ONHS Report: HT9427-26-R-E020

Prototype development for Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination

Solicitation ID: HT9427-26-R-E020

Agency: DHA

Type: Solicitation

Deadline: 2026-10-23T12:00:00 ET

Eligibility: Maybe (OTA/Consortium)

Funding: N/A

Doc Type: Other

Clearance: No

Program Manager: N/A

Last Updated: 2026-09-23 16:03

Analyzed File: Attachment C - Data Item Description (DID) DI-TCSP-82040 (REFERENCE ONLY).pdf

Eligibility Reasoning

The award, as a result of this RPP, will be awarded under the authority of prototype Other Transaction Authority (pOTA) 10 U.S.C. 4022.

Note: This is an AI-generated summary...

Summary

This document, Data Item Description (DID) DI-TCSP-82040, establishes the detailed format and content requirements for all technical data deliverables for contracts involving the research and development of medical products regulated by the U.S. Food and Drug Administration (FDA). Published by the U.S. Army Medical Research & Materiel Command (USAMRMC), it specifies the documentation required across the entire product lifecycle for drugs, biologics, and medical devices. Key areas covered include product development planning (regulatory, clinical, manufacturing), FDA interaction records (meetings, submission packets like INDs or 510(k)s), pre-clinical (GLP) and clinical trial data, manufacturing controls (cGMP/QSR), quality assurance plans, risk management, and system engineering documentation, including compliance with relevant military standards.

Overall Technical Areas

Antimicrobial/Antifungal FormulationWound Barrier TechnologyCombination Product DevelopmentPreclinical In-Vitro & In-Vivo StudiesPharmacokinetics & Pharmacodynamics (PK/PD)Medical Device Design ControlsGood Manufacturing Practice (GMP) ValidationAnalytical Assay DevelopmentBiocompatibility & Sterility TestingSystem Safety & Risk AnalysisHuman Factors EngineeringClinical Data ManagementBiostatistics & Statistical AnalysisProduct Stability & Shelf-Life Testing

Probable LBNL Areas

BSACSAEESAETAOperationsPSA

Focus Areas

Example Priorities:

The final product MUST be a combination wound treatment that includes a barrier component that is either infused or impregnated with antimicrobial and/or antifungal properties and have U.S. Food Drug Administration (FDA) approval (or clearance).
Describe the product development planning documents that will outline the product development strategy, including regulatory pathway risks and timelines across the phases of the product development cycle.
Describe the regulatory pathway for FDA regulatory approval/licensure and any possible post-marketing commitments.
Describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user.

Specific Technical Skills:

Regulatory AffairsFDA Submissions (IND, IDE, 510(k))Combination Products RegulationMedical Device ClassificationTarget Product Profile (TPP) DevelopmentRegulatory StrategyProject ManagementRisk AssessmentGXP Compliance

Potential PIs for this Area:

Name	Score	Organization
Kristina S. H. LaCommare	0.74	ETA \| Building Tech. & Urban Sys. \| Whole Building Sys Dept · Project Management
Thomas Hendrickson	0.72	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Risk Assessment
Abigayle Hodson	0.72	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Risk Assessment
Peter Cappers	0.72	ETA \| Energy Analysis \| Energy Markets & Planning · Regulatory Strategy
Laura Crosby	0.72	Operations \| Office of the Chief Finance Officer (OCFO) \| Procurement · Project Management
Drew Paine	0.70	CSA \| SciData \| Data Science Applications · Medical Device Classification
Louis-Benoit Desroches	0.70	ETA \| Energy Analysis \| Energy Efficiency Studies · Regulatory Affairs
Seth Carbon	0.70	BSA \| Env. Genomics & Sys. Biology \| BioSystems Data Science · GXP Compliance
Eric Masanet	0.70	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Medical Device Classification
Guillermo Pereira	0.70	ETA \| Energy Analysis \| Energy Markets & Planning · Regulatory Strategy

Example Priorities:

Describe the goals and objectives of the pre-clinical program for the drug/biologic. This plan shall include, but is not limited to: background, scientific summary of the drug; pharmacokinetic and pharmacodynamics (PK/PD); mechanism of action; side-effects; a list of any/all: in-vitro and/or in-vivo pre-clinical safety toxicology or animal qualification and efficacy studies planned or completed...
Provide documents related to clinical studies performed for phase 1, 2, or 3; post-market, or any other studies for the clinical development of drugs and biologics products.
Describe how pre-clinical testing performed in support of a premarket submission of a medical device will comply with 21 CFR Part 58, GLPs, and provide evidence of GLP compliance.
Provide Federal Wide Assurance (FWA) compliance number(s), documentation, and any approvals to meet Army Human Subjects Research Protection Office (HRPO) requirements.

