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WEDNESDAY, DECEMBER
7 • MINNEAPOLIS, MN
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This is the 10th ANNIVERSARY
of the Conference & Expo |
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| PREMIER SPONSORS: |
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| Speaker
Biographies |
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Since
its inception,
the
LifeScience Alley® Conference
& Expo has attracted hundreds of speakers
from all over the globe-government
and industry leaders, Nobel
Prize Laureates, and senior international
officials. This year's event promises thought-provoking
presentations related to current trends
and innovations in the life science industry. |
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| Breakfast General Session -
Seeing Beyond Silos - Innovative Collaborations Among Providers, Payors, and Industry |
| David Moen, MD, President, Fairview Physician Associates, Fairview Health Services |
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Dr. Moen leads this integrated, multi-specialty provider network built on the belief that providers are in the best position to transform care. He provides strategic and visionary leadership to create a common operating framework, innovative care delivery models, and resources so network members are equipped to accept and manage risk.
He has served as Fairview's Medical Lead in partnership with Target Corporation, Chief of Medical Staff for award-winning Fairview Lakes Regional Medical Center, and on Boards of Directors for Fairview Lakes Health Services, Lakes Region Ambulance Service, and the Minnesota College of Emergency Physicians.
Dr. Moen also currently serves as Chief Medical Officer of NetClinic, a web-based program that serves as an interactive personal health portal to allow virtual care delivery involving patients and clinicians.
He holds an MD from University of Wisconsin and completed his Family Medicine residency at the University of Minnesota.
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| Richard Kuntz, MD, MSc, Senior Vice President & Chief Scientific, Clinical & Regulatory Officer, Medtronic, Inc. |
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Dr. Rick Kuntz is Senior Vice President and Chief Scientific, Clinical and Regulatory Officer of Medtronic, Inc. In this role, which he assumed in August 2009, Kuntz oversees the company's global regulatory affairs, health policy and reimbursement, clinical research, ventures and new therapies and innovation functions.
Kuntz joined Medtronic in October 2005 as Senior Vice President and President of Medtronic Neuromodulation which encompasses the company's products and therapies used in the treatment of chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis. In this role he was responsible for the research, development, operations, and product sales and marketing for each of these therapeutic areas worldwide.
Kuntz brings to Medtronic a broad background and expertise in many different areas of healthcare. Prior to joining Medtronic he was the Founder and Chief Scientific Officer of the Harvard Clinical Research Institute (HCRI), a university-based contract research organization which coordinates National Institutes of Health (NIH) and industry clinical trials with the United States Food and Drug Administration (FDA). Kuntz has directed over 100 multicenter clinical trials and has authored more than 200 original publications. His major interests are traditional and alternative clinical trial design and biostatistics.
Kuntz also served as Associate Professor of Medicine at Harvard Medical School, Chief of the Division of Clinical Biometrics, and an interventional cardiologist in the division of cardiovascular diseases at the Brigham and Women's Hospital in Boston, MA.
Kuntz graduated from Miami University and received his medical degree from Case Western Reserve University School of Medicine. He completed his residency in internal medicine at the University of Texas Southwestern Medical School and then completed fellowships in cardiovascular diseases and interventional cardiology at the Beth Israel Hospital and Harvard Medical School, Boston. Kuntz received his master's of science in biostatistics from the Harvard School of Public Health.
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| Alison H. Page, MHA, MSN, RN, CEO, Baldwin Area Medical Center, Inc. |
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Alison joined BAMC as its CEO in 2009. From 1996 to 2008 she was a member of the administrative team of Fairview Health Services, a large, integrated health care delivery system in Minnesota. At Fairview, Alison served as the company's Chief Safety Officer for seven years. Prior to that, she oversaw operations of the hospital and clinics in the Fairview Red Wing Care System. She also has 15 years of clinical experience as a registered nurse.
Alison received her Master of Healthcare Administration degree and Master of Science degree from the University of Minnesota. She also holds a Bachelor of Science degree in Nursing from Marquette University.
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| Craig E. Samitt, MD, MBA, President & CEO, Dean Health System |
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As President and CEO of Dean Health System since 2006, Dr. Samitt leads one of the largest integrated delivery systems in the Midwest. Under Dr. Samitt's leadership, Dean has achieved a rapid transformation of its operational and strategic performance, and through delivery of "better care at a lower cost," has become one of the nation's leading examples of a high-performing Accountable Care Organization.
Dr. Samitt has served for over 15 years in senior healthcare leadership roles. He began his career at Harvard Community Health Plan, where he served as Executive Director of HCHP's flagship site. Dr. Samitt subsequently served on the turnaround team of Harvard Pilgrim Health Care as Senior Vice President. He was then Chief Operating Officer at Fallon Clinic, a leading multi-specialty group practice in New England.
Dr. Samitt received his BS from Tufts University, his MD from Columbia University and his MBA from the Wharton School.
