Presenters:
The eConference will be co-presented by experts from FDA/CDRH/OIVD.

Sousan S. Altaie, Ph.D. Scientific Policy Advisor Office of In Vitro Diagnostics CDRH/FDA, Dr. Altaie received her Ph.D. in Clinical Microbiology and Immunology from the University of North Texas in Denton in 1989. After completing a two-year Fellowship in Medical Microbiology at the Medical College of Virginia in Richmond, she joined the Department of Pediatrics, Division of Infectious Diseases at the State University of New York as an Assistant Professor, and also was appointed Director of Bacteriology and Serology Laboratories at the Children’s Hospital of Buffalo. In 1995 she joined the Food and Drug Administration in the Center for Drug Evaluation and Research in the Division of Anti-infective Drug Products as a primary reviewer. Six years later she joined the FDA’s Center for Devices and Radiological Health as the Chief of Immunology and Molecular Diagnostics Branch. Recently Dr. Altaie became the Scientific Policy Advisor for the Office of In Vitro Diagnostic Devices and is actively working as a member of the Global Harmonization Task Force (GHTF) and International Standards Organization (ISO) working groups. She was appointed the CDRH Critical Path Coordinator in 2004 and is actively involved in the Agency’s Critical Path initiative.

Reena Philip, Ph.D. Scientific Reviewer, Office of In Vitro Diagnostics CDRH/FDA. Reena Philip, PhD, has been employed by FDA’s Office of In Vitro Diagnostics Evaluation and Safety (OIVD) in the Division of Immunology and Hematology Device evaluation (DIHD) since September 2004. She received her PhD in molecular biology from University of Illinois at Urbana-Champaign in 1997, followed by post doctoral training. Prior to joining OIVD, she spent three years in biotechnology sector. At OIVD, she is an active member of the ‘Omics’ working group, serves as a scientific reviewer on Immunology, Genetics, Genomics In Vitro Devices (IVD) and participates in drafting guidances. She is the author of many peer reviewed articles.

Elizabeth Mansfield, PhD. Dr. Mansfield is a Science Policy Analyst in the Office of In Vitro Diagnostic Devices at the Center for Devices and Radiological Health, FDA. She received a BA from the University of Pennsylvania in 1986, and a PhD from the Johns Hopkins University in 1993. Prior to her current tenure at OIVD, she was the Director of Regulatory Affairs at Affymetrix, Inc. Dr. Mansfield was previously a scientific reviewer in OIVD, and held postdoctoral fellowships at NCI and NIAMS in the National Institutes of Health.

Kristen Meier, PhD. Dr. Meier is a Mathematical Statistician at the US Food and Drug Administration, Center for Devices and Radiological Health, Division of Biostatistics in Rockville, MD, where she reviews in vitro and in vivo diagnostic device submissions and contributes to FDA statistical guidance development. She received her Ph.D. in statistics from North Carolina State University in Raleigh, NC in 1990. Before coming to FDA in 1995, she worked as a staff fellow in statistics at the National Institute of Environmental Health Sciences, NIH and then as a mathematical statistician for the USDA Food Safety and Inspection Service, where she first became interested in the area of diagnostic tests. Dr. Meier is an active participant in Clinical Laboratory Standards Institute (CLSI) standards development and has served as a member of CLSI’s Area Committee for Evaluation Protocols and various subcommittees.

Sally A Hojvat, MSc., Ph.D. Dr. Hojvat currently holds the position of Director of the Division of Microbiology Devices, in the Office of In Vitro Diagnostic Device Evaluation and Safety, at CDRH/FDA. Prior to joining the FDA in 2003, Dr. Hojvat’s experience included 18 years in the IVD industry, holding management positions in product development, quality control and clinical research. Dr. Hojvat received her B.Sc. from the University of Wales, UK, a M.Sc. in Microbiology from the University of Alberta, Canada, and a Ph.D. in Biochemistry from Loyola University Medical School, Chicago. She also completed post doctoral training fellowships in Clinical Chemistry from Loyola Medical School and in Pharmacology from the University of Chicago. Her academic research publications are concentrated in the fields of Microbiology, Pharmacology and Neuroendocrinology.

Arleen Pinkos, M.T. (ASCP). Ms. Pinkos, a native of Pittsburgh, Pennsylvania, has worked at the Food and Drug Administration since 1993. As a Scientific Reviewer in the Office of In Vitro Diagnostic Device Evaluation and Safety, she has worked with a broad range of medical devices and innovative technologies, including those that noninvasively predict blood glucose concentrations. She is Chair of the Interagency Artificial Pancreas Working Group, a multi-disciplined group of scientists from the FDA and the National Institutes of Health who are collaborating with stakeholders to accelerate the availability of an artificial pancreas. She is also the co-chair of an artificial pancreas working group within the Center for Devices and Radiological Health. She recently received FDA’s Scientific Achievement Award for her work in these initiatives. Ms. Pinkos has written peer review articles on the artificial pancreas, point of care testing, and evidence based medicine. Prior to her work at the FDA she received a Bachelor of Science in Medical Technology from Indiana University of Pennsylvania. Ms. Pinkos held clinical laboratory positions at Veterans Administration Medical Centers in New Jersey and Maryland, where she was instrumental in developing the first mobile laboratory which later received a patent. She has also consulted for physician office laboratories, and managed a private physician referral service.

Date, time, registration: The 150-minute event will be presented on February 19, 2008, at 11:00 am Central Time. The registration fee is $595 per computer connection. Event materials will be distributed the day before the eConference for photocopying. Each attendee will receive 0.25 CEU. To register go to http://clinicaldevice.webex.com.