GeneTox: A Pivotal Part of Safety Assessment

Genotoxicity testing is the basic requirement for regulatory submission of drug candidates and other regulated chemicals. Historically, GeneTox data have been used in hazard identification to evaluate if the test material cause DNA damage with the results only in form of Binary outcome (Yes or No). Most recently, with the approval of ICH S2(R1) and ICH (M7) guidelines, GeneTox data is used for risk assessment and risk management. An in vitro positive data can be followed up to de‑risk using assays like Transgenic Rodent (TGR), Comet, and Pig‑a. This webinar will highlight the standard battery and the follow up assays, and the approaches for selection of these assays. Frontage Laboratories offer standard battery of GeneTox assays, and our experts can guide our clients for the follow up assays, if and when needed. 

Individuals from the following areas can benefit from this webinar;

  • Pharmaceutical
  • Flavor and Fragrance
  • Tobacco
  • Chemical
  • Regulatory
  • Academia
  • Consultants

Featured Speaker

Javed Bhalli, M.Phil, Ph.D, ERT

Director, DMPK, Safety and Toxicology

Frontage Laboratories

Dr. Bhalli received his Ph.D. in Biotechnology in 2009 from the Department of Environmental Biotechnology of the National Institute for Biotechnology and Genetic Engineering (NIBGE), Pakistan with thesis title “Genotoxic Environmental Risk Assessment of Pesticides Using Molecular Biomarkers”. Dr. Bhalli joined NCTR/US FDA in 2008 as postdoctoral fellow and played a pivotal role in development of the Pig‑a assay. He contributed making this assay high throughout and studied novel compounds to evaluate the potential of the assay to detect the compounds which are gene mutagens only and to differentiate between week and strong mutagens. He was an active member of the OECD Test Guideline development of the Pig-a assay. Dr. Bhalli worked as Study Director (GeneTox) at Covance Laboratories from 2012 to 2017, Associate Director (GeneTox) at BioReliance from 2017 to 2018, and as Study Director (General Tox) at Covance Laboratories from 2018 to 2021. He is currently working as Director of DMPK, Safety and Toxicology at Frontage Laboratories. His area of interest for the past 10 years has been pre-clinical drug development with focus on toxicology and safety assessment of the potential drug candidates. Dr. Bhalli is an active member of the US Environmental Mutagenesis and Genomics Society (EMGS) and the Society of Toxicology (SOT). He has published over 50 research papers and book chapters in peer reviewed journals.

Date: Wednesday, August 17, 2022 Time: 11am ET / 8am PT
Duration: 1 Hour

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