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APPENDIX B – FY 2007 OSEL Presentations

January 1, 2007 – December 31, 2007

Agrawal A , Pfefer J. Characterization of gold nanoshells for optical imaging and laser therapy. FDA Science Symposium on Nanotechnology, 2007.

Agrawal A, Parker C, Qazi T, Agrawal KM, Pfefer TJ. Sensitivity and robustness of methods for analyzing time-resolved fluorescence measurements of layered biological tissue. SPIE BiOS, Jan 2007.

Bandos A, Rockette HE, Gallas BD, Gur G. Multi-Reader ROC methods: Explicit formulations and relationships between DBM, multi-WMW, BWC and Gallas’s methods. International Biometric Society, Eastern North-American Region Conference (ENAR), Atlanta Georgia, 2007.

Bassen H , Seidman S, Rogul J, Desta A, Wolfgang S. An exposure system for evaluating possible effects of RFID on various formulations of drug products. IEEE International Conference on RFID, Gaylord Texan Resort, Grapevine, TX, USA, March 26-28, 2007.

Chan DD, Krauthamer V. Effects of high-rate stimulation in modeled axons and role of calculation time step interval on simulations, Biomedical Engineering: Recent Developments, 2007.

Chiesa OA, Li H, Karanian JW, Pritchard WF, Smith M, von Bredow J. Gasless (isobaric) laparoscopic serial kidney and liver biopsies in standing sedated steers. 4 th Veterinary Endoscopy Society Meeting. Hawk’s Cay, FL, March 26-28, 2007.

Coelho SG, Yamaguchi Y, Miller SA, Zmudzka BZ, Takahashi K, Beer JZ, Hearing VJ. Skin pigmentation induced by repeated uv exposures and the role of melanin in photoprotection. 14 th Annual Meeting of the PanAmerican Society for Pigment Cell Research, Chicago, IL, September 13-16, 2007.

Elespuru RK. FDA use of genotoxicity data. Toxic Embedded Fragments meeting, Veteran’s Administration, Baltimore, MD, November 6, 2007.

Harris GR, Diagnostic ultrasound regulatory guidance and output display indices (invited presentation), Short Course on Regulatory and Safety Issues in Biomedical Ultrasound 2007. IEEE International Ultrasonics Symposium, New York City, NY, October 2007.

Hitchins VM, Petricoin EF, Calvert V, Kaplan DS, Au R, Grzanna R, Wood SC, Frondoza CG. Phenotype shift of human chondrocyte monolayer cultures maintained on polystyrene surfaces is associated with AKT/GSK/Forkhead pro-survival signaling. Gordon conference, Holderness School, Holderness, NH, July 22-27, 2007.

Hsu ER, Gallas BD, Jeronimo J. Colposcopic reader agreement using images of the cervix. Biomedical Engineering Society 2007 Annual Fall Meeting, Los Angeles, CA, September 26-29, 2007.

Karanian JW, Chiesa OA & Pritchard WF, Modeling Drug Delivery: Tools for Assessment of Arterial Intramural Kinetics. 14 th International Local Drug Delivery Meeting. Geneva, Switzerland, February 1-3, 2007.

Karanian JW. Future perspectives and challenges for the validation of devices to treat cardiovascular disease. Vulnerable Plaque Summit 2007, Houston, TX, September 15, 2007.

Karanian JW. Preclinical animal studies: DES: TCT 2007, Washington, DC, October 20, 2007.

Liang H, Park S, Gallas BD, Badano A, Myers KJ. Assessment of temporal blur reduction methods using a computational observer that predicts human performance. SID (Society for Information Display) international symposium, Long Beach, CA, May 19-25, 2007 (oral presentation).

Liang L A. Xu, Gallas BD, Park S, Myers KJ, Badano A, Detectability decreases when browsing large image sets in slow display devices. RSNA 2007, Chicago, IL, 2007 (oral presentation).

Li J, Huang A, Yao J, Petrick N, Choi JR, Pickhardt PJ, Summers RM. Improved performance of computer-aided detection for medium-sized polyps on CT colonography. European Congress of Radiology Program, ECR, March 2007.

Midgette WH. ISO 14971 and the 3 rd edition. 2007 AAMI International Standards Conference, March 21, 2007.

Midgette WH. Risk management and the 3 rd edition. 2007 AAMI International Standards Conference, Marech 21, 2007.

Myers KJ, Barrett HH, Gallas BD, Gagne RM, Petrick N, Wagner RF. Unique issues in the assessment of biomarkers from imaging. RSNA Imaging as a Biomarker for Planning and Monitoring Therapy Workshop, Bethesda, MD, May 3-4, 2007.

