FY20 BAA Award Announcement_BetaSam.pdf

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

75F40120C00158 $ 11,106,465.00 $ 11,106,465.00 CERUS CORP 1457308 1220 CONCORD DRIVE SUITE 600 CA 94520-4813 Conduct a study entitled, " Development of an optimized pathogen inactivation process

75F40120C00207 $ 1,470,387.82 $ 1,470,387.82

GEORGIA TECH RESEARCH CORP

160612

GEORGIA TECH RESEARCH

CORPORATION 926 DALNEY ST NW

ATLANTA GA 30318

study entitled, “Identification of Critical Quality Attributes of Cell Therapy Products by Multi-Omics Analyses and Predictive Modeling”

75F40120C00187 $ 298,914.00 $ 298,914.00

UNIVERSITY OF GEORGIA

RESEARCH FOUNDATION INC

104442

621-630 GRADUATE STUDIES

ATHENS GA 30602-7411

study entitled, “Salmonella source attribution by machine learning and whole genome sequencing"

75F40120C00161 $ 1,299,875.92 $ 3,153,835.91 CONCEPTANT INC 1497637 7323 ELMWOOD DR FALLS CHURCH VA 22042-1409 Optimizing Regulatory Affairs Operations

75F40120C00124 $ 100,000.00 $ 100,000.00

NORTH CAROLINA STATE

UNIVERSITY 180521

2700 SULLIVAN DR STE 7514

RALEIGH NC 27695-7514

study entitled, “A Quantitative Approach to Assessing Drug Supply Chain Disruptions Leading to Shortages."

75F40120C00135 $ 347,335.00 $ 347,335.00

THE CHILDREN'S HOSPITAL OF

PHILADELPHIA 356961

CHILDREN'S HOSPITAL OF

PHILADELPHIA

3401 CIVIC CENTER BLVD

PHILADELPHIA PA 19104-4319

study entitled “Incidence and Outcomes of Human Adenovirus Infection and Disease among a Multicenter Observational Cohort of Pediatric Allogeneic Hematopoietic Cell Transplant Recipients”

75F40120C00154 $ 1,062,995.00 $ 4,551,098.00 LUMENDATA INC. 1468150

5201 GREAT AMERICA PKWY STE

320 SANTA CLARA CA 95054-1140

conduct a study entitled, “Master Data Management Informatics Analysis for the Center for Drug Evaluation and Research (CDER).”

75F40120C00194 $ 436,800.00 $ 436,800.00

RESEARCH TRIANGLE INSTITUTE

105107

RESEARCH TRIANGLE INSTITUTE 30

3040 E CORNWALLIS RD

RESEARCH TRIANGLE PARK NC 27709-0155

study entitled, “Benefit-Risk Preferences for the use of artificial intelligence and machine learning in imaging diagnostics”.

75F40120C00069 $ 696,359.00 $ 696,359.00 DUKE UNIVERSITY 132317 2200 W MAIN ST STE 710 DURHAM NC 27708-4677 study entitled, "Evaluating physical functioning using patient-reported outcome measures: How does the question form and

75F40120C00179 $ 1,092,665.00 $ 1,664,528.00 DUKE UNIVERSITY 132317 2200 W MAIN ST STE 710 DURHAM NC 27708-4677 study entitled, “Quantifying Patients’ Benefit- Risk Tradeoffs Associated with Percutaneous Revascularization Options for Peripheral Arterial Disease: A Collaborative Effort with the RAPID PATHWAYS Patient Science Working Group.”

75F40120C00085 $ 5,402,198.00 $ 6,634,520.00 THE UNIVERSITY OF LIVERPOOL

THE

FOUNDATION BUILDING, 765

BROWNLOW

HILL, LIVERPOOL,

MERSEYSIDE L69 7ZX,

UNITED KINGDOM

study entitled, “Characterization of severe coronavirus infection in humans and model systems for medical countermeasure development and evaluation

75F40120C00176 $ 1,550,500.00 $ 3,448,008.00 STANFORD UNIVERSITY 217691

LELAND STANFORD JUNIOR

UNIVERSITY, 450 JANE STANFORD

WAY STANFORD CA 94305-2004

a study entitled, “Pathology and Pathogenesis of Coronavirus Infections in Animal Models

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

75F40120C00021 $ 973,184.00 $ 973,184.00

UNIVERSITY OF CONNECTICUT

297690

438 WHITNEY RD EXTENSION UNIT

1133 STORRS CT 06269-1133

Study entitled, "Impact of Polymer Attributes on the Performance of in Situ Forming Implants, Improved Scientific Approaches to Evaluate Generic Drugs"

