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Appendix C Biographical Sketches of Committee Members Brigadier General Rhonda Cornum, Ph.D., M.D. (Chair), retired from the U.S. Army and joined TechWerks as the director of health strategy in 2012. Although TechWerks is a software develop- ment and psychological fitness training company, Dr. Cornum started her career as a biochemist for the Army, doing preclinical work on wound healing agents and blood preservation and amplifica- tion. After later earning an M.D., and while engaged in a urology residency, she continued research interests and tested liquid and lyophilized fibrin products as both hemostatic and local drug delivery vehicles in rabbits, pigs, and dogs. As a staff member and later the commander of several military medical centers, she has served as the director of clinical investigation and on multiple institu- tional animal care and use committees. More recently, Dr. Cornum served from 2009 to 2012 as the first director of the U.S. Armyâs novel Comprehensive Soldier Fitness initiative. This strategy represents the model for universal implementation of physical and psychological health promotion within the U.S. Department of Defense. She previously served as the assistant surgeon general for force projection, responsible for the policies and procedures to prepare soldiers and units for deployment, and she commanded the Landstuhl Regional Medical Center, the evacuation hub for Iraq, Afghanistan, Africa, and Europe. During this assignment she commissioned development of the Joint Patient Tracking Application and pioneered the use of the Nova Lung during critical care air transport. Dr. Cornum has written or co-authored one book, seven book chapters, and numer- ous scientific articles. She is a professor of military and emergency medicine at the Uniformed Services University of the Health Sciences. She is board certified in urology, is a fellow in both the American College of Surgeons and the Aerospace Medical Association, and is a member of the American Society of Nutrition. Her decorations include the Distinguished Service Medal, Legion of Merit (with two oak leaf clusters), Distinguished Flying Cross, Bronze Star, Meritorious Service Medal, Purple Heart, Air Medal, and Prisoner of War Medal. She holds a Ph.D. in biochemistry and nutrition from Cornell University and an M.D. from the Uniformed Services University of the Health Sciences in Bethesda, Maryland. 149
150 NECESSITY, USE, AND CARE OF LABORATORY DOGS AT THE VA W. Ron DeHaven, D.V.M., M.B.A. (Vice Chair), has an extensive background in the veterinary profession, including 9 years as the chief executive officer of the American Veterinary Medicine Association (AVMA). At AVMA, he served more than 88,000 members and worked to meet the challenges of improving human and animal health. Mr. DeHaven also worked with the U.S. Depart- ment of Agricultureâs (USDAâs) Animal and Plant Health Inspection Services (APHIS) for nearly three decades, finishing his career there as the administrator, the agencyâs top position. At the USDA APHIS he focused on protecting U.S. agriculture and natural resources from exotic pests and diseases, handling wildlife management activities, and overseeing the Animal Welfare Act. Mr. DeHavenâs work with the USDA APHIS, where he also served as the chief veterinary officer for animal health for the United States, gained him national prominence in 2003 and 2004 when bovine spongiform encephalopathy (mad cow disease) and H5N1 avian influenza were making national headlines. His public service earned him many awards, including two Presidential Rank Awards for his leadership in government, two USDA Secretaryâs Honor Awards, and AVMAâs Meritorious Ser- vice Award. He received his D.V.M. in 1975 from Purdue University and was awarded an honorary doctor of science degree from Purdue University in 2005. After leaving AVMA, Mr. DeHaven cre- ated a veterinary consulting business with clients in academia, government, and the private sector. Donna K. Arnett, Ph.D., M.S.P.H., B.S.N., is the dean of the University of Kentucky (UK) College of Public Health and the Norton Healthcare professor in the Department of Epidemiology. Prior to her appointment at UK in 2016, Dr. Arnett was the associate dean and the chair of the Department of Epidemiology at the University of Alabama at Birmingham. With 25 years of continuous funding from the National Institutes of Health (NIH), Dr. Arnett studies the genetic architecture of cardiovascular disease and its risk factors. A past president of the American Heart Association (AHA), she has led AHAâs research committee and scientific publishing committee. Dr. Arnett is also an elected fellow of AHA, the American College of Epidemiology, and the American Epidemiological Society. She has more than 25 years of experience leading the recruitment and scientific oversight of large, multi-site cardiovascular cohort studies, including the NIH-sponsored clinical studies âThe Hypertension Genetic Epidemiology Network (HyperGEN)â and âThe Genetics of Lipid Lowering and Diet Network.