IMI – Innovative Medicines Initiative

Safety has its price. Especially when it comes to the safety of a drug. For a pharmaceutical company, the development of a new product means an investment of over a billion euros. A princely sum, and it's not a figure we have made up out of thin air: this is a Sisyphean task that begins with the screening of about 2.5 million compounds. Fewer than one percent of these prove to be a 'hit'. The best are chemically optimized to create so-called lead structures.

Only a small number meet the stringent demands that are made on an active ingredient and make it as far as pre-clinical research. In the end, it is usually only one that manages to get over the final hurdle: it is given regulatory approval and comes onto the market. The others have fallen by the wayside during the trials – mostly due to a lack of efficacy or side effects.

It is the toxicologists' job to test a substance for possible risks and side effects. These days, this means much more than using different test procedures to determine the dose of active substance at which side-effects occur – for example in mice – and the lower dose at which this is no longer the case. Before the clinical trials begin, every finding must be investigated in cell cultures and animal models to clarify the molecular mechanism that led to this effect. This means there already have to be a number of further studies during the early research phase, because this is the only way to predict with a high degree of probability whether a similar undesirable reaction could also occur in humans. If this is the case, the project can be called off early on and the financial resources used for other projects.

Scientific advances, cutting-edge technologies, and a large number of statutory requirements make very complex demands on toxicologists working in pharmaceutical research. In drug development today, the focus is very much on safety issues from the outset, starting with the first pharmacological tests. "Function-specific thinking no longer exists. We regard the development of a drug as an integrative process," says Dr. Matthias Gottwald, who is responsible for IMI at Bayer Schering Pharma. "We therefore need toxicologists who see the issue of safety not only from the restricted perspective of their own field, but also in an interdisciplinary way." A European master's degree course is therefore being developed to train the future experts in drug safety – as part of an IMI project called SAFESCIMET (Safety Sciences of Medicines Training).

The postgraduate course, which will be offered for the first time in the 2010 summer semester, is made up of 20 modularly structured courses, at least 17 of which must be completed for the candidate to graduate as a Master of Advanced Safety Sciences of Medicines. The courses cover all aspects in the preclinical safety evaluation of drugs. They can be pursued on-campus at the participating universities and are also accessible throughout Europe via an e-learning platform. Blocks of on-campus seminars alternate with self-training phases. Practical knowledge is taught on the basis of case studies during the largely theoretical course. It ends with an oral examination and the master's thesis. Not only students, but also scientific staff from the pharmaceutical industry and regulatory agencies will be able to improve their qualifications in this way.

A total of 19 European institutes and universities and 16 pharmaceutical companies are taking part in designing and implementing the master's course. In Germany, these are the universities of Konstanz and Halle-Wittenberg and the Charité Hospital Berlin; on the pharmaceutical side, the participants are Boehringer-Ingelheim, Bayer Schering Pharma and Merck Serono. Experts from Bayer Schering Pharma AG are developing the modules on two subject fields: galenics (drugs preparation) and pharmacokinetics (quantitative analysis of the absorption, distribution and metabolism of an active ingredient in the body, and its excretion).