Final FY26 Awards.pdf
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- Attached to
- FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
- Solicitation number
- FDABAA-26-00123_Award
About this file
This document is a federal contract award summary listing 71 contracts awarded by the Food and Drug Administration (FDA) across multiple centers, including the Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue, and Gene Therapies (OCE), Center for Veterinary Medicine (CVM), and Office of Counterterrorism and Emerging Threats (OC). The total amount obligated across all contracts is $63,603,152.00, with a total estimated contract value of $120,774,129.00.
The contracts support three primary charge descriptions aligned with FDA strategic initiatives: (I) Modernize development and evaluation of FDA-regulated products (majority of awards), (II) Strengthen post-market surveillance and labeling of FDA-regulated products, and (III) Invigorate public health preparedness and response of the FDA, patients, and consumers, with one award supporting Medical Countermeasures (MCMs). Award recipients include academic institutions (University of Maryland, Purdue University, Duke University, University of Connecticut, Emory University), research organizations (Dana-Farber Cancer Institute, American Type Culture Collection), and private companies (Malcova Inc., Nudge BG Inc., Diagnostic Biochips Inc., Simulations Plus Inc.). Contract values range from $256,446.00 to $6,515,098.00 obligated amounts. Projects encompass advanced pharmaceutical manufacturing technologies, digital health platforms, artificial intelligence applications for regulatory science, bioequivalence studies, lyophilization processes, real-world evidence generation, and patient-focused drug development methodologies. Contract numbers follow the format 75F40126C followed by sequential identifiers, and each award is designated with a BAA (Broad Agency Announcement) number beginning with FY25 or FY26.
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Contract Number Amount Obligated Total Estimated Contract Value Center Awardee Name Awardee Address BAA Number Award Title Charge Description
75F40126C00039 $872,653.00 $872,653.00 CDRH University of Maryland, College Park
3112 Lee Bldg 7809 Regents Dr College Park MD 207425100 FY25C1AP20 Machine Learning-Guided 3D Nanoprinting of a Retinal Vascular Phantom Library
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00019 $1,004,344.00 $1,004,344.00 CDRH Malcova Inc.
39655 EUREKA DR
NEWARK CA 945604806 FY25C1CP50 BREVITY: A Patient-Derived Digital-Twin Platform for Breast-Cancer Imaging
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00020 $1,736,780.00 $1,736,780.00 CDRH Nudge BG Inc.
725 OLD FARM RD
THOUSAND OAKS CA
91360 FY25C1CP51 Automated Insulin Delivery Interoperability Framework Extension
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00021 $1,667,902.00 $1,667,902.00 CDRH
North Carolina Community Health Care Association
4917 WATERS EDGE DR
STE 165
RALEIGH NC 27606 FY25C1EP7 Making Older Americans and Rural Populations Healthier - Supporting Rural Clinical Investigator Readiness
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00035 $1,294,042.00 $1,294,042.00 CDRH Cognita Imaging Inc.
845 LIVE OAK AVE
MENLO PARK CA
940254911 FY25C2BP11 Virtual Subject Matter Expert Agents for Radiology Report Evaluation
(II) Strengthen post-market surveillance and labeling of FDA-regulated products
75F40126C00025 $325,000.00 $325,000.00 CDER Institute for Clinical Pharmacodynamics
242 BROADWAY STE 101
SCHENECTADY NY 12305 FY25C3BP4
Development of Susceptibility Guidance for Daptomycin and Enterococcus Species Using Pharmacometric Approaches
(III) Invigorate public health preparedness and response of the FDA, patients, and consumers
75F40126C00208 $918,951.00 $918,951.00 OCS Diagnostic Biochips, Inc .
