Pharmacometrics Faculty

Arya

Vikram Arya, PhD, FCP

Dr. Arya earned his Ph.D. in Pharmaceutics from the University of Florida.  He has presented at various national and international conferences and has published peer reviewed articles on drug-drug interactions (DDIs), optimizing drug development in patients with kidney disease, challenges in developing long acting antiretrovirals for treatment and prevention of HIV infection and direct acting antiviral drugs for the treatment of chronic hepatitis C virus infection.  He is a Fellow of the American College of Clinical Pharmacology (ACCP) and serves as President of ACCP. He is a Clinical Pharmacology Team Leader in the Division of Infectious Disease Pharmacology (DIDP), Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), FDA and is primarily responsible for providing technical and strategic leadership on the assessment of clinical pharmacology aspects of antiviral drugs.

He is the recipient of the FDA Outstanding Service Award, FDA Leveraging and Collaboration Award, and several CDER Regulatory Science Excellence and Team Excellence Awards to recognize his contributions to review and active participation in a variety of regulatory science and policy setting initiatives.  He holds an Adjunct Clinical Professor appointment in the Department of Pharmacy Practice at Mercer University, Atlanta, GA, Adjunct Assistant Professor appointment in the Department of Pharmaceutical Sciences at the University of Tennessee, Adjunct Associate Professor appointment in the Department of Pharmaceutics, University of Florida, and Adjunct Professor appointment in the Department of Pharmacotherapy in the University of North Texas System College of Pharmacy. He serves on the Editorial Board of the Journal of Clinical Pharmacology (JCP).

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Ayyappa Chaturvedula, PhD, FCP

Dr. Chaturvedula is an Associate Professor of Pharmacotherapy at the health science center. He received bachelor’s in pharmacy from the University College of Pharmaceutical Sciences (UCPSC), Kakatiya University, India and PhD in Pharmaceutical Sciences from Mercer University, Atlanta, GA. He worked for pharmaceutical industry as product development scientist and clinical pharmacokineticist before moving to academia. He received advanced training in pharmacometrics as a visiting scientist in the Department of Bioengineering and Therapeutic Sciences, School of Pharmacy, University of California San Francisco, in association with the Center for Drug Development Science (CDDS). He has been awarded with 2020 Tanabe Young Investigator award by the American College of Clinical Pharmacology (ACCP). His current research interests are in the application of pharmacometrics in optimizing drug therapy.

 

E Ette

Ene I. Ette, PhD, FCP, FCCP, MBA

Dr. Ette is an accomplished clinical pharmacist, outstanding clinical pharmacologist, pharmacometrician, and drug developer. He is an inventor/co-inventor with several patents, including the first ever reduction in hepatitis C treatment duration from 48 to 24 weeks with telaprevir. Dr. Ette is a fellow of the American Colleges of Clinical Pharmacology and Clinical Pharmacy, a fellow of American Association of Pharmaceutical Sciences, and a Fulbright Specialist Fellow. He is the recipient of the Russell Miller Award and the Therapeutic Frontier Lecture Award. He is the major author of the FDA unique 1999 Guidance for Industry: Population Pharmacokinetics, revised in 2019 after 20 years, a policy document used worldwide in drug development. Dr. Ette is a prolific author and the senior editor of the Pharmacometrics classic reference text, Pharmacometrics: The Science of Quantitative Pharmacology.

 

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Michael J. Fossler, PharmD, PhD, FCP

Dr. Fossler is Vice-President, Clinical Development and Quantitative Sciences, at Trevena, Inc. He received the Pharm. D. (1992) and Ph. D. (1995) degrees from the University of Maryland. From 1995 to 2000, Dr. Fossler was employed by the FDA as a clinical pharmacology reviewer in the Division of Metabolic and Endocrine Drug Products.  In 1998, he was promoted to Senior Reviewer, and joined the Pharmacometrics group at FDA, where he was responsible for reviewing and performing population PK/PD analyses. He left the Agency in 2000 and joined the Clinical Pharmacokinetics Group at DuPont Pharmaceuticals, where he had major responsibility for PK/PD analyses in the cardiovascular and anti-inflammatory areas. In November, 2001, he joined GlaxoSmithKline, where he continued to work in the cardiovascular area, and eventually headed a group of nine pharmacometrics scientists. He left GSK in 2015 to assume his present role at Trevena, Inc., where he heads up clinical pharmacology, clinical operations, biostatistics, programming and data management.

Dr. Fossler is a Fellow of the American Foundation for Pharmaceutical Education, a Fellow of the American College of Clinical Pharmacology, a past President of the College and is an Honorary Regent.  He holds adjunct faculty appointments at the University of Maryland School of Pharmacy, Mercer University, and the University of North Texas, and is on the faculty of the University of California’s American Course on Drug Development and Regulatory Science.

