Pharmaceutical medicine is
the medical specialty concerned with the research, development and monitoring of new medicines.
Pharmaceutical physicians are involved at every stage of the drug development pipeline – using their expertise to advance pioneering medicines and ensure they are effective for patients.
Pharmaceutical medicine is one of the fastest-growing medical specialities in the UK. Back in the 1970s, there were only 260 pharmaceutical physicians. By the mid-90s, that figure was 700. Nowadays, more than 2,500 doctors are working in the speciality – and around 140 are undergoing their training to become pharmaceutical physicians at any one time.
Globally, there are more than 7,000 new medicines in the pipeline. Doctors who specialise in pharmaceutical medicine use their clinical skills and knowledge of human biology to advance these for the benefit of patients. They work in many different environments including the pharmaceutical industry, research organisations and drug regulatory authorities.
Although most pharmaceutical physicians will no longer have direct contact with patients, their work has a wider impact on public health. They work within the strict legal regulations that apply to medicines and the ethical and professional codes that exist to protect the best interests of patients.
Pharmaceutical medicine is a global discipline and requires close international collaboration with other specialists, companies and regulatory bodies. As a result, many pharmaceutical physicians will spend a lot of their time working or travelling abroad.
Pharmaceutical physicians contribute their expertise to a wide range of activities including:
Translating knowledge into new medicines
Evaluating medicines in clinical trials
Ensuring the well-being of volunteers taking part in clinical trials
Understanding the safety profile of medicines and their risk/benefit balance
Ensuring that the promotional materials and patient information that accompany medicines are medically sound
The drug development pathway
Translating a laboratory discovery into a new medicine is a long, complex and expensive process – with no guarantee of success. Only a very few of the potential new drug compounds that scientists uncover during the early stages of research will become an effective medicine.
- Out of 10-20 candidate molecules entering early clinical trials, only one will be successfully approved
- It takes around 12 years for a laboratory discovery to become an approved medicine and costs around £1.1 billion
The drug development pathway follows a sequence of well-defined phases:
Preclinical research
Any potential new drug must first undergo extensive preclinical testing in the laboratory to evaluate its safety before it can be given to humans. Many different basic research scientists are involved in these initial stages – including chemists, pharmacologists and toxicologists.
Phase 0
In a Phase 0 trial, a small number of volunteers will be given very low doses of the experimental drug to check it isn’t harmful and acts in the way that researchers expect.
Development time:
Year 1-4 (including preclinical)
Number of research subjects in this phase:
10-15
Cumulative cost:
£500 million (including preclinical)
Candidate molecules:
10-20
Phase 1
Phase 1 trials look at the safety of a potential new medicine in around 10-15 people (usually healthy volunteers). The main aim is to get information about its safe doses and side effects.
Development time:
Year 4-7
Number of research subjects in this phase:
20-80
Cumulative cost:
£700 million
Candidate molecules:
5-10
Phase 2
An experimental drug will then move into Phase 2 studies involving around 100-300 people with the condition that it is designed to treat. The aim is to assess both that it works and does not have unacceptable side effects.
Development time:
Year 7-9
Number of research subjects in this phase:
100-300
Cumulative cost:
£900 million
Candidate molecules:
2-5
Phase 3
A drug will then move into a Phase 3 study involving many thousands of people who are usually recruited from many hospitals and even different countries. These trials compare the new drug with the current ‘gold standard’ treatment and/or placebo to find out which works better, monitor any side effects and collect safety information.
Development time:
Year 9-11
Number of research subjects in this phase:
1,000-3,000
Cumulative cost:
£1.1 billion
Candidate molecules:
1-2
Licensing
The appropriate regulatory authority will then evaluate the evidence from clinical trials. They will issue a licence if they are satisfied that the new drug is effective and of suitable quality. It is now an approved medicine and can be sold in the relevant country.
Development time:
Year 11-12
APPROVED MEDICINE
Phase 4
Phase 4 trials aim to find out more about the side effects and safety of an approved drug and its long-term risks and benefits. For instance, a side effect may only become apparent once the drug has been given to thousands of people in the real world.
Development time:
Ongoing
Number of research subjects in this phase:
Many thousand
Cumulative cost:
£1.2 billion
Candidate molecules:
1
