Laura S. Kaufman, Ph.D., DABT
Senior Consultant

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LocationHouston, TX
Address23501 Cinco Ranch Blvd
Suite B226
Katy, TX 77494

 

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Professional Profile

Dr. Laura Kaufman is a toxicologist in ToxStrategies’ Biopharmaceutical/Pharmaceutical Practice. She has more than three decades of experience in designing, conducting, overseeing, and reporting pharmacology/ toxicology studies in the drug development and consulting sectors. As a senior-level pharmaceutical regulatory toxicologist, she has garnered an extensive interdisciplinary understanding of drug development and a track record of advancing compounds through the development pipeline, studying large and small molecules across most therapeutic areas, including oncology. Dr. Kaufman’s expertise includes interactions with FDA; oversight of CRO activities; preparation of nonclinical modules, requests for proposals, and federal grants; electronic data management; negotiation of contracts; and familiarity with the Biodefense/Animal Rule (i.e., report, submission, and program reviews). In the consulting arena, she has most recently assisted an oncology company in refining a protocol for a Phase I clinical trial, based on results from toxicology studies, and in reviewing early-stage, small-molecule oncology programs to assess feasibility for further development. She assisted a data management company in developing tools to convert nonclinical toxicology studies and oncology pharmacology to electronic formats suitable for visualization and analysis. She has also consulted with small to medium pharmaceutical companies, providing strategic guidance and technical assistance, including development of IND and NDA submittal sections and monitoring of toxicology, pharmacokinetics, safety pharmacology, and pharmacology programs at multiple CROs. Finally, Dr. Kaufman is active in PhUSE[1] and is part of the CDISC SEND Leadership Team, heading up the CDISC SEND Scope team.

Dr. Kaufman holds a Ph.D. from the University of Pennsylvania, and she was a postdoctoral fellow at The Rockefeller University in New York. She regularly publishes in the scientific literature, attends and presents at professional conferences and events, and is a frequently invited speaker, panelist, and session chair for various scientific meetings and symposia. For several years, Dr. Kaufman has served with the Therapy Acceleration Program (TAP) of the Leukemia & Lymphoma Society. TAP is a group of experts from industry and academia who volunteer to assist in reviewing innovative programs for potential funding by the Society. Specifically, she reviews nonclinical safety programs and associated regulatory information to assess feasibility for further development and Society support.

[1] PhUSE is an independent, non-profit organization whose members share ideas, tools, and standards around data, statistics, and reporting technologies. CDISC and PhUSE combine efforts on key initiatives concerning standards and semantics.