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This is the printed program for OCTANe's 4th Annual CA Medical Device & Investor Forum, which took place Nov 9 - 10 2009 in Orange County, Calif.
This is the printed program for OCTANe's 4th Annual CA Medical Device & Investor Forum, which took place Nov 9 - 10 2009 in Orange County, Calif.
November 9 - 10, 2009 Hyatt Regency Irvine Orange County, CA AGENDA AT A GLANCE Monday, November 9th TIME 5:30 p.m. 5:30 p.m. 6:30 p.m. 7:15 p.m. PROGRAM Registration & Cocktail Reception (Grand Foyer) Exhibits Open VIP Reception – Invitation Only (Trabuco) Dinner and “Pulse of the Industry” Report by Ernst & Young (Ballroom) The Big Deal: Medical Device M&A (Ballroom) Tuesday, November 10th TIME 7:00 a.m. PROGRAM Registration and Continental Breakfast (Grand Foyer) Healthcare IT ReUsense Eyelight Epicardial Technologies Medical Device Design 7:30 a.m. 8:20 a.m. Networking Break (Grand Foyer) Dallen Medical Tinnitus Otosound Products Adventus DxTerity Diagnostics 8:30 a.m. Cardiovascular Mock IP Due Diligence 9:20 a.m. Networking Break (Grand Foyer) Exhibits Open OrthAlign NeoMatrix Reverse Medical CardioPolymers 9:30 a.m. Ophthalmology The Regulatory Road Less Traveled 10:20 a.m. 10:30 a.m. 11:20 a.m. 11:30 a.m. 1:30 p.m. 1:45 p.m. Forecast for Washington Networking Break (Grand Foyer) Follow-up Meetings with Presenting Companies European Opps for Medical Device Companies Networking Break (Grand Foyer) Lunch Panel: Health Care Policy & Reform (Garden Pavilion) Networking Break (Grand Foyer) Medical Device Investor Panel (Salon D & E) 1 THE BIG DEAL: MEDICAL DEVICE M&A Monday, November 9 6:45 p.m. Pulse of the Industry: Global Medical Technology Report 2009 This seminal report classifies medtech companies by product and disease segments and represents a comprehensive measurement of the industry’s performance across several measures – financial performance, financing, mergers and acquisitions and public policy trends. At the end of September 2008, when Ernst & Young released its inaugural report, the industry’s aggregate market capitalization, public equity financing, venture capital and deal activity were extremely healthy. To put it mildly, the world has changed a lot since then. Stocks have plummeted, governments have spent billions to shore up their economies, and the crisis has spread swiftly across industries and geographies. How has medtech held up during the global financial crisis? Dan Lemaitre, Former CEO, CoreValve Dan Lemaitre most recently served as the President and CEO of CoreValve which was acquired by Medtronic in April 2009. CoreValve’s unique self-expanding percutaneous aortic valve has been implanted in more than 4,000 patients since obtaining CE Mark in 2007. At the time of acquisition end-market revenue was annualizing at a $100MM run-rate. Mr. Lemaitre led negotiations that led to the sale of CoreValve in a deal worth $700MM in cash, with an additional $150MM payable upon the achievement of milestones. Prior to joining CoreValve, Mr. Lemaitre was a Senior Vice President at Medtronic where he led strategic planning and corporate development. Dan was also a member of Medtronic’s executive and operating committees. While at Medtronic, he helped revamp the strategic planning process. In addition, more than 50 acquisitions, divestitures and license deals were completed during his tenure, including the $4.2 billion acquisition of Kyphon. Prior to joining Medtronic, Dan spent 28 years in the medical device field as an investment analyst. He began his career as a buy-side analyst in 1978 working at National City Bank in Cleveland and later, Standish Ayer & Wood in Boston. His sell-side career included 18 years with SG Cowen, where he was a managing director and led the health care research team. In 1999, Dan moved his team to Merrill Lynch where he headed-up the medical technology effort for six years. During his Wall Street tenure, Dan was named to Institutional Investor’s All American research team for 19 consecutive years, capturing first place honors a record 8 times as the top ranked medical supply and technology analyst in the country. Dan has a BA in Economics (1976) from Bethany College (West Virginia) and an MBA (1978) from Bowling Green State University in Ohio. He is a Chartered Financial Analyst. Originally from Woodbury, Connecticut, Dan is married and has two daughters. Lemaitre is a trustee for Lawrence Academy in Groton Massachusetts and served for ten years on the board of Emerson Hospital in Concord, Massachusetts. James V. Mazzo, President, Abbott Medical Optics, Senior Vice President, Abbott James (Jim) Mazzo is Senior Vice President at Abbott and president of Abbott Medical Optics Inc. (AMO), the global leader in advanced refractive technologies for eye care professionals and patients. Mr. Mazzo assumed the position of president following the company’s February 2009 acquisition by Abbott [NYSE: ABT], a global, broad-based healthcare company with more than$29 billion in annual sales. Previously, he was chairman and CEO of Advanced Medical Optics, Inc., a position he assumed following the company’s 2002 spin-off from Allergan. While CEO of Advanced Medical Optics, Mr. Mazzo grew the company’s sales from $538 million in 2002 to more than $1 billion in 2008 and increased the market cap from approximately $429 million to approximately $1.5 billion. During this time, he also engineered several strategic acquisitions worth more than $3 billion, staking the company to clear leadership positions in the cataract and eye care markets and the global No. 1 position in refractive surgery. Prior to leading AMO, Mr. Mazzo progressed throughout a 22-year career at Allergan, where he held a variety of senior executive-level positions. Mr. Mazzo is a strong believer in education and serves on the University of California at Irvine (UCI) Dean’s Board of Directors’ Executive Committee, UCI Dean’s Board of Business and Engineering and is chairman of the UCI Foundation. He is a trustee for Chapman University and the University of San Diego. Additionally, Mr. Mazzo is a member of the International Intraocular Implant Club (IIIC) and sits on the boards of AdvaMed, the world’s largest medical device organization, and OCTANe. Mr. Mazzo actively works with federal, state and local elected officials to address a variety of issues that impact the ophthalmic and medical device industries. Speaker: Scott Sarazen, Global Life Sciences Markets Leader, Ernst & Young 7:15 p.m. - Presentation (following dinner) Come hear the stories of three of the biggest deals in recent OC history, including Abbott and AMO ($2.8B), Medtronic and CoreValve ($700M+), and Bausch & Lomb and Eyeonics (undisclosed). During this lively panel discussion, you’ll hear from both sides of the table and discover what it took to plan, structure and execute the deals that have made Orange County a hotbed of M&A activity over the past two years. Speakers: Matthew Jenusaitis, President & CEO, OCTANe Matthew Jenusaitis is the President and CEO of OCTANe, an Orange County, CA nonprofit organization focused on catalyzing innovation, starting new biomedical and high technology companies, and creating jobs. Matthew is an experienced medical device industry professional with more than 25 years of engineering, sales and marketing, and executive level general management experience. Before OCTANe, Matthew worked with the venture backed accelerator fund, ConcepTx, identifying unmet clinical opportunities and developing new technologies and companies. Prior to ConcepTx, Matthew was and executive in residence for the private equity firm Warburg Pincus, LLC. This led to Matthew assuming the role of President of ev3 Nonvascular, one of Warburg’s portfolio companies. Matthew led their growing division (formerly Micro Therapeutics Inc., now a wholly-owned company subsidiary) through a combination of organizational development activities, and by launching and developing markets for a number of new products. Prior to ev3, Matthew spent 15 years at Boston Scientific Corp., where he served in numerous executive marketing and general management positions. His most recent position with Boston Scientific was as the president of the $600 Million Peripheral Interventions Division. Prior to Peripheral Interventions, Matthew led the integration of Interventional Technologies increasing their annual revenues from $25 Million in 2001 to more than $150 Million in 2003. Before that, he held executive marketing and marketing management positions in the Microvasive Endoscopy, International, and Scimed Life Sciences division. During his career, Matthew also spent 8 years at Baxter Healthcare in both marketing and engineering management positions. Matthew holds a bachelor of science in chemical engineering cum laude from Cornell University, a master of science in bio-chemical engineering from Arizona State University and a master of business administration from University of California, Irvine. 2 3 THE BIG DEAL: MEDICAL DEVICE M&A Monday, November 9 7:15 p.m. - Presentation (following dinner) Sean Murphy, Vice President, Licensing/New Business Development, Abbott Sean Murphy is Vice President, Licensing/New Business Development. Murphy joined Abbott in 1979 and held several positions in Finance, Operations and Marketing within the Hospital Products Division. In 1997, he was named Divisional Vice President, New Business Development for Abbott’s Hospital Products Division. In 2000, he was named Divisional Vice President and General Manager of Perclose. He assumed his current role in Jan. of 2003. Prior to joining Abbott, Murphy was an associate for an international management consulting firm. He is a member of the American Institute of Certified Public Accountants, the American Heart Association and the Licensing Executive Society. Murphy earned a bachelor’s degree in finance from Western Illinois University in Macomb and a master’s degree in finance from the University of Illinois in Champaign and is a Certified Public Accountant from the state of Illinois, and he currently resides in Lake Forest, Ill. Stephen N. Oesterle, M.D., Senior Vice President for Medicine and Technology, Medtronic Stephen N. Oesterle, M.D., joined the company in 2002 as Senior Vice President for Medicine and Technology. In this role, Steve provides executive leadership for Medtronic scientific research, formation of technological strategies and continued development of strong cooperative relationships with the world’s medical communities, technical universities, financial institutions and emerging medical device companies. Previously, Steve served as Associate Professor of Medicine at the Harvard University Medical School and as Director of Invasive Cardiology Services at Massachusetts General Hospital, Boston. A teacher and innovator in the field of cardiac catheterization, he has also developed and directed interventional cardiology programs at Good Samaritan Hospital, Los Angeles; at Georgetown University; and at Stanford University. Steve is a 1973 summa cum laude graduate of Harvard College and received his medical doctorate from Yale University in 1977. He completed his internship and residency at Massachusetts General Hospital and also served a fellowship in interventional cardiology at Stanford. Charles Warden, Managing Director, Versant Ventures Charles Warden has been an active medical device venture investor since 1992. Charles works closely with entrepreneurial device companies from inception along the path to success. Prior to joining Versant he was a general partner at Schroder Ventures Life Sciences (now SV Life Sciences) where he led SV’s medical device effort. Previously, Charles worked with Boston Capital Ventures, where he concentrated on medical device and other healthcare investments. Before becoming a venture capitalist, Charles was a consultant