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| Luncheon General Session - Body Computing and Patient-Networked Technologies |
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| Leslie A. Saxon, MD, Chief, USC Division of Cardiovascular Medicine, Executive Director, USC Center for Body Computing, Keck School of Medicine, University of Southern California |
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Leslie A. Saxon, M.D., is Chief of Cardiovascular Medicine at the Keck School of Medicine of USC and specializes in the diagnosis and treatment of arrhythmias in patients with congestive heart failure. In addition to using state-of-the-art resynchronization devices in patients with arrhythmias, Dr. Saxon frequently collaborates with medical device companies to evaluate the latest, most innovative interventional gadgets for patients with difficult-to-treat heart conditions. In 2010, she formed the USC Center for Body Computing, which brings together diverse faculty from USC's schools of medicine, business, cinematic arts, engineering, and others to work collaboratively with industry leaders on Health innovations. |
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| Afternoon General Session - Regulatory Science: Reducing the Cost and Time to Market Through Scientific Innovations |
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| Jeff Shuren, MD, JD, Director, Center for Devices and Radiological Health (CDRH), United States Food and Drug Administration (FDA) |
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Jeffrey E. Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products; and fostering device innovation. Dr. Shuren has held various policy and planning positions within FDA, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy. |
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| Speakers
are listed in alphabetical order by last
name |
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| Blair Allen, Vice President, Global Sales & Marketing, ACIST Medical Systems |
| Sales & Marketing | Session 2 |
Blair Allen is the Vice President of Global Sales and Marketing for ACIST Medical Systems, a company dedicated to providing novel Advanced Contrast Imaging System Technologies in the field of interventional cardiology and radiology. ACIST is a privately held company owned by the Bracco Group in Milan, Italy. ACIST Medical Systems has over 200 employees and a global reach in over 50 countries. Blair has over 20 years of sales and marketing experience in medical devices, bio technology, and pharmaceuticals. He has held marketing and sales leadership positions at Eli Lilly and Company, Guidant Corporation, and now ACIST Medical Systems. He joined ACIST in 2008 and leads a global commercial team focused on executing sales and market penetration strategies across the world. In his current role Blair has responsibilities for both upstream and downstream marketing, leading a sales team of 70 people and managing a large network of global distributors.
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| Christopher Anderson, BSEE, Chief Solutions Technologist, Spectrum Design Solutions |
| Product Development | Session 1 |
Chris obtained a BSEE from the Milwaukee School of Engineering in 1997 and has focused on radio related product development ever since. Chris’s professional career includes positions at Grayhill, NextNet, Motorola, and finally at Spectrum Design. At Spectrum, Chris has executed and overseen hundreds of successful RF/cellular product developments for companies like Qualcomm, Medtronic, Bosch, GE, Honeywell, Goodrich, Boston Scientific, Emerson, and others. Chris has been responsible for all aspects of radio product development including designing the radio solution, custom antennas, and production test systems to carrying the product development through agency certifications and manufacturing. |
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| Rose Anderson, Designer & Researcher, Center for Innovation, Mayo Clinic |
| Research & Innovation | Session 1 |
Rose Anderson is a designer / researcher at the Mayo Clinic Center for Innovation where she leads research, design, and development efforts to transform health care experiences and amplify innovation across the clinic. Her role includes facilitating workshops on design methods and advising project teams through iterative, user-centered development processes. She is an advocate for sustainability as an integral component of good design and future resilience. Her project work often blurs the boundaries between products, spaces, and services with a current focus on community health and remote care delivery. A recipient of the International Design Excellence Award in 2008, Rose has seven patents and has held medical device design positions with Farm Product Development and HLB Inc. She has a Bachelor of Science in Industrial Design from the University of Cincinnati.
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| Babette Apland, MS, MBA, Senior Vice President, Health and Care Management, HealthPartners |
| Reimbursement | Session 2 |
Babette Apland is Senior Vice President of Health Management for HealthPartners. In this role, she provides executive leadership for JourneyWell health and wellness solutions, behavioral health, disease and case management, and quality improvement. In addition, her responsibilities include oversight of HealthPartners provider network, which involves managing relationships with primary care physicians, specialty physicians, and hospitals.
Prior to coming to HealthPartners, Ms. Apland was a health care consultant for hospital and clinic care systems. Before that, she served as vice president of Mount Sinai Hospital, and was executive director of Phillips Eye Institute. Ms. Apland holds M.B.A. and M.S. degrees.
