Beauty and the Beast?
Beauty and the Beast?
Several large Pharma companies have announced interest in acquiring small biotech companies. Many Pharma companies have reduced or eliminated drug discovery efforts, and with stock prices back at 2003 levels, there certainly is a great deal of sense in these acquisitions. But finding another way to integrate these companies and their development portfolio also makes a great deal of sense.
Due diligence is often done in haste and with an eye towards the big issues of safety and efficacy. But the devil is in the details as well, especially the details about dose selection and justification. Almost by definition, the biotech compounds will be in early stages of development. Instead of rushing to put these compounds into clinical trials as the industry is wont to do, how about a more thoughtful approach? How about systematically identifying and assessing the knowledge gaps, including the basis for dose selection, using modeling and simulation techniques. The ensuing development plan would then be designed to systematically address these gaps. This process does not have to take very long nor use many resources, but the opportunity to avoid late stage failures would be priceless (or at least the several hundreds of millions of dollars typically spent on late stage clinical trials).
Importantly, the goal of this assessment does not have to be a yes/no answer. Armed with the gaps in knowledge the result could be a plan to address the gaps with a more realistic strategy and more realistic expectations about the anticipated level of clinical and commercial success.
So what is the plan for this assessment?
- Constitute an Integrated Project Team that is incentivized to uncover gaps in knowledge, not just for starting clinical trials.
- Assemble all available data and perform exploratory analyses to underscore the knowledge gaps – and identify the informatic elements required to expedite future data collection, programming and modeling efforts.
- Implement a formalized pharmacometric modeling and simulation process to explicate the knowledge gaps and explore strategies for closing these gaps.
- Detail the gaps and proposed development strategies, along with an estimate of the probability of clinical and commercial success.
The modeling and simulation tools and strategies for more reliably selecting doses and predicting the probability of success with clinical trials are available. These tools, and the skilled personnel to perform modeling and simulation, are not usually available to the biotech companies. A systematic approach to assessing knowledge gaps, however, would appeal to the scientist-within at both big and small companies. This assessment would provide an objective way of bridging the divide between discovery and development while playing to the strengths of both types of companies.
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