z_Do Not Use - Closed: Systems Pharmacology Community

  • 1.  QSP (or T) for safety assessment

    Posted 03-08-2018 09:13
    Hi All

    Having gone through QSP literature, in the majority of cases, we have seen the QSP models are used for assessing efficacy. Do you think such models can be used to understand and/or predict toxicity in specific organs/tissues? Which specific toxicity challenges will benefit the most from QSP models or better say Quantitative Systems Toxicology models?

    Thanks
    Masoud

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    Masoud Jamei
    VP of R&D
    Simcyp
    Sheffield
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: QSP (or T) for safety assessment

    Posted 03-09-2018 11:23
    Hi Masoud, great question:
    I have worked on characterising changes in potential safety biomarkers during clinical trials (Karelina 2016). We showed that increase in blood eosinophils is probably not a potential safety signal, but is probably just a sign of engaged pharmacology engagement. 
    There are some reports of use of QSP for toxicology (DILISim, virtual liver project, etc). Does anyone on this group have any informatjon on these packages/initiatives? I would love to learn more about them. 

    Balaji

    ------------------------------
    Balaji Agoram Ph.D.
    Head of Clinical Pharmacology and DMPK
    Forty Seven Inc
    Menlo Park CA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 3.  RE: QSP (or T) for safety assessment

    Posted 03-12-2018 19:22
    Hi Balaji

    Many thanks for your response and great to know about your case and the other ones which are very interesting. I'd imagine quantitative systems models can also be used in other areas like cardiotoxicity and immunogenicity, assuming the latter is a safety issue. Has anyone in the group used a QSP model in such applications?

    Regards
    Masoud

    ------------------------------
    Masoud Jamei
    VP of R&D
    Simcyp
    Sheffield
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message


  • 4.  RE: QSP (or T) for safety assessment

    Posted 03-13-2018 12:29
    @Paolo Vicini has previously published on the use of a systems model for ADA prediction. So, there is some precedence for this.
    @Hitesh Mistry has also recently published on predicting cardiotoxicity.
    Would be good to hear from these two about their experiences. ​​

    ------------------------------
    Balaji Agoram Ph.D.
    Head of Clinical Pharmacology and DMPK
    Forty Seven Inc
    Menlo Park CA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------

    Original Message