Leanne L. Bedard, Ph.D., RAC, DABT
Leanne Bedard specializes in drug metabolism, pharmacokinetics and mechanistic toxicology. She has a multidisciplinary background in Chemistry and Toxicology, as well as drug discovery and early development experience in several therapeutic areas including respiratory diseases, inflammatory diseases, infectious diseases, pain and oncology. Leanne is a board-certified toxicologist (DABT) and is also certified in Regulatory Affairs (RAC).
Leanne completed her undergraduate and Master’s degree studies in Chemistry at Carleton University in Ottawa, Ontario, Canada. For her MSc thesis research, she worked under the supervision of the world-renowned free radical chemist Dr. Keith U. Ingold. She investigated the chemical kinetics of free-radical initiated human low-density lipoprotein oxidation and the pro-oxidant activity of vitamin E, published in the Journal of the American Chemical Society. Leanne then pursued her PhD in Toxicology at Queen’s University in Kingston, Ontario, under the supervision of Dr. Thomas E. Massey. Her research focused on the mechanisms of chemically-induced lung cancer, particularly those initiated by the mycotoxin Aflatoxin B1. She also characterized the involvement of biotransformation enzymes in the bioactivation of the tobacco-specific nitrosamine, NNK, in human lung. Leanne’s research led to first-authored publications in high impact journals including Cancer Research and Chemical Research in Toxicology. She is also the first author of an invited mini-review about Aflatoxin B1 carcinogenicity.
Leanne was formerly employed as a DMPK Drug Design Leader at AstraZeneca R&D Montréal, specializing in pain control therapy. In support of discovery projects in lead optimization, she proposed and implemented strategies to improve the ADME-PK properties of newly designed molecules. Prior to this, Leanne worked at the Merck Frosst Centre for Therapeutic Research as a Senior Research Chemist in Preclinical DMPK. She contributed to the progress of several drug discovery projects for the treatment of respiratory and infectious diseases, reducing late-stage attrition of drug candidates due to poor ADME-Tox properties. Leanne was also the recipient of a Merck Frosst Discovery and Preclinical Sciences Special Achievement Award for her significant contributions made to the discovery of Doravirine (MK-1439), currently in Phase 3 clinical development for the treatment of HIV-1.
Using her expertise in pulmonary xenobiotic metabolism gained during her PhD, Leanne established a DMPK platform to support the discovery of inhaled medicines. She represented Merck Frosst on global scientific initiatives to identify best practice and harmonize methodology for in vivo DMPK studies and human PK projections. She co-authored guidance documents and experimental protocols for in vivo ADME studies, used across Merck Research Laboratories globally. She was actively involved in 2 initiatives with Global Safety Assessment to design and implement discovery toxicology studies in genotoxicity and oxidative stress.
As a consultant, Leanne has served well over a dozen clients (CROs, biotech, small pharma) in Canada, the US and China in the interpretation of drug metabolism, ADME-PK and toxicological data in drug discovery and development. She has contributed to the discovery, preclinical development and successful regulatory filing for 4 drug candidates: 2 first-in-class in oncology, both in Phase I (IND); 1 for inflammatory pain, currently in Phase II (CTA); 1 first-in-class for HBV, currently in Phase II (IND). Leanne also serves as a scientific reviewer of nonclinical PK and toxicology studies of New Drug Submissions to Health Canada, providing expert scientific opinion on whether findings in nonclinical studies pose safety concerns for humans and ensuring that these are reflected in drug product labeling.
Leanne has also been active in the scientific community. She currently holds an adjunct appointment in the Department of Biomedical and Molecular Sciences at Queen’s University in Kingston, Ontario (2007-present). Leanne was a Councilor on the Board of Directors of the Society of Toxicology of Canada (2009-2012) and also served as a Councilor on the executive committee of the Drug Discovery Specialty Section of the Society of Toxicology, USA (2014-2016). Leanne is the author of 15 publications in the peer-reviewed literature, including an invited mini-review.
Leanne completed her undergraduate and Master’s degree studies in Chemistry at Carleton University in Ottawa, Ontario, Canada. For her MSc thesis research, she worked under the supervision of the world-renowned free radical chemist Dr. Keith U. Ingold. She investigated the chemical kinetics of free-radical initiated human low-density lipoprotein oxidation and the pro-oxidant activity of vitamin E, published in the Journal of the American Chemical Society. Leanne then pursued her PhD in Toxicology at Queen’s University in Kingston, Ontario, under the supervision of Dr. Thomas E. Massey. Her research focused on the mechanisms of chemically-induced lung cancer, particularly those initiated by the mycotoxin Aflatoxin B1. She also characterized the involvement of biotransformation enzymes in the bioactivation of the tobacco-specific nitrosamine, NNK, in human lung. Leanne’s research led to first-authored publications in high impact journals including Cancer Research and Chemical Research in Toxicology. She is also the first author of an invited mini-review about Aflatoxin B1 carcinogenicity.
Leanne was formerly employed as a DMPK Drug Design Leader at AstraZeneca R&D Montréal, specializing in pain control therapy. In support of discovery projects in lead optimization, she proposed and implemented strategies to improve the ADME-PK properties of newly designed molecules. Prior to this, Leanne worked at the Merck Frosst Centre for Therapeutic Research as a Senior Research Chemist in Preclinical DMPK. She contributed to the progress of several drug discovery projects for the treatment of respiratory and infectious diseases, reducing late-stage attrition of drug candidates due to poor ADME-Tox properties. Leanne was also the recipient of a Merck Frosst Discovery and Preclinical Sciences Special Achievement Award for her significant contributions made to the discovery of Doravirine (MK-1439), currently in Phase 3 clinical development for the treatment of HIV-1.
Using her expertise in pulmonary xenobiotic metabolism gained during her PhD, Leanne established a DMPK platform to support the discovery of inhaled medicines. She represented Merck Frosst on global scientific initiatives to identify best practice and harmonize methodology for in vivo DMPK studies and human PK projections. She co-authored guidance documents and experimental protocols for in vivo ADME studies, used across Merck Research Laboratories globally. She was actively involved in 2 initiatives with Global Safety Assessment to design and implement discovery toxicology studies in genotoxicity and oxidative stress.
As a consultant, Leanne has served well over a dozen clients (CROs, biotech, small pharma) in Canada, the US and China in the interpretation of drug metabolism, ADME-PK and toxicological data in drug discovery and development. She has contributed to the discovery, preclinical development and successful regulatory filing for 4 drug candidates: 2 first-in-class in oncology, both in Phase I (IND); 1 for inflammatory pain, currently in Phase II (CTA); 1 first-in-class for HBV, currently in Phase II (IND). Leanne also serves as a scientific reviewer of nonclinical PK and toxicology studies of New Drug Submissions to Health Canada, providing expert scientific opinion on whether findings in nonclinical studies pose safety concerns for humans and ensuring that these are reflected in drug product labeling.
Leanne has also been active in the scientific community. She currently holds an adjunct appointment in the Department of Biomedical and Molecular Sciences at Queen’s University in Kingston, Ontario (2007-present). Leanne was a Councilor on the Board of Directors of the Society of Toxicology of Canada (2009-2012) and also served as a Councilor on the executive committee of the Drug Discovery Specialty Section of the Society of Toxicology, USA (2014-2016). Leanne is the author of 15 publications in the peer-reviewed literature, including an invited mini-review.