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J Clin Exp Tox 2017 | Volume 1 | Issue 2

Toxicology and Pharmacology

November 01-02, 2017 | Toronto, Canada

International Conference on

Developing new approaches to the health hazard assessment of potent pharmaceuticals

Tracy A Kimmel

SafeBridge Consultants, Inc., Canada

he current approach to setting “safe” levels of exposure

to potent pharmaceutical compounds has remained

fundamentally unchanged for over 50 years. This approach

has been applied to both worker setting (through the setting

of Occupational Exposure Limits) and, more recently, patient

and/or product safety (through the setting of Permitted

Daily Exposures). New developments in pharmaceutical

technology (i.e., antibody-drug conjugates, nanodrugs, viral

vectors and other biologicals, and emerging immunotherapy

targets) have combined with ever-increasing drug potency

present challenges to the paradigm of hazard assessment,

and have spurred advances and adaptations by which

robust evaluations of these compounds can be performed.

The purpose of this presentation is to deliver an overview

of the hazard assessment process and its applicability to

both work and patient/product safety, which will include a

description of what constitutes a “potent” pharmaceutical

agent. Application of hazard assessment methodologies to

novel drug candidates and drug delivery technologies, which

stretch the boundaries of established approaches to hazard

assessment, will then be discussed.

Speaker Biography

Tracy A Kimmel has received her PhD in Environmental Health Sciences from New York

University, and is a Diplomate of the American Board of Toxicology. She has almost

25 years’ experience in the pharmaceuticals industry, including 12 years working with

Corporate EH&S groups. She is currently Senior Manager of Toxicology at SafeBridge

Consultants, Inc. Her primary responsibilities include performing health hazard

assessments of pharmaceutical and industrial compounds, predicting the toxicity

of compounds using computational modeling software and qualitative analyses,

evaluation of pharmaceutical impurities and synthetic intermediates, and assisting

with environmental risk assessments. She is a former Chair of the Occupational

Alliance for Risk Science (OARS) Workplace Environmental Exposure Level (WEEL)

Committee, and now serves on the ACGIH Threshold Limit Value (TLV®) Committee.

She has contributed to peer-reviewed journal articles and publications, has prepared

white papers on occupational hazard assessment, and has delivered presentations and

workshops at worldwide locations.