The legal and regulatory environment for pharmaceutical, biotech and device companies is becoming increasingly demanding, with no sign of letting up. 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 stake in all of this for pharmaceutical, biopharmaceutical and device companies are hundreds of millions of dollars, the threat of exclusion from federal healthcare programs, and the potential for massive disruption during the time of an investigation. Moreover, 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 new regulatory context and to understand the interface between compliance with these regulations 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 enterprise of the future will look like
• The building blocks necessary to design a world-class compliance organization for both today and tomorrow
• The challenges of operating under a number of international regulatory environments and an overview of successful models for addressing the international regulatory arena
• 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 truly 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