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European Pharmaceutical Contractor
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Our thoughts have already turned to Autumn, although I am writing this at the beginning of August and summer is only just reaching us. As with all projects, there is a lead-time and it requires the co-operation of many individuals to ensure that the magazine is delivered on time. So too with drug development - so many groups and individuals are involved in the process that it is vital to plan early, and to integrate each function, whether in-house groups or outsourcing partners. The range of articles that we have in this issue exemplifies the intricacies of drug development - you will find an interesting perspective from Helen Springford of IMFORM and Sue Lee of World Courier, who describe a day in the life of a clinical trial sample, highlighting the apparently simple things that we take for granted.
We also take for granted that medical research will continue to ensure improvements in the treatment of disease. Cancer research is an area that continues to receive much attention and funding, and there are possibly between 400 and 600 new molecules in the development pipeline. An overview of some of the most recent developments and the ways in which they contribute to the formation of a scenario for cancer treatment in 2025, are presented in an article by Inveresk, in which treatment will be highly targeted and any surgery minimally invasive. Medical treatments will be personalised for the type of tumour and for the genomic/proteomic signature of the patient. The unanswered question, however, is how will patients be able to pay for such treatments? There are predictions that the class divide in health care provision will widen considerably.
I recently returned from a trip to India, visiting Mumbai, Bangalore and Hyderabad, all of which are attracting new business, particularly in the biotechnology and pharmaceutical areas, and I met with several CROs involved in both bioavailability/bioequivalence studies and later phase clinical research. Clinical CROs are relatively new to India, but the sector is preparing itself for an anticipated increase in activity from 2005 onwards, following changes in law that will increase product patent protection. I am therefore pleased that we are able to include two articles that consider India as a location for clinical trials. India does have the capability to conduct clinical trials, and to use this to the best advantage will require careful planning, as with any new area. The regulatory process may be lengthy, and I have heard concern expressed that the regulatory agency is not prepared for a large influx of clinical trial applications. This lead time must be factored into a development plan and the payoff will be that patient recruitment can be very quick, and it is the reduction in development time that is the real advantage of conducting research in India.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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