The Blue Ribbon Commission has been created to shape and guide CDISC’s future. Composed of global leaders from academia, the pharmaceutical industry, government agencies (including regulatory bodies), patient foundations and fellow standards development organizations, the Blue Ribbon Commission will advise CDISC Board and leadership on what changes we must prepare for to serve clinical data standards needs now and in the coming decade. We will actively engage our stakeholders in gathering information and needs as well as in communicating our findings broadly.
Robert M. Califf, MD, MACC, is vice chancellor for health data science and director of Duke Forge, the Center for Actionable Health Data Science at Duke Health, Donald F. Fortin, MD Professor of Cardiology in the Duke University School of Medicine, Chair of the Board of the People Centered Research Foundation, and an advisor for Verily Life Sciences, a member of the Alphabet family of companies formed by Google. He served as Commissioner of Food and Drugs in 2016-2017 during the Obama administration. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He was founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in peer-reviewed literature. Dr. Califf is a member of the National Academy of Medicine (formerly the Institute of Medicine). He has led major initiatives aimed at improving methods and infrastructure for clinical research and served on many NIH advisory committees, including the Institutes of Aging, National Heart, Lung and Blood Institute, National Cancer Institute and National Library of Medicine.
Joyce Sensmeier is the Vice President, Informatics for HIMSS North America, a strategic business unit of HIMSS, the global, cause-based, not-for-profit organization focused on better health through information and technology. In her current role she is responsible for the areas of clinical informatics, interoperability and standards programs and initiatives. She also oversees the HIMSS Innovation Center in Cleveland, OH. An internationally recognized speaker and author of multiple book chapters and articles, Sensmeier achieved fellowship in the American Academy of Nursing in 2010.
She is co-founder and ex-officio chair of the Alliance for Nursing Informatics, a global collaboration of 30 distinct nursing informatics groups representing a unified voice for nursing informatics professionals. In 2017 she received the Virginia K. Saba Nursing Informatics Leadership Award from Sigma Theta Tau, International. Sensmeier is president of IHE USA, which serves as a voice representing national efforts fostering the adoption of a consistent set of standards to enable interoperability of health IT systems. Sensmeier currently serves on the boards of CDISC, the Sequoia Project, and IHE International. She is active in her community, serving as a Commissioner on the Parks and Recreation Commission, San Marcos California.
Dr. Gina Agiostratidou is the Program Director for the Helmsley Charitable Trust’s Type 1 Diabetes (T1D) Program, which aims to advance research, treatments, technologies, and services that improve the life of people with type 1 diabetes. Previously, Gina was the scientific program manager at the Children’s Tumor Foundation, bringing scientists from around the globe to collaborate on research opportunities in the field of neurofibromatosis. She has completed two post-doctoral fellowships at Albert Einstein College of Medicine and Mount Sinai School of Medicine, focusing primarily on molecular biology and biochemistry.
Gina earned a PhD in Molecular Biology from the Medical School, National and Capodistrian University of Athens, Greece, and an MSc degree in Advanced Molecular Biology and Biotechnology at the University of London, UK. She recently earned her MBA from New York University, Stern Business School.
Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. She received a master’s degree in Engineering from Tokyo Science University, and PhD in Health Science from Osaka University. In 1997, she joined the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), which was established that year and subsequently transformed into the current PMDA. Currently she is responsible for the biostatistics review and consultation in the new drug and device review offices in PMDA. Additionally, she works as a leader of business part of Advanced Review with Electronic Data Promotion Group, the group which is responsible for the use of patient level electronic study data that are submitted with new drug applications in Japan. She is responsible for promoting CDISC implementation and the use of submitted electronic data in new drug review in PMDA.
David R. Bobbitt is an entrepreneur, fundraiser, and nonprofit executive who has been privileged to lead and launch many amazing organizations. Prior to joining CDISC, he served as President of the SCORE Foundation in Washington, DC, where he led the organization to significant growth while maintaining high-quality services to America’s entrepreneurs. He served in a senior executive role to launch New York Genome Center, the newest next generation genomic sequencing and bioinformatics platform in the world. David also built the largest private sector fundraising program for kidney disease services and research in the U.S. He holds an MSc in engineering and an MBA from Darden Graduate School of Business at the University of Virginia.
