Tuesday, November 9
7:30 - 11:20 a.m.

7:30 - 8:20 - Healthcare IT
8:30 - 9:20 - Cardiovascular
9:30 - 10:20 - Ophthalmology
10:30 - 11:20 - Forecast for Washington

Healthcare IT

Sponsored by:


Speakers:

Dr. Ralph Cygan, Chief Medical Information Officer, UC Irvine School of Medicine
Dr. Cygan is a Clinical Professor of Medicine and Public Health at UC Irvine where he has been a faculty member since 1980.  He is the former Chief Executive Officer of UC Irvine Medical Center and he is currently the Chief Medical Information Officer overseeing the implementation of the UC Irvine’s new Electronic Medical Record System. His career has been devoted to improving the quality of clinical care provided at the Medical Center and its ambulatory clinics.
In 1970 Cygan received his BA cum laude in Social Psychology from Harvard College. From 1970-1973 he worked as a research assistant at the rheumatology and allergy research laboratories at the Massachusetts General Hospital in Boston. He graduated magna cum laude form SUNY College of Medicine in Brooklyn in 1977 where he was a member of Alpha Omega Alpha Honors Medical Society.  He completed his residency in Internal Medicine at UCI Medical Center in 1980 after which he joined the faculty in the Department of Medicine.
He was a founding member of the UCI’s Division of General Internal Medicine in 1980.  From 1980-1995 he served as the Director of the Internal Medicine Clinic, the major teaching clinic at the hospital. From 1984-1988 Cygan served as the first President of the UCI Faculty Practice Group.  In 1992 Cygan founded the Primary Care Medical Group (PCMG) and served as the President of the group until 2000.  In this role he oversaw the clinical activities of over fifty primary care faculty from the departments of Medicine, Pediatrics, and Family Medicine practicing at six primary care centers. 
From 1998-2000 Cygan served as President of the UCI Medical Staff, and Vice Chair for Clinical Affairs in the Department of Medicine. From 2000-2005 he served as the Chief Executive Officer of UC Irvine Medical Center. As CEO, Cygan focused his efforts on improving the quality of patient care and patient services.  During Cygan’s tenure the Medical Center quality and performance have were lauded by a number of national organizations including University Healthsystems Consortium, Leapfrog, Joint Commission on Hospital Accreditation, Solucient’s Top 100      Hospitals, and US News and World Report Best Hospital survey.  In addition, Cygan also was responsible for the planning, design, and capital campaign for UC Irvine’s new 400 million dollar university hospital which opened earlier this year. 
His clinical interests include general internal medicine and primary care, preventive medicine and the management of obesity.  He was the founder of UCI Executive Health Program and the UCI Obesity Program.  He has been repeatedly selected by his peers as one of the top internists in the Western United States in a poll conducted by “Best Doctors in America” in the fields of general internal medicine and treatment of obesity.
As CMIO Dr. Cygan is leading the design, testing, and implementation of a new electronic medical record system for the Medical Center and its affiliated physician practices.  When completed in 2012 physicians, nurses and patients will benefit from a state-of-the-art electronic system which promises to improve quality, safety and efficiency of the UC Irvine health care system.

Michael J. Doyle, President and Chief Executive Officer, 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.

Michael McKinnon, Partner, Paul Hastings

Michael McKinnon advises clients in mergers and acquisitions, joint-ventures, 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.

His recent transactions include:

·  Equity and debt recapitalization of Sunrise Aston Gardens Joint Venture, a large senior living facilities operator in Florida owned by GE Healthcare Financial Services.

·  Sale of clinical trial company, Vince & Associates Clinical Research, and CRO, Synteract Holdings, to private equity firm Gryphon Investors. Mr McKinnon also worked on the prior acquisition of Vince and Synteract by private equity firm Celerity Partners;

·  Acquisition of urgent care/walk-in clinic operator, MedExpress Urgent Care Holdings, and pain management provider, Advanced Pain Management, for private equity firm Excellere Partners;

·  Acquisitions of various CROs and clinical trial companies for KRG Capital, which owns Cetero Research, one of the largest CROs in the US.

·  Development and funding of physician-hospital joint ventures for St. Joseph Health System.

·  Technology licensing for medical device companies, such as Anodyne Medical Device, Inc. and Masimo Corporation.

 

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.

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 Business.

Emerging Trends in Cardiovascular Medicine

Sponsored by:

 

Hussein R. Al-Khalidi, PhD, Director of Biostatistics, Statking

(Moderator)

Dr. Al-Khalidi brings a wealth of knowledge and experience to his new role as Director of Biostatistics at STATKING Consulting, Inc. 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.

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, mid-South law firm (Jones, Walker, Waechter, Poitevent, Carrère and Denègre) 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 Chief Executive Officer 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 (BSC) in March 2005. 

Prior to AST, Jay held several positions with a large US-based agri-chemical 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

Mahmood K. Razavi, M.D., joined the staff of St. Joseph Vascular Institute in August 2005 and currently serves as the Director of Clinical Trials and Research Center. Dr. Razavi specializes in image-guided therapy for cancer and endovascular treatment of vascular disease including carotid artery stent placement. Before moving to Southern California, 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.

To date, he has authored or co-authored more than 250 scientific publications, abstracts, and book chapters and has been the recipient of many honors and awards from various professional medical societies. He has given over 120 invited lectures at national and international meetings and is considered an authority in the field of minimally invasive image-guided procedures.

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.

Ophthalmology

Sponsored by:



Speakers:

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. 

Mr. Alexander holds a Master’s Degree in Biological Sciences from Marshall University.

Roger Anderson, Managing Partner & Co-founder, BioQuest, Inc.
(Moderator)
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.

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, ans 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.

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.

Areas of focus include:

• Key agency priorities for the US Food and Drug Administration (FDA), Centers for Medicare and & Medicaid Services (CMS), Office of Inspector General (OIG), Department of Health and Human Services (HHS), and Department of Justice (DOJ)
• Enforcement priorities and trends in False Claims Act prosecutions
• Leading congressional, legislative and oversight initiatives, including Health Care Reform
  

Speakers:

B. Melina Cimler, Ph.D., Senior Vice President of Government Affairs, Beckman Coulter

Melina Cimler is the Senior Vice President of Government Affairs at Beckman Coulter Inc.  Until October 2009, she was the Senior Vice President of Quality & Regulatory Affairs at Beckman Coulter where she was responsible for worldwide quality and regulatory strategies and activities.  She joined Beckman Coulter in December 2005 as Vice President, Regulatory Affairs.  She is an industry leader in Regulatory and Legislative Affairs, actively engaged in industry working groups advocating for the value of in vitro diagnostic testing and global access to novel and cost-effective diagnostic technologies.

Prior to joining Beckman Coulter, she was the Divisional Vice President of Quality, Regulatory & Clinical Affairs at Abbott Molecular, a Division of Abbott Laboratories.  Prior to her tenure at Abbott, she was Senior Director of Quality Assurance at Gen-Probe and led the quality systems effort to support regulatory approval and launch of the Procleix® HIV-1/HCV blood-screening assay.  She has held progressively responsible positions in R&D, Product Development and Quality Systems at CR Bard, Epitope and MicroProbe.  She received her Ph.D. in Pharmacology from the University of Washington in Seattle. 

Shayne Kennedy, Partner, Latham & Watkins