75F40120C00036 $ 129,469.00 $ 129,469.00 NANOPHARM LTD 1558826

5 LEEDS TWEN 5 LEEDS TWENTY-

SEVEN INDUSTRIAL EST LEEDS WEST YORKSHIRE LS27

study entitled, “INVESTIGATING

ORTHOGONAL ANALYTICAL

APPROACHES TO DEMONSTRATE

BIOEQUIVALENCE OF NASAL SUSPENSION

FORMULATIONS.”

75F40120C00055 $ 567,980.00 $ 567,980.00

LANDRAU SCIENTIFIC

INNOVATIONS LLC 1560241

LANDRAU SCIENTIFIC

INNOVATIONS, LLC , 17 DEVENS ST

MARLBOROUGH MA 01752-2207

study entitled, “Evaluation of Critical Process Parameters for the Preparation of Amphotericin B That Influence Toxicity”.

75F40120C00198 $795,703.00 $ 795,703.00

UNIVERSITY OF TEXAS SYSTEM

166534

110 INNER CAMPUS DR MN 13

AUSTIN TX 78712-1139

study entitled, “Effect of repeat unit ordering on the properties of meltextruded, poly(lactide-coglycolide)-based, long-acting,implants”

75F40120C00127 $ 323,132.00 $ 997,608.00

REGENTS OF THE UNIVERSITY OF

MICHIGAN 221536 503 THOMPSON ST ANN ARBOR MI 48109-1340

study entitled, “Characterization of Exparel®, understanding of critical manufacturing process parameters and characterization of drug release mechanisms in vitro and in vivo.”

75F40120C00150 $ 1,158,642.00 $ 1,158,642.00

ST LOUIS COLLEGE OF PHARMACY

1564171

4588 PARKVIEW PL

SAINT LOUIS MO 63110-1088

study entitled, “Food and Drug Administration Broad Agency Announcement for the “Robust in vitro/in silico Model to Accelerate Generic Drug Product Development for the Oral Cavity Route of Administration.”

75F40120C00136 $ 1,131,742.00 $ 1,131,742.00

UNIVERSITY OF CONNECTICUT

297690

438 WHITNEY RD EXTENSION UNIT

1133 STORRS CT 06269-1133

study entitled “Assessing Long-Acting Injectable Formulations Using in Vivo Imaging”.

75F40120C00172 $ 562,455.00 $ 1,613,656.00

VIRGINIA COMMONWEALTH

UNIVERSITY 164539

912 W FRANKLIN ST

RICHMOND VA 23284-9040

study entitled, “Evaluation of Current Approaches Used to Establish Bioequivalence of Nasal Sprays for Local Action in Children”.

75F40120C00125 $ 2,192,399.00 $ 2,192,399.00

RUTGERS, THE STATE UNIVERSITY

299012

RUTGERS, THE STATE UNIVERSITY

OF NJ

3 RUTGERS PLZA

NEW BRUNSWICK NJ 08901-8559

study entitled, “Development and Round- Robin Verification of Dynamic RTD Models for the Online Product Quality Analysis”.

75F40120C00168 $ 1,256,778.00 $ 1,256,778.00

RESEARCH CENTER

PHARMACEUTICAL ENGINEERING

GMBH 1563506 INFFELDGASSE 13 GRAZ STEIERMARK 8010

study entitled, “Precision modeling tool for evaluating CM Control Approaches: A high-fidelity digital twin for industry and FDA”

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

75F40120C00157 $ 1,160,437.00 $ 1,160,437.00 CUBRC, INC 405986

CUBRC, INC.

4455 GENESEE ST STE 106

BUFFALO NY 14225-1955

study entitled, “Immunogenicity Risk of Peptide Drug Generics and their Impurities:

In Silico and In Vitro Assessment and Validation Methods.”

75F40120C00200 $ 2,212,490.00 $ 2,212,490.00

THE REGENTS OF THE UNIVERSITY

OF MICHIGAN

1058 WOLVERINE TOWER - DRDA

3003 S. STATE ST.

ANN ARBOR MI 48109-1274

study entitled, “Setting Patient-Centric Quality Standards (PCQS) for Modified Release (MR) Oral Drug Products with Biopredictive in Vitro Dissolution-Models.”