with Monitor Company, a strategy consulting firm. Charles has served on numerous medical device company boards, including the following currently: AcuFocus, Celula, Concentric Medical, Glumetrics, Halscion, iTherapeutix, and WaveTec. Prior board memberships include Insulet (Nasdaq: PODD), Confluent Surgical (acquired by Covidien), CardioFocus, Liposonix (acquired by Medicis), Neovista, Sadra Medical, and Heritage Health Systems (acquired by Universal American Financial Corp). Since its inception, Charles has been actively involved with The Innovation Factory, a medical devices incubator. He is also involved in ForSight Labs, an ophthalmic incubator. Charles holds a Bachelor’s degree from Beloit College and an MBA from Harvard Business School. INDUSTRY TRACK Tuesday, November 10 7:30 – 11:20 a.m. - Salon A & B Healthcare IT 7:30 – 8:20 a.m. Experts tackle the top issues like: what are the technical and cultural issues of privacy and security in electronic medical records? Who’s going to get a piece of the $19 billion in federal stimulus funding for digital healthcare? Do consumers really want e-health enough to drive regulatory changes? How are hospitals preparing for and adapting to this new generation? Dr. Ralph Cygan, Chief Medical Information Officer, UC Irvine School of Medicine. Michael J. Doyle, President & CEO, Medsphere. Michael J. Doyle is an entrepreneur and Chief Executive Officer who has excelled at creating value for investors in healthcare and technology. Mike joined Medsphere in October 2007 after serving as President and CEO of Advantedge Healthcare Solutions, a New York-based Software as a Service (SaaS) outsourced physician-billing company backed by private equity investors. From 2000 to 2004, Mike served as Chairman and CEO of Salesnet, one of three pioneering global enterprise software providers who established the SaaS customer relationship market. In 1989 Mike founded The Standish Care Company, a provider of assisted living and long-term care services. As Chairman and CEO, he built the company organically, and in 1992 guided it through the first successful initial public offering (IPO) for an assisted-living service provider. A series of mergers and acquisitions in the years that followed resulted in the merger in 1996 of Standish with Carematrix; after the merger Mike served as CEO of the combined companies, which retained the Carematrix name. Mike’s efforts ultimately yielded a highly successful organization with a market capitalization in excess of $500 million. In his career, Mike has held senior management positions at Voluntary Hospitals of America, and Tenet Healthcare Corporation’s predecessor National Medical Enterprises. He received a bachelor of science in biology with a minor in community health from Tufts University, and an MBA with a focus on healthcare and finance from the University of Chicago, where he was a Kaiser Fellow. Jeff Tangney, Co-Founder, President & COO, Epocrates. Jeff brings over 15 years of healthcare/pharmaceutical experience to his position at Epocrates. Prior to co-founding Epocrates in 1998, Jeff was a pharmaceutical strategy consultant at ZS Associates, where he counseled Fortune 500 clients on marketing strategy. At ZS, Jeff advised clients in 16 countries and helped structure the largest co-promotion alliance in pharmaceutical history. Jeff’s industry experience also includes positions at Goldman Sachs as a healthcare investment banker and at biotech start-up Pangene Corporation as a director of business development. Jeff graduated summa cum laude from the University of Wisconsin with a B.S. in Economics, and earned an M.B.A. from Stanford University’s Graduate School of Busine Michael McKinnon, Partner, Paul Hastings. Michael McKinnon advises clients in mergers and acquisitions, jointventures, equity and debt financings, with a primary focus on the life sciences industry. Mr. McKinnon has assisted both companies and private-equity sponsors in their acquisitions and sales of various health care providers, including diagnostic imaging providers, PPO networks, diabetic supply businesses, clinical trial companies, home health companies and urgent care centers. Mr. McKinnon also serves as outside general counsel for a variety of life sciences companies, including medical device firms and large health systems. Mr. McKinnon is the leader of the Life Sciences Group for the Orange County office and a member of the firm’s M&A and Private Equity practice group. He is also a member of the American Health Lawyer’s Association. Prior to joining Paul Hastings, Mr. McKinnon served as in-house counsel for Apria Healthcare (home health) and InSight Health Services Corp. (diagnostic imaging centers), both publicly traded companies, with primary responsibility for the companies’ acquisitions, joint ventures and securities matters. Mr. McKinnon received his B.S. degree from Cornell University in 1990, and his J.D. degree, cum laude, from Pepperdine University School of Law in 1994. 4 5 INDUSTRY TRACK Tuesday, November 10 7:30 – 11:20 a.m. - Salon A & B Tuesday, November 10 7:30 – 11:20 a.m. - Salon A & B Emerging Trends in Cardiovascular Medicine 8:30 – 9:20 a.m. Bruce J. Brumfield, Jr. (“Jay”), Managing Director, Finistere Ventures. With 15 years of management experience in both established and start-up companies and seven years practicing law as an associate and partner at a large, midSouth law firm, Jay has a unique and diverse background for the assessment and operation of emerging technologies and startups in the life sciences sector. Prior to joining Finistere in July 2005, Jay was most recently President and CEO of Advanced Stent Technologies (“AST”), a medical device startup focused on developing and commercializing a proprietary stent system for the treatment of coronary artery bifurcation disease. Under his leadership, AST was sold to Boston Scientific Corporation in March 2005. Prior to AST, Jay held several positions with a large US-based agrichemical company. His last position was Vice President of Strategic Initiatives where he was responsible for identifying emerging technology investment and partnering opportunities in the agbio and agritech fields. Jay is Chairman of the Board of Directors of Catharos Medical Systems, Inc. and sits on the Boards of Biabsorbable Therapeutics, Inc., nContact Surgical, Inc., SquareOne Inc., and Generic Medical Devices, Inc. He is also a board observer at Sadra Medical, Inc. Mahmood K. Razavi, M.D., Director of Clinical Trials and Research Center, St. Joseph Vascular Institute. Dr. Razavi joined the staff of St. Joseph Vascular Institute in August 2005 and specializes in image-guided therapy for cancer and endovascular treatment of vascular disease including carotid artery stent placement. Previously, he was an Associate Professor of Interventional Radiology at the Stanford University Medical Center and the Director of the fellowship program. He had also served as the Acting Chief of Interventional Radiology at Stanford University Hospital. Dr. Razavi received his medical degree from the University of Southern California and completed his Radiology residency training at UCLA, where he served as the Chief Resident. He has had two subspecialty fellowship trainings; first in Medical Imaging at UCLA, where his research concentrated on instrumentation and clinical evaluation of Picture Archiving and Communication Systems (PACS), and second in Cardiovascular and Interventional Radiology at Stanford University Hospital. Dr. Razavi then joined the faculty of Interventional Radiology at UCLA and was the director of Special Procedures at the West Los Angeles VA Medical Center. In 1996, he went back to Stanford, where he was on the full time faculty in the Vascular Center until 2005. Dr. Razavi is also the editor of Techniques in Vascular & Interventional Radiology and has served on the editorial board of other prestigious scientific journals. His scientific work has been featured in over 100 national and international radio, television and press news articles and programs. Dr. Razavi also serves on the Board of Directors and the Scientific Advisory Boards of several device and biotechnology companies. He is a consultant to many medical device manufacturers and is co-founder of three medical device companies. Hussein R. Al-Khalidi, PhD, Director of Biostatistics, Statking. Dr. Al-Khalidi has over 15 years of statistical experience in Phase I, II and III clinical trials and pre-clinical development and has extensive experience in designing, sizing and analyzing clinical trials for new drug development with an emphasis on cardiovascular trials. Prior to joining STATKING Consulting, Inc., Dr. Al-Khalidi was a Principal Statistician at Procter and Gamble Pharmaceuticals (P&GP) and an Adjunct Associate Professor at the University of Cincinnati for the past 15 years. At P&GP, Dr. Al-Khalidi was fully responsible and accountable for statistical leadership in the development and execution of strategies and plans for securing regulatory approval of a new cardiovascular drug as well as a pediatric indication on a marketed osteoporosis drug for children. Dr. Al-Khalidi was also responsible for the statistical leadership of the largest primary percutaneous coronary intervention trial in the United States. Dr. Al-Khalidi has been the lead statistician for several NDA submissions. He has written statistical analysis plans, interim analysis plans, stand alone statistics reports, the statistical sections of clinical study reports and integrated summaries of efficacy and safety. He has interacted with FDA statisticians and medical personnel both as a representative of his company and also in an advisory capacity. He has particular statistical expertise in the areas of recurrent events analysis, adaptive designs, dose ranging, QT prolongation studies and randomization methods. Dr. Al-Khalidi earned his PhD in Statistics from Texas A&M University. He has published over 40 articles in a variety of technical and scientific journals. He is the Associate Editor for the Journal of Biopharmaceutical Statistics. Ophthalmology 9:30 – 10:20 a.m. Explore the advances of So Cal ophthalmology companies, and hear about national trends. Updates in cornea, glaucoma, neuro-ophthalmology, refractive surgery, and retina will be discussed. J. Randy Alexander, President & CEO, ReVision Optics. With an extensive background in ophthalmic surgical products, Mr. J. Randy Alexander is well known for leading several successful and innovative ophthalmic companies. Because of his expertise, he has been instrumental in the development and market introduction of contact lenses, intraocular lenses, viscolastic surgical products, femtosecond lasers and numerous other successful ophthalmic products that are currently marketed worldwide. Mr. Alexander began his career at Bausch and Lomb where he was involved in introducing the soft contact lens to the consumer market. He has been the President and Chief Executive Officer of Intermedics and IntraLase as well as holding senior positions at CILCO and Chiron Vision. During his tenure as CEO of several ophthalmic companies, Mr. Alexander has raised over $150 MM in Venture Capital while creating close to $ 1 BB in value. Currently as the President and CEO of ReVision Optics, he is developing a novel patented product for the treatment of presbyopia. Thomas Berryman, President & CEO, WaveTec Vision Systems. Thomas Berryman joined WaveTec Vision Systems as President and CEO in May 2005. Prior to joining WaveTec, he was President & CEO of Genyx Medical, Inc., which he founded in 1997. Tom led Genyx through its early development activities, a large multi-center randomized trial, approval of a PMA for its principal product, two rounds of venture capital financing and negotiating the sale of the company to C.R. Bard in March 2005. Prior to founding