Frank Rockhold, ScM, PhD
Board Chair, Frontier Science Foundation; Professor of Biostatistics and Bioinformatics, Duke Clinical Research Institute; Managing Partner of HunterRockhold, Inc.
Frank Rockhold, ScM, PhD has had diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, and most recently, safety and pharmacovigilance. He has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. Dr. Rockhold is a full Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute and Managing Partner of HunterRockhold, Inc. His 40+ year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he recently retired as Senior Vice President of Global Clinical Safety and Pharmacovigilance. Dr. Rockhold has also held faculty appointments at six different universities. He served for 9 years on the board of directors of the non-profit Clinical Data Interchange Standards Consortium (CDISC), most recently as Chairman, and is past president of the Society for Clinical Trials. He is a past member of the PCORI Clinical Trials Advisory Panel. Dr. Rockhold holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. He is a Fellow of the American Statistical Association and the Society for Clinical Trials and an Accredited Professional Statistician, PStat®. He is widely published in major scientific journals across a wide variety of research topics. Dr. Rockhold’s CV is available here.
Treasurer, Frontier Science Foundation
For the past 40 years Gregory Pavlov has been engaged in clinical trials data management and related research efforts in a range of technical and managerial capacities, including database administrator, programmer analyst, director of data management and computing for the ACTG and IMPAACT clinical trials, and director of the Frontier Science Amherst, NY office. Mr. Pavlov was president of Frontier Science from July 2014 until July 2017. Throughout his career, Mr. Pavlov created systems that facilitated national and international trials collaboration including clinical trials networks such as the CALGB, ECOG, IBCSG and RTOG; trials conducted by the Dana-Farber and other research institutes; and various industry sponsors.
Urania Dafni, ScD
Director of Frontier Science Foundation-Hellas
Dr. Urania Dafni, Director of Frontier Science Foundation–Hellas (FSF-H) and Professor of Biostatistics at the University of Athens, is a founding member and served as President (2005-2007) of the Eastern Mediterranean Region of the International Biometric Society (IBS). Dr. Dafni was the Scientific Director of the National Syndromic Surveillance program for the Athens 2004 Olympic Games and is currently a member of the Board of Directors of the Hellenic Center for Disease Control and Prevention, Ministry of Health. She is a member of the Education committee of IBS, the American Society of Clinical Oncology (ASCO), and the European Society for Medical Oncology (ESMO), reflecting her over 25-year experience in Clinical trials.
David DeMets, PhD
Professor Emeritus, Department of Biostatistics & Medical Informatics, University of Wisconsin Madison
David DeMets is the Max Halperin Professor of Biostatistics, Emeritus, and former Chair of the Department of Biostatistics and Medical Informatics at the University of Wisconsin Madison. He has authored numerous statistical methods papers, collaborative scientific and clinical papers, book chapters, and has co-authored four books, Fundamentals of Clinical Trials, Data Monitoring in Clinical Trials: A Case Studies Approach, Data Monitoring Committees in Clinical Trials: A Practical Perspective, and Statistical Methods for Clinical Trials. Dr. DeMets has served on numerous NIH and industry-sponsored Data Safety and Monitoring Committees for clinical trials in diverse disciplines. He served on the Board of Directors of the Society for Clinical Trials (1983-1987), American Statistical Association (1987-89), as well as having been President of the Society for Clinical Trials (1989) and President of the Eastern North American Region (ENAR) of the Biometric Society (1993). Dr. DeMets was Elected Fellow of the International Statistics Institute in 1984, the American Statistical Association in 1986, the Association for the Advancement of Science in 1998, the Society for Clinical Trials in 2006 and the American Medical Informatics Association in 2008. In 2013, he was elected as a member of the Institute of Medicine, now the National Academy of Medicine. Dr. DeMet’s research interests include the design, data monitoring and analysis of clinical trials, especially large Phase III randomized clinical trials. He is well known for his work on sequential statistical methods for monitoring interim data for early evidence of intervention benefit or possible harm. See Dr. DeMet’s Faculty page at the University of Wisconsin.
Scott Evans, PhD
Founding Chair and Professor in the Department of Biostatistics and Bioinformatics, and Director of the Biostatistics Center, George Washington University
Dr. Scott Evans is a Professor and Founding Chair of the Department of Biostatistics Bioinformatics and the Director of the George Washington Biostatistics Center. He is the Director of the Statistical and Data Management Center (SDMC) for the Antibacterial Resistance Leadership Group (ARLG). Professor Evans has been a member of an FDA Advisory Committee, and the Board of Directors for the American Statistical Association (ASA), the Society for Clinical Trials (SCT), and the Mu Sigma Rho (the National Honorary Society for Statistics). He is a member of the Steering Committee of the Clinical Trials Transformation Initiative (CTTI), the Executive Committee for the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, and Networks (ACTTION), and serves as the Co-chair of the Benefit-Risk Balance for Medicinal Products Working Group for the Council for International Organizations of Medical Sciences (CIOMS). His methodological contributions include the desirability of outcome ranking (DOOR), sequential multiple assignment randomized trials for comparing antibiotic strategies (SMART COMPASS), and benefit:risk evaluation for diagnostics: a framework (BED-FRAME). Professor Evans is the Editor-in-Chief of Statistical Communications in Infectious Diseases (SCID), and the Co-Editor of a Special Section of Clinical Infectious Diseases (CID) entitled Innovations in Design, Education, and Analysis (IDEA). Dr. Evans is a recipient of the Mosteller Statistician of the Year Award, the Robert Zackin Distinguished Collaborative Statistician Award for contributions to the AIDS Clinical Trials Group (ACTG), an elected member of the International Statistical Institute (ISI), and is a Fellow of the American Statistical Association (ASA), Society for Clinical Trials (SCT), and the Infectious Disease Society of America (IDSA).
