Can Charles River Retune its Preclinical Operations?

Today’s news that contract research organization (CRO) Charles River Labs will be suspending its preclinical operations by mid-2010 in hopes of a biotech recovery is being met with the usual hand-wringing about the state of the industry following the near collapse of the global financial system in 2008.  I look at this a bit differently.  This suspension is a wonderful opportunity for Charles River to come roaring back with preclinical services better attuned and better able to take advantage of cutting-edge medicinal product development techniques.

In my book, Get to Market Now (slated for a May 2010 publication through Logos Press), I argue that firms can be making much better use of the preclinical stage through techniques such as:

• Crafting a clinical regulatory integrated strategic plan
• Bookshelving of previous studies into large databases
• Mining the data of those databases as part of an extended literature survey
• Capturing the voice of the customer (e.g., physicians, prospective patients, etc.)
• Summarizing preclinical studies to include potential critical product quality attributes (CQAs) and a risk analysis
• Planning and undertaking Phase 0 feasibility studies

Charles River has a good six months to put in place a strategy that incorporates tactics just like these, and offering them to clients (something that will save their clients money and time as well).  If your firm already has a number of preclinical studies underway - or planned - consider any of these tactics to help you improve R&D productivity and speed time to market.  Recent FDA and ICH guidelines encourage the adopting of many of these tactics through the quality by design philosophy.  Firms that ignore all the new product development options available to them in the 21^st century in the preclinical stage risk staying back at the 1 in 250 success rate of the 20^th century’s preclinical stage.

If you’d like to learn more about these tactics and adopting them into your preclinical development efforts, contact me through my firm.

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Comments

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