BAAwardedFY24.pdf
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- Solicitation number
- FDABAA-24-00123_Award
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This document is a spreadsheet detailing 22 contract awards made under the FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. The contracts were awarded by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services, with a total obligated amount of $20,640,972.28 and a total estimated contract value of $31,086,978.28.
The contracts cover a range of regulatory science research and development efforts, including developing universal control peptides for T cell assays, conducting systematic reviews of vulnerable pediatric populations at risk from opioid and anesthetic exposure, analyzing stimulant and opioid use disorder trajectories, developing drug development tools for Autosomal Dominant Tubulointerstitial Kidney Disease (ADTKD), ensuring the quality and safety of botanical drug candidates, advancing bispecific engagers for NK cell immunotherapy in pediatric gliomas, modernizing nitrofurantoin susceptibility guidance, enhancing FDA's SOURCE model, analyzing neurodevelopmental and mental health outcomes in preterm infants exposed to opioids and anesthetics, validating real-world data to support regulatory decision-making, developing a virtual reality experience for home environments that foster health and wellness for those with diabetes, harnessing benefit-transfer methods for diabetes device regulation, developing a how-to guide for adopting sensor-based digital health technologies in clinical trials, characterizing albumin-bound nanoparticle drugs, improving rAAV gene therapy product quality and scalability, and establishing a multi-regulatory collaborative framework in the cloud.
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Contract Number Amount Obligated Total Estimated Contract Value
Center Awardee Name Awardee Address BAA Number Award Title
75F40124C00094 $1,014,000.00 $2,161,743.00 CDER CUBRC, Inc.
4455 GENESEE ST
STE 106
BUFFALO NY 14225
FY24C2GP1
Developing Universal Control Peptides for
T cell Assays Supporting
Immunogenicity Assessments for
Regulatory Filings
75F40124C00087 $243,473.00 $243,473.00 CDER Columbia University
630 W 168TH ST FL 4
NEW YORK NY 10032
FY24C3DP2
Systematic Reviews of Vulnerable
Pediatric Populations at Risks for Adverse
Neurodevelopmental Outcome from
Exposure to Opioid Analgesics, Anesthetic and Sedative Agents
75F40124C00131 $569,780.00 $2,235,290.00 CDER University of Michigan
3003 S. STATE ST.
ANN ARBOR MI
481091274
FY24C3DP3
A Mosaic Approach for Understanding
Stimulant and Opioid Use and Use Disorder
Trajectories and Associated
Consequences in US Adults
75F40124C00106 $951,000.00 $3,376,000.00 CDER Critical Path Institute
1840 E RIVER RD
SUITE 100
TUCSON AZ 85718
FY24C1DP4
Development of drug development tools for ADTKD
75F40124C00118 $399,999.00 $399,999.00 CDER
The National Center for
Natural Products Research, The University of Mississippi
113 Falkner
UNIVERSITY MS
386779704
FY24C1CP18
Quality and Safety of Botanical Drug Candidates –
Development of Chemical and
Xenobiotic Profiles to Ensure the Clinical Relevancy of Herb-
Drug Interaction Potentials
75F40124C00125 $564,246.00 $564,246.00 OCE Purdue University
NORTHWESTERN AVE
# 1100
WEST LAFAYETTE IN
47906
FY24C1BP30
Advancing bispecific engagers for NK immunotherapy in pediatric gliomas
75F40124C00080 $248,553.46 $248,553.46 CDER
Institute for Clinical Pharmacodynamics
242 BROADWAY STE
SCHENECTADY NY
12305
FY24C3BP4
DEVELOPMENT OF
MODERNIZED
SUSCEPTIBILITY
GUIDANCE FOR
NITROFURANTOIN
DOSING USING A
DYNAMIC URINARY
TRACT IN VITRO
INFECTION MODEL
AND
PHARMACOMETRIC
APPROACHES
75F40124C00128 $978,324.00 $978,324.00 CDER
The General Hospital
Corporation d/b/a Massachusetts
55 FRUIT ST
BOSTON MA 02114
FY24C3DP4
Enhance FDA’s SOURCE model by incorporating and analyzing state and regional-level data
75F40124C00081 $1,050,310.00 $1,050,310.00 CDER Columbia University
630 WEST 168TH
STREET BOX 49
NEW YORK NY 10032
FY24C3DP5
Neurodevelopmental and Mental Health
Outcomes in Preterm Infants: Effects of
Exposures to Opioid Analgesic, Anesthetic and Sedative Agents
75F40124C00119 $2,982,375.00 $2,982,375.00 CDER Verantos, Inc
325 SHARON PARK DR
#730
MENLO PARK CA
94025
FY24C1JP9
Valid Evidence and Reliable real-world data Increasing Fidelity and Yielding clarity in regulatory decision-making
(VERIFY)
75F40124C00047 $1,189,903.56 $1,189,903.56 CDRH HKS, Inc.