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| Jonathan Brenner, Director, Health Policy and Reimbursement, MEDRAD |
| Reimbursement | Session 1 |
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| Joseph Cafazzo, PhD, PEng, Director of Healthcare Human Factors & Personal Health Information Technology Lead, Centre for Global eHealth Innovation, University Health Network (UHN) |
| Research & Innovation | Session 1 |
Dr. Joseph Cafazzo founded Healthcare Human Factors at UHN, the largest group of its kind devoted to the application of human factors engineering to problems of healthcare delivery and patient safety, hosted in Toronto General Hospital's state-of-the-art usability facility, with 70 researchers and staff. Dr. Cafazzo has been an active in ethnographic research-related new modes of patient care mediated by technology. He has advised and conducted research for public sector policy makers and private sector medical technology companies on the design and safety of technology in healthcare. He is Assistant Professor in the Faculty of Medicine, University of Toronto, where he teaches and conducts research in the areas of human factors, clinical engineering, and health informatics. |
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| Henry Chang, MBA, Vice President, Strategy & Business Development, 3M Health Care |
| Finance & Leadership | Session 1 |
Henry Chang is a strategy and corporate finance professional with extensive experience in developing organic and inorganic growth strategies for corporations. He is currently with 3M Health Care where he is Vice President of Strategy and Business Development. Prior to 3M, he was a Managing Director with the Boss Group, a private investment management firm. Prior to private equity, he was a Vice President with U.S. Bancorp Piper Jaffray’s investment banking practice and a management consultant with the Cambridge Group. He also worked in a variety of business development roles in the consumer packaged goods and telecommunications industries. Mr. Chang earned a Bachelor of Science in industrial engineering from Northwestern University and Master of Business Administration from J. L. Kellogg Graduate School of Management. |
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| Nathan Clevenger, Chief Mobility Architect, ITR Group |
| Health IT | Session 2 |
Nathan Clevenger has been developing mobile software for over 12 years. In addition to his role as Enterprise Editor for iPhone Life magazine, he leads the Mobility Practice at ITR Group, a management and IT consulting firm, where he works with clients to develop strategies, architectures and applications for mobile health care solutions. He regularly speaks at industry events around the country, and is extremely passionate about the unrealized potential for mobile technology within healthcare. |
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| Chris Conger, MSc, Vice President of Research & Development, IntriCon Corporation |
| Product Development & Engineering | Session 2 |
Chris Conger serves as Vice President of Research & Development at IntriCon Corporation, a Minnesota-based designer and manufacturer of miniaturized body worn medical and audio devices. He joined the Company in September 1997. Mr. Conger received a Bachelor of Science degree in Electrical Engineering from the University of Missouri and a Master of Science degree in Electrical Engineering from the University of Minnesota. Prior to his current position, Mr. Conger served as Director of Research and Development from 1997 to 2005. Before joining IntriCon, Mr. Conger served in various positions in the hearing health industry including 3M Company and Siemens. |
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| Jeffrey Davis, MD, MS, Director, Space Life Sciences, NASA |
| Research & Innovation | Session 2 |
Dr. Davis currently serves as Director, Space Life Sciences, as the Chief Medical Officer for the NASA Johnson Space Center, and as the Director of the NASA Human Health and Performance Center. The Space Life Sciences Directorate (SLSD) provides the research and technology development required for exploration, as well as all human health and performance support to space flight operations of the International Space Station. The SLSD is also responsible for human health and performance requirements for new programs such as commercial space flight and Advanced Exploration Technologies. Dr. Davis received his B.S. degree in Biology from Stanford University and M.D. from the UofC at San Diego. He also holds a Master of Science degree from Wright State University. |
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| Michael Dale, BS |
| Finance | Session 2 |
Michael Dale is an accomplished medical device executive with more than 25 years of experience as a leader in both early and late stage development companies. Most recently Mr. Dale served as Chairman, President, and CEO of publicly-traded ATS Medical until its acquisition in 2010 by Medtronic. During his tenure, beginning in 2002, ATS Medical established itself as a leader in the surgical treatment of heart valve disease and atrial fibrillation, resulting in significant expansion of the company's market capitalization from $7.5 million to more than $375 million. Mr. Dale's medical device industry experience spans cardiovascular, neuromodulation, and electrophysiology markets, including past executive leadership roles with Endocardial Solutions, Cyberonics, St. Jude Medical, and Edwards Life Sciences. At present Mr. Dale serves on the board of directors of Neuronetics, Inc., a Philadelphia-based company and Rhythmia Medical, based in Boston. Mr. Dale holds a Bachelor of Science degree from California Polytechnic State University in San Luis Obispo, California. |
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| Mark Deem, Vice President, Sales Operations, Airstrip Technologies |
| Finance & Leadership | Session 2 |
| Mr. Deem joined The Foundry at its inception in 1998. In addition to spearheading the research and invention process on new clinical opportunities, Mr. Deem leads the early stage effort in The Foundry's new companies until the company's CEO and Senior Staff is hired. Prior to joining The Foundry, Mr. Deem served in a founding role as consulting Director of Research and Development for Ventrica, Inc. Previously, Mr. Deem was a senior member of the Research & Development team at Medtronic Micro Interventional Systems. Mr. Deem joined MIS as one of the initial members of the company's engineering team and remained there through the acquisition by Medtronic. He is a co-inventor on over 150 issued and pending U.S. patents. Mr. Deem earned his B.S. degree in biomedical engineering from Boston University. |