â Dr. Arnett has published more than 650 peer- reviewed papers and 2 books. In 2017 she received the Population Research Prize from AHA. She holds a B.S. in nursing and an M.S.P.H. in biostatistics and epidemiology from the University of South Florida and a Ph.D. in epidemiology from the University of North Carolina at Chapel Hill. Warren Casey, Ph.D., DABT, is the acting chief of the U.S. National Toxicology Programâs (NTPâs) Biomolecular Screening Branch at the National Institute of Environmental Health Sciences (NIEHS) and the executive director of the U.S. Interagency Coordinating Committee on the Vali- dation of Alternative Methods, serving previously as the director of NTPâs Interagency Center for the Evaluation of Alternative Toxicological Methods. These groups work together to facilitate the development, validation, regulatory acceptance, and industry adoption of non-animal test methods. Prior to joining NIEHS Dr. Casey worked at GlaxoSmithKline for 15 years in a variety of roles, including manager of pharmaceutical microbiology, head of in vitro biomarker development, and manager of discovery and investigative toxicology. Dr. Casey received his undergraduate degree in biochemistry and his Ph.D. in microbiology from North Carolina State University, where he also holds an adjunct professorship and has been named a distinguished alumnus in both the Depart- ment of Microbiology and the College of Agriculture and Life Sciences. He has been a diplomate of the American Board of Toxicology since 2007, co-chairs the OECD Validation Management GroupâNon-Animal (2015âpresent), received the 2016 Society of Toxicology (SOT) Animal Wel- fare Award, and is past president of the SOT In Vitro and Alternative Methods specialty section. Dr. Casey served as a captain in the U.S. Army and Army National Guard during the Gulf War
APPENDIX C 151 and was awarded the National Defense Service Medal, the Southwest Asia Service Medal, and the Kuwait Liberation Medal. Chris Green, J.D., is the executive director of Harvard Law Schoolâs Animal Law & Policy Program. He is a graduate of the Harvard Law School and the University of Illinois, where he created the schoolâs first environmental science degree. Mr. Green is a former chair of the American Bar Associationâs TIPS Animal Law Committee and previously was the director of legislative affairs for the Animal Legal Defense Fund. Mr. Green currently serves on the executive board of the National Sheriffsâ Associationâs Coalition on Violence Against Animals, previously served on the board of the National Center for Animal Law, was an advisor to the National Canine Research Council, and is a member of both the American Veterinary Medical Law Association and the Illinois Farm Bureau. Mr. Green was a member of the California Veterinary Medical Associationâs Non- Economic Recovery Task Force, helping explore legislative options to balance the professionâs increasing liability exposure with a more equitable assessment of companion animal value. He later acted as an advisor to members of the American Veterinary Medical Associationâs Task Force on the Legal Status of Animals, addressing those same legislative issues at a national level. Mr. Green served on the National Academies committee that organized the Workshop on Future Directions for Laboratory Animal Law in the United States (2017â2018) and co-hosted the event at the Harvard Law School. Mr. Green has consulted on animal legal issues for CNN, CBS News, NBC News, Headline News, Politico, The Atlantic, Bloomberg News, Harperâs, Huffington Post, Science magazine, Smart Money magazine, The New York Times, Chicago Tribune, San Francisco Chronicle, The Wall Street Journal, and The Washington Post. He also has spent the past 20 years managing an Illinois farm that has remained in his family for 180 consecutive years. Joan C. Hendricks, V.M.D., Ph.D., served on the faculty of the University of Pennsylvania School of Veterinary Medicine for more than 20 years. Her research focused on sleep biology. She con- ducted National Institutes of Health (NIH)-supported biomedical studies in animals from cats to English bulldogs to fruitflies, from 1980 until becoming dean. In 2001 she was named the Henry and Corinne R. Bower Professor of Small Animal Medicine, the first woman to be named to an endowed professorship at the school. Dr. Hendricks also served as the chief of critical care in the Department of Clinical Studies at Philadelphia, she was the founding director of the Veterinary Clinical