spacer
home > ict > spring 2008 > beyond fast filling
PUBLICATIONS
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).


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
4
     

There are no comments in regards to this article.

spacer
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
spacer
David Edwards
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Mr Turhan Ozen Chief Cargo Officer at Turkish Airlines elected to the International Air Cargo Association (TIACA) Committee

Turhan Ozen, serving as Chief Cargo Officer at the global brand Turkish Airlines, was elected to the International Air Cargo Association (TIACA) Committee, the joint voice of the industry that aims to enhance the air cargo profile with intensive efforts towards the global standards.
More info >>

White Papers

Bonfiglioli Engineering Headspace Gas Analysis Systems for Parenteral Manufacturing Processes: One Step Beyond Product Quality and Patient Safety

Bonfiglioli Engineering

This white paper presents the innovative solutions that Bonfiglioli Engineering has been developing in the field of HGA and their significant advantages over other existing systems.
More info >>

 
Industry Events

Clinical Trial Supply Global Forum

20-22 May 2019, Brussels, Belgium

You can’t get a drug to market without a clinical trial. You can’t run a clinical trial without product supply. We understand that your role is critical in ensuring the on time and efficient development of the next life saving drug and we know that this makes your time precious. In 2019 we have condensed everything you need to advance your Clinical Trial Supply into three jam packed days. The industry's most interactive and solution focused CTS forum features deep dive workshops, live polls, panel debates, round table discussions and exclusive key note case studies to ensure that you leave with the industry's best solutions and strategies to transform your clinical trial supply. If there is ONE Clinical Trial Supply conference that you attend in 2019, make sure that it is this one.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement