Government regulators can help speed this trend—or delay it. The problem is that key agencies like the FDA are way behind
industry in adapting to the IT revolution.
Internal reforms are vital, because done right IT can help advance the portfolio through faster lead times and building that
better case for competitive differentiation. "IT can be a driver or a drag on productivity—the results depend on whether IT
is mapped to optimize business processes that control how data is accessed, aggregated, and utilized and where these processes
are conformed across the company," says Oracle senior vice president Neil de Crescenzo. Conformed is a key word, because the best systems balance the global scope of today's pharma business model against the importance
of local due diligence and each local operation's specific challenges.
Another asset, says de Crescenzo, is how effective IT systems act as a safeguard against the misinterpretation of data. "Data
vendors today have the technology to create databases so large they literally defy the laws of physics. It is analytics at
the speed of thought, which if not handled correctly can produce signal detection problems and an overemphasis on population-based
surveys against specific patient interests. We need to work cooperatively with industry and regulators to develop the tools
to monitor and assess data on the basis of heterogeneity, as the use of these large data sets to drive healthcare decision
accelerates."
Finally, IT is already established as the "fourth hurdle" in obtaining access and reimbursement. Says Terry Hisey, national
sector leader for life sciences at Deloitte, "In a registration environment where proof of safety, efficacy, and quality are
givens, what now makes the difference is cost effectiveness. The link is still implicit here in the U.S., but promotion of
the accountable care organization model under health reform—where providers are rewarded on the basis of the total cost of
the condition under treatment—makes it a central part of the approval equation." Scale-up this year of Obamacare's Patient
Centered Outcomes Research Institute (PCORI) and, more importantly, its billion-dollar budget, promises to make the U.S. the
global epicenter for value-based drug assessment. This is true even though PCORI's mandate is to conduct comparisons among
therapies that avoid an explicit focus on cost. The UK's Commission on the Value of Medicines is another group to watch.
4) Preserve those reputational assets. Maintaining a "license to operate" is becoming more important as the reach of governments extend from regulatory oversight
to direct involvement in the business—as a payer and customer. The gap between strict legal prohibition and the more murky
terrain of ethical lapses is narrowing; overall, the "zone of vulnerability" is expanding and is now global in scope. 2012
will see major new efforts by U.S. and European regulators to apply anti-bribery statutes to companies' overseas promotional
activity, including inducements by CROs and other third parties to influence the conduct of foreign clinical trials. Active
management of the drug shortage problem is another imperative; it is not enough to blame the problem on FDA or on quality
issues linked to generics.
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