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Colloquium Overview |
Welcome to the Second Annual Pharmaceutical, Biotech and Device Colloquium on the campus of Princeton University. In the summer of 2004 over 300 leaders in the pharmaceutical, biotechnology and device sectors came together at the First Colloquium to discuss business strategy and regulatory challenges. We reconvene in 2005 to address even greater challenges. Pharmaceutical, biotechnology and device enterprises are subject to unprecedented cost-pressures, weaker pharmaceutical pipelines, a commercial "arms race" that has led to some 75 - 90,000 pharmaceutical sales reps on the ground, and increased regulatory scrutiny. Nearly every large and small pharmaceutical and biotech company (and some device companies as well) is asking the same question: How can we reinvent the way we currently do business? Most enterprises are looking at truly transformational change in their cost base across the business system, which includes everything from outsourcing research and clinical trials to India to reducing the field force in favor of other more targeted approaches such as e-detailing. Some in the industry have opted-out of the primary care business entirely to focus on specialty care. Others are looking to analogies from other industries in order to help them design a model that allows them to do their business in a profitable way, while achieving competitive advantage. Some continue to look to mergers and acquisitions and other deals to capitalize on economies of scale. The regulatory environment remains unforgiving. Over the last 18 - 24 months, there has been a massive escalation in the number of high-profile investigations of global pharmaceutical and biopharmaceutical enterprises, both criminal and civil. Settlements for the top 8 - 10 investigations of pharmaceutical companies have totaled between $1.5 and 2.0 billion. Inquiries into sales and marketing fraud have skyrocketed, driven largely by whistleblowers who can profit handsomely from these investigations. And the regulations themselves have become increasingly ambiguous. This regulation ranges from the traditional regulatory schemes implemented by the Food and Drug Administration and the Department of Health and Human Services to the imposition of newer governance standards under Sarbanes-Oxley. Private and public payment for drugs and devices are complex. It is anticipated that this complexity, as well as government scrutiny, will increase under the new Medicare prescription drug law. At some point, the regulations and payment policies that constrain the strategic business alternatives for these enterprises can have a negative impact on the innovation that has transformed healthcare globally and improved the lives of millions. The Pharma, Biotech and Device Colloquium on the campus of Princeton University seeks to make sense of, and tackle, the key challenges and opportunities facing the industry, as well as the new regulatory context. Out goal is to understand the interface between compliance with the regulatory environment and the impact on business strategy and organization. Beyond merely providing an education on the latest regulatory activities, the Colloquium assembles a truly extraordinary faculty of world-renowned chief executive officers and chairs, senior executives, policy makers, investment analysts, management consultants, health policy experts, academics and futurists to articulate these emerging issues and illuminate strategic responses. Specifically, through a series of keynote addresses, detailed discussions and comprehensive, concurrent tracks, the Colloquium addresses the following timely and critical areas:
At the crossroads of enterprise and science, global pharmaceutical, biotechnology and medical device enterprises face extraordinary challenges in the future. This Colloquium will provide a extraordinary faculty to explain and analyze the convergence of emerging regulatory issues and business strategy. |
Who Should Attend: |
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Learning Objectives |
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