Monday, September 22
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TIME |
TRACK |
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9:00-10:30 a.m. |
Emerging Company Issues |
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Panel: |
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9:00-10:30 a.m. |
International |
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Panel: |
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9:00-10:30 a.m. |
Legal / IP |
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Panel: |
Still Exposed? Legislative and Product Liability Risks for PMA Devices |
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9:00-10:30 a.m. |
Medical Technology Product Innovation |
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Panel: |
Technology’s Role in Improving Medical Care and Reducing Treatment Costs |
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9:00-10:30 a.m. |
Regulatory |
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Panel: |
Understanding the New MDFUMA Clinical Trial Registry Requirements |
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10:30-10:45 a.m. |
Refreshment Break |
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10:45 a.m.-12:15 p.m. |
InHealth Symposium |
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Panel: |
Cardiovascular Technologies: Recognizing Rewards and Reducing Risks |
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10:45 a.m.-12:15 p.m. |
CEO Panel |
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CEO Panel: A Candid Discussion about Innovation and Competition in the Global MedTech Marketplace |
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10:45 a.m.-12:15 p.m. |
Emerging Company Issues |
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Panel: |
What Emerging Companies Must Know: Product Approval, Coverage, Coding, Reimbursement… |
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10:45 a.m.-12:15 p.m. |
Legal / IP |
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Panel: |
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10:45 a.m.-12:15 p.m. |
Medical Technology Product Innovation |
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Panel: |
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10:45 a.m.-12:15 p.m. |
Regulatory |
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Panel: |
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2:00-3:30 p.m. |
InHealth Symposium |
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Panel: |
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2:00-3:30 p.m. |
Emerging Company Issues |
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Panel: |
Strategic Product Management: If I Knew Then What I Know Now |
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2:00-3:30 p.m. |
Legal / IP |
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Panel: |
New Trends in Medical Device Fraud and Abuse/Off-Label Promotion Enforcement |
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2:00-3:30 p.m. |
Medical Technology Product Innovation |
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Panel: |
The Future of Innovation in Cardiovascular Disease Treatments |
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2:00-3:30 p.m. |
Regulatory |
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Panel: |
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3:30-4:00 p.m. |
Refreshment Break (Exhibit Hall) |
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4:00-5:30 p.m. |
InHealth Symposium |
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Panel: |
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4:00-5:30 p.m. |
Emerging Company Issues |
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Panel: |
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4:00-5:30 p.m. |
Legal / IP |
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Panel: |
Can You Really Mitigate the Risk of Whistleblower and False Claims Act Enforcement? |
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4:00-5:30 p.m. |
Medical Technology Product Innovation |
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Panel: |
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4:00-5:30 p.m. |
Regulatory |
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Panel: |
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4:00-5:30 p.m. |
Reimbursement |
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Panel: |
State Government Regulation: A Multi-front Assault on the Industry |
Partnering between Large & Small Diagnostics Companies
Track: Emerging Company Issues
Monday, September 22, 9:00-10:30 a.m.
Room Location: Washington 1
This panel will explore partnering trends between early stage diagnostics companies and large, well established diagnostics or pharmaceutical companies. Alternative partnering models (licensing, co-development, marketing) will be discussed along with best practices and lessons learned.
Moderator: Jonathan Cohen, CEO, 20/20 GeneSystems, Inc.
Panelists:
Robert Hallenbeck, Vice President, Business Development & Strategic Investments, BD
Charlie Raffin, Vice President, Commercial Assessment, Worldwide Franchise Development, Ortho Clinical Diagnostics, a Johnson & Johnson Company
Robert A. Schueren, Senior Director, Companion Diagnostics, Genentech Inc.
Richard Tarbox III, Senior Vice President, Corporate Development Officer, Quidel Corporation
Lucy Lu, Vice President, Business Development, Rigen
Still Exposed? Legislative and Product Liability Risks for PMA Devices
Track: Legal / IP
Monday, September 22, 9:00-10:30 a.m.
