Public Workshop on the Uses of Dogs in Biomedical Research

A workshop was held on Wednesday, March 27 and Thursday, March 28, 2019 at the National Academies Keck Center Building in Washington, DC. The workshop was an open session where members of the public were welcome to attend in person or watch via live webcast.

The public session included time for interested parties to give short public statements for the committee’s consideration in person. Input can also be submitted in writing through the study website. All written materials submitted to the committee will be included in the Public Access File created for the Committee and may be quoted in whole or in part in the Committee’s report with attribution.

Agenda
March 27-28, 2019
National Academies Keck Center Building
500 5th St. NW Washington, DC 20001

Wednesday, March 27, 2019
8:00 am Welcome, Introductions, Process for Open Session
– Rhonda Cornum, Committee Chair, Techwerks and US Army (Retired)
Video
Panel on Comparative Modeling in Cardiovascular Research
Cardiovascular research is a key priority for the VA and one of the areas in which dogs serve as models of disease. This panel will examine various approaches to modeling diseases of the heart for research and translational purposes.
8:10 am Panel Introduction
– Donna K. Arnett, Committee Member, University of Kentucky
Video
8:15 am Modeling Cardiovascular Disease Using Canine Models 
– Rodney A. White, Committee Member, Long Beach MemorialCare Heart & Vascular Institute
Bio | Video | Slides

Rodney A. White M.D., is Director, Vascular Surgery Services at Long Beach MemorialCare Heart & Vascular Institute, Long Beach, California and prior Chief of Vascular Surgery at Harbor-UCLA Medical Center, Torrance, California. His academic appointment is Emeritus Professor of Surgery, 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 (RVT) certified by the American Registry of Diagnostic Medical Sonographers (ARDMS). Dr. White’s 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 US 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 co-author or editor of twelve books addressing a broad spectrum of topics in vascular and endovascular surgery. He is Co-Editor of the Journal of Endovascular Therapy (JEVT). He is a member of several industrial and governmental panels evaluating new medical technologies. He is past Vice-Chairman of the Board of Directors of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. Dr. White is an active member of 15 regional, national and international societies and is past-President of the International Society for Endovascular Specialists, and past Secretary of the Society for Vascular Surgery.

8:35 am Translational Approaches in Cardiovascular Disease Research Using Rodent Models 
– David Harrison, Vanderbilt University Medical Center
BioVideo | Slides

Dr. Harrison is the Betty and Jack Bailey Professor of Medicine and Pharmacology and the Director of Clinical Pharmacology at Vanderbilt University School of Medicine. He received his MD degree from the University of Oklahoma in 1974 and obtained his house staff and clinical cardiology training at Duke University. From 1980 to 1982, he completed a cardiovascular research fellowship at the University of Iowa. In 1982, he joined the faculty at the University of Iowa, and was promoted to the rank of Associate Professor in 1987. In 1990, he moved to the Cardiology Division at Emory University, where he was appointed Professor of Medicine. In the 1980s and 1990s, Dr. Harrison has served as the Director of Cardiology at both the Iowa City and Atlanta VA hospitals and was the Director of Cardiology at Emory from 2000 to 2009. In 2011, he was named the Director of Clinical Pharmacology at Vanderbilt University. Dr. Harrison has been an Established Investigator of the American Heart Association and has served on numerous committees for the AHA, including the AHA Scientific Sessions Planning Committee, the AHA Research Committee, the Novartis Award committee and the Credentialing committee for the Council on Circulation, which he chaired. He also served as the Chairman of the AHA Council on Circulation. In 1992, he was elected to the American Society of Clinical Investigation and in 2002 to the Association of American Physicians. Dr. Harrison has served as the Chairman of the National Institutes of Health Experimental Cardiovascular Studies Study Section (ECS). Dr Harrison has served on the editorial boards of multiple journals, including Cardiovascular Research, Circulation, Circulation Research, Atherosclerosis Thrombosis and Vascular Biology, the Journal of Clinical Investigation and Hypertension. In 2002, Dr. Harrison received the Robert M. Berne Award from the Cardiovascular Section of the American Physiological Society. In 2004, Dr. Harrison received the Novartis Award from the American Heart Association Council on High Blood Pressure, which is the highest award given for hypertension research. In 2010, he received the Carl Wiggers Award for Cardiovascular Physiology from the Amercian Physiological Society. In 2010, he was named a Distinguished Scientist of the American Heart Association. In 2012, he received the Distinguished Scientist Award from the American Society of Hypertension and was named a Fellow of the American Association for the Advancement of Science. In 2018, he received the Basic Research Science Award for “lasting contributions that changed the direction of research in hypertension and its complications. His career has been devoted to basic research related to vascular function and hypertension. He work has been seminal in understanding how vascular cells produce reactive oxygen species (ROS) and the consequences of these in diseases such as hypertension and atherosclerosis. He and his colleagues have defined roles of the NADPH oxidases in hypertension, and have shown that these enzymes produce radicals that promote inflammation, vasoconstriction and hypertension. His work has also shown that reactive oxygen species produced by the NADPH oxidases lead to activation of other sources of ROS, leading to a feed-forward amplification of oxidant injury. His recent research has focused on the role of inflammation and immunity in hypertension. His research team has shown that T cells derived cytokines affect renal sodium and volume handling and that this is crucial for development of hypertension. He and his colleagues have discovered a novel role of isoketal-adducted proteins acting as neoantigens in hypertension. Dr. Harrison has also been actively involved in Medical and Scientific Education throughout his career. He has had over 50 post-doctoral fellows train in his laboratory, and many of these have developed their own successful research careers.