Genyx, Tom was with Micro Therapeutics, Inc. from 1994 though 1997 as its CFO. Prior to MTI, Tom served since 1985 as CFO in several venture-funded and publicly held device companies in Orange County, including Advanced Surgical Intervention and VLI Corporation. He received a BS degree from Cal Poly, Pomona and a MBA with Honors from the University of California, Irvine. He also serves on the Boards of Glumetrics, Inc. and OCTANe. Dr. Arturo Chayet, Codet Vision Institute. Doctor Arturo Chayet is world renowned as a leader and pioneer in vision correction procedures such as Laser Refractive Surgery and Intraocular Lens Surgery (Cataract surgery).. His professional activities include personal care for his patients, research, and training of future Refractive Surgeons. Moreover, Dr. Chayet has written numerous articles in prestigious Scientific and Ophthalmology Journals, and he is regularly invited as a Professor to the major academic institutions and associations on the five continents. One of Dr. Chayet’s recent achievements has been his participation in the development project of the Light Adjustable Lens (LAL) representing the cutting edge in cataract surgery technology. It has been research in which he has collaborated with the 2005 Nobel Prize winner in Chemistry, Professor Robert H. Grubbs. Dr. Chayet and his staff have consolidated CODET Vision Institute as the worldwide Leader Institute in Research and Treatment of Refractive Surgery and Intraocular Lenses. Roger Anderson, Managing Partner & Co-founder, BioQuest, Inc. BioQuest specializes in consulting with venture-backed, small and mid-size companies on executive-level positions in the Biopharmaceutical, Medical Device and Diagnostics sectors. As co-founder and Managing Partner, Roger sets the highest standards for client service for the firm. His vision and commitment to excellence provide the platform for the BioQuest service model, which, over the last 20 years, has helped grow the firm into one of the leading specialty executive search firms in the United States. Roger’s practice is focused on the medical device sector, conducting searches at the CEO, Board and VP levels. Prior to entering the executive search field in 1981, Roger had ten years of successful medical device sales with IVAC Corporation (now Alaris Medical) and American Hospital Supply (McGaw Laboratories Div). He is also an active member of the Life Science Angels and has been a panel member at several medical technology conferences. He received his BS in Biological Sciences from the University of Wisconsin, followed by four years as a US Naval Officer. 6 7 INDUSTRY TRACK Tuesday, November 10 7:30 – 11:20 a.m. - Salon A & B TOOLS TRACK Tuesday, November 10 7:30 - 11:20 a.m. - Salon D & E Forecast for Washington 10:30 – 11:20 a.m. The Changing Legal, Policy, and Enforcement Landscape Affecting Device Companies. 2009 has seen significant changes in Washington, D.C. and its regulation of the medical device industry. This panel will provide the opportunity to hear from and question leading healthcare and life sciences lawyers who have a wealth of industry expertise on what they foresee as the potential changes to the legal, policy and enforcement landscape and its impact on the device industry in 2009 and beyond. Shayne Kennedy, Partner, Latham & Watkins. B. Shayne Kennedy is a partner in the Orange County office of Latham & Watkins and serves as the Co-Chair of the Corporate Department. Mr. Kennedy’s practice focuses on corporate finance, general corporate representation and mergers and acquisitions. Most recently, Mr. Kennedy was involved in the initial public offerings of EnteroMedics, Hansen Medical, Masimo Corporation, Trans1 and Xtent. Other highlights of Mr. Kennedy’s practice include his representation of Allergan in its spin-off of Advanced Medical Optics, and PIMCO Advisors and its related entities in their sale to Allianz AG. Mr. Kennedy’s other corporate finance experience includes the representation of both underwriters and issuers in public and private offerings for Allergan, American Medical Systems Holdings, American Oriental Bioengineering, Array Biopharma, Ceradyne, Corcept Therapeutics, Dexcom, Digirad, Mannkind, Masimo, MSC Software, Neurogen, Oratec Interventions, Peplin, Resources Connection, Seattle Genetics, ResMed, Vital Images, VNUS Medical Technologies and Volcom, as well as private offerings for Cayenne Medical, OrthAlign, PrairieComm and Viacore. His underwriting clients include Citigroup, Credit Suisse, Deutsche Bank Securities, Jefferies & Company, J. P. Morgan, Merrill Lynch, Morgan Stanley, Piper Jaffray & Co. and Thomas Weisel Partners. Mr. Kennedy continues to provide outside corporate counsel to various public and private companies including Cougar BioTechnology, Neurogen, ResMed, PIMCO, Cayenne Medical and OrthAlign. Mr. Kennedy is a member of the American Bar Association and is actively involved in a variety of charitable and church-related activities. John R. Manthei, Partner, Latham & Watkins. John R. Manthei is a partner in the Washington, D.C. office of Latham & Watkins and serves as Global Co-Chair and Washington, D.C. Department Chair of the Healthcare and Life Sciences Practice. His practice focuses on regulatory and legislative matters involving the Food and Drug Administration (FDA) for the medical device, pharmaceutical and biotechnology industries. Mr. Manthei’s practice includes assisting clients with all aspects of the FDA-regulated product life cycle. Prior to joining Latham, Mr. Manthei served as Majority Counsel for the US House of Representatives’ Committee on Energy and Commerce (1998-2000). He counseled the Commerce Committee Chairman; the Health and Environment Subcommittee Chairman; the Oversight and Investigations Subcommittee Chairman; as well as the House Leadership on matters relating to the FDA and legislation concerning the Federal Food, Drug and Cosmetic Act; the Public Health Service Act; and the Controlled Substances Act. Since 2000, Mr. Manthei has represented the pharmaceutical, biotechnology and medical device industries as counsel in nearly every major FDA legislative initiative. He has also testified before Congress on several occasions involving FDA and DEA regulatory and enforcement matters. Mr. Manthei serves as outside FDA counsel to the Medical Device Manufacturers Association (MDMA), is a member of the Food & Drug Law Institute’s Advisory Committee for Drugs and Biologics, and has been recognized in Chambers USA, Who’s Who in America, Who’s Who in American Law and Who’s Who International. In 2006, he was named as one of the “Top 40 Lawyers Under 40” by Washingtonian Magazine. Daniel Meron, Partner, Latham & Watkins. Daniel Meron, recently recognized as one of the top 12 outstanding healthcare fraud and compliance lawyers by Nightingale’s Healthcare News, is Global Co-Chair of the Latham & Watkins’ Healthcare & Life Sciences Practice Group. He is in the Litigation Department of the firm’s Washington, D.C. office and is also a member of the appellate practice group. Mr. Meron has deep regulatory, investigatory and litigation expertise across a broad range of healthcare and life sciences matters, from product approval, exclusivity determinations and promotional regulation by the FDA to coverage and reimbursement regulation by CMS, including fraud and abuse and white collar enforcement investigations and litigation. Mr. Meron joins Latham & Watkins from the United States Department of Health and Human Services (HHS), where he served as General Counsel from 2006 to 2007. At HHS, he supervised the work of approximately 500 attorneys and was heavily involved in advising the Department’s leadership on sensitive and high priority matters involving all of the key statutes and regulations that HHS enforces, including the Food, Drug and Cosmetic Act and the Medicare and Medicaid statutes, as well as the federal Anti-Kickback Statute. As General Counsel, Mr. Meron worked closely with the Office of Inspector General in coordinating positions on enforcement matters relating to FDA and CMS statutes and regulations. During his time at HHS, Mr. Meron also served as a senior policy advisor to Secretary Leavitt on the Secretary’s healthcare transparency initiative. Medical Device Design - How to Deliver Technology that People Value 7:30 – 8:20 a.m. Breakthrough technologies are being developed in labs and universities around the world everyday. Doctors, nurses, patients, and caregivers value technology that combines improved outcomes with a clear, enhanced user experience. Their satisfaction is the key to your success. This session will focus on the activities that are essential to bridging the gap between the user and technology for business success. Allan Cameron, Principal - Industrial Design, Continuum. Allan is a integral member of the medical design practice in Continuum’s Health and Medical Group. At Continuum, he has managed and designed a diverse group of medical devices from a pediatric sedation headset to a POC respiratory product to a revolutionary device to treat depression. He has also lead several large laboratory instrumentation projects for the clinical, microbiology, and life sciences field. These projects have included intensive work on architectural design, user interaction and disposables, their life cycle and packaging. Before coming to Continuum, Allan Cameron worked in the Southern California design community for over 23 years, acquiring a broad range of experience in medical device design. Mr. Cameron’s medical projects have included surgical tools and controls, heart/lung machines, dialysis equipment, laboratory instrumentation, handheld and diagnostic devices with their accompanying disposables/packaging. Some of his clients have included Bayer, Baxter, Dade-Behring, Cobe, Dura Pharmaceuticals, Birtcher Medical Systems, Allergan, Micro-Scan and BioRad. Mr. Cameron has a strong mechanical background, holding many patents, which allows a seamless mating of both the Industrial Design and Engineering disciplines. Mr. Cameron received his BFA from the Cleveland Institute of Art. Stuart Perry, Director - Electrical Engineering, Continuum. Stuart Perry is responsible for electrical engineering and design in both implementation and project leadership roles. He has experience in diverse aspects of systems engineering and product development with technical strengths that span motion control, instrumentation, testing, simulation, analog and digital signal processing, analog and digital circuit design, wireless system design and software. Prior to joining Continuum, Mr. Perry worked for eleven years at the Eastman Kodak Company in the R&D laboratories for optical disk recording. He led a team of mechanical, optical, electronic, and software engineers as the system architect and project leader for a DVD-R optical disc recorder. In previous assignments at Kodak, he developed control strategies from concept through implementation for next generation optical disk drives. Mr. Perry also has product development experience leading the electronic design of a broad array of products, including an advanced infusion pump, a three dimensional printer, a medical-grade audiometric amplifier, an ultrasonic cleaner, a PC-based analog telecommunications device, and a low-cost avionics instrument. Mr. Perry received an MS in Electrical Engineering, and a BE as a double major in Electrical Engineering and Math from Vanderbilt University. He holds six patents in the areas of power amplifier design, computational methods for control systems, and resonant load stabilization. Mock IP Due Diligence 8:30 – 9:20 a.m. Learn about the IP issues facing investors, acquirers and companies through a mock IP due diligence. Panelists roleplaying both sides of a potential investment, including investor and company representatives and IP counsel, will