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Calendar Year 2006 Presentations

Wednesday, January 18, 2006
Stem Cell Applications in Biomedicine, Tissue Engineering, and Regenerative Medicine
Daniel Kraft, M.D.
Stanford University Medical School

Changed Location: Room M114 of the Stanford Medical School, in Stanford Hospital.
(Room M114 is located near the "M" on this map.)

Dr. Daniel Kraft will provide an overview of stem cell biology, including embryonic and adult stem cells, their current use in the clinic, and ongoing developments in the push for therapeutic applications utilizing stem cells for use in biomedicine and the evolving field of tissue engineering and regenerative medicine. This talk will include a summary of major stem cell technologies, and related bioengineering and devices.

Daniel Kraft, MD is a physician-scientist at Stanford University Medical School, where his clinical focus is hematology/oncology and stem cell transplantation. He is also on clinical faculty at UCSF on the bone marrow transplant service and is a lecturer for the Stanford Bioengineering program. Daniel graduated cum laude from Brown University, and received his medical degree from Stanford University, where he was also a Howard Hughes Research Fellow, and graduated with honors in research. He went on to complete a combined residency at Harvard in Internal Medicine and Pediatrics at the Massachusetts General Hospital and Boston Children's Hospital, followed by fellowships in hematology/oncology and bone marrow transplantation at Stanford. He is currently funded by the NIH and conducting research in the laboratory of Irv Weissman.

Daniel has extensive biomedical research experience, including at the National Institutes of Health, where his proof of concept publications demonstrating monoclonal antibody mediated inhibition of allergic reactions laid the groundwork for Xolair, an approved therapy by Genentech. Additional research at Brown University, Stanford, Systemix Inc, and Harvard has resulted in multiple peer reviewed publications. Daniel is also an avid pilot with extensive space life sciences research experience with NASA, and serves as a flight surgeon with an F-16 squadron in the California Air National Guard. He was recently a finalist in NASA astronaut selection.

Dr. Kraft has extensive medical device experience from his work with the Stanford Biodesign Innovation Program, and has two patents pending. He is the founder of StemCor Systems Inc, developing tools to enable stem cell therapy, including his invention for a minimally invasive device for the harvest of adult marrow derived stem cells. He previously founded 'The Online Medical Bookstore' which was acquired by Medinex Inc. as part of its IPO.

Wednesday, February 15, 2006
Biometrics: A Brief History and Review of Current Programs
Dr. James L. Wayman
Director, Biometric Identification Research Program
San Jose State University

Clark Center Auditorium

Although it was the Frenchman, Alphonse Bertillion, who developed the first scientific method of recognizing people in the1870s, it was the British who simplified and advanced the art and science of human recognition with the development and promotion of fingerprinting in the decades that followed. It took Californians, however, to apply computers to automating these processes in the 1960s. In this talk, we will review British and Californian contributions to automated human recognition (a field now called "biometrics"), explain a bit about the recent algorithmic approaches to face and iris recognition, and discuss current national biometric programs within both governments.

Dr. Jim Wayman is Director of the Biometric Identification Research Program of San Jose State University He received the Ph.D. degree in engineering in 1980 from the University of California, Santa Barbara. In the 1980s, under contract to the U.S. Department of Defense, he invented and developed a biometric authentication technology based on the acoustic resonances of the human head. He joined San Jose State University in 1995 to direct the Biometric Identification Research Program, serving as Director of the U.S. National Biometric Test Center at San Jose State from 1997-2000. He has written dozens of book chapters and journal articles on biometrics and is co-editor of J.Wayman, A. Jain, D. Maltoni and D.Maio (eds) Biometric Systems (Springer, London, 2005). He is a Fellow of the British Institution of Electrical Engineers, a "Principle UK Expert" on the ISO/IEC JTC1 SC37 standards committee on biometrics, a "core member" of the U.K. Biometrics Working Group, a member Biometrics Executive Committee of the U.K. Home Office, a member of the EC-funded BioSecure Network of Excellence and a member of the International Board for External Review and Validation of the US Dept of Homeland Security. He is also a member of the U.S. National Academies of Science/National Research Council Committee "Whither Biometrics?" and previously served on the NAS "Authentication Technologies and their Implications for Privacy" committee. He holds 4 patents in speech processing and has served as a paid biometrics adviser to eight national governments. His Erdos number is four.

Wednesday, March 15, 7:30pm
Thomas Rusch, Ph.D.
Xoft, Inc.

