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European BioPharmaceutical Review
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Much has been written recently about the burgeoning growth of biopharmaceutical business and the looming capacity crunch in biologics manufacture. Numerous enterprises are investing heavily in the production of stainless steel so that they are positioned to churn out lucrative, premium-priced biopharmaceuticals that are already approved or forecast to be approved in the coming years. The emergence of biopharmaceuticals as effective therapeutics, coupled with a trend to outsource biologic manufacturing, has led to unprecedented growth in 'third party' contract manufacturing organisations (CMOs) and much of the additional capacity will come from that sector. Here in Canada for example, a €100 million expansion to provide 60,000L of animal cell culture capability has recently been announced by DSM Biologics.
Many of the CMOs are positioning themselves to capture the long-term, large-volume supply contracts offered by big pharma or big biotech that are more lucrative than the high-risk developmental projects typical of smaller, early-stage biotech companies trying to get their products into the clinic for the first-in-man trials. Due to the high risk of failure for early-stage biotech projects, the chances of them eventually leading to long-term supply agreements are relatively small.
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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 Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
More info >> |
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