Michael Rouse, Ph.D. Email & Phone Number

Silver Spring, Md, Us

Bethesda, Maryland, United States

• Direct and manage a high-performing accredited (GCLP/CAP/CLIP) molecular biology/immunology laboratory (SC2i Core) and laboratory science and operations across a 7-institute translational research consortium.• Provide strategic leadership and project management to optimize workflows and collaboration to drive the identification of biomarkers and clinical parameters to enhance outcomes in complex clinical decision making.• Serve as high-level thought partner with organizational VPs, CEOs, and Presidents for product development and programmatic strategy to fortify client goals and objectives.• Provide strategic vision to optimize financial and operational efficiency for biomarker and therapeutic discovery, ensuring regulatory compliance (FDA, federal, ISO, IFU) to accelerate product development• Collaborate with discovery, preclinical, and clinical product development teams as scientific advisor, ensuring strategic alignment across project portfolios• Lead and advise the design and development of multi-omic workflows to create Laboratory Developed Tests (LDTs) and Clinical Decision Support Tools (CDSTs) for translational and clinical research and diagnostics.• Demonstrate strong track record of risk management, delivering scientific results on time and within budget, and balancing competing priorities in a dynamic, collaborative environment.• Manage budgets and timelines with a focus on cost optimization, demonstrating accurate forecasting and successful resource allocation.• Develop a diverse and inclusive team, providing mentorship and career development opportunities to drive high performance and staff empowerment.• Leverage diverse scientific expertise to foster start-up/incubator labs, solve project challenges, and ensure data-driven decision-making.• Lead the development and implementation of comprehensive and rigorous standards (SOPs, QMS), ensuring compliance with federal and institutional guidelines.

United States

• Lead and facilitate the development of biomarker-driven Clinical Decision Support Tools (CDSTs), such as advanced analytics, machine learning, and precision medicine diagnostics• Lead SC2i's molecular core laboratory to become Good Clinical Laboratory Practices (GCLP), College of American Pathologists (CAP) accredited and Clinical Laboratory Improvement Program (CLIP) registered.• Support SC2i under the Department of Surgery at the Uniformed Services University of the Health Services (USUHS) and the Walter Reed National Military Medical Center (WRNMMC)• Drive clinical research towards improving clinical outcomes and mitigating costs throughout the continuum of surgical care• Lead a clinical research team to identify biomarkers and conditions that help maximize outcomes across any discipline requiring complex medical decision making, including surgery, critical care, emergency medicine, orthopedics, and transplant• Develop, qualify, and validate Laboratory Developed Tests (LDTs) that are intended to be translated to clinical diagnostics, which include proteomic, transcriptomic, molecular/cellular, and immunological methodology• Manage clinical research and SOPs according to GLP/GCLP, QA/QC validation, CLIA/CLIP, and involvement with FDA submissions• Routinely collaborate with multidisciplinary consortium members, which include seven Federal and non-Federal entities (Uniformed Services University, Walter Reed National Military Medical Center, Naval Medical Research Center) and non-Federal (Duke, Emory, DecisionQ, Henry M. Jackson Foundation)• Responsible for the scientific oversight of experimental execution, troubleshooting, validation of data, analysis/interpretation, maintaining records of test, and report project milestones• Generate formal reports, attend national and international scientific meetings, and publications in peer-reviewed journals• Routinely work with regulatory officers and guidelines to advance CDSTs for FDA approval

Naval Medical Research Center: Wound Infections Department

• Spearheaded a multi-project Immunology Division as Principal Investigator, securing $14M+ in funding to propel advances in critical care.• Increased departmental funding by 400%, enabling accelerated product development and translational research.• Directed IND-enabling research, advancing novel wound care therapies through development phases towards clinical trials and FDA approval.• Oversaw successful research initiatives, driving product development, investor outreach, and strategic budgeting.• Forged 25+ collaborative partnerships across the biomedical research landscape, both domestically and internationally.• Enhance and established preclinical paradigm to comprehensively evaluate novel therapeutics for activity, PK/PD, dosage, mode of delivery, and product advancement• Ensured research integrity by developing, reviewing, and adhering to IACUC protocols and federal guidelines.• Improved data quality and analytics through QMS development, optimizing decision-making processes.

Baltimore, Maryland Area

• Enhanced post-doctoral engagement and development as NIA Felcom representative, organizing career programs and research symposia.• Championed diversity and inclusion by launching new scientific programs (Shock Academy, Diversity in Aging Pipeline), fostering skill-building and representation.• Oversaw collaborative research projects (NIH, FDA, academia), driving scientific progress and managing multi-sector partnerships. • Guaranteed research integrity through SOP development and rigorous preclinical drug development workflows.• Communicated research findings effectively through international presentations, publications, and scientific reports.

Columbia, South Carolina Area

• Propelled preclinical drug development for inflammation/autoimmune therapeutics, driving innovation with two filed therapeutic patents.• Demonstrated drug discovery excellence, recognized by the USC Graduate Student Day Award and Society of Toxicology Emil A. Pfitzer Award.• Selected for the prestigious Nobel Laureates meeting, collaborating with international peers and Nobel Laureates to assess knowledge gaps in various scientific fields• Authored four first-author publications and secured an NIH Pre-doctoral Fellowship, showcasing research and grant-writing capabilities.• Assessed drug candidates in mouse models, evaluating pharmacological, toxicological, and immunogenic effects to inform development strategies.

Charlottesville, Virginia Area

• Led preclinical development of novel therapeutics for inflammation, type I diabetes, and kidney disease clinical applications.• Evaluated drug for therapeutic activity, PK/PD, toxicological, and immunogenic profiles.• Ensured product safety and research rigor by developing new SOPs, including vascular permeability assays.• Analyzed rodent models for physiological and metabolic changes, informing drug development strategies.• Collaborated with academic partners on the evaluation of adenosine and sphingosine 1-phosphate receptor agonists/antagonists, expanding research scope.

Doctor Of Philosophy (Ph.D.), Biomedical Sciences, Immunology

Master Of Science (Ms), Biological And Physical Sciences

Bachelor'S Degree, Biochemistry And Molecular Biology

• Meyerhoff Scholar and MARC U* STAR Scholar • Served as a mentor and counselor during Meyerhoff Scholarship Program Summer Bridge • ASBMB.