Room Location: Washington 4
The Supreme Court’s recent decision in Riegel v. Medtronic, Inc. confirms the long-standing holdings of lower federal courts granting medical device manufacturers protection against certain product liability lawsuits. Manufacturers of medical devices approved by FDA for marketing through the pre-marketing approval process (“PMA”) now have strong preemption defense to most product liability claims. Although Riegel by no means signals an end to product liability litigation against even PMA-approved devices, the decision has sparked vigorous legislative efforts to reverse the Supreme Court’s decision. Anti-preemption legislation is pending in both the House and the Senate, and Congress has demanded substantial amounts of information from FDA on its policies affecting preemption. This panel will explore the legislative landscape as it intersects with medical device litigation. It will focus on the potential course of the legislative initiatives and possible strategies – political, public relations, regulatory and legal – that will or should emerge. It will also consider the future path of litigation against medical device manufacturers, with or without legislation – in particular, the degree to which “fraud on the FDA” claims afford plaintiffs a detour around Riegel, and how that prospect might affect the legislative and regulatory arenas.
Moderator: Robert N. Weiner, Partner, Arnold & Porter LLP
Panelists:
Jim Ladner, St. Jude Medical
Globalization of DRGs
Track: International
Monday, September 22, 9:00-10:30 a.m.
Room Location: Washington 2
This panel, composed of experts on the French, Swiss and U.S. DRG systems, will discuss advice they have provided, or would provide, to other countries on DRGs – including budgetary implications and data requirements. For example, Germany signed an MOU with China to provide guidance on DRGs.
Moderator: Gabriella Soskuty, Vice President, Government Affairs, Health Policy & Economics, B.Braun
Panelists:
Martine Aoustin, Ph.D., Director of Operations, Mission T2A, Ministry of Health & Welfare (France)
Steve Phillips, Director, Health Policy, Johnson & Johnson
Carlo Conti, President, SwissDRG Invited
Technology’s Role in Improving Medical Care and Reducing Treatment Costs
Track: Medical Technology Product Innovation
Monday, September 22, 9:00-10:30 a.m.
Room Location: Harding
Some say healthcare costs are rising globally in part due to increased availability of sophisticated devices and tests supporting medical diagnosis and treatment. The burden to payors is substantial and increasingly prominent in the introduction of new technologies. This panel will discuss the emergence of diagnosis and treatment options that reduce the overall cost burden while maintaining the same or higher quality of medical care. Ranging from improved hospital and outpatient IT structures to sophisticated at-home medical devices, the panel will explore both technological and regulatory frontiers and evaluate how medical device industry, policy makers and payors can work together towards bringing these novel technologies into the market. Speakers on the panel represent international companies acting as integrators for new technologies, health policy responsible for improving efficiency through use of integrated solutions, small companies with devices that can be integrated to assist medical professionals and payors who are focusing on patient outcome and cost savings in their approval processes for new products.
Panelists:
Brian Russell, CEO, Zephyr Technologies
David G. Armstrong, DPM, Ph.D., Professor of Surgery, University of Arizona College of Medicine
Liesl M. Cooper, Ph.D., Vice President, Global Healthcare Economics, Policy & Reimbursement, Covidien
Chris Miller, Senior Director, Healthcare Economics and Reimbursement, Medtronic Asia Pacific
Understanding the New MDUFMA Clinical Trial Registry Requirements
Track: Regulatory
Monday, September 22, 9:00-10:30 a.m.
Room Location: Washington 5
The Medical Device User Fee and Modernization Act (MDUFMA) has been reauthorized for fiscal years 2008 – 2012. In doing so, Congress provided the FDA with new responsibilities and they established new requirements of manufacturers. The focus of this panel is to discuss the new MDUFMA Clinical Trial Registry requirements and its implementation while addressing the uncertainties about the new legislation. Medical Device companies must comply with the new provisions and regulatory professionals are required to know what studies need to be reported and how to comply. This panel session will be interactive and informative with speakers representing industry and the legal aspects of the Act.
Moderator: Mark Heller, Esq., Partner, Goodwin Procter, LLP
Panelists:
Lisa Griffin Vincent, Ph.D., Senior Director, Corporate Clinical and Healthcare Policy, Medtronic, Inc.
Jodi Raus, RAC, Director of Regulatory Affairs, AGA Medical Corporation
Cardiovascular Technologies: Recognizing Rewards and Reducing Risks
Track: InHealth Symposium
Monday, September 22, 10:45 a.m.-12:15 p.m.