walk through common due diligence issues and problems using the example of a hypothetical medical device company seeking financing and positioning itself for acquisition. Sabing Lee, Partner, KMOB. Sabing H. Lee is a partner in the Orange County office of Knobbe Martens Olson & Bear LLP. Mr. Lee received his Bachelors Degree in Materials Engineering, Phi Beta Kappa and summa cum laude, from UCLA, and also received his Masters Degree in Materials Science and Engineering from UCLA. He received his J.D. from the University of California, Berkeley School of Law (Boalt Hall), where he was an Articles Editor and Executive Editor for the Berkeley Technology Law Journal. Mr. Lee’s practice includes strategic patent procurement, patent portfolio management, intellectual property due diligence, general counseling on infringement and licensing, interferences, reexaminations, and other related issues. Mr. Lee currently represents clients in a wide range of technologies, including medical devices, nanotechnology, and semiconductor fabrication. Mr. Lee joined the firm in 1997 and became a partner in 2003. He has been named as one of Southern California’s “Rising Stars” in intellectual property law in a survey of his peers, published in Los Angeles magazine and Super Lawyers magazine, consistently since 2004. In the medical 9 8 TOOLS TRACK Tuesday, November 10 7:30 - 11:20 a.m. - Salon D & E device field, Mr. Lee has worked extensively with cardiovascular and orthopedic technologies. He has been involved in the intellectual property strategy and acquisitions of PercuSurge, Inc. (acquired by Medtronic, Inc.), Flex-Foot, Inc. (acquired by Össur hf.) and Endius, Inc. (acquired by Zimmer Holdings, Inc.). Gerard von Hoffmann, Partner, KMOB. Gerard von Hoffmann is a partner in our Orange County office, where he specializes in intellectual property strategies, financings and strategic transactions in the medical device industry. Mr. von Hoffmann holds an A.B. in Chemistry from Rice University and Occidental College and received a J.D., cum laude, from the University of San Diego School of Law. Mr. von Hoffmann attended the Institute on International and Comparative Law at Oxford University, England, and served as a law clerk for the Honorable Helen W. Nies, Circuit Judge, United States Court of Appeals for the Federal Circuit. Mr. von Hoffmann has served as an Adjunct Professor of Patent Law at the University of San Diego School of Law, and also on the Board of Directors of several private and public medical device companies including CardioVascular Dynamics, Inc., Radiance Medical Systems, Inc., Triage Medical, Inc., NeoMatrix, LLC, and ValenTx, Inc. His technical experience involves a wide variety of diagnostic and therapeutic cardiovascular interventions, throughout the peripheral and coronary vasculature, intracranial access devices and procedures, and various coronary implants and procedures. He has also been involved in a variety of orthopedic projects. His activities have also involved a variety of intraocular, gastrointestinal, OB/GYN and respiratory technologies. Mr. von Hoffmann joined the firm in 1986 and became a partner in 1989. Vito Canuso, In-house IP litigation Counsel, Medtronic-CoreValve. Vito Canuso is in-house IP litigation counsel for Medtronic-CoreValve, responsible for handling IP litigation matters involving cardiovascular technologies. He was previously responsible for both litigation and prosecution for a start-up cardiovascular company before and during its acquisition by Medtronic. Prior to May of 2008, Mr. Canuso was a partner with Knobbe Martens Olson & Bear, where he has been practicing as an IP lawyer since early 1990, having become a partner in 1995. His practice historically focused boardly on IP litigation and IP prosecution matters for various types of clients, from billion-dollar international comglomerates to small garage inventors. He has litigated IP issues involving a wide variety of technologies, including consumer electronics, semiconductor processing equipment, medical devices, pharmaceuticals, telephony, motorized watercraft, controllers, and circuit board devices. Mr Canuso has litigated cases before district courts throughout the United States and before the ITC, and has prepared and argued appeals to the Federal Circuit. While at Knobbe, Martens, his patent prosecution docket focused primarily on medical devices for numerous life science applications in the cardiovascular and pulmonary fields, and clean technology, including electrochemical applications. Mr. Canuso spent a great deal of his latter career advising start up companies in IP strategy, primarily in the medical and clean tech fields. Mr. Canuso received his Juris Doctor degree from the University of San Diego. He earned a master’s of science degree in Environmental Health Engineering from the University of Notre Dame and a bachelors of science degree in Mechanical Engineering from Villanova University. Tuesday, November 10 7:30 - 11:20 a.m. - Salon D & E European Opportunities for Medical Device Companies 10:30 – 11:20 a.m. International experts will discuss how Europe is driving growth and innovation for many American medical device companies. A case study outlining a recent international expansion project will be analyzed and experts will be available to share information on incentives, research and development opportunities, and overall global industry trends. Douglas K. Ebert, Executive Director North America, Development Economic Western Switzerland. For nearly two decades Doug Ebert has represented Switzerland, most particularly the Canton of Neuchatel and most recently DEWS, the combined economic development regions of the Cantons of Neuchatel, Vaud, Valais and the Jura (Western Switzerland) in the area of Economic Development and Direct Foreign Investment. As the Executive Director of North America for DEWS, Development Economic Western Switzerland, Doug is the team leader of the DEWS development organization in the US and Canada. Prior to his work with Neuchatel and DEWS, Doug was Sr. Vice President for Consulting and Client Services for an international outplacement firm where he had oversight for over 50 offices nationwide. Nanci Govinder, Head of Medtech Coaching at the EPFL (Ecole Polytechnique Federale – Lausanne) Science Park. Nanci Govinder has worked for more than 12 years in the medical deviceindustry as a researcher, senior business manager and international marketing manager for companies such as Johnson & Johnson and Medtronic. She works as a business consultant at the Parc-Scientifique, EPFL, coaching startups from idea generation to go-tomarket, and is the CEO of a medical device startup in Geneva, Switzerland. Nanci is also a guest lecturer and facilitator at IMD, one of Europe’s leading business schools. She has a Bachelor of Science degree in Chemistry and Applied Chemistry and an MBA. She is a member of the Worldwide and European Medical Device Networks. Gerry Hammarth, Vice President, Finance, Masimo Corporation. Gerry Hammarth has served as Vice President, Finance for Masimo Corporation, a publicly traded medical device manufacturer, since June 2002. From April 1997 to June 2002, Mr. Hammarth served as Controller for Powerwave Technologies, Inc., a publicly traded manufacturer of telecommunications equipment. Previously, Mr. Hammarth has served in various finance positions in the computer manufacturing, retail, food and fashion apparel industries. Mr. Hammarth holds a B.A. in Psychology from the State University of New York at Stony Brook and an M.B.A. in Finance from the Wharton School of the University of Pennsylvania. Pierre Ihmle, Head of Partnership Development, EPFL (Ecole Polytechnique Federale – Lausanne). Pierre Ihmle has a dual scientific and management career in top institutions in the USA and in Europe. Pierre worked several years as a project manager for an internationat management consultancy. In 2002, Pierre Ihmle founded VPI Management consulting. In 2005, he co-founded Cinetis SA, a start-up in Martigny devoted to film digitization technologies. Pierre is regularly involved in teaching programs at IMD, and teaches strategy, entrepreneurship, innovation and finance classes at various universities and programs (VentureLab). He is Chairman of the Board of Cinetis SA. He is on the Advisory Board of Spectraseis, a geophysical start-up in Zurich. Pierre is on the Board of two non-for profit organizations. Pierre Ihmle holds a degree in natural sciences from the ETHZ in Zurich (summa cum laude) and a Ph.D. in geophysics from M.I.T. in Cambridge, USA. He has been active as a senior research scientist at the Institut de Physique du Globe de Paris and at Institute of Geophysics at ETHZ. The Regulatory Road Less Traveled: de novo 510(k)s and HUD/HDEs 9:30 – 10:20 a.m. For many companies there may be regulatory alternatives to pursuing conventional pre-market FDA approvals. The presenter - Alquest CEO Linda Alexander - will cover justifications for lesser-used, yet important approval strategies known as de novo 510(k)s and HUD/HDEs. Alexander will address considerations involving product design, steps, costs and timelines, as well as regulatory “fall back” options if these approaches are not supported by regulators. Linda Alexander, CEO, Alquest, Inc. Linda Alexander founded Alquest, Inc. in 1993 after working in management and director-level positions in regulatory and clinical affairs for Brennen Medical, Bioplasty and Medtronic. During her career, Linda established worldwide regulatory and clinical strategy and requirements for over 50 devices, including cardiovascular, audiology, interventional vascular, dental, neurovascular, orthopedic, plastic surgery, general surgery, neurology, gastroenterology and urology devices. Linda has obtained clearance/approval for more than 50 premarket notifications; 15 IDE applications; and six PMA applications. Linda is a nationally-recognized and sought expert and presenter on clinical and regulatory strategy for medical device companies. She earned a B.S. degree in biology and chemistry from Iowa State University, and M.S. in Technical Communication from the University of Minnesota. 