8:55 am Modeling Cardiovascular Disease Using Swine Models
– Daniel D. Myers, University of Michigan
Bio | Video | Slides

Dr. Daniel Myers received his DVM degree from Tuskegee University in May 1997, and completed his comparative medicine training in 2001 at the University of Michigan. Dr. Myers received his Masters of Public Health in hospital and molecular epidemiology in 2003 from the University of Michigan. He is a Diplomat of The American College of Laboratory Animal Medicine. Dr. Myers has a joint appointment with the Department of Surgery and the Unit of Laboratory Animal Medicine. Currently Dr. Myers is Director of the Conrad Jobst Vascular Research Laboratories, University of Michigan and is nationally recognized for his expertise in translational animal model development.

9:15 am Break
9:25 am Using Human Hearts to Study Arrhythmogenesis 
– Igor Efimov, The George Washington University
Bio | Video | Slides

Professor Efimov is an inaugural chairman of Biomedical Engineering Department at the George Washington University, which he joined in 2015. He is also the Director of Cardiovascular Engineering Laboratory, an NIH-funded cardiovascular research and engineering laboratory, which focusses of the physiological mechanisms of cardiovascular disease and on development of novel therapies for heart diseases with emphasis on heart rhythm disorders. In 2008, Dr. Efimov founded Cardialen to develop low energy electrotherapy, with a primary focus on atrial fibrillation. In August 2018, Cardialen raised $16M Series B funding. Dr. Efimov earned his M.Sc. and PhD from Moscow Institute of Physics and Technology in 1986 and 1992, respectively, and completed his postdoctoral training at the University of Pittsburgh (1992-1994). He served on the faculty of the Cleveland Clinic Foundation (1994-2000) and Case Western Reserve University (2000-2004) in Cleveland, OH, and Washington University in St. Louis, MO (2004-2015), prior to joining the George Washington University in 2015 as the founding chairman of its new BME Department. Dr. Efimov is Fellow of the National Academy of Inventors, the American Institute for Medical & Biological Engineering, the Heart Rhythm Society and the American Heart Association. He has received numerous awards including: RASA George Gamow Prize, Astor Visiting Fellowship at University of Oxford, Washington University Chancellor’s Hartwell Prize for Innovative Research, The Doris J.W. Escher Lectureship at Montefiore Medical Center of the Albert Einstein College of Medicine, Walter Lillehei Lectureship at University of Minnesota, Richard B. and Lynne V. Cheney Lectureship at the George Washington University, etc. Dr. Efimov held visiting or adjunct professorships at the University of Bordeaux, France; University of Nizhny Novgorod, Russia; and Moscow Institute of Physics and Technology, Russia. He has served as Associate Editor of the American Journal of Physiology: Heart and Circulatory Physiology and IEEE Transactions in Biomedical Engineering. He has served on editorial boards of Circulation Research, Heart Rhythm Journal, Journal of Cardiovascular Electrophysiology, Journal of Molecular and Cellular Cardiology, and other premier cardiovascular and biomedical engineering professional journals. He has served as a chartered member of National Institutes of Health Electrical Signaling, Transporters and Arrhythmia (ESTA) Study Section and NHLBI Systems Biology Collaborations review group. He served on numerous expert panels of the World Bank, Canadian Academies, British Heart Foundation, Russian Ministry of Science and Education, the Royal Society of New Zeeland, Swiss National Science Foundation, National Sciences and Engineering Research Council of Canada, and other international funds and organizations.