Room Location: Coolidge
As treatments for heart and vascular diseases have advanced, left behind are the days when mortality was high and costs were low. With the development of catheters, stents, implantable devices and imaging technologies, treatments that once were invasive, painful and risky have been replaced by safer procedures with better benefits. Yet as deaths from heart disease have dropped, concerns about costs and therapeutic risk have risen. Panelists will bring data and informed opinion to a comprehensive discussion of how best to maximize public benefit through technology innovation.
Moderator: Peter W. Groeneveld, M.D., M.S., Assistant Professor of Medicine, University of Pennsylvania
Panelists:
Thomas J. Philipson, Ph.D., Daniel Levin Professor of Public Policy Studies, Irving B Harris Graduate School of Public Policy Studies, University of Chicago
David J. Magid, M.D., M.P.H., Director of Research, Colorado Permanente Medical Group
Sarah J. Goodlin, M.D., President, Patient-Centered Education and Research, Inc.
CEO Panel: A Candid Discussion about Innovation and Competition in the Global MedTech Marketplace
Track: CEO Panel
Monday, September 22, 10:45 a.m.-12:15 p.m.
Room Location: Harding
The CEOs of today's leading medtech companies must foster and promote climates of innovation within their organizations, yet manage resources wisely and keep their companies focused on meeting the needs patients and the global marketplace. In this wide-ranging panel discussion moderated by Steve Halasey, editor in chief of MX magazine, company CEOs share their experience in assessing the effects of current market trends and recent events on key leadership decisions. Panelists will offer their views on a variety of considerations, including:
- Current sources of intellectual property and medtech innovation.
- Keeping informed about rapid changes in the global marketplace.
- Models for funding innovation while minimizing financial risk.
- How to plan for the medtech marketplace of the future.
- Balancing short-term and long-term corporate objectives.
Moderator: Steve Halasey, Editor, MX Magazine
Panelists:
Michael Dale, President & CEO, ATS Medical
James Mazzo, Chairman, President & CEO, Advanced Medical Optics (AMO)
Michael Mussallem, President & CEO, Edwards LifeSciences
Sandra Peterson, CEO, Bayer Healthcare LLC, Diabetes Care Division
What Emerging Companies Must Know: Product Approval, Coverage, Coding, Reimbursement…
Track: Emerging Company Issues
Monday, September 22, 10:45 a.m.-12:15 p.m.
Room Location: Washington 1
This panel will provide critical insights into several of the most important and timely issues that confront every emerging company in the medical device arena. Investors expect emerging companies to have appropriate plans and even back-up plans in place to respond to these issues. Panelists will address practical strategies for manufacturers of new medical devices for meeting FDA requirements. In addition, the panel will address Medicare coverage and coding decisions and their impact on Medicare and other payor payment determinations. Panelists will share their expertise and personal experiences in dealing with these issues
Moderator: Alan K. Parver, Esq., Partner, Powell Goldstein LLP
Panelists:
Steven K. Stranne, M.D., J.D., Partner, Powell Goldstein LLP
Bryan H. Benesch, Special Assistant to the Director, Center for Devices and Radiological Health, FDA
Janet Garetto, Esq., Partner, Nixon Peabody LLP
Value and Enforcement of Patents Outside the United States
Track: Legal / IP
Monday, September 22, 10:45 a.m.-12:15 p.m.
Room Location: Washington 4
Companies that sell products internationally need carefully crafted IP protection strategies that safeguard valuable intangible assets in strategically competitive markets, at a cost that makes good business sense. It is not always easy to know whether the cost of the protection is worth its price, not only in markets with strong IP policies, but in emerging markets like China and India. This panel will discuss the enforceability of IP rights in jurisdictions around the world, including Europe, Japan, China and India, then will discuss global enforcement strategies, including procedures for stopping goods at the U.S. border through the U.S. International Trade Commission and issues surrounding compulsory licensing in certain countries. The panel will address how one can enforce patents throughout Europe by beginning proceedings in one European country and extending to others. The panel will then provide an overview of patent filing strategies that consider the cost and effectiveness of obtaining and enforcing IP rights. This panel brings together representatives of medical device companies with outside law firms having experience enforcing intellectual property rights around the world. A good enforcement strategy requires a realistic consideration of cost, and the panelists will address cost considerations surrounding global IP protection and enforcement. Costs involved in enforcement activities can be substantial, and the costs associated with filing and maintaining patents around the world can at times exceed the value of the protection provided. While each business person must make such decisions based on specific business strategies, the panel will provide a legal framework for evaluating these decisions based on real-world experience.
