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  1. FDA Meetings, Conferences and Workshops

Speakers' Biographies: Advancing the Development of Pediatric Therapeutics (ADEPT): Application of "Big Data" to Pediatric Safety Studies

September 18 - 19, 2017

Michael D. Blum, MD, MPH is currently Deputy Director, Office of Pharmacovigilance and Epidemiology in the CDER Office of Surveillance and Epidemiology.  He is a pediatric infectious diseases specialist.  Dr. Blum worked as a medical reviewer in the CDER Division of Anti-Infective Drug Products, followed by over 20 years in the pharmaceutical industry in a variety of vaccine and safety leadership positions.  He has experience in the industry with the use of real-world data for safety and risk management purposes and, in his current position, a strong interest in extending the use of real-world data for effectiveness and other regulatory decisions. (Michael.blum@fda.hhs.gov)

Jeff Brown, PhD is an Associate Professor in the Department of Population Medicine (DPM) at Harvard Medical School and the Harvard Pilgrim Health Care Institute.  He is Research Director of the Therapeutics Research and Infectious Disease program at DPM and Associate Director of the FDA’s Mini-Sentinel project. Dr. Brown is a health services researcher with expertise in pharmacoepidemiology and medical product safety, with primary research interests in the development of approaches to facilitate multi-institutional medical product safety surveillance and research using electronic health data. Dr. Brown is the lead architect and inventor of PopMedNet, an open-source software platform that facilitates the creation and operation of large-scale distributed health data networks. He is the co-lead of the PCORnet Distributed Research Network Operations Center, co-chair of the Informatics Core of the NCI Cancer Research Network, and co-lead of the EHR Core of the NIH Health Care System Research Collaboratory. (jeff_brown@harvardpilgrim.org)

Bruce Carleton, PharmD is Professor and Chair, Division of Clinical Pharmacology, Department of Pediatrics, Faculty of Medicine, University of British Columbia.  He also holds appointments in the Department of Medical Genetics, School of Population and Public Health, Centre for Health Services and Policy Research and the Faculty of Pharmaceutical Sciences.  He founded the Canadian Pharmacogenomics Network for Drug Safety in 2004 with a special emphasis on pediatric drug outcomes. The network has enrolled nearly 100,000 adverse drug cases and drug-matched controls, all with DNA and complete adverse drug event data collected. (bcarleton@popi.ubc.ca)

Robert M. Califf, MD, MACC is vice chancellor for health data science and director of the Center for Integrated Health Data Science at Duke Health, the Donald F. Fortin, MD Professor of Cardiology in the Duke University School of Medicine, and an advisor for Verily Life Sciences, a member of the Alphabet family of companies formed by Google. He served in the administration of President Barack Obama as Deputy Commissioner for Medical Products and Tobacco in the U.S. Food and Drug Administration (FDA) from 2015-106, and as Commissioner of Food and Drugs from 2016-2017. Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke. robert.califf@duke.edu

Alison Cave, PhD is a Principal Scientific Administrator at the European Medicines Agency within the Pharmacovigilance and Epidemiology Department where she leads work developing mechanisms to increase capacity in the use of real world data in medicines regulation. She co-chairs the recently established HMA-EMA Big Data taskforce. She has over 20 years of academic research experience in the cardiovascular field including post-doctoral fellowships in US and London before joining King’s College London where she was a Senior Lecturer.  Prior to joining the EMA she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and, prior to this, an Expert Scientific Assessor at the UK Medicines and HealthCare products Regulatory Agency. (Alison.Cave@ema.europa.eu)

William O. Cooper, MD, MPH is the Cornelius Professor and Vice Chair for Faculty Affairs, Department of Pediatrics and Professor of Health Policy, Vanderbilt University.  Dr. Cooper is a pediatrician and pharmacoepidemiologist who focuses on the adverse effects of prescription medications as an epidemiologist and child health services researcher.  He is on the executive faculty of the Vanderbilt Center for Health Services Research.  He led a recent FDA- and AHRQ-funded multi-site study of sudden cardiovascular death in children who take stimulant medications for ADHD, which was published in New England Journal of Medicine.  (william.cooper@Vanderbilt.Edu)

Joshua C. Denny, MD, MS is a Professor of Biomedical Informatics and Medicine, Director of the Center for Precision Medicine and Vice President of Personalized Medicine at Vanderbilt University Medical Center. He is Principle Investigator (PI) of nodes in the Electronic Medical Records and Genomics (eMERGE) Network, Pharmacogenomics Research Network (PGRN), and the Implementing Genomics into Practice (IGNITE) Network. He is PI of the Data and Research Center of the Precision Medicine Initiative (PMI) All of UsSM  Research Program. Dr. Denny remains active in clinical care and in teaching students.( josh.denny@Vanderbilt.Edu)

