MedTech - - Speakers

MEDTECH 07 Speakers and Speaker Bios:

Susan Alpert
Cheryl R. Blanchard
Andrea Casper
Robert J. Corona
Heather Erickson
Clifford Goldsmith
Karen Katz
Guy Lowery
Kenneth McLeod
Jose Mir
Vinny Sastri
Julie A. Shimer
Stephen D. Terman
Michael P. Williams
Melissa M. Zambri

	Susan Alpert , Ph.D., M.D. Senior Vice President, Chief Quality and Regulatory Officer, Medtronic, Inc. 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. Dr. Alpert was formerly on the board of the Food Drug Law Institute (FDLI), a forum for the FDA and the legal, business, academic and consumer communities to exchange perspectives on public policy, law and regulation relating to products subject to FDA jurisdiction. Dr. Alpert also serves on the board of the Medical Technology Leadership Forum (MTLF), an educational organization headquartered in Washington, D.C., focused 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), an organization of women leaders in the health care sector and also, on the board of the Minnesota International Center. She is also Chairman 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 dealing with drugs, devices and radiological health, and foods, 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.
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	Cheryl R. Blanchard , Ph.D. Sr. Vice President, Research and Development, Chief Scientific Officer, Zimmer, Inc. Dr. Blanchard joined Zimmer in October 2000 as Director of Research, after 15 years of experience in biomaterials research and in directing basic and applied research for the government, corporations, and academic institutions. In January 2006, Dr. Blanchard was promoted into her current role and is now responsible for Global Research, Global Development, Global Quality, Global Regulatory, the Austin-based Biologics group, External Research, and Emerging Technologies. Prior to joining Zimmer, she served in Manager, Professor and Fellow roles at the Southwest Research Institute, the University of Texas Health Science Center and the Oak Ridge National Laboratory, respectively. She is currently a member of Biomedical, Regenerative Medicine and Engineering advisory boards at Notre Dame, Indiana-Purdue and Alfred Universities, respectively. Cheryl also serves as a member of the orthopedic device forum.
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	Andrea Casper Vice President, WorldWide Regulatory Affairs Ortho-Clinical Diagnostics, Inc, A Johnson & Johnson Company Andrea J. Casper is an accomplished Regulatory Affairs professional with expertise in regulations of licensed biologics and in-vitro diagnostic medical device approvals; domestic and global biological and device manufacturing procedures; and quality system standards. Her career has included assignments at The National Cancer Institute, NIH, the FDA, Somerset Laboratories, Roche Molecular Systems and Ortho Clinical Diagnostics. Andrea holds a BS degree in Biology from the State University of NY at Oneonta. She is a graduate of the Medical Technology program of the Veterans Administration Hospital in Washington DC and the Specialist in Transfusion Medicine Program at the National Institutes of Health, Bethesda, MD. She is board certified in Medical Technology (MT (ASCP)), Blood Banking (SBB, (ASCP)) and Regulatory Affairs (RAC). Andrea has attended graduate programs in Regulatory Affairs at the Kellogg School of Business, Northwestern University and Smith College Consortium for Leadership and Strategic Planning. Her career began as a Medical Technologist at the National Cancer Institute, VA Hospital in Washington, D.C. She then moved to the National Institutes of Health in Bethesda Maryland , where she held positions of increasing responsibility over ten years and became the Blood Bank Technical Supervisor of a team focused on innovative transfusion and treatment therapies, laboratory quality control and research projects in collaboration with manufacturers. Andrea then moved to the Food and Drug Administration, in the Center for Biologics Evaluation and Research, (CBER), Division of Blood Products in Bethesda, MD , as a Regulatory Review Biologist. As such, she provided technical regulatory review of applications for IVD products, reagents, blood and source plasma; conducted establishment and manufacturing inspection; and provided regulatory and technical guidance to manufacturers and the FDA. In 1989, she then joined Ortho Diagnostic Systems, in Raritan, NJ , as Manager, Regulatory