Clinical and Translational Science

Editorial Team
John A. Wagner, MD, PhD

Senior Vice President, Takeda Pharmaceuticals International Co.
Dr. Wagner's experience encompasses a broad spectrum of clinical and translational science, and he is highly respected for his roles both within and outside of ASCPT. Dr. Wagner has over 20 years of academic and industry professional experience, including pharmaceutical research and development, translational medicine, experimental medicine, clinical pharmacology, biomarkers and surrogate endpoints, modeling and simulation, and precompetitive collaborations. Currently, he is head of Clinical and Translational Sciences at Takeda Pharmaceuticals International Co.  Dr. Wagner received his MD from Stanford University School of Medicine and his PhD from Johns Hopkins University School of Medicine. 

Deputy Editor-in-Chief 
Deanna L. Kroetz, PhD

Professor, University of California, San Francisco
Dr. Kroetz is a Professor of Bioengineering and Therapeutic Sciences in the Schools of Pharmacy and Medicine at the University of California San Francisco where she also directs the Pharmaceutical Sciences and Pharmacogenomics graduate program. Her research interests are in the area of pharmacogenetics with a focus in oncology and HIV. She uses the latest genomic technologies to identify genetic predictors of drug response and toxicity and cells and model organisms to define the molecular basis for these genetic signatures. Dr. Kroetz also conducts research on the role of cytochrome P450 eicosanoids in acute and chronic kidney injury with the long term goal of identifying novel therapeutic approaches to the treatment of these conditions.

Associate Editors
Mark Dresser, PhD
Head of Development Sciences, Denali Therapeutics 
Dr. Dresser is the Head of Development Sciences at Denali Therapeutics, a biotechnology company focused on the discovery and development of therapies for patients with neurodegenerative diseases.  His group is responsible for translational biomarkers, quantitative pharmacology and pharmacometrics, clinical pharmacology, bioanalytical sciences, toxicology, and pathology.  Prior to joining Denali, Dr. Dresser was the Director and Head of the Oncology Clinical Pharmacology Department at Genentech and he served as the Project Team Leader for Genentech’s atezolizumab Anti-PD-L1 molecule, which has received FDA Breakthrough Therapy Designation in bladder cancer and non-small cell lung cancer.  He started his industry career at ALZA Corporation, a Johnson & Johnson Company, where he was an Associate Director in the Department of Clinical Pharmacology.  Dr. Dresser is the Chair of ASCPT’s Scientific Program Committee and is a former member of the Board of Directors of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ).  He earned his Ph.D. in Pharmaceutical Chemistry from UCSF and his B.S. and M.S. degrees in Chemistry from Rensselaer Polytechnic Institute and the Swiss Federal Institute of Technology.

Naoto Uemura, MD, PhD
Oita University Hospital, Japan
Dr. Uemura received his MD and PhD from Oita University Faculty of Medicine and its graduate school following completion of his initial training in internal medicine at Okayama University Hospital.  He was then trained in the United States to be a clinical pharmacologist through Merck Sharp & Dohme International Fellowships in Clinical Pharmacology at the University of California, San Francisco and continued his career in clinical pharmacology at  Merck Research Laboratories, focusing on early clinical development studies from FIH to POC for new drugs.  After spending more than 15 years in the US academia and industry, he returned to Japan in 2014 where he was appointed Professor of Clinical Pharmacology, Oita University Faculty of Medicine, as well as Head of Clinical Pharmacology Center and General Clinical Research Center at Oita University Hospital.   With his extensive experience in building global early development strategies and their executions, Dr. Uemura also serves as a Specially Appointed Professor at Department of Medical Innovation, Osaka University Hospital as well as Clinical Development Director, Riken Program for Drug Discovery and Medical Technology Platforms, supporting various clinical and translational science programs.