Moderator: Luca Sutto, Principal, Fish & Richardson P.C.
Panelists:
Gael Diane Tisack, Esq., General Counsel Terumo Cardiovascular Systems
Peter L. Olson, Esq., Office of Intellectual Property Counsel, 3M Innovative Properties Company
James R. Chiapetta, Esq., Senior Patent Counsel, Boston Scientific Corporation
David Knight, Esq., Partner, Field Fisher Waterhouse
Guiding Principles for Global Wound Care Policy
Track: Medical Technology Product Innovation
Monday, September 22, 10:45 a.m.-12:15 p.m.
Room Location: Washington 2
The Guiding Principles for Wound Care Policy were developed by the World Union of World Healing Societies Global Reimbursement Task Force as a platform for development of patient assessment, patient and caregiver education, clinical practice guidelines, research protocols and public health policy. The principles were presented for final public comment at the World Union of Wound Healing Societies in Toronto in June 2008. Following that meeting, the final edited version will be submitted for endorsement by patient advocate groups, clinical and professional organizations and public policy bodies throughout the world. This panel session will be the first U.S. presentation of the final principles. Panel representatives will review the individual principles for patients, caregivers and health policy makers and will discuss implementation opportunities and obstacles in all care settings globally. The panel will be comprised of a wound care patient advocate, a wound care clinical expert, international representatives from companies engaged in the manufacture and development of advanced wound technologies, and a U.S. government health policy maker. This panel is being sponsored by the AdvaMed Advanced Wound Management Sector.
Moderator: Joseph Rolley, Director, Public Policy & Reimbursement, ConvaTec Inc.
Panelists:
R. Gary Sibbald, BSc, MD, FRCPC (Med) (Derm), Med, Professor of Medicine & Public Health Sciences, University of Toronto; Director of Wound Healing Clinic, New Women's College Hospital; Clinical Associate Editor, Advances in Skin & Wound Care
Elizabeth A. Ayello, PhD, RN, APRN, BC, CWOCN, FAPWCA, Clinical Associate Editor, Advances in Skin & Wound Care; Faculty, Excelsior College, School of Nursing; Executive Editor, Journal of the World Council of Enterostomal Therapists
The Postmarket Transformation Initiative: An Update
Track: Regulatory
Monday, September 22, 10:45 a.m.-12:15 p.m.
Room Location: Washington 5
This session will examine the Postmarket Transformation Initiative established by the FDA in January 2006. The session will explore how improved data systems and communications efforts, and the culture of collaboration within the agency, have affected enforcement strategies and outcomes. The session will also examine the effect upon industry and opportunities for increased communication with the agency in the context of the Postmarket Transformation Initiative.
Moderator: Michael Morton, Senior Director, Regulatory Affairs, Medtronic Inc.
Panelists:
Jonathan Sackner-Bernstein, M.D., Associate Center Director for Postmarket Operations, FDA CDRH
Diane Mitchell, M.D., Postmarket Team Leader, FDA CDRH
Tim Ulatowski, Director of Office of Compliance, FDA CDRH
Beverly Lorell, M.D., Senior Medical & Policy Advisor, King and Spalding
Nancy Coulson, Director of Regulatory Affairs, Cordis Corporation
Comparative Effectiveness: For Whom Does this Bell Toll?
Track: InHealth Symposium
Monday, September 22, 2:00-3:30 p.m.
Room Location: Coolidge
Comparing competing diagnostic and therapeutic technologies at first seems obvious, although studies are few and variation among treatment patterns across the USA remains great. As the nation’s health bill rises, comparative effectiveness research (CER) is considered a valuable tool for multiple purposes. It provides information for physicians and patients to select the best therapy. And it may enable payors to make coverage decisions. But for individual patients should we seek lowest cost – or best practice? And will forcing reductions in clinical practice variation enable future innovative medical technologies to emerge? This panel will address current proposals for CER and their implications for coverage and private and public sector reimbursement policies. Audience members will be updated on the status of current legislative efforts to address CER, ongoing government research in this area, and the likelihood of CER contributing to a reasonable balance between improved health outcomes and reduced costs. As the 2008 Presidential Election heats up, panelists will bring focus to this vital discussion and seek to balance the understanding of its risks and rewards.