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| John Dzarnoski, PhD, Director of Microelectronic Packaging, Starkey |
| Product Development & Engineering | Session 2 |
Dr. Dzarnoski received his PhD from the University of California at San Diego while researching ways to make more efficient solar cells. He worked at Unisys developing thin film multi-chip modules for main frame computers. Dr. Dzarnoski used his semiconductor expertise to drive silicon wafer processing technology into the production of magnetoresistive recording heads while Senior Director of Wafer Process Development at Seagate Technology. He is currently Director of Microelectronic Packaging at Starkey Labs in Eden Prairie, Minnesota. |
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| Jon Fredrickson, Global Vice President, Government, InnoCentive, Inc. |
| Research & Innovation | Session 2 |
For nearly 30 years Jon has lead teams in building new businesses and best practices within Fortune 100 companies, Federal, State and Local governments and in the new Web economy. Jon has worked with government teams across Europe, Asia, North and South America in defining key innovation priorities and delivering superior results. Today, Jon leads a team of professionals at InnoCentive whose mission is to help Governments identify and implement new strategies and solutions for using Open Innovation and InnoCentive's exclusive methodology of Challenge Driven Innovation to optimize public spending and accelerate innovation into the Government initiatives and programs. |
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| Mark Gardner, MBA, JD, Associate Attorney, DuVal & Associates P.A. |
| Clinical & Regulatory | Session 1 |
Mark Gardner, MBA, JD, is an Associate Attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice focuses on compliance and promotion. Prior to joining the firm, Mark worked in the medical device industry for 10 years as a marketer in product management and sales roles. While working at ev3, Celleration, and Medtox, Mark focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications. Mark earned his Juris Doctor from Hamline University School of Law, his Master of Business Administration from the University of St. Thomas, and his Bachelor of Science, double major, Finance and Economics from the University of Wisconsin-La Crosse. |
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| Trevor Gunn, PhD, Senior Director, International Relations, Medtronic, Inc. |
| Sales & Marketing | Session 2 |
| Trevor Gunn is Senior Director, International Relations for Minneapolis-based Medtronic, the world's largest independent medical technology company. Trevor Gunn was formerly long-time Director of the Commerce Department's Business Information Service for the Newly Independent States (BISNIS), the clearinghouse for US Government information for doing business in the former Soviet Union. He has served as Adjunct Professor at CERES/School of Foreign Service, Georgetown University for the past 17 years. He received his B.A. from University of San Francisco. He received his Ph.D. in International Relations from the London School of Economics in 1992. He has worked with the Chamber of Commerce of Southern Sweden, Dover Elevator Corporation (now Thyssen), International Executive Service Corps and on the staffs of the former San Francisco Mayor and two U.S. Senators from California. He sits on the U.S. State Department's Advisory Committee on International Economic Policy; is an official Trade Advisor to the Office of the US Trade Representative (USTR) in the "Industry Trade Advisory" system of the US Government (Vice Chair for Health). Further, he is Member the Board of Directors for the US-Russia Business Council, the Washington Export Council(Washington, D.C.), the Board of Advisers of the Washington International Business Council, Co-Chair of the Brazil-US Business Council's Regulatory/Standards Working Group, the Board of Directors of the Executive Council on Diplomacy and the Board of the Center for Citizens Initiatives(San Francisco) and on the Board of Advisors of the University of Wisconsin (Madison) CIBER (International Business) program. Equally, he is a member of the Board of Advisors of Professionals in Russian, East European and Eurasian Affairs (Georgetown University) and is a member of the US Department of Commerce's District Export Council (Virginia). Gunn speaks Swedish, French and Russian. Gunn, his wife and their three children live in Suburban Maryland, a short distance from Washington, D.C. |
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| Aileen Haan, Solutions Marketing Manager, GE Healthcare |
| Sales & Marketing | Session 1 |
| Aileen Haan is Solutions Marketing Manager for GE Healthcare Performance Solutions, a team dedicated to helping healthcare systems improve the safety, efficiency, and cost-effectiveness of its operations. Aileen is responsible for marketing and developing innovative solutions for patient safety. Prior roles include Services Marketing management and Account Management for GE. Her expertise includes customer- focused solution design and strategy development. She is a guest lecturer at the University of Notre Dame's Mendoza College of Business. |
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| Chris Hoffman, Senior Director & Chief Marketing Officer, TripleTree |
| Finance & Leadership | Session 1 |
Chris has over 23 years of experience as an operating executive, analyst, and entrepreneur in the technology industry. He leverages this experience at TripleTree in his role as Senior Director overseeing research, as well as leading the firm’s marketing and executive programs. Prior to TripleTree, Chris was president of Tier1 Research and held executive positions at Gartner, GE Capital Consulting, and IBM Global Services and founded an IT services start-up. He has been quoted in numerous trade and industry publications including the Wall Street Journal, New York Times, and CNN Money and is a frequent presenter at industry events. |