9:45 am CiPA: Evaluating Risk Using Mechanistic Electrophysiologic Understanding of Proarrhythmia
– Alexandre Ribeiro, U.S. Food and Drug Administration
Bio | Video | Slides

Alexandre Ribeiro is a researcher in the Division of Applied Regulatory Science of the FDA since January 2017 and he supervises the FDA Integrated Cellular Systems Laboratory, where research is developed on evaluating and using physiological and human in vitro cellular systems for drug development. Alexandre Ribeiro received a PhD degree in Biomedical Engineering from Carnegie Mellon University in 2010, where he researched the mechanics of the nucleus of adult stem cells and cancer cells. He then became a postdoctoral fellow in the Stanford Microsystems Laboratory at Stanford University – Pruitt Lab – to develop microfabricated devices that engineer biological properties of mammalian cells and analyze cell mechanobiology. Dr. Ribeiro later joined the Srivastava Lab at the Gladstone Institute of Cardiovascular Disease in 2013 to study stem cell-derived heart muscle cells (cardiomyocytes) with engineered physiological microsystems and he leveraged novel tools to mature and functionally analyze stem cell derived cardiomyocytes. At the FDA, Dr. Ribeiro has been continuing his research in stem cell derived cardiomyocytes and is also evaluating microphysiological systems as drug development tools.

10:05 am Cardiovascular Research in Humans: The Clinician’s Perspective
– Scott A. Bernstein, NYU Langone Health
Bio | Video | Slides

Scott Bernstein is an Assistant Professor of Medicine in the Leon H. Charney Department of Cardiology at NYU School of Medicine in New York, NY. A native Texan, Dr. Bernstein attended Texas A&M University where he earned a Bachelor of Science degree in Biomedical Engineering in 1995, and then an M.D. at UT Southwestern School of Medicine in Dallas, TX in 1999. He completed Residency in Internal Medicine at UT Southwestern in 2002. During residency Dr. Bernstein became interested in Clinical Cardiac Electrophysiology (CCEP), the sub-specialty of Cardiology which deals with the diagnosis and treatment of all manner of cardiac arrhythmia disorders. Feeling that CCEP would be a natural fit with his engineering background he started fellowship in Cardiovascular Disease in 2002, completing this at New York University in 2005. From 2004-2006 he focused on basic and translational cardiac electrophysiology research, working with mentors Gregory Morley, PhD and Glenn Fishman, MD at NYU. He was then a CCEP fellow from 2006-2008, where has been on the NYU faculty since completing fellowship. He is a board-certified Clinical Cardiac Electrophysiologist (CCEP) and Site Director of the NYU CCEP Fellowship Training Program at the Manhattan VA Medical Center. He currently performs a high volume of invasive electrophysiology procedures at three hospitals representing a very broad cross section of patients: NYU Langone Health, Bellevue Hospital (the flagship hospital of New York City Health & Hospital Corp), and the Manhattan VA Medical Center. His clinical practice is focused on high-complexity cardiac ablation procedures and advanced cardiac rhythm device lead management. Throughout his career, Dr. Bernstein’s area of research interest has been translational research, including development of new catheter ablation technologies, ablation techniques, biophysics of ablation, modulation of the autonomic nervous system for the treatment of atrial fibrillation, and animal models of cardiac arrhythmias and arrhythmia substrate. Dr. Bernstein has published numerous manuscripts in peer-reviewed journals concerning a broad area of translational and clinical topics in Cardiac Electrophysiology, such as novel ablation techniques, atrial fibrillation, biophysics of ablation, and cardiac rhythm device therapies. During his research fellowship Dr. Bernstein utilized a technique called optical voltage mapping in animal models common cardiac arrhythmia in humans, such as ventricular tachycardia (VT) and atrial fibrillation (AF). By describing the electrophysiologic basis of atrial fibrillation in animal models, Dr. Bernstein and others have elucidated some of the mechanisms of this very common disorder. Doing so has enabled more effective treatment modalities of AF, both catheter and surgical-based. Dr. Bernstein and his colleagues have studied the biophysics of cardiac ablation in both small and large animal models, both long-term and short-term. This line of investigation has improved the understanding of lesion delivery by radiofrequency ablation catheters, the long-term effectiveness of those lesions, the effects of systemic steroids on durability of RF ablation lesions, and evaluated techniques used to assess clinical lesion durability and tissue contact duration ablation. Utilizing a long-term canine model of atrial fibrillation, Dr. Bernstein and his colleagues described both the acute and chronic effects of autonomic nervous system modulation by spinal cord stimulation on a model of atrial fibrillation. Spinal cord stimulation is currently in clinical use for non-cardiac indications, such as chronic pain; applying it for the treatment of cardiac arrhythmias represents of novel use of such devices. Clinical electrophysiology is a dynamic sub-specialty within cardiology marked by very rapid advances in technology and continuous refinement in techniques, many of which have been made possible by large and small animal models of disease.

