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A life full of contrasts
When he isn’t sitting in his office at the Berlin headquarters of Bayer Schering Pharma or on a business trip on behalf of the company, Bernard Better (59) has a tendency to slack off a bit. “I hate planning things at home,” says the certified chemist and industrial engineer. It’s not unusual for him to pack his suitcase only shortly before leaving on a business trip, or to leave his tax return until he comes back.
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| MRT is used to diagnose and treat illnesses. |
There is a certain contrast between Bernard Better’s behavior at home and his everyday work – and his work in turn has been characterized solely by contrasts for decades. Better is Global Project Leader for magnetic resonance products at Bayer Schering Pharma – in other words, he is responsible for the contrast agents so essential to modern imaging technology in medicine. The product names – such as Magnevist®, Gadovist®, Primovist® and Resovist® – may not be well known to the public, but they are firmly established brands in hospital radiology departments and clinics worldwide.
When we see fascinating, extremely high-resolution internal images of the human body, the impressive devices used to produce these pictures usually come to mind. Yet it is the contrast agents which spread throughout the body that make modern medical imaging techniques so sophisticated that they make earlier X-ray images look like cave paintings in comparison.
Better has made it his calling in life to coordinate the development of these products and manage their life cycles. “Seven years pass on average between the time that a substance is discovered and the time it is first put on the market,” Better reports.
Only seven years, one must add. This process would take even longer if it weren’t for interdisciplinary interplay between numerous departments and the precise planning that characterizes the working day of people like Bernard Better – in contrast to his private life. “This system of cogs and the many different people behind it fascinated me right from the beginning – and that’s still the case today.”
The planning of the necessary experiments in test tubes, animals and later in clinical trials; the documentation of these tests in accordance with a wide variety of regulations and with the state-of-the-art; the communication of the results across departmental boundaries and with authorities; knowledge of international discrepancies in connection with registration applications; and last but not least the constant coordination with users and equipment manufacturers: the steering of all these processes is the responsibility of Bernard Better.
“Contrast agents depend on the systems used to produce pictures from within the body, and they are produced in parallel to the system technology,” Better explains. “However, while I have to think and plan in terms of periods of several years with contrast agents, the systems and particularly the associated software are often updated on a yearly basis.” Only those who remain in constant contact with – and work together with – users and system manufacturers can keep pace.
Unique challenges are also posed by the large volumes used when working with contrast agents. Between 10 and 150 grams of a contrast agent need to be injected into the body depending on the imaging technology. This is a different dimension from the milligram volumes that are usually used in medicine.
“Before a newly developed substance can be tested for the first time in humans, we must already have manufactured between 50 and 60 kilograms or more of it – and the purity requirements are the same as with other pharmaceutically active substances.” Laboratories cannot handle such volumes. Instead, quality-assured production processes have to be established at an early stage in manufacturing facilities, and at the same time must often be prepared on a scale of tons.
Medical application customs often change as well. For example, contrast agents today are sometimes sold in sterile, pre-filled needles. The planning of a production facility for such a purpose is a mammoth logistical task. “It takes about three years for such a facility to be assembled according to regulations and approved by the authorities, and another two years for a retail license to be granted for such pre-filled products,” says Better.
“If we were to perform all of the activities involved in the development of a contrast agent one after the other, the process would take well over 20 years,” Better emphasizes. It is partly due to the project leaders at Bayer Schering Pharma that the entire process instead only takes seven years.
It is their planning that ensures that doctors are able to provide better diagnosis much sooner – and that patients in turn can receive better treatment on the basis of this diagnosis.
In view of this, Bernard Better can be forgiven for being somewhat more chaotically organized at home.
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