Welcome to UTHF

Yue-Teh Jang, Ph.D. , General Partner, The Vertical Group

Since 2000, Dr. Jang has been a General Partner of The Vertical Group, a US based venture capital firm that manages $425 million with a focus on medical device and biotechnology investment.

While serving as a board member for many of the firm’s portfolio companies, Dr. Jang was the co-founder and CEO of many startup companies, including Ensure Medical, which was acquired by Johnson and Johnson in 2006, and Integrated Vascular Systems, acquired by Abbott Laboratories in 2004. In addition, Dr. Jang was the President and CEO for Kyphon, which went public in 2002 and recently acquired by Medtronic for $3.9 billion, and President and CEO for EMBOL-X. Dr. Jang’s prior experience also includes Vice President of Corporate R&D for Boston Scientific Corporation (BSC) and Vice President of R&D for Cardiovascular Imaging Systems, a start up company in intravascular ultrasound imaging that went public and was later acquired by BSC. He also worked as a project manager at Mallinckrodt, now a Tyco company and a scientist at Deseret Medical.

In addition to his professional engagements, Dr. Jang was the former board member and President of Silicon Valley Taiwanese American Industrial Technology Association (TAITA). He is also actively involved in Taiwan’s ITRI projects, by serving as a board member for ITRI International, an advisor to ITRI Biomed program and a member of the Advanced R&D Advisory Committee. Dr. Jang also serves as a committee member/advisor for many government level biotech projects in Taiwan.

Dr. Jang received his Ph.D in Materials Science and Engineering from The University of Utah and B.S. from National Tsing Hua University in Taiwan. He is the author of numerous publications on materials and inventor of over 40 US and international patents.

Dr. Michael Farn, Partner, Intellectual Property Group, Fenwick & West LLP

Mike Farn has over ten years experience in IP wealth creation for Silicon Valley companies. He specializes in the development of intellectual property assets, with particular focus on building, acquiring, managing and licensing patent portfolios. Among the clients he has represented are C8 MediSensors, Fortebio and Reliant Technologies.

Before embarking on his legal career, Mike was a member of the technical staff at M.I.T./Lincoln Laboratory. There, his primary responsibilities were to invent new optical technologies and then transfer these technologies to private corporations for commercialization. He entered the legal field in part because the attorneys supporting Mike’s activities as a scientist did not adequately understand the commercial world. There was and continues to be a significant need for legal specialists who can understand and solve legal problems from the client’s point of view not from a lawyer’s point of view, who can explain legal concepts in ordinary English, and who can relate these concepts to the marketplace and to the client’s commercial risk and reward.

Mike graduated with distinction from Stanford law school. He also received his Ph.D. in electrical engineering from Stanford University.

Topic: Medical Device IP
Abstract: SmartIP for Medical Device Companies. More than almost any other industry segment, the medical device industry is characterized by intense, high stakes intellectual property battles. In this session, Dr. Farn will provide an overview of the fundamentals of intellectual property and then describe the most common intellectual property strategies for medical device companies.

Song Zhu, Ph.D., J.D., Senior Associate, Squire, Sanders and Dempsey L.L.P.

Dr. Zhu, a registered patent attorney, practices intellectual property law including preparing and prosecuting patent applications in the United States and throughout the world, writing patent opinions and licensing agreements, participating in patent litigation and counseling clients on worldwide patent procurement strategies and management of patent portfolios.

Dr. Zhu’s practice encompasses a variety of technologies including medical devices telecommunications, semiconductor manufacture, computer software, and automotive systems.

Prior to practicing law, Dr. Zhu was a senior engineer at General Motors, where he conducted research on electronic systems, engines and powertrains, and coordinated research projects involving engineers from different GM divisions.

Topic: IP Protection / Freedom to Operate
Abstract: In the medical device industry, the success of a business requires it to protect its inventions and to avoid infringing its competitors’ patents. To protect its inventions requires the business to have an effective system for recognizing patentable inventions, working with patent attorneys to prepare and file patent applications, prosecuting patent applications, and enforcing its patent rights. To avoid infringing its competitors’ patents requires it to conduct an effective freedom-to-operate search and analysis before it puts a product on the market.

