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Accelerating Time to Market for Tobacco/Nicotine Products: A Deep Dive into MicroFlow® Flow Cytometry Micronucleus Assays
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Moderator
Presenters
Bonnie G. Coffa, PhD.
DABT, Scientific Director Toxicology, Labstat and Regulatory Toxicology Consultant, Chemular Regulatory Consulting
Bonnie is a board-certified Toxicologist with Chemular and specializes in ingredient and product risk assessments, in vitro regulatory assays for product stewardship testing, and regulatory applications for tobacco-, nicotine- and cannabinoid-containing products. She is also a consultant for Labstat in the role of Scientific Director Toxicology.
She has over a decade of experience in tobacco and nicotine regulatory testing, FDA applications and scientific communication. Bonnie received her PhD in Pharmacology from Vanderbilt University, where she studied the involvement of dopamine systems in neuropsychiatric disorders, including schizophrenia and Parkinson’s Disease using a variety of approaches, ranging from neuroanatomical to pharmacological. She completed postdoctoral training in tobacco regulatory science at Altria Client Services.
Jeffrey Bemis, PhD.
Director of Clinical Studies, Litron Laboratories
Dr. Jeffrey Bemis received his PhD in Environmental Health and Toxicology from the University at Albany School of Public Health in Albany, NY. Jeff then spent three years as a Postdoctoral Fellow in the Department of Environmental Medicine at the University of Rochester School of Medicine and Dentistry in Rochester, NY.
Jeff began his work in genetic toxicology when he joined Litron Laboratories in 2006 as a research scientist and is now Director of Clinical Studies. In his current position Jeff serves as a principal investigator for internal research efforts, in-house service work and also manages human studies for clients. Jeff regularly presents at national and international meetings and is an author on over fifty peer-reviewed journal articles and book chapters.
Manoj Misra, PhD.
Chemular Regulatory Consulting
Manoj is currently working with Chemular Regulatory Consulting group and managing product development, Chemistry and Toxicology for clients. Manoj holds Ph.D. in Toxicology.
He has over twenty years of professional experience in top-tiered tobacco international companies including JUUL, PAX, ITGB-Imperial Tobacco and Lorillard.
He has managed aerosol chemistry, GLP pre-clinical toxicology, environmental exposure, risk assessment, flavor and device development and commercial product testing.
Manoj has been involved in several toxicological and safety assessment for regulatory document preparation of e-cigarette products for several clients for PMTA following FDA-CTP and European TPD guidelines.
Sean Oh, MSc.
Scientist, Labstat
Sean Oh is a Scientist at Labstat in Kitchener, Canada, specializing in the Commercial Product Development Department. He earned his M.Sc. in Immunology from Yonsei University in Seoul, Korea. In 2004, Sean joined ViroMed as a Research Scientist, where he made contributions to the development of gene therapy for cancer. His responsibilities included overseeing preclinical studies, encompassing PK, PD, and toxicology assays. Following the FDA’s approval for clinical trials, Sean transitioned to Canada, where he continued his research. He has managed multiple clinical trials in North America and Asia.
Sean has more than 20 years of experience in flow cytometry, and recently he joined Labstat, where he is dedicated to establishing various toxicological assays.
Moderator
Bonnie G. Coffa, PhD.
DABT, Scientific Director Toxicology, Labstat and Regulatory Toxicology Consultant, Chemular Regulatory Consulting
Bonnie is a board-certified Toxicologist with Chemular and specializes in ingredient and product risk assessments, in vitro regulatory assays for product stewardship testing, and regulatory applications for tobacco-, nicotine- and cannabinoid-containing products. She is also a consultant for Labstat in the role of Scientific Director Toxicology.
She has over a decade of experience in tobacco and nicotine regulatory testing, FDA applications and scientific communication. Bonnie received her PhD in Pharmacology from Vanderbilt University, where she studied the involvement of dopamine systems in neuropsychiatric disorders, including schizophrenia and Parkinson’s Disease using a variety of approaches, ranging from neuroanatomical to pharmacological. She completed postdoctoral training in tobacco regulatory science at Altria Client Services.
Presenters
Jeffrey Bemis, PhD.
Director of Clinical Studies, Litron Laboratories
Dr. Jeffrey Bemis received his PhD in Environmental Health and Toxicology from the University at Albany School of Public Health in Albany, NY. Jeff then spent three years as a Postdoctoral Fellow in the Department of Environmental Medicine at the University of Rochester School of Medicine and Dentistry in Rochester, NY.
Jeff began his work in genetic toxicology when he joined Litron Laboratories in 2006 as a research scientist and is now Director of Clinical Studies. In his current position Jeff serves as a principal investigator for internal research efforts, in-house service work and also manages human studies for clients. Jeff regularly presents at national and international meetings and is an author on over fifty peer-reviewed journal articles and book chapters.
Manoj Misra, PhD.
Chemular Regulatory Consulting
Manoj is currently working with Chemular Regulatory Consulting group and managing product development, Chemistry and Toxicology for clients. Manoj holds Ph.D. in Toxicology.
He has over twenty years of professional experience in top-tiered tobacco international companies including JUUL, PAX, ITGB-Imperial Tobacco and Lorillard.
He has managed aerosol chemistry, GLP pre-clinical toxicology, environmental exposure, risk assessment, flavor and device development and commercial product testing.
Manoj has been involved in several toxicological and safety assessment for regulatory document preparation of e-cigarette products for several clients for PMTA following FDA-CTP and European TPD guidelines.
Seah Oh, MSc.
Scientist, Labstat
Sean Oh is a Scientist at Labstat in Kitchener, Canada, working within the Commercial Product Development Department. After earning his M.Sc in Immunology from Yonsei University, Seoul, Korea, Sean joined ViroMed in Korea as a Research Scientist in 2004, where he played a role in the development of gene therapy for cancer. Following FDA approval for clinical trials, Sean relocated to Canada and continued his research. Recently, Sean has joined Labstat, where he is focused on establishing multiple toxicological assays.