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What is Pharmaceutical Medicine?

Careers in Pharmaceutical Medicine

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Pharmaceutical medicine is the medical scientific discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of marketing of medicines for the benefit of patients and the health of the community.

At core of the discipline is the clinical testing of medicines, translation of pharmaceutical drug research into new medicines, safety and well-being of research participants in clinical trials, and understanding the safety profile of medicines and their benefit-risk balance.

In addition to expertise in the science of drug development pharmaceutical physicians need a thorough understanding of pharmacoeconomics, medical aspects of the marketing of medicines, business administration and the social impact of healthcare on patients and public health.

Pharmaceutical physicians work in the pharmaceutical industry, drug regulatory authorities and contract research organisations, but have a close affinity with their medical colleagues in primary and secondary health care and at universities.

The drug development process: what do pharmaceutical physicians do?

Development time Number of research subjects in each phase Total cost Candidate molecules
Translational and Phase 0 trials
Translational medicine is the process of getting a new therapeutic idea from the laboratory to the clinic. Phase 0 trials are first-in-human trials. Subtherapeutic doses of the study drug are given to gather preliminary data
Year 1-4 (including preclinical) 10-15 £500 million (including preclinical) 10-20
Phase 1
The experimental drug or treatment is tested in a small group of people (usually healthy volunteers) to evaluate its safety, determine a safe dosage range, and identify side effects.
Year 4-7 20 - 80 £700 million 5-10
Phase 2
The treatment is given to a larger group of people (usually patients with the disease) to see if it is effective compared with another treatment or with placebo and to further evaluate its safety, determine the most appropriate dose and any side effects.
Year 7-9 100–300 £900 million 2-5
Phase 3
The treatment is given to large groups of people with the disease to confirm effectiveness, monitor side effects, compare it to commonly used treatments, and collect safety information.
Year 9-11 1,000–3,000 £1.1 billion 1-2
Regulatory approval
Regulators assess the safety, quality and efficacy of new medicines. If a medicine is approved then it is given a licence and is able to be sold in the relevant country
Year 11-12
APPROVED MEDICINE
Phase 4
Conducted after a drug has been approved to find out more about the side effects and safety of the drug, what the long term risks and benefits are.
Ongoing Many thousands £1.2 billion 1

For more information on pharmaceutical medicine please download this article (PDF) on the specialty.

The roles of pharmaceutical physicians

Below are just some of the roles that are typically performed by qualified pharmaceutical physicians.

Clinical Pharmacologist
Responsible for the design, performance and interpretation of studies focussed particularly on the collection of pharmacokinetic data. Working as an investigator is probably the role that is closest to clinical medicine. Physicians in this role take medical histories and perform physical examinations, predominantly in healthy volunteers.

Clinical research physician
Responsible for clinical plans, design of phase 2 and 3 clinical trials, safety monitoring and medical governance of new medicines.

Medical Assessor
Works in a regulatory body to approve new trials and to evaluate clinical efficacy and safety of medicines submitted for approval.

Medical Affairs
Work with commercial colleagues to ensure the sales and marketing strategies are based on accurate clinical data and executed in a medically sound and ethical way.

Regulatory Affairs
Ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products.

Pharmacovigilance
Analyses data to identify the safety profile of a medicine, including drug reactions, adverse reactions (or side effects), contraindications, warnings, interactions and special populations.


International Pharmaceutical Medicine

Developing new medicines and making them available for patients is an international endeavour, and pharmaceutical medicine is a global discipline, demanding good communication with other pharmaceutical specialists, companies and regulatory bodies across the world. Pharmaceutical physicians work within legal and regulatory frameworks, and within ethical and professional codes of medical practice and governance.

A large number of the Faculty's members work abroad and a lot of those who don't will still spend a lot of their time travelling.

Pharmaceutical Medicine as a medical specialty

Pharmaceutical medicine has been recognised as a full medical specialty since 2002. There are currently around 140 doctors undergoing training (PMST) in the discipline.

As a postgraduate medical discipline, pharmaceutical medicine has a recognised international syllabus, training courses with examinations and qualifications, its own research methodologies, professional bodies and academic societies, journals and texts, and embraces new technologies and regulations in pursuit of proof of efficacy, safety and effectiveness of medicines.