Jeffrey Brown, PhD is an Associate Professor in the Department of Population Medicine (DPM) at Harvard Medical School and the Harvard Pilgrim Health Care Institute. Within DPM, Dr. Brown serves as the Research Director of the Therapeutics Research and Infectious Disease Epidemiology program, overseeing a staff of over 100 researchers. His primary research activities involve new approaches to facilitate large-scale multi-institutional research through the use of distributed health data networks to support a learning health system.
This research established the basis for several established research networks, including the FDA’s Sentinel System and PCORnet. He has leadership roles in FDA Sentinel, PCORnet, the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), the Innovation in Medical Evidence and Development Surveillance (IMEDS) program, and the NIH Health Care Systems Research Collaboratory. Dr. Brown is the inventor of PopMedNet, an open-source software platform that facilitates creation and operation of distributed health data networks. Dr. Brown holds a Master’s degree in Economics from Tufts University and a PhD in Social Policy from Brandeis University.
Dr. Cave joined the European Medicines Agency in January 2016 as a Principal Scientific Administrator in the Pharmacovigilance and Epidemiology Department where she leads on developing mechanisms to increase capacity in the use of real world data in medicines regulation. She also co-chairs the HMA-EMA Joint Big Data taskforce, which is exploring the regulatory challenges presented by Big Data. She holds a BA Honours degree and PhD from the University of London and has over 20 years of academic research experience in the cardiovascular field. 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
Jonathan is British, and originally from Bournemouth, England. He has a scientific education, including a BSc Hons. in Pharmacology from the University of Bath, England.
Over the past 20 years he has worked across a number of disciplines and for a number of different companies within the biopharmaceutical industry in England, Switzerland, and the United States including pre‐clinical pharmacological research (Ciba‐Geigy), clinical data management (Parexel), statistical programming & analysis (Pfizer, Novartis), applications development (Pfizer, Roche), and process analysis, data standards & governance (Roche).
This cross‐functional and multi‐cultural experience is serving Jonathan well in his current role as Global Head, Data Standards & Governance within the Biometrics function of Product Development at Roche‐ Genentech. He is currently located in South San Francisco, California and is also currently chair of the CDISC Advisory Council.
Sherry Chou is a Principle Statistical Programmer located in the PAREXEL office in Taipei, Taiwan. She has been in the CRO industry for over 10 years, with career starting in Data Management and later on in Statistical Programming. She currently leads the CDISC Implementation Committee in PAREXEL, and also acts as one of the SMEs for CDISC standards in the company. Over the past years, she had also involved herself in the development of CDISC training, applications and work processes within PAREXEL.
Anthony Chow serves as Director of CDISC SHARE. He plays a leadership role in defining and administering processes and policies for governing the metadata that becomes the CDISC standards. His primary duties include creating, maintaining, curating, and ensuring high quality of the metadata in the CDISC SHARE suite of tools and services, the centerpiece of which is a metadata repository.
Anthony has previously held several essential IT roles at Allergan and Octagon Research Solutions, focused on delivering data integration and migration systems. He holds a bachelor’s degree in Computer Science from Northeastern University.
David Evans is Principal Director, Global Head of Quality Governance and Regulatory Compliance for Accenture Research and Development Services. With over 35 years’ experience in the clinical research, regulatory and healthcare industries, he is recognized industry-wide as a leading technology visionary for developing and implementing complex process and system solutions. Mr. Evans was the architect and developer of the first electronic drug submission to the FDA in 1985, and has been responsible for more than 100 electronic regulatory submission and complex clinical data warehouse systems. He holds a master’s degree in Biomedical Engineering and has previously held executive-level positions (CIO, CTO, COO, CQO) at software development, clinical research, regulatory and industry consulting companies.
Rhonda Facile identifies and grows strategic relationships and alliances that support the global development, improvement and implementation of CDISC standards. She brings over 25 years of clinical development experience to CDISC and has worked at a global CRO, as well as pharmaceutical and biotechnology companies in the United States and abroad. Ms. Facile has worked at CDISC since 2006, previously leading staff and volunteers committed to the development, publication and implementation of therapeutic area standards to ensure all CDISC standards projects progress and comply with CDISC development processes and policies. She holds a BA degree from the University of Texas at Austin and an MS in Organization Leadership and Ethics from St. Edwards University.
