Policy-forward framing throughout every bullet leads with governance

DEBRA (DEBBIE) BRATT

Senior Federal Health Policy & Biodefense Strategist Research Governance Program Operations Regulatory Affairs

Woodsboro, MD (Washington, DC Metro Area)

************@*****.*** linkedin.com/in/Debbie-bratt

PROFESSIONAL SUMMARY

Senior federal health policy strategist with more than 20 years of progressive experience spanning NIH, NIAID, DoD/MRDC, academic medical centers, and rural health systems. Proven record of architecting multi-agency program frameworks, navigating complex regulatory landscapes across FDA, USDA, CDC, BARDA and DoD, and translating intricate policy requirements into actionable strategy for senior decision-makers. Deep expertise in biodefense and biosecurity governance, clinical research compliance, federal acquisition operations, and stakeholder engagement across government, military, and academic institutions. Adept at synthesizing scientific intelligence, regulatory risk, and programmatic data into executive-level briefings that drive mission-critical outcomes. Currently advancing a Master of Public Health and holds PMP, CSM, FAC-P/PM, FCR, CRC, and CTPM certifications. Bridges the intersection of policy, operations, and science to deliver strategic counsel that strengthens institutional readiness and national health security posture.

CORE COMPETENCIES

Federal Health Policy Advisory

Biodefense & Biosecurity Strategy

Research Governance & Compliance

Regulatory Affairs (FDA, USDA, CDC, DoD)

Multi-Agency Program Architecture

Clinical Research Operations

Federal Contracting & Acquisition (FAR/COR)

Stakeholder & Government Engagement

Policy Analysis & Interpretation

Risk Assessment & Mitigation

Executive Reporting & Briefings

Rural Health & Equity Strategy

PROFESSIONAL EXPERIENCE

PRINCIPAL CONSULTANT

Bratt Consulting

2025 – Present

Advise federal agencies, defense contractors, and academic institutions on research governance frameworks, regulatory strategy, and multi-site program architecture to ensure compliance and mission alignment.

Develop policy-aligned standard operating procedures, governance documentation, and compliance frameworks supporting complex federally funded research portfolios.

Provide strategic counsel on biodefense preparedness, biosafety policy, and institutional biosecurity posture to strengthen organizational readiness for emerging threats.

Translate complex federal regulatory requirements across FDA, USDA, CDC, and DoD into actionable operational guidance and decision-support materials for senior leadership.

ENGAGEMENT OFFICER & LEAD PRINCIPAL INVESTIGATOR (PART TIME)

Beacon Dx / SRI International (ARPA-H Funded)

2025 – Present

Direct community engagement strategy for ARPA-H-funded oncology diagnostic device development, targeting rural and underserved populations to advance federal health equity objectives.

Lead IRB-governed human-subjects research protocols designed to validate early cancer detection technologies and inform national screening policy priorities.

Architect stakeholder engagement frameworks bridging federal funders, academic research partners, and community health systems to ensure programmatic alignment with policy goals.

Inform national health equity policy through systematic data collection on diagnostic access disparities, generating evidence to support federal resource allocation decisions.

PROGRAM MANAGER / SITE LEAD

BIRCO – DoD / U.S. Army MRDC Contract

August 2024 – October 2025

Directed multi-year federal public health initiative under DoD/MRDC, leading integrated product teams across military and civilian stakeholders to advance blast injury research coordination.

Shaped program governance frameworks and policy-aligned deliverables ensuring adherence to defense health research standards and federal reporting requirements.

Earned positive CPAR performance ratings (Satisfactory/Very Good) for program execution, stakeholder management, and regulatory compliance across all contract performance periods.

Synthesized defense health research findings into executive-level briefings and policy recommendations for senior DoD leadership and interagency partners.

Managed cross-functional teams ensuring adherence to federal acquisition regulations, contractual performance standards, and quality assurance protocols.

PROGRAM MANAGER II

ATCC (American Type Culture Collection)

January 2023 – September 2023

Supported NIH grant proposals and federal partnership development, advising on regulatory alignment, governance readiness, and strategic positioning for competitive awards.

Initiated FAR training programs for program management staff to strengthen organizational federal acquisition compliance posture and reduce contracting risk.

Assessed organizational readiness for federal contracting engagements and recommended policy-aligned operational improvements to enhance competitive positioning.

SCIENTIFIC PROGRAM MANAGER

NIH/NIAID Vaccine Research Center (CAMRIS International)

May 2021 – February 2023

Led international scientific program under NIH/NIAID to identify viral variants and predict vaccine efficacy, directly supporting federal pandemic response strategy and national health security objectives.

Introduced novel analytical technologies and standardized protocols across multi-national research sites, ensuring regulatory harmonization and data integrity across jurisdictions.

Translated emerging scientific intelligence into policy-relevant briefings for federal health leadership, enabling evidence-based decision-making during rapidly evolving threat landscapes.

Coordinated cross-border research partnerships requiring navigation of international regulatory frameworks, diplomatic protocols, and multi-agency data-sharing agreements.

ASSOCIATE DIRECTOR OF RESEARCH & OPERATIONS / CVI RESEARCH MANAGER

University of Georgia

October 2018 – May 2021

Led biosafety strategy and regulatory alignment for BSL-3 infectious disease research facility supporting national biodefense priorities, ensuring compliance with federal select agent regulations.

Directed facility renovation and licensing negotiations with state and federal regulators, securing operational approvals for high-containment research infrastructure.

Launched clinical trials and introduced governance systems for multi-site collaborative research under NIH-funded programs addressing emerging infectious disease threats.

Developed institutional biosecurity policies and SOPs governing select agent handling, personnel reliability programs, and facility access controls.

Advised senior university leadership on regulatory risk, compliance posture, and research policy interpretation across federal and state jurisdictional frameworks.

RESEARCH MANAGER & PROGRAM OPERATIONS

University of Washington (WANPRC/AID & Orthopaedics)

2011 – 2018

Managed IND-enabling clinical research programs under FDA regulatory oversight, ensuring compliance documentation, governance readiness, and alignment with federal submission requirements.

Directed core facility operations supporting NIH-funded translational research with responsibilities spanning study design advisory, financial tracking, and regulatory filings.

Built institutional expertise in federal research compliance, human and animal subjects governance, and sponsored program administration across multiple departments.

Coordinated multi-PI research portfolios and synthesized programmatic data into executive reports for departmental leadership and federal sponsors.

EDUCATION

Master of Public Health (MPH) — University of Washington, In Progress

Bachelors — University of Washington

CERTIFICATIONS & CREDENTIALS

PMP (Project Management Professional) CSM (Certified ScrumMaster) FAC-P/PM (Federal Acquisition Certification for Program/Project Managers) FCR (Federal Contracting Representative) CRC (Clinical Research Coordinator) CTPM (Certified Technical Program Manager)

COMMUNITY LEADERSHIP & SERVICE

2ND Vice President/Program Chairperson & Recording Secretary

Frederick County Art Association (FCAA) / 2026- Present

Oversee program planning, board governance, and organizational operations for a 70+ year community arts nonprofit.

Lead development of monthly programs, member engagement activities, and strategic initiatives that strengthen community impact.

Manage board documentation, meeting records, and governance processes to ensure transparency and continuity.

Support cross committee collaboration and long range organizational planning.

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