Investigation Center at the school, and she held a secondary appointment as professor in the Department of Medicine at Penn Medicine. She is a recognized expert in the field of sleep and sleep disorders and has, for decades, studied the physiology and anatomy of sleep and an animal model of sleep apnea (the English bulldog). She later switched to using Drosophila as a model to study sleep and sleep disorders. From 2006 to 2018 Dr. Hendricks was the Gilbert S. Kahn Dean of Veterinary Medicine at the School of Veterinary Medicine. In this capacity, she oversaw all research conducted in the school and in collaborations across Penn. Penn Vet has the largest portfolio of individual NIH-supported grants of any veterinary school in the United States. Dr. Hendricks has a B.S. in biology and psychology from Yale University and a V.M.D. and a Ph.D. from the University of Pennsylvania. Dr. Hendricks retired in August 2019. As the daughter of a career Army officer, Dr. Hendricks has a personal interest in the health and well-being of veterans. Jonathan Kimmelman, Ph.D., is the James McGill Professor and the director of the Biomedical Ethics Unit/Social Studies of Medicine at McGill University. He has cross appointments in experimental medicine, epidemiology, biostatistics and occupational health, and human genetics. Dr. Kimmelman holds a Ph.D. in molecular biophysics and biochemistry from Yale University, and he joined McGill in 2005. His research group, Studies of Translation, Ethics, and Medicine (STREAM), uses empirical and conceptual research methods to study the ethical, social, and
152 NECESSITY, USE, AND CARE OF LABORATORY DOGS AT THE VA policy dimensions of translational research. He received the Institute of Genetics Maud Menten New Investigator Prize, a Canadian Institutes of Health Research (CIHR) New Investigator Award (2008), and a Friedrich Bessel-Humboldt Award (2014). Dr. Kimmelman chaired the ethics committee of the American Society of Gene and Cell Therapy (2008â2010) and of the International Society of Stem Cell Research (2014â2016). He also served on the CIHR Stem Cell Oversight Committee, currently serves on several data and safety monitoring boards of the U.S. National Institutes of Health, and has been a member of three National Academies committees. His book, Gene Transfer and the Ethics of First-in-Human Trials: Lost in Translation, was published by the Cambridge University Press. In 2018 he was elected as a Hastings Center Fellow. Current projects being pursued in STREAM include the empirical study of prediction in clinical research and the implications of clinical trial portfolios for drug development, human protections, and clinical decision making. Lewis B. Kinter, Ph.D., DABT, Fellow A.T.S., is currently the president and the principal scientist at GLP Scientific Consulting in Unionville, Pennsylvania. He has been engaged in pharmaceuti- cal, biological, and medical device research and development for more than 35 years and is an internationally recognized expert in cardiovascular/renal physiology, pharmacology, toxicology, and nonclinical research and development (R&D). Dr. Kinter received his B.S. in biology at Union College (1973) and his doctorate in medical physiology from Harvard University (1978). From 1981 to 2014 he held positions of increasing responsibility in biomedical R&D with Smith Kline & French, SmithKline Beecham, Sterling Winthrop, Nycomed Amersham, Astra Merck, and Astra- Zeneca. Dr. Kinter is a diplomate of the American Board of Toxicology, a fellow of the Academy of Toxicological Sciences, a professor of pharmacology and toxicology (adjunct) at Michigan State University, and a former professor of physiology (adjunct) at the University of Pennsylvania School of Medicine. He has authored more than 100 research manuscripts and book chapters and organized and participated in numerous courses, workshops, symposia, and professional meetings in basic and applied physiology, pharmacology, toxicology, and nonclinical pharmaceutical R&D. Dr. Kinter currently holds memberships in the American Physiological Society (38 years), the American Society for Pharmacology and Experimental Therapeutics (31 years), the Society of Toxicology (21 years), and the Safety Pharmacology Society (18 years). He is a founder and the former presi- dent of the International Consortium for Innovation and Quality in Pharmaceutical Development, a former chairman of the Pharmaceutical Research and Manufacturersâ Association Preclinical Sciences Leadership Group, and the founder and the former president of the Safety Pharmacology Society. Throughout his career Dr. Kinter has served as research scientist, co-investigator, principal investigator, study director, and department manager or director for authorized in vivo physiologi- cal, pharmacological, and