Nina Isoherranen, PhD
Associate Professor of Pharmaceutics, School of Pharmacy, University of Washington
Dr. Isoherranen’s main research interests relate to vitamin A disposition and drug-drug interactions. Her NIH funded research incudes studies of the role of CYP26 and ALDH1A enzymes in retinoic acid metabolism and synthesis and the pharmacological consequences of altered activity of these enzymes. She has active research ongoing in characterization of how drug metabolism changes during pregnancy and on developmental toxicity of environmental toxicants and xenobiotics. As part of her research she is a scientific contributor to the University of Washington Drug Metabolism and Transport drug-drug interaction database, and her laboratory continues the research of in vitro-to-in vivo predictions of complex drug-drug interactions related to inhibitory metabolites. Her laboratory also has active ongoing projects with several collaborators on preclinical characterization of the pharmacokinetics and drug disposition of novel small molecule compounds for variety of clinical indications. Dr Isoherranen was the recipient of the Drug Metabolism Division Early Career Achievement Award by ASPET in 2013 and the ISSX North American New Investigator award in honor of James R Gillette in 2014. 

Michael A. Pacanowski, PharmD, MPH
US Food and Drug Administration
Dr. Pacanowski received his PharmD from the Philadelphia College of Pharmacy and his MPH from the University of Florida.  He completed a residency in clinical pharmacology at Bassett Healthcare in Cooperstown, NY, and a clinical research fellowship in cardiovascular pharmacogenomics at the University of Florida. Dr. Pacanowski is currently the Associate Director for Genomics and Targeted Therapy in the Office of Clinical Pharmacology at the US Food and Drug Administration, where he oversees a program focused on reviewing investigational new drugs, developing policies and processes, engaging stakeholders, and conducting regulatory science research.  

Sarah M. Robertson, PharmD
Director, Clinical Pharmacology, Vertex Pharmaceuticals, Inc.
Dr. Robertson received her Bachelor of Science in Chemistry at Marquette University, followed by her Doctor of Pharmacy degree from the University of Wisconsin. She completed a Pharmacy Practice Residency at Northwestern Memorial Hospital in Chicago and a fellowship in Clinical Pharmacokinetics at the National Institutes of Health.  Dr. Robertson was a reviewer in the Office of Clinical Pharmacology in CDER, FDA for 6 years, including three years as the Team Leader for Antiviral Drug Products. She has sat on the NIH-CDC-HIVMA/IDSA Committee on the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV. Dr. Robertson has published and presented extensively on clinical pharmacology topics, many related to antiviral drugs. She is currently a Director at Vertex Pharmaceuticals in the Department of Clinical Pharmacology. 

Valentina Shakhnovich, MD
Children’s Mercy Hospital
Dr. Shakhnovich is an Assistant Professor of Pediatrics and the University of Missouri-Kansas City Medical School and a Pediatric Clinical Pharmacologist and Gastroenterologist at the Children’s Mercy, Kansas City, MO.  She received her MD and pediatric residency training from the University of Wisconsin School of Medicine and Public Health.  She is a graduate of the prestigious NIGMS-NICHD T32 training program in developmental/pediatric clinical pharmacology and completed fellowship training in pediatric gastroenterology and clinical pharmacology at the Children’s Mercy Hospital in 2014 and 2015, respectively.  She has clinical trial experience through work with the Pediatric Trials Network on the impact of obesity on CYP2C19 metabolism in children.  Her research interests include the influence of ontogeny, disease and genetic variability on drug disposition and response in children, with a specific focus on drug metabolizing enzymes and xenobiotic receptors expressed in the pediatric intestinal tract. 

  Chief Science Advisor
Christopher P. Austin, MD

Director, National Center for Advancing Translational Sciences
Christopher Austin is Director of the National Center for Advancing Translational Sciences (NCATS) at the U.S. National Institutes of Health. NCATS’ mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Before becoming NCATS Director in September 2012, he was Director of the NCATS Division of Preclinical Innovation, which focuses on translating basic science discoveries into new treatments, particularly for rare and neglected diseases, and developing new technologies and paradigms to improve the efficiency of therapeutic and diagnostic development. In this role, he founded and directed numerous initiatives including the NIH Chemical Genomics Center (NCGC), the Therapeutics for Rare and Neglected Diseases (TRND) program, and the Toxicology in the 21st Century (Tox21) program. Before joining NIH in 2002, Dr. Austin directed research programs genomics-based target discovery, pharmacogenomics, and neuropsychiatric drug development at Merck, with a particular focus on schizophrenia. Austin earned an A.B. in biology from Princeton University and an M.D. from Harvard Medical School. He completed clinical training in internal medicine and neurology at Massachusetts General Hospital, and a research fellowship in genetics at Harvard.
Chief Patient Advisor
Sharon F. Terry

