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FDA & MCERSI: Pediatric Dose Selection WorkshopBIO BOOKDr. Gilbert Burckart is presently Associate Director for Pediatrics,Office of Clinical Pharmacology, U.S. Food and DrugAdministration. Dr. Burckart has served on the faculties of fouruniversities (Buffalo, Tennessee, Pittsburgh, Southern California)as a Professor of Pharmacy, Pediatrics and Surgery for 33 yearsprior to coming to the FDA. He has previously served as Presidentof the American College of Clinical Pharmacy and as President ofthe American College of Clinical Pharmacology. He moved to theUS FDA in 2008, and his duties include the direction of thePediatric Clinical Pharmacology program within the Office ofClinical Pharmacology, and participation in the FDA’s PediatricReview Committee. His present educational and researchprogram focuses on pediatric drug development studies.E-mail:gilbert.burckart@fda.hhs.govDr. Jeff Barrett is Senior Advisor at the Critical Path Institute (CPath) serving as a critical liaison between C-Path and thepharmaceutical industry, foundations, and other keystakeholders, helping grow C-Path’s portfolio in drugdevelopment solutions, with a focus, but not limited to modelinformed drug development (MIDD) and real world data (RWD)technologies. Jeff also has experience as Head of QuantitativeSciences at the Bill & Melinda Gates Medical Research Institute,and Vice President of Translational Informatics at SanofiPharmaceuticals. Jeff spent 10 years at the University ofPennsylvania where he was Professor, Pediatrics and Director,Laboratory for Applied PK/PD at the Children’s Hospital ofPhiladelphia. Jeff received his B.S. in Chemical Engineering fromDrexel University and Ph.D. in Pharmacokinetics from Universityof Michigan. He has co-authored over 175 manuscripts, and isfellow of both ACCP and AAPS (where he has won numerousawards). Dr. Barrett was awarded for Exceptional Innovation andAdvancing the Discipline of Pharmacometrics at the InternationalSociety for Pharmacometrics (2013) and elected ISOP Fellow(2017). He was a past acting chair of the FDA AdvisoryCommittee for Pharmaceutical Science and ClinicalPharmacology; a voting member of the committee for 8 years.E-mail:jbarrett@c-path.org
Page 2Dr. André Dallmann works as Scientist for Systems Pharmacologyat Bayer, Germany. He completed his PhD in Clinical Pharmacy atthe University of Münster, Germany, in 2017. Thereafter, heworked as a postdoctoral researcher at the PediatricPharmacology & Pharmacometrics Research Center at theUniversity Children’s Hospital Basel in Switzerland and joined thedepartment of Clinical Pharmacometrics at Bayer in 2018. Hisresearch interests focus on in vitro to in vivo extrapolation fororal drug formulations, DDI modeling and the exploration ofobstetric and neonatal pharmacology through PBPK modeling.E-mail:andre.dallmann@bayer.comDr. Joga Gobburu is a Professor with the School of Pharmacy andthe School of Medicine, University of Maryland, Baltimore, MD,USA. He held various positions at the US FDA between 1998 and2011.E-mail:jgobburu@rx.umaryland.eduDr. Daniel Gonzalez, Pharm.D., Ph.D., is an associate professor inthe Division of Pharmacotherapy and Experimental Therapeuticsof the UNC Eshelman School of Pharmacy. He has an adjunctappointment within the Department of Pediatrics in the UNCSchool of Medicine. He joined the UNC Eshelman School ofPharmacy in 2014 after completing a postdoctoral fellowshipthrough the UNC-Duke Collaborative Clinical Pharmacology T32Postdoctoral Training Program. Gonzalez received his Pharm.D.and Ph.D. from the University of Florida College of Pharmacy in2008 and 2012, respectively. His research interests includepediatric clinical pharmacology and the application ofmathematical modeling and simulation techniques tocharacterize the pharmacokinetics and pharmacodynamics ofdrugs, guide drug dosage selection, and improve drug safety inchildren. Gonzalez’s research program is funded by the EuniceKennedy Shriver National Institute of Child Health and HumanDevelopment (NICHD), and he has published 75 peer-reviewedpublications and 40 abstracts.E-mail:gonzalezd@email.unc.edu
