Welcome
Chuck R. Reed, Mayor of San Jose

Matthew Gardner, President, BayBio and Steve Halasey, Editor in Chief, MX Magazine

KEYNOTE PANEL DISCUSSION: HEALTHCARE'S BIG PICTURE

• Identifying cross-sector opportunities for advancing healthcare by developing next-generation products.
• Evaluating technologies to discover commercially viable approaches.
• Creating the right business and policy environment to stimulate cross-sector exploration.
• Building life sciences companies with the capabilities needed to support and advance cross-sector product development.

Chair: Robert B. Chess, Chairman of the Board, Nektar Therapeutics
Panel Members: Dr. William Hunter, MD, MSc, President and Chief Executive Officer, Angiotech Pharmaceuticals, Inc.; Howard B. Rosen, Vice President, Commercial Strategy, Gilead Sciences; Peyton Anderson, CEO, Affinergy, Inc.; Thomas L. Gutshall, Co-Founder and Chairman of the Board, Cepheid

11:00-11:45 a.m.

Panel Discussion: Intellectual Properties and Licensing

• What intellectual property protection can be obtained for combination products, especially in light of the recent Supreme Court decision on patent obviousness in KSR International v. Teleflex?
• How does the IP component of cross-sector deals differ from or resemble traditional drug development and in-licensing deals done by large pharma companies and biotech start-ups?
• How is the IP component of such cross-sector deals valued, from the perspectives of the participating companies?
• How do venture capitalists view cross-sector uses of IP? How do they see such deals increasing valuation or the likelihood of a liquidity event?
• How are such cross-sector IP deals typically structured in terms of upfront payments, licensing royalties, milestone payments, and other research and development obligations?
• How should companies protect their IP when negotiating such a transaction? How do the perspectives of biotechnology, medical device, and pharmaceutical companies differ in this regard?

Chair: Richard C. Hsu, Attorney at Law, Townsend and Townsend and Crew LLP
Panel Members: Jim Heslin, Partner, Townsend and Townsend and Crew LLP;
Melinda Griffith, Former Senior Vice President of Law and Licensing, Roche Molecular Systems; Leslie Lippard, Independent Consultant; Ken Haas, Venture Partner, Abingworth Management Inc.

11:45-12:30 p.m.

Defining the Product Development Process

• The public policy context for regulating medical product development
• Results of the Stanford BioDesign study to define the medical device development process
• Implications of results for medical device regulation
• Distinctive characteristics of processes in use among biotechnology, medical device, and pharmaceutical companies
• Implications of results for regulating and managing cross-sector partnerships

Moderator: Martyn W. C. Howgill, Executive Director, InHealth: The Institute for Health Technology Studies
Presenters: John H. Linehan PhD, Consulting Professor of Bioengineering, Stanford University and Jan B. Pietzsch, Consulting Assistant Professor, Department of Management Science and Engineering, Stanford University

2:00-2:30 p.m.

Big Money, Small Money, Converging Money

Session Keynote Presenter: J. Leighton Read, MD, General Partner, Alloy Ventures

2:30-3:00 p.m.

Panel Discussion: Venture Capital and Angel Investor

• Capital available to fund biotech and medtech ventures.
• Roles of angel, VC, and public markets in supporting biotech and medtech companies.
• What start-up or emerging companies should know when seeking funding partners.
• What sectors are hot today.
• Role of corporate partners in funding private companies.

Chair: Frederick J. Dotzler, Managing Director, De Novo Ventures
Panel Members: J. Casey McGlynn, JD, Chairman, Life Sciences Group, Wilson Sonsini Goodrich & Rosati; Robert S. Behl, President and CEO, Percutaneous Systems Inc.;
Mike Carusi, General Partner, Advanced Technology Ventures

Panel Discussion: Corporate Partnering

• How recent cross-sector partnerships and licensing arrangements set the stage for future deals
• What private investors and cross-sector company partners should know when providing support for a convergence venture

Chair: Bruce W. Jenett, Shareholder, Heller Ehrman LLP
Panel Members: TBA

CLOSING REMARKS

Matthew M. Gardner, President, BayBio and Steve Halasey, Editor in Chief, MX Magazine

Panel Discussion: Combination Products Coalition

• Regulatory challenges caused by the regulatory, cultural, business, technological, and legal differences among the biotechnology, medical device, and pharmaceutical industries.
• Working with Washington regulators to develop cohesive policy when the affected industries are fragmented and insular.
• Regulatory schemes for coping with a wide variety of potential types of convergence.
• Dealing with FDA's regulatory systems and cultures, which vary tremendously among biotechnology products, medical devices, and pharmaceuticals.

