Preclinical Development

Preclinical Development conducts GLP-aligned in vitro, ex vivo and animal studies to define pharmacology, PK/PD, toxicology, device biocompatibility and stability. For military-relevant candidates—hemostats, antimicrobials, regenerative constructs and diagnostics—this stage de-risks efficacy, dosing, manufacturability and regulatory readiness prior to IND/IDE.

Technical Challenges

  • Translational gap: many in vitro and animal models poorly predict human responses for polytrauma, blast, and hemorrhage.

  • Model relevance: crafting reproducible, GLP-compliant models that replicate complex combat injuries and delayed evacuation scenarios.

  • Regulatory complexity: meeting GLP, IND/IDE, and DoD-specific requirements while compressing timelines for force health protection.

  • Manufacturing & scale-up: translating lab-scale formulations and biologics to GMP production with consistent stability and sterility.

Emerging Opportunities

  • Human-representative microphysiological systems and validated correlates of protection for combat injuries.

  • Robust biomarkers and imaging endpoints that predict clinical outcomes in prolonged or austere care.

  • Streamlined regulatory pathways and pre-IND engagement tailored to military dual-use products.

  • Integrated tox-to-clinic frameworks that combine efficacy, immunogenicity, and AMR (antimicrobial resistance) risk assessments.

Current and Emerging Technologies in Preclinical Development

Microphysiological systems & organoids

Human-derived organoids and organ-on-chip platforms model tissue responses to trauma, infection, and therapeutics, improving prediction of human efficacy and reducing reliance on less-predictive animal models.

Advanced animal models for combat injury

GLP-compliant models of hemorrhage, polytrauma, blast, inhalation injury and delayed evacuation permit testing of hemostatics, resuscitation strategies, regenerative therapies and device performance under military-relevant physiology.

Quantitative imaging & molecular biomarkers

Multimodal imaging, proteomics, metabolomics and validated biomarkers accelerate objective efficacy readouts—critical for device validation, TBI assessment, infection clearance and correlates of protection.

High-throughput screening & omics

Automated screening, single-cell and multi-omics identify mechanisms, off-target effects and resistance pathways—informing lead selection for antimicrobials, biologics and tissue-engineering candidates.

In silico modeling, PK/PD & AI

Computational PK/PD, physiologically based models and machine learning predict human dosing, simulate delayed evacuation scenarios, and optimize formulation and delivery strategies to shorten time-to-clinic.

GMP biomanufacturing & formulation sciences

Scalable production, stability testing, aseptic fill-finish and device sterilization are required to convert successful preclinical candidates into deployable medical countermeasures for field and clinical use.

Importance to Military Medicine

De-risk lifesaving interventions

Rigorous preclinical evidence reduces failure in clinical trials for hemostatics, antimicrobials and regenerative therapies that address combat injuries.

Enable prolonged & austere care

Testing stability, ruggedization and function under extreme conditions supports devices and therapeutics for delayed evacuation and prolonged field care.

Support readiness and force protection

Preclinical validation of vaccines, antimicrobials and diagnostics preserves force health during outbreaks and biothreats.

Accelerate regulatory approval

Well-designed GLP studies and validated endpoints shorten IND/IDE pathways, enabling faster deployment to military and civilian users.

Alignment with the MTEC Mission

Accelerates translation of military-relevant medical technologies into operational use consistent with MTEC’s DoD-focused mission.

Supports a broad portfolio—trauma, infection, regenerative medicine and diagnostics—that maps to MTEC program thrusts.

Enables dual-use outcomes that benefit civilian healthcare while prioritizing Warfighter readiness and force health protection.

Leverages consortium expertise and cross-sector partnerships to compress timelines from concept to clinic under DoD constraints.

Dual-Use (Military + Civilian) Applications

Hemorrhage control: preclinical testing of topical hemostats, sealants and resuscitation adjuncts to ensure efficacy during massive blood loss and prolonged transport.

Infectious disease & biodefense: validation of rapid diagnostics, vaccines and antimicrobials against battlefield-relevant pathogens and AMR threats.

Regenerative & reconstructive therapies: preclinical efficacy and integration testing for bone, nerve and soft-tissue constructs used in limb salvage and reconstruction.

Field diagnostics & monitoring: bench and animal validation of point-of-care devices and biosensors for austere, prolonged-field-care environments.