Peter Fitzgerald, M.D., Ph.D., Co-Director, CCAL, Stanford University

Dr. Peter Fitzgerald is the Co-Director of the Center for Research in Cardiovascular Interventions and Director of the Cardiovascular Core Analysis Laboratory (CCAL) at Stanford University Medical School. He is an Interventional Cardiologist and has a PhD in Engineering. Presently, Dr. Fitzgerald’s laboratory includes 14 postdoctoral fellows and graduate engineering students focusing on state-of-the-art technologies in Cardiovascular Medicine. He has led or participated in over 80 clinical trials, published over 300 manuscripts/ chapters, and lectures worldwide.

Peter has been principle/founder of six medical device companies in the San Francisco Bay Area. He serves on several boards of directors, advised dozens of medical device startups as well as multinational healthcare companies in the design and development of new diagnostic and therapeutic devices in Cardiology, Neurology and Orthopedics.

Topic: Building Taiwan’s Medical Devices Industry

Hong-Jen Chang, MD, MPH, MS, President and CEO, Taiwan Global BioFund, Chairman & CEO, YFY Biotech Management Company

Dr. Hong Jen Chang is currently the President & CEO of Taiwan Global BioFund(TGB). Before joining the Fund, Dr. Chang has extensive experience in health care. During his 16 years service with the Taiwanese government, he held several key positions such as Deputy Minister of health, President & CEO of Bureau of National Health Insurance (BNHI), and Director General of Center of Disease Control. Dr. Chang is known for his expertise in Health policy and management, Health care financing, Disease Control, Investing in biotechnology, and Health information systems.

During his tenure as President and CEO of BNHI, which is the governmental body responsible for the operation of the universal health care system, Dr. Chang spearheaded the smart card program, and has successfully brought the system into operation in 2003.

Dr. Chang received his medical degree from the National Yang-Ming Medical College, Taipei, Taiwan; he also holds a Master of Public Health degree from the National Taiwan University, and a Master of Science in Health Policy and Management from Harvard School of Public Health.

Topic: Perspective of Biotech Industries in Taiwan

Ms. Nancy M. Lince, President and CEO, Lince Consulting

Nancy has over 16 years of experience in regulatory, clinical and quality affairs spanning a wide range of technologies including innovative medical device, combination and drug delivery products. Nancy has written over 125 submissions, has conducted extensive negotiations with FDA and International regulatory agencies, and developed regulatory strategies resulting in significant cost savings and decreased time to market. She has conducted numerous internal audits preparing medical device manufacturers for regulatory inspections and helping companies manage their regulatory compliance efforts. Nancy is the founder and President of Lince Consulting, a consulting practice focused on delivering top quality, responsive regulatory, clinical and quality consulting services to a variety of clients ranging from small start-up companies to large established corporations. Lince Consulting is an expanding group of professionals with over 50 years of combined experience working in the field of innovative medical device development, helping clients gain regulatory approvals to investigate and sell their devices and maintain regulatory compliance worldwide. Prior to founding Lince Consulting in 2001, Nancy was Vice President, Clinical and Regulatory Affairs at Eclipse Surgical Technologies, Inc, where she was responsible for the definition and execution of global clinical and regulatory strategies required to gain and maintain regulatory approval and managed a staff of 18. At Conceptus, Inc., Nancy prepared and managed regulatory submissions, participated in extensive FDA negotiations, and developed new and updated existing quality systems to prepare for ISO compliance and managed clinical study efforts. At Origin Medsystems (Guidant), Nancy managed the international regulatory process and defined and integrated international standards into product development and manufacturing processes. She is a member of the Regulatory Affairs Professional Society (RAPS) and holds a B.Sc. in Business Management from Merrimack College in Andover, Massachusetts.