Brachytherapy traditionally has been a therapeutic radiation procedure in which a capsule or seed of radioactive material is placed in close proximity to the tissue being treated. One common brachytherapy procedure is the placement of radioactive iodine seeds in the prostate to control prostate cancer. Electronic Brachytherapy is a new technology platform designed to deliver localized radiation treatment using a miniature x-ray source to replace the radioactive material. The use of an x-ray source allows the radiation for brachytherapy to be turned on and off as needed, much as the linear accelerator has allowed electronic control of radiation generation for external beam therapy. An electronic source also eliminates the risks of transporting, storing and handling radioactive materials which have received increasing scrutiny in the last few years. Because the maximum source operating voltage is 50 kV, therapy can be given in a minimally-shielded clinical setting which has the potential to make radiation therapy accessible to a much larger number of patients. The Axxent Electronic Brachytherapy System, incorporating the miniature x-ray source, was recently cleared by the FDA to deliver a course of radiation therapy after lumpectomy for early stage breast cancer.

Data from several randomized controlled clinical studies have demonstrated that radiation therapy is an essential component of treatment for breast cancer when the patient wishes to conserve her breast with lumpectomy surgery as opposed to undergoing a full mastectomy. However, more recent studies have shown that many patients opt out of receiving breast sparing surgery with radiation therapy due to time, distance, or difficulty accessing radiation therapy centers.

Thomas Rusch, Ph.D., received undergraduate and graduate degrees in electrical engineering and management of technology from the University of Minnesota. Dr. Rusch spent 26 years developing electron and ion spectroscopies for surface chemical characterization, primarily at 3M and Perkin Elmer Physical Electronics Division. Since co-founding Xoft, Inc, in 1998, he has been actively involved in miniature x-ray source development and dosimetry. More recently he has focused on preparing for clinical introduction of the Axxent Electronic Brachytherapy System.

Wednesday, April 19, 7:30pm
Dr. Dimitre Hristov
Oncology Care Systems
Siemens Medical Solutions

Radiotherapy plays a major role in achieving cure in cancer patients. For the effective treatment of tumors, precise target localization and fast, accurate patient positioning prior to each treatment fraction are crucial clinical challenges that need to be overcome. In order to address these challenges and enable Image-Guided Radiation Therapy some systems that integrate imaging and delivery capabilities have been recently introduced based on: (i) the integration of a traditional multi-slice computed tomography (CT) scanner "on rails" with a C-arm gantry linear accelerator; (ii) the development of a high sensitivity, fast, megavoltage (MV) electronic portal imaging device capable of clinical MV Conebeam CT (MVCBCT) reconstruction and fluoroscopy mounted on a C-arm gantry linear accelerator; and (iii) the development of an in-line megavoltage and kilovoltage flat panel imaging system that has the potential to image both anatomical and dosimetric information in "real-time" utilizing the traditional C-arm gantry linear accelerator geometry. The design and clinical utility of these systems will be discussed in the context of precision, image-guided adaptive radiation therapy.

Dr. Hristov is a Clinical Development Manager at Siemens Medical Solutions, Oncology Care Systems. A PhD graduate from McGill University and a member of the Canadian College of Physicists in Medicine, Dr. Hristov has worked as a clinical physicist, researcher and teaching faculty at the Montreal University Hospital Centre and McGill University in Canada as well as at King Faisal Specialist Hospital and Research Centre in Jeddah, Saudi Arabia. At Siemens, he had been a Senior Staff Physicist, doing research in the areas of 4D imaging, therapy imaging, inverse planning and adaptive radiotherapy. His contributions are published in Medical Physics, Physics in Medicine and Biology and The international Journal of Radiation Oncology, Biology and Physics.

Wednesday, May 17, 7:30pm
Recent Developments in EMF Exposure Research

Robert Kavet, MS, MEE, ScD
Program Manager, EMF and RF Safety
Electric Power Research Institute

Several recent high-profile risk assessments have concluded that an association exists between childhood leukemia incidence and residential magnetic fields above 0.3-0.4 μT. The relative risk for these exposures is between 1.7 and 2.0, using fields <0.1 μT as a reference. Thus far, a causal role for the magnetic field has not been justified based on unresolved questions about potential biases and confounding, negative bioassay results and the lack of biophysical plausibility. Over the past six years we have developed a hypothesis that magnetic fields serve as a surrogate for exposure to contact current, and that the source voltage for this exposure is the potential between a residence's grounding system - which includes residential water pipes - and the earth. We have proposed that exposure would occur when the wet hand of a bathing child contacted the faucet, spout or the water stream; the proximal source would be the closed-circuit voltage from the water system to the drain (the latter would necessarily need to be conductive and sunk in the earth). Three criteria, at a minimum, must be satisfied for contact current to qualify as candidate exposure that explained the epidemiology. The failure to verify any one of the three would be a signal to stop this line of research. The three are (1) Plausible dose to bone marrow; (2) Strong association of magnetic fields with the source of contact current; and (3) Frequent access to exposure. Each has been satisfied, as described in this presentation, and as a result, epidemiology and laboratory studies are under way to further address the contact current hypothesis' validity.

