BARDA Absorption, Distribution, Metabolism, and Elimination (ADME) Subject Matter Expert

Background. In 2006 the Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. The BARDA model’s success is codified in 1) 60+ Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.  Subject Matter Expert Responsibilities – General.Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats) as well as the research, development, manufacture and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics, preventives, and therapeutics.Provide guidance and recommendations on key issues related to the area(s) identified above.Review study protocols, study reports, regulatory documents, presentations, proposals, and related documents.Provide senior-level briefing(s) to ASPR/BARDA as required.Prepare regular reports to ASPR/BARDA management on various technical issues identified as required.Provide recommendations for project development level portfolio management and oversight as required.Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.Participate in Market Research efforts.Absorption, Distribution, Metabolism, and Elimination (ADME) Subject Matter Expert Specific ResponsibilitiesProvide subject matter expertise in ADME (Absorption, Distribution, Metabolism, and Elimination).Provide support across all BARDA divisions on Product Coordination Team (PCTs).Develop decision gates and checklists to ensure all BARDA programs are evaluating and considering ADME during product development.Providing support and advice to clients on the design, interpretation, and associated risks of nonclinical studies (e.g., pharmacology; toxicology; absorption, distribution, metabolism, and excretion [ADME]; toxicokinetics (TK); and safety) and on Good Laboratory Practice (GLP) requirements for programs as needed.Coordinate with program managers, scientists, and other subject matter experts as required.Serving as a subject matter expert supporting development strategies and identifying strategic resolutions to issues identified during drug development regarding nonclinical pharmacology and toxicology studies.Preparing as primary author, reviewing, and providing regulatory input to nonclinical pharmacology/toxicology portions of relevant regulatory documents (IND, NDA, BLA, MAA, Meeting Briefing Packages, IB, annual reports, etc.) for drugs or biologics or other technical reports (e.g., white papers, memos, literature reviews).Advising clients on and/or providing interpretation of relevant regulatory requirements (e.g., for FDA, Health Canada, EMA, etc.).Collaborating cross-functionally with other organizational practice areas (e.g., CMC, clinical); communicating with clients and project managers regarding technical issues, timelines, deliverables, etc.Providing training and mentorship to internal staff, clients, and external vendors as needed.