Eleanor McFadden, MS
Board Chair; 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.
Hans-Olov Adami, MD, PhD
Professor Emeritus, Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Professor Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway; Professor Emeritus, Department of Epidemiology, Harvard T.H.Chan School of Public Health, Boston, MA
With a long background as a practicing surgeon with a focus on oncology, Dr. Adami has always conducted clinical and epidemiologic research in parallel. His clinical research includes randomized trials, prognostic studies, and studies of clinical issues using an observational study design. He has focused on cancer epidemiology, and has worked on a large number of cancer sites and types. Dr. Adami is now Professor Emeritus of Karolinska Institutet where he was the founder, and during many years Chair of the Department of Medical Epidemiology and Biostatistics. Dr. Adami is now affiliated with the Clinical Effectiveness Research Group at the University of Oslo. He is also Professor Emeritus of Epidemiology at Harvard University where he held different professorial positions since 1992 and was Chair of the Department of Epidemiology during several years. See Dr. Adami’s full Researcher page at HSPH here.
Michael Bretthauer, MD, PhD
President, Frontier Science; Director of the Boston, Massachusetts Office
Michael Bretthauer, MD PhD, President, Frontier Science, Boston, USA is also a Professor of Medicine at the University of Oslo, a Gastroenterologist at Oslo University Hospital, and a Guest Researcher at Harvard School of Public Health. Throughout his distinguished career, Dr. Bretthauer has held many leadership, clinical, and research positions in Oslo, Norway, and in Boston, Massachusetts, US. He has been awarded numerous awards and honors, and has participated on many boards and committees. He is involved in editorial and teaching activities, and has an extensive list of publications. Dr. Bretthauer’s entire CV is available here.
Tianxi Cai, ScD
Professor of Biostatistics, Harvard T.H. Chan School of Public Health; Professor of Biomedical Informatics, Harvard Medical School
Dr. Tianxi Cai is a professor of Biostatistics at Harvard T.H. Chan school of public health and a professor of Biomedical Informatics at Harvard Medical School. She received her Doctoral degree from Harvard in 1999 and taught at the University of Washington for two years before returning to Harvard as a faculty. Dr. Cai’s current research focuses mainly in the areas of risk prediction and personalized medicine with biomarkers and genomic studies, statistical and machine learning, and analysis of EHR data. Dr. Cai’s faculty page is available here.
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.
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.
Lawrence Huffman, MBA
Mr. Lawrence Huffman’s career includes over 30 years in the health industries, with extensive international experience. He worked at the EU Commission in Brussels (1979-1980). At Lederle Division Hospital Products, he was General Manager in the UK (1980-1984), was Vice-President in Asia/Pacific and Regional Director, Canada and Latin America (1984-1989). Mr. Huffman was President of Robert et Carrière-Lederlé in Paris, France (1989-1994). He was a Corporate Vice President at MediSense, Inc. in Waltham, Massachusetts (1994-1996); Vice President Abbott Diabetes Care 1996-1999 and 2004-2009 and Vice President of International Sales and Business Development at TheraSense, Inc. (1999-2004) both in Alameda, California. Mr. Huffman is currently based in New York, NY as a Venture capital consultant. He was educated in Electrical Engineering at the University of Pennsylvania, and earned an MBA in Accounting and Finance at the Wharton School. Read Mr. Huffman’s Career Experience summary here.
Mette Kalager, MD, PhD
Associate Professor, University of Oslo; Visiting Scientist, Harvard T.H.Chan School of Public Health
Dr. Kalager is a trained surgeon and is an associate professor at the University of Oslo, Norway. She is the head of the Clinical Effectiveness Research Group at the University of Oslo. She is a guest researcher at Harvard CH Chan School of Public Health and currently serves on the Scientific board of the French National Cancer Institute. Her research has a strong focus on clinical trials and epidemiology, including screening, surveillance, and studies in gastroenterology. She has a special interest in disseminating research to the general audience and has been on numerous radio programs including NPR and the Norwegian equivalent thereof, in the News (New York Times, Spiegel, Die Zeit). See Dr. Kalager’s professional page at the University of Oslo here. You can read more about Dr. Kalager at the Harvard School of Public Health website here.
Mary Long, BS
Manager, Project Management, eClinical Solutions
Mary Long has been working in data management and cancer research for over 25 years. She has worked for ECOG-ACRIN Cancer Group, and for over ten years Mary was Senior Director of Administrative Programs for Eastern Cooperative Oncology Group, where she was involved in operational activities for all phases of clinical research with direct and indirect management of operational project leaders and undertakings such as study life cycle management, publication planning, literature reviews and advisory boards. Mary Steele Long is currently the Manager of Project Management with eClinical Solutions. Mary’s entire CV is available here.
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.
Frank Rockhold, ScM, PhD
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.
Lee-Jen Wei, PhD
Professor of Biostatistics, Harvard T.H.Chan School of Public Health
L.J. Wei is a professor of Biostatistics at Harvard University. Before joining Harvard, he was a professor at the University of Wisconsin, the University of Michigan, and at George Washington University. His main research interest is in clinical trial methodology, especially in design, monitoring and analysis of studies. He has developed numerous statistical methods which are utilized in practice. Dr. Wei received the prestigious Wald Medal in 2009 from the American Statistical Association for his contribution to clinical trial methodology. In January 2014, to honor his mentorship, Harvard School of Public Health established a Wei family scholarship to support students studying biostatistics. His recent research area is concentrated on the personalized medicine under the risk-benefit paradigm via biomarkers and revitalizing clinical trial methodology. Dr. Wei has been closely working with pharmaceutical industry and the regulatory agencies for developing and evaluating new drugs/devices. Dr. Wei’s CV is available here.