Dr. Robert Kavet is the Program Manager for both the EMF Health Assessment and Radio-Frequency Safety program and the Occupational Health and Safety program. Dr. Kavet's primary research activities focus on unraveling the basis for the association between magnetic fields and childhood leukemia reported in epidemiologic studies, and elucidating the technical basis for guidelines that recommend exposure limits for electric fields, magnetic fields, and contact currents. In collaboration with several teams of investigators, Dr. Kavet is investigating whether the association between magnetic fields and childhood leukemia might be attributable mainly to children's exposure to contact current in their residences.

Dr. Kavet is responsible for developing the programs' technical research projects; communicating research results to members; and expanding the programs' membership and resources. In addition, Dr. Kavet currently holds the position of Visiting Lecturer on Environmental Health Sciences at Harvard University.

Dr. Kavet was a Senior Staff Scientist with the Health Effects Institute in Cambridge, MA, joining in 1984. From 1986 until 1992 he worked as a consultant, focusing largely on potential health effects from exposure to electric and magnetic fields (EMF). He has published extensively in the area of EMF health effects, and has directed short courses and seminars on this subject.

Dr. Kavet received his ScD degree in respiratory physiology and his MS degree in environmental health sciences, both from Harvard School of Public Health. He received a BS degree in electrical engineering as well as an MEE degree from Cornell University.

Wednesday, June 21, 7:30pm
The Biomedical Entrepreneur
Rodney Perkins, M.D.

The entrepreneurial gene is in the DNA of many in Silicon Valley. Although entrepreneurship, innately, must come from the individual, there are a number of elements that make up the environment that the entrepreneur draws from to create innovation, invention and form a successful enterprise. The presentation will discuss the value of the entrepreneur, the nature of information and discovery, invention, and the role of the entrepreneur.

Several lessons learned in the industry will be described utilizing real experiences in companies founded by the author. In addition, the future of the world-wide healthcare opportunity, 'Megatrends in Healthcare', and a 'Survival Kit for Entrepreneurs' will be presented.

Dr. Perkins is an internationally known otologic surgeon who has participated actively in the development of multiple successful medical device companies. He is the founder of the California Ear Institute at Stanford and a Professor of Surgery at Stanford. Dr. Perkins has created a number of surgical procedures and techniques that have become widely practiced by ear surgeons throughout the world.

Dr. Perkins is the founder of three public companies: Collagen Corporation (collagen based bioimplant materials and related products), Laserscope (surgical lasers and delivery devices) and ReSound Corporation (digital signal processing hearing devices), and was chairman of both Lasercope and ReSound.

He was founder and chairman of Cohesion Corporation (bioadhesives, sealants and hemostats) which was sold to Collagen Corporation and a founder and chairman of Novacept (a women's health care company). Novacept was recently sold to Cytyc Corporation.

Dr. Perkins is also the founder and Chairman of Sound ID (a hearing science company); founder and chairman of Pulmonx (a private company pioneering interventional pulmonology) and chairman of Surgrx (electrosurgical instrumentation based on a new resistive matrix technology).

Dr. Perkins has ten issued patents.

Dr. Perkins attended Indiana University and Oxford for his medical education and served a surgical residency at Stanford University School of Medicine.

Wednesday, September 20, 7:30pm
Clark Center Auditorium
Micromachined Transducers for Medical Ultrasound Imaging and Therapy
Butrus T. Khuri-Yakub
Professor of Electrical Engineering
Stanford University

Capacitive Micromachined Ultrasonic Transducers (CMUTs) have been developed in the past decade as alternative transducers for generating and detecting ultrasound. Capacitor ultrasound transducers have been known for over 100 years; however, the advent of silicon micromachining has enabled the realization of the full potential of these transducers. Silicon micromachining allows the manufacture of capacitors with very thin gaps, and with electric fields of the order of 109 V/m that determines their performance. It is now possible to make immersion CMUTs with over 100 % fractional bandwidth, with an electromechanical coupling coefficient close to unity, and to make single element and one-dimensional (1D) and two-dimensional (2D) arrays of tens of thousand of elements, as well as annular arrays. CMUTs have been operated in the frequency range of 100 kHz to 50 MHz, and with a dynamic range of the order of 150 dB/V/Hz.

