Assessment of Neurotoxicity: Biomarkers and Beyond

January 29, 2013
1:00 pm – 3:30 pm EST



Learning Objectives: 

  • Importance of CNS toxicity as attrition in drug discovery
  • Current assessment strategies for neurotoxicity and gaps
  • Potential translational biomarker solutions integrated into drug discovery

Who Should Attend: 
Scientists in drug safety, safety pharmacology, toxicology, biomarker discovery, and neuroscience

1:00 Chairperson's Remarks
Andreas Jeromin, Ph.D., CSO, NextGen Sciences Inc. 

1:15 CNS/Neurobehavioral Safety Biomarkers in Pre-Clinical Drug Research
James Lynch, Ph.D., Senior Scientist III, Department of Integrative Pharmacology, Global Pharmaceutical Research and Development, Abbott Laboratories
Potential CNS/neurobehavioral side effects should be uncovered as soon as possible during the drug discovery and development process to help determine whether to shift resources to other compounds. Balancing this with the relatively limited finances and head count available during the earlier stages of pre-clinical drug research, this session discusses which CNS/neurobehavioral safety pharmacology assays produce the most critical data in regards to further drug development, and optimization of such assays.

2:05 Pre-clinical In Vivo Imaging of Neurotoxicity
Serguei LiachenkoSerguei Liachenko, Ph.D., Director of Bio-Imaging, National Center for Toxicological Research, Food and Drug Administration
Modern in vivo imaging technologies like magnetic resonance imaging and spectroscopy have attained an important role in medical research due to low invasiveness and ability to provide functional information about biological systems. Such information could be obtained from the same subject repeatedly and with the least possible interference, which makes in vivo imaging a unique and indispensable tool to support drug safety evaluation and other toxicological research in preclinical settings.

2:35 Current Biomarkers of Neurotoxicity: Conventional Morphological Analyses
Brad Bolon, DVM, Ph.D., DACVP, DABT, Veterinary Pathologist, Department of Veterinary Biosciences and Associate Professor, Clinical, The Ohio State University
Conventional neurotoxicity testing depends on morphological biomarkers to screen neural tissues for xenobiotic-related changes. Gross morphological endpoints are generally limited to the brain and include examination of structural landmarks and acquisition of total brain weight. Histopathological endpoints are limited to light microscopic evaluation of tissue sections. Neurotoxicity assays detect various molecular markers to show patterns indicative of a response to prior damage. Despite some limitations, routine morphological methods represent the current "gold standard" of testing and they will undoubtedly remain the benchmark against which potential novel biomarkers will be validated.

3:15 Addressing questions from attendees 

3:30 End of Webinar 

Speaker Biographies

Brad BolsonBrad Bolon, DVM, Ph.D.
, earned B.S. (1983; Agriculture [with honors]), D.V.M. (1986) and M.S. (1986; Veterinary Biomedical Sciences [emphasis in neurotoxicology]) degrees in six years at the University of Missouri (Columbia, MO), “enjoyed” an anatomic pathology residency (1986-1989) at the University of Florida (Gainesville, FL), and obtained a Ph.D. (1993; Pathology [emphasis in developmental neuropathology]) from Duke University (Durham, NC) while completing postdoctoral training at the Chemical Industry Institute of Toxicology in Research Triangle Park, NC (1989-1993). He worked for Pathology Associates International as associate director of the Molecular and Immunopathology Division (Frederick, MD; 1993-1994) and later as staff pathologist at the National Center for Toxicological Research (Jefferson, AR; 1994-1996). Brad next served as an experimental at Wyeth-Ayerst Research (Plainsboro, NJ; 1996-1997) and Amgen (Thousand Oaks, CA; 1997-2004), where he assessed genetically engineered rodent phenotypes and the efficacy of biopharmaceuticals. From 2004 to 2011 he maintained a solo consulting practice (named GEMpath, for “Genetically Engineered Mouse Pathology”). He has been on staff as a comparative pathologist at The Ohio State University College of Veterinary Medicine (Columbus, OH) since 2011. Dr. Bolon is a Diplomate of the American College of Veterinary Pathologists (ACVP, anatomic pathology specialty, 1991) and American Board of Toxicology (1996; re-certified 2001, 2006, and 2011) as well as a Fellow of the Academy of Toxicological Sciences (2011) and also the International Academy of Toxicologic Pathology (2007). He has written prolifically and is regularly invited to speak at national and international meetings on his twin professional interests of genetically engineered mouse pathology (especially in embryos and fetuses) and neuropathology.

Andreas JerominAndreas Jeromin, Ph.D., has successfully established research programs in translational neuroscience in both industry and academia for the last 15 years. He has co-authored more than 100 publications in journals such as Nature, Science, Neuron, PNAS and several others and is a member of the Dana Alliance for Brain Initiatives. Dr. Jeromin is a member of the scientific advisory board or steering committee of several biomarker qualification initiatives in CNS disorders, including the Alzheimer's Disease Neuroimaging Initiative (ADNI), the Coalition Against Major Diseases and consortia in Parkinson's disease, Multiple Sclerosis and ALS. He held the positions of Director of Business Development and Analytical Services and Senior Scientific Director at Banyan Biomarkers, Inc., before joining NextGen Sciences Dx as Chief Scientific Officer. Andreas oversees the scientific development of NextGen's own biomarker development programs and CRO services.

 James LynchJames J. Lynch, Ph.D., received his Ph.D. degree in Toxicology, in 1991, from the University of Rochester Medical Center where his research focused on the toxicology of the visual system in non-human primates. His postdoctoral training was in the field of neuronal ischemia in the laboratory of Dr. Dennis Choi at Washington University School of Medicine. In 1994, he joined the preclinical Neuroscience division of Abbott Laboratories where he worked as a research pharmacologist on a variety of early discovery projects in the areas of neuronal ischemia, pain and urology. Since 2004, he has been Abbott's CNS safety pharmacology coordinator for early-stage discovery compounds and he serves as its primary coordinator for GLP core battery safety pharmacology testing during later stage preclinical development. He is an active member of Abbott's Seizure & CNS Signs working group, Abuse Liability Assessment working group, and Target Safety Assessment team. He is the author of numerous publications across a range of scientific disciplines.

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