801 Cromwell Park Dr Ste Glen Burnie MD 21061- 2539 FY26C1AP10 A High-Throughput Physiology Tool for NAMs-based Safety Studies
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00096 $1,517,015.00 $2,998,734.00 OCE The Brigham and Womens Hospital INC 75 Francis St Boston, MA 02115 FY26C1AP15 A Long-Term Vascular MPS to Assess Cyclic Cardiovascular Toxicity of Oncology Drugs
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00089 $645,503.00 $1,667,347.00 CDER University of Florida
1523 UNION RD RM 207
GAINESVILLE FL 32611 FY26C1AP28 Mechanistic Gastric NAM and PBPK Framework to Interpret Bioequivalence of Oral Peptide Drug Products
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00080 $884,879.12 $1,742,521.12 OCE American Type Culture Collection
10801 UNIVERSITY BLVD
MANASSAS VA
201102204 FY26C1AP30
A NAM-Aligned Pediatric Glioblastoma CIVM with EV-Enabled Non-Destructive Molecular Fidelity Assessment
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00101 $534,032.00 $760,505.00 CDER University of Strathclyde 16 Richmond ST Glasgow G1 1XQ FY26C1AP5
Enhancing Regulatory Confidence in Pediatric Bioequivalence Through Validated TIM Based Mechanistic Platforms and Model Integrated Evidence
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00156 $861,756.00 $861,756.00 CDER University of Massachusetts Lowell 220 Pawtucket St Ste 400 Lowell MA 018543573 FY26C1BP12 Multiscale Digital Twin Framework for Flexible Biomanufacturing
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00086 $1,845,938.00 $1,845,938.00 CDER Purdue University
SPONSORED PROGRAM
SERVICES
302 WOOD ST. (YOUNG
HALL)
WEST LAFAYETTE IN
479072108 FY26C1BP19
Risk-based digital design and operation of sustainable end-to-end optimal modular pharmaceutical manufacturing systems
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00085 $1,365,711.00 $1,365,711.00 CDER Purdue University
2550 Northwestern Ave
STE 1120
West Lafayette IN 47906 FY26C1BP21
Microwave-Assisted Lyophilization for Advanced Manufacturing of Pharmaceuticals and Biologics in Glass Containers and Bulk Lyobeads
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00048 $1,019,732.00 $1,019,732.00 CDER Physical Sciences Inc.
20 NEW ENGLAND
BUSINESS CTR DR
ANDOVER MA 018101022 FY26C1BP25
Advanced Control Techniques for Product Temperature during Pharmaceutical Lyophilization: A feedforward and feedback approach
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00066 $2,682,546.00 $6,954,936.00 OCE Trustees of the University of Pennsylvania
3451 WALNUT STREET
5TH FLOOR, FRANKLIN
BUILD
PHILADELPHIA PA 19104-
6205 FY26C1BP32
Targeted polymer-lipid nanoparticle platform for bioPROTAC-mediated degradation of oncofusion proteins in Ewing Sarcoma
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00098 $733,525.00 $733,525.00 CDER
RESEARCH CENTER PHARMACEUTICAL
ENGINEERING GMBH
INFFELDGASSE 13
GRAZ 8010 FY26C1BP33
Next generation process development and quality control in protein lyophilization using mechanistic and AI approaches
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00054 $1,517,240.00 $1,517,240.00 CDER
The National Institute for Pharmaceutical Technology & Education
717 DELAWARE ST SE
STE 482
MINNEAPOLIS MN
554142959 FY26C1BP4 Smart Quality Control for 3D Printed Solid Dosage Forms using In-Situ Metrology and Machine Learning
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00093 $456,721.00 $456,721.00 CBER University of Massachusetts Lowell 220 Pawtucket St Ste 400 Lowell MA 018543573 FY26C1BP9 AI-Assisted Digital Twin Platform for Real-Time Lyophilization Process Development and Scale-Up
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00177 $947,034.00 $947,034.00 CDRH Barco Inc.
3059 Premiere PKWY
STE 400
Duluth Georgia 30097-
4905 FY26C1CP1
Advanced physical and digital slides for Characterization, Performance and Interoperability Assessment of Digital Pathology Systems
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00056 $2,456,000.00 $2,456,000.00 CDRH
The Research Foundation for The State University of New York
BINGHAMTON NY
139026000 PO BOX 6000 FY26C1CP12 Estimation of In-vivo Tissue Properties using Clinical MR Thermometry Data
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00087 $1,173,033.00 $2,432,643.00 CDER University of Connecticut
438 Whitney Rd Extention Unit 1133 Storrs, CT 06269 FY26C1CP13
Investigating the impact of diastereomers and synthesis-related impurities on the immunogenicity of oligonucleotides
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00154 $599,999.00 $599,999.00 CDER University of Connecticut
438 Whitney Rd Extention Unit 1133 Storrs, CT 06269 FY26C1CP17
Release mechanisms of oral modified-release products: dissolution method development and mechanistic insights
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00088 $657,981.00 $1,207,750.00 CDER University of Connecticut
438 Whitney Rd Extention Unit 1133 Storrs, CT 06269 FY26C1CP2
Mechanistic Insights into Aggregation Behavior and Predictive Modeling of Long-Acting Injectable Nano- Suspensions
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00082 $256,446.00 $867,832.00 CVM The Texas A&M University Health Science Center
8441 Riverside Pkwy
SUITE 3100
BRYAN TX 77807 FY26C1CP22
Impact of Critical Material Attributes of Hard Compressed and Soft Chewable Animal Products on Critical Quality Attributes: Chewing, In Vitro Dissolution, In Vitro Permeation, Bioavailability, and Stability
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00059 $511,219.00 $789,844.00 CDER University of Connecticut
438 Whitney Rd Extention Unit 1133 Storrs, CT 06269 FY26C1CP3 Advancing LNG-IUSs Development Through Accelerated Testing, IVIVR, and Predictive Modeling Approaches
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00060 $688,145.00 $990,864.00 CDER University of Texas at Austin
110 INNER CAMPUS DR
AUSTIN TX 78712-1139 FY26C1CP31
Effects of Material Property and Manufacturing Process on the Physicochemical Attributes and in vivo Performance of Peptide Implants
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00063 $575,554.00 $1,650,102.00 CDER Simulations Plus, Inc.
