This module is core to both MSc programmes and follows the process of drug development. It runs throughout the second term and builds upon concepts from term 1 as we progress along the drug discovery pipeline. The module includes:

 Physicochemical Properties of Drugs (Absorption, Distribution Metabolism)

 This section provides understanding of the physicochemical properties of molecules that can be used for compound selection at the early discovery stage. Course content includes:

 Discussion and practical demonstrations of methods for lipophilicity determination (octanol/water partition, chromatographic hydrophobicity index, micellar electrokinetic chromatography). Discussion and demonstration of methods for solubility determinations and their automation. Practical determinations of pKa values. Commercially available instruments with various levels of automation.

 Preclinical Development

 This section covers phase 1 and phase 2 drug metabolism and factors that affect these processes. This includes chemical modification and the use of prodrugs to protect from metabolism. The industrial approach to Clinical Pharmacology is covered by Dr G Meneses-

 Lorente (Roche). The use of preclinical toxicology studies which are necessary before the drug can be administered to humans will be discussed in detail.

 Clinical Development

 The choice, preparation for and execution of the four phases of clinical trials are investigated.

 External experts from Roche, CRUK and NHS discuss a variety of issues and expertise.

 Regulatory Affairs, Commercial Affairs and Intellectual Property

 Once a lead compound has been suitably developed it then has to be tested extensively in animals before going into the first human clinical trials. If it successfully completes these trials, then the company has to apply for a license to market the product from the appropriate Government agency e.g. FDA in the USA, MHRA (Medicines and Healthcare products Regulatory Agency) in the UK and EMA (Europe). Before granting a license, these agencies will require extensive evidence that the product is efficacious and safe i.e. has a positive risk/benefit ratio. It is crucial that Intellectual Property (known as IP) surrounding novel drug products are protected by processes such as filing patents and registering trademarks. Once protection is in place, a company that may have spent many millions discovering and developing a product can then freely market it for approximately 20 years in the countries in which it is protected without fear of other manufacturers marketing a similar or generic product. Once patent protection has lapsed, then other companies are free to market generic versions of the products. This section will describe in detail all aspects of the IP protection process. It will discuss the recent trends for large pharmaceutical companies to merge into large international conglomerates, and for the formation of numerous small start-up biotechnology companies often based around academic programmes of research. These changes have transformed the pharmaceutical industry in the last 10 years with a trend towards new lead molecules being discovered, predominantly by smaller companies which then license their IP to the larger merged pharmaceutical companies. Many of the latter focus more on lead development, clinical trials and marketing than lead discovery.