From idea to drug
The development of new drugs is a long and complicated process. It usually takes from 10 to 15 years to turn an idea into a product that is approved and marketed, and very few ideas make it that far. Only about 10 out of every 10.000 ideas that become the object of close investigation in the laboratory of a pharmaceutical company reaches the clinical development phase where it is tested on people. And only one of these drug candidates will actually become a drug.
Bridge builder in a complex process
Approximately every fourth person who works in drug development trained as a pharmacist, doctor, engineer, chemist, biochemist or similar. The majority work in research, development, production, quality assurance and information. Work is project oriented in all phases of drug development and typically involves interdisciplinary cooperation. People with an MSc in the pharmaceutical sciences are part of this cooperation and key to building bridges between the various professional groups.
The figure below illustrates the process underlying the development of a new drug. The phases frequently overlap and the length of the individual phase varies. Drug development is fuelled by the interest to launch new drugs as quickly as possible – at the lowest cost possible – balanced by the interest to achieve maximum product safety shared by the regulatory authorities and the drug industry.
The figure shows the work areas and processes in the drug industry in which a person with an MSc in the pharmaceutical sciences could make a valuable contribution.
Idea
Idea
An idea or hypothesis based on an interesting or inexplicable observation is the first step on the way to a new drug. The source of a new idea could come from a university scientist, a researcher in the drug industry’s own laboratories or a researcher combing patent literature.
Basic research
Basic research
A small team of experts uses biochemical methods and/or animal research to determine whether the idea has potential. If the results of the experiments are positive and the team is able to identify promising chemical compounds, there is a basis for an actual research project that can be used to optimise and further describe the active substance.
Drug formulation
Drug formulation
Now the chemical compounds must be formulated, that is, modified or combined with excipients that allow the active substance to be absorbed by the organism and transported in the right concentration to the organ in which it is intended to act. Depending on the active substances, excipients and area of efficacy, the finished formulation can be in the form of tablets, creams or liquid for injection. The production method for producing the active substance and the finished drug influence the choice of formulation.
Preclinical development
Preclinical development
The potential drug is then tested on animals to see how it affects the organ system. Thorough long-term investigations are made of drug safety in the animal trials. The medical hypothesis is tested via research on human material, that is, tissue or blood. This phase often marks the transition from research to development.
Clinical development
Clinical development
Once the potential drug has been assessed as safe and effective on animals, it is tested on people. Trials are conducted over several years in four different phases, each of which has a purpose. See the diagram below. Regulatory approval may be applied for after phase 3. Phase 4 trials are not initiated until the drug is on the market.
Registration
Registration
When a drug candidate is considered safe and effective on the basis of phase 3 trials, it must be approved internationally before being marketed. Regulatory Affairs is the area with a broad overview and the responsibility for collecting all data from the development processes and sending it to regulatory authorities in Denmark and abroad.
Drug production and quality assurance
Drug production and quality assurance
The drug can now be produced in volume for sale to patients worldwide. The choice of production equipment and process plays a vital role for quality, which is subject to ongoing control to ensure that it lives up to regulatory requirements on uniformity, stability and purity.
Marketing and information
Marketing and information
A marketing strategy is drawn up to disseminate knowledge about the newly developed drug. The plan must consider differences in drug legislation in the various countries where the drug will be marketed. Drug companies hire people with an education in the pharmaceutical sciences to work in their marketing and information departments in order to prepare the company for a professional dialogue with the healthcare personnel who distribute and prescribe.
Clinical development
When a drug is being tested on people, we call it a clinical trial. The purpose of all four phases of clinical trials is to find out whether the drug or treatment form is safe and effective for treating a specific condition or illness. Special international guidelines ensure that ethics and good clinical practice are upheld.
Pre-clinical studies
Before a potential drug can be tested on people, thorough pre-clinical trials of safety and efficacy are conducted on animals. Studies on human material, i.e. tissue or blood, are also conducted in this phase. Trials are conducted all the way to registration of the drug.
Phase 1
In phase 1 trials the potential drug is studied in a limited number of healthy human volunteers – usually from 10 to 100 people. How the drug is absorbed, distributed and metabolised in the organism are investigated.
Phase 2
Phase 2 trials test various dosages on people who are ill, usually from 50 to 300. Efficacy and adverse drug reactions are examined to try to find the optimal dosage. The trials must show specifically how the potential drug works in the body and how it influences the illness in question.
Phase 3
In phase 3 trials the drug is tested in a large patient population, where a control group gets a different drug or a placebo. These trials typically include from 1500 to 4000 people. If the phase 3 results are positive, a registration application is sent to the regulatory authorities.
Phase 4
Phase 4 trials are conducted after the drug has been approved and launched. Treatment experiences are monitored continually, with focus on new indications or special safety issues. These trials typically involve from 500 to 3000 patients.
Copenhagen Master of Excellence
As of January 1, 2011 The MSc programme in Pharmaceutical Sciences will be a Copenhagen Master of Excellence programme (COME). COME covers a select group of two-year master's programmes designed to challenge students at the highest international academic level.
