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APPENDIX B – FY 2003 OSEL Presentations

October 1, 2002 – September 30, 2003

Alderson N, Ali SF, Bond S, Coles B, Debrabant A, Faustino PJ, Grant M, Khan A, Kulka A, Lucas A, Momcilovic D, Patterson T, Rosebaugh C, Spence M, Stern A, Ward J, Wood G. Committee for the advancement of FDA science (CAFDAS): the FDA scientist's liaison to the Commissioner's office. FDA Science Forum, Washington, DC, April 2003.

Alderson N, Ali SF, Bond S, Coles B, Debrabant A, Faustino PJ, Grant M, Khan A, Kulka A, Lucas A, Momcilovic D, Patterson T, Rosebaugh C, Spence M, Stern A, Ward J, Wood G. Committee for the advancement of FDA Science (CAFDAS): a series on leveraging techniques. FDA Science Forum, Washington, DC, April 2003.

Badano A., Gallas BG, Myers KJ, Burgess AE. Translating viewing angle measurements into signal detectability maps. MIPSX: Medial Image Perception Conference, Durham, NC, September 2003.

Beer JZ. Sunlamps and tanning: our research and our positions. Tanning Symposium: American Academy of Dermatology Association, American Society for Photobiology and the U.S. Food and Drug Administration. Washington, DC, June 28, 2003.

Beer JZ, Hearing VJ, Miller SA, TadokoroT, Yamaguchi Y, Zmudzka BZ. DNA damage and the dynamics of its removal in different racial/ethnic groups. 31st Annual Meeting of the American Society for Photobiology, Baltimore, MD, July 5-9, 2003.

Beer JZ, Hearing VJ, Miller SA, Tadokoro T, Yamaguchi Y, Zmudzka BZ. UV-induced erythema and DNA damage in different U.S. racial/ethnic groups. Invited lecture, 10th Congress of the European Society of Photobiology, Vienna, Austria, September 6-11, 2003.

Beer JZ, Hearing VJ, Miller SA, Tadokoro T, Yamaguchi Y, Zmudzka BZ. UV responses in human skin of different racial/ethnic origin. Invited lecture: 1st Annual Skin of Color Summit, organized by Johnson & Johnson/Neutrogena, Philadelphia, PA, 2003. [ ]

Bowley SM, Malinauskas RA. Evaluation of parameters affecting bovine blood hemolysis testing. American Society of Mechanical Engineers: 2003 Summer Bioengineering Conference, Key Biscayne, FL, June 2003 (extended abstract).

Brown RP, Stratmeyer ME, Alonge LA, Phillips PJ. Use of safety assessment to support regulatory decision making and risk communication efforts in CDRH: DEHP in PVC medical devices. FDA Science Forum, Washington, DC, April 2003.

Brown RP, Stratmeyer ME. Conversion factors for deriving interim parenteral tolerable intake (TI) values from oral toxicity data. FDA Science Forum, Washington, DC, April 2003.

Brown SA, Merritt K. Studies on the effects of nitric acid and citric acid on neutralization of endotoxin. Presented to ASTM F04.12, May 2003.

Brown SA, Asher D. CDRH-CBER TSE instrument decontamination project. Presented to the TSE Advisory Committee, July 17, 2003.

Brown SA. Issues in SUDs reuse. MDUFMA ReSUDs course. Presentation (LOCATION??), July 28, 2003.

Brown SA, Asher D. CDRH-CBER TSE instrument decontamination project. Progress report and presentation to FDA Office of Science and Health Coordination, September 4, 2003.

Brown SA, Merritt K. Biocompatibility, metal ions, and corrosion products. Abstract and presentation for the ASMInternational, Materials and Processes for Medical Devices Conference, Anaheim, CA, September 8-10, 2003.

Brown SA. Let's not repeat history: good examples of bad ideas. Abstract and keynote address for the ASM International. Materials and Processes for Medical Devices Conference, Anaheim, CA, September 8-10, 2003.

Coelho S, Miller SA, Beer JZ. The use of digital photography to document & quantify erythema & pigmentation induced in human skin exposed to tanning lamps. 31st Annual Meeting of the American Society for Photobiology, Baltimore, MD, July 5-9, 2003.

Coleman JA, Wood B, Phillips JL, Lee C, Pritchard WF, Wray-Cahen D, Walther M, Linehan WM. Circumferential radiofrequency coagulation for partial nephrectomy and partial adrenalectomy. American Urological Association, Chicago, IL, April 2003.

