BAATrackingSheet_AwardsFY25Data-01-08-2026.pdf
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- Attached to
- FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
- Solicitation number
- FDABAA-25-00123_Award
About this file
This document is a federal contract award summary listing 13 research contracts awarded by various centers within the FDA, totaling $14,335,517.89 in obligated funds. The contracts span multiple research domains including medical countermeasures, clinical trial design, bioprocessing, vaccine technologies, patient preference studies, and digital health innovations. Award recipients include academic institutions like Rutgers University, Johns Hopkins University, Duke University, and Florida State University, as well as research organizations like SimVantage GmbH and the Digital Medicine Society. Research project titles reflect cutting-edge scientific investigations, such as "Combining Machine Learning and Mechanistic Models to Create a Digital Framework for Rapidly Designing Continuous Bioprocess Operations" and "Modernizing and Decentralizing Clinical Trials with AI, Digital Health, and Community-Driven Innovation to Deliver Better Health for All Americans". Contract values range from $288,274 to $3,090,714.59, with most awards between $500,000 and $1,200,000, indicating substantial investment in advanced research initiatives across multiple FDA research centers.
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Contract Number Amount Obligated Total Estimated Contract Value Center Awardee Name Awardee Address BAA Number Award Title
75F40125C00073 $661,012.30 $661,012.30 CDER SimVantage GmbH
SIMVANTAGE GMBH
Inffeldgasse 13 Graz 8010 FY25C1BP3
Combining Machine Learning and Mechanistic Models to Create a Digital Framework for Rapidly Designing Continuous Bioprocess Operations
75F40125C00085 $324,978.00 $324,978.00 CDER Hartford Hospital
80 Seymour St PO Box 5037 Hartford, CT 06102 FY25C3BP2
Pharmacodynamics of Daptomycin against Enterococcus faecium and Enterococcus faecalis in the Murine Thigh Infection Model
75F40125C00095 $3,090,714.59 $3,090,714.59 OCS Vahan Simonyan
3909 Fox Valley Rd Rockville,MD
20853 FY25C3AP3
HIVE 2.O (H2O) – a next generation medical countermeasures scientific platform for regulatory evaluation and preparedness
75F40125C00089 $999,347.00 $999,347.00 CDER Rutgers University
3 RUTGERS PLAZA
NEW BRUNSWICK NJ 089018559 FY25C1BP27
Development and implementation of AI/ML toolbox for digitalization of advanced modular continuous API manufacturing process
75F40125C00069 $1,085,530.00 $1,085,530.00 CDER Genentech Inc.
GENENTECH, INC.
1 DNA WAY
SOUTH SAN FRANCISCO CA 94080 FY25C1FP4
Novel hybrid randomized clinical trial designs for longitudinal outcomes with applications to rare disease settings
75F40125C00075 $1,064,238.00 $1,064,238.00 OCE
The University of Texas MD Anderson Cancer Center
THE UNIVERSITY OF TEXAS M D
ANDERSON CANCER
1515 HOLCOMBE BLVD
Box 1676
HOUSTON TX 77030 FY25C1FP6
Statistical designs and considerations for dose optimization with drug combination and multiple indications
75F40125C00072 $799,998.00 $799,998.00 CDER
The National Center for Natural Products Research (NCNPR), The University of Mississippi
THE UNIVERSITY OF MISSISSIPPI
SPONSORED PROGRAMS
ADMINISTRATION
UNIVERSITY OF MISSISSIPPI
P.O. Box 1848 100 Barr Hall UNIVERSITY MS 386779704 FY25C1CP32 Quality and Safety of Botanical Products: Addressing Herb-Drug Interactions in Healthy Individuals
75F40125C00105 $2,277,208.00 $2,277,208.00 CDRH
Florida State University, Center of Population Sciences for Health Equity
874 Traditions Way Tallahassee, FL 32306 FY25C3CP4
Modernizing and Decentralizing Clinical Trials with AI, Digital Health, and Community-Driven Innovation to Deliver Better Health for All Americans
75F40125C00034 $867,755.00 $1,981,317.00 CTP
The Ohio State University College of Public Health
OHIO STATE UNIVERSITY, THE 1960
KENNY RD
COLUMBUS OH 43210 FY25C1CP40
The Determination of Repeatability (r) and Reproducibility (R) for the measurement of total particulate matter and nicotine in combustible and electronic nicotine delivery systems (ENDS) using a universal smoking machine adaptor (USMA).
75F40125C00054 $1,138,631.00 $1,138,631.00 OCE
Johns Hopkins University School of Medicine
W-400 WYMAN PARK
3400 N CHARLES ST
JOHNS HOPKINS UNIVERSITY
BALTIMORE MD 212182685 FY25C2DP7
Application of Computable Phenotyping to Real-World Data to Support the Active Safety Surveillance of CAR T-cell Therapies
75F40125C00071 $492,000.00 $1,265,103.00 OCET
University of Maryland, Baltimore
UNIVERSITY OF MARYLAND, BALTIMORE
220 ARCH STREET, OFFICE LEVEL 2
BALTIMORE MD 212011531 FY25C3AP15 Noninvasive Fingerprinting of Aluminum-adjuvanted Vaccines
75F40125C00053 $749,661.00 $749,661.00 CDRH Duke University
Duke University
2200 WEST MAIN STREET SUITE 300
DURHAM NC 27705
FY25C1IP7 Quantifying Patient Preference Information in Small-Scale Studies for Regulatory Decision Making
75F40125C00009 $496,171.00 $496,171.00 CDRH
DIGITAL MEDICINE SOCIETY
INC
DIGITAL MEDICINE SOCIETY INC 90 Canal St Boston MA 02114 FY24C1IP4
FY24C1IP4/ Vision 2030: Strategic roadmap for implementing patient voice into the total product lifecycle for medical devices via patient-generated health data
75F40125C00049 $288,274.00 $288,274.00 CDER
University of Maryland Baltimore
THE STATE OF MARYLAND 1378167
UNIVERSITY OF MARYLAND BALTIMORE
601 W LOMBARD ST
BALTIMORE MD 21201 FY25C3BP5
Developing studies needed to define clinical and/or surrogate endpoints that can be used for the regulatory approval of decolonizing agents, microbiome therapies, or similar products
$14,335,517.89 $16,222,182.89
FY25 BAA Awards
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