10 11 START-UP COMPANY PRESENTATIONS Tuesday, November 10 7:30 - 11:20 a.m. - Salon C (listed in order of presentation) IV glucose monitoring system for tight glycemic control in hospitals • Improves patient outcomes • Improves clinician productivity, thus drives down hospital labor costs • Improves patient satisfaction of the hospital experience Tuesday, November 10 7:30 - 11:20 a.m. - Salon C (listed in order of presentation) Adventus Technology is developing two unique ophthalmic devices. • Corneal Onlay – a small, thin, biocompatible lenticule placed under the front surface of the cornea (epithelial layer), changing the corneal shape and therefore the eye’s refractive power for vision correction. • Dynamic Vision Gel – a soft, cohesive, flexible gel that replaces the human crystalline lens in presbyopic cataract and non cataract eyes providing the ability to focus at all distances, reducing the need for glasses Sundeep Karnik, CEO Tustin, CA 312-515-7186 www.reusense.com Seeking $3.5M Richard Franz, OD, FAAO Irvine, CA 92612 949-474-1478 www.adventustechnology.com Seeking $10M Michael S. Berlin, M.D., President Los Angeles, CA 310-855-1112 www.eyelightmedical.com Seeking $3M EyeLight, Inc. has developed the first clinically proven, minimally invasive, lasting solution for the treatment of open-angle glaucoma. EyeLight’s ELT (Excimer Laser Trabeculostomy) system treats open-angle glaucoma by creating drainage channels between two structures within the eye (Schlemm’s Canal and Trabecular Meshwork). EyeLight’s patented first generation ELT procedure has been performed on over 2,000 patients in Europe with 5 years of follow-up data. EyeLight is developing its second generation, patent-pending ELT prototype for the U.S. market. A 25% market share using EyeLight’s ELT system represents a market potential of $65 M in annual device sales. The treatment of glaucoma represents a $6 billion dollar market. Bob Terbrueggen, PhD Rancho Dominguez, CA 310-537-7857 www.DxTerity.com Seeking $10M DxTerity has developed a revolutionary, patent protected DNA testing system that allows doctors and emergency response personnel to test patients in 1 hour at the point of need. DxTerity has received a $40 million government contract to fund the development and FDA approval a high throughput version of the system for emergency response situations and hospital based genetic testing. France Dixon Helfer, Founder, President & CEO San Clemente, CA 949-366-1870 www.epicardialtech.com Seeking Total $15M/$3M round Epicardial Technologies Inc. (“ETI”) is a Southern California electrophysiology product start-up company developing an IP-licensed suite of products for access, protection and therapeutics. Single use minimally invasive devices will expand the treatable AF and VT cardiac arrhythmia patient base by allowing safer, more complete ablations, in less time, with fewer repeat procedures. Our unique technologies enable EP’s to use their current ablation catheters more effectively, with ETI’s access device and protective balloon catheters, by minimizing patient complications caused by damage to structures around the heart. Additionally, minimally invasive procedures currently performed by CV surgeons will be able to be performed by EP’s. Rory Gleadhill, VP Marketing Irvine, CA 949-715-2424 www.orth-align.com Open OrthAlign is developing a line of palm-sized, computer-assisted surgical devices for use in total joint replacement. CAS systems have proven to be more accurate and to reduce the incidence of malalignment outliers in total knee and hip replacement procedures. The current generation of large CAS systems has, for a variety of reasons, failed to become the standard of care. OrthAlign’s solutions are quick and easy to use, affordable, and adaptable to the surgeon’s existing technique using mechanical instrumentation. OrthAlign’s goal is to create new standards for accuracy and consistency in total joint replacement by making computer-assisted total joint surgery accessible to all surgeons and their patients. Dallen Medical’s patented orthopedic technology offers significant improvement in fixation with compression over existing products which will provide better patient outcomes, resulting in cost savings and reductions in length of stay. David H. Mills President & CEO San Clemente, CA 949-218-0030 www.dallenmedical.com Seeking $3-5M Dallen’s first product offers cardiac and cardiothoracic surgeons a better closure of the chest with the ease of use associated with sternal wire. The second offering is a product-line of titanium and bioabsorbable compression staples for small bone applications where current products deliver sub-optimal results. Additional applications are envisioned in long bone, maxillofacial and ultimately the spine. Combined applications represent more than a $1 billion market opportunity. Management is comprised of two start-up veterans whose focus is capital efficiency while building shareholder value. Shareholder liquidity is anticipated by means of acquisition by an established distribution company. John K. Stroh, CEO Irvine, CA 949-753-7844 www.neomatrix.com Seeking $16.5M Series 3 The HALO® Breast Pap Test is FDA approved for the collection of nipple aspirate fluid for cytological evaluation. The collected fluid can be used in the determination and/or differentiation of normal versus pre-malignant versus malignant cells. Incorporating Halo into routine practice will enable physicians and patients to monitor cellular changes within breast ducts earlier, before they develop into larger, potentially cancerous lesions. Catheter based devices for treating acute ischemic stroke patients. Richard Alcott,CEO Torrance, CA 310-600-0654 www.otosound.com Seeking $2M round One in five persons suffers with tinnitus. Today’s therapeutics address only patient symptoms – ringing in the ears. Our therapeutic platform addresses the neurological cause of tinnitus and is the first integrated FDA cleared diagnostic and treatment. Our patented, noninvasive, non-pharma, sound therapy platform is intuitive to use for Audiologists and patients. It effectively addresses tinnitus and potentially other central nervous system disorders. We have commercial devices inventoried, excellent clinical data and we are ready to launch our sales and marketing initiative in Europe and the USA. $2M in funding will initiate our sales effort in Europe and the US. Jeffrey Valko, CEO Irvine, CA 949-215-0660 Seeking $15M Raymond W. Cohen, CEO Laguna Hills, CA 949-215-3613 www.cardiopolymers.com Seeking $5.0 to $7.5M CardioPolymers has developed a novel biopolymer implant technology for mitral valve regurgitation and congestive heart failure patients which has yielded impressive pre-clinical and early human data. This “medical device” therapy involves strategic implantations of its proprietary inert biopolymer (Algisyl-LVR®) into the dilated left ventricle (LV) via catheter or during a concomitant open chest surgical procedure. Algisyl® thickens the LV wall and modifies the geometry of the heart. The effect is immediate and durable increase in cardiac function. Over 120 large animals have been studied and a Phase I European clinical study is near completion. A phase II randomized clinical study in anticipated for Spring 2010. 13 12 HEALTHCARE POLICY & REFORM PANEL Tuesday, November 10 11:30 a.m. – Garden Pavilion A Healthy Debate: Healthcare Policy & Reform Most people agree that the healthcare system in the United States is in need of significant reform. Policy changes not only affect the individual, but have the ability to drastically change the way medical device companies do business. Here, you’ll hear from leading experts actively engaged in policy and advocacy at the national level. Learn about the important decisions being made in the Obama administration what they will mean for the medical device industry across the US. Christopher Cox, Partner, Bingham; Former Chairman of the SEC Chris Cox is a partner at Bingham and a principal of Bingham Consulting Group. He also serves on the board of the National Endowment for Democracy in Washington, D.C. He has been chairman of the U.S. Securities and Exchange Commission, chairman of the Homeland Security Committee in the U.S. House of Representatives, the fifth-ranking elected leader in the House, and a 17-year member of Congress from California. He began his Washington career as a White House counsel to President Ronald Reagan, after serving as a partner in the international law firm of Latham & Watkins in Los Angeles and Orange County. In addition, Chris has taught corporate and individual income tax at Harvard Business School. While in Congress, Chris worked with CEOs and boards of directors of virtually every Orange County public company and business as well as the Los Angeles Chamber of Commerce to assist in job creation and growth. He also served as chairman of the Task Force on Capital Markets and chairman of the Task Force on Budget Process Reform. As a member of the House, in addition to his role as chairman of the Committee on Homeland Security, Chris was chairman of the Select Committee on U.S. National Security and a senior member of the Energy and Commerce Committee and the Financial Services Committee. For 10 years he served as chairman of the House Policy Committee. In each of these capacities he was responsible for significant legislation, including the Internet Tax Freedom Act, the Securities Litigation Reform Act and the Support for Eastern European Democracy Act. In 1977, he simultaneously received a Master in Business Administration degree from Harvard Business School and a Juris Doctor degree from Harvard Law School, where he was an editor of the Harvard Law Review. He graduated from the University of Southern California in 1973. Scott Gottlieb, M.D., Resident Fellow, American Enterprise Institute; Former Deputy Commissioner for Medical and Scientific Affairs, US Food and Drug Administration Scott Gottlieb, MD is currently a practicing physician and Resident Fellow at the American Enterprise Institute (AEI), a private, nonpartisan, not-for-profit institution dedicated to research and education on issues of government, economics and social welfare. From 2005-2007, Dr. Gottlieb served as FDA Deputy Commissioner and before that, from 20032004, as a senior advisor to FDA Commissioner Mark McClellan and as the FDA’s Director of Medical Policy Development. He left FDA in the spring of 2004 to work on implementation of the new Medicare Drug Benefit as a Senior Adviser to the Administrator of Medicare and Medicaid Services, where he supported the agency’s policy work on quality improvement and coverage and payment decision-making, particularly related to new medical technologies. Dr. Gottlieb is the author of more than 300 articles that have appeared in leading medical journals as well as The Wall Street Journal, The York Times, USA Today and Forbes Magazine. Dr. Gottlieb has held editorial positions on the British Medical Journal and the Journal of the American Medical Association and appears regularly as a guest commentator on the cable financial news channel CNBC. Dr. Gottlieb completed his residency in internal medicine at the Mount Sinai Hospital and is a graduate of the Mount Sinai School of Medicine and of Wesleyan University, in Connecticut. Dr. Gottlieb practices medicine as an attending physician at Stamford Hospital in Connecticut where he is an internist on the hospital’s inpatient medical wards. Jeffrey J. Kimbell, President, Jeffrey J. Kimbell & Associates Mr. Kimbell represents clients in the life sciences community seeking legislative remedies for their needs. Kimbell & Associates was founded in 1998 and has since grown to include five fulltime lobbyists and/or policy experts in the field of medical devices, pharmaceuticals, biodefense and biotechnology. The firm has 17 hand-selected clients, all in the life sciences space. Three years after establishing his firm, in January of 2001, Mr. Kimbell was named to President George W. Bush’s Transition Team Advisory Committee for the U.S. Department of Health and Human Services (HHS). He was the only consultant to serve on the Committee. Prior to Kimbell & Associates, Mr. Kimbell served as the first Executive Director of the Medical Device Manufacturers Association (MDMA) from 1994-1998. While at MDMA, he directed all Washington policy initiatives on behalf of MDMA’s member companies. During his tenure, the association grew from 25 companies to 130, an increase that can be directly attributed to a number of legislative victories, including passage of a landmark bill to overhaul the product approval process at the U.S. Food and Drug Administration. Prior to MDMA, Mr. Kimbell was a personal aide to former Senator Howard H. Baker, Jr. (R-TN) and former Secretary of State Lawrence S. Eagleburger in the Washington office of the Tennessee-based law firm Baker, Worthington, Crossley & Stansberry. While at Baker-Worthington, Mr. Kimbell tracked legislative activity for a host of Fortune 500 clients and helped coordinate events for U.S. Senate Majority Leader Bill Frist, MD (R-TN), U.S. Senator Lamar Alexander (R-TN) and former Senator Fred Thompson (R-TN). Mark Leahey, President & CEO, MDMA Mark Leahey is the President & CEO for the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents research-driven medical technology companies. Mr. Leahey’s responsibilities include advocating on behalf of the entrepreneurial sector of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and other federal and state agencies. He has lobbied for a more reasonable user fee for smaller companies, worked to open access to the hospital marketplace by challenging the exclusionary and anticompetitive nature of certain large group purchasing organizations (GPOs), as well as ensure that medical device technologies are reimbursed adequately. Mr. Leahey currently sits on the Medical Devices Committee for the Food and Drug Law Institute (FDLI) and the Editorial Advisory Board of Medical Product Outsourcing. He is a member of the Massachusetts Bar and a graduate of Georgetown University, the Georgetown Law Center and Georgetown’s McDonough School of Business. 