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.

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.

• 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.

• 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.
• 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.

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