Borje Darpo, MD, PhD

Chief Scientific Officer, Cardiac Safety, ERT

Borje Darpo, MD, PhD is board certified in cardiology and previously Associate Professor of Cardiology at the Karolinska Institute, Sweden. He specialized in clinical electrophysiology and presented his thesis on the clinical development of an antiarrhythmic drug in 1995. In 1998 he joined Pharmacia and has held positions as Clinical Program Leader in Cardiovascular, Regional Head of EU for Clinical Pharmacology and Senior Director in Pfizer’s Clinical Technologies group in Sandwich, UK. Between April 2004 and March 2006, Dr Darpo held the position as Chief Medical Officer of Daiichi Medical Research in UK and USA.

In 1997 Dr. Darpo participated as a member of the expert committee that drafted the CPMP’s “Points to Consider” on clinical QT assessment. Dr Darpo represented the European Pharmaceutical industry (EFPIA) as deputy topic leader of the ICH E14 Expert Working Group and Implementation Working Group between 2000 and 2008.
As the co-chair of the Scientific Oversight committee of CSRC, Dr Darpo led and coordinated the successful IQ-CSRC study, which contributed to the revision of the ICH E14 clinical guidance on QT assessment. He currently serves as the Chief Scientific Officer, Cardiac Safety of ERT, and works with sponsor clients on strategies for ECG assessment in clinical development and design and analysis of ECG studies.

Guohua An, MD, PhD

Assistant Professor

 Dr. An joined Ruijin Hospital for 2 years as a clinical pharmacist and research scientist after receiving her MD from Taishan Medical College and MS in Clinical Pharmacology from Fudan Univ. Then she pursued a further study and got her PhD degree in Pharmaceutical Sciences from SUNY at Buffalo. Her graduate research focused on the role of transporter on the pharmacokinetics (PK) and pharmacodynamics (PD) of anticancer agents. Her research was further expanded after she joined the R&D group of Abbott, where she gained extensive hands on experience in clinical drug development, PK/PD modeling and simulation. Prior to joining Univ of Iowa, Dr. An worked at Univ of Florida as an Assistant Professor for one and half years. Her research interests include mechanism-based PK/PD modeling, model-informed drug development, pediatric clinical pharmacology, quantitative systems pharmacology, as well as applying proteomics in allometric scaling and IVIVE.  Dr. An has been in the PK/PD field for 15 years and has published 66 peer-reviewed articles. Dr. An serves as an editorial board member for The Journal of Clinical Pharmacology (since 2014), Journal of Pharmaceutical Sciences (since 2016), and The AAPS Journal (since 2020). 

Alexander J. Prokopienko, PharmD, PhD (Moderator)

Clinical Pharmacologist

Dr. Prokopienko graduated from Albany Coll of Pharmacy with his PharmD and subsequently from the Univ of Pittsburgh with his PhD in Clinical Pharmaceutical Sciences. During his PhD, Alex was selected as a recipient of the AFPE Pre-Doctoral fellowship, NIH TL1 Post-Doctoral fellowship and NIH Clinical Research Loan Repayment Program. After completing his PhD, he joined Vertex Pharmaceuticals as a Clinical Pharmacologist. 

Michael Fossler, PharmD, PhD

Vice-President, Clinical Development and Quantitative Sciences

Dr. Fossler is Vice-President, Clinical Development and Quantitative Sciences, at Trevena, Inc. He received the Pharm. D. (1992) and PhD (1995) degrees from the Univ 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 (GSK), 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 Univ of Maryland School of Pharmacy, Mercer Univ and the Univ of North Texas, and is on the faculty of the Univ of California’s American Course on Drug Development & Regulatory Science.

Lorraine Rusch, PhD

Vice President, Scientific Strategy & Commercial Development

Dr. Rusch is the Vice President, Scientific Strategy & Commercial Development at Celerion. Dr. Rusch is a metabolism chemist by training, holding a PhD in Bioanalytical Chemistry and Laboratory Medicine. She has led IND and NDA programs at biotechnology companies as well as launched clinical pharmacology offerings in areas as diverse as human abuse liability, QTc cardiovascular safety assessment and metabolic disease offerings at leading CROs. As an experienced drug development professional, Dr. Rusch has significant preclinical and translational medicine expertise designing, overseeing and executing NDA-enabling studies with a focus on challenging areas of translational development. She provides clinical pharmacology leadership of the medical and operations clinical team for early clinical pharmacology studies evaluating the safety profiles of renally-eliminated novel drug candidates in potentially vulnerable or impaired patient populations.

Oliver Grundmann, PhD (Moderator)

Clinical Associate Professor, Director, Univ of Florida Coll of Pharmacy, Medical Chemistry

Dr. Grundmann is the Clinical Associate Professor and Director of Graduate Programs in Clinical Toxicology & Pharmaceutical Chemistry at the Coll of Pharmacy, Univ of Florida. His primary research focus is centered on natural products, specifically with CNS activity for depression, anxiety and other mood disorders. Clinical investigations into potential integrative and complementary use of natural products in a variety of best practice settings have provided him with a wide range of collaborative opportunities. Aside from his research interests, Dr. Grundmann is a staunch advocate for interdisciplinary and collaborative teaching in a connected global world allowing him to travel and frequently meet with colleagues and students from all areas of the world. In a sense, both a holistic research and teaching approach. He has been a member of ACCP, a Fellow and serves currently on the Board of Regents. As part of his ongoing research collaborations, he is familiar with the significant efforts involved in writing and publishing a scientific manuscript.

Alexander J. Prokopienko, PharmD, PhD (Moderator)

Clinical Pharmacologist

Dr. Prokopienko graduated from Albany Coll of Pharmacy with his PharmD and subsequently from the Univ of Pittsburgh with his PhD in Clinical Pharmaceutical Sciences. During his PhD, Alex was selected as a recipient of the AFPE Pre-Doctoral fellowship, NIH TL1 Post-Doctoral fellowship and NIH Clinical Research Loan Repayment Program. After completing his PhD, he joined Vertex Pharmaceuticals as a Clinical Pharmacologist. 

Joshua Brown, PharmD, PhD

Assistant Professor

Joshua Brown joined the Dept. of Pharmaceutical Outcomes and Policy as an assistant professor in 2016. He has experience in clinical pharmacy, health economics and outcomes research, and pharmacoepidemiology across academic, pharmaceutical industry, and managed care. His past and ongoing clinical interests have been in the cardiovascular and hematology/oncology therapeutic areas including comparative effectiveness and safety research with a focus on anti-coagulation and quality of care in thrombotic conditions such as atrial fibrillation, venous thromboembolism, and cancer. His current research program and collaborations focus on research methods for pharmacoepidemiologic and pharmacoeconomic generic and biosimilar evaluations, developing real-world evaluations of drug-drug interactions, and drug re-purposing studies (e.g. aging and Parkinson’s Disease). In 2017, Brown was named a Claude D. Pepper Junior Scholar to conduct translational research in geriatric pharmacoepidemiology and healthy aging. His academic work has been funded by the NIH, FDA, Bill & Melinda Gates Foundation, and the PhRMA Foundation in addition to contracts with pharmaceutical industry. Dr. Brown has published over 75 research articles and holds several editorial positions with high impact specialty journals in pharmacy and cardiovascular diseases and is actively involved in AMCP, ISPE, and ISPOR scientific societies. Dr. Brown was awarded as the AMCP Foundation’s “New Practitioner” for his early career contributions to managed care pharmacy and as a National Academy of Medicine Emerging Leader in 2019.

Mariam Ahmed, PhD (Moderator)

Clinical Pharmacology Reviewer

Dr. Mariam Ahmed is an early career clinical pharmacologist. She is currently a clinical pharmacology reviewer at the US Food and Drug Administration. Dr. Ahmed graduated from the University of Minnesota. Her thesis focused on applications of quantitative clinical pharmacology to rare diseases. 

Jennifer Goldman, MD, MS

Associate Professor, Pediatrics, Children's Mercy Kansas City

Dr. Goldman is a pediatric infectious diseases physician and clinical pharmacologist. She serves as the Medical Director of both the Antimicrobial Stewardship Program and the Drug Safety Service at Children's Mercy in Kansas City. Dr. Goldman's primary research is focused on pediatric adverse drug reactions. She is investigating potential biomarkers that may predict and hopefully prevent severe adverse drug reactions in the future. Her long term goal is to individualize therapeutic treatment in children so that unintended consequences of medications can be avoided. Her research has been funded by the National Inst of Health, Kansas City Area Life Sciences Inst, and the Marion Merrell Dow Clinical Scholars Award.