Explore MTEC Members with Preclinical Development Capabilities

MTEC members bring multidisciplinary expertise—GLP study conduct, specialized animal models, translational biomarkers, GMP manufacturing and regulatory strategy—to accelerate preclinical milestones. Explore member profiles to identify partners with the technical depth and DoD experience required to move candidates from proof-of-concept to IND/IDE-ready dossiers.

191 Members with Preclinical Development capabilities.

Member
The University of Texas System

The University of Texas System is a leading public university system in the United States, dedicated to improving lives through education, health care, and research. With over 256,000 students enrolled across 14 institutions, the UT System is committed to providing affordable access to higher education and producing a skilled workforce to drive Texas's economy.

Member
SIMETRI

SIMETRI is a woman-and-minority owned small business based in Winter Park, Florida, specializing in modeling, simulation, and training technologies. Founded in 2009, the company focuses on delivering innovative products and services that enhance the human experience and improve client outcomes through advanced training and program management analysis.

Member
Advanced Regenerative Manufacturing Institute (ARMI)

The Advanced Regenerative Manufacturing Institute (ARMI) is a member-based, nonprofit organization dedicated to advancing the bioeconomy of the United States. Its mission encompasses enhancing manufacturing, healthcare, and education and workforce development, aiming to create a scalable and effective manufacturing ecosystem for engineered cells, tissues, and organs.

Member
Georgia Southern University

Georgia Southern University is a vibrant institution with over 26,100 students across three campuses in Statesboro, Savannah, and Hinesville. The university offers 132 degree programs at the associate, bachelor’s, master’s, and doctorate levels, emphasizing student success, community impact, and research excellence. With a commitment to inclusivity and engagement, Georgia Southern fosters a supportive environment for diverse learners, including military-affiliated and adult students. The university is dedicated to transforming lives through education and community engagement, aligning its programs with regional needs. Additionally, Georgia Southern provides accelerated pathways for students to fast-track their master's degrees, enhancing educational opportunities. The university also emphasizes career readiness and public impact research, preparing students for successful careers and contributing to community development.

Member
Nanohmics Inc.

Nanohmics Inc. is a Texas-based research and development company founded in 2002, specializing in the applied sciences of light, molecule, and advanced material interactions. The company focuses on designing and developing smart technology solutions that enhance product, technology, or system performance across various industries. With a multidisciplinary team of scientists and engineers, Nanohmics integrates advanced materials and state-of-the-art instrumentation engineering to create custom-engineered sensing technologies and platforms. Their mission is to accelerate client success through innovative product development, providing solutions for detection, surveillance, electro-optic imaging, performance characterization, environment awareness, and energy conversion applications.

Member
Institutes for Behavior Resources, Inc.

Founded in 1960 by Dr. Joseph V. Brady, the Institutes for Behavior Resources, Inc. (IBR) is a nonprofit organization dedicated to enhancing the growth of behavioral sciences and their application to human affairs through research, clinical services, and educational initiatives. IBR focuses on addressing social challenges through innovative research and comprehensive health services.

Member
Nuclera

Nuclera develops automated benchtop platforms and integrated systems for rapid protein expression, optimization, and purification, utilizing cell-free synthesis, digital microfluidics, and software-driven workflows. Their technology enables miniaturized and scalable protein prototyping—including challenging targets such as membrane proteins—directly at the lab bench. Nuclera serves academic and industrial researchers, focusing on reducing turnaround time for functional protein access and streamlining screening and production. The company has secured significant funding to enable broad commercialization, expanded their leadership team to support scale-up, and continues to drive advancements in drug discovery, proteomics, and experimental automation.

Member
Alithia Life Sciences

Alithia Life Sciences is an Australian-owned, boutique, full-service Contract Research Organization (CRO) dedicated to supporting pharmaceutical, biotechnology, device companies, and institutional research groups with their projects in Australia and beyond. With over 25 years of operational expertise across a wide range of therapeutic areas, Alithia offers personalized project management from Phase I to Phase III, aiming to deliver efficient project outcomes, add value to client programs, and ultimately improve human health and wellbeing.

Member
Humanetics Corporation

Humanetics Corporation is a clinical-stage pharmaceutical company based in Minneapolis, Minnesota, focused on developing and commercializing products to enhance human health and wellbeing. Founded in 1988, the company specializes in radiation modulators, adjunctive oncology therapies, and pulmonary protective therapies, particularly for COVID-19. Humanetics is known for its lead drug candidate, BIO 300, which is being developed as a radioprotectant for military and civilian use, as well as a treatment to improve outcomes in cancer patients receiving radiotherapy. The company is actively engaged in research programs for non-small cell lung cancer, prostate cancer, and head and neck cancers.

