Drug development is hard and costly. Clearly, something must change if the scenario of $10m drugs with 2 year development times is going to emerge by 2020. (see #7).
To get an idea of the cost issues facing today's pharma industry, I highly recommend Derek Lowe's recent coverage of the subject. For example, in...
- Darn those R&D costs, he rightly agrees with others on $805 million cost/drug
- How drugs die he reviews how 46% of all failures result from lack of efficacy in Phase II
- Drug prices and costs he shares his concerns over Phase III failure rates
- More on high prices and otherwise he investigates pricing power and patents
As I explored last year in pharma's coming industrial implosion, the entire industrial organization (indeed the economic geography) of the pharmaceutical industry is in for a radical change as we enter the era post-genome pharmacology.
Helping support my distant projections is a piece by 35 year biotech veteran, G. Steven Burrill in the most recent Drug Discovery World: (not yet on-line)
"We are about to see the pharmacoeconomic model change...the integration of genomic information into drug design...will make the firms horizontally, instead of vertically integrated."
"Targeted pharmaceuticals and biologics...do work for the betterment of healthcare by reducing the cost and time of development and time to market. As we better understand the body as a biologic system (systems biology)...It is not just changing the healthcare paradigm, it is changing life itself."
Getting from time A to time B will not be simple. Trillions of dollars (and even more Yen and Euros) of investment capital in NBIC-related technologies will be needed if we are to see this level of change in the coming decade. More on the shifting economic geography of the pharma industry in time...
Zack Lynch is author of 
1. Reason on February 20, 2004 11:04 PM writes...
I think that, in addition to pharma's internal struggles with business models and the grand and impressive new technologies that are already revolutionizing research, we have to take a long hard look at the damage that the FDA is doing to the process. I'm sure you're familiar with:
http://www.fdareview.org
FDA employees, managers and political appointees hav no incentive to make decisions that benefit consumers, and every incentive to keep bloating the cost and time of development beyond all sense and reason.
Unless the FDA goes, there is no way we are going to see 10M/2year drug development timelines from inception to commericial availability.
Reason
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