BAA_AwardedFY24.pdf

Contract Number Amount Obligated Total Estimated Contract

Value Center Awardee Name Awardee Address BAA Number Award Title

75F40124C00013 $1,956,704.00 $1,956,704.00 CDER Emerald Innovations Inc 1 BROADWAY

CAMBRIDGE MA 02142

FY23C1FWP11 Development An Objective and Quantitative Endpoint for Atopic Drmatitis in Pediatric and Adult Populations

75F40124C00027 $2,000,000.00 $6,914,101.00 CDRH Beth Israel Deaconess Medical Center 330 BROOKLINE AVENUE, 20 OV-5

BOSTON MA 02215

FY23C1JWP13 Large Scale Interactive Lab-Test Driven Insight Discovery Engine

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 2550 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 101

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 300

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

$24,597,676.28 $39,957,783.28

FY24 BAA Contracts Awards