10:25 am Discussion with Panelists
Video
10:55 am Break
Panel on Ethical and Societal Issues Regarding the Use of Dogs in Biomedical Research
11:10 am Panel Introduction
– Margaret (Mimi) Foster Riley, Committee Member, University of Virginia School of Law
Video
11:15 am Establishing a Necessity-Based Approach to the Use of Chimpanzees in Research
– Jeffrey Kahn, Johns Hopkins University
Bio | Video | Slides

Jeffrey Kahn, Ph.D., M.P.H., is the Andreas C. Dracopoulos Director of the Johns Hopkins Berman Institute of Bioethics, a position he assumed in July 2016. From 2011, he has been the inaugural Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy. He is also Professor in the Dept. of Health Policy and Management of the Johns Hopkins Bloomberg School of Public Health. He works in a variety of areas of bioethics, exploring the intersection of ethics and health/science policy, including human and animal research ethics, public health, and ethical issues in emerging biomedical technologies. Prof. Kahn has served on numerous state and federal advisory panels; he is currently chair of the National Academies of Sciences, Engineerin, and Medicine’s Board on Health Sciences Policy, and has previously chaired its committee on the Use of Chimpanzees in Biomedical and Behavioral Research (2011) and the committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights (2014). He formerly served as a member of the National Institutes of Health (NIH) Recombinant DNA Advisory Committee. In addition to committee appointments, Prof. Kahn was the founding president of the Association of Bioethics Program Directors, an office he held from 2006-2010. He is also an elected Fellow of The Hastings Center. Prof. Kahn’s publications include Contemporary Issues in Bioethics; Beyond Consent: Seeking Justice in Research; and Ethics of Research With Human Subjects: Selected Policies and Resources, as well as over 115 articles in the bioethics and medical literature. He also speaks widely across the U.S. and around the world on a range of bioethics topics, in addition to frequent media outreach. From 1998-2002 he wrote the bi-weekly column Ethics Matters on CNN.com. Prior to joining the faculty at Johns Hopkins, Prof. Kahn was Director of the Center for Bioethics at the University of Minnesota.

11:45 am Discussion with Panelist
Video
12:00 pm Lunch
Panel on Ethical and Societal Issues Regarding the Use of Dogs in Biomedical Research
(continued)
1:00 pm An Ethical Framework for the Use of Animals in Research
– David DeGrazia, The George Washington University
Bio | Video | Slides