Carla Falkson, M.B.Ch.B., M.Med., M.D.
Professor in the Department of Medicine, Hematology & Oncology and in the Wilmot Cancer Institute, University Of Rochester Medical Center
Dr. Carla Falkson is a faculty professor at the University of Rochester Medical Center. Dr. Falkson’s research is focused on developing innovative treatments for patients with breast cancer. For the past three decades, she has been actively involved in the development and planning of clinical trials using new agents, including genomic and other translational approaches such as circulating tumor DNA, to improve the selection of patients for specific treatments and thus improving the outcome for patients. As a seasoned investigator, she has led the Eastern Co-operative Group Research at her previous two institutions and now continues this legacy of excellence at the University of Rochester Medical Center. See Dr. Falkson’s Faculty page at the University of Rochester Medical Center.
Richard Gelber, PhD
Professor of Pediatrics (Biostatistics), Harvard Medical School; Professor of Biostatistics, Harvard T.H. Chan School of Public Health
Dr. Richard Gelber is Professor of Pediatrics (Biostatistics) at Harvard Medical School and Professor in Biostatistics at the Department of Biostatistics, Harvard T.H. Chan School of Public Health, and the Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute. He is a recognized expert for his contributions to the design and analysis of many important clinical trials, improving cure rates for pediatric leukemia, pediatric AIDS and perinatal transmission of HIV, and breast cancer. Dr. Gelber served as the Statistical Director for the International Breast Cancer Study Group (IBCSG) at the Dana-Farber Cancer Institute for over 40 years (1977 to 2018), and has collaborated with the Breast International Group (BIG) since 1998, serving in the BIG Executive Board from 2010 to 2014. He has developed statistical methodologies for quality of life (Q-TWiST) and for subpopulation analyses (STEPP), both designed to increase the relevance of clinical trial data for use in patient-care decision-making. Dr. Gelber has been awarded numerous honors including the prestigious Brinker Award for Scientific Distinction in Clinical Research, Susan G. Komen for the Cure, and an honorary Doctorate in Medicine from the University of Göteborg, Sweden.
Eleanor McFadden, MS
Managing Director, Frontier Science (Scotland) Ltd.
Eleanor McFadden has almost 40 years of experience in the management of clinical trials, including more than 20 years spent with Frontier Science Foundation in Boston, MA, US where she was Director of the Coordinating Center for the Eastern Cooperative Oncology Group. In 2000, Ms. McFadden returned to Great Britain to establish a Frontier Science office in in the Scottish Highlands. She has authored a book, Management of Data in Clinical Trials, and is a past President of the Society for Clinical Trials. Ms. McFadden received the Life Science Business Leadership prize at the 2015 Scottish Enterprise Life Sciences Awards. She has served on many review panels for various organisations such as the US National Cancer Institute, Cancer Research UK, the Irish Health Research Board and has been chair of the International Panel for the UK Clinical Research Network review and registration of UK Clinical Trials Units.
Nuala McGrath, BSc, MSc, ScD
Professor of Epidemiology and Sexual Health, and National Institute for Health Research (NIHR) Global Health Professor, University of Southampton, UK; Honorary Professor at the School of Nursing and Public Health, University of KwaZulu-Natal, South Africa
Professor McGrath has more than 30 years of experience in HIV surveillance, treatment and prevention studies and intervention trials in sub-Saharan Africa. Professor McGrath received her undergraduate degree in Mathematics, Statistics and Operational Research (University of Exeter, UK); a Masters in Biometry (University of Reading, UK); and a Doctorate in Infectious Disease Epidemiology (Harvard School of Public Health, USA). She was a Wellcome Trust Research Career Development Fellow (2008-2015), has lived in the USA, Tanzania, Uganda, Malawi and South Africa, and has previously held Honorary appointments with the HIV/AIDS, STIs and TB research program, Human Sciences Research Council, South Africa (2007-2010), and the Research Department of Epidemiology & Public Health, University College London, UK (2014-2017). Professor McGrath has served on Steering Committees and Independent Data and Safety Monitoring Boards for NIMH, NIHR and ANRS funded multi-site HIV studies and clinical trials. She has also served on fellowship panels for the Welcome Trust, the African Academy of Sciences and the Royal Society. Since 2017, Professor McGrath is a UK Commonwealth Scholarship Commissioner and Lead Commissioner for Equity and Access. See Dr. McGrath’s Faculty page at the University of Southampton.
Suzanne Siminski, MS, MBA
Chief Executive Officer, Frontier Science Foundation
Suzanne Siminski has been working in clinical trials data management and related research activities for more than 30 years. Sue has taken a leadership role in the development of Frontier Science’s laboratory data expertise and software. While Director of the New York office, Sue oversaw leadership groups involved in data management, software development, regulatory oversight and key projects. She currently serves as the Frontier Science Principal Investigator for PHACS and CPQA projects, as co-Principal Investigator of the coordinating center for the C3PNO project, and as Director of the Data Management and Reporting Unit for the Cancer Prevention Clinical Trials Network (CP-CTNet), all programs funded by the NIH. As Chief Executive Officer of Frontier Science Foundation, Sue is strategically increasing the repertoire of clinical research services provided by the organization, and actively building global collaborative partnerships with investigators around the world. Sue’s entire CV is available here.