assessing variability and reproducibility of manual and automated patch clamp platforms

75F40119C10151 $333,751.00 $413,889.00 Duke University Department of Pediatrics

DUKE UNIVERSITY

2200 W MAIN ST STE 710

DURHAM NC 94612‐3466

CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot Study

75F40119C10152 $699,945.00 $699,945.00 University of Connecticut School of Pharmacy

UNIVERSITY OF CONNECTICUT

438 WHITNEY RD EXTENSION UNIT

STORRS CT 39046‐7900

The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcome.

75F40119C10154 $524,342.00 $922,521.00 University of Florida and S5 Consulting

UNIVERSITY OF FLORIDA

1523 UNION RD RM 207

GAINESVILLE FL 19355‐9528

Systematic Evaluation of the Ex‐Throat Plume Properties of MDI Formulations

75F40119C10155 $411,646.00 $411,646.00 Putnam Data Science, LLC

GRUBER, SUSAN

PUTNAM DATA SCIENCES, LLC

85 PUTNAM AVE

CAMBRIDGE MA 19044‐2321

Learning Framework for Casual Effect Estimation Using Real World Data

75F40119C10157 $400,003.00 $400,003.00

DigiM Solution LLC and University of Connecticut, Department of Pharm.

Science

DIGIM SOLUTION LLC

2 CHESTNUT ST

WINCHESTER MA 10029‐6504

Microstructure Characterization with Micro‐imaging and Image‐based Analytics: A new tool to characterize complex polymer‐based long acting drug products

75F40119C10158 $1,433,914.00 $2,332,506.00 Southwest Research Institute

SOUTHWEST RESEARCH INSTITUTE

6220 CULEBRA RD

SAN ANTONIO TX 20005‐1019

Evaluate the Safety and Quality of a 3D Printed, Single‐Use Bioreactor for Beads‐ Free CART T‐cell Manufacturing

Totals $55,266,341.17 $69,839,526.94