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Module 4 - Clinical Drug Development

Module Objectives

This module will provide a framework for performing the interdisciplinary synthesis while ensuring alignment of the strategic, operational, and technical aspects of study design, planning, execution, analysis and interpretation of results. This module will provide information on the following topics:
  • The design of effective Proof-of Concept studies is a critical function of Pharma research and development teams. An interdisciplinary synthesis of data from in vitro and in vivo research plays a critical role in the design of effective studies. The lack of this synthesis can result in 1) unintended or unrecognized knowledge gaps and 2) research plans that rely on intuition rather than an explicit synthesis of knowledge and result in an erroneous assessment of drug potential.
  • Describe and demonstrate state-of-the-art adaptive trial designs and clinical trial simulations for clinical drug development.
  • Describe the latest approaches for combining multi-dimensional data sets and population-based exposure-response models to identify determinants of inter-individual variability in drug responses.
  • Feature case studies in which translational sciences are utilized to better predict drug disposition and dynamics in pediatric patients. Such capability might serve to guide drug development strategies involving this patient population.
Upon completion of this fourth module, the learner should be able to:
  1. Describe how PK/PD approaches can be utilized to improve the probability of success for a new drug candidate;
  2. Discuss the basic principles of experimental design;
  3. Discuss why incorporation of the model informed decision making is critical in drug development;
  4. Explain how pharmacometrics can facilitate the development of informative pediatric clinical studies; and
  5. Describe PKPD alterations in special populations such as obese patients, elderly patients and pediatric patients.

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