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:

• What a winning pharmaceutical, biotechnology and device model enterprise of the future will look like
• The challenges that pharmaceutical, biotechnology and device enterprises face when doing business abroad
• The benefits of an integrated approach to compliance across all regulatory and payment disciplines that can be put in place through a program of enterprise-wide risk management
• The specific regulatory challenges facing pharmaceutical, biotechnology and device manufacturers
• The importance of, and approach to, building a culture of corporate integrity and trust through performance leadership and developing people capabilities
• Key success factors for building the medical affairs organization and sales force of the future
• The regulators' perspective on future high risk areas
• The public and employer's perception of the pharmaceutical, biotech and device industry

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.

• Pharma, Biotech and Device Board Members and Senior Executives
• Pharma, Biotech and Device Legal Counsel and Compliance Professionals
• Pharma, Biotech and Device Medical Affairs, Marketing and Sales Force Leaders
• Health Care Regulators and Policy Makers
• Private Employer and Public Purchaser Representatives
• Health Plan, Third Party Administrator, PBM and Pharmacy Representatives
• Hospital and Health System and Physician Organization Representatives
• Institutional Investors, Investment Bankers and Venture Capitalists
• Health Care Attorneys, Consultants and Vendors
• Health Care Auditors and Actuaries
• Health Policy Experts and Health Services Researchers

• To Provide a Primer on Regulatory Compliance and Risk Management in Pharmaceutical, Biotechnology and Medical Device Enterprises and Implications for Business Strategy
• To Articulate the Perspectives of Employers, Health Plans and PBMs regarding the Roles and responsibilities of Pharmaceutical, Biotechnology and Medical Device Enterprises
• To Assess the Implications of Regulation and Compliance on the Future of Sales and Marketing and Medical Affairs Organizations
• To Present a Pharma/Biotech/Device Regulators Roundtable and Law School for Pharmaceutical, Biotechnology and Medical Device Manufacturer Executives
• To Outline Application of a Risk-Based Compliance Model to Clinical and Manufacturing Operations
• To Share Best Practices in Regulatory Compliance, Governance and Enterprise-Wide Risk Management Across organizations
• To Describe and Assess the Interface of Regulation and Business Strategy for Global Pharmaceutical, Biotechnology and Medical Device Enterprises