42505 10th ST W Lancaster CA 93534-
7059 FY26C1CP40
Development of a Predictive PBPK Framework Informed by In Vitro Assays for Oral Lipid-Based Drug Delivery Systems
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00097 $499,922.00 $499,922.00 CDER Uppsala Universitet P.O. Box Uppsala 75105 FY26C1CP41 Robust clinical endpoint bioequivalence studies using model-integrated evaluation approaches
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00107 $500,000.00 $500,000.00 CDER University of California San Francisco
1855 FOLSOM STREET
SAN FRANCISCO CA
94143
BOX 0816 FY26C1CP48
A Multi-Agent AI System for High-Throughput PBPK Modeling: Predicting Formulation Effect on Drug Absorption and Human Pharmacokinetics
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00071 $352,968.00 $1,083,957.00 CDER Certara UK Limited
SHEFFIELD SOUTH
YORKSHIRE S2 4S
JOHN STREET FY26C1CP53
Advancing integration of in vitro topical product characterization and skin permeation data with PBPK approaches to study the influence of excipients and compositional changes on drug products bioequivalence
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00153 $540,907.00 $540,907.00 CDER Purdue University
SPONSORED PROGRAM
SERVICES
302 WOOD ST. (YOUNG
HALL)
WEST LAFAYETTE IN
479072108 FY26C1CP7
Developing Regulatory Science Tools for Oral Peptide Delivery: Integrating Mechanistic Understanding with Predictive In Vitro Models
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00100 $1,149,236.00 $1,149,236.00 CDRH Emory University
201 DOWMAN DR NE
ATLANTA GA 30322 FY26C1EP1 Evaluating the Fit-for-Purpose of Patient Reported Outcomes for Medical Device Evaluation
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00158 $948,781.00 $948,781.00 CDRH Digital Medicine Society Inc.
90 CANAL ST
FL 4
BOSTON MA 02114 FY26C1EP3
Modernizing Outcome Data for Opioid Use Disorder (MOD-OUD): A prospective study to modify episodic patient reports into continuous sensor-based relapse risk assessments for safety surveillance
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00068 $933,028.00 $1,583,356.00 OCE Dana-Farber Cancer Institute, Inc.
450 BROOKLINE AVENUE
BOSTON MA 022155450 FY26C1EP4
A Multiomics Approach to Improving the Identification of the Side Effects of Immune Checkpoint Inhibitors (ICIs)
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00181 $1,256,810.00 $1,256,810.00 OCE Duke University
0 DUKE UNIVERSITY
DURHAM NC 277088990 FY26C1FP3
Towards ML-Powered, Efficient and Robust Inference of Average and Individual Treatment Effects for Novel Clinical Trials in Rare Diseases
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00055 $752,304.00 $752,304.00 OCE
The University of Texas MD Anderson Cancer Center
1515 HOLCOMBE BLVD
BOX 1676
HOUSTON TX 77030 FY26C1FP7 Evaluating Bayesian Effective Sample Size and Decision Criteria for Pediatric and Rare Disease Trials
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00081 $749,762.00 $749,762.00 CDRH DUKE UNIVERSITY
0 Duke University Durham NC 27708-8990 FY26C1IP1 AI-Driven Adaptive Adolescent Patient Preference Elicitation for Regulatory Decision Making
(I) Modernize development and evaluation of FDA-regulated products
75F40126C0012 $1,456,427.00 $1,456,427.00 CDER Duke University 0 Duke University Durham NC 27708-8990 FY26C1IP3
Developing Evidence-Based Training Methodologies for Implementing FDA’s Patient-Focused Drug Development Guidance
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00094 $749,621.00 $749,621.00 CDRH University of Maryland, Baltimore
220 Arch ST, Office Level Baltimore, MD 212011531 FY26C1JP1 REAL-AI:PE - Real-world Evidence And Localized AI imaging Testbed for Pulmonary Embolism
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00120 $1,994,855.00 $1,994,855.00 CVM University of Maine System
CONTROLLER'S OFFICE
65 TEXAS AVE
BANGOR ME 044014324 FY26C1JP17 Determining the pharmacokinetics of PFAS contamination in dairy cattle across lactations