Chair: Bradley Merrill Thompson, JD, Member of the Firm, Epstein Becker & Green PC
Panel Members: Mark D. Kramer, Vice President, Regulatory Affairs, GE Healthcare and Patrick F. Terry, Co-Founder and Director of Industry Relations, Genomic Health Inc.,
William Andrew Heaton, MD, Vice President, Chief Medical Officer, Chiron, a Novartis Business, Novartis Vaccines and Diagnostics Inc.

Healthcare Economics in a World of Convergence

• The criteria for evaluating medical practice: reasonable and necessary standards meet evidence-based medicine.
• Assessing the value of medical technologies: the CMS Council on Technology and Innovation, and beyond?
• How will the value of next-generation cross-sector products and services be determined?
• What policy changes should third-party payers implement to streamline the development and adoption of new cross-sector medical solutions?

Presenter: John W. Peabody, MD, PhD, Professor, University of California, San Francisco and Los Angeles, Senior Vice President and Medical Director, Sg2

Panel Discussion: Reimbursement

• Creating a critical path for speeding reimbursement: strategic planning versus tactical execution.
• Private-payer technology assessment strategies.
• Role of costs and cost-effectiveness in reimbursement decision making.

Chair: Kuo Bianchini Tong, President and Founder, Quorum Consulting
Panel Members: Gerald N. Rogan, MD, Reimbursement Consultant, Gerald N. Rogan, MD, Consulting; Robin R. Bostic, Vice President, Reimbursement, Thoratec Corp;
Michael Beebe, Director, CPT Editorial and Information Services, American Medical Association; Tien T. Bui, Vice President, Medical Affairs, Monogram Biosciences;
Guy P. Nohra, Co-Founder and Managing Director, Alta Partners

KEEPING IN BOUNDS

2:00-2:45 p.m.

Cross-Sector Views of Product Liability Issues

• Cross-sector concerns presented by direct-to-consumer marketing.
• The increasing industry use of direct-to-consumer advertising and its impact on the liability of manufacturers and on the learned intermediary doctrine.
• Status of federal preemption as a defense to state tort claims.

Presenter: Kevin J. Dunne, Chairman, Sedgwick Detert, Moran & Arnold LLP

Panel Discussion: Liability Issues

• Both FDA and Congress have expressed concern about widespread off-label use of approved medical products. What are the implications of such activity for defending against product liability claims?
• Can informed consent during clinical trials influence the outcome of later product liability claims?
• Does the increasing use of direct-to-consumer advertising by medtech companies affect the availability of the learned intermediary defense in product liability litigation?
• How can the use of consumer-directed information on a Web site sponsored by a medtech company alter the company's product liability risks?
• Review of industry concerns related to the October 2007 Supreme Court review of Riegel v. Medtronic and the issue of federal preemption of state tort laws in suits involving FDA-approved medical devices?
• How and when should cross-sector partners consider how their business venture will address product liability issues?

Chair: Genese Kay Dopson, Attorney at Law, Sedgwick, Detert Moran & Arnold LLP
Panel Members: Kevin M. Quinley, Senior Vice President, Risk Services, Medmarc Insurance Co.; John (Rick) F. Runkel, Senior Vice President and General Counsel, Intuitive Surgical Inc.; Elona Baum, Esq., Director, Policy and Management Operations, Regulatory/Quality/Compliance, Genentech; Madhuri Bhat, Associate Director, Regulatory Affairs, Abbott Vascular

3:30 p.m.