Outsourcing Articles

In the pharmaceutical industry today, outsourcing has become a customary strategy for reducing costs and enhancing or maintaining the productivity of the drug development, approval, and manufacturing processes. Although outsourcing professional project management can also provide similar benefits, it is less commonly used because its potential application and effect (i.e., the amount of training that a project manager requires and the value of hiring one) are misunderstood.

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In the highly regulated pharmaceutical industry,methods validation documentation must support the suitability of analytical test methods for drug substances and drug products. A suitable method consistently provides accurate results under a normal range of operating conditions, with the goal of evaluating samples to determine whether they meet the product’s specifications. Validated test methods ensure that products are safe and effective and have appropriate storage conditions and expiry periods.

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One of the first hurdles biopharmaceutical companies
face when developing a new drug product is testing
the hypothesis that the molecule will ameliorate the
disease state for which it is being targeted.After being
tested for safety in humans, the molecule must undergo a proofof-
concept study that may provide positive signs that the substance
will perform as expected. The decision whether to commit
significant resources to full clinical development will be
made on the basis of the outcome of this first efficacy study.
Because many molecules (greater than 80%) fail during the
early stages of clinical testing, it is imperative that biotechnology
companies commence human testing as quickly and as inexpensively
as possible. The reason to “fail fast” is to enable a
company’s resources to be targeted at a backup or alternative
molecule(s) that will improve the probability of a successful

2005 is shaping up as a big year for preclinical and clinical CROs, while contract manufacturers hope to see a reversal of a depressing four-year trend.

The CRO industry ended 2004 on a roll, and it looks like the good times will continue well into 2005.

Too many players and threats to the main customer base challenge European dose manufacturers.
Clients are always asking us for more information about the European market for contract manufacturing. They seem to think they are missing out on business opportunities by not participating more fully in that marketplace. Well, they should probably feel lucky that they don’t have more European exposure.European contract manufacturers are getting squeezed by adverse developments on the supply and demand sides of their market, and they have no obvious means of escaping their problems.

Pharmaceutical companies have long relied on contract resource organizations (CxOs) and other service providers to resolve capacity shortages, tighten development timelines, and reduce processing costs. But CxOs, especially those in formulation development, have grown quickly, evolving from “an extra pair of hands” into strategic business partners, purveyors of innovation, and proprietors of novel drug-development technologies. To stay competitive, a contract service organization must continuously assess the changing needs of its current and potential clients and position itself to address these needs.