David DeGrazia is Elton Professor of Philosophy at George Washington University, whose faculty he joined in 1989, and Senior Research Fellow in the Department of Bioethics, National Institutes of Health, which he joined on a part-time basis in 2013. DeGrazia earned a B.A. from the University of Chicago (1983), an M.Stud. from Oxford University (1987), and a Ph.D. from Georgetown University (1989), all in Philosophy. His research interests focus primarily in applied ethics and ethical theory and secondarily in personal identity theory and the philosophy of mind/cognitive sciences. DeGrazia is the author, coauthor, or coeditor of seven published books, including his monographs Taking Animals Seriously: Mental Life and Moral Status (Cambridge University Press, 1996), Human Identity and Bioethics (Cambridge University Press, 2005), and Creation Ethics: Reproduction, Genetics, and Quality of Life (Oxford University Press, 2012). He was an editor through four editions of Biomedical Ethics (McGraw-Hill), one of the most widely used bioethics anthologies. His book with Tom Beauchamp, Principles of Animal Research Ethics, will be published later in 2019 by Oxford University Press. In addition to books, DeGrazia has published over 120 journal articles, book chapters, review essays, and shorter writings—most of them solo-authored—in such journals as The Hastings Center Report, Ethics, Philosophy and Public Affairs, and Public Affairs Quarterly. His research has been supported by major grants from the American Council of Learned Societies, the National Institutes of Health (before he became an employee), and the National Endowment for the Humanities (twice). In 2012, he worked part-time as Senior Advisor to the staff of the Presidential Commission for the Study of Bioethical Issues. He also served, at GW, a three-year term as Chair of the Philosophy Department. Outside of GW, he has served as Co-Chair of the 2000 Program Committee for the American Society for Bioethics and Humanities and Chair of the Committee on Philosophy and Medicine for the American Philosophical Association. He is currently a member of the editorial boards of Public Affairs Quarterly and The Journal of Applied Ethics. In 2018 he was named a Fellow of the Hastings Center and the recipient of GW’s Office of the Vice President of Research Distinguished Scholar Award.

1:30 pm The Unique Role of Dogs in Society 
– James A. Serpell, University of Pennsylvania
Bio | Video | Slides

James Serpell holds the Marie A. Moore endowed Chair of Animal Welfare & Ethics at the School of Veterinary Medicine, University of Pennsylvania. He received his bachelor’s degree in Zoology from University College London and his PhD in Animal Behavior from the University of Liverpool, UK. At Penn Vet he teaches veterinary ethics and animal welfare. His research focuses on the behavior and welfare of dogs and cats, the development of human attitudes to animals, and the history and impact of human-animal relationships. He has published more than 180 articles and book chapters on these and related topics, and is the author, editor or co-editor of several books including Animals & Human Society: Changing Perspectives (1994), In the Company of Animals (1996), Companion Animals & Us (2000), and The Domestic Dog (2016). He is also the creator of the widely-used Canine Behavioral Assessment and Research Questionnaire (C-BARQ: www.cbarq.org).

2:00 pm Discussion with Panelists
Video
2:30 pm Break
Panel on Comparative Modeling in Spinal Cord Injury Research
Spinal cord injury (SCI) research is a key priority for the VA and one of the areas in which dogs serve as models of disease. This panel will examine various approaches to modeling SCI for research and translational purposes.
2:45 pm Panel Introduction
– Warren Casey, Committee Member, National Institutes of Environmental Health Sciences
2:50 pm Rodent Models of Spinal Cord Injury 
– Warren J. Alilain, University of Kentucky College of Medicine
Bio | Video | Slides

Warren J. Alilain is an Associate Professor in the Department of Neuroscience at the University of Kentucky (UK) College of Medicine and his laboratory is a part of the Spinal Cord and Brain Injury Research center. He completed his undergraduate studies at the University of California at San Diego. Following this he was a research assistant at the Veterans Administration (VA) Medical Center in San Diego where he was first exposed to the fields of neurodegenerative diseases and spinal cord injury (SCI). His graduate and postdoctoral work was focused on rodent models of cervical SCI and the resulting respiratory motor deficits. Dr. Alilain has continued this line of investigation in his own laboratory which he started in 2011 at MetroHealth Medical Center at Case Western Reserve University School of Medicine in Cleveland, Ohio. In 2015, he moved his laboratory to UK. In addition to cervical SCI, his research interests include neural plasticity in both injury and learning models, the therapeutic potential of stem cells, and functional electrical stimulation. Dr. Alilain’s approach towards exploring strategies to restore function after SCI is through first developing a pre-clinical animal model which closely reflects the human clinical population. This includes the use of cervical contusion injuries, chronic injured animals, and “humanized” rodents. Dr. Alilain has reviewed for 20+ scientific journals and a number of federal and private funding agencies including the National Institutes of Health, National Science Foundation, the VA, and the Department of Defense. He is currently a committee member on the Research Committee of the American Spinal Injury Association and has previously served on an IACUC committee at Case Western Reserve University.