Coleman JA, Wood B, Phillips JL, Lee C, Pritchard WF, Wray-Cahen D, Walther M, Linehan W. Characterization of renal lesions created during circumferential RF assisted partial nephrectomy. World Congress of Endourology, Montreal, September 2003.

Elespuru RK Genetics vs. genomics: a paradigm for microarray issues. FDA Science Forum, Washington, DC, April 24-25, 2003.

Elespuru RK, Garrett-Young R. Analysis of p53 mutations in human tumors: integration of new technology in pre-clinical cancer risk assessment. FDA Science Forum, Washington, DC, April 24-25, 2003.

Elespuru RK. Analysis of p53 mutations in colon adenocarcinomas: molecular epidemiology approach using the IARC TP 53 database, at the Environmental Mutagen Society satellite meeting on colon cancer, Miami, FL, May 2003.

Elespuru RK. Analysis of p53 mutations in human esophageal cancer: a molecular epidemiology approach, Environmental Mutagen Society annual meeting, Miami, FL, May 2003.

Gagne RM. Relationship of DQE to visual signal detection. Invited talk at Annual Meeting of American Association of Physicist in Medicine, San Diego, August 2003.

Gagne RM. Measures of image quality in digital mammography invited talk at Johns Hopkins University Breast Imaging Physics Symposium, Baltimore, MD, September 2003.

Gummalla S, Krause PR, Merritt K, Hitchins VM, Kopecko DJ, Mtungwa AR, Wekell MM, Bhiladvala R, Craighead HG, Hall RH. Nanotechnology biosensor to identify microbial contamination of foods, biologics and medical devices. FDA Science Forum, Washington, DC, April 2003.

He Z, Grimm S, Wagner RF, Wear KA, Jannicky E, Garra BS. Dependence of tissue characterization features on region of interest size: studies on phantoms and in vitro tissues. Proceedings of the 28th International Symposium on Ultrasonic Imaging and Tissue Characterization, Arlington, VA, May 28 - 30, 2003.

He Z, Grimm S, Trainer TD, Kalof A, Souchon R, Ophir J, Wear KA, Wagner RF, Huston D, Weiss LJ, Garra BS. Integrating elastography with ultrasound (US) backscatter and image texture features for prostate cancer detection: pathology - US data registration method and results. Tenth Congress of the World Federation for Ultrasound in Medicine and Biology, Montreal, Canada, June 1-4, 2003

Hilbert SL . Preclinical evaluation of flexible leaflet replacement heart valves: assessment of the potential for calcification. Biomineralization in Biomaterials Workshop sponsored by the Surfaces in Biomaterials Foundation, Scottsdale, AZ, 2002.

Hilbert SL. Preclinical in vivo studies: FDA perspective. Bioengineering and Materials Applications, National Academy of Sciences, Washington, DC, 2002.

Hilbert SL. Replacement heart valve-related pathology: preclinical in vivo studies. 9th Annual Science Forum, Washington, DC, April 24-25, 2003.

Hitchins VM, Mtungwa AR, Merritt K. Induction of TNF-alpha, IL-6 and nitric oxide by titanium nitride, titanium silicide and titanium telluride particles and LPS in RAW 264.7 murine macrophage cells. FDA Science Forum, Washington, DC, April 2003.

Hitchins VM, Mtungwa AR, Merritt K. Induction of TNF-alpha, IL-6 and nitric oxide by titanium nitride, titanium silicide and titanium telluride particles and LPS in RAW 265.7 murine macrophage cells. Society for Biomaterials Meeting, Reno, NV, April 30-May 3, 2003.

Hitchins VM, Merritt K. Production of IL-6, IL-1 beta, TNF-alpha, and nitric oxide by murine macrophages, murine bone cells and human bone cells exposed to alginates of different MG ratios and different purities. Gordon Research Conference on Biomaterials/Biocompatibility/Tissue Engineering, July 21-25, 2003.

Howard PC, Molefe DF, Koddel RF, Wamer WG, Beer JZ, Mellick PW. Photocarcinogenesis: histological classification of skin lesions induced in mice by simulated solar light. 31st Annual Meeting of the American Society for Photobiology, Baltimore, MD, July 5-9, 2003.