Topic: Essence of Regulatory Affairs
Abstract: In today's global marketplace, the development and marketing of medical products is highly regulated with strict governmental requirements both domestically and internationally. Understanding and complying with the governing regulations is essential for the success of companies planning to enter the vast and rapidly evolving field of medical products. Providing safe and effective products requires an intimate knowledge of the various regulatory requirements effecting your product and how best to implement such requirements to enable the most rapid time to market and continued compliance post-market. Establishing optimum safety and performance requires cooperation among all who are involved in the life cycle of a medical product. This presentation is an overview of the essential global elements of medical device regulations with focus on the regulatory requirements in the U.S., which are governed by the Food and Drug Administration (FDA). The presentation will focus on the FDA’s organization, product classification, pre-market and post-market requirements, Quality System Regulation (QSR) and enforcement activities. The presentation will walk you through the key regulatory requirements that govern medical devices and you’ll receive an understanding of the basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with.

Mr. Dennis McHugh, Managing Director, Bailer Research

Dennis is the Managing Director of Bailer Research, a Contract Research Organization that manages investigational device trials, with an emphasis on interventional cardiology. With their operations based in the San Francisco Bay Area, Bailer Research has worked with numerous innovative companies, from small start-ups to Multi-national market leaders. Bailer has contributed to 27 new cardiovascular device introductions since 1997.

Dennis has been engaged in all levels of medical product development over 30 years. Starting with pre-clinical work then clinical research with Hoffmann-LaRoche and followed by senior level program positions with Syntex where he led multidisciplinary project teams for new chemical entities and ACS/Guidant where he provided the clinical impetus for their first coronary stent approval.

Dennis holds a M.S. in Biology from Seton Hall University

Topic: Overview of Cardiovascular Device Clinical Development Program
Abstract: The goals of this presentation are to:
�- Provide an Introduction to the Basics of a Cardiovascular Device Clinical Development Program
�- Highlight key considerations to keep in mind
�- Overview the similarities and differences of US, EU and international development
�- Offer experiential anecdotes of success and failure

Mr. Cameron Kerrigan, J.D., Partner, Squire, Sanders and Dempsey L.L.P.

Cameron Kerrigan is an intellectual property lawyer and has represented clients in the electrical, mechanical, semiconductor processing, pharmaceutical and chemical arts. Mr. Kerrigan has prepared and prosecuted patent applications in a variety of technical areas including medical devices, drug delivery systems, in vitro pharmaceutical applications, chemical-mechanical polishing equipment, excimer lasers, photo-ionization detectors, programmable logical devices, CMOS and MOSFET transistors, chemical vapor deposition, plasma enhanced etching and microelectronic packages.

Mr. Kerrigan has also provided patent validity and infringement opinions, as well as assisted clients in developing intellectual property portfolios and obtaining licensing agreements. Mr. Kerrigan has experience in both US and foreign patent laws. Prior to becoming a patent lawyer, he was involved in business and trade secret litigation.

Luke Liang, Ph.D., RAC, President and Sr. Consultant, Glisland, Inc

Luke Liang is President and Sr. Consultant of Glisland, Inc., a company focusing on delivering integral solutions for regulatory affairs. Besides eight years of teaching and research experience in academia, Luke has more than fifteen years of industrial experience in pharmaceuticals, life sciences, and medical devices. He has involved in successful delivery of more than 20 commercial products.

Prior to Glisland, Inc., he was Director of QA and Regulatory Affairs at iMetrikus, Inc., a healthcare technology company pioneering in Internet-based remote health monitoring systems. Previously, he was Principal Scientist and Manager at Johnson & Johnson, Principal Engineer and Manger at Caliper Life Sciences, Inc. , Architect at Healtheon/WebMD Corporation and Engineer at Date Behring, Inc.

Luke has PhD in Physical and Computational Chemistry from the University of Tennessee at Knoxville, and RAC (Regulatory Affairs Certified) from Regulatory Affairs Professionals Society. He received postdoctoral training from Oak Ridge National Laboratory and U.C. Berkeley.

Topic: Integral Solutions for Regulatory Affairs
Abstract: The critical path to medical product development is regulated path. The success of getting through the critical path depends on the effectiveness of regulatory affairs integration within the development team. The key elements to measure this effectiveness include a sound regulatory strategy and its effective execution, lean and check balanced quality system, team work, effective use of regulatory options and tools, competent skills and training. For start-ups and small firms, it is very difficult to completely rely on internal resources to deal with dynamic and complex regulatory affairs challenges. Time and cost effective regulatory affairs solutions may come from external resources.

