Mary J. Homer

• Strategic Development: Conceived, planned, and executed direction for medical countermeasures (MCMs) product development program for the Radiological/Nuclear Countermeasures Branch, including re-strategizing and realigning priorities
• Since its inception in 2007, the portfolio has included over 40 products at many stages of development –from pre-clinical through FDA approval of three products as MCMs
• Currently, portfolio includes 25 products and other developmental activities and is funded at $230M for FY2018 including both advanced research and development (AR&D) funding and Project Bioshield (PBS) procurements
• Portfolio Management: Managed advanced research and development and procurement budget of approximately $75M annually, a total of $560M including AR&D and procurements since 2014
• Lead and supervise team of eleven high level professionals including doctors, scientists and program analysts for management of contracts and public/private partnerships with product sponsors
• Matrix with BARDA subject matter experts in manufacturing, regulatory, clinical, and preclinical areas in oversight of product development
• Collaboration: Coordinated Interagency collaborations as Chair of the Radiological/Nuclear Integrated Program Team as part of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE); the lead advisory body of radiological experts across US government agencies (including Department of Defense, Department of Homeland Security, Department of Energy, Centers for Disease Control, Food and Drug Administrative, National Institutes of Health) that informs on policies, requirements, medical practices, and strategies
• Key Responsibilities and Contributions:
• Develop and promote short term and long term strategic plans to enhance and manage the Radiological/Nuclear countermeasures portfolio
• Advocate the Radiological/Nuclear MCM development strategy through presentations and invited talks at national and international conferences, internal government strategy meetings, and outreach meetings with potential developers
• Develop, calculate, and advocate for appropriate budget and funding levels to implement the Radiological/Nuclear MCM development strategy
• Provide narratives and responses to technical questions to support funding requests
• Develop business cases and risk assessments to support justification for products maintained in portfolio
• Lead development of new initiatives within the Radiological/Nuclear portfolio
• Develop and guide the development of acquisition strategies to meet the needs of Radiological/Nuclear strategy and initiatives
• Perform market research and develop business cases to support potential new initiatives and projects
• Lead all contract negotiations for product development and procurement contracts for MCMs for radiological and nuclear threats for RN Branch
• Develop and advise staff on contractual and negotiation strategies for Radiological/Nuclear MCM development programs and procurement activities
• Provide administrative, technical, and scientific guidance and oversight for all staff and product development and procurement contracts managed by the Radiological and Nuclear Branch
• Inter- and Intra- agency point of contact for Rad/Nuc Medical Countermeasures
• Coordinate activities with all agencies partners, particular stakeholders in the PHEMCE (includes FDA, CDC, NIH, DoD, DHS, DOE, NASA, and USDA)
• Supervise and lead any response to address Radiological/Nuclear related inquiries from senior leadership or congressional sources.

Responsible for oversight of portfolio funded at $95M

• Provide technical and scientific oversight on all aspects of product development as the Contracting Officer's Representative (COR)/Program Manager (PM) on assigned contracts for development of medical countermeasures (MCM) for radiological and nuclear threats
• Lead Project Coordination team comprised of matrixed team members from BARDA divisions and interagency partners in administration of contracts for medical countermeasures for radiological and nuclear threats
• Review and approve invoices, progress reports, milestone deliverables, risk matrices, and other contract deliverables
• Oversight of areas of expertise including non-clinical, clinical, and manufacturing components of product development contracts
• Provide Project management for contracts for product development of MCMs for radiological and nuclear threats including facilitation with Contractor, project evaluation and risk mitigation to ensure appropriate project management
• Maintain records compatible with GAO requirements
• Develop Memoranda Of Understandings and Inter-Agency Agreements
• Includes working with the NIH to promote pipeline development through funding grants and administrative supplements for relevant projects and to allow BARDA to use resources and staff expertise
• Lead on development of Blood products initiative and portfolio
• Includes establishing MOUs with DoD and National Heart, Lung, and Blood Institute (NIH)
• Chaired planning and execution of Interagency Blood Products and Emergency Use Symposium (November 2012)
• Serve as BARDA Lead on the Decision Gate process/ASPR Acquisition Management System for the BARDA Director and in partnership with the Office of Acquisition Management, Contracts, and Grants (AMCG) staff
• Includes coordinating Project Coordination Teams (PCT) and Contractors to participate in In-Process Reviews, coordinating interaction and administering meetings with interagency partners (DoD, FDA, CDC, NIH, DHS), drafting and maintaining documentation of proceedings
• The Reviews advise the Milestone Decision Authority on Acquisition decisions
• Draft Rad/Nuc communications, including drafting communication documents for GAO, congressional inquiries, outside government requests
• Prepare press releases for contract awards and other BARDA actions of note.

• Provide leadership, oversight, management, and scientific expertise in the planning and implementation of the peer review process, an essential component of the NIAID award process.

• Personally manage, as lead SRA, extramural scientists (as reviewers) for meetings to evaluate grant applications and contract proposals

• Recruitment of scientific expertise for participation in Internal Review Groups. Involved direct interaction through face to face meetings, phone conversations and emails with highly experienced extramural scientists and other professionals throughout the review process.

• Responsibility for the management and conduct of review meetings for evaluation of grants and contracts by serving as the Designated Federal Official. Facilitation of 5-40 professional level extramural panel members including scientists and other professionals with relevant expertise. Required detailed knowledge of policies and procedures for the review of grants and contracts through NIAID, NIH, DHHS, and the PHS.

• Participate in the development of research initiatives (both RFAs and RFPs) that involved interaction with Program and Grants or Contract staff.

• Administrative review, management, and preparation of grants and contracts for peer review. Required broad knowledge of biomedical and technological areas, including a detailed understanding of infectious disease, emerging biotechnologies, and immunological areas covered by research program areas of the grants and contracts. Required detailed understanding of the grants review and award policies and process for the Public Health Service and NIAID/NIH. Required detailed understanding of relevant RFAs and RFPs for the implementation of fair and unbiased reviews.

• Supervision of professional level staff. Administration of peer review process required oversight of grants clerk staff and other professional level Scientific Review Administrator (PhD level) staff for larger reviews.

• Provide leadership, oversight, management, and scientific expertise in the planning and implementation of the peer review process, an essential component of the NIAID award process
• Personally manage, as lead SRA, extramural scientists (as reviewers) for meetings to evaluate grant applications and contract proposals
• Recruitment of scientific expertise for participation in Internal Review Groups
• Involved direct interaction through face to face meetings, phone conversations and emails with highly experienced extramural scientists and other professionals throughout the review process
• Responsibility for the management and conduct of review meetings for evaluation of grants and contracts by serving as the Designated Federal Official
• Facilitation of 5-40 professional level extramural panel members including scientists and other professionals with relevant expertise
• Required detailed knowledge of policies and procedures for the review of grants and contracts through NIAID, NIH, DHHS, and the PHS
• Participate in the development of research initiatives (both RFAs and RFPs) that involved interaction with Program and Grants or Contract staff
• Administrative review, management, and preparation of grants and contracts for peer review
• Required broad knowledge of biomedical and technological areas, including a detailed understanding of infectious disease, emerging biotechnologies, and immunological areas covered by research program areas of the grants and contracts
• Required detailed understanding of the grants review and award policies and process for the Public Health Service and NIAID/NIH
• Required detailed understanding of relevant RFAs and RFPs for the implementation of fair and unbiased reviews
• Supervision of professional level staff
• Administration of peer review process required oversight of grants clerk staff and other professional level Scientific Review Administrator (PhD level) staff for larger reviews.