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Hospital Pharmacy

EAHP: Is man the new guinea pig in drug development?

Many potential drug therapies are failing late in the development process because early pre-human investigations have not been fully explored, according to Maria Beatriz da Silva Lima, of the faculty of pharmacy at Lisbon University, Portugal, during the 15th anniversary congress of the European Association of Hospital Pharmacists.

Ever more attention is being directed towards the non-clinical aspects of drug development, said Professor Silva Lima, who is an expert in so-called non-clinical research, suggesting that pre-clinical work could be the basis for better R&D success.

Research, she said, reveals that over two fifths of drugs in clinical development failed because of lack of efficacy, with poor understanding of the pre-clinical research model and of the disease being investigated, and in some cases premature advancement into clinical trials, among the root causes of these failures.

“The first time a product is used in humans, of course the information related to human safety does not exist. [Data] must be extrapolated from non-human systems through non-clinical research programmes,” she explained. “There is a need for researchers to have the appropriate knowledge and strategies to extrapolate the information that is gained from animal and other pre-human studies.”

She told participants: “A lack of human experience with a specific molecule might be more or less relevant depending on the novelty of that molecule. If the molecule is totally new in terms of mechanism of action or structure — something we’ve never seen before — the lack of knowledge is much greater than for one of the ‘me toos’ where similar molecules have already been tested and you know the structure-related activities.”

First-in-man use of those novel products, she pointed out, requires reassurance of the rationale for the drug’s use and the conditions that will be behind the administration.

Professor Silva Lima described some of the difficulties with translating findings for studies in animals to humans, citing the 2006 first-in-human trial for TGN1412 as an example of where interspecies variability had serious consequences. “A challenge we have with new technologies is finding a model with good predictability for the clinical situation. A lot of thinking is really needed.”

She highlighted moves towards the “refinement, reduction and replacement” of animals for scientific research. “There is a huge pressure from the European Commission and internationally to avoid animal experimentation, particularly primate experimentation.

“The most innovative solution,” said Professor Silva Lima, “is the earlier human studies that are now in place, known as ‘exploratory clinical trials’. … These don’t have any type of therapeutic intent, so we are not talking about [a company’s] lead molecule — we are talking about investigational molecules that are to be tested in humans.”

She said that exploratory clinical trials are designed to provide insight into human physiology and pharmacology, assess the relevance of a therapeutic target and identify biomarkers, to inform selection of suitable candidates for drug development.

“Man,” she asserted, “has been upgraded to experimental animal, for sure.”

Citation: Clinical Pharmacist URI: 11004644

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