Understanding Local, Thinking Local, Being Local The biopharmaceutical industry stands at a crossroads with its very future in question. The problem is deep-seated, arising from serious structural flaws in the way the industry has been constructed. Incremental innovations are no longer sufficient. The industry needs a radical transformation, and Asia offers a unique opportunity for remodeling the system. The pre-requisite, however, is that biopharmaceutical companies truly comprehend the emergence—or re-emergence—of Asia, and meet the challenge of understanding local, thinking local and being local. Contract Research Organizations (CROs), with their cross-industry view of the landscape, must understand their pivotal role within the new “wheel-and-spoke” partnership model, and evolve from being pure service providers to becoming key enablers of healthcare transformation in Asia.
Introduction As the world stands at a crossroads with respect to the global economy, geopolitical power shifts and climate change, so too is the biopharmaceutical industry approaching its own moment of truth. While the fundamental problems of low R&D productivity, rising R&D costs, price cuts and patent expiration remain, the pharmaceutical industry is actively, if somewhat desperately, trying to reinvent itself. It is using a variety of strategies ranging from branded generics and fixed-dose combinations in emerging markets, to global biosimilar programs that aspire to capture a piece of the US$ 50 billion opportunity arising from a handful of blockbuster biologics that come off patent in the next five years. There are almost daily announcements of mergers and acquisitions, of new partnerships and alliances. It is said that innovation is being stifled by ultra-conservative and bureaucratic approval processes, and there is discourse everywhere on different and often wondrous in silico and open innovation models of virtual drug development. The celebration that 2011—with its bumper crop of 35 NDA approvals in the US— heralds a turnaround for the industry is tempered by the observation that pipeline drugs in Phase I and II are at an all time low, leading at least one commentator to observe that the turnaround was perhaps in FDA regulations, rather than in R&D productivity1.
All this activity leads one to ask: “Is the industry breathing new life or experiencing agonal gasps?” The cacophony confuses rather than informs, and ultimately distracts from the fundamental challenges at hand. In this white paper, written as a follow up to last year’s “Asia: A New Frontier in Strategic Drug Development”2, we examine: