The Seminar will take place on Wednesday, September 14 and Thursday, September 15, 2016, from 8:00 AM – 5:00 PM at “The University of Miami Bank United Center located at 1245 Dauer Drive, Coral Gables, FL 33146.” The cost of registration for the two-day seminar is $175.00 (breakfast, lunch and refreshments for both days are included in the registration fee)
Robert M. Califf, MD, MACC, is the Food and Drug Administration’s commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.
Previously, Dr. Califf served as the FDA’s Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as commissioner in February 2016. In that capacity, he provided executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He also oversaw the Office of Special Medical Programs and provided direction for cross-cutting clinical, scientific, and regulatory initiatives, including precision medicine, combination products, orphan drugs, pediatric therapeutics, and the advisory committee system.
Before joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research, Dr. Califf, has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.
Dr. Califf has served on the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market, as well as on the IOM Committee on Identifying and Preventing Medication Errors and the IOM Health Sciences Policy Board. He has served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Institutes of Health and the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging.
While at Duke, Dr. Califf led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke’s Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory Coordinating Center. Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke.
Dr. Jonca Bull, MD serves as Assistant Commissioner for Minority Health, US Food and Drug Administration. In addition to her past experience in the private sector and clinical practice, Dr. Bull has served in FDA in a variety of leadership positions in both the Center for Drug Evaluation and Research (CDER) and the Office of the Commissioner. She holds an appointment as an Assistant Clinical Professor at George Washington University Medical Center. Dr. Bull is a graduate of Princeton University and received her medical degree from Duke University School of Medicine. She did her postgraduate training at George Washington University, is board certified in Ophthalmology, and is a fellow of the American Academy of Ophthalmology.
Cynthia Kleppinger, M.D. is currently a Senior Medical Officer in the Good Clinical Practice Assessment Branch, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Center for Drug Evaluation and Research at the US Food and Drug Administration. In this capacity, she directs, and may participate in, onsite inspections of clinical investigators, sponsors, monitors, and contract research organizations in collaboration with FDA’s field team to monitor clinical drug product studies and initiate administrative and corrective regulatory measures as necessary.
Since joining CDER in 2008, Dr. Kleppinger has also held the positions of Team Leader for the Policy and Planning Team and Team Leader for International Policy in the Office of Scientific Investigations. Work included launching and then overseeing the collaborative FDA-European Medicines Agency Good Clinical Practice Initiative as well as issues relating to capacity building, bilateral agreements, and international standards development and harmonization.
Before her work at CDER, Dr. Kleppinger was a Clinical Reviewer for four years in the Division of Vaccines and Related Products Applications, Center for Biologics Evaluation and Research/FDA. She also spent 3 ½ years at Science Applications International Corporation-Frederick, overseeing clinical trials as Director of the Clinical Safety Office in the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases/National Institutes of Health. Preceding that job, she was a Senior Medical Officer and Project Coordinator in the Center for the Clinical Trials Network at the National Institute on Drug Abuse at the NIH. She also has over 16 years as an active practicing clinician in academia, private practice, family, and emergency medicine.
Bhanu Kannan is a Consumer Safety Officer in Bioresearch Monitoring Branch (BIMO), Division of Inspections and Surveillance, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER). She has been working in BIMO Branch for nearly 16 years assigning inspections and assessing regulatory compliance of the inspected parties concerning FDA regulations. Bhanu is actively participating within the agency in inter and intra-center activities in the development of guidance and related documents. Bhanu received her Sc.M degree in Chemistry from Brown University, Providence, RI, and M.Sc., and M.Phil. degrees in Chemistry from Madras University, India.
Before joining BIMO Branch Bhanu participated in basic research in the CBER laboratories for nearly nine years. She participated in basic research on signal transduction mechanisms in CBER laboratories, Georgetown University’s Lombardi Cancer Center, Washington, D.C., and Roger Williams Hospital, Providence, RI, and contributed to publications in peer-reviewed journals.
Dr. James Saviola joined the Center for Devices and Radiological Health (CDRH) in
1986. He is a Captain in the U.S. Public Health Service and holds consulting staff credentials with the Optometry Department at the Walter Reed National Military Medical Center, Bethesda, MD. Jim was a branch chief in the Office of Device Evaluation involved with ophthalmic devices from 1991 until January 2008. He then served three years in the Center Director’s Office where he was responsible for helping to promote information exchange within CDRH to better identify and analyze medical device risks and develop public health responses. Jim has been with the Division of Bioresearch Monitoring in the Office of Compliance since January 2011. He’s been serving as the BIMO Director since the fall of 2011. Under his direction, the division has to focus on developing expertise in various program areas and expanding support of Class II medical device clinical study activities.
Susan Turcovski began her tenure as Director for FDA’s Florida District at the end of August 2014. Susan was the Director Investigations Branch in Dallas District from January 2010 to August 2014. She is a member of the ORA Biologics Program Committee and ACRA’s IT Advisory Council. Susan’s career with FDA began in 1996 as a Compliance Officer in Rockville, MD at the Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Division of Case Management. She later transferred to ORA’s Florida District Boca Raton Resident Post as an Investigator in July 2000 and became Supervisory Investigator of the Resident Post in November 2005. Prior to Susan’s FDA career, she conducted medical research in Multiple Sclerosis, Alzheimer’s, Vaccine Development, and melanoma. Susan has a Bachelor’s of Science Degree in Microbiology from the University of Maryland College Park and has done graduate studies at Johns Hopkins University.
