BIOMEDevice Forum is the nation’s premier executive-level conference focusing on convergence and cross-sector collaborations among companies in the biotechnology, medical device, IVD, and pharmaceutical industries. This two day event brings together key players involved in investing, partnering, licensing, and developing business opportunities in the rapidly growing market for innovative healthcare products.

WEDNESDAY, SEPTEMBER 10, 2008

8:45	Chair's Opening Remarks
Technology
9:00 - 9:45	Keynote - Converging Visions Convergent medical technologies are transforming healthcare as we currently know it through crosssector collaborations of biotechnology, medical device, pharmaceutical, diagnostics, and information technologies industries. Examine the opportunities convergence has to offer the life sciences. Dr. Mike Samoszuk, Chief Medical Officer, Roche Diagnostics
9:45 - 10:30	The Future of Convergence in Clinical Medicine This session addresses the growing role of convergent technology in the context of the evolving practice of clinical medicine with a focus, in particular, on personalized medicine, improved safety, and expanded capabilities. Examine convergent technology challenges from the perspective of the clinician. Discover how convergence impacts the clinicians and patients in a variety of clinical areas. Hear what physicians need and how it compares to what they are currently receiving. Moderator: Ogan Gurel, MD, Aesis Group Panelists: John Lopez MD, Director, Cardiac Catheterization Laboratory, University of Chicago Hospitals Gokhan Mutlu MD, Assistant Professor, Division of Pulmonary & Critical Care, Northwestern University Pierre Gobin, MD, Professor of Radiology in Neurology and Neurosurgery Director, Interventional Neuroradiology, Weill Cornell Medical College of New York Presbyterian Hospital M. Bret Schneider, MD, Consulting Assistant Professor, Department of Psychiatry, Department of Neurosurgery, Stanford University School of Medicine Geoffrey Gurtner, MD, Professor of Surgery, Division of Plastic Surgery and Reconstruction, Stanford University School of Medicine
10:30–11:00	Networking Break
11:00 - 11:45	Convergent Technologies: Challenges and Opportunities Explore technological timeline and differential effectiveness in terms of convergence activities. Hear which new technologies are effective and which are not, and how new technologies have affected business structures of the cross-sector collaborations among biotechnology, medical device, pharmaceutical, and IVD industries. George Poste, Director, BioDesign Institute
11:45 - 12:30	Enabling Technology in Healthcare Examine convergent medical technologies that enable early detection, prevention, more-targeted delivery, less-invasive surgical procedures, improved efficacy and efficiencies. Hear strategies to integrate and leverage technology platforms to minimize risks and optimize quality and safety. Moderator: Stuart Breslin, Director, Global Delivery Devices, Research & Development, Eli Lilly & Company Panelists: Josiah Wilcox, VP, Technology & Science, Medtronic Cardiovascular Tim Bertram, Senior Vice President, Science and Technology, Tengion Amir Belson, MD, Co-founder and Chief Technical Officer, Neoguide Systems
12:30 - 2:00	Lunch
Innovation
2:00 - 2:45	Strategies for Innovation, Corporate Growth, and Sustainability Examine critical issues in the development and commercialization of combination products, which must be addressed in the development of a convergence strategy. Discuss which pathway to convergence may be appropriate for your organization. Panelists discuss business strategies to address convergence through improved innovation, novel business models, and risk management. Dennis Goldberg, President & CEO, Transport Pharmaceuticals
Collaborations
2:45 - 3:45	Structuring Effective Partnerships Cross-sector collaborations are being utilized to achieve sustainable pipelines, continued profitability, and advancements in healthcare. Different business models are used in each of the converging industries. Enhance your understanding of the values of the various industries and examine the challenges and opportunities of cross-sector partnerships. Co-presenters: Michael Dunn, Vice President Business Development and Chief Business Officer, Monogram Biosciences Stephen Dahms, PhD, President and CEO, Alfred E. Mann Foundation for Biomedical Engineering
3:45 - 4:30	Benchmarking Convergent Medical Technology Partnerships Discuss critical issues impacting the success of cross-sector collaborations. Determine benchmarks for different business models that will allow you to establish a successful combination product partnership strategy. Scott Taper, Analyst, Nerac
4:30	Chair's Closing Remarks

Thursday, September 11, 2008

9:00	Chair's Opening Remarks
Regulatory
9:15 - 10:00	FDA Keynote Frank M. Torti, Principal Deputy Commissioner and Chief Scientist, FDA
10:00 - 10:45	Navigating the Regulatory Landscape for Combination Products Examine the unique regulatory challenges for convergent technologies required to navigate two FDA quality systems. Hear from regulators and industry what’s needed, what’s on the way, and how to best work together for accelerated approvals, while maintaining safety. Moderator: Bradley Merrill Thompson, Executive Director Combinations Products Coalition Panelists: Suzanne Kiani, Genentech Geoffrey Levitt, Vice President and Chief Counsel, Regulatory and Research, Wyeth
10:45 - 11:15	Networking Break
12:30 - 2:00	Lunch
Reimbursement
11:15 - 12:00	Reimbursement Policies Does current Medicare legislation permit coverage for next generation therapies involving combination products? What role do evidence-based medicine and diagnostics play in determining reimbursement assessments? What CMS regulations and policies need to change? How will these changes impact the healthcare systems costs and third party payers? Dennis Goldberg, President & CEO, Transport Pharmaceuticals
12:00 - 12:45	Examine the Economic Feasibility to Develop Convergent Products in Terms of Reimbursement Identify the key economic considerations to determine entry into cross-sector collaboration. Enhance your understanding of evidence-based medicine with regard to the economics of reimbursement for combination products. Address issues of cost-effectiveness and improved health outcomes necessary to achieve reimbursement. Nancy L. Reaven, President, Strategic Health Resources
12:45	Lunch
Intellectual Property/Finance
2:15 - 3:00	Market Growth Combination products are designed to increase efficacy, improve adherence due to ease of use, extend the lifecycle of the product, and improve health outcomes. Of new products currently in development, thirty percent are combination products. Revenue for combination products continues to rise, but where are the areas of growth for combination products? Eduardo Schur, Managing Director, Navigant Consulting
Intellectual Property/Finance
3:00 - 3:45	Intellectual Property Examine the intellectual property issues unique to combination products. Hear the key considerations of venture capitalists surrounding intellectual property of convergent medical technologies. Discuss how to adapt your intellectual property strategies with the ever changing legislative rulings. Moderator: Walter Wu, Associate, Morrison & Foerster Panelists: William C. Revelos, General Counsel, Zeltiq Aesthetics Sanjay S. Bagade, Partner, Levine Bagade Han, LLP Additional Panelist To Be Announced
3:45 - 4:30	Positioning for Investment Hear the insider’s perspective in assessing value and risk of a combination product. What are the key considerations when it comes to investing in a combination product for venture capitalists and angel investors? Moderator: Moderator to be announced Panelists: Ken Andrews, CEO & President, Histogenics Leslie Bortorff, General Partner, Medical Technology, Roeder-Johnson Corporation Nandini Tandon, PhD, Managing Director, Lumira Capital
4:30	Chair's Closing Remarks