FRONTIER SCIENCE & TECHNOLOGY RESEARCH FOUNDATION - Key Persons
Job Titles:
- Member of the Leadership Team
- Director of Software Engineering
Adel Ahmed oversees the software engineering division and database operations at Frontier Science, where he is responsible for devising technological strategies and optimizing engineering resources. With extensive expertise, he excels in implementing cutting-edge software solutions, leading software engineering teams, and developing specialized applications for clinical and laboratory research while ensuring compliance with regulatory standards.
Actively involved in leadership, steering, and compliance committees, Adel also provides invaluable insights as a consultant to external collaborators. For over two decades, he has been instrumental in advancing the company's mission and enhancing its software and IT infrastructure. Adel graduated summa cum laude with a Bachelor's degree in Computer Science and holds a Master's degree in Computer Science and Engineering from the University at Buffalo.
Job Titles:
- Director of Project Operations
In her role as Director of Project Operations, Carol Pulver advises data management teams on the best methods to organize workflows so as to ensure data integrity and quality. With over 30 years of experience in clinical trial data management and clinical research, she has collaborated with a variety of clinical research partners, including research sites, sponsors, CROs, regulatory specialists, pharmacists, statisticians, and software engineers.
Prior to assuming the position of Director of Project Operations, Carol served as Amherst Office Director, Director of User Support and Randomization Services, Deputy Director of Business Development, Deputy Chief of the Programming Division, and Software Project Leader. She received a Bachelor's in Computer Science and Mathematics from the State University of New York at Fredonia and a Master's in Business Administration from the University at Buffalo.
Colleen Woodworth is the Compliance Officer at Frontier Science, and is responsible for the management and implementation of the quality management system (QMS) and the organization's compliance with all current domestic and federal regulations. She works closely with various Frontier Science departments to ensure that all procedures and workflows meet industry best practices and regulatory expectations. Having practiced as an attorney on HIPAA and related health insurance legal matters, Colleen has extensive experience in regulatory compliance.
Colleen advises the organization's leadership on issues related to data privacy and security, data management best practices, FDA compliance, and international regulatory compliance. She earned her Juris Doctor from the University at Buffalo.
Job Titles:
- Treasurer
- Treasurer of the Board of Directors
- Professor of Economics at Boston University
David Lagakos is a professor of economics at Boston University, a lead academic for the International Growth Center, and a research associate at the National Bureau of Economic Research. He has previously held faculty appointments at the University of California San Diego, Arizona State University, and the Federal Reserve Banks of New York and Minneapolis. Professor Lagakos has published numerous articles in leading economics journals and serves as a co-editor of the Journal of Political Economy. He is a co-organizer of Yale University's Research Initiative on Innovation and Scale, and an advisory board member for the research program on Structural Transformation and Economic Growth at the Centre for Economic Policy Research. Lagakos's recent research includes randomized controlled trials in Africa and economic analyses of the COVID-19 pandemic in developing countries. He holds a PhD and MA in economics from UCLA and a BA in mathematics and economics from the University of Rochester.
Job Titles:
- Member of the Board of Directors
Darren Gibson joined Frontier Science (Scotland) Ltd in January 2022 as Executive Director. He is a skilled executive with over 20 years of experience and substantial knowledge in the health and medical research and innovation sector, nationally and internationally.
Before joining FSS, Darren spent 3 years as the Director of Research and Innovation at the Department of Health in Western Australia (WA); facilitating, supporting, and promoting high-quality research and innovation. Additionally, he led the implementation of the WA Future Health Research and Innovation Fund. Previously, he led the collaboration, innovation and industry engagement program at Edith Cowan University. He also has extensive research governance experience, including managing the Scottish Mental Health Research Network and serving on multiple Boards and Committees. Darren has extensive medicinal chemistry experience, having been a senior research scientist within Biotechnology (UK and New Zealand) investigating novel oncology and HIV therapeutics.
Darren graduated in Medicinal Chemistry, BSc (Hons), from Dundee University, and obtained a PhD in Biological Chemistry from the University of St Andrews (2001). He also completed an LLM in Medical Law and Ethics from De Montfort University (2011) and an MBA (2022).
Job Titles:
- Member of the Board of Directors
- Professor at the 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.
Job Titles:
- Member of the Board of Directors
- Professor of Biostatistics
Dr. 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, and 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) and 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. DeMets' 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. DeMets' Faculty page at the University of Wisconsin.
Job Titles:
- Member of the Board of Directors
- Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute
Dr. 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 nine 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.
Job Titles:
- Member of the Board of Directors
- Professor of Epidemiology
Dr. Nuala McGrath is 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. Dr. McGrath has more than 30 years of experience in HIV surveillance, treatment and prevention studies, and intervention trials in sub-Saharan Africa.
Dr. McGrath received her undergraduate degree in Mathematics, Statistics and Operational Research (University of Exeter, UK); a Master's 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).
Dr. 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 Wellcome Trust, the African Academy of Sciences, and the Royal Society. Since 2017, Dr. McGrath has been a UK Commonwealth Scholarship Commissioner and Lead Commissioner for Equity and Access.
Job Titles:
- Member of the Board of Directors
- Professor of Pediatrics
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 on 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 Susan G. Komen Foundation Brinker Award for Scientific Distinction in Clinical Research and an honorary Doctorate in Medicine from the University of Göteborg, Sweden.
