Program Faculty and Affiliates
Kenneth R. Baker, BS Pharm, J.D.
Ken Baker is a pharmacist and an attorney. In addition to his position as consultant with several companies, including Pharmacists Mutual Insurance Company, Ken practices law, of counsel, with the Phoenix, Arizona, law firm of Renaud Cook Drury Mesaros, PA. His areas of concentration are medical and pharmacy malpractice and administrative law. Ken also writes, consults and lectures on subjects ranging from pharmacy law, pharmacy compounding, insurance, risk management, reducing medication errors and quality assurance systems and has served as expert witness in standards of pharmacy practice.
In addition to consulting and law practice, Ken teaches as Adjunct Assistant Professor at MidWestern University College of Pharmacy in Glendale, Arizona where he teaches courses in Ethical Decision Making and a course in Risk Management & Patient Safety. He is also Adjunct Assistant Professor for the University of Florida, where he teaches three courses (State Regulations; Enterprise Risk Management; and Pharmaceutical Crimes) in the Masters of Pharmacy Internet program. PreviouslyMr. Baker taught Pharmacy Law & Ethics at the University of Iowa.
Following graduation from Purdue University, School of Pharmacy Ken practiced pharmacy prior to returning to law school. He worked in independent and chain pharmacies and managed a chain pharmacy in Indianapolis, Indiana. Upon graduation from Indiana University School of Law, Indianapolis (Cum Laude), Ken entered law practice in Lebanon, Indiana where he practiced general trial law, including service as a deputy prosecuting attorney for Boone County, Indiana.
Kimberly A. Burns, R.Ph., J.D.
Dr. Burns is a licensed pharmacist and attorney in Pennsylvania. In addition to her academic career, she practiced community pharmacy for over 14 years and has provided assistance on various legal cases regarding pharmacy law issues.
Michael E. Clark
Michael E. Clark is a litigator who has a wide variety of experience, including matters with various regulatory agencies, contract disputes including DTPA allegations, complex fraud allegations (including violations of the False Claims Act), environmental allegations, securities law allegations, and financial fraud allegations. He has been lead counsel in over 100 jury trials, and has handled dozens of appeals. In addition to his trial work, Mr. Clark has counseled clients, including healthcare providers, insurers, and financial institutions, and has conducted internal investigations and advised on regulatory compliance and corporate governance matters.
Mr. Clark is a Past Chair of the American Bar Association’s Section of Health Law and a former chair of the ABA Section of Business Law’s White-Collar Crime Committee. He has helped devise, co-chaired, and served on Planning Committees for various ABA National Institutes, including the National Institute on Corporate Internal Investigations; the National False Claims Trial Institute; the Foreign Corrupt Practical Act Mock Trial Institute; and the Medical Device Institute. A widely published and sought-after speaker, Mr. Clark has instructed on a diverse range of topics, ranging from cybersecurity and regulatory compliance, to litigation skills and ethics, to dealing with whistleblowers. He writes and presents on regulatory issues, such as cybersecurity, corporate compliance and governance, ethics, internal investigations, pharmaceutical and medical device law, securities law, and white-collar defense issues. He is the editor-in-chief for an annually supplemented treatise published by BNA/Bloomberg: Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing (2d Ed. 2015)
As an adjunct law professor at the Health Law & Policy Institute of the University of Houston Law Center, he has taught on food and drug law, civil and criminal trial advocacy, healthcare and antitrust, and the regulation of biomedical research. As an adjunct professor at the College of Pharmacy for the University of Florida, Mr. Clark has taught on pharmaceutical fraud and abuse. He is also a faculty instructor for the National Institute for Trial Advocacy, and has taught at its trial advocacy, depositions, and advanced deposition programs. He is also an AHLA-trained Health Law Arbitrator.
Mr. Clark is a 1982 graduate of South Texas College of Law and also holds an LL.M. in Health Law and an LL.M. in Tax from the University of Houston Law Center. He also is a graduate of the University of Texas at Arlington. Before entering private practice, Mr. Clark served as a federal prosecutor for the Southern District of Texas and was the head of its Criminal Division for four years.
Adrienne Dresevic, Esq., is a founding shareholder of The Health Law Partners, P.C. Ms. Dresevic practices in all areas of healthcare law and devotes a substantial portion of her practice to providing clients with counsel and analysis regarding compliance and Stark and fraud and abuse. Ms. Dresevic is a published author and regular speaker on matters relating to Stark and fraud and abuse at industry and professional conferences.
Ms. Dresevic is a member of the American Health Lawyers Association, American Bar Association (“ABA”), State Bar of Michigan, and State Bar of New York. She is a member of the ABA Health Law Council within the Health Law Section of the ABA. In addition to her role on the Council, she also is the Co-Chair of the Physicians Legal Issues Conference, Vice Chair of Programs Executive Leadership, and Vice Chair of Sponsorship. Ms. Dresevic has also served as the Chair of the ABA eSource publication. Ms. Dresevic has written extensively on subjects across the spectrum of health care law, including, co-authoring a monthly column in the Association for Medical Imaging Management’s (AHRA) publication, Link, regarding up-to-date legal issues relevant to imaging providers and suppliers.
A member of the American Bar Association (ABA), the American Society for Pharmacy Law, and the American Association of Colleges of Pharmacy (AACP), Smith has served as an author, speaker and leader in areas such as pharmacy law, cultural competency, health disparities, bioethics, and disability law. In 2013-2014, Dr. Smith completed AACP’s Academic Leadership Fellows Program. He currently is serving a three-year term on the ABA Health Law Section’ leadership council, and is the immediate-past chair of AACP’s Health Disparities and Cultural Competence special interest group.
Brian T. Guthrie
Brian is an attorney and pharmacist whose primary practice involves preparing the defense of pharmaceutical and medical device manufacturers in complex product liability matters. He works on behalf of the pharmaceutical industry to defend claims arising out of the use of prescription drugs, implantable medical devices and consumer products in state and federal courts throughout the country. Brian also counsels FDA-regulated companies on regulatory and compliance issues involving the federal Food, Drug and Cosmetic Act and other health care laws and regulations regarding prescription and over-the-counter medications and medical devices. Brian practiced for several years as a registered pharmacist in community, hospital and long-term care settings before practicing law. This training and experience has benefited both his litigation and regulatory practices by enabling him to understand and appreciate the complexity of the medications and medical devices he encounters as well as how these products fit into the FDA’s regulatory framework.
Randy Hatton, Pharm.D., is the academic director of the second year of the College of Pharmacy’s curriculum. he teaches the evidence-based pharmacy course and content throughout the first 3 years of pharmacy education. He also serves as a clinical pharmacist in Internal Medicine Service at UF Health Shands Hospital, providing clinical pharmacy services while supervising working-professional doctor of pharmacy students.
Kem P. Krueger, Pharm.D., Ph.D.
Dr. Kem Krueger serves as an instructor and director of the Applied Pharmacoeconomics specialty area in the online MS program in pharmaceutical outcomes and policy. He has spent years conducting pharmacoeconomic and outcomes research, specifically measuring the clinical and economic impact of pharmacy services, modeling disease interventions, and validating disease state models. He received his Doctor of Pharmacy degree from the University of Missouri–Kansas City in 1993. He then completed a general pharmacy practice residency at the Kansas City Veterans Administration Medical Center. Following the residency, he completed his Ph.D. at the University of Arizona. He has experience in hospital pharmacy, independent pharmacy, and chain pharmacy settings. Dr. Krueger has worked for the U.S. Public Health Service, and for Marion Merrell Dow Inc. in the Health Economic and the Global Scientific Competitive Intelligence departments.
Dr. Krueger is on the residential faculty at the University of Wyoming where he serves as Dean of the School of Pharmacy. He was on faculty at Auburn University for seven years prior to joining the University of Wyoming, School of Pharmacy.
Robert Navarro is Clinical Professor in the Department of Pharmaceutical Outcomes & Policy, University of Florida, College of Pharmacy, Gainesville, FL.
Navarro has practiced pharmacy as a medical center pharmacy co-owner, hospital clinical pharmacist, medical school geriatrics pharmacology instructor, long term care consultant pharmacist, and a health plan and PBM pharmacy director.
He became involved in managed care in 1982, when he joined United Health Care to write their first drug formulary and was involved with the first pharmaceutical industry rebate contract. He managed the prescription drug benefit at Physicians Health Plan of Minnesota as pharmacy director, Health Net in California as Vice President of Provider Services, and at Express Scripts as Vice President, Pharmacy & Therapeutics.
Navarro has been involved in developing two PBMs, and has provided managed markets consulting services, advisory board moderation, and market research to the pharmaceutical industry for eighteen years. He has also been recognized by the courts as an expert witness in managed prescription drug benefit issues in various litigations.
As Professor at the University of Florida College of Pharmacy, Navarro teaches a managed healthcare course and classes in the online Master of Pharmaceutical Science program, and is adapting this course for PharmD programs. He is also developing additional courses in related topics, accountable care, and the PPACA, and is involved in coordinating online MS program seminars.
Robert is a co-founder and the first president of the Academy of Managed Care Pharmacy and the Foundation for Managed Care Pharmacy, where he remains involved with the FMCP Learning Institute. Navarro received the FMCP Steven G. Avey Award in 2009.
Navarro has edited both editions of the textbook, Managed Care Pharmacy Practice (1999 and 2009; third edition in progress), and has been lead author in the managed care pharmacy chapters of the last three editions of the textbook Essentials of Managed Health Care. He has also been on the editorial advisory board of the Journal of Managed Care Pharmacy, and serves as a manuscript reviewer for various health care publications.
Christopher Owens Pharm.D., M.P.H.
Dr. Christopher Owens is an associate professor at Idaho State University College of Pharmacy and Chair of the Department of Pharmacy Practice and Administrative Sciences. He joined the faculty in July 2003. Before entering the professional pharmacy program at ISU, he served as a Hospital Corpsman in the U.S. Naval Reserve and earned his B.A. degree in German at Utah State University. After graduating with his Doctor of Pharmacy degree, he completed a specialty residency in ambulatory care at the Southeast Idaho VA Outpatient Clinic in Pocatello. In 2013, he earned a master’s degree in Public Health (MPH) and his master’s project “Online Sources of Herbal Product Information” was published in the American Journal of Medicine. Dr. Owens is a past recipient of Mylan’s Excellence in Pharmacy Award and was named an American Foundation for Pharmaceutical Education (AFPE) Scholar for advanced study in the pharmaceutical sciences.
His instructional interests include Alzheimer’s disease and other neurodegenerative disorders, pain management, alternative and complementary medicine, professionalism and medical ethics, and inflammatory bowel conditions. In addition to his teaching duties in the college of pharmacy, he coordinates the clinical pharmacology course for PT/OT students, dental hygiene students, and nursing students. He lectures in both the Physician Assistant and Nurse Practitioner programs.
Dr. Owens served as the staff coordinator for the Idaho Drug Utilization Review (DUR) project from 2003 to 2008, which conducted educational interventions and collected and analyzed drug use data for the State of Idaho’s Department of Health and Welfare. His clinical practice site is at the Pocatello Health West Community Clinic where his duties include the management of an anticoagulation and diabetes clinic and provision of drug information services to clinic staff members.
He has published work in the peer-reviewed pharmacy and medical literature, including the Journal of the American Pharmacists Association, Journal of Managed Care Pharmacy, and Clinical Therapeutics. A commentary published in the journal Obstetrics and Gynecology on the topic of pharmacists’ refusals to dispense emergency contraception received national attention in 2006.
Dr. Karen Rascati’s research interests include economic and outcomes evaluations for several disease states as well as for pharmacy services. She has conducted over 60 funded research projects and has served on various grant review panels. She has supervised 40 MS and 25 PhD graduate student projects. She has authored or co-authored more than 100 publications (including five textbook chapters) and more than 100 national and international presentations. Her textbook, Essentials of Pharmacoeconomics was published in 2008, and was translated into Portuguese in 2009. In addition, she received the 2009 University of Texas Hamilton Book Award. The second edition became available in 2013.
Kraig L. Schell, Ph.D.
Kraig L. Schell is Professor of Psychology, Director of the Consultation and Research Institute (CRI), and Director of Academic Assessment at Angelo State University (TX) as well as Affiliate Professor of Pharmaceutical Outcomes and Policy at the University of Florida. Dr. Schell’s pharmacy-relevant expertise is in the application of psychological principles to patient safety, patient engagement, and employee well-being, as well as organizational assessment and evaluation of processes. He has served as an expert witness in patient safety and has written continuing education for several outlets, including McKesson’s PharmSafety.org, Texas Tech’s Health.edu and RxLaw.
Jason Scott, MSc, MPH, MBA
Jason Scott, MSc, MPH, MBA, currently serves as Area Vice President of Clinical/Care Management Analytics for ComplexCare Solutions (CCS) and is responsible for developing and implementing CCS’s comprehensive clinical analytic strategy, reporting directly to the Corporate Chief Medical Officer.
Prior to joining ComplexCare Solutions, Jason was Director of Healthcare Informatics at Magellan Health, reporting directly to the Corporate Chief Medical Officer. In this role his emphasis was on analytic leadership and consultative support at all subsidiaries, including pharmacy benefits administration programs, specialty and medical pharmaceuticals management, (Magellan Rx Management Inc.), commercial and public sector behavioral health affiliates and integrated health business (Magellan Healthcare Inc. Including Magellan Complete Care and Magellan Federal) and radiology benefits management (NIA Magellan Inc.).
This encompassed overseeing the health informatics staff and operations across the organization, and leading or participating in the development, implementation, and continuous improvement of a corporate health technology infrastructure, predictive modeling programs, risk adjustment programs, provider profiling programs, and clinical study methodology to maximize the return on organizational assets. Jason’s role also included the education, supervision, development, mentoring, and evaluation of health analytic staff personnel in all business units.
Richard Segal, Ph.D.
Richard Segal, Ph.D., is a professor of Pharmaceutical Outcomes & Policy at the University of Florida College of Pharmacy. He also holds faculty appointments in the college’s Department of Pharmacotherapy and Translational Research, and in the UF College of Public Health and Health Professions. His research interests include disease management and outcomes research particularly in the areas of drug prescribing, pharmaceutical care, and medication therapy management.
Segal is widely recognized for his work in explaining why clinical practice is so often inconsistent with evidence-based best practices. His research in the area of changing prescribing behavior has been the basis of prescribing interventions throughout the world. Segal was Co-PI on the first major research project focused on training community pharmacists to identify and prevent drug related problems which contribute to preventable drug related morbidity called Therapeutic Outcomes Monitoring (TOM). Their research has helped to shape many medication therapy management interventions used by Medicare Part D prescription drug plans.
Segal has extensive experience statewide Medicaid and with the Florida Department of Health in data analysis and studying the impact of interventions such as formulary changes, physician profiling, and provider/patient education. He also works closely with technology changes such as bar code medication administration, the College of Pharmacy’s MTM Communication and Call Center, and is seeing ways to improve patient participation rate in MTM services and also in improving physician’s acceptance of drug therapy recommendations. Segal is also collaborating on a series of initiatives with Professor Folake Odedina in addressing health disparities in prostate cancer.
Dr. W. Thomas “Tommy” Smith has served on the faculty of the University of Florida College of Pharmacy since 2008. For his first seven years with the College, he was a part of the residential faculty with active teaching appointments in both the PharmD and graduate programs. He served as director of the online MS program in pharmaceutical outcomes and pharmacy for two years.