Page 3Dr. Dionna Green is the Deputy Director of the Office of PediatricTherapeutics in the Office of Clinical Policy & Programs in theOffice of the Commissioner at the US FDA. The Office of PediatricTherapeutics is charged with assuring access for children toinnovative, safe, and effective medical products. Dr. Green hasbeen with the US FDA since 2009 and originally worked as aMedical Officer in the Office of Clinical Pharmacology in theCenter for Drug Evaluation and Research (CDER). Dr. Green’straining is in pediatric medicine and clinical pharmacology andher research interests include regulatory science and innovativepediatric clinical trial methodology.E-mail:dionna.green@fda.hhs.govDr. Ibrahim Ince has an interdisciplinary background ometrics. After completing his PhD in 2013, he workedas a consultant PK-PD modeler at LAP&P in Leiden, TheNetherlands. In 2014 he joined Bayer AG in Germany, where hecurrently works as Scientist for Systems Pharmacology andMedicine and Pharmacometrics leader in the field of oncology,infectious disease, cardiovascular disease and pediatric drugdevelopment in the department of Clinical Pharmacometrics. Hisresearch interests include various applications of PBPK modeling,such as PK translation to pediatric populations and other specialpopulations, and preclinical to clinical extrapolations.E-mail:Ibrahim.Ince@bayer.com
Page 4Dr. Alice Ke obtained her PhD in pharmaceutics from theUniversity of Washington, Seattle, where her research wasfocused on the assessment of fetal and CNS drug distributionusing clinical imaging techniques. She then accepted an ORISEfellowship in the Office of Clinical Pharmacology at the FDA,where she developed and validated PBPK and population PKmodels to support dose adjustment for pregnant women. Aftercompleting her fellowship, Dr. Ke was a research scientist in theDepartment of Drug Disposition and PK/PD at Lilly ResearchLaboratories, where she applied population PK and PBPKmodeling & simulation techniques to provide model-basedadvice on the design of clinical pharmacology studies. Currently,Dr. Alice Ke is a senior Consultant and Scientific Advisor atSimcyp. She has over 10 years of experience in applyingmechanistic modelling and simulation to influence drug researchand development programs. Her research interests continue tocenter around the applications of PBPK and PK/PD modeling topredicting complex drug interactions and PK/PD in specialpopulations.E-mail: alice.ke@certara.comDr. Mona Khurana has been a Pediatric Team Leader in theDivision of Pediatric and Maternal Health in the Center for DrugEvaluation and Research at FDA since 2016. In this role, herefforts predominantly focus on working collaboratively withreview divisions in the Office of New Drugs to promote pediatricdevelopment of small molecules and therapeutic biologics in alltherapeutic areas. Dr. Khurana is board certified in generalpediatrics and in pediatric nephrology. Prior to joining FDA in July2009, Dr. Khurana was an Assistant Professor of Pediatrics atChildren’s National Hospital in Washington DC where sheprimarily managed hospitalized children with kidney disease,including those requiring dialysis and kidney transplant.E-mail:Mona.Khurana@fda.hhs.gov
Page 5Efthymios Manolis is since 2007 a scientific officer in theEuropean Medicines Agency (EMA). He is the focal point onpharmacometrics in the Agency. He had a central role in theestablishment of the EMA modelling and simulation workingparty, and the organisation of many international workshops. Heis author of multiple articles in peer reviewed journals. Beforejoining the Agency, Efthymios worked as modeller in industry.Efthymios obtained his pharmacy degree from the NationalUniversity of Athens, Greece in 2002 and his MSc degree inPK/drug metabolism and modelling from Paris XI University,France, in 2003.E-mail:efthymios.manolis@ema.europa.euDr. Bernd Meibohm, Ph.D., is a Professor of PharmaceuticalSciences and Associate Dean for Research and GraduatePrograms at the College of Pharmacy, The University ofTennessee Health Science