Member
The University of Texas at San Antonio

The University of Texas at San Antonio (UTSA) is dedicated to the advancement of knowledge through research, teaching, and community engagement. As a premier public research university, UTSA embraces multicultural traditions and serves as a catalyst for socioeconomic development, providing access to educational excellence and preparing citizen leaders for the global environment.

Member
Precision Vaccines Program (PVP) at Boston Children’s Hospital

The Precision Vaccines Program (PVP), based in the Department of Pediatrics at Boston Children’s Hospital, is an academic research initiative dedicated to discovering and developing next-generation vaccines tailored to vulnerable populations. PVP conducts both basic and translational research to create novel vaccines and therapeutics for diseases that disproportionately affect infants, older adults, and immunocompromised individuals. The program brings together experts in vaccinology, clinical trials, immunology, molecular biology, data management, biostatistics, bioinformatics, and systems biology, fostering international collaboration among academia, government, and industry to advance precision medicine in vaccinology.

Member
Auburn University

Auburn University Research & Economic Development is dedicated to advancing research and economic growth through a collaborative effort among its various colleges and departments. The organization focuses on fostering innovation, supporting faculty and student research, and facilitating partnerships with industry and government to address societal challenges and enhance the quality of life. Recent initiatives include the launch of the Team Science Series to promote interdisciplinary collaboration and the development of the Gulf Coast Engineering Research Station to address coastal environmental challenges.

Member
Deloitte

Deloitte is a leading global provider of audit, consulting, tax, and advisory services. The company is committed to improving public outcomes through a focus on people and developing relevant, timely, and sustainable solutions for clients. Deloitte's mission is to lead with purpose and drive positive change for people and communities, with a strong emphasis on social impact, sustainability, equity, and trust. Deloitte is also dedicated to helping the power, utilities, and renewables industry grow to become more sustainable, safe, and efficient, and is a fierce champion of industrials, inspiring optimism for the future.

Member
IRAZÚ Bio-Holdings

IRAZÚ Bio-Holdings bridges the gap between academic research and drug development by partnering with academic investigators and university centers to accelerate translational research into clinical applications. The company focuses on increasing the value of transformative intellectual property assets and either licenses these to pharmaceutical companies or forms new ventures with VC groups. Their mission is to leverage natural biochemical mechanisms and innovative research to promote survival, prevent disease, and improve quality of life, especially in the context of neuroprotection, immuno-oncology, and gene therapy.

Member
BioPharma Connections

BioPharma Connections is an independent, woman-owned consulting firm founded in San Francisco in 2007, providing strategic business development, technical operations, regulatory, product development, and commercialization support to the life sciences industry. Serving pharmaceutical, biotechnology, medical device, and diagnostic companies globally, the firm specializes in facilitating connections between organizations, service providers, CROs, CDMOs, and investors—guiding clients from concept to commercialization, with deep expertise in regulatory compliance, emerging technologies, and diverse therapeutic areas.

Member
Ethos Solutions LLC

Ethos Solutions specializes in rapid problem solving in dynamic environments through the Ethos IDEALs (Identification, Define, Engagement, Alignment, and Leveraging). Ethos leverages module working groups (or cells) consisting of Subject Matter Expert (SMEs) clinicians, training cadre, warriors, academics, and researchers able to rapidly identify and solve problem sets that require a grounded approach forged in austere and dynamic environments.

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Projects

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Safi Biotherapeutics

Next-Generation Manufactured Red Blood Cells for Extended Battlefield Blood Supply: Safi Biotherapeutics

Safi Biotherapeutics is developing manufactured red blood cells (mRBCs) with extended shelf life to improve battlefield transfusion readiness and emergency trauma care.

Non-Invasive Glymphatic (GF) Monitoring and Recovery Optimization for Warfighter Cognitive Readiness

Applied Cognition is developing non-invasive glymphatic monitoring and recovery technologies to enhance warfighter cognitive readiness, resilience, and sleep recovery.

Moberg Analytics

Moberg Analytics – Advanced Brain Monitoring & Critical Care Informatic

Moberg’s platform unifies brain monitoring data for faster, precise treatment of severe brain injuries in military and civilian care.

University of California San Francisco

TemPredict: AI-Driven Wearable Monitoring for Early Illness Detection and Warfighter Readiness

TemPredict: AI wearables detect early illness and health risks to support warfighter readiness.

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