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How Modeling and Simulation is becoming core part of drug development ?

  • 1.  How Modeling and Simulation is becoming core part of drug development ?

    Community Leadership
    Posted 10-12-2022 10:55
    Dear All, 
    In the past we used to think Modeling and Simulation is for computer geeks in R&D and interesting.  Not anymore, now M&S is used for regulatory approvals and labeling.  Always seeing a live example as how it is done and see where  else M&S has been to reduce clinical costs is always exciting. Bottom line  for any industry is R&D cost minimization with faster approvals.    

    AAPS RS community keeps an eye on what is innovative and helps pharmaceutical drug development.  Two well known scientists in the area of PBPK Modeling are going to speak about how PBPK Modeling has helped approvals at the FDA or expected to help acceptable drug development.  

    Anyone that use M&S in clinical/nonclinical drug development will benefit from this session.  Nice educational material for students also.  

    If you are around at the PharmSci 360 in Boston, come and join us.

    -Raja

    Session Detail: 

    Hot Topic: PBPK modeling: Exponentially Expanding Science
    Wednesday, October 19, 2022, Room 153 A, 9:00 AM – 10:00 AM

    Moderator: Raja Velagapudi, PhD

    Sr. Dir., Clinical Development, Tolmar Inc.

    9:00 – 9:30 am Speaker: Heidi J. Einolf, Ph.D.

    Exec. Dir., Modeling & Simulation, Novartis

    Scemblix: Use of PBPK Models In Lieu of Clinical Trials

    9:30 am – 10:00 am Speaker: Hannah M. Jones, Ph.D. 

    SVP, Head of PBPK Consulting, Simcyp, Certara

    Applications and Regulatory Acceptance of PBPK Modeling



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    Raja Velagapudi Ph.D.
    Sr. Director, Clinical Development
    Tolmar Inc
    Monmouth Junction NJ
    [email protected]

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