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Study: Forget the 'Blockbusters'
A study whose results were reported December 8 asserts that the pharmaceutical industry's “blockbuster” approach to developing new drugs is no longer viable in today's marketplace. The study, conducted by Bain & Co., a business consulting firm with offices in 19 countries, found that the costs for discovering, developing and launching each new drug had risen to $1.7 billion, an increase of 55% over the average costs for the 5 years from 1995 to 2000. Driving costs upward, the study reports, are declining R&D productivity (one drug compound for every 13 discovered and placed in clinical trials now makes it to market, compared to one in eight between 1995 and 2000), rising costs of commercialization, increasing payor influence (including aggressive patent challenges) and shorter exclusivity periods. These rising costs are expected to drive down investment returns.
One of the co-authors of the study, Ashish Singh, director of Bain's Global Healthcare Practice, opines that large pharmaceutical concerns will need to abandon their present drug development models if they are to remain competitive, but they have thus far failed to do so because they are “prisoner[s] of past successes.” The study suggests that a better strategy for pharmaceutical product development would include increased use of partnerships to spread risk, a more customer-driven approach and development of a more decentralized organizational model based on discrete business units.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
Compliance Officers: Recent Regulatory Guidance and Enforcement Actions and Mitigating the Risk of Personal Liability
This article explores legal developments over the past year that may impact compliance officer personal liability.