Broad-ranging science and technology reviews are designed to extend the students' understanding of how contemporary biological and applied medical research generates exploitable science. Each module provides detailed analysis of current research and industrial practise, illustrated by company case studies that highlight the management, legal, ethical and regulatory issues associated with bringing scientific advances to market.
This module provides a foundation in the pathologies and treatment of major disease categories, which represent enormous unmet medical needs and are thus key targets for the drug discovery efforts of the pharmaceutical and biotechnology industries. The syllabus covers cancer, inflammation, pain, obesity and diseases of the metabolism, central nervous system and gastrointestinal tract. Contributors to the course include representatives from pharmaceutical and technology companies, academics and medical professionals specialising in particular disease areas, from whom students learn first hand about key targets for drug discovery efforts and the innovative technology platforms which are anticipated to be a source of new therapies.
Students follow the process of and challenges encountered in drug discovery with respect to small molecule and biological entities and also molecular technologies, from target identification and validation through to clinical trials. Significant progress has been made in developing biological therapies for major diseases using molecules such as antibodies, enzymes and other protein and gene therapeutics. The technical difficulties encountered in scale-up of manufacturing processes for complex, highly purified macromolecules, cells and tissues is considered, together with other barriers to development and commercialisation of these therapeutic approaches.
The increasing value of candidate drugs as they progress through the development process is demonstrated through case studies that illustrate how value informs and shapes the business strategy of enterprises active in the drug discovery arena. Information on USA and European regulatory frameworks is integrated throughout the module. Building on the ‘toolbox’ of drug discovery techniques provided, teaching later encompasses the structure of pharma companies and the functional commercial relationships within them. In this context, late stage development and post-launch product, marketing and portfolio management strategies are considered.
Designed to give the perspectives and methods needed to assess and manage medical device and diagnostics businesses, the module provides a framework for assessing the utility of new technologies and processes to facilitate the development of products. Key and emerging technologies that underlie recent innovations will be considered, as will the challenges in developing and marketing successful, regulatory-compliant devices and diagnostics products. Case examples will focus on opportunities for new diagnostic products and therapeutic devices, in the context of the clinical needs that motivate the industry.
Plants are the ultimate biorefineries and can be engineered to produce compounds for medical and industrial uses. Improved nutritional content, decreased allergenicity and the ability to tailor crops to their environment are powerful, if controversial, technologies. This module covers plant genetic engineering, an overview of companies active in this area, nutritional enhancement, food security and sustainability, biodiversity, industrial uses of non-food crops, together with the legal, regulatory and ethical issues associated with the issue of GM crops.