In 2015, he became Assistant Dean for Assessment and Accreditation at Manchester University College of Pharmacy. However, he has maintained a faculty appointment at UF and continues as an instructor and Director of the Pharmaceutical Regulation specialty area in the online MS program in pharmaceutical outcomes and policy. Dr. Smith is a 1994 graduate of the St. Louis College of Pharmacy. He began his pharmacy career as the operations director of Corum Health Services, Inc. – a long-term care pharmacy in St. Louis, Missouri.
In 2002, he enrolled in law school at St. Louis University School of Law and graduated in 2005 with a Juris Doctor degree and certificate in health law from the school’s top-ranked Center for Health Law Studies. Dr. Smith served on the faculty of the Saint Louis College of Pharmacy from 2005 to 2008.
A member of the American Bar Association (ABA), the American Society for Pharmacy Law, and the American Association of Colleges of Pharmacy (AACP), Smith has served as an author, speaker and leader in areas such as pharmacy law, cultural competency, health disparities, bioethics, and disability law. In 2013-2014, Dr. Smith completed AACP’s Academic Leadership Fellows Program. He currently is serving a three-year term on the ABA Health Law Section’ leadership council and is the immediate-past chair of AACP’s Health Disparities and Cultural Competence special interest group.
Cody Wiberg, the Executive Director of the Minnesota Board of Pharmacy, received a Doctor of Pharmacy from the University of Minnesota in 1985. He has worked as a clinical pharmacist, community pharmacist and nursing home consultant. From 1999, until he joined the Board in September of 2005, he was the Pharmacy Program Manager for the Minnesota Department of Human Services. In that position, he supervised the staff the managed the State’s publicly funded pharmacy benefits, including those for Medicaid. Dr. Wiberg is a Clinical Assistant Professor for the University of Minnesota College of Pharmacy and an Instructor and Course Director for the University of Florida Graduate School. (From which he received a Master of Science in Pharmacy Policy and Outcomes in 2009). Dr. Wiberg was named to Minnesota Physician’s quadrennial list of the state’s 100 Most Influential Health Care Leaders in 2008, 2012 and 2016.
Almut Winterstein, RPh, Ph.D., FISPE
Almut Winterstein received her pharmacy degree from Friedrich Wilhelm University in Bonn, Germany and her Ph.D. in Pharmacoepidemiology from the Charité Humboldt University in Berlin, Germany. She joined faculty at the University of Florida in 2000 and holds the position of Professor in the Department of Pharmaceutical Outcomes and Policy at the College of Pharmacy, and in the Department of Epidemiology at the Colleges of Public Health and Health Professions and Medicine.
Almut’s research interests focus on drug safety and effectiveness, and the evaluation and prevention of inappropriate medication use. Clinical areas of pharmacoepidemiologic studies include in particular pediatrics, psychiatry, and infectious disease. Her interest in quality of care issues focuses on the development and evaluation of medication safety programs, clinical decision support systems and quality metrics. Almut has received funding from AHRQ, CMS, FDA, NIH and various professional associations and state agencies including the Florida Department of Health. She chairs the FDA/CDER Drug Safety and Risk Management Advisory Board (DSaRM), serves on the Federal Interagency Work Group on Adverse Drug Events, and as consultant on medication safety issues for the Florida.
Gary L. Yingling
Gary L. Yingling draws on his experience as a former US Food and Drug Administration (FDA) lawyer to advise individuals, partnerships, and corporations in matters involving new drug applications, food ingredient marketing, product labeling, importation, regulatory marketing strategy, recalls, seizures, and criminal matters. His practice focuses on food and drug industry issues, with a particular interest in clinical research, contract research organization, and sponsor matters. Clients seek his advice in matters ranging from ingredient safety questions and product labeling to the preparation of New Drug Applications (NDA) and GRAS Notifications.