toxicological investigations in vertebrates including fish, mice, rats, rab- bits, ferrets, swine, dogs, and non-human primates (NHPs). He is accomplished in small animal survival surgery and championed the early use of chronically implanted vascular catheters, sensors, and telemetry devices in mice, rats, rabbits, dogs, and NHPs to improve scientific data quality and laboratory efficiency, and to reduce animal use (the Reduction and Refinement objectives in the 3Â Rs). His efforts have been recognized to reduce annual animal use in susceptible applications by 75 percent or more. Dr. Kinter has been an active participant, a member, and a chair of institutional animal care and use committees in several organizations in which he was employed or volunteered. Dr. Kinter continues to serve in leadership capacities on several boards of professional scientific and charitable organizations. Sarah L. Lathrop, D.V.M., Ph.D., is a professor of pathology at the University of New Mexico (UNM) School of Medicine, currently conducting research on infectious diseases and injury. After receiving her B.S. in animal science from Colorado State University, she earned her D.V.M. from
APPENDIX C 153 the University of Minnesota College of Veterinary Medicine. She practiced both small and large animal clinical veterinary medicine in Cortez, Colorado, and then completed a Ph.D. in veterinary preventive medicine at The Ohio State University, focusing on infectious disease research in cattle while also providing veterinary care for gnotobiotic research animals at the Ohio Agricultural Research and Development Center. Dr. Lathrop served a 2-year postdoctoral fellowship at the Centers for Disease Control and Prevention (CDC) as an epidemic intelligence service officer, studying vector-borne infectious diseases such as plague, tularemia, and dengue and the impact of zoonotic diseases. She then conducted vaccine research in cattle, swine, dogs, and cats at Merialâs Athens Clinical Unit in Georgia, focusing on vaccine development and licensure. Dr. Lathrop joined UNM in 2003 to conduct research on infectious diseases and injury, with continuous extramural funding from CDC and, more recently, the U.S. Department of Defense. She also serves as the principal investigator for the Foodborne Diseases Active Surveillance Network portion of New Mexicoâs Emerging Infections Program, managing a staff of 10 researchers. She has served on numerous institutional animal care and use committees, biosafety committees, and scientific review committees for tissue repositories, as well as a reviewer for numerous peer-reviewed journals. Nancy Figler Marks, D.V.M., M.S., DACLAM, is a diplomate of the American College of Labo- ratory Animal Medicine (ACLAM). She serves as the veterinarian and director of the institutional animal care and use committee (IACUC) office at The University of Iowa in Iowa City, Iowa, where she oversees the IACUC office staff and IACUC functions. She serves as a veterinary reviewer for animal protocol submissions and is a voting member of the IACUC. Dr. Marks led the develop- ment of an electronic animal protocol form to improve the review and oversight of animal research proposals. Prior to joining The University of Iowa in 2012, she held various positions of increasing responsibility with Parke Davis Pharmaceutical and Pfizer from 1998 to 2012. She received her D.V.M. from the VirginiaâMaryland Regional College of Veterinary Medicine where she special- ized in government and corporate medicine. Dr. Marks did her postdoctoral training at Parke Davis Pharmaceutical in conjunction with the University of Michigan in Ann Arbor, Michigan. Her areas of expertise include veterinary care of a wide variety of laboratory animal species, extensive knowledge of animal welfare regulations, inspection of animal facilities, and experience evaluating common research procedures. Additionally, Dr. Marks has an M.S. in biology from Texas A&M University. Her primary professional interest is to support compliant research involving animal models while assuring the best possible care and welfare of the animals. She has developed content and lectured in the American Association for Laboratory Animal Science, ACLAM, and the Public Responsibility in Medicine and Research symposia, conferences, courses, and workshops relevant to the role of the IACUC, animal protocol development and review, decreasing regulatory burden while maintaining animal welfare, methods for promoting animal welfare, implementing the 3 Rs, as well as aspects of human safety in the vivarium. Dr. Marks has also authored and co-authored papers related to sea turtle physiology and behavior, protein biochemistry, and various laboratory animal topics. Christian E. Newcomer, V.M.D., M.S., DACLAM, is a 1977 