O’Hara MD. Seminar series at the FDA's White Oak Campus Department of Radiation Oncology, University of Maryland, College Park, MD, September 10, 2007.

Paquerault S , Petrick N, Myers KJ, Samuelson FW. Impact of a computer-aided detection (CAD) system on reader performance: assessment based on a truthing panel compared to the true gold standard. Radiological Society of North America (RSNA 2007).

Petrick N , Gallas BD, Samuelson FW, Paquerault S. Assessing computer-aided diagnosis algorithms: Algorithm architecture, statistical tools and study designs. Eastern North American Region International Biometric Society Annual Meeting, Atlanta, GA, March 2007.

Pfefer TJ. Introduction to Biomedical Optics,” presentation for FDA Staff College Course on Modern Topics in Biomedical Optics, 2007.

Pritchard WF, Peregoy JA, Murray TL, Chiesa OA, Karanian JW. Computed tomography and uniquely labeled therapeutic agents allow detailed evaluation of pharmacokinetics in local drug delivery. 2nd Imaging in Pre-clinical & Clinical Drug Development. Boston, MA, March 10-14, 2007.

Rasooly AR. Microarrays for analysis and detection of microbial pathogens and their toxins (invited presentation). Annual Meeting of the International Association for Food Protection, Orlando FL, July 11 2007.

Seidman S, Ruggera P, Lewis B., Brockman R, Shein M., “Electromagnetic Compatibility of Pacemakers and Implantable Cardiac Defibrillators Exposed to Radio Frequency Identification Readers,” Academic Convocation at RFID Journal Live April 30-May 2, Orlando FL, 2007.

Spees W. Medical device plug and play prototype SW interface. Center for the Integration of Medicine & Innovative Technology (CIMIT), Cambridge, MA, June 25, 2007.

Stratmeyer M. Safety and regulatory considerations in the non-clinical use of medical ultrasound devices (invited presentation). WFUMB/ISUOG Workshop on Safety of Non-Clinical Use of Ultrasound, 17 th World Congress on Ultrasound in Obstetrics and Gynecology, Florence, Italy, October 7-11, 2007.

Tata D, Waynant RW. Applications of Novel sources in the Suppression of Human Brain Cancer Metabolic activity: An In-vitro study. To be published in the proceedings of Light-Activated Tissue Regeneration and Therapy II, Tomar, Portugal.

Tata D, Waynant RW. Near-IR picosecond pulsed laser induced suppression of metabolic activity in malignant human brain cancer: An in-vitro study. To be published in the proceedings of Light-Activated Tissue Regeneration and Therapy II, Tomar, Portugal.

Taylor A. Compliance alliance. Medical Device Validation Seminar, NEMA, San Francisco, CA, March 13-15, 2007.

Taylor A. Overview of design controls and Cybersecurity for medical devices. Safety Risk Management and Design Control, Compliance Alliance, MITA, McLean, VA, September 11-13, 2007.

Wallace G, Chiesa OA. Penicillin tissue-fluid correlations in swine using video-assisted serial sampling. Food and Drug Administration, Center for Veterinary Medicine, Office of Research, Laurel, MD, August 24, 2007.

Wang Q, Agrawal A, Pfefer J, Wang NS. Measurement of internal tissue optical properties in ultraviolet and visible spectral regions: development and implementation of a multi-wavelength system. University of Maryland Bioscience Research & Tech Review Day, 2007.

Wang Q , Agrawal A, Matchette S, Wang NS, Pfefer J. Evaluation of a multi-wavelength reflectance system for determination of tissue optical properties in the UVA-VIS. Conference on Lasers and Electro-Optics, 2007.

Weininger S. Plan for Quality. The Future of Manufacturing is Innovation conference, CT Center for Advanced Technology, East Hartford, CT, June 21, 2007.

Witters D. Wireless Technology in Healthcare: an FDA Perspective, ECRI Institute’s web conference on Managing a Hospital Wireless infrastructure, November 14, 2007.

Witters D. Addressing RF Wireless Technology and Electromagnetic compatibility (EMC) for Medical Devices: an FDA Perspective, GLORE Global Coordination of Research on Electromagnetic Fields, EMF-NET Coordination Action Funded by the European Union's Sixth Framework Programme of Research, Nov 26-27, 2007, Brussels, Belgium.

Wilson O, Agrawal A. Inorganic Liquid Crystals for Biomedical Imaging. Materials Science and Technology Conference, September 2007.

Yamaguchi Y, Coelho SG, Beer JZ, Miller SA, Hearing VJ. Photoprotection of human skin against repeated UV exposures. Meeting of the European Society for Pigment Cell Research, Bari, Italy, October 14-16 2007 (Invited Lecture).