Drug discovery and drug development

Considering the above; the learning outcome of this particular essay is to critically appraise the processes involved in drug development.

Assessment Brief:

There are numerous stages involved in the production of a successful new drug, and the process takes many years.
The overall process can be split into two distinct stages, namely drug discovery and drug development.
Drug discovery primarily takes place in vitro.
Its purpose is to identify a lead compound, and includes
the following stages:
• Target identification and validation (including genomics and proteomics)
• Hit discovery (including high throughput screening – biochemical assays and cell line assays)
• Lead identification (including ADME and cell viability assays)
Once a lead compound has been identified, drug development tests the drug in vivo, before
ultimately taking it to market.
It includes aspects such as:
• In vivo lead optimisation (including animal models and pharmacokinetics)
• Human clinical trials
• Scale up chemistry
• Regulatory body approval

In this assessment, you are required to write an essay on the process of bringing a novel drug to
market.
You do not need to cover every aspect mentioned above, but you do need to include a consideration of both drug discovery AND drug development.
In to meet the learning outcome, your answer should include elements of critical appraisal (for example in terms of cost, effectiveness, success rate, time, ethics etc.).
To help give your essay a coherent structure, you are encouraged to focus your answer around cancer, infection, or one or two bodily systems of your choice (e.g. cardiovascular, nervous, renal, musculoskeletal, endocrine, reproductive, respiratory, gastrointestinal), and the production of drugs for named diseases within those systems.

In to meet the learning outcome, you may wish to include a combination of a) current research themes in drug discovery (i.e. drugs which have yet to make it to market) and b) established pharmaceutical products that have made it through the process of drug development
to reach the market. Further guidance will be given throughout the module.