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Consideration for Program Design in Nonclinical Development of Gene Therapy

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Contributors

  • Edward (Ted) Barrett, Ph.D.

    Ted Barrett, Ph.D., is Senior Director, Pharmacology at Lovelace Biomedical. Dr. Barrett has spent most of his career investigating the effects of small molecule, biologic, nucleic acid and medical device technologies in various animal models of disease. His programs aim to translate nonclinical efficacy, pharmacokinetic, and pharmacodynamic data obtained by from species ranging from rodents to nonhuman primates to the human clinical paradigm. Dr. Barrett received his doctorate in toxicology from the University of Rochester and joined Lovelace in 1999.

  • Janet Benson, Ph.D.

    Dr. Benson has been a toxicologist at Lovelace for 42 years. She has investigated the toxicity, PK, or biodistribution of metals, solvents, polymers, natural products, select agents, vesicants and gene therapeutics. As a member of the NHLBI Gene Therapy Resources Program, Pharmacology/Toxicology core for over 11 years, she has assisted investigators in the development of their pre-clinical safety and biodistribution studies to support IND applications. She has also participated in preparation and/or review of INTERACTor pre-IND packages and participated in multiple, associated meetings with investigators and the FDA.

    Dr. Benson holds a BS degree in Chemistry from the University of California, Berkeley and a PhD in Comparative Pharmacology and Toxicology from UC, Davis. She was a Diplomate of the American Board of Toxicology from 1981 - 2017. She has over 100 publications in the scientific literature. She currently serves on the US Transuranium Uranium Registry Scientific Advisory Committee and has served on scientific advisory Committees (National Academy of Sciences, the EPA IRIS review Committee, and American Conference of Industrial Hygienists Threshold Limit Value Committee).

April 22, 2021
Thu 12:30 PM EDT

Duration 1H 30M

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