Fang-Yuh (Frank) Hsieh, Ph.D., Partner, StatLogic Consulting, Inc.,

Dr. Hsieh has earned a BS degree from National Taiwan University, a MS degree in Biometry from Case Western Reserve University, and a Ph.D. in Statistics and Computer Sciences from University of Wisconsin. He has published eleven papers in Statistics, either as a sole author or as the first author, and sixteen medical papers as a co-author. Most publications appear in the top journals of each field, including the New England Journal of Medicine, and Biometrika. He has made numerous presentations at national/international scientific meetings, Biostatistics Seminars at Stanford University, NDA review meetings at the FDA and the EMEA, and a public hearing at Institute of Medicine of the National Academies. Currently he is an editorial board member of Evalution & the Health Professions and was an editorial consultant of American Journal of Epidemiology (AJE).

Dr. Hsieh’s career of over 28 years has focused exclusively on the application of statistics to both clinical and epidemiological research. He has held numerous managerial positions in pharmaceutical industries, such as Hoffmann-La Roche, Schering-Plough, and Bayer-Schering Pharmaceuticals, a senior mathematical statistician (GS-14) position in the federal government, and a faculty position at Albert Einstein Medical School. He has worked in the therapeutic areas of cardiovascular, renal, central nervous system, urology, dermatology, infectious diseases, immunology, ophthalmology, endocrinology, anesthesiology, psychology, hematology (Factor VIII), gerontology, virology (AIDS), and oncology. In addition, he has also worked in the areas of diagnostic devices, medical devices, Bioassay, ROC analysis, animal toxicological experiments, health economics, epidemiologic survey researches, and gene microarrays and Taqman PCRs.

In terms of statistical methodologies, Dr. Hsieh’s publications concentrate on sample size calculations for logistic regression and survival analysis, as well as mixed models with repeated measurements. Some of these methods have been implemented in commercial software such as nQuery Adviser, ExpDesign Studio, NCSS PASS, and SSIZE. Other publications include cluster randomization, mixed model, variance estimation, and missing data imputation.

Mr. Augustine (Augie) Y. Lien, Chairman and CEO of Cardiva Medical, Inc.,

Augustine “Augie” Lien has been a successful entrepreneur and corporate executive in the medical device and computer industries in the past 20 some years. He has participated in many startup companies, from inceptions to fruition, as a founder and executive officer. He has a very impressive track record of providing investors with excellent exits either through IPO and/or M&A.

Currently Augie is the founder, Chairman and CEO of Cardiva Medical, Inc. a medical device company engages in the manufacturing and marketing of vascular closure systems for diagnostic and interventional cardiology procedures. Previously he was founder, Chairman and CEO of Eyden Corporation (Internet web-base document automation software systems), Chief Operating Officer of Embolic Protection, Inc (distal protection devices for interventional cardiology procedures, acquired by Boston Scientific Corporation in March 2001), Founding member and Senior VP of Gynecare Inc. (surgical devices for Gynecologists, IPO in 1996, subsequently acquired by Johnson & Johnson in November 1997), Executive VP of Operations Menlo Care Inc (cardio/vascular access devices, IPO pending, acquired by J&J Medical Inc in 1994). Before 1990, he held various executive positions at Nellcor Inc. (surgical patient monitoring systems, IPO 1987), Four Phase Systems (mini-computer company, IPO 1984, subsequently acquired by Motorola), and Diablo Systems (computer peripherals company, acquired by Xerox).

Augie received his Master of Science Degree in Operations Research from Stanford University, MBA from Santa Clara University, MS degree in Statistics from National Chen Chi University and BS degree in Industrial and Business Management from Taiwan National Cheng Kung University.

Abstract: Unlike many well known consumer products that create fierce competition within a few months of a new product introduction, medical device companies usually can enjoy market dominance for many years, thanks to IP protection and regulatory approval barrier.