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00064 $6,000,000.00 $12,000,000.00 CDRH The Medical Device Innovation Consortium 1655 Fort Myer Dr FL12 Arlington, VA 22209-2403 FY26C1JP2
Enhancing Infrastructure for Real-World Data (RWD) Sources and Real-World Evidence(RWE) Generation in Medical Devices
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00065 $6,515,098.00 $35,194,704.00 CDRH Rutgers The State University of New Jersey
33 Knighsbridge Rd, 2nd FL east Piscataway, NJ 08854 FY26C1JP8
Identification and Performance Assessment of Medical Devices in Electronic Health Record Data – Development of a Transparent and Repeatable Framework to Enhance Medical Device Integration in Real- World Evidence Generation
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00157 $286,130.00 $286,130.00 CDER George Mason University
4400 UNIVERSITY DR
FAIRFAX VA 22030 FY26C1JP9 Regulatory Grade Frameworks for Assessing Record Linkage Uncertainty in Real-World Evidence
(I) Modernize development and evaluation of FDA-regulated products
75F40126C00217 $2,131,932.00 $2,131,932.00 CDRH Emergency Care Research Institute
5200 BUTLER PIKE
PLYMOUTH MEETING PA
194621241 FY26C2AP11 Development and Implementation of a Surveillance and Evaluation System for AI-enabled Medical Devices
(II) Strengthen post-market surveillance and labeling of FDA-regulated products
75F40126C00069 $634,642.00 $634,642.00 CDER
The National Institute for Pharmaceutical Technology & Education
717 DELAWARE ST SE
STE 482
MINNEAPOLIS MN
554142959 FY26C2AP9
Advanced CMC Index and Intelligence Platform for Drug Quality Control, Shortage Prediction, and Strategic Reshoring
(II) Strengthen post-market surveillance and labeling of FDA-regulated products
75F40126C00084 $732,673.00 $1,411,508.00 CDRH The Regents of the University of California
1855 FOLSOM ST STE 425
SAN FRANCISCO CA
9410334 FY26C2BP1 Scalable monitoring procedures for generative AI-based medical devices
(II) Strengthen post-market surveillance and labeling of FDA-regulated products
75F40126C00070 $435,178.88 $435,178.88 CDER Universitat St.Gallen 1592134
DUFOURSTRASSE 50
ST. GALLEN SG 9000 FY26C2DP2 Beyond Compliance: Integrating Quality Culture and Risk in Pharmaceutical Quality Management Oversight
(II) Strengthen post-market surveillance and labeling of FDA-regulated products
75F40126C00083 $1,500,000.00 $9,900,000.00 OC
University of Nevada, Reno (with Wyss Institute at Harvard, Stanford University, and Beth Israel Deaconess Medical Center)
1664 N. VIRGINIA ST
204 ROSS HALL, MS 325
RENO NV 89557 FY26C3AP4
A Cross-Species Immune Organ Chip Reference Framework for Regulatory Evaluation of Vaccine and Antiviral Medical Countermeasures ( III) Medical Countermeasures (MCMs)
75F40126C00151 $580,601.00 $580,601.00 CDER Johns Hopkins University
W-400 WYMAN PARK
3400 N CHARLES ST
BALTIMORE MD
212182685 FY26C3BP5 Leveraging Real World Data to Develop External Controls for Invasive Fungal Infection Trials
(III) Invigorate public health preparedness and response of the FDA, patients, and consumers
75F40126C00197 $293,829.00 $293,829.00 CDER Carelane LLC 69 W 107th St Apt 2D New York NY 100253284 FY26C3BP6
Advancing the Development of External Controls for Invasive Fungal Infection Trials - University Hospital Cologne; Carelane LLC
(III) Invigorate public health preparedness and response of the FDA, patients, and consumers
75F40126C00095 $995,374.00 $995,374.00 CDER The Task Force for Global Health Inc.
330 W PONCE DE LEON
AVENUE
DECATUR GA 30030 FY26C3CP11 Developing Standardized Case Definitions for Cannabis Adverse Events
(III) Invigorate public health preparedness and response of the FDA, patients, and consumers
75F40126C00123 $1,863,392.00 $1,957,886.00 CDRH MedTech Innovator
907 WESTWOOD BLVD
SUITE 1067
LOS ANGELES CA 90024 FY26C3EP3
A Publicly Available FDA-Hosted Playbook for Strategic Planning of End-to-End Stakeholder Evidence Generation in Medical Device Development
(III) Invigorate public health preparedness and response of the FDA, patients, and consumers
$63,603,152.00 $120,774,129.00
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