Summary
The monkey neurovirulence check (MNVT) is the gold normal for neurovirulence security evaluation of oral polio vaccines and has been used for 80 years for lot particular launch testing. The MNVT bioassay can also be required for testing new vaccine seed heaps for dwell attenuated neurotropic viruses when there’s a change to manufacturing. The dosing process entails direct injection of a dwell virus into the central nervous system to judge neurobehavioral results and histopathology adjustments.
We’ve got validated the MNVT mannequin and have evaluated dwell attenuated viral vaccines for yellow fever. On this webinar, we reveal profitable analysis of the neurovirulence of grasp and dealing seed a lot of 17D viruses for yellow fever compared to Stamaril and the WHO 17D 168-73 reference vaccine. We’ll current knowledge from examine endpoints together with adjustments in scientific scores and microscopic analysis of the mind and spinal wire, plus measurement of viral replication.
No single species or check can predict the neurovirulence of all dwell viral vaccines. Southern Analysis helps the refinement of animal use and options to the MNVT. As such, we current outcomes from a pilot examine in suckling CD-1 mice that makes use of intracranial administration and demonstrates excessive sensitivity. We additionally talk about latest regulatory acceptance of different rodent fashions for neurovirulence testing.
Speaker: Joseph Randall
Director of Toxicology, Southern Analysis
Joseph C. Randall, Ph.D., is the Director of Toxicology at Southern Analysis. Dr. Randall has greater than 20 years of expertise in drug growth and administration of regulated toxicology research in assist of IND and NDA functions. His experience consists of lead choice and optimization, in vitro and in vivo toxicology research, security pharmacology, genetic toxicology, and carcinogenicity evaluation in rodents. Dr. Randall has in depth expertise within the security evaluation of antivirals and medicines to deal with neurodegenerative illnesses, most cancers, and ocular indications.
Dr. Randall’s deep understanding of FDA, ICH, and OECD steering paperwork pertaining to each normal and specialised toxicology research has enabled him to co-author 5 profitable NDAs and 10 INDs and contribute to a number of profitable NDAs for prolonged launch opioids and an abuse deterrent reformulation of oxycodone. As well as, Dr. Randall has participated in a number of FDA advisory committees to defend the security of investigational drug candidates.
Throughout his profession, Dr. Randall has managed bioanalytical, pharmacokinetic, and GLP toxicology research for Part 1 and a pair of scientific trials. For 8 years, he labored at Mallinckrodt Prescribed drugs on the security evaluation of nanoparticle reformulations of most cancers chemotherapeutics, oxaliplatin and docetaxel. He additionally developed two extended-release acetaminophen and opioid fastened dose combos that have been FDA authorised and a novel abuse deterrent reformulation of Roxicodone utilizing plant-based polymers and aversive brokers to reduce diversion and use by way of non-oral routes. He has held management roles at Covance Laboratories, Amgen, Oxigene, Inc., Idenix Prescribed drugs, MDS Pharma Providers, Chemocentryx, Inc., and Kartos Therapeutics. Dr. Randall accomplished his doctoral and postdoctoral analysis in neurotoxicology on the College of Michigan in Ann Arbor.
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