Staff Biographies
Principal Investigator: Kenneth F. Schulz, PhD, MBA
Dr. Schulz is Vice President of the Quantitative Sciences Department at FHI, and in this capacity oversees the Biostatistics Division and the Data Management Division. He also serves as the P.I. on the International Clinical Sciences Support Contract with DMID, NIAID, NIH.
Dr. Schulz earned a Ph.D. from the Tropical Health Epidemiology Unit, Department of Epidemiology and Population Sciences, London School of Hygiene and Tropical Medicine with a concentration in Medical Statistics (Thesis: Methodological Quality and Bias in Randomised Controlled Trials).
Prior to joining FHI, Dr. Schulz was at the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia for 25 years, during which he served for 11 years as the Assistant Director for International Activities of the Division of STD/HIV Prevention, National Center for HIV, STD, and TB Prevention. In that position, Dr. Schulz managed the complex spectrum of CDC’s international STD prevention research activities, which included activities in South America, the Caribbean, Asia, and Africa.
From 1991 to 1994, he was an Honorary Research Fellow, National Perinatal Epidemiology Unit and The UK Cochrane Centre, University of Oxford, Oxford, England. Three times each year he conducts a six-day workshop on epidemiologic research methods in reproductive health for medical school faculty in obstetrics and gynecology. He also currently holds the position of Adjunct Clinical Professor, Department of Obstetrics and Gynecology, The School of Medicine, The University of North Carolina at Chapel Hill.
Dr. Schulz has authored or co-authored over 200 scientific publications, many of which address randomized controlled trial methods. He has conducted and published research on the methodological quality of RCTs and bias in estimates of treatment effects. Recently, Elsevier has published a book he has authored with Dr. David Grimes on The Lancet Handbook of Essential Concepts in Clinical Research. He also participated in the fashioning and authoring of the CONSORT guidelines for the reporting of RCTs, which have been adopted by hundreds of medical journals, including JAMA, The Lancet, BMJ, New England Journal of Medicine, and the Annals of Internal Medicine, while being supported by the International Committee of Medical Journal Editors and the World Association of Medial Editors. Dr. Schulz currently is a Member of The Lancet International Advisory Board and an Associate Editor of Trials.
Project Director: Michelle Immelman, PharmD, MS
Dr. Immelman manages and coordinates the daily operations of the ICSSC. She also works on developing study related materials; conducting field site evaluations; and training and advising field research staff in operational aspects of clinical studies. Dr. Immelman collaborates closely with DMID and other contractors to provide DMID-supported international clinical research teams with current information and resources.
Dr. Immelman is an Associate Director of Clinical Operations at Family Health International (FHI) in North Carolina. Dr. Immelman earned a Bachelor of Science degree in Pharmacy from Rhodes University in South Africa. She earned her Master of Science in Pharmaceutical Sciences degree from Campbell University, graduating summa cum laude. Dr. Immelman went on to earn a Doctor in Pharmacy degree from the University of North Carolina at Chapel Hill, graduating with distinction.
Dr. Immelman has over 15 years of experience in drug development and clinical research. She has worked with regulatory authorities throughout the world to register pharmaceuticals for human use. In addition to her responsibilities with the ICSSC, Dr. Immelman is also responsible for providing leadership and guidance to the HIV Prevention Trials Network (HPTN) in fulfilling its obligations to ensure that HPTN research is being conducted in compliance with FHI and ICH guidelines.
Administrative Manager: Laura Phillips
Laura is new to the ICSSC team, having joined in June 2007. She provides administrative support, logistics and travel coordination for sponsored workshops and meetings. As administrative manager, she is the primary point of contact within the ICSSC
Laura has over 15 years of professional logistics experience in fields ranging from corporate and private event planning to disaster response. As part of the National Disaster Medical System, in which she is still active member of both a Disaster Medical Assistance Team and a National Medical Response Team she has participated in both disaster response and National Security Special Event Standby deployments. She also has over 7 years experience participating in management, planning and field operations with wilderness search and rescue and is a certified Search and Rescue Technician II and EMT - B, In addition she brings many years of customer service and accounting experience to her position with the ICSSC. Laura holds B.A. from Furman University in Greenville, South Carolina.