Finale Doshi-Velez, PhD is an Assistant Professor in Computer Science at the Paulson School of Engineering and Applied Sciences at Harvard University.  Her interests lie in the intersection of machine learning and healthcare.  Prior to joining the faculty at Harvard, she was an NSF CiTRaCS postdoctoral fellow at Harvard Medical School.  She completed her PhD in Computer Science from MIT, and her MSc at the University of Cambridge as a Marshall Scholar.  (finale@seas.harvard.edu)

Jennifer Goldman, MD, MS is an Assistant Professor in the Department of Pediatrics at Children’s Mercy Kansas City. She completed a combined Pediatric Infectious Diseases and Clinical Pharmacology Fellowship at Children’s Mercy Hospitals & Clinics in Kansas City, Missouri. She serves as the Director of the Antimicrobial Stewardship Program and Director of the Drug Safety Service. (jlgoldman@cmh.edu)

Mark Hoffman, PhD serves as the Chief Research Information officer for Children’s Mercy Hospital (CMH) and the Children’s Research Institute.  Dr. Hoffman has delivered a TED talk on the “Envirome” and won the iThermometer category in the Google wearable devices in healthcare challenge in 2015.  He is an inventor on 19 issued patents and a member of the American Academy of Inventors. Dr. Hoffman is the PI on a CDC funded data warehouse project. Prior to CMH, he served as VP for Research and Genomics at Cerner, where he led their drug safety team (Galt) and initiatives in public health and “big data”. (mhoffman@cmh.edu)

Rishikesan Kamaleswaran, PhD is an Assistant Professor at the Center for Biomedical Informatics and Division of Critical Care Medicine at the University of Tennessee Health Science Center. He earned his PhD in Computer Science from the University of Ontario Institute of Technology in Canada. His research interests include real-time sensor data analytics at the bed-side to identify the onset of abnormal conditions using data driven and online learning approaches. (rkamales@uthsc.edu)

Mona Khurana, MD is a pediatric nephrologist who joined the US Food and Drug Administration (FDA) in 2009 after a 5-year academic career at the Children’s National Medical Center in Washington DC.  Dr. Khurana began her FDA career as a medical officer in the Division of Nonprescription Drug Products where she developed extensive experience in OTC drug regulations for both the adult and pediatric population.  She joined the Division of Pediatric and Maternal Health as a medical officer in 2015 where she has been exclusively involved in promoting pediatric drug development across the different therapeutic areas within the Office of New Drugs in the Center for Drug Evaluation and Research at FDA.  Dr. Khurana is currently a pediatric team leader in the Division of Pediatric and Maternal Health.  (Mona.khurana@fda.hhs.gov)

Isaac Kohane, MD, PhD is the inaugural Chair of the Department of Biomedical Informatics and the Marion V. Nelson Professor of Biomedical Informatics at Harvard Medical School. He develops and applies computational techniques to address disease at multiple scales—from whole healthcare systems as “living laboratories” to the functional genomics of neurodevelopment with a focus on autism. Kohane’s i2b2 project is currently deployed internationally to over 120 major academic health centers to drive discovery research in disease and pharmacovigilance (including providing evidence on drugs which ultimately contributed to “Boxed Warnings” by the FDA). He is a member of the Institute of Medicine and the American Society for Clinical Investigation. (Isaac_Kohane@hms.harvard.edu)

Carolyn McCloskey, MD, MPH  is a medical officer epidemiologist in the Division of Epidemiology I, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, CDER, FDA.  After working for several years in pediatrics, she joined FDA and worked mainly on the safety of products, first in CBER, then CDER.  For over 20 years in CDER her epidemiological work has focused on evaluating observational safety studies for products under review for FDA approval and for post-marketed products. (carolyn.mccloskey@fda.hhs.gov )

Ann McMahon, MD, MS is Deputy Director of Science and the Director of Kidnet in the Office of Pediatric Therapeutics in the Office of the Commissioner at the FDA. She received a Master’s of Science in Health Policy and Management from the Harvard School of Public Health, and went on to receive an MD from the Case Western Reserve University School of Medicine. She completed her residency in Pediatrics at the Johns Hopkins Children’s Center, and continued with post-doctoral training both at the National Institutes of Health and Johns Hopkins Children’s Center in Virology and Pediatric Infectious Diseases, respectively. After an Assistant Professorship at the University of Chicago, she joined the Food and Drug Administration in 2002. Since joining the FDA, she has focused primarily on post-marketing safety. 

