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Collaboration Limits?


By Ernie Bush

August 2, 2011 | Bush Doctrine | In a recent brief for Nature Reviews Drug Discovery, John Arrowsmith of Thomson Reuters reported the following information regarding Phase II clinical failures in the period 2008-10. Of the 108 reported failures, 87 listed reasons for failure and they were distributed in four categories as follows: Efficacy (51%); Strategic (29%); Safety (19% both preclinical and clinical); and PK/BA (1%).

When he combined these data with the biological target areas for the failed compounds, Arrowsmith made the following observation:

“Although it is difficult to draw conclusions from these data, the finding that a substantial proportion of Phase II failures were due to strategic reasons suggests that one important underlying factor could be overlapping R&D activity between companies with drugs in Phase II trials. This raises the question of whether an increase in collaborative efforts between companies up to the point of proof-of-concept for novel targets or mechanisms might be more cost- and time-effective.”

While I know many companies conduct joint development efforts on a single compound, I find the idea of multiple companies joining to conduct clinical target validation studies, potentially across a range of compounds, a very intriguing idea. It is one that has come up before, however, but in a more limited context.

The Target Validation Consortium

Since the core of our business has always been about the “collaborative advantage,” we were approached a couple years ago by someone who wanted to build a collaborative organization of pharma companies for the purposes of establishing a “pharmacological targets” validation consortium.

The central thesis of his proposal was that all large pharmaceutical companies have a constant need to discover and validate novel biological targets as a basis for developing new medical therapies. In particular, he felt that the target discovery field is dominated by the academic research community because they are focused on the basic biological sciences needed to uncover the functional activities of proteins and pathways. This basic biology is then supplemented by activities needing larger investments, which include large-scale protein synthesis, building and executing high-throughput functional screens, and animal testing capabilities. Of course, all of these supplemental activities are usually provided or funded by pharma companies.

Unfortunately, these larger investments are often replicated across multiple pharma companies as is the cost of conducting early safety studies to determine if the target has unwanted pharmacology. As it is very common for multiple companies to be chasing the same targets, the overall duplication of efforts and expense to achieve a validated target is wasteful and arguably not as thorough or comprehensive as could be achieved in a collaborative effort. Or so he proposed... unfortunately, when we tried to formalize and build such a consortium, his employer decided they could not support the idea of taking collaboration to that level.

Of course, what is interesting to me is that Arrowsmith’s suggestion takes this proposal one step further. He is basically asking, “Why don’t companies collaborate not only on the discovery target validation, but on the validation of the target all the way through to human clinical studies?” This has the possibility of greatly reducing the number of failures both due to lack of efficacy but also of reducing the number of failures due to “strategic” reasons.

In a logical extension of Arrowsmith’s observation, one could also ask: Why would collaboration have to stop at target validation? What about collaborative Phase II and/or Phase III studies? At the very least, having a shared safety database on compounds hitting the same targets would be of value to the companies, to the regulators, and to the general public health. Or am I clear off the reservation?

As such, the larger question becomes one of “what are the limits of collaboration within the pharmaceutical R&D space?” Recent years have seen many types of ‘collaborations’ introduced such as the Enlight Biosciences (see, “Big Pharma’s Road to Enlight(enment),” Bio•IT World, Sept 2008) co-investment collaboration, the Pistoia Alliance (see, “The Italian (Informatics) Job,” Bio•IT World, Jan 2010) open software standards collaboration and the Preclinical Safety Testing Consortia biomarker discovery/development collaboration. All of these share the common thread of multiple pharmas joining together to achieve an objective that would be difficult or expensive for any one company to achieve independently; but they have very different operational characteristics and an even wider diversity of missions. But I must say that the concept of companies actually collaborating on the clinical development space truly looks like a significant step beyond anything actively ongoing to date. If there is real synergy and leverage to be obtained through collaboration, then why not collaborate across the whole R&D space? Or is the fact that contract organizations are becoming increasingly dominate across the entire R&D space really just another expression of this concept?

Ernie Bush is VP and scientific director of Cambridge Health Associates. He can be reached at: ebush@chacorporate.com.

This article also appeared in the 2011 July-August issue of Bio-IT World.
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