This past week, NeuroPerspective had the privilege of again participating in the annual meeting for the International Society for CNS Drug Development. It was the tenth anniversary of the founding of ISCDD by Amir Kalali, the head of CNS for Quintiles, who has patiently grown the organization into a force for change in the CNS drug development industry.
From the presentations made at ISCDD 2012, a few items stood out:
1) The expansion of pre-competitive space has shifted from a somewhat controversial, even antithetical concept in the industry, to one whose necessity is seldom questioned. However, the implementation of such expansion has been haphazard, particularly in the US, whereas the EU has been able to structure and fund several iterations of pre-competitive research through the IMI Initiative. While the NIH–as reported by their Senior Advisor (and ex-Lilly, ex-Merck) Bill Potter–is actively seeking input on a major Alzheimer’s initiative for which Congressional funding will be pursued, the FDA may itself end up taking a leadership role in the delineation of pre-competitive space and its utilization in the US. Given the concerns around datasharing and control, finding a trusted independent party to safeguard the process from industry is near impossible, given the legacy of IP wariness. The FDA may end up serving as the linchpin structure through which pre-competitive consortia can coalesce and establish accessible but regulated databases for mutual utilization. For an Agency traditionally not known for willingness to be in the vanguard of forward thinking, this would be a significant step forward. Indeed, Psychiatry’s Tom Laughren believes the industry is less prepared to conduct business in revamped fashion than is the FDA, and is challenging the pharma industry to propose streamlined approaches to drug development and regulatory review. How this will be operationalized has yet to be decided and demonstrated.
2) Is there anyone who believes that bapineuzumab will be successful in Phase III? The pessimism is pervasive and across-the-board in the industry. The only questions seem to be: Will a subset of patients be identified via datamining as showing some signs of benefit for bapineuzumab? And with so much pessimism present, how much damage to an already tarnished industry perception will trial failure actually do? The impression from some members of the investment community was that they believe that the media, and hence public, lags well behind the pharma industry in terms of this marked pessimism, which would mean that considerable damage may yet be incurred by trial failure.
3) Elan Pharmaceuticals has utterly failed to make a case for itself in how it handles information disclosure; their public pronouncements when the first hints of problems with bapineuzumab were not transparent or forthcoming, and it took quite a while for the extent of those problems to become apparent. Their credibility remains impaired in the eyes of many of their peers and within the VC investor community.
4) PhiloMetron presented on their array of wireless biological monitors which are in development, potentially offering the ability to obtain data for a wide variety of biomarkers–from sleep indices to physical activity to caloric intake–that is automatically and continuously transmitted from a patient’s home to a central data repository, providing more valid data at far less cost than is required by sleep labs, ADL assessments, and laboratory blood work. These tools have yet to be fully validated, but if they are, the inevitable next question will be how to maintain boundaries around such treasure troves of personal medical data, which could have myriad unanticipated consequences if accessed by the ‘wrong’ parties, such as insurors. In any event, the economies of scale offered by the miniaturization and industrialization of these remote sensors could greatly enhance the efficiency and quality of data obtained during clinical trials.
5) NeuroPerspective has previously published assessments of the current dismal funding climate for CNS R&D (Starvation Rations in the NeuroGulag), but there is some optimism in the venture capital community that 2012 will see an improvement in resource-availability, triggered by pharma acquisitions which will provide opportunities for investor exists. Such exits change the psychology for those considering entry, since CNS investments may not seem like the life sentences that has been the lot for many investors over recent years.
For those who are interested, brief selections from the PowerPoint presentations made by NeuroPerspective at ISCDD 2012 can be downloaded via these links:
Recent and upcoming events for the CNS area:
The 2012 Oscar for most entertaining press release from a CNS company: http://www.niresearch.com/ISCDD%2012%20Panache.pdf