14 15 INVESTOR PANEL Tuesday, November 10 1:45 – 3:00 p.m. - Salon D & E Featuring the PwC MoneyTree Report The MoneyTree Report is a quarterly study of venture capital investment activity in the United States. As a collaboration between PricewaterhouseCoopers and the National Venture Capital Association based upon data from Thomson Reuters, it is the only industry-endorsed research of its kind. The MoneyTree Report is the definitive source of information on emerging companies that receive financing and the venture capital firms that provide it. The study is a staple of the financial community, entrepreneurs, government policymakers and the business press worldwide. Tuesday, November 10 1:45 – 3:00 p.m. - Salon D & E FDA clearance of the FilterWire EX™ Device. Previously, Milt was the President and Chief Executive Officer of Genitope, Inc. an early stage biotechnology company focusing on patient-specific therapies for lymphoma which eventually became publically traded. Before joining Genitope, Milt was President and Chief Executive Officer of CSFluids, Inc. (later renamed Eunio), a development-stage company offering a surgical treatment for Alzheimer’s Disease. Prior to that he was Vice President of Regulatory Affairs, Quality Affairs, Clinical Affairs and Chief Medical Officer for Gynecare, Inc. (eventually acquired by Johnson and Johnson) and Director of Marketing for Origin Medsystems (acquired by Guidant Corporation). Milt began his career as a professional football player with the San Francisco Forty-Niners and Los Angeles Raiders from 1981 to 1989. He was a member of two Super Bowl Championship teams for the Forty-Niners and was a special team’s captain. Milt earned a B.S. in Biology from Stanford University and his M.D. from Stanford University School of Medicine. J.P. Peltier, Managing Director, Piper Jaffray J.P. Peltier is a Managing Director and member of the Health Care Team at Piper Jaffray. Peltier has 10 years of investment banking experience at Piper Jaffray focused exclusively on the medical technology sector. Peltier provides medical technology clients a full range of investment banking services from equity and debt financing to merger and acquisition advisory. Peltier’s prior experience includes five years at HomeServices of America, a Berkshire Hathaway subsidiary serving in a merger and acquisition advisory role and leading the mortgage banking division. Peltier graduated from the University of St. Thomas and received a Master of Business Administration degree from the J.L. Kellogg School of Management at Northwestern University. Jay Watkins, Managing Director, De Novo Ventures Jay is a Managing Director at De Novo Ventures. Prior to joining De Novo in 2002, Jay was a co-founder of Origin Medsystems, a venture-funded medical technology start-up that was purchased by Eli Lilly & Company in 1992. When Eli Lilly divested its medical device businesses to form Guidant in 1995, he became a member of the corporation’s management committee, serving in this role from 1995-2002. During this time, he served as president of numerous divisions, including the Minimally Invasive Surgery Group. In addition, Jay was the President of Compass, Guidant Corporation’s corporate business development and new ventures group. Prior to founding Origin, Jay held management positions in several start-ups, including Microgenics Corporation, and was a consultant with the international consulting firm of McKinsey & Company. He has been a member of the board of directors of several public companies, including Gynecare, Cardiogenesis, and Rita Medical. Jay received his MBA from Harvard University and his undergraduate degree from Stanford University. Jay sits on the boards of EBR Systems, PhotoThera, Pulmonx, Sierra Surgical, Synergeyes and Ventus Medical. He also represented De Novo on investments in Lumend and Hansen Medical. Michael Hedge, Shareholder, Stradling Yocca Carlson & Rauth Michael A. Hedge’s practice focuses on securities, mergers and acquisitions, corporate finance, venture capital, corporate governance and commercial transactions, representing both public and private companies in the life sciences and technology industries. Mr. Hedge received his J.D. in 2000 form the University of California, Los Angeles, where he completed the Business Law Program. He received his B.S. in accounting, cum laude, at California State University, Northridge, in 1997. Mr. Hedge is a member of the State Bar of California and the Orange County Bar Association, and he served in the U.S. Marine Corps Reserve from 1993 to 1999. Speaker: Randy Churchill, PricewaterhouseCoopers Dr. Thomas J. Fogarty Dr. Thomas J. Fogarty is an internationally recognized cardiovascular surgeon, inventor, entrepreneur and investor. Throughout his career, he has been involved with a wide spectrum of innovations in business and technology. He has served as founder, Chairman or board member for more than 30 medical device companies, the majority of which were based on devices designed and developed by his company, Fogarty Engineering Inc. Dr. Fogarty has published more than 180 scientific articles and textbook chapters in the fields of general and cardiovascular surgery, and is the author or co-author of more than 125 patents and patent applications. His patents include the industry standard Fogarty Balloon Embolectomy Catheter and the widely used AneuRx AAA Stent Graft System. Dr. Fogarty is currently Adjunct Professor of Surgery at Stanford University. Previously, he held the positions of President of the Medical Staff at Stanford University Medical Center and Director of Cardiovascular Surgery at Sequoia Medical Center. He recently added the Fogarty Institute of Innovation at El Camino Hospital. In addition to his work in the medical field, Dr. Fogarty is an accomplished investor. He founded and serves as Managing Director of Emergent Medical Partners LLP. He also was a founder and general partner at Three Arch Partners, and served as a general partner in five successive Three Arch venture funds. Dr. Fogarty is the recipient of countless awards and honors, including the Jacobson Innovation Award presented by the American College of Surgeons and the 2000 Lemelson-MIT prize for Invention and Innovation. In December 2001, he was inducted into the Inventors Hall of Fame. Dr. Fogarty received a Bachelor of Science degree from Xavier University and a medical degree from the University of Cincinnati. He completed his residency at the University of Oregon. Michael Buck, Divisional Vice President, Abbott Ventures Mike is currently the Vice President of Abbott Ventures, Inc., a subsidiary of Abbott Laboratories. Abbott recently formed this new venture group seeking to make investments in companies with technologies and developmental products of strategic interest to Abbott. It will manage an investment fund that will allow Abbott to take equity positions in companies doing promising work within Abbott’s current markets, and in others that Abbott may choose to enter in the future. With nearly 20 years of medical device experience, Mike joined Abbott as a result of Abbott’s acquisition of Guidant Corporation’s Vascular business in 2006. While at Guidant, Mike held various sales management and business development titles. Prior to joining Guidant in 2002, he also held multiple positions with Boston Scientific, Novoste, and Smith & Nephew Endoscopy. Mike earned a BA in Economics from the University of Iowa. Milt McColl, Venture Partner, New Leaf Milt McColl joined New Leaf as a Venture Partner in April 2007. Prior to joining New Leaf, Milt was President of the Neurovascular Division of Boston Scientific Corporation (BSC). Milt initially joined BSC in 2001 following the acquisition of Embolic Protection, Inc (EPI) where he served as Vice President and General Manager for the Embolic Protection Franchise, part of the Interventional Cardiology division of BSC. Milt joined EPI in 2000 as one of the first employees assuming the position of Vice President of Clinical, Regulatory and Quality Affairs and Medical Director. During his time there he managed the design, implementation and successful completion of the FIRE Clinical trial, an 800 patient pivotal study which led to the 16 17 CALIFORNIA MEDICAL DEVICE FORUM SPONSORS Alquest is a regulatory and clinical services firm focused exclusively on medical devices, diagnostics and biologics. Having supported more than 400 medical device firms in 16 years, Alquest is respected by leading manufacturers and investors in the device industry. Core services are regulatory strategy and submissions, clinical design and clinical trials, and quality systems. Alquest locations are in the San Francisco Bay Area and Minneapolis. Through an affiliate, Alquest also supports European regulatory and clinical needs. For more information see www.alquest.com Abbott Medical Optics, Inc. (AMO) is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages. We do this by providing a Complete Refractive Solution to address vision disorders at all stages of life. We offer market-leading technologies for myopia, hyperopia, astigmatism, contact lens care and corneal health, as well as proven educational and support programs that help eye care professionals master refractive technologies and grow their practices. We deliver our technologies through three complementary product lines, each providing specific solutions to address patients’ needs at certain stages of life. With our innovations, eye care professionals can optimize visual function based on each patient’s individual need. AMO is dedicated to improving the quality of vision – and life – for others. www.amo-inc.com. Aubrey Group, Inc. is a product development and manufacturing company using state-of-the-art technologies to develop new medical devices and biotech instruments. Our expertise is creating innovative solutions for clients in the therapeutic, surgical, patient monitoring and clinical diagnostic industries. We help our clients reduce cost and bring products to market faster. Our services include system design, electronics, software engineering, mechanical engineering, verification and validation, compliance testing, prototypes, contract manufacturing and clean room disposables. Our capabilities include electro-mechanical devices, RF generators, pumps, wireless devices, microfluidics, implantables, and disposables. We are ISO13485 certified, UL registered, and a FDA registered medical device manufacturer. www.aubreygroup.com With more than 1,100 lawyers in 12 offices in key international, national and California markets, including Orange County, Los Angeles, Santa Monica, San Francisco and Silicon Valley, Bingham provides a full complement of high quality legal services to a variety of emerging and high growth clients including venture capital, corporate and securities, M&A, intellectual property and licensing, litigation, antitrust and tax, among others. Bingham has the capability and agility to execute a broad range of complex transactions. We serve clients ranging from the world’s largest financial institutions and corporations to small and emerging entrepreneurial businesses across all areas of technology, including medical devices, pharmaceuticals, biotechnology, information