75F40120C00141 $ 1,303,695.00 $ 1,303,695.00

CENTRAL STATE UNIVERSITY

109828

1400 BRUSH ROW RD

WILBERFORCE OH 45384-5800

Characterization of Chemical Constituents from Smokable Hemp Flower and E-cigarette.

75F40120C00199 $ 386,681.00 $ 1,128,848.00

CRITICAL PATH INSTITUTE, THE

273869

CRITICAL PATH INSTITUTE, THE 1

1730 E RIVER RD STE 200

TUCSON AZ 85718-5893

study entitled, “Model-Informed Drug Development in the Evaluation and Development of Neurological Drug Products”

75F40120C00195 $ 799,670.00 $ 799,670.00

THE REGENTS OF THE UNIVERSITY

OF MICHIGAN

1058 WOLVERINE TOWER - DRDA

3003 S. STATE ST. ANN ARBOR MI 48109-1274

conduct a study entitled, “Innovative randomized trial design and Bayesian analysis for the registration of a drug for rare disease in small samples”

75F40120C00152 $ 248,725.00 $ 248,725.00 HARTFORD HOSPITAL 1364439

HARTFORD HOSPITAL 80 SEYMOUR

S

80 SEYMOUR ST

HARTFORD CT 06102-8000

study entitled, “Expanding Current and Future Susceptibility Testing Criteria with Genotypic Data: Comparative Efficacy of Human-Simulated Exposures of Ceftazidime/Avibactam, Imipenem/Relebactam, and Meropenem/Vaborbactam against OXA-48 β-lactamase-producing Enterobacterales in the Neutropenic Murine Thigh Infection Model”.

75F40120C00111 $ 313,326.00 $ 313,326.00

UNIVERSITY OF WISCONSIN

SYSTEM 254958 21 N PARK ST STE 6401 MADISON WI 53715-1218

conduct a study entitled, “Development of Modernized Acinetobacter Baumannii Susceptibility Guidance for Recommended Antimicrobial Agents Using Pharmacometric Approaches.”

75F40120C00164 $ 249,794.00 $ 249,794.00 HARTFORD HOSPITAL 1364439

HARTFORD HOSPITAL 80 SEYMOUR

S

80 SEYMOUR ST

HARTFORD CT 06102-8000

study entitled, “Metallo-β-Lactamase Resistance in Enterobacterales: Is it Time to Rethink Our In Vitro Assessment Tools?”

75F40120C00175 $ 1,082,140.00 $ 1,082,140.00

UNIVERSITY OF PENNYSLVANIA

178062

TRUSTEES OF THE UNIVERSITY OF

PENNS 3451 WALNUT ST RM 737 PA 19104-6245

to conduct a study entitled, “Efficacy of Chronic Opioid Pain Treatments: An RCT Reanalysis”

75F40120C00139 $ 1,502,158.00 $ 1,502,158.00

ALLIANCE NCTN FOUNDATION

1563549

125 S WACKER DR STE 1600

CHICAGO IL 60606-4404

study entitled “Integrating Clinical trials And Real world Endpoints data (ICAREdata) Data Capture and Standardization Study”

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

75F40120C00140 $ 994,896.00 $ 994,896.00

WEILL MEDICAL COLLEGE OF

CORNELL UNIVERSITY 141415

WEILL MEDICAL COLLEGE OF

CORNELL UN

407 E 61ST ST RM 106 1ST FL

NEW YORK NY 10065-4805

Development of rabbit animal models of ventilator-associated bacterial pneumonia produced by carbapenem-resistant Pseudomonas aeruginosa and Acinetobacter baumannii

75F40120C00044 $ 4,419,354.00 $ 4,419,354.00

BRIGHAM AND WOMENS HOSP

INC 124538 75 FRANCIS ST BOSTON MA 02115-6110

Study entitled, "Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge"

75F40120C00156 $ 486,580.00 $ 486,580.00

ANTICOAGULATION FORUM, INC

1523973 17 LINCOLN STREET NEWTON MA 02464-1559

Study entitled, "Mentored Implementation and Dissemination of Anticoagulation Stewardship (MIDAS) Program"

75F40120C00126 $ 200,884.00 $ 435,308.00

CHILDREN'S HOSPITAL,

CINCINNATI, OHIO, THE 148252 3333 BURNET AVE CINCINNATI OH 45229-3026

Study entitled, "Preventable Harm from Pediatric Outpatient Medication Errors:

Measure Development"

75F40120C00151 $ 1,152,427.00 $ 1,152,427.00

DENVER HEALTH AND HOSPITAL

AUTHORITY 366859

DENVER HEALTH AND HOSPITALS

AUTHORI 777 BANNOCK ST DENVER CO 80204-4507

Conduct a study entitled, “Evaluation of Stimulant Abuse in the United States: A mosaic epidemiology Study”

75F40120C00033 $ 917,860.88 $ 3,634,438.08

DELOITTE CONSULTING L.L.P.