Ilev I, Waynant R, Romanczyk T, Gorman E, Luedtke R, Pollard H, Anders J. On-the-spot brain tissue ablation using smart infrared fiber probes. LEOS 2002 – Annual Meeting of the IEEE Lasers and Electro-Optics Society, Glasgow, UK, November 10-14 2002.

Ilev I, Waynant R. Photonic biosensing using smart optical fiber structures. First World Congress on Biomimetics and Artificial Muscles, Albuquerque, NM, December 9-11, 2002.

Ilev I. Modern minimally invasive biophotonics delivery, sensor and imaging systems. National Institutes of Health/NICHHD, Bethesda, MD, January 16, 2003.

Ilev I, Waynant R, Gorman E, Luedtke R, Byrnes K, Anders J. Combined fiber-optic confocal microscopy for noninvasive optical sensing. Photonics West–BiOS 2003 International Conference, San Jose, CA, January 25-31, 2003.

Ilev I, Waynant R. Optical techniques for breath analysis. First FDA/Virginia Tech/AFOSR Workshop on Optical Techniques for Breath Analysis, Falls Church, VA, March 13, 2003.

Ilev I, Waynant R, Byrnes K, Gorman E, Anders J. In vivo spectral transmission measurements through single and multiple tissue layers and blood. International Conference on Lasers and Electro-Optics (CLEO-2003), Baltimore, MD, June 1-6, 2003.

Ilev I, Waynant R, Gorman E. A noncontact laser refractometer and caliper based on a simple dual-confocal fiber-optic sensor technique. International Conference on Lasers and Electro-Optics (CLEO-2003), Baltimore, MD, June 1-6, 2003.

Ilev I, Waynant R, Romanczyk T, Gorman E, Moore C, Anders J. In-vivo precise brain tissue ablation using smart infrared optical fiber. LEOS 2003 – Annual Meeting of the IEEE Lasers and Electro-Optics Society, Tucson, AZ, October 26-30, 2003.

Ilev I, Waynant R. Noninvasive optical monitoring of smoking-induced effects on exhaled nitric oxide. 2003 National Conference on Tobacco or Health, Boston, MA, December 10-12, 2003.

Kaplan DS. Development of standards for the characterization of natural materials used in TEMPs. ASTM Symposium on Tissue Engineered Medical Products (TEMPs), Miami, Florida, November 4-5, 2002.

Kaplan D, Malinauskas R, Vegella T, Schaefer D, Mars S. A mechanism for evaluating cell adhesion on natural materials. Gordon Research Conference on Biomaterials: Biocompatibility/ Tissue Engineering, Plymouth, NH, July 2003.

Karanian JW. Preclinical animal trials and cardiovascular interventional devices: academic and regulatory perspectives. Second International Interdisciplinary Conference on Cardiovascular Medicine, Surgery, Science, and Mechanics, Bethesda, MD, 2003.

Karanian JW. Thrombosis and restenosis: preclinical interventional device failure modes. International ICB Thrombosis Conference, Bethesda, MD 2003.

Karanian JW. Interventional device implant performance in preclinical animal models of cardiovascular disease. Holland Research Laboratory, ARC, Rockville, MD, 2003.

Kornhauser K, Wei RR, Beer JZ, Coelho SG, Miller SA, Zmudzka BZ, Hearing VJ. Effects of topically applied alpha- and beta-hydroxyacidshydroxy acids on the sensitivity of human skin to UV-induced damage. FDA Science Forum, Washington, DC, April 24-25, 2003.

Krauthamer V. The safety of electrical stimulation in the heart and nervous system. University of the District of Columbia, Department of Chemistry Seminar Series, Washington, DC, February 27, 2003.

Krauthamer V. The safety of electrical stimulation. CDRH Staff College "Meet the Experts" seminar, Rockville, MD, July 2, 2003.

Lucas AD, Merritt K, Hitchins VM. How much EO residue to expect if the device you mail gets EO sterilized? Society for Biomaterials Meeting, April 30-May 3, 2003.

Lucas AD, Merritt K, Hitchins VM. How much EO residue to expect if the device you mail gets EO sterilized? FDA Science Forum, Washington, DC, April 2003.

Luu HMD. Use of biological modeling in risk assessment. FDA Science Forum, Washington DC, April 24-25, 2003.

Luu HMD.: Bioavailability of Bisphenol A: prediction of estrogen disruption in humans. SOT Annual Meeting, Salt Lake City, Utah, March 2003.