technology, clean technologies and renewable energy. We offer a pragmatic approach, with the know-how and confidence to define key issues, keep deals moving and drive matters to successful conclusion. For more information on our firm please visit: www.bingham.com. BioQuest is a retained executive search firm focused exclusively on recruiting senior executives for the life sciences industry. Our clients range from VC-backed start-ups to mid-sized public companies across the broad spectrum of the life sciences industry including: medical devices, biopharmaceuticals, consumer/ medical, healthcare IT and healthcare services. We focus on the top two management tiers: CEO and VP, and we also conduct board searches. The firm was established in San Francisco in 1985 and today employs fourteen individuals dedicated to the service of our clients. With over 20 years in the business, we have developed an unrivalled network of contacts. We believe BioQuest’s major differentiator lies in the experience of our team. This enables us to identify and deliver the highest quality candidates. Each assignment is matched with the most relevant expert in our team who will personally lead the project. Our collaborative culture encourages team members to share collective knowledge to best serve clients’ needs. www.bioquestinc.com Canada’s R&D infrastructure, world-class innovative research and tax incentive programs make Canada one of the best places in the world to develop new products and medical devices. The Canadian Medical Device industry has strength in range of specialities including cardiovascular devices, medical imaging, in vitro diagnostics, dental implants, materials, and assistive devices/ home healthcare products. The Canadian medical device manufacturing and development industry consist of approximately 1000 firms, and offers global medical device manufactures tremendous opportunities in rapidly expanding domestic and international markets. With a combination of cost competitiveness, a strong and stable economy, a dynamic business environment, skilled labour force, access to North America market and high quality of life, Canadian locations present some of the strongest investment propositions among advanced economies. Canada has a global network of trade and investment professionals in more than 150 cities worldwide. They can help investors get the conversation started with a creative and competitive Canada. www.investincanada.com Capital Advisors Group (CAG) is among the nation’s most experienced, independent investment advisors with a primary focus on institutional investment advisory services. With more than 18 years of portfolio management experience through varied rate cycles, CAG has built its legacy upon deep, research-driven short-term cash investment strategies for its clientele. As a SECregistered investment advisor, CAG’s mandate is to work in the best interest of its clients, which we aim to accomplish by maximizing returns, minimizing risk and providing customized accounting reports that suit specific client needs. Capital Advisors Group also provides independent debt sourcing advisory services through its subsidiary Debt Advisors Group. For more information please visit www.capitaladvisors.com. Continuum is a global innovation and design consultancy that helps turn ideas into realities. We work at the intersection of technology, systems, and human-centered design to deliver innovation that impacts our client’s business. Through exhaustive investigation and user research, Continuum undertakes a deeply immersive role in a client’s businesses to develop solutions that are relevant to the end users. Since 1983, Continuum has created meaningful design for companies worldwide including NIH, Avedro, Herman Miller, Insulet, Amplifon, and Affymetrix. Continuum has offices in Boston, Los Angeles, Milan, Seoul and Shanghai. www.dcontinuum.com DeviceLab, Inc. is an innovative full-service, multi-disciplinary medical product design and engineering firm. We have years of experience in designing class I and II medical device and instruments. Our experience and expertise enable us to create marketdriven designs and deliver new or newly enhanced products for maximum market impact quickly and cost-effectively. Since 1998 DeviceLab completed over 89 projects. Our specialty includes custom medical cart projects and Point of Care medical instrument. We’ve completed 15 carts projects and 22 Point of Care table top devices. 18 Solid Concepts Inc. is a supplier of rapid prototyping, direct digital manufacturing, tooling and production molding services. Capabilities in PolyJet, SLA, SLS, QuantumCast™ cast urethanes, CNC and FRP prototypes and short run production parts. Tooling and Molding expertise to bring your project through to completion. ISO 9001 and AS9100 certified. Development Economic Western Switzerland (DEWS) is an international agency and joint partnership of the cantonal economic development agencies of Vaud (DEV), Valais (SDE), Neuchâtel (DEN) and Jura (DEJ), which provide assistance at no charge to foreign-based companies looking to establish business operations in Switzerland. The DEWS region is home to hundreds of multinational companies seeking a business-friendly and top high-tech center in the heart of Europe. Over 700 international companies are established in the region include: Edwards Lifesciences, Ferring International, Kyphon, Medtronic, Merck-Serono, as well Johnson & Johnson, PPG, Nestle, Eaton, Starbucks, Honeywell, and many others. Ernst & Young is a global leader in assurance, tax, transaction and advisory services. Worldwide, our 144,000 people are united by our shared values and an unwavering commitment to quality. We make a difference by helping our people, our clients and our wider communities achieve their potential. For more information, please visit www.ey.com. Ernst & Young refers to the global organization of member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. Edwards Lifesciences (NYSE: EW) is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine, California, Edwards has more than 6,200 employees worldwide, selling medical technologies in nearly 100 countries with 2008 sales of $1.24 billion. Eighty-five percent of the company’s sales come from brands with leading global market positions, including Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT and Swan-Ganz. Edwards Lifesciences leverages its research, design, development and marketing expertise to produce products that address specific cardiovascular opportunities including heart valve disease, vascular disease and critical care technologies. www.edwards.com Hantel Technologies (www.hanteltech.com) is a leading single-source provider of comprehensive medical product design and manufacturing solutions from concept through high-volume finished goods across all therapeutic and diagnostic needs. Its technically-driven, practical, quality oriented team has expertise in development and manufacturing of minimally invasive single use disposable devices, active and passive implants, IVD, medical electronics, surgical instrumentation, electromechanical devices, and manufacturing or test fixtures/equipment. Hantel is located in the heart of the Bay Area - East Bay is ISO13485 (2003) registered, holds a State of Calif medical device manufacturer’s license. Hantel’s manufacturing personnel specialize in the assembly of medical devices in accordance with ISO and FDA Quality System Procedures. We manufacture disposable and reusable medical devices, implants, and components for the BioTech Industry. Hantel can assist with your project at every level of development and assembly from initial prototypes to commercial distribution and warehousing. Contact us @ 510-441-4017 or 510-487-1561 Knobbe Martens Olson & Bear LLP is a law firm practicing exclusively in the area of intellectual property law including patents, trademarks, copyrights, trade secrets, rights of publicity, unfair competition, and related litigation and licensing. The firm maintains offices in Orange County, San Diego, San Francisco, Los Angeles, Riverside, Washington DC, and Seattle. Services are provided to clients throughout the United States and the world. At present, the firm is composed of more than 275 lawyers and scientists, nearly all of whom hold undergraduate or graduate degrees in either engineering or the technical sciences. This combination of law and technology makes Knobbe Martens uniquely qualified to represent a diverse array of clients in a broad spectrum of intellectual property matters. www.kmob.com With more than 25 years of experience in the life sciences industry, Latham & Watkins has a top tier life sciences practice representing more than 100 of the preeminent medical devices, biotechechnology, pharmaceutical and health care companies throughout the world at various stages of development. Our attorneys represent life sciences clients in the United States, Europe and Asia in multi-million dollar mergers; venture capital and public financings; complex litigation; regulatory matters; contract negotiations, including “bet the company” complex strategic alliances and global corporate partnering transactions; and the resolution of day-to-day operational matters. We have expertise across all aspects of life sciences technologies, including medical devices, biotechnology, bioinformatics, diagnostics, drug delivery, genomics, pharmaceuticals, proteomics, therapeutics, and research, discovery and development. As one of the world’s largest full-service law firms, we are able to tap in to our global network of approximately 2,000 lawyers with in-depth experience in essentially every area of law on behalf of our life sciences clients. www.lw.com MDCI is a full-service consulting firm and contract research organization (CRO) that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics, and combination products. Clients trust MDCI to deliver customized strategic guidance and creative “hands-on” solutions to address their unique regulatory, clinical trial, and quality assurance challenges at every stage of the product lifecycle. MDCI has helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally. By leveraging our comprehensive knowledge of FDA and international regulations, clients capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace. www.mdci.com Created in 1979 by the healthcare technology industry, Medmarc’s purpose is to be the superior provider of liability insurance and related risk management services and to support the development, testing and delivery of products that save and improve the quality of life. As a policyholder controlled company, we have deep knowledge of your unique products liability and clinical trial risks. We thrive on developing effective solutions to complex insurance needs and offer coverage that is tailored to your company. To provide superior, comprehensive protection, through a carefully integrated alliance, we partner with The Hartford to offer “all lines” coverage. 