Sarah Suppes, PharmD

Clinical Pharmacy Specialist

Dr. Suppes is a Clinical Pharmacy Specialist in the Division of Clinical Pharmacology, Toxicology and Therapeutic Innovation at Children’s Mercy - Kansas City and holds an adjunct faculty appointment at the University of Missouri-Kansas City (UMKC) School of Pharmacy.  She leads the Drug Safety Service which is a hospital-wide pharmacovigilance program, specializing in the identification and documentation of adverse drug reactions throughout the hospital.  She is actively involved in several clinical and research initiatives related to pediatric adverse drug reactions including the de-labeling of penicillin allergies in children and optimizing antimicrobial prescribing.  

Claude Abdallah, MD, MS (Moderator) (Moderator)

Associate Professor, Children's National Health System

Dr. Abdallah is a Pediatric Anesthesiologist, Associate Professor, at Children's National Health System. Dr. Abdallah joined ACCP in 2013 and was actively involved in the Honors & Award Committee from 2014 – 2016. She then joined the Education Committee in 2016. Dr. Abdallah received an MD from St Joseph's Univ Medical School in Beirut, Lebanon and then received her Master's in Pharmacology from Université de Montréal, Canada. She performed her residency in Anesthesiology at Yale-New Haven Hosp followed by a fellowship in pediatric anesthesia at the Hosp for Sick Children, Toronto, Canada. She has authored several publications in peer reviewed journals, abstracts and presented her research regionally, nationally and internationally at educational and organizational venues. She has been in practice for more than 15 years and has an interest in clinical research and pharmacology. 

Joseph S. Bertino Jr., PharmD, FCP, FCCP

Editor-in-Chief The Journal of Clinical Pharmacology

Dr. Bertino is currently a Principal at Bertino Consulting, located in Schenectady, NY.  He is an Associate Professor of Pharmacology at the College of Physicians and Surgeons, Columbia University, New York, NY and an adjunct Associate Professor at the University at Buffalo School of Pharmacy.  He is also an Honorary Professor, Hanoi University of Pharmacy and a Distinguished Professor of the Hai Phong University of Medicine and Pharmacy. Dr. Bertino received his B.S.Pharmacy and Pharm.D. degrees from the University at Buffalo in Buffalo, NY, USA.  He has published over 100 original research papers, review articles and book chapters and a textbook of pharmacogenomics. His publications have included work in the area of antimicrobial pharmacokinetics, pharmacodynamics and toxicity, drug-drug interactions, general clinical pharmacology, vaccine pharmacology and the application of pharmacogenetics and pharmacogenomics to the drug development process.

He serves on the Editorial Board of The European Journal of Clinical Pharmacology and Antimicrobial Agents and Chemotherapy.  Dr. Bertino has served on the Food and Drug Administration’s Antiinfective and Antiviral Advisory Committees.  He also serves as the Editor-in-Chief of the Journal of Clinical Pharmacology.

David J. Greenblatt MD, FCP

Professor, Tuffs Univ School of Medicine, Editor-in-Chief, Clinical Pharmacology in Drug Development

Dr. Greenblatt has been on the Faculty of Tufts University School of Medicine and the Staff of Tufts Medical Center since 1979.  He holds the Louis Lasagna, M. D., Endowed Professorship at Tufts University School of Medicine, in the Department of Immunology (formerly the Department of Pharmacology and Experimental Therapeutics), and is a senior faculty member in the Graduate Program in Pharmacology & Experimental Therapeutics at the Sackler School of Graduate Biomedical Sciences at Tufts University. He also holds appointments as Professor of Psychiatry, Medicine, and Anesthesia, Tufts University School of Medicine.  He has previously served as Chair of the Department of Pharmacology and Experimental Therapeutics at Tufts University School of Medicine, Program Director and Associate Program Director of the institution’s Clinical/Translational Research Center (formerly the General Clinical Research Center), and Chair of the Institutional Review Board. He is Editor-in-Chief of Clinical Pharmacology in Drug Development, operated by the American College of Clinical Pharmacology.  He also is Co-Editor-in-Chief, with Dr. Richard I. Shader, of the Journal of Clinical Psychopharmacology,