Specific Technical Skills:

Good Laboratory Practices (GLP)Good Clinical Practices (GCP)Clinical Trial ManagementToxicology StudiesBiocompatibility TestingIn-vitro/In-vivo TestingAnimal Model DevelopmentHuman Subjects Protection (IRB/HRPO)Clinical Data ManagementBiostatistics

Potential PIs for this Area:

Name	Score	Organization
Reginald Lee	0.71	PSA \| Engineering \| Mechanical Engineering · Biocompatibility Testing
Jamie Inman	0.71	BSA \| Biological Systems & Engineering \| Department of BioEngineering and BioMedical Sciences · In-vitro/In-vivo Testing
Momoe Kato	0.70	BSA \| Env. Genomics & Sys. Biology \| Comparative and Funct Genomics · Animal Model Development
Josh North	0.70	EESA \| CESD \| Earth System Sciences · Biostatistics
Seth Carbon	0.70	BSA \| Env. Genomics & Sys. Biology \| BioSystems Data Science · Clinical Data Management
Marion Russell	0.70	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Good Laboratory Practices (GLP)
Wenming Dong	0.70	EESA \| EG \| Geochemistry Dept · Toxicology Studies
Harry Caufield	0.70	BSA \| Env. Genomics & Sys. Biology \| BioSystems Data Science · Good Clinical Practices (GCP)
Stephanie Holm	0.69	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Human Subjects Protection (IRB/HRPO)
Nomi Harris	0.69	BSA \| Env. Genomics & Sys. Biology \| BioSystems Data Science · Clinical Trial Management

Example Priorities:

Describe the manufacturing process for the drug/biologic product to ensure conformity with §501(a)(2)(B) of the Food, Drug, and Cosmetics Act (FD&C Act, Title 21 United States Code (USC) §351 (a)(2)(B)), regarding good manufacturing practices (GMP).
Provide documentation, protocols, and reports of the methods used in and the facilities and controls used for the manufacture, processing, and when relevant, packing and installation of the device.
The QSR Plan – describe plan for compliance with evidence of appropriate QSs to support compliance for devices subject to 21 CFR Part 820 QSR.
System engineering plan that documents that will describe the how system engineering deliverables will meet FDA requirements described for design and manufacturing documentation described under the QS Regulation (QSR, 21 CFR Part §820).

Specific Technical Skills:

Current Good Manufacturing Practices (cGMP)Quality System Regulation (QSR)Design Controls (21 CFR 820.30)Process Validation (IQ/OQ/PQ)Quality Assurance/Quality Control (QA/QC)Systems EngineeringDesign History File (DHF)Risk Management (FMEA)Sterile ManufacturingSupply Chain Qualification

Potential PIs for this Area:

Name	Score	Organization
Thomas Hendrickson	0.77	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Supply Chain Qualification
Eric Masanet	0.75	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Systems Engineering
Alexandre Bayen	0.74	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Systems Engineering
Nica Campbell	0.73	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Supply Chain Qualification
Minliang Yang	0.73	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Current Good Manufacturing Practices (cGMP)
Gregory Lemieux	0.73	EESA \| CESD \| Earth System Sciences · Quality Assurance/Quality Control (QA/QC)
Nihan Karali	0.72	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Process Validation (IQ/OQ/PQ)
Danielle Svehla Christianson	0.72	CSA \| SciData \| Data Science Applications · Design History File (DHF)
Sukhpreet Kaur	0.72	PSA \| Engineering \| Electronic Engineering · Design Controls (21 CFR 820.30)
Peter Tennessen	0.72	PSA \| Engineering \| Mechanical Engineering · Sterile Manufacturing

Potential LBNL PIs (Overall)

Note on PI Matching: These suggestions are generated through an AI-driven semantic analysis of LBNL staff profiles.

Name	Score	Organization
Natalia Molchanova	0.75	ESA \| MF \| MF Biological Facility · Antimicrobial/Antifungal Formulation
Alexandre Bayen	0.74	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · System Safety & Risk Analysis
Eric Masanet	0.72	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Human Factors Engineering
Thomas Hendrickson	0.72	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Product Stability & Shelf-Life Testing
Markus de Raad	0.72	BSA \| Env. Genomics & Sys. Biology \| Molecular Ecosystems Bio · Analytical Assay Development
Peter Tennessen	0.72	PSA \| Engineering \| Mechanical Engineering · Combination Product Development
Marion Russell	0.72	ETA \| Energy Analysis \| Systems & Energy Tech Analysis · Biostatistics & Statistical Analysis
Sukhpreet Kaur	0.72	PSA \| Engineering \| Electronic Engineering · Medical Device Design Controls
Amy Herr	0.72	BSA \| Biological Systems & Engineering \| Process Engr & Analytics · Wound Barrier Technology
Yan Chen	0.71	BSA \| Biological Systems & Engineering \| Process Engr & Analytics · Good Manufacturing Practice (GMP) Validation

Fundamental Research Exemption (FRE)

Not Mentioned