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picture1_Primary Cell Culture Slideshare 77708 | Cp Invitro Chapin


 144x       Filetype PPT       File size 0.49 MB       Source: www.toxicology.org


File: Primary Cell Culture Slideshare 77708 | Cp Invitro Chapin
background and stage setting i spent 18 yrs at niehs doing male reproductive tox developing methods in primary cell culture running a lab and overseeing contract studies been at pfizer ...

icon picture PPT Filetype Power Point PPT | Posted on 03 Sep 2022 | 3 years ago
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      Background and Stage-Setting
      •  I spent 18 yrs at NIEHS doing male reproductive tox, developing 
         methods in primary cell culture, running a lab and overseeing contract 
         studies. 
      •  Been at Pfizer for 9 yrs now, in a lab which develops in vitro predictive 
         assays and troubleshoots DART issues. 
      •  I am a very strong advocate of and believer in a future for toxicology 
         based increasingly on measuring biochemical and genomic responses in 
         cells in culture, and in computational modeling of complex systems. 
      •  My comments will come mostly from the pharma perspective, we’ll 
         spend less time on environmental chemicals. 
      What are the motivations to get safety right?
      •  Chasing positives:
          – The more specific and beneficial our meds can be, the more people will be helped 
             by them.
          – Safer meds have an easier time finding a new indication.
          – Safer and more specific pesticides (“plant protection agents”) will provide more 
             food for a hungry world with less environmental damage
      •  Avoiding negatives
          – Every adverse effect is undesired
          – No one wants them; toll of human suffering, etc
      Safety Assessment
      •  Current state: We give animals more and more of a compound and 
         watch what goes wrong. We then examine the low end of the dose-
         response curve and extrapolate that to humans based on experience and 
         some “safety factors”. It’s certainly not perfect, but it’s worked pretty 
         well (we think).
      •  “Alternative models” are cell culture or tissue culture methods (or any 
         other method) which reduce the numbers of animals treated with 
         toxicants. 
      Alternatives going mainstream:
      •  Future state: as laid out in the NAS book “Toxicity Testing in the 21st 
         Century”.  Focused on cell culture (with human cells) and progressively 
         more computational predictions. 
      •  We’ll use the term “predictive model”. This  can be
          – a well-characterized cell culture system whose data are massaged a certain way to 
             give a prediction of toxicity
          – A combination of different kinds of data from cell cultures which, when combined 
             using a certain statistical method, yields an estimate of the in vivo activity of 
             this compound
          – A combination of different computer programs (each of which predicts different things) 
             which together predict the in vivo toxicity of an exposure
  Historically
  Safety assessors have relied on animals because
    – Assumptions of relevance based on conserved evolutionary features
    – Have integrated ADME (absorption, distribution, metabolism, and 
     excretion)
    – Have integrated physiology that allows for recovery and adaptation
    – All target tissues are there in the relevant milieus
    – The target tissues have all the appropriate cells there in the right 
     configuration
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...Background and stage setting i spent yrs at niehs doing male reproductive tox developing methods in primary cell culture running a lab overseeing contract studies been pfizer for now which develops vitro predictive assays troubleshoots dart issues am very strong advocate of believer future toxicology based increasingly on measuring biochemical genomic responses cells computational modeling complex systems my comments will come mostly from the pharma perspective we ll spend less time environmental chemicals what are motivations to get safety right chasing positives more specific beneficial our meds can be people helped by them safer have an easier finding new indication pesticides plant protection agents provide food hungry world with damage avoiding negatives every adverse effect is undesired no one wants toll human suffering etc assessment current state give animals compound watch goes wrong then examine low end dose response curve extrapolate that humans experience some factors it s ...

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