Wednesday, September 9, 2009

Matt's right; people don't walk in a straight line in Tokyo. Heading home. I'm going to buy myself a bottle of wine...

09/09/09 - Nothing Special Here

I just popped in at the office for a few minutes to try and catch up with some news. There was a bit of info on the ""specialness" of today, Wednesday, September Ninth, Two Thousand and Nine, or 09/09/09.

Well, I didn't win a million dollars, I didn't get a raise, I didn't get laid, but I didn't get yelled at either.... so was it special? Nothing out of the ordinary here.

How about where you are?

I love you!

Cam

Wednesday, September 2, 2009

This is my New Industry

 Contract Research Organization, also called a Clinical Research Organization, (CRO) is a service organization that provides support to the pharmaceutical/biotech industry. CROs offer clients a wide range of "outsourced" pharmaceutical research services to aid in the drug and medical device research & development process. 

Services offered by CROs include: product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and medical writing services for preparation of an FDA New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA); regulatory affairs support; and many other complementary services. CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services.

The CRO industry developed mostly in the late 1990s when pharmaceutical R&D efforts became more complex and competition in rapidly-growing therapeutic areas increased. Particularly over the last few years, this forced the pharmaceutical industry to utilize ‘downsizing’ strategies more to concentrate resources on core skills. As industry margins come under increasing pressure, companies could begin outsourcing aspects of their development, manufacturing or marketing processes so as to concentrate on their core specialties.

Outsourcing has been particularly influential in the pharmaceutical industry as the success of a large pharmaceutical company depends on competence in fields as diverse as combinatorial chemistry, computer integrated manufacturing and marketing medicines directly to consumers.

External cost pressures have acted as a major driver for the pharmaceutical outsourcing market. At bottom, the outsourcing market has developed in response to the downward and upward cost pressures exerted on pharmaceutical manufacturers’ profit margins. Given that such pressures are likely to increase in the future, CROs will become more and more important strategic partners for pharmaceutical companies. It is, therefore, in the latter’s interest to consider probable developments in the CRO market and its major players.

This is the industry in which I am about to immerse myself in (if I can stay awake!!!)

I love you!

Cam