Job Titles:
- Member of the Board of Directors
- 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 more than 25 years of experience in clinical trials.
Job Titles:
- Member of the Board of Directors
- Director of the Institute of Informatics & Telecommunications
Dr. Karkaletsis is the Director of the Institute of Informatics & Telecommunications at NCSR Demokritos, and a member of the High Level Advisory Committee on AI to the Greek Prime Minister. Also member of the National Commission for Bioethics & Technoethics and the Expert Group on AI Incidents at OECD.AI.
Job Titles:
- LDMS Program Director
- LDMS Program Director, Deputy Director of Business Development
- Program Director for Laboratory Data Management System
Howard Gutzman is the Program Director for Laboratory Data Management System (LDMS) and the Deputy Director of Business Development at Frontier Science. He oversees the development and implementation of LDMS at over 360 laboratories, and works with numerous collaborative groups to conduct clinical trials around the world.
He works closely with the Frontier Science business development team to continuously evaluate and improve existing workflows within the organization to ensure efficiency, scalability, and consistency. With over 15 years of experience in project management, he currently serves as the Frontier Science Principal Investigator on several projects utilizing LDMS, including PHIA, a multi-country population-based HIV Impact Assessment in Africa.
Howard began his career at Frontier Science as a laboratory data manager for the Adult and International Maternal Pediatric Adolescent HIV Clinical Trials (IMPAACT) networks, and was a member of the LDMS training team where he oversaw LDMS related projects. He received a Bachelor's of Science in Forensic Chemistry from Buffalo State University.
Job Titles:
- Biostatistician
- Boston Office Director Madison Office Director
- Director of ISC
Jamie Hoel is a biostatistician and the Office Director for the Boston and Madison offices at Frontier Science, where he provides biostatistical oversight and direction for projects across the organization. He has over 20 years of clinical trials experience, working primarily in the field of interim data monitoring, and has worked on a wide variety of statistical analyses, including nonparametric methods, Kaplan Meier estimates, futility analyses, conditional power calculations, O'Brien-Fleming monitoring boundaries, Inverse Probability of Censoring Weighting, and projections for event driven trials.
His experience also spans many different disease areas, including relapsing multiple sclerosis, secondary hyperparathyroidism, atrial fibrillation, atrial flutter, acute decompensated heart failure, dyslipidemia, breast cancer, Clostridium difficile-associated diarrhea, diabetes, insomnia, pulmonary arterial hypertension, HIV, and ulcerative colitis. Jamie holds a Master's of Science in Biostatistics from the University of Minnesota.
Job Titles:
- Chief Operating Officer
- Member of the Leadership Team
Job Titles:
- Data Management Center Director for ACTG and IMPAACT
- Director for the ACTG and IMPAACT Projects
Marlene Cooper is the Data Management Center Director for the ACTG and IMPAACT projects at Frontier Science. In this role, she ensures that dedicated data management services and core resources for software engineering, study build, data standards, user training, database operations, and information technology are available for the projects.
Marlene has been a part of Frontier Science for over 25 years, and uses her expertise to support NIH funded HIV/AIDS-related research projects and advise leadership committees on general data management workflows, controlled documents, inspection readiness, and related initiatives. Marlene holds a Master's in Epidemiology from Case Western Reserve University.
Job Titles:
- Director of Research and Development
In his role as Director of Research and Development, Matt Cole leads efforts to identify, onboard, and implement new software technologies in support of project and infrastructure needs. With over two decades working in the software engineering field, including more than 15 years at Frontier Science, Matt uses his expertise to lead the design and development efforts for many of Frontier Science's bespoke systems as well as working on setup and integration with third party software and systems. He holds a Bachelor's in Computer Science from the University of Essex.
Job Titles:
- Member of the Board of Directors
- Senior Finance Manager at Massachusetts General Hospital
Matt Mues is a senior finance manager at Massachusetts General Hospital for the Center of Systems Biology. Matt attended the Brooks School prior to University of Vermont where he received a BA in Biology. He has served the UVM board in many capacities and most recently as Chair of the Boston Regional. He has now joined the Brooks School alumni board. He stays very vested in the city of Boston neighborhood associations in conjunction with the blackstone franklin squares NA supporting their ongoing scholarship mission for first in their families going to higher education and protecting the oldest american elm trees in the local squares by his house.
Job Titles:
- Secretary
- Secretary of the Board of Directors
Biostatistics and 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 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 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).
Job Titles:
- CEO
- President
- Chief Executive Officer of Frontier Science Foundation
Job Titles:
- CEO
- Member of the Board of Directors
- Member of the Leadership Team
- President
Suzanne Siminski has been working in clinical trials data management and related research activities for more than 30 years. Her expertise lies in innovative data collection strategies, data harmonization and data-sharing initiatives.
She currently serves as an MPI for the NCI sponsored HIV/Cervical Cancer Prevention ‘CASCADE' Clinical Trials Network, and the Frontier Science Principal Investigator for: The Pediatric HIV/AIDS Cohort Study (PHACS) Network, The RePORT International Consortium for Tuberculosis Research, and The Clinical Pharmacology Quality Assurance (CPQA) Program, all programs funded by the NIH.
Job Titles:
- Member of the Leadership Team