Novel biologic therapies developed from basic research observations must go through a rigorous testing process before they can be used in patients. This online course describes the pathway taken from the identification of a drug target to a potential new therapy as it moves from a research observation to an approved and regulated patient treatment, from 'Bench to Bedside'. The emphasis in this module is on biologic drugs including recombinant proteins including antibody therapeutics, and cell based therapies. The scope includes the development of predictive biomarkers and how biologic drugs can be used in personalised medicine. We will have a particular focus on cancer, inflammation and autoimmune disease.

This module is divided into the following sections: 1. Drug target identification and validation in patient populations 2. Methods of recombinant protein production 3. Pharmacology of Biologic Drugs 4. Clinical Trials and development of companion diagnostics 5. Case Studies in Autoimmunity 6. Case Studies in Cancer

On completion of this module students will: 1. Understand concepts of drug target identification in patient populations e.g. GWAS and that target has a confirmed role in the pathophysiology of a disease and/or is disease-modifying. 2. Understand modern methods of genetic engineering; advantages and disadvantages of different eukaryotic and prokaryotic recombinant protein production methods. 3. Understand how proteins, in particular antibodies, are metabolised and how they interact with the body; e.g. development of anti-drug antibodies 4. Gain an appreciation for the usefulness and limitations of in vitro and animal models when evaluating biologic drugs, linking also to molecular-level design in the contemporaneous module on predictive modelling 5. Gain an overview of the clinical trial process 6. Understand the ethical issues surrounding use of biobanks and patient consent for participation in research 7. Be aware of the economic, social and political issues regarding the introduction of high cost biologic medications to patients.

On completion of this module students will: Appreciate the importance and value of the knowledge to be obtained, particularly in the context of the focus on cancer, inflammation, and autoimmune disease

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The module will be taught online by lectures, case studies and directed reading. The module will incorporate a significant component of reading involving current primary literature, in this context research findings will be incorporated into the learning experience.