Renu Lal joined the Food and Drug Administration in October 2002, where she has worked for the Division of Drug Information (DDI) in CDER’s Office of Communications. In DDI, Renu is also part of the Small Business Assistance Program (SBIA). She is responsible for answering emails from the public regarding a wide range of topics, from drug safety to drug development. She also is active in maintaining and developing the SBIA Program, developing web-based learning tutorials for industry, writing newsletters for the CDER SBIA Chronicles, and maintaining the SBIA Small Biz Buzz listserv and SBIA webpage. In addition to her time at FDA, Renu has spent time in the industry, retail pharmacy, and hospital pharmacy. Renu received her Doctor of Pharmacy from the Medical University of South Carolina and her Bachelor’s degree in Pharmacy from the University of Connecticut.
Craig A. Garmendia is a Consumer Safety Officer/Investigator with the U.S. Food and Drug Administration, dedicated to the Bioresearch Monitoring (BIMO) program. Since joining the Agency in 2009, Investigator Garmendia has excelled within the BIMO program with notable accomplishments that include participation in the working group for the revision of the Bioequivalence Compliance Program Guidance Manual, Clinical BIMO Investigator Certification Test Item Writing workshop, and serving as a presenter and discussion panel member for the 2014 FDA/UM Symposium on Clinical Research. Investigator Garmendia has received numerous awards including the 2015 and 2016 ORA Honor Award, 2012 Commissioner’s Special Citation, and 2011 CBER Center Director’s Honor Award. Investigator Garmendia’s inspectional findings have resulted in criminal conviction, Clinical Investigator disqualification, and clinical study data invalidation. Investigator Garmendia is completing his doctorate in Public Health – Epidemiology at Florida International University.
Ethan P. Stegman, BS, is a Bioresearch Monitoring (BIMO) Specialist/Investigator for the U.S. Food and Drug Administration. He has been with the FDA since 2008. Early in Ethan’s FDA career, he was working in multiple program areas, including: Drug GMPs, Dietary Supplement GMPs, and Biological Product CGTPs/GMPs. In 2011, he found his calling in the field of Bioresearch Monitoring and has been a Specialist for Florida District since March of 2015. As a BIMO Investigator, Ethan performs inspections of Clinical Investigators and Sponsors worldwide. He also performs inspections of domestic ethics committees and assists in monitoring the BIMO program area for Florida District. He contributed to the development of the initial Clinical BIMO Investigator Certification Test, and has won a variety of achievement awards throughout his FDA career.
Johanna Stamates holds a master’s degree and a bachelor’s degree in hospital economics and registered nursing, and completed several certifications for the conduct of research and research compliance. She has over 30 years of combined experience in healthcare, healthcare compliance, as well as research compliance and management. Her expertise ranges from nursing, study coordination, the development and delivery of research training and seminars, research site management and research compliance, to the creation, implementation and oversight of total quality management systems, in accordance with International Organization for Standardization (ISO) 9000. Johanna Stamates currently directs the Office of Research Compliance and Quality Assurance (RCQA) at the University of Miami. This includes the oversight of human subject research compliance programs such as Quality Assurance, Clinical Trials Disclosure, Corrective and Preventive Action System and research compliance related education.
She maintains memberships with ACRP, SQA, University of Miami Bio Ethics Committee and HCCA.
Khemraj Hirani As Associate Vice Provost, Khemraj Hirani (known as “Raj”) is responsible for overall leadership of the Human Subject Research Office (HSRO), overseeing the activities of the IRB committees and of the HSRO staff, and acting as a liaison between the IRBs and the Vice Provost for Research and the Executive Dean for Research of the Miller School.
He has served on UM’s Institutional Review Board (IRB) since 2008. His areas of expertise include investigational medicinal products, non-clinical behavioral testing, research pharmacy, human subject protection, compliance assessment and safety pharmacology. Dr. Hirani is also the Director of Regulatory Affairs and Quality Assurance at the Diabetes Research Institute.
Raj graduated graduated from the College of Pharmaceutical Sciences in Manipal, India, in 1999 and received advanced training in pharmacology at RIKEN Brain Science Institute in Wako-shi, Japan, the National Brain Research Center in India, and the Department of Anatomy at the College of Medicine at the University of South Florida. His research on neuroactive steroids and GABAergic/adenosinergic/serotonergic modulation has been published in leading journals, including Brain Research, Psychopharmacology, Neuropharmacology, British Journal of Pharmacology, European Journal of Pharmacology and Nature Neuropsychopharmacology.
Dr. Hirani has demonstrated ability to critically review, evaluate and interpret regulatory guidance and scientific data with proven cross-functional leadership across UHealth clinical research departments. In addition to serving HSRO, as a drug safety expert of Jackson/UHealth Systems and on multiple committees across UHealth, to include SCCC Data & Safety Monitoring Board, CRS Protocol Review Committee, Clinical Research Feasibility Committee, SNCC and UM Disclosure and Conflict Management Committee.
Ann Glasse As the Director of Clinical Research Operations & Regulatory Support (CRORS) and Assistant Director, CTSI Regulatory Program at the University of Miami, Ann has 20 years of clinical research experience in medical, pharmaceutical and biotech industries. She is an expert in clinical trial strategy and management, regulatory and clinical trial monitoring. Ms. Glasse serves on the CTSA IND/IDE workgroup as well as the CTSI’s Faculty Council Compliance & Training Task Force. She also serves on the UMH/UMHC Ethics Committee.