Moderator: Lu Zawistowich, Sc.D., Senior Health Policy Advisor, Patton Boggs, LLP
Panelists:
Carolyn Clancy, M.D., Director, AHRQ
Liz Fowler, JD, Ph.D., Senior Counsel to the Chairman and Chief Health Counsel, Finance Senate Committee
Strategic Product Management: If I Knew Then What I Know Now
Track: Emerging Company Issues
Monday, September 22, 2:00-3:30 p.m.
Room Location: Washington 1
You have a convincing business plan, confident management team, adequate capital, disruptive technology, an exit strategy and support from your Board of Directors. Now all you have to do is guide your executive management team to and through milestones that will lead to success. Attend this interactive session and reach out, network, discuss issues impacting successful product launches and gain first-hand insights from a panel of medical technology Chief Executive Officers who have "been there and done that" and will share how they responded to unexpected opportunities, road blocks, questions from stakeholders and issues raised by board members in the quest to reach their strategic goals.
Moderator: David Cassak, Managing Partner, Windhover Information Inc.
Panelists:
Thomas M. Loarie, Chairman & CEO, Mercator MedSystems, Inc.
Rick Randall, President & CEO, Trans 1
Robert Rabiner, President & CEO, Illuminoss Medical Inc.
Mir Imran, Managing General Partner, In Cube Ventures
Richard Tarbox III, Senior Vice President, Corporate Development Officer, Quidel Corporation
New Trends in Medical Device Fraud & Abuse/Off-Label Promotion Enforcement
Track: Legal / IP
Monday, September 22, 2:00-3:30 p.m.
Room Location: Washington 4
After principally focusing on medical providers and the pharmaceutical industry, federal fraud and abuse enforcement is now aimed squarely at the medical device industry. Several companies recently paid approximately $310 million to settle alleged fraud and abuse violations. Moreover, fraud and abuse laws have become the latest enforcement tool to attack off label promotion. The pharmaceutical industry has already been hard hit by off-label enforcement. Last year, Pfizer paid nearly $35 million to settle off-label marketing claims of its growth hormone Genotropin, joining the ranks of companies large (Eli Lilly) and small (Intermune) to recently settle with the DOJ over alleged off-label promotion. Less than two years ago, a subsidiary of Schering-Plough agreed to pay $435 million in criminal and civil fines related to a single count of off-label promotion. Now, the US DOJ is apparently investigating more than 150 drug and medical device companies for alleged off-label promotion. The costs of fraud and abuse enforcement include not only significant fines but multi-year Corporate Integrity Agreements, which require companies to restrict and monitor their business practices and add significant expense to compliance efforts. Moreover, companies' reputations and relationships with clients are also adversely effected. The purpose of this panel will be to provide medical device companies with guidance for fraud and abuse and off-label promotion compliance in an increasingly scrutinized enforcement environment.
Moderator: W. Andrew Gantt, Partner, Latham & Watkins LLP
Panelists:
Jesse A. Witten, Deputy Associate Attorney General, U.S. Department of Justice
Jeffrey Senger, Deputy Chief Counsel, Food & Drug Administration
Daniel Meron, Partner, Latham & Watkins LLP
The Future of Innovation in Cardiovascular Disease Treatments
Track: Medical Technology Product Innovation
Monday, September 22, 2:00-3:30 p.m.
Room Location: Washington 2
Cardiovascular disease is the number one killer in the world and future innovations in this field are critical. How fast will a shift to minimally invasive procedures occur? Are approval and reimbursement systems appropriately encouraging investment in these areas? Will such systems be able to keep up with the fast pace of change? Hear a distinguished panel of experts in the field discuss these unanswered questions, and more.
Moderator: Stephen Levin, Executive Editor, IN VIVO
Panelists:
Lowell F. Satler, M.D., Director of Interventional Cardiology, Washington Hospital Center
Daniel G. Schultz, M.D., Director of the Center for Devices and Radiological Health, Food and Drug Administration (FDA)
Larry L. Wood, Corporate Vice President, Transcatheter Valve Replacement, Edwards Lifesciences
Jeffrey Rich, M.D., Director of CMS Center for Medicare Management
510K Program
Track: Regulatory
Monday, September 22, 2:00-3:30 p.m.