3:10 pm An Overview of Large Animal Models of Spinal Cord Injury
– Candace L. Floyd, University of Utah Health
Bio | Video | Slides

Candace L. Floyd, Ph.D. is an Associate Professor and the Vice Chair for Research for Physical Medicine and Rehabilitation at the University of Utah. She is also an investigator at the VA Salt Lake City Health Care System. She directs the Translational Neurotrauma Laboratory at the University of Utah. Her research focuses on understanding mechanisms, development of new models, and discovery of new therapeutic approaches for the treatment of traumatic brain injury and spinal cord injury. More recently, her research team has focused on the use of porcine models of neurotrauma as translational intermediaries that can potentially accelerate translation of key findings from bench to bedside. Dr. Floyd received her Ph.D. from Medical College of Virginia/Virginia Commonwealth University where she studied astrocyte responses to mechanical injury under the tutelage of Dr. Earl Ellis. She then conducted a post-doctoral fellowship at the University of California, Davis with Dr. Bruce Lyeth, continuing her research on neurotrauma. She also served as an Assistant Professor in the Department of Neurosurgery at the University of California, Davis. She subsequently served as an Associate Professor in the Department of Physical Medicine and Rehabilitation at the University of Alabama at Birmingham. Dr. Floyd frequently reviews manuscripts related to neurotrauma and serves on the Editorial Board for the Journal of Neurotrauma. She also is an active member in the National Neurotrauma Society, where she has previously served as Secretary/Treasurer, Vice President, and President.

3:30 pm The Natural SCI Model of Canine Intervertebral Disk Herniation 
CANSORT-SCI and the International Canine SCI Registry; Tools for Identifying and Assessing the Impact of Therapeutic Strategies
– Sarah Moore, The Ohio State University College of Veterinary Medicine
Bio | Video | Slides

Dr. Sarah Moore is an Associate Professor at The Ohio State University College of Veterinary Medicine and is a board-certified veterinary neurologist and neurosurgeon. She is the program director for the OSU Center for Clinical and Translational Sciences (CCTS) Comparative and Translational Medicine Program. Her research focuses on translational studies of spinal cord disease using canine disease models (pet dogs with naturally occurring disease). In her role as a clinician in the OSU Veterinary Medical Center (VMC), she manages approximately 150 dogs per year with spontaneous acute spinal cord injury (SCI) and many others with neurodegenerative spinal cord disease. These veterinary patients bridge the gap between laboratory models of disease and the human clinical setting by serving as a spontaneous clinical trial model system where lessons learned stand to benefit both the veterinary patient and people with the same disease. Dr. Moore currently chairs OSU’s IACUC privately owned animals subcommittee, which functions as the veterinary medical center’s IRB for veterinary clinical research. She is a member of the CTSA One Health Alliance (COHA) Clinical Trials Subcommittee and COHA One Health Datasets working group both of which focus on integrating natural animal models of disease into the translational research process. She is a founding member and current faculty lead for a group of veterinary spinal surgeons, human physicians, and basic science researchers focused on dog models of SCI as translational tools to improve health outcomes in people (CANSORT-SCI). She also holds a recently awarded R21 from NIH/NCATS focusing on development of a veterinary platform trial for canine degenerative myelopathy (a spontaneous large animal model of ALS) to facilitate translational efficiency in drug development for neurodegenerative diseases.

3:50 pm The Natural SCI Model of Canine Intervertebral Disk Herniation (continued)
Clinical Trials of Novel Therapies
– Nicholas Jeffery, Texas A&M College of Veterinary Medicine
Bio | Video | Slides

Nickolas Jeffery is a UK-qualified veterinarian who has worked in many fields of veterinary medicine, including primary care practice and private referral practice and also as a bench-top neuroscientist. Specialist interest in in spinal cord injury, as both a clinical and research topic. Recent Master’s degree training in clinical trial design and analysis and during the last decade have completed two clinical trials in dogs of novel therapies for chronic spinal cord injury. Have held academic posts in both UK and the USA and currently Professor in Neurology and Neurosurgery at Texas A&M and also Editor-in-Chief of the Journal of Small Animal Practice (a UK-based veterinary journal focusing on treatment of dogs and cats).