Goyal

Navin K. Goyal, PhD, FCP

Dr. Goyal is currently a Director in Clinical Pharmacology at GlaxoSmithKline, Pennsylvania. Dr. Goyal graduated from the Department of Pharmaceutics in College of Pharmacy at University of Florida, Gainesville. Thereafter, he started at the Clinical Pharmacology, Modeling and Simulation group at GSK. Dr. Goyal’s primary role involves application of clinical pharmacology and pharmacometrics to aid drug development spanning from early clinical studies through registration and beyond. He has worked across multiple therapy areas including respiratory, CNS, cardiovascular and infectious diseases in areas ranging from optimizing formulations to drug development in special populations e.g. pediatric drug development.

Apart from his day job, Dr. Goyal continues to mentor student interns, post-doctoral fellows and scientists within his group at GSK and through external collaborations. He has also served as instructor at clinical pharmacology and pharmacometric workshops in US, EU and India. Dr. Goyal is a Fellow and Board Regent within American College of Clinical Pharmacology (ACCP). He is also an adjunct faculty at the College of Pharmacy at University of Florida.

 

Jann

Michael Jann, PharmD, FCP

Dr. Jann graduated with B.S. in Biology from California State University in Los Angeles and the Doctor of Pharmacy (Pharm.D.) degree from the University of Southern California. He completed a post-doctoral residency in mental health pharmacy practice at the University of Tennessee Health Sciences Center Memphis. Upon completion of the post-doctoral residency, he was the pharmacy director for the San Antonio State Hospital / State School for 4 years and held an adjunct faculty appointment at the University of Texas at Austin College of Pharmacy (UTACOP) located in the Division of Pharmacotherapy in San Antonio. Dr. Jann’s next position for the next four years was a clinical pharmacologist at the San Antonio State School and also a part-time clinical assistant professor with the UTACOP. In 1989, Dr. Jann accepted a full-time faculty appointment at Mercer University College of Pharmacy (MUCOP) as an associate professor.

During the following 25 years, Dr. Jann established a 18-bed Drug Development Research Unit conducting a variety of phase I to phase IV clinical drug trials. He was promoted to full professor in 1993 and became the Department Chair of Pharmacy Practice in 2002. In 2013, Dr. Jann accepted the position of Professor and Department Chair of Pharmacotherapy at the University of North Texas System College of Pharmacy (UNTSCP). He returned to the full-time UNTSCP faculty in 2018. He has authored or co-authored over 250 peer-review publications, book chapters, abstracts, and other scientific publications. He was the senior editor for the book “Applied Clinical Pharmacokinetics and Pharmacodynamics of Psychopharmacological Agents” and a member of six editorial boards for medical and scientific journals.

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Tina Machu, PhD, RPh

Dr. Machu is the Senior Associate Dean of Academic Affairs and Professor of Pharmaceutical Sciences at the UNT System College of Pharmacy with a focus on teaching pharmacology and neurosciences. With more than 20 years in professional and graduate education, Dr. Machu received a BS in Pharmacy and a PhD in Pharmacology from the University of Texas at Austin. She completed postdoctoral training at the University of Colorado Health Sciences Center in Aurora, Colo. Dr. Machu has held previous positions as an Assistant Dean in the Texas College of Osteopathic Medicine (TCOM), UNT Health Science Center and held a faculty position at Texas Tech University Health Sciences Center (TTUHSC) in Lubbock, Tex.

Rasu

Rafia Rasu, PhD, MBA

Dr. Rasu is a health services outcomes researcher. She analyzed numerous national level datasets, EMR, and hospital quality/safety dataset to evaluate effectiveness and safety of care. Her academic and research objectives are focused on pharmacoepidemiology and economic evaluation of health care interventions. Her wide-range of background in pharmacy, epidemiology, economics, finance, and public health allowed her to collaborate with many multidisciplinary professionals. She applied risk adjustment techniques with real world evidence to make informed health care decisions.

Sale

Mark E. Sale, MD, MA

Dr. Sale has been involved in population pharmacokinetic/pharmacodynamic modeling for more than thirty years, including academics, big pharma companies and consulting. He is currently a Senior Vice President of Pharmacometrics at Nuventra PharmaSciences. Hi research interests focus on algorithms, including machine learning algorithms for model selection.

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Annesha White, PharmD, MS, PhD

Dr. White is Associate Dean for Assessment and Accreditation and Associate Professor of Pharmacotherapy at UNT System College of Pharmacy. Her teaching efforts focus on Pharmacoeconomics, Public Health and Pharmaceutical Policy and her primary research interests include the design of studies to address issues in the health services research arena, such as Health Services, Managed Care, Pharmacoeconomics and Outcomes Research. Dr. White has worked on funded projects with the Florida Medicaid program including studies on COX-2 Inhibitors, Hepatitis C and End Stage Renal Disease, in addition to working for the Government Accountability Office (the investigative arm of Congress), to examine Pharmacy Benefit Managers impact on Health Plans, Enrollees, and Pharmacies. Dr. White graduated from Florida A&M University with a Doctor of Pharmacy Degree in 2001. She holds a Master of Science degree with a focus in Pharmacoeconomics and obtained a PhD in Health Services Research from the College of Public Health at the University of Florida with an Alumni Fellowship to support her graduate studies.

 

This page was last modified on May 7, 2020