Dr. Lynn D. Hudson serves as the Chief Science Officer for the Critical Path Institute (C-Path) and the Executive Director of the International Neonatal Consortium (INC) and the Multiple Sclerosis Outcome Assessments Consortium (MSOAC). She started at C-Path by overseeing the first regulatory qualification of an imaging biomarker for patient enrichment in clinical trials for Alzheimer’s disease. Recent collaborative efforts include launching INC and co-chairing the Scientific Advisory Committee of CFAST, the partnership between C-Path and CDISC for creating and maintaining therapeutic area data standards. Lynn graduated with a B.S. in Biochemistry from the University of Wisconsin and a Ph.D. in Genetics and Cell Biology from the University of Minnesota, and trained at Harvard Medical School and Brown University.
As Chief of the Developmental Genetics Section at the National Institute of Neurological Disorders and Stroke, she conducted research to define the network of genes involved in neural development. She served as an officer for the American Society for Neurochemistry and the PMD Foundation, and as an advisor for a number of granting agencies, including NIH, NSF, and the National MS Society. At the National Institutes of Health, Lynn directed the Office of Science Policy Analysis from 2006-2011. Presently Lynn represents C-Path at the National Academy of Science Forum on Drug Discovery, Development and Translation as well as on the board of BIOSA, the Bioindustry Organization of Southern Arizona. She has a Research Professor appointment in the College of Medicine at the University of Arizona, and was honored by AZBIO as the 2015 Arizona Bioscience Leader of the Year.
Hugh has 30 years’ experience in Health Informatics, filling roles from software developer to lead architect. He is a partner in Blue Wave Informatics LLP, providing informatics consultancy to clients ranging from supra-national authorities, through national healthcare informatics programmes, to corporate clients in the healthcare systems and pharmaceutical domains. Since 2016, Hugh has also been Principal Information Architect at PAREXEL Informatics. He has also been heavily involved with HL7 and is currently co-chair of the Biomedical Research and Regulation work group.
Dr. Hardison focuses on helping life science organizations optimize evidence planning, generation and management throughout the product life cycle. This includes leveraging his extensive global experience in the healthcare ecosystem to develop strategies, tactics, and technologies for gaining optimal insights across proprietary research data, public data and Real World Data that help companies embrace Precision Medicine and Value-based Reimbursement. He has served as a strategic advisor to healthcare executive teams, physician organizations and boards of trustees on continuous quality improvement and served the dual role of Vice President of Continuous Improvement and CIO of a health system. Dr. Hardison has served in several industry leadership positions and is current Past - Chairman of the CDISC Board of Directors and remains on the Board as Board Member Emeritus.
Sam Hume leads the CDISC Data Science team, which collaborates with CDISC staff and stakeholders to develop tools and standards that support clinical and translational data science. Dr. Hume directs delivery of the CDISC SHARE metadata repository that houses all CDISC standards, co-leads the CDISC Data Exchange Standards team, and leads the CDISC Real World Data efforts. He has 25 years’ experience in clinical research informatics and has held a number of senior technology positions in the biopharmaceutical industry.
Dr. Hume holds a doctorate in Information Systems.
Dave has over 35 years of industry experience with nearly 20 years in the pharmaceutical industry during which time he has been using and helping develop the CDISC standards. During that time, Dave led CDISC Technical work for 2.5 years, been the ODM and SHARE team leads and has co-led HL7’s Regulated Clinical Research Working Group. He has worked closely with the FDA, CDISC, HL7, ISO, IHE and other organisations that promote better electronic processes for medical research. He was the lead author for the CDISC white paper of electronic source data that was used as the basis for EMA’s guidance document.
He currently volunteers with the CDISC XML Technology and define.xml teams and participates in the PhUSE FDA Computational Science Symposium working groups. He is now exclusively focused on the effective management and use of metadata within pharmaceutical companies to improve process and data quality. Dave presents regularly at industry conferences including CDISC, PhUSE and DIA.