Allen Mitchell, MD is a pediatric and reproductive pharmacoepidemiologist, Professor of Epidemiology and Pediatrics at the Boston University Schools of Public Health and Medicine, and Director Emeritus of the Slone Epidemiology Center at Boston University.  In 1974, he initiated the PeDS Program designed to quantify known and identify unknown adverse drug events in children, and in 1976 he initiated the Birth Defects Study to identify drug risks/safety in pregnancy.  Dr. Mitchell is an FDA SGE and serves on a number of editorial boards and advisory committees. (allenmit@bu.edu)

Adam Perer, PhD is a Research Scientist at IBM's T.J. Watson Research Center, where he is a member of the Healthcare Analytics Research Group. He is also an Adjunct Professor at Carnegie Mellon University. His research focuses on the design of novel visual analytics systems to help users make sense out of Big Data, particularly in the healthcare domain. This work has been published at premier venues in visualization, human-computer interaction, and medical informatics. He holds Ph.D. and master’s degrees in Computer Science from the University of Maryland, College Park. ( adam.perer@us.ibm.com)

Patrick Ryan, PhD is Senior Director of Epidemiology and the Head of Epidemiology Analytics at Janssen Research and Development, where he is leading efforts to develop and apply analysis methods to better understand the real-world effects of medical products.  He is also Assistant Professor, Adjunct at Columbia University Medical Center in the Department of Biomedical Informatics.  He is currently a collaborator in Observational Health Data Sciences and Informatics (OHDSI), a multi-stakeholder, interdisciplinary collaborative to create open-source solutions that bring out the value of observational health data through large-scale analytics. He served as a principal investigator of the Observational Medical Outcomes Partnership (OMOP), a public-private partnership chaired by the Food and Drug Administration. He received his undergraduate degrees in Computer Science and Operations Research at Cornell University, his Master of Engineering in Operations Research and Industrial Engineering at Cornell, and his PhD in Pharmaceutical Outcomes and Policy from University of North Carolina at Chapel Hill and has worked in various positions within the pharmaceutical industry at Pfizer and GlaxoSmithKline, and also in academia at the University of Arizona Arthritis Center. (PRyan4@ITS.JNJ.com)

Michiyo Sakiyama, MD is a senior reviewer in the office of Vaccines and Blood Products at the Pharmaceuticals and Medical Devices Agency (PMDA). She is a pediatrician and currently involved in reviewing vaccines and anti-cancer drugs. She is also a leader of the Pediatric Drugs Working Group that is one of the projects across multiple offices in the PMDA. (sakiyama-michiyo@pmda.go.jp)

Shohko Sekine, MS is a reviewer in the Office of Safety II at Pharmaceuticals and Medical Devices Agency (PMDA) Japan. She reviews post-marketing drug safety information as well as pre-marketing drug safety information as a Risk Manager who acts as liaison between the Office of New Drugs and the Office of Safety II. She is also a member of an internal working group on pediatric drugs. (sekine-shoko@pmda.go.jp)

Stephen P. Spielberg MD is a retired pediatric clinical pharmacologist.  He continues serving on the Council of NCATS/NIH, and as a consultant in pediatric drug development.  He has worked in academia (Johns Hopkins University, Hospital for Sick Children (Toronto), Children’s Mercy Hospital, and as Dean, Dartmouth Medical School), industry (including as Vice President for Pediatric Drug Development at Johnson and Johnson), and at FDA (serving as Deputy Commissioner for Medical Products and Tobacco). (stephen.p.spielberg@gmail.com)

Miriam Sturkenboom, PhD is professor in Observational Data Analysis, Utrecht University Medical Center. She worked at the department of Medical Informatics of the Erasmus University Medical Center in the Netherlands from 2008 until 2017 and recently transferred to the department of Global Health at the Julius Center at Utrecht University Medical Center in the Netherlands. She has a PhD from the Faculty of Mathematics and Physics in Groningen (cum laude), has a pharmacy degree from University of Groningen,and has a Master’s in Epidemiology from the Harvard School of Public Health. She is president of the VACCINE.GRID foundation and past president of the International Society for Pharmacoepidemiology.

Mark Turner BSc, MBChB, DRCOG, MRCP, MRCPCH, PhD is a Neonatologist at Liverpool Women’s Hospital and the University of Liverpool. He aims to improve the access of newborn babies and children to high quality medicines. He has studied the dosing, safety and efficacy of 12 medicines in neonates with rare conditions in the past 5 years. He works to develop efficient medicines research infrastructure in Europe and globally as Lead for International Liaison at the English National Institute for Health Research Clinical Research Network’s Children Theme (NIHR CRN:C), Chair of the European Network for Paediatric Research at the European Medicines Agency (EnprEMA), Convenor of the European Paediatric Clinical Trials Research Infrastructure, co-Director of the International Neonatal Consortium and as co-Scientific Coordinator of the European Commission-funded Network of Excellence, Global Research in Paediatrics (GRiP). (Mark.Turner@liverpool.ac.uk

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