Room Location: Washington 5
The United States Food and Drug Administration’s 510(k) process for medical devices is of critical importance in ensuring that medical devices are neither under-regulated nor over-regulated. This critical regulatory program is too often misunderstood and mischaracterized, but has tremendous significance in the everyday lives of our citizens. Although largely unrecognized, it is estimated that 90% of medical devices have been authorized to be marketed in the US through the 510(k) process. This panel will describe the history of the 510(k) process, the application of the process to medical devices entering the market today, and ability of the process to appropriately address the broad range of medical technology.
Moderator: Pat Shrader, Senior Vice President, Corporate Regulatory & External Affairs, BD
Panelists:
Pat Shrader, Senior Vice President, Corporate Regulatory & External Affairs, BD
Susan Alpert, M.D., Ph.D., Senior Vice President, Chief Quality & Regulatory Officer, Medtronic, Inc.
Mark Gordon, Vice President, Global Regulatory Advocacy and Policy, Boston Scientific Corporation
Personalized Medicine: Realizing the Potential
Track: InHealth Symposium
Monday, September 22, 4:00-5:30 p.m.
Room Location: Coolidge
Health care is becoming an information technology, as the human genome is decoded and technologies developed that permit its repair and predict our response to tailored therapies. These advances allow us to improve stratification and diagnosis of disease and target it with more effective and ever less-invasive treatments. While this field holds much promise, significant barriers for broader adoption remain. These include lack of financial incentives, regulatory uncertainty, clinician education, access and integration of supportive evidence. Panelists representing different constituencies will review the state of diagnostic and personalized medical science, examples of success (including K-Ras), barriers to adoption, the most promising policy alternatives and current initiatives.
Moderator: Iain D. Miller, Ph.D., Senior Director, Oncology Strategy and Theranostics, bioMerieux
Panelists:
Gregory J. Downing, D.O., Ph.D., Senior Advisor and Project Director, Personalized Health Care Initiative, Immediate Office of the Secretary, Department of Health and Human Services
Carol McCall, Vice President, Research, Humana
David Reese, M.D., Executive Director, Global Program Area Leader, Oncology Therapeutics, Amgen
The Insider’s View on Medical Device Investing: Perspectives from Private Equity, Venture Capital, and Other Institutional Investors
Track: Emerging Company Issues
Monday, September 22, 4:00-5:30 p.m.
Room Location: Washington 1
This panel will be moderated by Ted Kennedy, Jr., President and Co-Founder of the Marwood Group & Co. The members of the panel are private equity professionals that spend the majority of their professional time investing in medical device transactions. We will have one individual from each of the three size-bands of institutional investors. This would include one venture investor, one middle-market healthcare investor and one LBO (leveraged buy-out) investor. Each of the panelists will discuss where they are currently investing within the medical device space and the trends they are seeing. They will provide a case study each of prior transactions they have engaged in and how they got to their exit.
Moderator: Ted Kennedy, Jr., President, The Marwood Group
Panelists:
James Thomas, Partner, Thomas, McNerney & Partners
David Milne, Partner, SV Life Sciences
Zubeen Shroff, Managing Director Galen Partners
Can You Really Mitigate the Risk of Whistleblower and False Claims Act Enforcement?
Track: Legal / IP
Monday, September 22, 4:00-5:30 p.m.
Room Location: Washington 4
The medical device industry has adopted the AdvaMed Code and related standards as part of extensive compliance programs designed to meet all applicable requirements. These efforts include mechanisms to identify and address problems before they ripen into whistleblower claims. False Claim Act (FCA) enforcement efforts involving medical device companies and related providers continue to intensify. Given the serious nature of these cases, it has become critical to understand the factors that have contributed to the substantial financial penalties and awards to whistleblowers as well as CIAs, DPAs, appointed monitors and other onerous terms imposed in these cases. It has also become necessary to understand why increasing Medicaid enforcement and new state false claims laws will help enforcers, relater counsel and whistleblowers to view medical device companies as tempting FCA targets. The panel will discuss this growing threat and address whether existing compliance, governance and related protective measures are sufficient. The panel will review trends in FCA enforcement, and share insights on the future of governmental and relater enforcement. Key prosecution, defense, compliance and governance issues will be reviewed as the panelists share their views on lessons learned in the course of whistleblower cases. The panel will also identify compliance, governance and operational strategies that have assisted companies in avoiding problems. The panelists will also assist attendees in understanding how these controversies are triggered, and practical steps that can be taken to reduce the likelihood of whistleblower controversy.
