The Pharmaceutical Safety Data Problem

January 10, 2012 | Bush Doctrine | I doubt most people fully appreciate the size and scope of the pharmaceutical safety informatics space. I consider myself an avowed information systems advocate with decades of pharma R&D experience, but I did not begin to get a handle on this issue until the last few years.  

What we in the industry call “safety data” covers everything from discovery-oriented in vitro or cell based studies (e.g. cytochrome P450 drug-drug interaction results) to extensive and regulated GLP toxicology study data, voluminous clinical study records, and finally to the complex and extensive post-marketing/pharmacovigilance systems. It leads one to wonder: does anyone have informatics systems that allow safety investigators across the pharma enterprise to effectively mine this ocean of information? In my experience the answer is clearly no, or at best only on a very limited scale. This may be a major missed opportunity.  

As with many aspects of pharma R&D issues there is both a corporate (or human) aspect and a technology (or systems) aspect. Of these, I have always found the corporate to be the most difficult to address. 

Nearly all major pharma companies have three separate divisions that are responsible for some aspect of safety data generation and maintenance: Research (discovery and early development), Development (clinical trials and regulatory submissions) and Marketing (post launch surveillance and pharmacovigilance). These usually report up to the CEO through separate VPs and have different goals, milestones, and bonus/reward structures. No wonder their informatics systems tend to be disparate and lacking good mechanisms to share knowledge or be easily mined across the enterprise.  

The solution is probably similar to the one implemented for financial-based issues within the enterprise: have one individual that is accountable for all financial aspects of the business, the Chief Financial Officer. A Chief Safety Officer with the mandate and authority to drive an integrated safety organization would undoubtedly also help drive a more thorough and robust safety informatics strategy.  

But the problem is much deeper than just lack of alignment. Perhaps the biggest issue is that neither toxicologists nor clinicians want to open up their data to those “unblessed” members of the company whom they believe unqualified to interpret the results. There is a fear that individuals without the proper training and background will somehow abuse the information and the professionals would like to limit access to only those they believe will treat the data appropriately. That sense of proprietary ownership between different groups within the same company (sometimes within the same building) is very difficult to address, but will have to change if we are to truly leverage our safety investment to the maximum. 

The Technology Is Here 

The problems associated with disparate safety information systems are, in fact, smaller now than five years ago and much, much smaller than ten years ago. And, at least from a technology perspective, it should only get better. The new systems for clinical safety data management and pharmacovigilance are merging (or at least becoming more aware of each other) and the tools for accessing data from multiple legacy systems have blossomed.  

Ultimately, however, the big question remains: If we truly could mine the entire safety space across the enterprise, would it make a difference? Traditionally the answer was believed to be no, or at least not very much. There has always been a sense that the clinical study data “trumps” the other data and therefore other data—especially preclinical—does not add a lot to late stage or post-marketing safety assessment. And from a traditional “observational” based safety assessment point of view, that seems logical.  

But increasingly, safety assessment is moving to a biochemical- and mechanism-based approach. And here, all three legs of the safety informatics space really carry an equal amount of the insights. After all, it is in the preclinical area where we develop the best understanding of the mechanisms of adverse effects. For example, currently most companies screen against 800 to 1,000 off-target receptors in order to get a feeling for what kinds of adverse events could be seen in the clinic. This is very valuable data, yet how many post-marketing surveillance organizations can explore whether there was an activity at an off target receptor that might help manage an adverse event in a new population? Actually, a few do and the list will grow more, which proves the point.  

An enterprise-wide safety assessment informatics solution is the optimal tool for fully leveraging the investment in generating and collecting this data—especially to achieve a mechanism-based understanding of what is behind the safety issues. This in turn greatly improves the ability to manage or mitigate these adverse effects. • 

Ernie Bush is VP and Scientific Director of Cambridge Healthtech Associates. Email. 

This article also appeared in the January 2012 issue of Bio-IT World magazine.  


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