Malinauskas RA. Hemocompatibility testing of medical devices based on damage to red blood cells. Second International Conference on Cardiovascular Medicine and Science, Bethesda, MD, July 2003. Abstract published in International Journal of Cardiovascular Medicine and Science, Vol. 6, No.2, 2003.

Merritt K, Hitchins VM, Lucas AD. Effect of gamma, electron beam and ethylene oxide gas (ETO) sterilization on various medical and personal use items. FDA Science Forum, Washington, DC, April 2003.

Merritt K, Hitchins VM, Lucas AD. Effect of gamma, electron beam and ethylene oxide gas (ETO) sterilization on various medical and personal use items. Society for Biomaterials Meeting, April 30-May 3, 2003.

Miller SA, Beer JZ, Coelho SG, Sliney DH. UV tanning – the good, the bad, the beautiful and the ugly. 5th International Lighting Research Symposium on Light and Human Health, Orlando, FL, November, 2002.

Miller SA, Coelho SG, Howard P, Kornhauser K, Wei RR, Beer JZ. UV tanning – the good, the bad, the beautiful, and the ugly. FDA Science Forum, Washington, DC, April 24-25, 2003.

Miller SA, Beer JZ. UV optimization study: research and standards. The Joint Meeting of the American Academy of Dermatology, the American Society for Photobiology and the Food and Drug Administration, Washington, DC, June 28, 2003.

Miller SA, Zmudzka BZ, Coelho S, Beer JZ. How much UV is really needed to produce a tan? 31st Annual Meeting of the American Society for Photobiology, Baltimore, MD, July 5-9, 2003.

Myers KJ. Objective assessment of image quality. NIBIB/UMMC Workshop on Defining the State-of-the-Art in Biomedical Imaging: Research Needs for the Future, Jackson, MS, March 2003.

Myers KJ. Quantitative system evaluation and optimization. Biomedical Imaging Research Opportunities Workshop I, Bethesda, MD, January 2003.

Petrick N, Hadjiiski, LM, Chan H-P, Helvie M.A, Sahiner B, Myers KJ. Assessment of a mammographic mass detection scheme with prior cases. MIPSX: Medical Image Perception Conference, Durham, NC, September 2003.

Petrick N, Badano AG, Chan HP, Sahiner B, Helvie. Digital flat-panel x-ray detectors: improving light collection with microlenses. FDA Science Forum, Washington, DC, April 23-24, 2003.

Pfefer TJ, Matchette LS, Bennett CL, Gall JA, Wilke JN, Durkin AJ, Ediger MN. Reflectance-based determination of optical properties in highly attenuating tissue. FDA Science Forum, Washington, DC, 2003. (Poster presentation)

Ranamukhaarachchi D, Bright R, Chan M, Farr S, Langone J, Neft R, O’Neill JP, Slater J, Wood S, Elespuru R. Development of a diagnostic microarray for type 1 latex allergy, FDA Science Forum, Washington, DC, April 24-25, 2003.

Papaconstantinou AD, Goering PL, Umbreit TH, Brown KM. Regulation of uterine hsp90, hsp72 and HSF-1 expression in B6C3F1 mice by ß-estradiol and Bisphenol A: involvement of the estrogen receptor and protein kinase C. Annual Meeting of the Society of Toxicology, Salt Lake City, Utah, March 2003.

Papaconstantinou AD, Goering PL, Umbreit TH, Brown KM. Does Bisphenol A, a medical device material, mimic the actions of beta-estradiol on heat shock protein and HSF-1 expression in the uterus? FDA Science Forum, Washington DC, April 2003.

Pritchard WF, Karanian JW. Regulation of medical devices: FDA perspectives for university researchers. Institute for Medicine and Engineering, University of Pennsylvania, Philadelphia, PA, 2003.

Ranamukhaarachchi D, Langone J, Elespuru R. Assessment of target cell and mRNA detection limits in disease diagnosis using real-time PCR, FDA Science Forum, Washington, DC, April 24-25, 2003.

Stratmeyer ME. Regulatory approaches to natural latex allergy. Meeting of the Additives and Ingredients Subcommittee, Food Advisory Committee of the US FDA’s Center for Food Safety and Applied Nutrition, Washington, DC, August 2003.

Tomazic-Jezic VJ, Sanchez BA.. Allergenic natural rubber latex (NRL) proteins binding to glove powder. FDA Science Forum, Washington, DC, April 2003.

Tomazic-Jezic VJ. Comparative evaluation of non-ammoniated latex (NAL) protein extracts for the D6499 revision studies. Semi-annual ASTM D11.40 meeting, Denver, CO, June 2003.

