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International Clinical Trials

Beyond Fast Filling

The strategy of powder-in-capsule has the ability to accelerate the clinical development cycle. David Edwards of Capsugel investigates new developments on the drug market

The early stage is a critical time during the development life cycle of a new drug. Like a newly hatched tadpole, it has to compete for resources, not only with its tadpole siblings, but with all the others sharing the pond in order to survive. No matter how large it is, the parent drug company has to choose which of its newly hatched drug candidates are best suited to survive and grow in the marketplace, and then direct available resources accordingly.

TIME IS MONEY

There are many resource constraints in early stage drug development, such as available drug quantities, testing personnel, equipment, funding and, perhaps most crucially, time. With a patent life of 20 years and a development timescale of 10-12 years, the window of opportunity for a drug is limited and it is imperative that the drug has enough time on the market to recoup investment and to be profitable in line with the company’s needs. Any legitimate reduction in the development process can result in an extension of the profit window for the drug. Consequently, such shortcuts are avidly sought by R&D departments.

With this in mind, let’s focus on one of the first key ‘go/no-go’ decision points for the new molecular entity (NME) drug candidate for many pharma companies – Phase I clinical trials, or ‘First in Human’ studies. Phase I includes the initial introduction of an investigational new drug into humans. These studies are closely monitored and usually conducted in healthy volunteer subjects, with a focus on safety. They are also often designed to better clarify the pharmacokinetic and metabolic properties of the drug. During Phase I, sufficient information should be obtained to permit the design of well-controlled, scientifically valid, Phase II studies.

The first-in-human hurdle is important for a number of reasons; it gives a first indication of tolerance and prospective efficacy in humans and, because trial participant numbers are typically small, the cost is relatively low. This means that a number of candidate compounds can be assessed for comparative viability without committing excessive financial resources. The faster this can be done, the faster less viable candidates can be eliminated, so the concept of ‘faster-time-tofirst- in-human’ can also be construed as the rather negative sounding ‘faster-time-to-fail’. Knowing that a compound will not make it any further to market will release precious time and other resources in order to concentrate on other NMEs that have potential, and will also reduce the risk of failure at much later and far more expensive stages of the clinical development process.

HISTORICAL CHALLENGES OF MICRO-FILLING

Much work has been done by pharma companies to speed up or improve R&D processes in order to reduce timescales, and real savings can be achieved with the use of new technologies. One, which has come to the fore over the last few years, involves dosing pure drug or active pharmaceutical ingredient (API) rather than formulated or blended product for production of Phase I clinical trial materials (CTM).


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David Edwards is Director of Pharmaceutical Technology at Capsugel, a division of Pfizer, and is globally responsible for the commercialisation of Capsugel’s pharmaceutical equipment. David has worked in the pharmaceutical industry for over 30 years, holding a number of senior positions in Meridica (a start-up drug delivery technology company), which was successfully sold to Pfizer in 2004; PA Consulting; Roche; and Nicholas Laboratories. He started his career as a Laboratory Microbiologist with Oxoid Ltd. A graduate with degrees in Microbiology and Business Studies, David is based in Cambridge, UK
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