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| Ken Hoyme, MS, CSEP, Senior Fellow, Systems Engineering, Boston Scientific |
| Health IT | Session 1 |
| Mr. Hoyme is a Senior Fellow in the Cardiac Rhythm Management External Systems group. He provides technical leadership for the LATITUDE Patient Management system, which remotely monitors patients implanted cardiac devices in their homes. Ken is an active leader in the development of improved processes for systems engineering of complex systems and safety risk management. He has designed product features that improve the safety and security of both implantable and external medical devices. Ken has 13 patents. He is a member of IEEE and INCOSE and is an INCOSE Certified Systems Engineering Professional. He received the Bachelors and Masters Degrees in Electrical Engineering from the University of Minnesota. |
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| Andy LaFrence, CPA, Chief Financial Officer, CNS Therapeutics, Inc. |
| Finance & Leadership | Session 2 |
Andy LaFrence is the CFO for CNS Therapeutics, a venture-backed drug company. Andy has over 25 years of financial and management experience and was previously an audit partner at KPMG LLP where he focused on supporting venture-backed, high growth medical technology, pharmaceutical, biotech, and clean tech private and public companies, including 15 IPOs. Andy is on the board of directors of the American Heart Association, Biothera, EarthClean, and Cardia Access. Mr. LaFrence is a certified public accountant and has a B.S. in accounting and a minor in Business Administration from Illinois State University. |
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| Todd Leonard, Executive Director, Minnesota Angel Network |
| Finance & Leadership | Session 1 |
Prior to his appointment as Executive Director of Minnesota Angel Network in 2010, Mr. Leonard worked with a number of successful companies ranging from startups to multi-million dollar companies. He has successfully raised more than $50 million in equity for various start-up companies, closed multiple international licensing agreements, and closed more than $350 million of industrial construction contracts. Mr. Leonard is also an angel investor and has worked on behalf of venture funds and investors. |
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| Thomas Marr, MD, Medical Director for Clinical Relations & HealthPartners Health Plan |
| Reimbursement | Session 1 |
Thomas J. Marr, MD is the Medical Director for Clinical Relations, HealthPartners Health Plan. Tom has been the liaison with medical groups and hospitals for HealthPartners for 11 years. Prior to that he had leadership positions as a residency program director, a department chair, and as Executive Medical Director of a Children’s Hospital. He consulted with more than 200 medical groups and hospitals about organizational and leadership issues for five years prior to joining HealthPartners. He has authored more than 25 articles and book chapters as well as presented at national meetings on multiple areas of healthcare leadership. He teaches at the University of ST Thomas, the University of Minnesota, and the Minnesota State University. He received his undergraduate and medical education at Loyola University of Chicago. His postgraduate training was at Children’s Memorial Medical Center in Chicago. He has boards in Pediatrics, Pediatric Nephrology, and Medical Management. He is a Fellow in Advanced Standing in the American College of Physician Executives. |
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| Randall Moore, MD, MBA, CEO, American TeleCare |
| Reimbursement | Session 2 |
Randall S. Moore, MD, MBA, CEO of American TeleCare, graduated AOA from Johns Hopkins School of Medicine, is board certified in internal medicine, and completed his MBA from Northwestern University. Dr. Moore's experience includes more than 25 years working as both an academic physician and an executive in the medical industry, with a focus on system level reengineering, integrating advanced business and clinical models, and reforming health care compensation models. Moore believes health care transformation can be built upon, and financed by, the extension of patient-centric, 24/7 interdisciplinary care continuums into the daily lives of the highest need segment of our population. |
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| John F. Nealon, Senior Vice President, General Manager, Women's Health |
| Sales & Marketing | Session 2 |
John F. Nealon has served as Senior Vice President and General Manager, Women's Health since April 2008. Prior to his appointment as General Manager, Mr. Nealon served as Senior Vice President of Business Development from April 2005 to July 2008. From January 2002 to April 2005, he served as Vice-President of Global Marketing at AMS. Mr. Nealon has over 15 years of experience in the medical device industry. From 1996 to 2001, he served on the management team at Survivalink, a start-up medical device company which developed and marketed automated external defibrillators (AEDs). His final three years at Survivalink, he served as Vice-President, Marketing and International Sales. In 1996, he served as Director of Product Marketing for Summit Medical. From 1989 to 1996, he served in a variety of global product marketing roles at GE Medical Systems in the x-ray, surgery, and cardiology businesses. |
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| Scott Nelson, PhD, Executive Vice President & Chief Technology Officer, Logic PD, Inc. |
| Health IT | Session 2 |
Dr. Scott Nelson, Logic PD’s executive vice president and chief technology officer, leads the company in leveraging cutting-edge technology to innovate and develop market changing products for customers. Dr. Nelson has nearly 25 years of experience overseeing product development for multiple markets, including advanced medical technology. Prior to joining Logic PD in 2000, Dr. Nelson worked for 3M and Honeywell. He holds a Ph.D. in applied and engineering physics from Cornell University, a doctoral minor in business administration from the Samuel Johnson School of Management at Cornell University, and he earned a bachelor’s degree in physics and mathematics from St. Olaf College. |