Moderator: Patrick S. Coffey, Partner, Locke Lord Bissell & Liddell LLP
Panelists:
Michael W. Peregrine, Partner, McDermott Will & Emery LLP
Katie A. Arnholt, Senior Counsel, Office of the Inspector General, Department of Health & Human Services Invited
Peg Hutchinson, Assistant U.S. Attorney, U.S. Attorney's Office for the Eastern District of Pennsylvania
Jeffrey E. Rogers, Partner, McGuire Woods LLP
Emerging Opportunities for Medical Devices Used in Oncology
Track: Medical Technology Product Innovation
Monday, September 22, 4:00-5:30 p.m.
Room Location: Washington 2
Approximately 20 million people have cancer in Japan, Europe and North America and 10 million new cases of cancer are diagnosed each year worldwide. Almost 1.5 million Americans will be diagnosed with cancer this year, and more than 500,000 Americans will die of the disease in 2008. The death rate per 100,000 population in the United States has been fairly stable since 1950, highlighting the clear failure of current pharmaceutical intervention in cancer treatment. The 5-year relative survival rate for all cancers diagnosed between 1996 and 2003 has increased primarily due to earlier detection, a direct result of superior medical device technology. Cancer imposes a heavy economic burden on the healthcare system, with spending in the U.S. alone of $89.0 billion for direct medical costs (total of all health expenditures). Medical device technology will play a key role in successfully treating cancer and reducing these healthcare costs. Applications for medical devices in cancer treatment include cancer detection and staging, surgical intervention and reconstruction, direct medical device therapy, therapy delivery and treatment efficacy monitoring. This panel / workshop will discuss current and future applications for medical devices used in cancer treatment. The panel will provide a broad overview of medical devices that are currently used in this market, along with potential new technologies to address the unmet need. Future challenges in developing medical devices for use in cancer treatment will be discussed, including market development, safety, regulatory, reimbursement, and ethical considerations.
Moderator: Lydia Villa-Komaroff, Ph.D., CEO, Cytonome, Inc.
Panelists:
Thomas Miller, CEO, Workflow and Solutions, Siemens HealthCare
Deborah J. Neff, President and CEO, Pathwork Diagnostics, Inc.
Euan Thompson, Ph.D., CEO, Accuray Incorporated
Global Regulatory Challenges & Opportunities
Track: Regulatory
Monday, September 22, 4:00-5:30 p.m.
Room Location: Washington 5
The United States, European Union (EU) and Japan are overwhelmingly the largest markets for medical technology and affect regulatory practices in other countries. The panelists would discuss regulatory issues in these various markets, including the EU’s proposed “recast,” the US heightened focus on import safety, and Japan’s response to its lengthy approval process (the “device lag.”). The moderator will tie together these markets and assess whether regulatory trends are converging, as proposed by the Global Harmonization Task Force – of which all three countries are members – or diverging.
Moderator: Janet Trunzo, Vice President, Regulatory Affairs, AdvaMed
Panelists:
Harold Smith, Representative Director, LEK/Acumen Japan
Tim Ulatowski, Director of Office of Compliance, FDA CDRH
Peter Bischoff-Everding, Legal Officer, European Commission, DG Enterprise and Industry, Unit F-3 "Cosmetics & Medical Devices"
State Government Regulation: A Multi-front Assault on the Industry
Track: Reimbursement
Monday, September 22, 4:00-5:30 p.m.
Room Location: Harding
While Washington is the primary source of government regulation impacting access to medical technology, state governments are increasingly considering and adopting initiatives ranging from marketing restrictions to technology assessment programs that have the potential to create significant barriers to appropriate patient access. Learn about these challenges, as well as potential opportunities, and their impact on your company from key industry state government relations professionals.
Moderator: Marcie M. McNelis, Executive Vice President, Corporate Secretary & Principal, Multistate Associates
Panelists:
Don Bohn, Vice President, U.S. Government Affairs, Johnson & Johnson
Don Gerhardt, President & CEO, LifeScience Alley
Peter Slone, Vice President of Government Affairs, Medtronic, Inc.