This presentation will first review the modes of operation of CMUTs then introduce two different technologies for making CMUTs along with a technology for integrating electronics, which is one of the major advantages of this approach. Next, examples of various types of transducers (single element, 1-D, 2-D and annular arrays with frequency response ranging from 1-50 MHz) will be presented. Lastly, we will show examples of ultrasonic imaging, functional imaging, and high intensity focused ultrasound (HIFU) therapy applications.

Dr. Khuri-Yakub is a fellow of the IEEE and Senior Member of the Acoustical Society of America. He has been Professor of Electrical Engineering for almost 25 years at Stanford University, where he obtained his PhD and worked as Senior Research Associate for many years. Dr. Khuri-Yakub has received many awards, including Stanford University Outstanding Inventor in 2004. Research interests include microfluidic devices and air-coupled acoustic microsensors, in addition to micromachined ultrasonic arrays.

Wednesday, October 18, 7:30pm
Clark Center Auditorium
MEMS for Medical Applications
Alissa M. Fitzgerald, Ph.D.
Founder and Managing Member of A.M. Fitzgerald & Associates, LLC

MEMS, or microelectromechanical systems, is a catch-all term for a manufacturing technology that enables the production of devices with micron-scale features. Although the technology developed from the semiconductor industry, it is quickly evolving beyond silicon-based devices to include microsystems made from glass, silicon carbide, diamond, and flexible polymers. The capability to create micron-sized devices from biocompatible materials, that may also be readily interfaced with microelectronics, opens up great opportunities for the development of novel medical devices.

In this talk, an overview of MEMS manufacturing approaches will be presented, in order to acquaint the audience with the huge potential for MEMS in medical applications. The products and approaches of some companies who are developing MEMS-based medical devices will also be presented and discussed.

Alissa Fitzgerald founded A.M. Fitzgerald & Associates, LLC in 2003 to provide custom prototyping and R&D services to clients developing MEMS devices. Her company has consulted on MEMS sensors for automotive, industrial, and medical applications. Dr. Fitzgerald was previously employed by Sensant Corporation, where she worked on the development of micromachined ultrasound transducers for medical imaging applications. She has also been employed by the Jet Propulsion Laboratory and Orbital Science Corporation. Dr. Fitzgerald received her bachelor and master degrees from the Massachusetts Institute of Technology and her doctorate from Stanford University, all in the discipline of Aeronautics and Astronautics.

Wednesday, November 15, 7:30pm
Clark Center Auditorium
Advances in Technology for the Treatment of Aneurysms
Stephen P. Hanlon
Vice President, Research & Development
Neurovascular division, Boston Scientific

The treatment of aneurysms with devices is a relatively new area within the field of minimally invasive medical treatment. Aneurysms previously required an open neurosurgical procedure and the use of spring-type clips between the aneurysm and parent vessel. Many aneurysms are still treated this way throughout the world, but increasingly small platinum coils are threaded through vascular access under fluoroscopic guidance to fill the aneurysm. These coils are detached from catheters via electrolytic junction techniques.

A treatment more recently joining the arsenal involves the use of stents placed in the parent artery beneath the aneurysm. Typically today, coils are then threaded through the stent into the aneurysm. Stents will become more common as stand-alone treatment devices. Other techniques are under development including liquid embolics, continuous coils, and flow diversion devices.

Stephen P. Hanlon is currently Vice President, Research & Development for the Neurovascular division of Boston Scientific. Boston Scientific is a world-wide leader in minimally invasive medical devices with products in coronary, neuro, urology, peripheral vascular, and neurostimulation fields.

Stephen Hanlon has held various positions in the medical device field for Cobe Laboratories, Pfizer, Tyco, PhotoElectron, and Boston Scientific. He has been a Design Engineer, R&D Director, General Manager, Operations Manager, and Vice President of Research & Development. Product experience includes neurovascular treatment devices, radiation delivery systems, RF generation, electrosurgical generators, ultrasonic surgery systems, and dialysis delivery systems. He has a bachelor's degree in Electrical Engineering from the University of Wyoming, a master's degree in Electrical Engineering from Arizona State University, and an MBA from the University of Colorado

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