Conference

Wednesday, June 4, 2008
9:00 A.M. - 4 P.M.

ABOUT THE INSTRUCTORS

John H. Linehan, Ph.D., Professor of Biomedical Engineering and Medicine, Northwestern University

John H. Linehan, Ph.D. is Consulting Professor of Bioengineering in Stanford University’s Program in Biodesign and the Department of Bioengineering. Linehan was the Vice President of the Whitaker Foundation from 1998 - 2005. Prior to 1998, Linehan was the Rose Bagozzi professor and the founding chair of the biomedical engineering department at Marquette University and an adjunct professor of physiology and pulmonary medicine at the Medical College of Wisconsin. He is a founding fellow and past president of the American Institute for Medical and Biological Engineering, a fellow of the International Academy of Medical and Biological Engineering and a member of the National Academy of Engineering.

Jan Pietzsch, Ph.D., Co-Founder, President, and CEO, Wing Tech Inc.

Jan B. Pietzsch is Co-Founder, President and CEO of Wing Tech Inc., a technology consulting firm, and Consulting Assistant Professor in the Department of Management Science and Engineering at Stanford University. His work at Wing Tech focuses on early-stage technology assessment and strategic decision-support for manufacturers and investors, with primary application to medical devices. Before starting Wing Tech, Jan pioneered new approaches for the early evaluation of medical devices during his doctoral research at Stanford. During this period, he also worked as a research fellow with the FDA's Office of Device Education. At Stanford, Jan is involved with the Biodesign Program, and is teaching a graduate-level course on technology assessment and regulation of medical devices. He holds a Ph.D. degree in Management Engineering and a M.S. degree in Engineering-Economic Systems and Operations Research from Stanford University, as well as an Engineer degree from the University of Karlsruhe, Germany.

Martyn W.C. Howgill, Executive Director, InHealth

Martyn Howgill is the Executive Director of the Institute for Health Technology Studies. Prior to joining InHealth, Howgill served as Vice President of International Business Development and Chief Marketing Officer at The University of Texas M. D. Anderson Cancer Center in Houston, Texas. While there, he launched a successful direct-to-consumer advertising program, “Making Cancer History®.” He also developed M. D. Anderson Cancer Center’s International Outreach program, specifically initiating its “Sister Institution” program that created links with leading academic and community cancer programs worldwide.

Mir Imran, CEO, InCube Labs

Mir Imran founded InCube Laboratories in 1995 to focus on his passion: creating medical device solutions that change the standard of care in critical healthcare markets. Mir began his career as a med-tech entrepreneur in the late 1970’s, and has founded numerous game-changing companies since those early days. Over the decades, he has become one of the world’s most successful inventors, entrepreneurs and investors in healthcare.

Mir now holds more than 200 issued patents – and is perhaps most well known for his pioneering contributions to the first FDA-approved Automatic Implantable Cardioverter Defibrillator. However Mir has invented a number of breakthrough devices that set new standards of care for their industries. Highlights include depth of anesthesia monitors, Trans-Urethral Needle Ablation (TUNA) procedures, embolic protection devices, and systems to treat cardiac tachyarrhythmias. Mir's current crop of inventions includes advanced treatments for neural aneurysms, epilepsy, ulcerative colitis, obesity and chronic pain, among others. Most of these will enter clinical trials in the 2008 to 2010 timeframe.

As an entrepreneur, Mir has founded over 20 medical device companies, including: Vidamed (acquired by Medtronic), Physiometrix (IPO 1996), Cardiac Pathways (IPO 1996), Advanced Cytomextrix (acquired by Oncotech 1997), Percusurge (acquired by Medtronic 2001), Reflow, Inc. (acquired 1999), Safeview (acquired by L3 2006) Intrapace ( founded 2001), Spinal Modulation (founded 2005) and Zonare (founded 1999).

As an investor, Mir serves as the Life Science Venture Partner for DFJ ePlanet, where he has led 9 investments in a range of promising ventures around the globe. In addition to his venture capital activities, Mir is an active angel investor, with a portfolio based around both medical and pharmaceutical ventures.

Mir currently holds board seats with Bodymedia, Cardiovasc, Intrapace, Egeen International, Spinal Modulation, ZARS and Zonare. Mir holds an MS in Bio-Engineering and a BS in Electrical Engineering from Rutgers, where he spent three years as a Research Specialist.

Lex Bayer, Director of R&D, Avantis Medical Systems

Lex joined Avantis Medical in 2005 as Director of Product Development and R&D where he leads the development of catheter-based endoscopic devices for use in detecting and treating cancers and other abnormalities of the gastrointestinal (GI) tract. His core technical expertise is in the field of sensor development and device miniaturization.

Lex earned his M.S. in Mechanical Engineering in the Smart Products Program at Stanford University, where he also received his B.S. degree in Mechanical Engineering.

Janice Hogan, Partner, Hogan & Hartson

Janice Hogan focuses primarily on the representation of medical device, pharmaceutical, and biological product manufacturers before the U.S. Food and Drug Administration (FDA).

Janice is a biomedical engineer and focuses on regulatory counseling related to high technology medical products. Prior to becoming an attorney, she held positions in marketing/ marketing research for a major pharmaceutical manufacturer. She has authored articles regarding orphan drug regulation and medical device products liability. She is currently authoring articles regarding the use of finite element analysis and other engineering modeling methods in FDA submissions, as well as the interface between FDA regulatory and reimbursement considerations in the design of medical product clinical trials. She has authored a chapter of a recent textbook, Promotion of Biomedical Products (FDLI 2006) and is authoring a chapter of a forthcoming textbook on the regulation of orthopedic implants. Janice has served as an adjunct professor at the University of the Sciences in Philadelphia and as a guest lecturer at Drexel University. She is also a frequent lecturer at FDA regulatory law symposia and conferences on topics related to premarket approval of medical products, combination products regulation, and product development.

Janice formerly served as a law clerk to The Honorable Irma S. Raker of the Maryland Court of Appeals.

Justin Stebbins, Vice President, Corporate Research and Development Services, Edwards Lifesciences

Information to come.

Susan Alpert, Ph.D., M.D., Senior VP & Chief Quality and Regulatory Officer, Medtronic Inc.

Susan Alpert, PhD, MD, was named senior vice president - chief quality and regulatory officer in 2005.

Dr. Alpert joined Medtronic in July 2003 as vice president - regulatory affairs and compliance from C.R. Bard, Inc., where she was vice president of regulatory sciences. She was on the board of the Food Drug Law Institute (FDLI), a forum through which the FDA and the legal, business, academic, and consumer communities exchange perspectives on public policy, law, and regulation related to products subject to FDA jurisdiction.

Dr. Alpert also serves on the advisory board of the Medical Technology Leadership Forum (MTLF), an educational organization that focuses on policy makers, the general public, and the media, regarding critical issues affecting the development and adoption of advanced medical technology. In addition, Dr. Alpert serves on the board of the Women Business Leaders (WBL), a health care organization, and is past president of the Regulatory Affairs Professional Society.

Before joining Bard, Dr. Alpert served at the FDA, where she held a variety of positions in the Centers, including six years as the director of the Office of Device Evaluation. She is a microbiologist and pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials.

Dr. Alpert completed her undergraduate degree at Barnard College, Columbia University, and holds an MS and PhD in biomedical sciences from New York University. She received her MD from the University of Miami (Florida) and completed her clinical training at Montefiore Medical Center in the Bronx, New York, and at Children's National Medical Center in Washington, D.C.