116706 1919 N LYNN ST ARLINGTON VA 22209-1742

study entitled, “Optimizing Regulatory Data Processing and Curation Through the Use of Intelligent Automation and Cloud Enablement.”

75F40120C00138 $ 283,619.50 $ 584,639.00 HUSSON UNIVERSITY 1545484

HUSSON UNIVERSITY 1 COLLEGE CI

1 COLLEGE CIR BANGOR ME 04401-2929

Study entitled, "Predicting the Transfer of Breast Cancer Resistant Protein (BCRP) Substrates into Human Milk Using In Vitro Extrapolation (IVIVE)"

75F40120C00201 $ 349,364.00 $ 349,364.00

UNIVERSITY OF CONNECTICUT

297690

438 WHITNEY RD EXTENSION UNIT

1133 STORRS CT 06269-1133

study entitled, “Continue Processing of Liposomal Nanoparticles as Reference Materials for Dug Product Development”.

75F40120C00191 $ 631,011.00 $ 631,011.00

ALLIANCE NCTN FOUNDATION

1563549

ALLIANCE NCTN FOUNDATION 125 S

WACKER DR STE 1600 CHICAGO IL 60606-4404

Study entitled, "Adverse Event Reporting in the Intergrating Clinical trials And Real world Endpoints data (ICAREdata) Initiative"

75F40120C00122 $ 399,996.00 $ 399,996.00 NEW YORK UNIVERSITY 178278

NEW YORK UNIVERSITY 550 1ST AVE

NEW YORK NY 10016-6402

Study entitled, " Leveraging the EHR to Promote Pharmacy Adoption of Dosing Best Practices and Reduce Parent Errors in Administering Pediatric Liquid Medications:

A Health Literacy-Informed Approach."

75F40120C00123 $ 274,413.00 $274,413.00 DUKE UNIVERSITY 132317 P O BOX 104004 DURHAM NC 27708 study entitled, “Using Electronic Health Records to Identify and Assess Adverse Events for Biologic Therapies:

Developing and Validating Methodological Approaches.”

75F40120C00070 $ 831,964.00 $ 831,964.00

RESEARCH CENTER

PHARMACEUTICAL ENGINEERING

GMBH

RESEARCH CENTER

PHARMACEUTICAL ENGI

INFFELDGASSE 13 GRAZ STE 8010

study entitled: "OCT for Real-Time Monitoring of Coating Process Dynamics & Product Quality"

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

75F40120C00181 $ 54,500.00 $ 54,500.00 S-3 RESEARCH 1564164

S-3 RESEARCH LLC 3636 NOBEL DR

STE 170 SAN DIEGO CA 92122-1042

study entitled, “A using big data, machine learning, and infoveillance approaches to detect and characterize adoption and adherence to prep therapy among minority populations.”

75F40120C00171 $ 249,991.00 $ 249,991.00 HARTFORD HOSPITAL 1364439

HARTFORD HOSPITAL 80 SEYMOUR

ST HARTFORD CT 06102-8000

a study entitled, “Pharmacodynamics of Minocycline, Levofloxacin, and Trimethoprim/sulfamethoxazole against Stenotrophomonas maltophilia: Implications for Susceptibility Breakpoint Revisions”.

75F40120C00159 $ 527,735.00 $ 527,735.00

THE RESEARCH FOUNDATION FOR

STATE UNIVERSITY OF NEW YORK

ON BEHALF OF UNIVERSITY OF

BUFFALO

520 LEE ENTRANCE, STE 211

AMHERST, NY NY 14228-2567

Conduct a study entitled, “Evaluating LRT for Post-market surveillance of adverse events.”

75F40120C00174 $ 300,000.00 $ 1,499,999.00 YALE UNIVERSITY 105 WALL ST, NEW HAVEN, CT CT 06511-8917

Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in COVID-19 Clinical Trials

Totals $ 55,289,690.12 $ 71,253,309.81

Revised_Rob_BAA_SP