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Simon Lord Murali Kesavan
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LEARNING OUTCOMES:

By the end of this module the student will be able to:

1.   Identify and evaluate clinical trial designs

2.   Recognise the challenges and evaluate designs for pharmacodynamic clinical studies

3.   Identify the different types of current and emerging biomarkers in clinical trials

4.   Understand the challenges in developing companion biomarkers and diagnostics in drug development

5.   Understand how the integration of pharmacodynamic and pharmacokinetic assays in clinical studies can inform dosing and identify markers of drug toxicity

6.   Understand the challenges in taking new drugs to patients

Indicative Content

  • Basic concepts of clinical trial design
  • Genomic basis of: drug reaction, drug efficacy, ethnic differences in both these
  • Use of genomic information for targeted drug development
  • Precision cancer medicine as a tool to understand drug resistance and identify rational combinations
  • Companion diagnostics
  • Utility of imaging and circulating biomarkers in drug development
  • Regulatory aspects of drug development