049 Simcyp Focused Workshop: Biologics - March 28 -April 1, 2022

Content
14 modules

Instructor
Kelly Turton

Released
03 Nov 2021

Price
£1,100.00

Description

Predicting pharmacokinetics and pharmacodynamics of therapeutic proteins and antibody drug conjugates, and bispecific antibodies.

This workshop will introduce the mechanistic PBPK models available for therapeutic proteins, antibody drug conjugates and bispecific antibodies with participants learning how to apply these models.

Live Online Courses

There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.

Objectives

Key aspects covered in this course:
• The use of minimal physiologically-based pharmacokinetic models for both mAbs and other therapeutic proteins
• The use of the full PBPK models for therapeutic proteins available within the Simulator
• Prediction of pharmacokinetics of therapeutic proteins in populations as well as in an average individual

• Use of the allometric calculator tool
• The effect of FcRn affinity and charge state on the pharmacokinetics of monoclonal antibodies
• Demonstrating the utility of the target mediated drug disposition models (TMDD) within the Simulator
• The use of TMDD models that can account for the shedding of target from the cell surface into the interstitial space and plasma
• Linking the biologics/TMDD models to simulate pharmacodynamic effects
• Drug-biologics interactions
• PBPK modeling of antibody drug conjugates
• Predicting Ab/ADC penetration to solid tumours
• PBPK modelling of bispecific antibodies

Certificate

By completing/passing this course, you will attain the certificate Certificate of Completion - Biologics

1.
Pre Course Questionnaire - Your experience, expectations and area of interest, an optional survey to take prior to the course.
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2.
Biologics Agenda, March 28- April 1, 2022
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3.
Pre Workshop Reading List, A selection of publications related to the Simcyp Simulator and model-informed drug development.
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4.
Simcyp Simulator Download instructions (Amazon Workspaces download)
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5.
A beginners Introduction to the Simcyp Simulator
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6.
Slide Decks and Files for Loading - Biologics
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7.
Hands-on Materials
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8.
Presentation Recordings - Biologics
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9.

Biologics: Session 1 WebEx (UK time Zone)

10.

Biologics: Session 2 WebEx (UK time Zone)

11.

Biologics: Session 3 WebEx (UK time Zone)

12.

Biologics: Session 4 WebEx (UK time Zone)

13.

Biologics: Final Office Hour and Conclusion WebEx (UK time Zone)

14.
Survey, please complete for Certificate of completion
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