19 CALIFORNIA MEDICAL DEVICE FORUM SPONSORS & SUPPORTING ORGANIZATIONS The North England Inward Investment Agency is an international business development resource for US and Canadian companies. North England’s Life Science practice is headquartered in Boston, MA. We develop solutions tailored to meet our clients’ technical, financial, operational and strategic objectives. Our consultants will help you access the research excellence, skilled workforce and support that you need to establish a foothold in the fast-growing European market and gain direct entry into the largest public health organization in the world. With over 30% of the UK’s entire pharmaceutical workforce located in North England, investors can count on exceptional support to bring new products to market, access high grade GMP facilities, streamline clinical evaluations, and tap into regional know-how in bio-pharmaceutical production and regulatory affairs. The North England team works closely with our clients to connect them with a vast network of private and public sector experts in areas such as tissue engineering, regenerative medicine, medical instrumentation and bioprocess development. Our consulting engagements are confidential and funded entirely by the British government. We are driven by the success of some of the world’s best companies doing business in North England and we’d like you to join us. Orrick is an international law firm with more than 1,100 lawyers located throughout North America, Europe and Asia. Our depth and breadth of experience include a wide range of transactional and litigation matters. Orrick’s Intellectual Property group is chosen by leading companies in many industries. Our comprehensive, collaborative approach to IP planning, our successes in IP litigation and our appellate work make our IP team the go-to choice for resolving bet-the-company IP disputes and for helping to keep companies out of the courtroom. Orrick is also one of the premier legal advisors for emerging companies. Orrick offers its clients: in-depth experience representing emerging companies, a focus on emerging companies, a network of strong investor and other relationships, capabilities that scale with clients as they grow and global resources. Orrick lawyers are committed to providing high-quality, innovative solutions to the most complex legal challenges. www.orrick.com Paul Hastings’ dynamic professionals deliver innovative solutions to the complex legal challenges encountered by the world’s top financial institutions and Fortune 500 companies. With 18 offices in major business centers across Asia, Europe, and the U.S., Paul Hastings has the global reach and extensive capabilities to provide personalized service wherever our clients’ needs take us. At Paul Hastings, we work closely with our clients and build deep institutional relationships through our global practice groups and client service teams. About the Paul Hastings Life Sciences Practice: The Paul Hastings Life Sciences practice offers cutting edge advice to clients on transactional, patent, litigation, regulatory, real estate, tax, and employment matters unique to healthcare and life sciences companies and institutions. Our lawyers have a keen understanding of the healthcare industry and the unique economic and regulatory challenges that face participants in this important market. Promedica International (PMI), located in Costa Mesa California, is a privately, women-owned CRO. Our project experience spans a wide range of medical specialties and therapeutic areas. PMI performs 15 to 20 concurrent multicenter trials involving medical device, biotechnology and pharmaceutical products. We believe successful research projects are a balance of Clinical Study Management, Quality System/ISO certification and Technology. PMI’s processes are implemented in accordance with a formal Quality Management System. Our receipt of ISO 9001:2000 certification demonstrates our commitment to quality. PMI’s clinical data management systems are characterized by 21 CFR 11 compliance. We offer remote data capture and paper case report form double data entry clinical data management applications. Whether you plan to outsource individual activities or management of your entire project, PMI provides the people, processes and performance to facilitate the successful completion of your research project. PricewaterhouseCoopers (www.pwc.com) provides industry-focused assurance, tax and advisory services to build public trust and enhance value for our clients and their stakeholders. More than 163,000 people in 151 countries across our network share their thinking, experience and solutions to develop fresh perspectives and practical advice. The PricewaterhouseCoopers Emerging Company Services Practice is part of the Global Technology Industry Group, www.pwcglobaltech.com. The group is comprised of industry professionals who deliver a broad spectrum of services to meet the needs of fast-growth technology start-ups and agile, global giants in key industry segments: networking & computers, software & Internet, semiconductors, life sciences and private equity & venture capital. PricewaterhouseCoopers is a recognized leader in each industry segment with services for technology clients in all stages of growth. About the PricewaterhouseCoopers/National Venture Capital Association MoneyTree™ Report: The MoneyTree™ Report measures cash-for-equity investments by the professional venture capital community in private emerging companies in the U.S. It is based on data provided by Thomson Reuters. The survey includes the investment activity of professional venture capital firms with or without a U.S. office, SBICs, venture arms of corporations, institutions, investment banks and similar entities whose primary activity is financial investing. Source Scientific (Irvine, CA), a BIT Group Company, delivers complete services for complex medical instrumentation and devices. As part of financially strong MEC Group / Messer World, we utilize our international platform to offer services to OEM clients all over the world. From small start-up companies top tier OEM global players, we have been serving our valued customers for over 30 years. BIT Group functions in clean, cell based manufacturing areas based on the Kaizen philosophy of one piece work flow, insuring superior production quality. Optical labs, wet test labs, design engineering centers, and electronics testing labs are key areas where Source Scientific provides innovation and superior quality for our customers. Core competencies within our Instrumentation for Life commitment include product development, engineering, contract manufacturing and after-sale services in the clinical diagnostics, life science, and biotechnology industries. Quality standards: ISO 9001:2003, ISO 13485, FDA registered. Since 1989, STATKING Consulting, Inc. has provided strategic protocol development and data related services (biostatistics, clinical data management, clinical study monitoring, medical writing, project management and clinical trial management) for clinical trials performed to obtain regulatory approval of new pharmaceutical and medical device products. STATKING Consulting, Inc. provides full Phase I support services for pharmacokinetic related clinical studies through partnerships with key service providers. From randomization through final study report, STATKING provides the complete outsourcing solution for Phase I PK studies. In December 2008, STATKING Consulting, Inc. partnered with OmniComm Systems to provide electronic data capture software (TrialMaster®) to meet the needs of clients who wish to conduct EDC based clinical trials. For more information visit www.statkingconsulting.com Stradling Yocca Carlson & Rauth is a leading business law firm serving the needs of life sciences, healthcare, technology, financial, manufacturing and retail clients. The firm counts more than 100 lawyers practicing in corporate and securities, complex business litigation, securities litigation, intellectual property, tax and employment law. Stradling represents some of California’s leading companies in a wide range of matters. From venture capital financings, M&As, and IPOs to complex litigation related to securities and intellectual property, Stradling has the experience, sophistication and relationships to achieve optimal results for you. For more than 30 years, Stradling has built a solid reputation in the business community for providing the same high-level representation as national law firms but with a focus on more responsive, personal and value-driven service. For more information about Stradling, visit www.sycr.com. Tallega Software specializes in helping businesses purchase, implement and support “the right” document scanning, document management and workflow solutions guaranteed to reduce operational costs, increase productivity, enhance security and regulatory compliance. Whether it’s in-house, or hosted, departmental to enterprise, we offer highly scalable content management and workflow automation to fit each customer’s requirements. Tallega can also help with the storage management of emails, eDiscovery and retention management of emails within the archive. We provide implementation and technical support services for all the products we sell. Founded in 2005, Tallega Software offers the world’s leading capture and ECM technology, along with implementation and support services with a difference – we care more about the people. For more information, call (949) 367-9860, email firstname.lastname@example.org or visit www.Tallega.com. TriNet delivers HR outsourcing services that allow small companies to do what they do best. Over 8,000 companies have turned to TriNet for human resources, benefits, payroll, workers compensation, and strategic HR services. As their trusted HR advisor, TriNet helps these organizations contain HR costs, minimize employer-related risks, and relieve the administrative burden of HR. TriNet manages the entire spectrum of HR needs from core payroll and benefits administration to talent acquisition, performance management, and risk management. These services are delivered by a team of dedicated human capital consultants, and enabled by best-in-class HR technology from PeopleSoft/Oracle. With TriNet, small companies can offer employee benefits of unmatched choice and flexibility including immediate coverage without the usual clauses, conditions, and waiting periods. TriNet has the highest service levels in the industry and is at the forefront of delivering the broadest spectrum of HR services. www.trinet.com Underwriters Laboratories Inc.® (UL) Health Sciences is a leading provider of end-to-end regulatory, certification, and registration services for the medical industry. Through our portfolio of global accreditations, our customers have access to all the major medical device markets. In addition to certification testing to UL/IEC 60601 and IEC 61010, our services include: FDA 510(k) third-party reviews for the U.S., MDD / IVDD Notified Body certification for Europe, CB scheme certification, INMETRO certification for Brazil, PAL third party for Japan, risk management registration to ISO 14971, and ISO 13485 under CMDCAS. As a recognized third party for the major medical market public health organizations, UL Health Sciences can facilitate the timing and predictability of your product launch so you have market access to multiple countries with one set of tests, one quality system audit, and one company evaluating conformance of your technical file. For more information, visit your local office in Brea, CA or online at www.ul.com/medical. Usability.Pro (www.usability.pro) creates powerful user interface designs for medical devices, iPhone applications, enterprise software and consumer electronics. We research, analyze, design and document the entire process always keeping the user experience in mind. With over 20 years experience with human interface design as it applies to medical devices, we have an extensive portfolio of work including projects for Amgen, Epicor Medical, Invitrogen, LifePoint, LifeScan, Relsys and WebMD. Our specialties include: TouchScreen Devices, FDA Regulations and Guidelines, ISO Standards, International Electrotechnical Commission (IEC) Standards, Advanced R&D Concepts, and Usability Testing. SUPPORTING ORGANIZATIONS 20 21 OCTANe™ fuels the Orange County technology eco-system enabling connections, content, entrepreneurship, and local investment. Our goal is to help new companies get started, help existing companies grow, and create new jobs. 65 Enterprise • Aliso Viejo, CA • (949) 330-6569 • email@example.com • www.octaneoc.org
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