Center, Memphis, Tennessee. Hereceived his pharmacy degree and doctoral degree inpharmaceutics from Technical University Carolo-Wilhelmina,Braunschweig, Germany. After completion of a clinicalpharmacology research fellowship at the University of Florida in1997, he joined the faculty of the University of South Carolina,and in 1999 the University of Tennessee. Dr. Meibohm’sscientific interests include pulmonary infectious andinflammatory diseases, pediatric pharmacotherapy and theapplication of quantitative modeling and simulation techniquesin preclinical and clinical drug development, with specific focuson therapeutic proteins.E-mail:bmeibohm@uthsc.edu
Page 6Dr. Jill A. Morgan is a Professor and Chair in Pharmacy Practiceand Science at the University of Maryland School of Pharmacy.She received her Doctor of Pharmacy degree from the Universityof Illinois Chicago and completed pharmacy practice andpediatric pharmacy specialty residencies at the University ofMaryland Medical Center in Baltimore, Maryland. She is aPediatric Clinical Pharmacy Specialist with practice sites at thePresident’s Interdisciplinary GI clinic and the Children’s HospitalIntestinal Rehabilitation Program (CHIRP) at the University ofMaryland Medical Center. For several years, Dr. Morgan hasbeen teaching pediatric and neonatal pharmacotherapy tonursing and pharmacy students as well as medical residents. Shehas performed research in a variety of areas related to pediatrics.Dr. Morgan is the Director for the Pediatric Pharmacy Fellowshipprogram. She is also a board-certified aryland.eduDr. Clinton Stewart is a Member in the Pharmaceutical SciencesDepartment of St. Jude Children’s Research Hospital, Memphis,TN, where he directs a translational research laboratory focusedon developmental therapeutics for children with CNSmalignancies. Clinton has a particular interest in the studying theCNS penetration of drugs in mouse models using microdialysistechniques. He received his BS in Pharmacy from AuburnUniversity and PharmD from the University of Tennessee HealthScience Center.E-mail:clinton.stewart@stjude.org
Page 7Dr. John van den Anker, M.D., Ph.D., FAAP, FCP, is a Professor ofPediatrics, Pharmacology, Physiology, Genomics and PrecisionMedicine at the George Washington University School ofMedicine and Health Sciences, Washington, DC and holds theEvan and Cindy Jones Endowed Chair in Pediatric ClinicalPharmacology. He also is the Eckenstein-Geigy DistinguishedProfessor of Pediatric Pharmacology at the University Children’sHospital of Basel, University of Basel, Switzerland. Dr. van denAnker has been the President of the American College of ClinicalPharmacology (2016-2018) and twice the President of theEuropean Society of Developmental, Perinatal and PaediatricPharmacology (2006-2008 and 2017-2019). His awards includethe Distinguished Investigator Award from the American Collegeof Clinical Pharmacology (2008), the Distinguished Researcheraward of the George Washington University (2012), and theSumner J. Yaffe Lifetime Achievement Award in PediatricPharmacology and Therapeutics (2019) from the PediatricPharmacy Association. Over the past 30 years, Dr. van denAnker’s research has focused on developmental, neonatal andpediatric pharmacology. He has authored over 450 peerreviewed publications and has received NIH funding as well asfunding from the European Union to support his research and thedevelopment of training programs in Pediatric ClinicalPharmacology.E-mail: JVandena@childrensnational.orgDr. Alexander “Sander” Vinks, Ph.D., Pharm.D., FCP, is Professorof Pediatrics and Pharmacology at the University of Cincinnati,College of Medicine. He is the Cincinnati Children’s ResearchFoundation Endowed Chair and Director of the Division of ClinicalPharmacology. He serves as the program Director of the EuniceKennedy Shriver National Institute of Child Health and HumanDevelopment (NICHD) Pediatric Clinical Pharmacology T32training program at Cincinnati Children’s Hospital MedicalCenter. He directs a multidisciplinary Pharmacometrics Center ofExcellence, is Co-Director of Cincinnati Children’s GeneticPharmacology Service, and is Scientific Director for PharmacyResearch in the Division of Patient Services. His researchinterests include pharmacokinetic-pharmacodynamic ogenetics/genomics, and the application of populationand simulation methods to inform pediatric clinical trial designand therapeutic drug management through the egies.E-mail:sander.vinks@cchmc.org
