Amanda Lewin Email & Phone Number

Washington, Dc, Us

https://www.usp-pqmplus.org/The Promoting the Quality of Medicines Plus (PQM+) program, funded by the U.S. Agency for International Development (USAID), works to improve systems that assure the quality of essential medical products in low- and middle-income countries (LMICs) to help prevent maternal and child deaths, control the HIV epidemic, and combat infectious diseases through high-performing health systems. PQM+ (2019-2024) builds on the work of its predecessor, the Promoting the Quality of Medicines (PQM) program (2009-2020).Led by the U.S. Pharmacopeial Convention (USP) and its consortium of partners, PQM+ provides technical assistance to manufacturers of priority health products and technical support to medicines regulatory authorities to improve product registration, inspection, and post-marketing surveillance of product quality. This includes the accreditation of national drug quality control laboratories per international standards, including the International Organization for Standards (ISO) 17025 and World Health Organization (WHO) prequalification requirements.By sharing expertise and providing technical support and leadership, PQM+ supports LMICs in developing more resilient, robust, local health systems capable of preventing and responding to diseases such as tuberculosis, malaria, neglected tropical diseases, COVID-19, and other infectious diseases as well as improving maternal, newborn and child health. By working closely with country counterparts and stakeholders, PQM+ encourages the adoption of new strategies and tools to help optimize limited health resources and increase equitable access to quality-assured medical products.

Washington Dc-Baltimore Area

CDER/OTS/OSIS/DGDSI• Lead a team of three highly skilled reviewers by planning, coordinating, and evaluating the programs and activities of the team and division.• Advise team members to ensure adherence to the regulations, compliance programs, and guidance documents applicable to NDA, ANDA, and BLA clinical/analytical study review, including 21 CFR 312 and 21 CFR 320.• Serve as a lead and resource for team members preparing for and conducting pharmacokinetic, bioavailability, and bioequivalence study inspections.• Provide secondary review for all documents produced by the team, ensuring that documents are complete, accurate, logical, and in line with office standards.• Support team members in producing scientifically justified recommendations to CDER review divisions that are clear, concise, and actionable.• Counsel team members on available resources and best practices to improve skills critical to the work of the team including communication (written and oral), problem solving techniques, and team work.• Coach and train both new and experienced team members on routine and critical aspects of conducting their roles and responsibilities.• Expert working knowledge of all aspects of scientific collaborations, stakeholder interactions, and the latest multi-disciplinary scientific advancements for the bioavailability and bioequivalence inspections program (BIMO program). • Knowledge of a wide variety of analytical methods utilized in both in vivo and in vitro studies; thorough understanding of laboratory functions, clinical operations, and quality management systems related to principles of pharmacology, pharmacokinetics, and pharmacodynamics. • Experience evaluating various analytical assay formats and corresponding method validations including LC-MS/MS, ligand binding (ELISA and ECL), enzyme activity, and in vitro methods (PSD, GSD, IVRT, IVPT, morphology, spray pattern, plume geometry, ect.)

CDER/OTS/OSIS/DNDSIHighlighted Accomplishments• Identified extensive data integrity concerns during an inspection of a CRO which resulted in broad Agency action to reject all data generated at the CRO.• Consistently performed high quality, scientific based inspections as evidenced by unique/challengingassignments (e.g. novel assay approaches, controversial inspectional history, short deadlines).• Expertise and skills (e.g. efficiency, time management, and communication) have allowed for completing assignments well above the required minimum amount and well within office/application deadlines.• Regularly provided training, support, and scientific advisement to office members with more years ofexperience.General Summary• Identify, coordinate, direct and/or conduct clinical and analytical inspections of in vitro bioequivalence and in vivo pharmacokinetic, bioavailability and bioequivalence studies used to support ANDAs, NDAs, and BLAs.• Conduct bioanalytical inspections covering clinical and non-clinical studies individually and as part of acollaborative team.• Consistently utilize new tools/programs during all relevant inspections to identify potential data manipulation in data sets for in vivo bioequivalence studies.• Identify and resolve complex scientific and regulatory issues using principles of bioanalysis, pharmacology, pharmacokinetics, pharmacodynamics, and other relevant scientific disciplines.• Prepare written inspection reports that thoroughly and accurately document the conduct and findings from an inspection.• Prepare and provide oral and written reviews/recommendations to CDER review divisions that identify and resolve complex issues while focusing on safety and data integrity.• Develop solutions and clarifications to scientific and regulatory issues as part of a collaborative team.• Develop and maintain expertise in bioanalytical inspections covering an array of assay formats.

• Review, evaluate, and interpret in vivo and in vitro pharmacological and toxicological studies, individually and as part of a multi-disciplinary team, in order to recommend a direction for the given project• Present oral seminars to the scientific community and general public that (1) summarize current non-clinical pharmacological and toxicological studies relevant to presentation, (2) describe new data and analysis, and (3) offer evaluation and interpretation of the data presented• Participate in outreach to high school and undergraduate students through both classroom presentations (describing pharmacological and toxicological methods/ techniques) and individual mentorship• Participate in studies as part of a multi-disciplinary team in order to achieve goals outside of individual projects; equally comfortable with leadership and individual contributor roles• Determine the pharmacological and toxicological effects of drugs/ chemicals/ toxic agents on the neurological function of mice utilizing in vivo and in vitro methods• Perform, asses, and interpret in vitro (ex vivo) electrophysiology with brain slices obtained from transgenic animal models to (1) establish connectivity between two populations of neurons, (2) determine the effects of a variety of drugs/biologics and chemicals on a specific population of cells, (3) characterize the genetically established population of cellsExperience and Knowledge in the following pharmacological techniques in animals and/or cell lines, including the evaluation and interpretation of the data:In vitro• Electrophysiology (mouse brain slices)• Calcium Imaging (Confocal Microscopy)• Radio-Ligand binding• Rh+ efflux• ImmunohistochemistryIn vivo• Surgical application of retrograde tracers peripherally• Microinjections• Subcutaneous injections• Osmotic pump for in vivo drug administration (mice)Both• Transgenic animals• Optogenetics (in vivo, in vitro)

Washington D.C.

Washington D.C.

• Responsible for toxicological confirmatory tests of all urine samples collected by the District of Columbia Courts that were found positive for opioids after a high throughput primary screen• Employed various toxicological methods and techniques to analyze biological samples including: liquid-liquid extraction, solid-phase extraction, and GC-MS • Developed optimal derivatization techniques and programmed GC-MS analytical methods for new designer drugs• Assisted in determining limits of detection of compounds for novel extraction methods• Responsible for the acquisition and organization of collected biological samples

Doctor Of Philosophy (Phd), Pharmacology

Master Of Forensic Science, Forensic Toxicology

Bachelor Of Science (B.S.), Chemistry