Affairs. She worked with cross-functional project management teams, providing regulatory guidance and developing regulatory submissions for new products to help the organization meet business and compliance goals. In this position, she worked with state and government agencies to facilitate marketing products in the global marketplace. In 1994, she joined Roche Molecular Systems, Inc. in Somerville, NJ , as Senior Manager, Regulatory Affairs. In this capacity she managed a team responsible for the coordination and prioritization of FDA regulatory submissions and developed regulatory strategies in collaboration with CBER for approval of products derived from PCR technology. This work resulted in expedited FDA approvals for the first HIV-1 PCR assay. She became Vice President of World Wide Regulatory Affairs for Ortho-Clinical Diagnostics (OCD), in 2005, where she is responsible for leadership of OCD Regulatory Affairs globally as well as developing regulatory worldwide regulatory strategies for new business development at OCD. She is a member of the Quality Regulatory Compliance senior management team and is the FDA authorized official for OCD. In this role, Andrea also has oversight of the Product Vigilance organization responsible for worldwide complaint investigations and regulatory reporting. Andrea is a member of the AdvaMed Diagnostic Sector and Blood Sector Committees and the IVD Task Force. She is the industry representative to the Study Group 1 IVD subgroup of the Global Harmonization Task Force and a member of the Raritan Valley Community College Biotechnology Advisory Committee.
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	Robert J. Corona, D.O., CPE, FASCP Vice President of Clinical and Medical Affairs and Chief Medical Officer, Welch Allyn, Inc. Dr. Corona is a licensed physician and surgeon and is board-certified in 3 medical specialties; neuropathology, anatomic pathology and medical management. The American College of Physician Executives recently awarded him the status of Certified Physician Executive (CPE). He was formerly Physician Director of Medical Informatics, Laboratory Informatics and Telemedicine and neuropathologist at SUNY Upstate Medical University in Syracuse, New York. Dr. Corona is an appointed member of the New York State Department of Health’s Office of Professional Medical Conduct. He recently completed serving a ten year appointment on the State Board for Medicine in the New York State Department of Education. His academic appointments include: Adjunct Associate Professor of Pathology and Laboratory Medicine at Albany Medical College and Clinical Assistant Professor of Pathology, Emergency Medicine and of Family Medicine at Upstate Medical University in Syracuse. He is a Neuropathology consultant for the Central New York Region’s Forensic Sciences Center in Syracuse. Dr. Corona is a nationally recognized speaker on the use of information and communications technology in medicine and has won awards as best presenter at many conferences. He is the past recipient of the Computer Professional of the Year Award for the CNY region. He is the only physician to ever receive that award. Dr. Corona received a certificate of competency issued by the Association for the Advancement of Medical Instrumentation for the FDA Quality System Regulation. Dr. Corona’s teaching honors include: State University of New York President’s Award for Excellence in Teaching and Best Teacher Award for Pathology. He is listed in Who’s Who of Board Certified Medical Specialists. He has published journal articles in the fields of Alzheimer’s Disease and brain tumors and is a contributing author to a book chapter on Alzheimer’s Disease. Dr. Corona is a member of the United States and Canadian Academy of Pathology, the American Society of Clinical Pathologists, Regulatory Affairs Professionals, Association of Clinical Research Professionals, American College of Physician Executives and is a Fellow of the College of American Pathologists and the American Society of Clinical Pathologists. After graduating from Ithaca College in 1982, Dr. Corona attended medical school at NYCOM/ NYIT in Long Island, New York. He did a general medical internship at Southeastern Medical Center in Miami, Florida, and his residency and fellowship at SUNY Upstate Medical University and the Armed Forces Institute of Pathology in Washington, DC. He was Chief Resident in Pathology at SUNY Upstate Medical as well as Co-Chairman of the Chief Resident's Association.