Tomazic-Jezic VJ. Progress in the Management of NRL Allergy: impact on Food Safety. Meeting of the Additives and Ingredients Subcommittee, Food Advisory Committee of the US FDA’s Center for Food Safety and Applied Nutrition, Washington, DC, August 2003.

Tomazic-Jezic VJ. Validation of NAL reagent for the revision of the D6499 standard; round robin data report. Semi-annual ASTM D11.40 meeting, Tampa, FL, December 2003.

Waynant R, Ilev I. Delivery of coherent radiation from terahertz to x-rays. LEOS 2002 – Annual Meeting of the IEEE Lasers and Electro-Optics Society, Glasgow, UK, November 10-14 2002.

Waynant RW, Mitra K, Ilev IK. A concept for early cancer detection and therapy. Photonics West, BIOS 2003 International Conference, San Jose, CA, January 25-31, 2003. Published in Lasers in Surgery: Advanced Characterization, Therapeutics and System XII 4(1):425-432, 2003.

Waynant RW. Comparison between lasers and other treatments. Laser Florence 2003, Florence, Italy, November 6-8, 2003.

Wear KA, A Laib. The dependence of ultrasonic backscatter on trabecular thickness in human calcaneus: theory and experiment. Proceedings of the 28th International Symposium on Ultrasonic Imaging and Tissue Characterization, Arlington, VA, May 28-30, 2003.

Wear KA. The dependence of ultrasonic backscatter on trabecular thickness in human trabecular bone: theory and experiment. Proceedings of the Tenth Congress of the World Federation for Ultrasound in Medicine and Biology, Montreal, Canada, June 1-4, 2003, Ultrasound in Medicine and Biology, 29, 5S, p. S20, 2003.

Wear KA. Relationship between ultrasonic backscatter and trabecular thickness in human calcaneus: theory and experiment. SPIE Medical Imaging Conference, San Diego, CA, February 19, 2003.

Wear KA, Garra BS , Pinet MC , Felker S , Mai J. Measurements of ultrasonic backscattered spectral centroid shift from spine in vivo – methodology & preliminary results. SPIE Medical Imaging Conference, San Diego, CA, February 19, 2003.

Weber R., Waynant R, Ilev I, Key T, Norman P. Earth oxide: aluminum oxide for mid-range infrared devices. Photonics West–BiOS 2003 International Conference, San Jose, CA, January 25-31, 2003.

Weininger S. Design for quality. Drexel University, Department of Biomedical Engineering, Philadelphia, PA, February 24, 2003.

Weininger S. Integrating the product development process with regulatory requirements and 2. simulator requirements for pulse oximeters. The Fitzpatrick Center, The Pratt School of Engineering, Duke University, Durham, NC, February 25, 2003.

Weininger S. Systems engineering and software development for the NIH fetal saturation (FOX) trial. IEEE 29th Annual Northeast Bioengineering Conference proceedings, March 22, 2003.

Weininger S. Overview of FDA requirements and points to consider during prototype development. Drexel University, Department of Biomedical Engineering, Philadelphia, PA, May 9, 2003.

Woods T, Brown S, McNamee S, Merritt K, Lucas A, Hitchins V. The effects of loading and repeated ethylene oxide sterilization on the mechanical strength of opened but not used (OBNU) synthetic absorbable sutures. FDA Science Forum, Washington, DC, April 2003.

Wray-Cahen D, Pritchard WF, Hilbert SL, Ashby AE, Elsasser T, Vossoughi J, Abii PO, Karanian JW. The coronary artery histopathologic response to angioplasty balloon injury in a swine model is gender- and hormone-dependent. Endocrine Society Meeting, Philadelphia, PA, June 2003.

Yamaguchi Y, Tadokoro T, Beer JZ, Zmudzka BZ, Miller SA, Hearing VJ. Effects of UV on melanocytes in human skin of various phototypes. 31st Annual Meeting of the American Society for Photobiology, Baltimore, MD, July 5-9, 2003.

Zmudzka BZ, Beer JZ, Bushar HF, Coelho SG, Hearing VJ, Miller SA, Tadokoro T, Yamaguchi,Y. Constitutive melanin, MED, and UV-induced DNA damage in different racial/ethnic groups. 31st Annual Meeting of the American Society for Photobiology, Baltimore MD, July 5-9, 2003.