graduate of the School of Veteri- nary Medicine at the University of Pennsylvania. Following 1 year as a research associate/large animal intern at The Pennsylvania State University (1977â1978), he entered postdoctoral train- ing in laboratory animal medicine at the University of Michigan (1978â1981) and became board certified as a diplomate in the American College of Laboratory Animal Medicine (ACLAM) in 1982. During his career he held clinical, academic, and leadership positions in laboratory animal medicine at the Massachusetts Institute of Technology (1981â1987), TuftsâNew England Medi- cal Center and the Tufts University School of Veterinary Medicine (1987â1994), the University of North Carolina at Chapel Hill (1994â2001), the Veterinary Resources Program at the National
154 NECESSITY, USE, AND CARE OF LABORATORY DOGS AT THE VA Institutes of Health (2001â2003), and Johns Hopkins University (2003â2008). In 2008 he joined AAALAC International as its executive director, capping more than 25 years of involvement with that organization as an ad hoc site visitor and member of the Council on Accreditation; he retained the title of executive director emeritus upon retirement in 2016. He is a past-president of ACLAM (1996) and of the American Association for Laboratory Animal Science (2008) and the vice president of the AAALAC International Council on Accreditation (1996â1998). He served as a member of the Institute for Laboratory Animal Researchâs Committee on Occupational Health and Safety in Research Animal Facilities (1993â1996) and the chairman of the Committee on Cost of and Payment for Animal Research Institute for Laboratory Animal Research (1997â2000). He also has authored 26 peer-reviewed articles and 22 book chapters and has spoken extensively on many topics to promote the quality of care for research animal subjects and the discussion of the ethical considerations of their use. William Z. Potter, M.D., Ph.D., earned his B.A., M.S., M.D., and Ph.D. at Indiana University, after which he functioned in positions of increasing responsibility and seniority over the next 25 years at the National Institutes of Health (NIH) with a research focus on translational neuroscience. While at NIH, Dr. Potter was widely published and appointed to many societies, committees, and boards; these roles enabled him to develop a wide reputation as an expert in psychopharmacologi- cal sciences and for championing the development of novel treatments for central nervous system (CNS) disorders. Dr. Potter left NIH in 1996 to accept a position as the executive director for early clinical neuroscience at Lilly Research Labs, and in 2004 he joined Merck Research Labs (MRL) as the vice president of clinical neuroscience, after which he moved to the newly created position of translational neuroscience in 2006, a position from which he retired in January 2011. His experience at Lilly and MRL in identifying, expanding, and developing methods of evaluat- ing CNS effects of compounds in human brain cover state-of-the-art approaches across multiple modalities. These include brain imaging and cerebrospinal fluid proteomics as well as development of more sensitive clinical measures. Dr. Potter continues as an emeritus co-chair of the Neurosci- ence Steering Committee of the Foundation for NIH and served through 2019 as a senior advisor to the director of the National Institute of Mental Health, where he has championed the position that more disciplined hypothesis testing of targets in humans through publicâprivate partnerships is the best near-term approach to moving CNS drug development forward for important neurologic and psychiatric illnesses. David M. Powell, Ph.D., joined the Saint Louis Zoo as the director of research in August 2016. He is responsible for the oversight of behavioral, reproductive, and endocrine research as well as some visitor studies research. Prior to coming to Saint Louis, Dr. Powell was the associate curator of mammals at the Wildlife Conservation Societyâs Bronx Zoo in New York for 12 years, where he developed a strong background in captive mammal management and husbandry. Dr. Powell received his Ph.D. from the University of Maryland for his studies of behavior and reproductive biology in the feral horses on Assateague Island. Dr. Powell did his postdoctoral studies at the Smithsonian Institutionâs National Zoological Park in the Department of Conservation Biology studying giant panda behavior in U.S. and Chinese zoos for 4 years. Dr. Powell also worked at Zoo Atlanta from 1988 to 1993 in various roles, including animal keeper, animal diet technician, and research intern. He is actively involved in the Association of Zoos & Aquariums (AZA) professional activities, including serving on Taxon Advisory Group steering committees, managing breeding programs, and serving on the AZA Animal Welfare and Wildlife Conservation & Management Committee. He currently serves on the Research Review Committee of the Saint Louis Zoo. Previously, he served on the institutional animal care and use committees of Lehman College (2008â2014) and the National Zoo, Rock Creek Campus (2004). Dr. Powellâs research has focused on a number of species and