Steven E. Kern, PhD is Deputy Director of Quantitative Sciences at the Bill and Melinda Gates Foundation. The Quantitative Sciences group is focused on quantitative analysis to support program strategies for therapeutic projects that the foundation funds. This efforts extends across all therapeutic areas in which the foundation is involved including efforts for pandemic preparedness.
Prior to this, he was Global Head of Pharmacology Modeling at Novartis Pharma AG based in Basel Switzerland where he lead a team focused on providing model based drug development support to therapeutics in many disease conditions across all stages of drug development. He joined Novartis in 2010 from the University of Utah in Salt Lake City, Utah where he was Associate Professor of Pharmaceutics, Anesthesiology, and Bioengineering, and served as co-investigator for their NIH funded Pediatric Pharmacology Research Unit. He has designed, conducted, and served as a principal investigator for clinical pharmacology studies in adults and children that spanned the population from preterm infants to elderly adults.
Marine Laurent guides CDISC’s financial strategy and sustainability, working with the Leadership Team in achieving the CDISC mission, vision, and strategic goals. She is a seasoned professional with over 10 years’ operational finance, treasury and purchasing experience and a strong track record in supervising complete financial processes, including designing and executing financial and management reporting, structuring operations, and strategic business planning. Prior to joining CDISC, Ms. Laurent served as CEO/CFO of France Alter Eco, a French market organic and fair-trade food distributor. Earlier in her career, she was CFO of Australia-based Boost Media International. From 2005 to 2007, Ms. Laurent was an Internal Auditor for Sanofi-Aventis.
Bess LeRoy serves as a metadata engineer at CDISC. Bess has been a CDISC team member since 2011 and has been involved in the development of 16 CDISC Therapeutic Area User Guides. She is a member of the CDISC Technical Leadership Team and leads the Global Governance Group. Bess has over 15 years' experience working in public health research and has held positions at the Framingham Heart Study, the Rotterdam Study, the Arizona Cancer Center, and the Critical Path Institute. Bess has a BS from the University of Michigan, an MPH from Boston University, and is currently pursuing a DrPH from Johns Hopkins University.
Laura is Associate Director of the Infectious Diseases Data Observatory (IDDO), a scientifically independent, multi-disciplinary coalition across the global infectious disease community. Based in the Centre for Tropical Medicine and Global Health at the University of Oxford, Laura develops platforms which synthesise health data to generate reliable evidence and research-driven responses to major challenges in poverty related diseases and emerging infections. IDDO has developed platforms for malaria, Ebola, visceral leishmaniasis and beyond, by engaging the health, research and the humanitarian communities to collaboratively design ethical and legal frameworks tailored to impact individual diseases. Laura’s research interests include exploring issues in sharing biomedical research data and in changing the paradigm of clinical research in outbreaks to enable rapid research response.
Hidetoshi Misawa is Director of Data Monitoring and Management organization in Pfizer Japan supporting the portfolio across all therapeutic areas, with more than 20 years’ experience in data management. He is a member of Global Standards Governance Board at Pfizer.
He currently serves as the chair of Japan CDISC Coordinating Committee and also serves as a Vice Chair of Data Science Committee at Japan Pharmaceutical Manufacturers’ Association. Hidetoshi holds a Bachelor Degree in Pharmaceutical Sciences from Tokyo University of Science.
Jennifer leads on clinical trial data sharing work at Wellcome Trust. She is responsible for a number of data sharing and trial transparency projects at Wellcome, which includes working with academia, industry, publishers, funders and regulators to influence the research ecosystem in order to open up access to trial data. Prior to working at Wellcome, Jennifer worked on running cardiovascular clinical trials for the Medical Research Council. She has an academic background in genetics, public health and epidemiology and is a graduate of the University of Cambridge.
Ülo Palm is Senior Vice President Drug Development Operations with Allergan Pharmaceuticals. He is also Corporate Secretary and Oversight Committee Chair with TransCelerate Biopharma. Dr. Palm’s vision is to expedite drug development by linking top medical science to operational excellence and 21st century technology. He has published on this topic and is a frequent speaker at international conferences on strategies to cut drug development time and costs through process improvement and technology.
Dr. Palm earned his M.D.from the University of Berlin, where he received a postgraduate research training as a medical scientist. He completed his research training with a PhD. He is author and co- author of a number of scientific articles in international journals and holder of two medical patents. He earned his MBA degree with a major in Information Technology/Computer Sciences from the AKAD University for Applied Science in Rendsburg, Germany.