Sharon F. Terry is President and CEO of Genetic Alliance, a large network engaging individuals, families and communities to transform health. Genetic Alliance works to provide programs, products and tools for ordinary people to take charge of their health.

As ‘just a Mom’ with a master’s degree in Theology, she cofounded PXE International, a research advocacy organization for the genetic condition pseudoxanthoma elasticum (PXE), in response to the diagnosis of PXE in her two children in 1994. With her husband, she co-discovered the ABCC6 gene, patented it to ensure ethical stewardship in 2000, and assigned their rights to the foundation. Se subsequently developed a diagnostic test and conducts clinical trials. She is the author of 140 peer-reviewed papers, of which 30 are clinical PXE studies.

In her focus at the forefront of consumer participation in genetics research, services and policy, she serves in a leadership role on many of the major international and national organizations, including the Precision Medicine Initiative Cohort Advisory Panel, Accelerating Medicines Partnership, Institute of Medicine (IOM) Science and Policy Board, the IOM Roundtable on Translating Genomic-Based Research for Health, the PubMed Central National Advisory Committee, the PhenX scientific advisory board, the Global Alliance for Genomics and Health, the International Rare Disease Research Consortium Executive Committee and as Founding President of EspeRare Foundation of Geneva, Switzerland. Terry is co-founder of the Genetic Alliance Registry and Biobank. She is on the editorial boards of several journals. She led the coalition that was instrumental in the passage of the Genetic Information Nondiscrimination Act. She received an honorary doctorate from Iona College for her community engagement work in 2006; the Research!America Distinguished Organization Advocacy Award in 2009; and the Clinical Research Forum and Foundation’s Annual Award for Leadership in Public Advocacy in 2011. She was named one of FDA’s “30 Heroes for the Thirtieth Anniversary of the Orphan Drug Act” in 2013. She is co-inventor of the Platform for Engaging Everyone Responsibly (PEER). PEER received $500,000 from the Robert Wood Johnson Foundation in 2014. PEER undergirds the Community Engaged Network for All (CENA), a PCORnet member funded in 2013 for Phase I and in 2015 for Phase II. She is Co-PI of the PCORnet Coordinating Center and Chair of the PCORnet Engagement Committee.

Terry is an Ashoka Fellow. With her husband Patrick, she is an avid paragliding pilot, rock climber and weekend farmer.

Editorial Board
John Amory MD, MPH
Ioannis Androulakis, PhD
Akintunde Bello MSc, PhD
Ulf Bredberg, PhD.
Kim L. R. Brouwer, PharmD, PhD
Eileen Dolan, PhD
Jeremy Duffield, MD, PhD
Adam Frymoyer, MD
Andrea Gaedigk, PhD
Richard Hargreaves, PhD
Dan Hartman, MD
Pravin Jadhav, PhD
Mark R. Lackner PhD
Briggs Morrison, MD
Gianluca Nucci, PhD
Min Soo Park, MD, PhD
Saileta Prabhu, PhD

Raj Pradhan, PhD
Daniel Rader, MD
Balmiki Ray, MD
Ronda K. Rippley, PhD
Marcie Ruddy, MD
Michelle A. Rudek, PharmD, PhD
Heleen Scheerens
Catherine Sherwin, PhD
Aubrey Stoch, MD
Joel Tarning, PhD
Rommel Tirona, PhD
Karthik Venkatakrishnan, PhD, FCP
Zaiqi Wang
Harvey Wong, PhD
Sook Wah Yee, PhD

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