Page 8Dr. Jian Wang, Ph.D., is Associate Director for Regulatory Scienceat the Office of Specialty Medicine, Office of New Drugs, Centerfor Drug Evaluation and Research at the US Food & DrugAdministration (FDA). He obtained his PhD in Pharmacology andpharmaceutics science from the University of SouthernCalifornia.E-mail: Jian.Wang@fda.hhs.govDr. Yaning Wang, Ph.D., is the Director of the Division ofPharmacometrics in the Office of Clinical Pharmacology at FDA.Before joining FDA, Dr. Wang received his Ph.D. in Pharmaceuticsand master’s degree in Statistics from the University of Floridafrom 1999 to 2003. He also obtained a master’s degree inBiochemistry (1999) from National Doping Control Center and abachelor’s degree in Pharmacy (1996) from Peking University inChina. Dr. Wang oversees reviews, research projects, and policydevelopment within the Division of Pharmacometrics for alldisease areas.E-mail: yaning.wang@fda.hhs.govDr. Jun Yang is a is a Member (Professor) in the Department ofPharmaceutical Sciences, Department of Oncology at St. JudeChildren’s Research Hospital. His research program focuses ongenomics-guided precision medicine for pediatric cancers,especially the pharmacogenetics of adverse drug effects and itsclinical implementation. With childhood acute lymphoblasticleukemia (ALL) as a model disease, his group is a leader in usinggenome-wide association studies (GWAS) to discover genetic riskvariants related to a variety of leukemia treatment response andtoxicity phenotypes, many of which have direct clinical relevance.Dr. Yang’s group is part of the National Institutes of HealthPharmacogenomics Research Network and he serves as the Coleader of the Center for Precision Medicine in Leukemia. Dr. Yangis a member of the Children’s Oncology Group.E-mail:jun.yang@stjude.org
Page 9Dr. Lynne Yao, M.D., is the Director, Division of Pediatric andMaternal Health in the Office of New Drugs, Center for DrugEvaluation and Research. Dr. Yao received a B.S. degree inBiology from Yale University, and an M.D. degree from theGeorge Washington University School of Medicine. She is boardcertified in both Pediatrics and Pediatric Nephrology. Prior tojoining FDA, Dr. Yao was the Director of Dialysis and AssociatePediatric Residency Program Director at the Inova FairfaxHospital for Children in Fairfax, VA. She has been with the FDAsince 2008. The Division of Pediatric and Maternal Healthoversees quality initiatives which promote and necessitate thestudy of drug and biological products in the pediatric population;and improve collection of data to support the safe use of drugsand biological products in pregnant and lactating individuals. Shecollaborates with numerous stakeholders both inside andoutside of FDA to advance development of safe and effectivetherapies for children, and pregnant and lactating women.E-mail:lynne.yao@fda.hhs.govDr. Hao Zhu, Ph.D., is the deputy director at the Division ofPharmacometrics, Office of Clinical Pharmacology, Center ofDrug Evaluation and Research, U.S. Food and DrugAdministration (FDA).Dr. Zhu received his Ph.D. inpharmaceutical sciences and Master in statistics from theUniversity of Florida. He started his career in modeling andsimulation teams in Johnson & Johnson and Bristol-MyersSquibb. He joined FDA as a pharmacometrics reviewer more than13 years ago. His division reviews the pharamcometrics relatedsubmissions and supports pharamcometrics-related policydevelopment.E-mail: hao.zhu@fda.hhs.gov
pediatric pharmacy specialty residencies at the University of Maryland Medical Center in Baltimore, Maryland. She is a Pediatric Clinical Pharmacy Specialist with practice sites at the President’s Interdisciplinary GI clinic and the Children’s Hospital Intestinal Rehabilitation Prog
