In the current pharmaceutical model personalised medication designed for a specific individual patient will never be possible. It takes too long to develop and will be too expensive. A break through is bedside development and production, because the products do not need an expensive and time consuming marketing authorization procedure. Professor Huub Schellekens of Utrecht University makes this assertion in a publication in the respected scientific journal Nature Biotechnology this week. In an editorial devoted to the article, the journal emphasises the importance of his concept.
Commentary in Nature Biotechnology
Personalised medicine produced in a “Bionexpresso”
The advantage of preparing pharmaceuticals for an individual patient in the hospital pharmacy is that this is considered as ‘magistral production’. This means the medicine is made on the basis of a prescription of a physician. Therefore it is not subject to regulatory requirements such as marketing authorization, which is extremely expensive and involves an evaluation procedure that can take several years. This is much too long for a patient suffering from a serious disease that requires personalised medication, asserts Huub Schellekens, Professor of Pharmaceutical Biotechnology at Utrecht University.
Bespoke, yet less expensive
“The current pharmaceutical system is far too complicated, expensive, time-consuming and inflexible to provide medications tailored to individual patients”, according to Schellekens. “In the second half of the 20th century, medications were generally developed for large groups of patients. Now that the patents for these drugs have expired, pharmaceutical companies are focusing on drugs to treat rare diseases and for specific populations, such as patients suffering from cancer or chronic illnesses. The prices for these drugs are exceptionally high; treatments that cost more than € 100,000 are no longer the exception. Magistral production offers the opportunity to produce medications cheaper, and tailored to the individual patient.”
In their approach Schellekens and his colleagues focus on biomolecules, such as proteins. These are usually produced by living cells. For their running proof of principle they use existing equipment in the pharmacy of an academic medical centre to produce the relatively small quantities needed to treat a single patient. If the pilot is a success and other hospitals get involved, their pharmacies will not possess the necessary expertise and equipment. However, Schellekens predicts that technological development will soon produce a safe, easy-to-use ‘Bionexpresso’.
With such a Bionexpresso machine, any pharmacy would be able to produce biological medication, and in the long term, other pharmaceuticals as well. “Magistral production will not make the pharmaceutical industry obsolete, however. Large-scale production and distribution of standard pharmaceuticals by the industry will continue to be necessary”, Schellekens adds.
Proof of principle
Schellekens expects the proof of principle he and his colleagues are currently working on, will produce tangible results by next year. In order to guarantee that the medications meet the highest standards of quality and safety, time and patience are needed, but according to Nature Biotechnology, Schellekens’ concept is a major step towards realising the promise of personalised medicine. “Because...”, as the editorial concludes, “magistral production has an important ally: payers (of high costs for medication) will find it very attractive.”
Health insurers CZ, Zilveren Kruis and Menzis contribute financing for the proof of principle of magistral production in the pharmacy. They consider it to be a promising concept. The health insurers and the university have found a shared interest: effective, affordable medication.
Making individualized drugs a reality
Huub Schellekens, Mohammed Aldosari, Herre Talsma, Enrico Mastrobattista
Nature Biotechnology, June 2017, DOI 10.1038/nbt.3888
Monica van der Garde, Press Spokesperson, firstname.lastname@example.org, +31 (0)6 13 66 14 38.
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