Lisa Henderson

Arecent Frost & Sullivan report titled "Specialty Pharma and Biotechnology Drive Contract Research Organizations Growth" included many reasons the industry will grow by $14 billion over the next seven years. These included biotechnology fueling growth, along with specialty pharma and niche or startup pharmaceuticals. The reference that caught my eye in the report was, "Greater growth potential exists for CROs in early stage work with increased potential for outsourcing...several CROs are adding early stage capabilities to garner a greater share of outsourcing within this market segment." It further states that the interested CROs will add these capabilities on their own or acquire them.

To see if this forecast holds water, a perusal of company press releases since the report became available November 26th seemed in order. Keep in mind these releases would have been in the works long before any industry analyst could have used them as predictors (although sometimes analysts have more access to insider information than the trade press). So following is a roundup of those headlines, all from December:

• Patheon's New Laboratory and U.S. Headquarters in RTP, N.C.
• MDS Pharma Services Extension for its Early Clinical Pharmacology Services at its N.J. Facility by Daiichi
• A Duo of Ex-Lilly Executives Launch Centurion Clinical Research to Cater Specifically to Phase I Studies
• Metroplex Clinical Research Center Expands to Include Phase I Studies.

So where is the worm in early phase? The reward will be in having more intelligence in Phase I and Phase II. In a recent conversation with Murray Ducharme, PharmD, FCCP, FCP, chief science officer at Cetero Research, he noted that the failure rate in Phase III trials has been increasing from approximately 20% in the early 90s, to 50%. "This high of a failure rate had not been seen since the 70s," said Ducharme. "Too many drug regimens are found to either be ineffective or toxic in Phase III, contributing to this failure rate. In the next 10 years, it will be important to put much more emphasis on the 'Learn and Confirm' paradigm." Ducharme said the early phase must no longer be just a "check the box" in getting to the larger trial.

This month, Applied Clinical Trials features our annual Partnering with Central Labs, ECG, and Imaging Labs supplement, which is produced in conjunction with the IIR conference of the same name at the end of this month. More and more, we will be hearing of strategies to apply in early stage drug development, many which involve what is learned in Phase I, first-in-man studies, and through more sophisticated lab services.

The supplement features articles related to fostering better results with your central lab, as well as new technologies available that will help improve safety signaling.

We look forward to bringing you more information here and on our Web site that will give you practical knowledge into early stage/early phase developments. Articles on tap include biomarkers, molecular-based research, and adaptive clinical trials.

Lisa Henderson
Editor-in-Chief
email: lhenderson@advanstar.com

http://www.appliedclinicaltrialsonline.com/