Learn about key issues involved in developing novel cancer drugs, from pre-clinical discovery through to clinical implementation. This course will include pre-clinical and clinical components of target validation and disease linkage, the use of pharmacodynamic biomarkers and the development of companion diagnostics to enable personalized medicine strategies.

Lectures and tutorials over 5 weeks in semester 2.

Early-phase drug discovery proposal (1500 words) (50% weighting) ILO1-3, 7

Clinical development programme outline (1500 words) (50% weighting) ILO4-6, 7

The course aims to provide students with a critical comprehension of the stages involved in drug discovery and development, from lead compound identification to design and conducting of clinical trials. Students will examine the requirements, methods, challenges and limitations for identifying and validating 'druggable' targets. This includes identifying, validating, and optimising new compound leads, and the importance of pharmacokinetic/pharmacodynamic (PKPD) profiling and toxicology testing. Students will then address key principles of Clinical Trials from an organisational, ethical and regulatory perspective for conducting trials in human subjects and will understand optimal trial design and how to apply biostatistics to the design process.

By the end of this course students will be able to:

1. Critically discuss key phases and decision points of pre-clinical drug discovery pipeline;

2. Critically appraise methods and strategies for target validation, lead identification and optimisation, and in vivo efficacy testing.

3. Critically evaluate data generated during drug discovery and develop discovery plan. 

4. Critically discuss key phases and decision points of clinical drug development, and the package of preclinical and clinical information required;

5. Critically discuss the regulatory and ethical framework required for the design and implementation of clinical trials;

6. Critically evaluate the role of biomarkers and how to integrate them into a drug development programme;

7. Critically discuss issues related to drug discovery and development pipeline from an industrial and health economic perspective.

Students must submit at least 75% by weight of the components (including examinations) of the course's summative assessment.