350 N SAINT PAUL ST
STE 100
DALLAS TX 75201 FY24C1HP5
Developing a prototype virtual reality experience of home environments that foster health and wellness for those living with diabetes: A step towards health equity
75F40124C00083 $699,087.00 $699,087.00 CDRH Duke University
2200 West Main Street, Suite 900
DURHAM NC
277088990
FY24C1IP2
Harnessing the Power of Benefit-
Transfer Methods for Informed Regulatory Decision-Making: A
Case Study on Diabetes Medical
Devices
75F40124C00114 $811,126.00 $811,126.00 CDRH
Digital Medicine Society
(DiMe)
90 CANAL ST
FL 4
BOSTON MA 02114
FY24C1DP11
A how-to-guide for technology developers and the life sciences to drive adoption of sDHTs in clinical trials
75F40124C00132 $260,000.00 $460,000.00 CDER
University of Maryland, Baltimore
220 ARCH STREET,
OFFICE LEVEL 2
BALTIMORE MD
212011531
FY24C1CP43
Characterizing Albumin-bound
Nanoparticle Drugs using wNMR
75F40124C00130 $1,832,572.00 $6,038,686.00 CBER
Stacy Springs and the
Massachusetts Institute of Technology
77 MASSACHUSETTS
AVE
CAMBRIDGE MA
02139
FY24C1BP64
Advanced manufacturing approaches to improve rAAV gene therapy product quality and scalability
75F40124C00049 $1,910,049.00 $1,910,049.00 CDER
Accenture Federal Services, LLC. (Accenture)
800 N GLEBE RD STE
ARLINGTON VA 22203
FY24C3FP5
Multi-Regulatory Collaborative
Framework in the Cloud
75F40124C00121 $1,051,402.26 $1,051,402.26 OC DNAnexus
1975 W EL CAMINO
REAL STE 204
MOUNTAIN VIEW CA
940402218
FY24C1KP5
PRISM High-Impact Platform Pilot for Pre-
Submission Validation of eCTDs Supporting Sponsor- Reviewer Interaction
75F40124C00134 $497,579.00 $1,299,218.00 CDRH
PPD.
The project will be delivered by members of the Patient- Centered Research team at
Evidera, a PPD business
929 North Front Street
WILMINGTON NC
28401
FY24C3CP5
Understanding heterogeneity in preferences for clinical trial participation in diverse patient populations
75F40124C00117 $724,461.00 $724,461.00 CDRH
PPD Development, part of
ThermoFisher
929 N FRONT ST
WILMINGTON NC
28401
FY24C1EP6
Cardiovascular- Kidney-Metabolic (CKM) Syndrome Patient-Reported Outcome (PRO)
Burden Measure Assessment of the need to develop a novel, or modify an existing, measure and qualitative patient interviews
75F40124C00120 $332,866.00 $332,866.00 CDRH Milken Institute
1250 4TH ST FL 2
SANTA MONICA CA
90401
FY24C1IP3
Defining the Value and Return on
Investment of Patient Engagement in
Medtech Product Development
75F40124C00129 $762,969.00 $762,969.00 CDER
American College of
Emergency Physicians
4950 W ROYAL LN
IRVING TX 75063
FY24C2AP12
Comprehensive Real- World Evidence on Off-Label Ketamine
Safety to Inform Regulatory and Clinical Decision
Making
75F40124C00124 $1,566,897.00 $1,566,897.00 OCET
Advanced Regenerative Manufacturing Institute
(ARMI)
400 COMMERCIAL ST
MANCHESTER NH
03101
FY24C1BP70
A Scalable, Modular, Automated and Closed Medical
Product Manufacturing
System
$20,640,972.28 $31,086,978.28
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