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| Connie O'Connor, Senior Project Manager, DEKRA Certification Inc. |
| Clinical & Regulatory | Session 1 |
Connie O'Connor is a Senior Project Manager for DEKRA Certification B.V., a Notified Body for clients seeking CE Mark for entry into the European market. Connie performs assessments of non-active and in vitro diagnostic medical device dossiers for safety, performance, and regulatory requirements for CE marking. She performs on-site regulatory compliance and quality system audits in accordance with applicable European Medical Device Directives and ISO 9001:2008, ISO 13485:2003, and CMDCAS program as required for the Canadian market. In Connie's career in industry, she has been fully responsible for manufacturing, product development, and operational management of in vitro medical diagnostic devices. |
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| Donald Palme II, PhD, Head of Division, Sinclair Research |
| Clinical & Regulatory | Session 2 |
Head of Division for Sinclair Research, responsible for supporting Medical device testing and providing regulatory consulting. Former Vice President of Toxicology and In-Life Services. responsible for toxicology and In- Life Services including testing strategies, study designs, custom implantation work and client consulting fur WuXi AppTec More than 15 years of experience including materials, device and biological biocompatibility testing. Specializes in designing and directing preclinical in-vivo testing including safety, efficacy and materials biocompatibility. Experience in regulatory submissions with US and International regulatory agencies. Clinical study experience includes initiation of US non-significant risk acute clinical studies and OUS clinical studies including protocol development, site selections, physician management and site training. Previous positions include Boston Scientific, Aoom Cardiovascular and Guidant Corporation. Author of numerous per-reviewed journal articles, technical presentations and book chapters on biocompatibility, medical device performance, immunology, and pharmacokinetics. Ph.D. in Immunology and Pathology and M.S. and B.S. in Microbiology. |
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| Stephen Parente, PhD, MPH, MS, Director, Medical Industry Leadership Institute, University of Minnesota |
| Reimbursement | Session 2 |
Stephen T. Parente, PhD, MPH, MS is the Minnesota Insurance Industry Chair of Health Finance in Carlson School of Management and the Director of the Medical Industry Leadership Institute at the University of Minnesota. As a Professor in the Finance Department, he specializes in health economics, health information technology, and health insurance. He has served has a consultant to several of the largest organizations in health care delivery including: UnitedHealth Group, Blue Cross Blue Shield, the Center for Medicare and Medicaid Services, federal and state governments as well as medical technology firms. Dr. Parente’s recent peer-reviewed journal articles have focused on the consumer directed health plans, health reform, medical technology assessment and consumer choices in health and wealth management. As a principal investigator of several federal grants he has examined the national impact on productivity and cost impact of information technology investments in all US hospitals and has recently concluded several studies on topics including: innovations from health savings accounts and medical banking technologies. Dr. Parente was a health policy advisor for the McCain 2008 Presidential Campaign and served as Legislative Fellow in the office of Senator John D. Rockefeller IV (D‑WV) during the Bush and Clinton Administrations' health reform initiatives. He has a doctorate from Johns Hopkins University. |
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| Saurav Paul, PhD, JD, Director, Innovation Fellows Program, Medical Devices Center, University of Minnesota |
| Product Development & Engineering | Session 1 |
| Dr. Saurav Paul is the Director of Innovation Fellows Program at Medical Devices Center, University of Minnesota. He has a Ph.D. in Biomedical Engineering and M.S. in Civil Engineering from University of Minnesota, M.S. in Mechanical Engineering from Indian Institute of Science, Bangalore, India, and B.S. in Mechanical Engineering from National Institute of Technology, Jamshedpur, India. He received his J.D. from William Mitchell College of Law, St. Paul, with an emphasis in Intellectual Property law and Medical Device Amendment. He was the top inventor at St. Jude Medical’s Atrial Fibrillation Division and has over 130 U.S. and international patent publications. |
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| Barb Peterson, MBA, President & CEO, Emerson Consultants, Inc. |
| Reimbursement | Session 1 |
| Barb Peterson founded Emerson Consultants in 2003 after a long career in marketing, reimbursement, and communications with a number of the best-known companies in the medical device industry. Currently, she partners with numerous medical device, diagnostic, and biologic companies from start-ups to multi-billion dollar organizations to help them achieve their business objectives through integrated reimbursement, regulatory, clinical, and market development strategies. Prior to starting Emerson Consultants, Barb served as Director of Marketing, Reimbursement, and Communications for SpineTech (now Zimmer Spine) and Director of Reimbursement Cordis and Ethicon Endosurgery, J&J companies. |
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| Mathieu Petitjean, PhD, President, Mednest |
| Health IT | Session 2 |
| Mathieu Petitjean is an experienced operational leader with 15 years of executive-level and international business experience in Healthcare Diagnostics and Medical Technology including Strategic Marketing, New Product Introduction, Commercial Operations and Sales Force Effectiveness.
Former Chief Marketing Officer at General Electric and Leader of P&L Operations at GE Healthcare. Petitjean has held several business, product and technology leadership roles with GE Clinical Services and GE Medical systems in 6 different European, American and Latin-American markets. He started his career in Europe and Japan with several high technology start-up companies.