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	Heather R. Erickson President, MedTech Heather Erickson is President of MedTech, a not-for-profit association focused on connecting the Upstate New York biosciences community and facilitating the commercialization of new medical products. She has served in this capacity since the Association’s founding in 2004, building MedTech from four founding companies to more than 85 member organizations across the state. Prior to MedTech, Erickson was a Senior Consultant at the San Francisco headquarters of Edgar, Dunn & Company, an international strategy consulting firm. At Edgar Dunn she managed a senior executive benchmarking program representing more than 70% of the consumer credit industry, in addition to developing business plans and new product development strategies for her clients. She has also worked with the genomics research group at Chiron Corporation, now part of Novartis Vaccines and Diagnostics, and researched synthetic protein function in the Pathology Department at Yale Medical School. She currently acts as a board member for the American Heart Association and Central New York Biotechnology Research Center. Additionally, Erickson serves on the Metropolitan Development Association’s Grants for Growth advisory committee, the Life Sciences Industry Council Executive Committee, the New York State Center of Excellence in Photonics & Microsystems Infotonics Technology Center Economic Development Advisory Council, and the State University of New York at Oswego Engineering Advisory Board. A native of the San Francisco Bay Area, Erickson received a Bachelor of Science degree in Molecular, Cellular and Developmental Biology from Yale University.
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	Clifford Goldsmith, M.D., B.Sc. Chief Medical Officer Aptima, Inc. Prior to joining Aptima, Dr. Goldsmith worked for Microsoft, where he focused on numerous areas of healthcare information technology including clinical collaboration, pharmaceutical clinical trials, medical devices and embedded systems, agents for home care, Microsoft’s Physician Digital Dashboard and Clinical Portals. Dr. Goldsmith helped Microsoft executives set strategic direction for the healthcare investments. Most recently, he served as Microsoft’s United States Director for Healthcare Provider. Prior to Microsoft, Dr. Goldsmith was a founder of LINK Medical Computing, which produces a commercial product for integrating medical devices with Information Systems. He served as President of the company from 1990 to 1998. Dr Goldsmith represented LINK as a core member of Andover Working Group Medical Information Bus Special Interest Group and the Clinical Context Open Cardiology Initiative. Before LINK, he worked for Harvard University ’s Department of Medicine and the Center for Clinical Computing, developing and managing various aspects of the hospital information systems for both Beth Israel and Brigham and Womens’ Hospitals. During this appointment, he pioneered full, remote access electrocardiograph (ECG) integration with hospital information systems and implemented it at the Beth Israel Hospital . He was a founding member of Microsoft Healthcare Users Group (MSHUG) and joined the Health Level 7 Committee in its early years. Dr. Goldsmith received a M.D. and B.Sc. from the University of Witwatersrand, South Africa. He worked for the National Center for Occupational Healthcare, Division of Epidemiology, Johannesburg, , where he designed, developed and supported software for clinical research, including pulmonary function and surgical pathology databases.
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	Jose Mir Co-Founder and Chief Technology Officer SensiVida, Inc. Jose Mir works as the scientific lead for SensiVida, a start-up medical diagnostics company that is employing MEMS microneedles for allergy testing and other clinical applications. Before joining SensiVida, Jose was responsible for developing the biomedical strategy at the New York State Center of Excellence Infotonics Technology Center. He was previously Director of Business Development and Strategy in Kodak's Entertainment Imaging division. Jose joined Kodak's Physics Division in 1975 as a Research Scientist where his first assignment was focused on the development of a number of digital imaging technologies such as liquid crystal displays, laser scanning, digital input electrophotographic printers, electro-optic systems, and ASIC integrated circuit development; together, these technologies enabled the commercialization of some of Kodak's earliest digital imaging products. In 1984, Jose was appointed Department Head of the Ceramic Science Laboratory where he led the development of a very wide range of technologies such as organometalic precursor chemistry, thin film deposition, integrated optical devices, and structural ceramics. He also provided leadership to a multi-company initiative funded by the Department of Commerce developing blue lasers for optical recording and printing applications. Jose has written many referenced technical publications and holds a large number of US patents in addition to being recognized as a Kodak Distinguished Inventor.