APPENDIX C 155 topics over the years in zoos and in the field. Topics of study have included dominance in animal societies, reproductive competition, maternal behavior, impacts of environmental enrichment and other husbandry practices on behavior, animal welfare, the characterization of animal personality and personality measurement methods, the affective impact of zoo exhibits on visitors, and studies of animal care staff attitudes about population management practices. Margaret (Mimi) Foster Riley, J.D., is a professor at the University of Virginia (UVA) School of Law, with a secondary appointment at the School of Medicine and a program affiliation with the Batten School of Leadership and Public Policy. She teaches food and drug law, health law, animal law, bioethics, the regulation of clinical research, and public health law. Ms. Riley has written and presented extensively about health care law, biomedical research, genetics, reproductive technologies, stem cell research, animal biotechnology, health disparities, and chronic disease. She is the director of UVAâs Program in Animal Law. She serves as the chair of UVAâs Embryonic Stem Cell Research Oversight Committee and as the legal advisor to the Health Sciences Institutional Review Board. She served on the National Research Council Committee on Revisions to the Common Rule for the Protection of Human Subjects and the National Academies Committee on Controlled Human Exposure Studies at the U.S. Environmental Protection Agency and was a consultant on the National Academies Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse. She has advised numerous committees of the National Academy of Medicine and the Virginia Bar. Before coming to Virginia, Ms. Riley was an associate with Pepper Hamilton & Scheetz in Philadelphia, where she worked primarily in complex securities, commercial and mass tort litigation. Prior to that position, she was a litigation associate with Rogers & Wells in New York. Ms. Riley received her law degree from Columbia University and her bachelor of arts from Duke University. Rodney A. White, M.D., is the director of vascular surgery services at the Long Beach MemorialCare Heart & Vascular Institute in Long Beach, California and, prior to that, was the chief of vascular surgery at the HarborâUniversity of California, Los Angeles (UCLA), Medical Center in Torrance, California. His academic appointment is emeritus professor of surgery at the UCLA School of Medicine. He is certified by the American Board of Surgery with special qualifications in general vascular surgery and by the American Board of Laser Surgery. He also has a permit as a fluoroscopy supervisor and operator from the State of California and is a registered vascular technologist certified by the American Registry of Diagnostic Medical Sonographers. Dr. Whiteâs research interests include the development and evaluation of artificial implant materials and laboratory and clinical investigation of fundamental problems and new procedures in vascular surgery. He is co-inventor of a process for fabricating microporous biomaterials, including an artificial bone substitute that was recently awarded the first annual U.S. Congressional Golden Goose Award for federally funded research that has led to significant patient care and economic benefit. Current research programs involve the development and evaluation of endovascular surgical devices including atherectomy devices, stents, abdominal and thoracic endoluminal prostheses, and angioscopy and intraluminal ultrasound imaging technologies. Dr. White is the recipient of research grants from the National Institutes of Health, the American Heart Association, and numerous national clinical studies. Dr. White is the author of more than 300 papers and 200 book chapters and is the co-author or editor of 12 books addressing a broad spectrum of topics in vascular and endovascular surgery. He is the co-editor of the Journal of Endovascular Therapy. He is a member of several industrial and governmental panels evaluating new medical technologies. He is the past vice-chairman of the board of directors of the Los Angeles Biomedical Research Institute at HarborâUCLA Medical Center. Dr. White is an active member of 15 regional, national, and international societies and is the past-president of the International Society for Endovascular Specialists and the past secretary of the Society for Vascular Surgery.