Lead Statistician: Mario Chen, PhD, MS
Dr. Chen serves as the primary statistical reviewer of protocols submitted to the ICSSC for review and development, specifically with respect to evaluating their methodological and statistical soundness. Dr. Chen also has interest and experience in teaching others about statistical design and is available to provide training to investigators through workshops and other interactive means.
Dr. Chen is an Associate Director of Biostatistics at the Family Health Institute, a division of Family Health International in North Carolina. Dr. Chen earned a Bachelor of Science degree in Statistics from the University of Costa Rica, San José, Costa Rica in 1988, where he worked as an instructor. Dr. Chen obtained his MS in Biostatistics from the University of North Carolina at Chapel Hill in 1993 sponsored by the Fulbright/LASPAU scholarship. The same year he was inducted into the Delta Omega Honor Society for his work while completing his MS degree. Dr. Chen obtained his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 1997, when he also joined FHI. His dissertation research relates to measurement errors in the logistic model for dose-response. Dr. Chen spent two years as an Associate Professor for the Department of Statistics of the University of Costa Rica (UCR), while continuing to collaborate with FHI in several research projects. Dr. Chen has joined the FHI staff full time since 2001.
Dr. Chen has been the Lead Statistician (LS) for the ICSSC since its beginning in 2000. With extensive training and experience in biostatistical techniques across a variety of study designs and in different study settings, Dr. Chen is uniquely qualified to serve as the LS for the ICSSC. In this position, Dr. Chen provides statistical support to DMID and DMID sponsored investigators. He has participated in numerous international workshops and, as a faculty member of the Statistics Department of the UCR, he taught several courses both at the graduate and undergraduate levels.
In addition to his work as the LS for the ICSSC, Dr. Chen provides oversight, leadership, and support to FHI’s broad research agenda on clinical, behavioral, social, and health service issues and has also been providing biostatistical support to the Influenza Clinical Research Network, a network of investigators currently conducting research related to avian flu in South East Asia.
Data Manager: Patrick Murphy
Patrick is the Director of Data Management at FHI. He is responsible for developing data management site assessment tools, performing site assessments, and training investigators and staff at workshops. He provides input on data management plan preparation, case report form development and data entry system development to clinical sites as appropriate. In addition, Patrick supervises data managers from DMID-supported sites who may visit FHI for training opportunities.
Patrick provides bioinformatics support to international clinical research sites and evaluates and implements new data management systems including Internet data collection systems, remote data entry systems, and clinical data management systems. He manages and provides technical oversight to data management staff, of approximately twenty professionals, who design data structures, case report forms, and reports to track study progress. He has led his group and database system into 21 CFR Part 11 compliance and has been responsible for data management of over 100 clinical trials performed using GCP.
Patrick is FHI's lead technical person for evaluating data management technologies, transferring data between the Clintrial system, SAS, FoxPro, and EpiInfo, transporting data between the PC, VAX, and Internet formats. He provides expertise writing SQL code and developing MS Access applications for use in the data management group. Mr. Murphy has provided site specific data management support in Brazil, Mexico, Peru, Kenya, Mali, India, China, and Viet Nam. Mr. Murphy has performed WHO sponsored 21 CFR Part 11 audits for software companies in France, the Netherlands, and Sweden. In addition, he has taught data management fundamentals at NIH conferences in the United States, Brazil, South Africa, and Thailand. He has developed a one week clinical data management course which focuses on Good Clinical Practices and which uses hands-on MS Access tutorials to create a functioning data management system.
Web Manager: Paul Hespelt
Paul serves as the webmaster for the ICSSC website.