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	Karen Katz Director - Healthcare and MedTech Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Karen Katz is the Director of the Healthcare and MedTech practices at Mintz Levin. Prior to Mintz, Karen headed a legal placement and staffing company where she grew revenues and positioned the company’s Boston office for sale. Also, Karen was a member of Korn/Ferry’s legal and healthcare groups and she was selected as one of the Boston Business Journal’s 40 under 40. She is presently on the board of The Capital Network, a community of entrepreneurs and serves as an advisor to the 2007 "Building the Connected Health Economy: Innovation, Implementation and Investment" held by Partners Healthcare's Center for Connected for Health. Karen was on the Boston University School of Law’s law review and practiced law in the areas of antitrust, government investigations, healthcare and litigation at Crowell & Moring, Hale & Dorr and Todd & Weld. She also served as in-house counsel at St. Elizabeth’s Hospital in Washington, D.C. Additionally, she clerked for the Honorable Juan R. Torruella, First Circuit Court of Appeals. She received her B.A. with honors from the University of Michigan, Ann Arbor. Karen is the author of the comic AttorneyMan Conquers Cha Chingi Changa LLP.
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	Guy Lowery Managing Director and General Manager, Advance Patient Monitoring, ConMed Corporation APM is an effort by ConMed to grow a proprietary high technology business in the patient monitoring field. Prior to joining ConMed in 2003 to form the APM group, Mr. Lowery was Senior Vice President responsible for Research and business development at Imagyn Medical Technologies. Imagyn developed and marketed devices for less invasive therapeutic procedures including laparoscopic surgery, brachytherapy, excisional breast biopsy and other fields. He founded Imagyn Medical, Inc. in 1990, a pioneer in minimally invasive gynecologic therapeutic and endoscopic procedures (Imagyn was acquired by UroHealth in 1997 which then took the Imagyn name). Mr. Lowery spent the first 15 years of his medical device career at McGaw Laboratories and Edwards Laboratories in quality assurance and research and development. Throughout his career, he has continually pursued the advancement of minimally invasive technology through the incorporation of materials and processes from outside the medical field. Mr. Lowery graduated with a degree in Biology form the University of California at San Diego . He has over a dozen issued and pending patents.
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	Kenneth J. McLeod, Ph.D. Professor and Chairman, Department of Bioengineering Director, Clinical Science and Engineering Research Center Binghamton University Dr. McLeod was recruited to Binghamton University in 2002, following a teaching and research career at the Massachusetts Institute of Technology, SUNY Stony Brook, and Tufts University . Over the past 25 years he has been a founder in nine technology companies with product lines primarily focused towards the medical research, diagnosis and treatment markets. He is the holder of over 25 patents, and has been awarded the State University of New York Award for Invention, Creation and Discovery. While his primary expertise is in the area of electromagnetic interactions with living systems, his current research interests are directed towards understanding the etiology of failure of the second heart and the resulting hypoperfusion of tissues which can lead to conditions as diverse as osteoporosis, congestive heart failure, and Al zheimer’s Disease. He currently teaches entrepreneurship and design to senior engineering students at Binghamton University .
