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Fredric Abramson has been working for forty years in business, computer software development, management, bioscience, health care, and education. Abramson developed and implemented the first decision support computer system for health care in the early 1970s to control and reduce hospital-acquired infections. He founded a health and fitness center, the Association for Medical Emergency Informatics, Inc., United Software Associates, Inc. to bring innovative computer software to the American market from Europe, and the Fit America Research Center, to conduct research on weight loss.
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Thomas Colonna, PhD, JD has a broad educational background with a BS (Microbiology) from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a PhD (Molecular Biology) from the Johns Hopkins University, and a JD from the Georgetown University Law Center. He has published extensively in several areas and has extensive regulatory affairs experience. In addition to his consulting practice, Dr. Colonna is a lecturer in the Biotechnology and Bioscience Regulatory Affairs programs at the Johns Hopkins University.
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Alison Demarest is a principal at Meridian BioGroup LLC, a compliance and validation services provider to the Maryland biopharm community. Ms. Demarest co-founded Meridian in March 2007, bringing GMP, GLP, project management, and client service expertise. She has more than 20 years of experience in biotechnology and FDA-regulated industries, in both consulting and operating companies. Ms. Demarest has been director of Quality and Regulatory Affairs at BioReliance Invitrogen Bioservices, regulatory compliance director for AMEC Biopharmaceuticals (formerly Phoenix Imperative), and QA director for Bio Science Contract Production Corp. (now Lonza). She has managed compliance services on wide range of projects and conducted more than 50 audits domestically and overseas. Since 2002, she has taught at Johns Hopkins in the Biotech and Regulatory Affairs programs and she has lectured on compliance topics at ASME and ISPE conferences, NCARSQA and SIM meetings, Hood College, the University of Maryland, and Montgomery College. Ms. Demarest holds masters degrees in science and in business administration.
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Evan DeRenzo is a bioethicist with the Center for Ethics at the Washington Hospital Center, MedStar Health, Washington, D.C. Dr. DeRenzo received her Ph.D. from the University of Maryland in Human Development/Gerontology and was the first Senior Staff Fellow in bioethics at the National Institutes of Health (NIH). She is adjunct faculty in the AAP in Biotechnology at The Johns Hopkins University and serves/has served on numerous Institutional Review Boards (IRBs), Data Safety and Monitoring Boards, and hospital ethics committees.
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Thomas Koval received a B.S. in Biology from The Pennsylvania State University and a Ph.D. in Cell and Molecular Biology/Radiation Biology from The Ohio State University. He completed a postdoctoral fellowship in Physiology and Biophysics/ Bioengineering at the University of Illinois at Urbana-Champaign. Dr. Koval has held faculty positions at Hahnemann Medical College in Philadelphia, PA, the George Washington University School of Medicine and Health Sciences in Washington, DC, and Mayo Medical School/Mayo Graduate School in Rochester, MN. He has published extensively in cell and molecular biology, especially in the areas of cellular radiation damage/repair, stress-inducible cellular processes, and insect cell culture. Dr. Koval began teaching in the AAP Biotechnology Program in 2002 and currently teaches Advanced Cell Biology I and Radiation Biology and oversees the Independent Research Project course.
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David Landsman is the Chief of the Computational Biology Branch for the National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health. He received his Ph.D. in Biochemistry from the University of Cape Town, South Africa, and has since become an international leader in the field now known as bioinformatics: the management, analysis, and advance of extensive biological and genetics information with computer databasing and modeling technologies.
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Ning Li , M.D., PH.D, is currently a Team Leader, Branch of Cardiovascular and ophthalmology, Office of Surveillance and Biostatistics, US Food and Drug Administration. Prior to his current assignment, Dr Li was a senior reviewer and acting Team Leader in the Center for Drug Evaluation’s Division of Biometrics I/Division of Oncology Drug Products and Division of Scientific Investigation. Dr Li is a quantitative scientist with over 10 years of regulatory experiences in medical product development and expertise in regulatory review of clinical trial design, data analysis, overall risk/benefit assessment and postmarketing safety surveillance. He reviewed/peer reviewed over 50 NDA/BLA/PMAs and 400+ IND/IDEs during his tenure at the FDA. He had experience in drafting/implementing FDA guidance/process for variety of products and has unique international regulatory experiences in educating/training of regulatory scientists in the Asian Pacific region. Dr Li is a graduate of Shanghai Medical College (M.D., 1984), University of Iowa (M.S., Ph.D in Preventive Medicine, 1992, 1994), He received Merck MD/PhD Fellowship in 1992 and before he joined the FDA, he worked at the University of Iowa, Dept of Internal Medicine’s Division of Clinical Epidemiology and Westat Health Study Sector on anti-sepsis and anti-AIDS clinical trials during 1992-1997. A faculty member in Shanghai Medical University from 1984-1987. |
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Lisa Selbie is the Assistant Project Coordinator of the Australian Biotechnology Initiative for the Master of Science in Biotechnology, Johns Hopkins Advanced Academic Program. Dr. Selbie has worked for many years in medical research after receiving her PhD in Biochemistry, Molecular Biology and Cell Biology from Northwestern University in Evanston, Illinois.
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Karen Wells received her B.S. in Biochemistry in 1989 from the University of Illinois in Urbana-Champaign. After working for a short time for Union Carbide Corporation (now part of Dow Chemical), and then instructing Biology and Chemistry classes at Illinois Central College, she entered a graduate school program in the Biological Sciences Division at Emory University in 1991. She earned her Ph.D. in Physiology and Pharmacology from Emory University in 1997, and then completed a post-doctoral fellowship in the Department of Physiology at Johns Hopkins Medical Institute in 2000. Since 1999, Karen has taught and continues to teach numerous courses for the Advanced Academic Program in Biotechnology at Johns Hopkins University. Through 2003, while still living in Baltimore, Karen taught a mixture of on-site and online courses, including Biochemistry, Advanced Cell Biology I, Advanced Cell Biology II, and Neurobiology. Since relocating to Athens, Georgia in the Summer of 2003, Karen continues to teach exclusively online, with the same mixture of courses as well as a relatively new "Current Topics in Molecular & Cellular Biology" course.
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