Mathieu is a graduate from the General Electric Jack Welch Institute. He holds a Ph.D. in Solid State Physics from Ecole Polytechnique, France, and an Engineering Degree from ESPCI Paris. |
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| Brian Price, MBA, Senior Director of National Accounts, Reimbursement & Health Economics, Tornier |
| Sales & Marketing | Session 1 |
Brian Price is the Senior Director of National Accounts, Reimbursement, and Health Economics at Tornier, a global leader in extremity orthopedics. Brian has over 13 years of market development and sales execution experience across cardiology, urology, gynecology, and orthopedics with diverse employers including Guidant, American Medical Systems, WebMD, St. Jude Medical, and Tornier. Brian has launched new therapy platforms in the U.S. and international markets across various sites of service including the hospital, ambulatory surgery center, and physician office during this time. Brian holds a Bachelors degree from Purdue University and an MBA from the University of Minnesota Carlson School of Management. |
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| Elizabeth Roboy Kittrie, MMHS, Senior Policy Analyst, United States Department of Health Human Services |
| Research & Innovation | Session 2 |
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| Heather Rosecrans, Vice President of Regulatory Affairs, Medical Device Manufacturers Association (MDMA) |
| Clinical & Regulatory | Session 1 |
| Heather Rosecrans brings more than 30 years of public health and medical device experience to MDMA. Rosecrans continues her commitment to public health at MDMA where she provides strategic consulting services and works with MDMA members to bring innovative devices to patients. Prior to joining MDMA, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). In this role, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions, and other pre-market regulatory requirements. |
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| Stephen Ruble, PhD, Fellow, Boston Scientific Corporation |
| Research & Innovation | Session 2 |
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| Barbara Rummel, JD, Partner, Lindquist & Vennum, PLLP |
| Finance & Leadership | Session 1 |
For 20 years, Barb Rummel has been counseling boards of directors, executive officers, and owners of public and privately held businesses in making critical business decisions involving strategic objectives, corporate finance, and mergers and acquisitions, Barb has completed numerous M&A transactions
involving public and privately held businesses, ranging in size from $5 million to over $1 billion. Her
experience covers various industries, with particular emphasis on the life sciences, including medical
device and biotechnology companies. Barb currently serves on Lindquist & Vennum's management
committee and is past chair of the firm's Life Sciences industry group.
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| Greg Ruth, MD, Senior Innovation Fellow, University of Minnesota |
Research & Innovation | Session 1 |
| Greg is a board certified general surgeon from Mayo Health Systems in Menomonie Wisconsin who recently transitioned from surgical practice to an Innovation Fellowship position at the University of Minnesota. Greg previously attended the University of California Irvine where he earned a degree in biology. He then worked in a medical device lab for two years with Kurt Amplatz at the Unniversity of Minnesota. Later, he enrolled in the University of Minnesota medical school and then completed general surgery residency in Grand Rapids, Michigan. |
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| Joshua Schneck, Founder & President, Snow Communications |
| Reimbursement | Session 2 |
Joshua Schneck is founder and president of Snow Communications, a Minneapolis agency specializing in public relations and public policy for healthcare and technology companies. Josh worked as a Capitol Hill staffer in the United States Senate and the United States House of Representatives and is a registered lobbyist. Josh co-manages Snow's government relations practice with Bob Hussey, a former VP with UnitedHealth Group. Josh also directs integrated public relations and marketing programs for clients that target customers and key influencers through market research, branding, PR, advertising, and social media. |
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| Tad Simons, PhD, Co-Founder & Director, Pyxera |
| Research & Innovation | Session 1 |
Co-founder of Pyxera, Ted Simons has designed healthcare products since 1982 and has a passion for humanizing medicine by understanding the human stakeholders. Prior to co-founding Pyxera, Tad was co-leader of IDEO's global Health Practice for over 11 years, expanding work into all sectors of healthcare and life science (pharma, devices, diagnostics, biotech, consumer health, and hospitals & care delivery). Current interests include designing solutions across health sectors and building innovation capability inside corporations. Tad has BS and PhD degrees in Mechanical Engineering from Stanford University, and an MS degree from the California Institute of Technology. |
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| Dirk Smith, MS, Vice President of Engineering, Minnetronix, Inc. |
| Product Development & Engineering | Session 1 |
Dirk Smith is the Vice President of Engineering and a co-founder of Minnetronix, a company that develops and manufactures electronics-based medical devices. He has been in medical device development for over 24 years, with roles in executive management, systems engineering, program management and business development. Dirk’s experience in medical devices ranges from implantable and hand-held electrical stimulators to a multi-pump heart lung machine. Dirk has seven US patents and has authored several papers on signal processing and medical systems. Dirk earned a BSEE degree from the University of Iowa, and an MSEE degree from the University of Minnesota. |
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| Martyn Smith, PhD, Consultant, Adjunct Professor, Department of Biomedical Engineering, Michigan Technological University |
| Product Development & Engineering | Session 1 |
Martyn R. Smith teaches Biostatistics and Research Design in the Department of Biomedical Engineering at Michigan Technological University, where he served previously as Head of Mathematical Sciences, Dean of the Graduate School and Director of On-Line Learning. He is Professor Emeritus and former Director of CASPI , Center for Applied Statistics and Process Improvement, at Winona State University. Marty has been a consultant for companies including Procter and Gamble, Colgate, IBM, and the American Dental Association. He has held faculty positions at the University of Connecticut Medical Dental School and Mayo School of Health Related Sciences. Marty received his doctorate from Yale University. |