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	Vinny Sastri, Ph.D. President Winovia Consulting LLC Dr. Vinny Sastri, President of Winovia® LLC has over 20 years experience in new product development, quality improvement and high performance materials. Winovia LLC provides solutions, strategies and training in the FDA and ISO Quality Systems Regulations for Medical Devices, design controls, product and process validation, Design for Six Sigma and new product development, high performance materials, Six Sigma and Total Quality Management and strategic technology roadmaps. Before Winovia, Dr. Sastri held global leadership roles in technology, quality, marketing and training in BASF, Honeywell and General Electric. In 2002, as Global Technical Marketing Manager at GE Plastics, he formulated the global healthcare and medical device roadmap and strategy for the business unit. Dr. Sastri earned a Ph.D. from Rutgers University, and completed post-doctoral work at Brooklyn Polytechnic Institute. He was also an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. He has over 20 publications and 5 patents. He is a certified Six Sigma black-belt. His experiences span technology, manufacturing, marketing and quality in industries like medical devices, semiconductors, automotive, consumer goods, packaging, and textiles. He has been invited to many conferences to speak about new product development, high performance materials, nanotechnology and Design for Six Sigma. Dr. Sastri is a faculty member of the Association for the Advancement of Medical Instrumentation (AAMI) and has trained employees in medical device organizations on the FDA 21 CFR Parts 820 Quality Systems Regulations for Medical Devices in the United States and in Europe. Dr. Sastri serves on the TechForce board of the Albany-Colonie Regional Chamber of Commerce. Dr. Sastri also serves on local and national boards of the American Chemical Society, The American Society for Training and Development and the Society of Plastics Engineers.
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	Julie A. Shimer , Ph.D. President and Chief Executive Officer, Welch Allyn, Inc. Julie A. Shimer, Ph.D., is President and CEO of Welch Allyn, Inc. and has over 20 years of leadership experience with a successful track record of P&L management, product development, engineering and marketing efforts. Most recently she was President and CEO of Vocera Communications. Prior to Vocera Communications, Dr. Shimer was Vice President and General Manager of 3Com’s Residential Connectivity Group and was responsible for DSL and cable modems, home networking products, and Internet appliances. She is a senior member of the Society of Women Engineers and is actively involved in programs that encourage women to enter engineering fields. She is also a senior member of the IEEE and was on the Board of Directors of the Consumer Electronics Association.
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	Stephen D. Terman Attorney at Law, Olsson, Frank & Weeda, PC Mr. Terman is a principal at Olsson, Frank and Weeda. He was born in Washington, D.C., and received his B.S. in 1973 from the University of Maryland and his J.D. in 1976, also from the University of Maryland, where he was a Phi Kappa Phi. Mr. Terman was admitted to the Maryland Bar in 1976 and the District of Columbia Bar in 1979. He is currently a member of the District of Columbia Bar. Mr. Terman concentrates his practice in medical device law, FDA regulatory issues, and litigation. Until joining the firm in 1990, he served as Associate General Counsel of the former Health Industry Manufacturers Association (HIMA) - now AdvaMed. While there, he was responsible for handling the Association's FDA-related legal, regulatory, and Congressional issues. Before joining HIMA in 1987, Mr. Terman served as Associate Chief Counsel for Enforcement at FDA.
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	Michael P. Williams Director of Contracts, Licensing & Legal Affairs, AMRI Global, Inc. Michael P. Williams serves as director of contracts, licensing and legal affairs for AMRI Global, headquartered in Albany , NY . Mr. Williams oversees the company's legal activities and supports business development initiatives, including customer contracts and licensing activities. Prior to joining AMRI, he was a partner at the law firm of Hiscock & Barclay. He also served as senior counsel at Bond Schoeneck & King, and as an associate at Wall Marjama & Bilinski. Earlier in his career, he was a sales representative for the specialty chemical division of Pfizer Inc. Mike holds a B.A. in biochemistry from Lehigh University and a J.D. from Syracuse University College of Law.
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	Melissa M. Zambri Associate, Hiscock & Barclay, LLP Ms. Zambri focuses her practice on enterprise development and regulatory guidance for the health care industry. She provides counsel to individual practitioners, owners, administrators, executives and employees of health care and health care-related facilities, including physicians, licensed medical personnel, hospitals, clinics, home health agencies, senior residences and assisted living facilities, laboratories, health care trade associations, durable medical equipment providers, alcohol and substance abuse treatment facilities, physician practice management companies, mental health programs and medical transportation companies. In addition to her healthcare practice, Ms. Zambri also provides guidance in complying with the regulatory provisions of New York State’s Lobbying Act, and is a member of the real estate practice area with a concentration in leasing.
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