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Afternoon Plenary Session

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Contributors

  • Melanie Anderson, M.S., Merck and Co, Inc.

    Melanie Anderson is a principal scientist at Merck Research Laboratories (NJ, USA) in the Clinical Regulated Bioanalysis group. Melanie has over 15 years’ experience in both pharma and CRO settings, conducting LBA and LC–MS/MS analysis for quantitation of small and large molecules. Melanie has participated in FDA inspections and contributed to regulatory filings for multiple programs. Additionally, Melanie has experience in non-compartmental pharmacokinetic analysis of atypical compounds. Melanie currently co-chairs the TALG IQ Patient Centric Sampling working group. She is a Zone Leader for Bioanalysis Zone. In addition, Melanie is on the organizing committee for the Land O’ Lakes bioanalytical conference and will chair the CPSA-USA conference in 2020. Melanie’s scientific interests include analysis of unique matrices, unstable compounds, challenges in chromatographic separations, and patient centric micro sampling approaches. Recently, Melanie has evaluated and helped implement micro sampling devices in animal and human regulated studies. She received her BA in Chemistry from Hasting College (NE, USA) in 2002, and an MS in Chemistry from Lehigh University (PA, USA) in 2007.

  • Brian Booth, Ph.D., U.S. Food and Drug Administration

    Brian Booth, Ph.D., joined the Office of Clinical Pharmacology, FDA, in 1998. In 2004, he became the Acting Team Leader in the Division of Oncology Drug Products, after serving as a reviewer/pharmacometrician in this division. In November 2006, Dr. Booth was selected as Deputy Director of the Division of Clinical Pharmacology 5. At the FDA, Dr. Booth has been involved with the clinical pharmacology development of several hundred new oncology drugs, ranging from phase 1 to phase 4. In addition to IND and NDA reviews, Dr. Booth has been involved with teaching and development of new clinical pharmacology reviewers and medical officers, development of Guidances for Industry for bioanalytical method validation, liposome drug products, hepatic impairment studies and food effect studies. He has authored 60 peer-reviewed articles and book chapters. Dr. Booth is a member of AAPS and ACCP.

July 7, 2020
Tue 1:30 PM EDT

Duration 1H 30M

This live web event has ended.