Introduction to Issues Involved in Addressing the Drug Development Process and ICH and Human Research Protections.
Clinical Program Management and Budgeting
Bryan Mark Soronson, BS, MPA, is the Senior Administrator, Department of Neurology, University of Maryland Medical Center. He is responsible for the financial and administrative duties of the Department. He develops, manages, and administers the Department's 14 Million Dollar budget which includes the school, hospital, and practice research grant and contract funds; coordinates preparation and submission of grants and contracts and federal and private sources including two center grants-, coordinates administrative aspects of elecen University Multi-Center clinical trial; coordinates personnel and prcurement activites; oversees departmental group practice; serves as departmental administrative compliance liaison; supervises clerical, accounting and activites; coordinates relocations and renovations of the Department; manages administrative aspects of the Ambulatory Practice; chaired the Education section of the University Physicians Compliance Committee; coordinated selection of grant accounting package for most of the Departments of the Medical School, and initiated campus-wide research compliance initiative.
Clinical Program Management and Budgeting
John M. Kessler, BS Pharm, PharmD, is the Founder and Chief Clinical Officer of SecondStory Health. He has a special interest in medication safety. He has chaired and served on national and state committees to improve patient safety. His research is focused on medication safety in clinical trials. Dr. Kessler served 11 years as Chairman of the Duke University Health System IRB. He was a member of the Duke IRB from 1990-2016. Currently, he is a pharmacist member of the WIRB-Copernicus Group IRB. His former positions include Chairman of the North Carolina Ethical Review Board and Director of the Duke University Hospital Investigational Drug Service. Dr. Kessler completed a Fellowship in Post-marketing Surveillance at the University of Cape Town, South Africa. He received his Pharmacy degree from West Virginia University and his Doctorate degree from Duquesne University.
IRBs and Informed Consent
George H. D’Addamio, PhD is President of PharmConsult, Inc., a consulting firm in Atlanta, GA that specializes in the preparation of clinical development documents. During 8 years at SmithKline & French Laboratories (now Glaxo SmithKline), Dr. D’Addamio was responsible for preparing protocols, case report forms, integrated study reports, and regulatory submissions in Clinical R & D and Medical Affairs. As Scientific Manager, Clinical R & D, he was responsible for coordinating clinical research programs in Canada and Latin America. In Medical Affairs, he managed operational groups responsible for medical writing, clinical monitoring, and CRF safety reviews and auditing. After leaving SmithKline & French, Dr. D’Addamio worked with a CRO for 1.5 years before forming PharmConsult. His consulting experience includes project management and statistical services in addition to medical writing in various therapeutic areas for both domestic and foreign pharmaceutical companies.
Victor M. Santana, MD, is the Division Director for Solid Tumors, Department of Hematology – Oncology, St. Jude Children’s Hospital. Dr. Santana has received national recognition for the care he provides pediatric cancer patients at St. Jude Children’s Research Hospital. Voted one of the “Best Doctors in America” two years in a row, Dr. Santana is an expert on Neuroblastoma in children. He has collaborated with other St. Jude physicians and researchers to create innovative treatment plans for cancer patients. Dr. Santana chairs the Institutional Review Board at St. Jude. He is an associate professor in the department of pediatrics at the University of Tennessee in Memphis, Tennessee. Before joining St. Jude in 1984, Dr. Santana completed a six-year tenure at Johns Hopkins Hospital in Baltimore, Maryland.
Anatomy and Physiology, Genetics, and Cell Biology
Richard Sloane, MS, teaches Anatomy and Physiology, and Cell Biology at Durham Technical Community College. He received his MS from the University of Rochester, Rochester, NY, where he concurrently worked in their Center for Brain Research. Since then, he has had broad research experience in Inhalation/Respiratory Toxicology, Cardiovascular Toxicology, Liver Studies, and Reproductive Toxicology and Teratology at the National Institute of Environmental Health Sciences in the Research Triangle Park, NC. He was also an active member of Toastmasters International for over 13 years, achieving highest honors, and gives classes in effective speaking techniques.
Chemical Analysis of Laboratory Values
Sam McCash, MD, is an attending physician at Memorial Sloan Kettering Cancer Center, New York, NY, working in the Department of Laboratory Medicine, and is the Medical Director of their 53rd Street clinical laboratory. His background includes acquiring a bachelor’s degree in Clinical Laboratory Science from Andrews University, MI. Straight out of college he attended Loma Linda University School of Medicine, CA, earning an M.D. There he completed four years of medical school plus an additional year as a post-junior fellow in pathology. In 2007 Dr. McCash moved to New York, NY, for a four-year-long residency in anatomical and clinical pathology at Mount Sinai Medical Center where he became chief resident during his final year. Upon completion he participated in a yearlong fellowship in anatomic oncologic surgical pathology followed by an additional year fellowship in laboratory medicine, both at Memorial Sloan Kettering Cancer Center. Dr. McCash is currently a member of several academic/medical societies including the College of American Pathologists, American Association of Clinical Chemistry, and the American Society for Clinical Pathology.
Kazunori Murata, PhD, is an assistant attending clinical chemist in the Department of Laboratory Medicine at the Memorial Sloan-Kettering Cancer Center. He directs the protein immunology laboratory as well as the endocrine laboratory. He is also actively involved in graduate medical education as the director of the clinical chemistry fellowship program at Memorial. Dr. Murata received his PhD in pathobiology conducting research on transplantation immunology at the Johns Hopkins University, followed by a fellowship in clinical chemistry at the Mayo Clinic.
Epidemiology and Statistics
Brad Pollock, MPH, PhD, FACE, is Professor and Chairman of the Department of Public Health Sciences, Associate Dean for Public Health Sciences, and holds the Rolkin Chair in Public Health Sciences in the School of Medicine at the University of California, Davis. He is the Co-Director of the Population Sciences and Health Disparities research program of the UC Davis Comprehensive Cancer Center. He received his B.S. in Biological Science from the University of California Irvine and both his M.P.H. and Ph.D. in Epidemiology from the UCLA School of Public Health and is a Fellow of the American College of Epidemiology. Prior to joining the faculty at UC Davis, Dr. Pollock was Professor and founding Chair of the Department of Epidemiology and Biostatistics at the University of Texas Health Science Center at San Antonio School of Medicine from 2001–2014. Before that, he was on the faculty of the University of Florida College of Medicine. His research concentration is in pediatric and adolescent oncology with emphases in cancer epidemiology and cancer prevention/control research. He previously served as the Chair of the Clinical Translational Science Award (CTSA) Biostatistics, Epidemiology, Research (BERD) Key Function Committee, was Past President of the Association of Clinical and Translational Statisticians, and is the current Co-Chair of the Methods and Processes Domain Task Force for the CTSA Consortium. Dr. Pollock has worked in a wide variety of public health and medical domains. Dr. Pollock is an educator in graduate programs in public health.