In this brief introduction during the 2008 UTHF conference, I would like to use the block buster device-Drug Eluting Stent (DES) as an example to highlight the importance of setting up proper IP protection and developing regulatory/clinical strategy as the most crucial tools to protect the business. Hopefully this speech and the sharing from other industry experts in this conference will help the participants gain better understanding of the importance of these subjects.

San-Laung Chow, Ph.D. , Chairman of San Jose Canaan Christian Church, and President of Taiwanese American Industrial Technology Association

Dr. Chow is the co-founder, President and CEO of BioKey, Inc., a technology-based specialty pharmaceutical company focusing in the development of controlled release specialty pharmaceuticals. Dr. Chow devoted all of his life to the healthcare and pharmaceutical industry, and has more than twenty- five years of experience in managerial and R & D genesis in major pharmaceutical companies such as Lederle Laboratories, American Cyanamid Co., Pennwalts Pharmaceuticals and Fison Corporation. Previous to the founding of BioKey, he was the Chief Scientific Officer of Apex Pharmaceuticals and Vice President of Andrx Pharmaceuticals and Stason Pharmaceuticals respectively. Among his myriad technical skills, his expertise in controlled release technology is unrivaled. He has published more than 30 articles in professional journals and has been granted 15 patents in dosage formulation designs. In addition to being a scientist that graduated with a Bachelor of Pharmacy from Taipei Medical University and a Ph.D. in Pharmaceutics from Wayne State University, Dr. Chow also studied Business Administration at the Hagan School of Business at Iona College and is well versed in pharmaceutical regulatory affairs, healthcare policy and strategies. Aside from his professional career, Dr. Chow actively participates in community services. He is currently serving as Chairman of San Jose Canaan Christian Church, and President of Taiwanese American Industrial Technology Association.

Joseph Yang , Ph.D. , Director, Science and Technology Division, Taipei Economic and Cultural Office in San Francisco

Dr. Joseph Yang received his MS and PhD degrees in Electronics Engineering, Southampton University, UK, in 1974 and 1978 respectively. He started his career as an Associate Professor at Natinal Chiao-Tung University (1978-1979); Chairman, Dept. of Computer Science, Tamkang University (1979-1981), and President of Chun-Chou Institute of Technology (1982-1983). From 1983 to 1987, he joined industry as a Senior Technical Consultant in Fu-Sheng Industrial Group. After five years of industrial experiences, he was invited to join Government service as the Principal Advisor of EPA (1988-1991) and Chairman of Foreign Affairs Committee, Ministry of Transportation and Communications (1991-1993). Dr. Yang returned to academic career to join the founding of National Kaoshiung Institute of Technology as a Dean of academic affairs and Vice President (1993-2000). Between 2001 to present, Dr. Yang was invited by National Science Council to join government again; first as the Director General, Dept. of International Programs, National Science Council (2001-2002) and then current position, Director, Science and Technology Division, Taipei Economic and Cultural Office in San Francisco.

Ms. Hsing-Yi Jan, President, NATEA-SV

Ms. Jan has been working in biotech industry since 1995, and is currently the project manager at Maxygen, Inc, which focuses on the next-generation protein therapeutics for various diseases such as neutropenia, hemophilia, and rheumatoid arthritis. Prior to joining Maxygen, Ms. Jan worked at Baxter Healthcare, GenStar Therapeutics, and Corautus Genetics, which were in the field of gene therapy for hemophilia and cardiovascular diseases.

Ms. Jan joined NATEA-SV in 2005, and has been an active member since. She was the NATEA-SV General Secretary in 2007, and the President in 2008. While she was working at Baxter Healthcare in Chicago, she was involved in various local Taiwanese organizations: She was the president of the Chinese Students and Alumni Association in Chicago in 1997-98, Public Relation of Mid-America Chinese Science and Technology Association in 1997-98, Editor for ROCSA newsletter at Northwestern University in 1996-97, and a part-time reporter / columnist for Chicago Chinese News in 1996-98.

Ms. Jan earned her BA degree from University of Louisville in KY, MS from Northwestern University in IL, and MBA from San Diego State University in CA.