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	The industry is constantly developing new medicines. It invests nearly £9m a day in Research and Development (R&D). This is more than any other manufacturing sector and accounts for about a quarter of the money spent on R&D in the UK.

Development sequence - roll your cursor over the R & D stages to find out more

Picture 3.1 Discovery research using a computer.


	It takes up to 12 years to develop a new medicine. Each year, a company’s research teams may generate about 10 000 new molecules. These are screened and tested and only one or two will get as far as being given a licence. Only one in seven of these licensed medicines goes on to be a commercial success. The diagram above shows the progress of a new medicine from discovery, through development to launch. Let's see what happens at each stage.

Question 5

Look at rollovers for the R&D sections on the diagram at the top of this page. Some of the phrases have the meanings shown below. Choose the phrase with the given meaning from the drop down menu.

	Meaning	Phrase
a)	helps heal disease
b)	a dummy medicine given to patients on a trial
c)	a collection of living cells that respond as though they were part of an animal
d)	removal of a biproduct from the body
e)	testing the effects of a new substance on people

Contents	Close

1. Introduction to the pharmaceutical industry	5. Secondary manufacture
Medicines	Manufacturing tablets
2. Systems in pharmaceutical manufacture	Pressing
The tracking system	Coating
IT, delivery & control systems	6. Packaging
3. The development of a new medicine	The packaging process
4. Primary manufacture	7. What makes pharmaceutical manufacture different?
Chemical technology	7. What makes pharmaceutical manufacture different?
Biotechnology

Discovery Research

A pharmaceutical company chooses a disease which needs treatment. The scientists investigate its causes and effects. They then look for therapeutic compounds that might treat the disease. These might be extracted from a plant or found in their database of compounds. However, these days, many new molecules are generated on a computer.

All the new molecules are screened using biological techniques or computer models. During the screening, scientists can assess whether the molecule is likely to have the desired effect and how safe it might be. As soon as a molecule looks promising, it is patented. This prevents other companies from freely using the same molecule for 20 years.

Preclinical development

The promising compounds are then made up in small quantities and studied in the laboratory. Initially, they will be tested on cell cultures. These are collections of living cells that respond as though they were part of an animal. The scientists can determine if the molecules are toxic and if they have any therapeutic effects.

Eventually, after extensive testing in the laboratory, a few molecules will prove to have the right properties. These will be tested on animals. These tests can reveal new information about the effects of the molecule in a living body. Before a new compound can be given to humans, much work has to be undertaken to determine:

whether it is likely to be effective
whether it is acceptably safe
whether it is sufficiently stable
how it is going to be absorbed and excreted by the body.

The data from the preclinical tests are used to apply for a certificate to conduct clinical trials. In the UK, this is issued by the Medicines Control Agency (MCA). Independent medical and scientific experts review the large amount of data. They have to be certain that the medicine will not cause undue harm to people who are already ill.

Clinical trials - phase I

Phase I trials. This is the first time the new substance is administered to humans; usually the trial is conducted on a small number of healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine if the new compound is tolerated by the patients' bodies, and behaves in the predicted way. The initial dose of the medicine will be as low as possible, but enough to obtain the required information.

Clinical trials - phase II

Phase II trials. These are the first tests in which the illness is actually treated. A group of approximately 200 informed patients is given the medicine. The scientists monitor their progress. They use the results to determine that the medicine works and to check that it does not produce unacceptable side effects. They will also use a control group who are given a placebo. This is to measure how much better the patients feel because they think they are being treated. This has to be taken into account when calculating the effectiveness of the real medicine

Clinical trials - phase III
	Phase III trials. Now the trial is broadened to involve many more patients - between 1000 and 3000. The group is big enough for the company to use statistics to analyse the results. If the results show that the medicine is effective and acceptably safe, the data are presented to the licensing authorities for a commercial licence.

Clinical trials - phase IV
	Phase IV trials. This is a surveillance operation once the medicine is on the market. The medicine is made available to doctors, who start prescribing it. The effects can be monitored on thousands of patients to help identify any unforeseen side effects.