Drug Development to IND and to Market

Module Overview

Following on from the module Early Drug Discovery Research, the focus of this module is the further pre-clinical development of drugs or diagnostic tests. The module will examine how lead candidate molecules are identified, whether that is through in house development, licensing-in, or compound re-profiling. The highly important processes of pharmacological (ADME), toxicological testing, and compound formulation of lead compounds will be addressed. The design of clinical trials and pharmacovigilance will also be examined, highlighting the need for robust ethical and toxicological considerations. Finally, the module will inform about the regulatory approval processes involved for drug clinical assessment (IND application), the NDA submission, and potential marketing strategies.

Credits available

20 Masters level credits

Module attendance required

TBC, 30 hours contact time with lectures and small group teaching sessions

Module dates

TBC

Assessment

This module will require a 3000 word analysis of a case study worth 35%, an ICA short answer of 1500-2000 words worth 30% and an oral presentation worth 35%

Academics involved in the delivery of this module

  • Dr Paul Foster (Deputy Programme Lead, Module Lead, and Lecturer in Molecular Endocrinology) – University of Birmingham
  • Dr. Hannah Batchelor (Module Deputy Lead and Paediatric Formulations Research Fellow) – University of Birmingham
  • Dr. Tim Overton (Lecturer in Chemical Engineering) – University of Birmingham

How to register/apply

Contact our Course Administrator: 
Angela Oakley
a.oakley@bham.ac.uk  
(0121) 415 8118

Course fact file

Type of Course: Module