2004N-0181 - Critical Path Initiative; Establishment of Docket
FDA Comment Number : EC3
Submitter : Mr. Norman Goldfarb Date & Time: 06/29/2004 06:06:15
Organization : First Clinical Research
Drug Industry
Category :
Issue Areas/Comments
There are numerous ways that industry can streamline its business processes in collaboration with CROs and investigative sites. For example, I am Chairman of MAGI (http://firstclinical.com/magi), which is working on the process of negotiating clinical trials agreements. We can take, literally, months out of the drug development pipeline with this single initiative.

Overall, better and more integrated business processes can take at least a year out of the clinical trials timeline, as well as cutting the cost of clinical trials in half and doubling the quality of the data. (Feel free to be skeptical, but clinical trials is a VERY broken industry!)

I don't know what the FDA can do, other than to provide some encouragement to the industry, and answer questions from time to time when a revised business process may have regulatory implications, but I would appreciate the opportunity to talk with somebody there about these huge opportunities that just require some cooperation to achieve.

I am based in San Francisco. I will be speaking on this topic at the DIA 1st Annual Clinical Research Conference: The Future of Drug Development in a Cost-constrained Environment on September 20-22, 2004 in Philadelphia, in case someone from the Critical Path initiative happens to be attending, or could meet me there.

'We can agree to save lives!'

Thank you,

Norman Goldfarb
415) 681-4657