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| Mike Swenson, CIMA, Private Wealth Advisor, Private Banking and Investment Group at Bank of America, Merrill Lynch |
| Finance & Leadership | Session 1 |
Mike Swenson has worked in wealth management since 1990. He began his practice at Piper Jaffray, where he worked as a wealth consultant for 17 years before joining the Private Banking and Investment Group at Merrill Lynch in 2006. As a Private Wealth Advisor, Mike and his team focus on helping families and their businesses simplify the complexities brought on by substantial wealth. To properly execute their world-class service approach, Mike and his team limit the number of relationships they work with yet are entrusted to oversee nearly $2 billion of client net-worth. Barron's magazine named Mike one of the Top 1,000 Financial Advisors in America in 2009, 2010, and 2011. |
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| Andy Tsai, CEO & Co-Founder, ReFleX Wireless Inc. |
| Health IT | Session 1 |
Andy Tsai is the CEO and Co-Founder of ReFleX Wireless Inc. in Vancouver, Canada. With his leadership, his team of young engineers was recently named the winner of the NYC Next Idea Competition '11 by Mayor Bloomberg. His technical expertise spans the areas of nanotechnology, short-range RF communication, and Human Computer Interfaces. His experiences came from serving the software industry for seven years and his recent training in Electrical Engineering (in Nanotechnology) at the University of British Columbia. At present time, he is focusing on developing innovative medical devices for the Health Industry. |
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| Thomas Varricchione, RRT, MBA, Principal Advisor, Clinical & Regulatory Affairs, Ximedica, LLC |
| Clinical & Regulatory | Session 2 |
Tom has managed clinical and regulatory affairs for 23 years at several medical product development companies engaged in developing first-of-a-kind products and has obtained more than 50 first-time product and clinical investigation approvals in the U.S., E.U., Japan, and other markets. Earlier, he worked in clinical, research, and academic roles at Massachusetts General Hospital, Boston University Medical Center, and Northeastern University. Tom holds an M.B.A. from Boston University, a Post-Graduate Certificate in Respiratory Care from Northeastern University, and a B.A. with Honors from the University of Vermont. He is regularly invited to present at conferences and has coauthored several peer-reviewed medical papers. |
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| Vince Ventimiglia, JD, Senior Vice President, B&D Consulting |
| Clinical & Regulatory | Session 1 |
Vince Ventimiglia is a Senior Vice President in the Health and Life Sciences Practice at B&D Consulting, a division of Baker Daniels LLP, in Washington, DC. Prior to joining B&D Consulting, he was Assistant Secretary for Legislation at the US Department of Health and Human Services HHS) for more than three years. Mr. Ventimiglia focuses in health and life sciences where he offers clients extensive experience in government and the private sector. He is thoroughly familiar with health policy issues from legislative, regulatory, reimbursement, and budgetary perspectives – and he understands the need to advance policy solutions by involving a full range of stakeholders. |
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| Paul Wagner, Chairman & CEO, Minnesota Wire |
| Finance & Leadership | Session 2 |
| Paul J. Wagner is Chairman and CEO of Minnesota Wire. His entrepreneurial leadership has greatly expanded the company’s market exposure which includes the medical, defense, and industrial sectors, and he has made the company a national leader for the future of electrical conductors through federal R&D contracts. The company has a 75 percent capture rate on federal grant applications (compared with a 10 percent national average). In 2004 Mr. Wagner founded Defense Alliance, the region’s defense industry network, and he is the 5th Region President for the Association of the U.S. Army (AUSA) representing 9 states and 13 chapters. |
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| Steve Weeres, Director of Engineering, Spectrum Design Solutions |
| Product Development & Engineering| Session 2 |
Steve Weeres is currently Director of Engineering at Spectrum Design Solutions, a product design firm specializing in embedded wireless hardware and software development for medical, consumer, and industrial applications. Steve has over 25 years of experience in the development and implementation of embedded systems. He has held engineering leadership positions at Braemar, CyberOptics, Honeywell, and Goodrich. Steve also consults on product design process development and implementation for a variety of industries. |
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| Jeff Weness, Corporate Development and Innovation, Children's Hospital |
| Health IT | Session1 |
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| Lisa Wipperman Heine, MSc, Global Vice President, Clinical Affairs, Vascular Therapies, Covidien / ev3 |
| Clinical & Regulatory | Session 1 |
Lisa Wipperman Heine is currently Global Vice President of Clinical Affairs for Covidien/ev3's Vascular Therapies business. She has over 20 years of experience in the medical device industry including roles in clinical research, health policy, reimbursement and regulatory affairs. Her responsibilities have included the design and conduct of pre-clinical, clinical and outcomes research in support of regulatory approvals and product reimbursement. In addition, she has provided analysis and strategic direction for US and EU regulatory plan development as well as in support of FDA IDE and PMA submissions. She has extensive experience working with FDA, Centers for Medicare and Medicaid Services (CMS), other third party payers, and physician specialty societies. In addition, she has co-authored peer-reviewed literature involving outcomes research and health economics. Ms. Heine received her bachelor's degree from St. Olaf College and her master's degree from the University of Manitoba. |
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| Kai Worrell, President, Worrell Design Inc. |
| Health IT | Session1 |
| Kai joined Worrell Design Inc. in 2000 and for 11 years has lead product development as well as strategic research engagements for Worrell’s clients. Kai recently returned from Shanghai, where he lived with his family for almost 2 years while founding Worrell’s China research and design practice. Kai’s clients include Boston Scientific, Johnson & Johnson, Qualcomm, EV3, Pfizer, Biomet, and the San Diego Beacon Community Grant. Kai has been in hospitals, clinics, and patient homes around the world including Greater China, North America, and throughout Europe. The focus of this ethnographic research is to find opportunities to address unmet clinical and human needs by leveraging next generation technologies, innovative care models, and elegantly designed products. |
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