A native of Newton, Massachusetts, Dr. Greenblatt is a Magna Cum Laude graduate of Amherst College (1966), where he was senior class president and co-captain of the varsity football team. After college he attended Harvard Medical School, graduating in 1970.  Thereafter he trained in internal medicine at the Montefiore Hospital, New York City (1970-1971), and on the Harvard Medical Service at Boston City Hospital (1971-1972).  Following a Fellowship in Clinical Pharmacology at Massachusetts General Hospital under the mentorship of Dr. Jan Koch-Weser (1972-1974), he stayed on to head the Clinical Pharmacology Unit at Mass. General from 1975 to 1979, at which time he moved to Tufts.

Stephan Schmidt, PhD

Associate Professor

Dr. Schmidt is an endowed, tenured Associate Professor at the Univ of Florida’s Ctr for Pharmacometrics & Systems Pharmacology in Lake Nona, Orlando. He currently serves as the Associate Director of the Ctr. His research focuses on the development and application of mechanism-based drug-disease models in the area of antimicrobial chemotherapy, pediatrics, diabetes, cardiovascular safety and post-menopausal osteoporosis. Dr. Schmidt published more than 60 peer-reviewed articles in highly-respected journals in the clinical pharmacology arena as well as four book chapters. He is the lead editor of a book entitled, Applied Pharmacometrics, published in 2014 as part of an AAPS series on advancing pharmaceutical sciences. Dr. Schmidt received the Paul Ehrlich Society for Chemotherapy Thesis Award in 2010, the Univ of Florida Clinical Translational Science Inst Junior Faculty Pilot Program Award in 2012, the Univ of Florida Excellence Award for Assistant Professors in 2013 and the Tanabe Young Investigator Award from the American Coll of Clinical Pharmacology® (ACCP) in 2016. He serves as the Chair of the Special Interest Group on PK/PD and Systems Pharmacology of the Intl Pharmaceutical Federation (FIP) and the is the immediate Past Chair of the Systems Pharmacology Community for the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Dr. Schmidt is a Section Editor for the European Journal of Pharmaceutical Sciences and Editorial Board Member for The Journal of Clinical Pharmacology and ASCPT’s Pharmacometrics and Systems Pharmacology journal.

Matthew B. Dufek, PhD

Associate Director

Dr. Dufek completed his graduate training at the University of North Carolina at Chapel Hill and is currently a Director of Clinical Development at AbbVie Inc in Chicago, IL. For over 20 years, Dr. Dufek has worked at several small biotechnology as well as large pharmaceutical companies. Joining AbbVie in 2012, he currently holds a position as a Director of Clinical Development in the Department of Clinical Pharmacology & Pharmacometrics where he helps lead the clinical pharmacology & clinical development strategy/team for the development of new pharmaceutical therapies as well as supporting a diverse portfolio of marketed products. These projects have included supporting therapeutic areas of pulmonary medicine, immunology, men’s & women’s health, anti-infective (HIV, RSV and HCV), oncology, renal and pediatrics therapies. Dr. Dufek has an interest and has lectured at many conferences throughout the world as a leading expert in the development of novel approaches for pediatric drug development.

Oliver Grundmann, PhD

Clinical Associate Professor, Director, Univ of Florida Coll of Pharmacy, Medical Chemistry

Dr. Grundmann is the Clinical Associate Professor and Director of Graduate Programs in Clinical Toxicology & Pharmaceutical Chemistry at the Coll of Pharmacy, Univ of Florida. His primary research focus is centered on natural products, specifically with CNS activity for depression, anxiety and other mood disorders. Clinical investigations into potential integrative and complementary use of natural products in a variety of best practice settings have provided him with a wide range of collaborative opportunities. Aside from his research interests, Dr. Grundmann is a staunch advocate for interdisciplinary and collaborative teaching in a connected global world allowing him to travel and frequently meet with colleagues and students from all areas of the world. In a sense, both a holistic research and teaching approach. He has been a member of ACCP, a Fellow and serves currently on the Board of Regents. As part of his ongoing research collaborations, he is familiar with the significant efforts involved in writing and publishing a scientific manuscript.