4:10 pm Discussion with Panelists
Video
4:40 pm Public Comments
Video
4:55 pm Adjourn Open Session
Thursday, March 28, 2019
Video | Slides
8:30 am Welcome, Introductions, Process for Open Session
– Rhonda Cornum, Committee Chair
8:40 am Establishing Research Priorities at the VA
– Rachel Ramoni, Veterans Health Administration
Bio 

Dr. Rachel Ramoni, DMD, ScD was named Chief Research and Development Officer (CRADO) for VA as of Jan. 8, 2017. Previously, she was on the faculty at New York University College of Dentistry in the Department of Epidemiology and Health Promotion, and at Harvard Medical School in the Department of Biomedical Informatics. While at Harvard, Dr. Ramoni founded and led the Undiagnosed Diseases Network (UDN) Coordinating Center. The UDN, funded by the National Institutes of Health, brings together clinical and research experts from across the U.S. to solve challenging medical mysteries using advanced technologies. The Boston Globe called the network a “powerful new way to diagnose mystery illnesses.” Among Dr. Ramoni’s research interests are informatics, genomics, and precision medicine. Prior to her role with the UDN, she was executive director of the Substitutable Medical Applications, Reusable Technologies project, or SMART. Initially launched with federal funding, SMART aims to make it easier for providers across different health systems to securely share information from electronic health records. The overarching goal is to improve the quality and continuity of care for patients. Dr. Ramoni also has worked on implementing standardized diagnostic terms for dentistry, and developing a patient safety system that would help dentists identify and prevent adverse events. As CRADO, Dr. Ramoni oversees VA’s nationwide research enterprise, encompassing some 2,000 active projects at more than 100 sites. The program’s total budget in FY2016 was $1.8 billion. The figure includes both direct VA support, and research funding from outside entities, including other federal agencies, as well as nonprofit and private organizations.

– Karen Lohmann Siegel, Veterans Health Administration
Bio

Karen Lohmann Siegel, PT, MA is currently the Deputy Director of the Rehabilitation Research and Development Service and previously served as the Capacity Building Program Manager for the Health Services Research and Development Service in the VA Office of Research and Development. Before joining the Department of Veterans Affairs, Ms. Siegel served nearly 28 years as a commissioned officer in the US Public Health Service (USPHS), focusing on the generation and application of research evidence to inform clinical practice, policy, and regulation. Captain Siegel began her career at the National Institutes of Health conducting research resulting in over 100 published manuscripts, abstracts and chapters on the motor control of walking. She subsequently served at the Agency for Healthcare Research and Quality as Associate Director of the Evidence-based Practice Center Program, a group of contracted institutions that produced comparative effectiveness reviews of scientific evidence on health care interventions to help payers, providers, and patients make better treatment decisions. She concluded her active duty career as the founder and leader of the Functional Performance and Device Use Laboratory in the Center for Devices and Radiological Health at the Food and Drug Administration, generating scientific evidence about medical devices to inform regulatory decision-making. Captain Siegel was concurrently appointed by the Surgeon General as Chief Therapist Officer, leading the 150-member therapist category of physical therapists, occupational therapists, speech language pathologists, audiologists and respiratory therapists and providing discipline-focused advice to the Office of the Surgeon General. Her contributions have been recognized with a Surgeon General’s Exemplary Service Medal, a Meritorious Service Medal, Commendation Medals, and other national professional awards.

– Chris Bever, Veterans Health Administration
Bio

Christopher Bever, MD, MBA has been the Director of the Biomedical Laboratory Research and Development Service since 2016. Prior to moving to the VA Office of Research and Development he had devoted his career to VA clinical care and research. He joined the Memphis VA as a staff neurologist in 1984 and received a VA Research Career Development Award for studies of the pathogenesis of multiple sclerosis one year later. In 1987 he moved his research program to join the staff of the Baltimore VAMC and the Department of Neurology at the University of Maryland. There he was continuously funded for more than 28 years with VA Merit Awards from the Biomedical Laboratory Research and Development Service. In addition he received funding from the VA Rehabilitation Research and Development Service, the VA Cooperative Studies program, the National Institutes of Health and the National Multiple Sclerosis Society. In 2003 he was awarded a VA Research, Education and Clinical Center for multiple sclerosis and continued as Director of that national program until 2016. At the University of Maryland, School of Medicine he rose to the rank of tenured Professor in the Departments of Neurology, Pharmacology and Physical Therapy. He authored more than 120 publications in peer-reviewed journals primarily in the areas of multiple sclerosis pathogenesis and treatment, robot assisted neuro-rehabilitation and clinical quality improvement in neurology. Dr. Bever’s research has always been grounded in his clinical care of veterans with neurological illnesses, particularly multiple sclerosis, and he continues to see patients as a staff neurologist at the Baltimore VA.

10:00 am Adjourn Open Session/Break