Dr. Palm is a Senior Member of the American Society for Quality (ASQ) and a certified Manager of Quality and Organizational Excellence (ASQ-CMQ/OE). His work at the ASQ includes initiating and co-authoring the ASQ report on “Best Quality Practices for Biomedical Research in Drug Development”. He also serves on the Board of Directors of ANAB, the ANSI-ASQ National Accreditation Board.
Maria has over fifteen years of experience managing operational and strategic ventures in the biotech and pharmaceutical industries. As a consultant for WMackin & Associates, a small, virtual drug development and regulatory professional services company, she supports the electronic submissions of INDs, NDAs and BLAs to FDA for small and emerging biopharmaceutical companies. She is a self-taught programmer and co-owns Formed, Inc, a digital health web technology company with her husband. After their daughter was born with the rare genetic disorder Prader Willi-Syndrome, they committed to creating solutions for rare disease and together founded TREND Community, building software that empowers patients and caregivers to turn their anecdotes into evidence.
Frank 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.
Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute and Managing Partner of HunterRockhold, Inc., (www.hunterrockhold.com). 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. He has also held faculty appointments at six different universities. Frank served for 9 years on the board of directors of the non-profit 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 and is on the board of the Frontier Science and Technology Research Foundation.
Frank holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. Frank is a Fellow of both 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. Rosario is the Director of the Office of Computational Science (OCS) in the Office of Translational Sciences, Center for Drug Evaluation and Research. OCS leads and directly supports the modernization of CDER’s scientific review capabilities.OCS innovates tools, technologies, and services specifically for drug product review and then provides these to reviewers at the right time backed up with training and support. Acknowledging that successful review starts with quality data, OCS continues to support efforts to regularly achieve high quality data. Recently, OCS received the Health and Human Services Secretary’s Award for its work in developing CDER’s JumpStart program, an innovative initiative dedicated to enhancing the efficiency of CDER’s new drug development and review process.OCS continues to innovate and service reviewers as Dr. Rosario has led to the OCS to make real it’s motto: Better data, better tools, better decisions. Dr. Rosario received her bachelors of science in Chemistry from the University of Puerto Rico and attended Rutgers University where she earned her Ph.D. in Neuroscience. Dr. Rosario joined the FDA in 2000.
Dr. Volchenboum is an associate professor of pediatrics and the associate chief research informatics officer for the biological sciences division at the University of Chicago. His clinical speciality is pediatric hematology / oncology, caring for kids with cancer and disease of the blood. In addition to his clinical practice, he directs the University of Chicago’s Center for Research Informatics, a 40-person group that supports biological research throughout the division. As director of this center, he oversees high-performance computing, HIPAA-compliant storage and backup, application development to support clinical trials, development and maintenance of the clinical trials management system, the clinical research data warehouse, data analytics and visualization, and bioinformatics, including high-throughput genomic analyses and machine learning. He oversees data governance for the division and medical center, facilitates stewardship and oversight of research data produced by hospital transactional systems, and works to produce policies and procedures for both data governance and security. He is the director of the Informatics Core for the Clinical and Translational Science Award (CTSA). Since 2015, he has been the faculty director for the Masters in Biomedical Informatics at the Graham School at University of Chicago. Dr. Volchenboum’s major research interest is in building commons to support scalable and extensible biological research.
Anita Walden holds more than 20 years of experience in clinical research and 15 years in informatics-related activities. She has managed data operations for large domestic and international trials conducted in over 25 countries and has supervised data integration and informatics teams. Her informatics background is diverse, with experience in data standards development, data integration, and mobile and electronic health technology development. In the international standards arena, she has held leadership roles in Health Level Seven (HL7) and the Critical Path Institute, and has a strong relationship with CDISC, collaborating on standards methodology activities. As an informatics project leader and investigator, she led and managed grants funded by the FDA, NIH, and Gates Foundation and developed nine therapeutic area standards in infectious disease, mental health, cardiology, anesthesiology preoperative assessment, emergency services, trauma, and bio-banking.
She is also an industry educator and trainer in data management, clinical research informatics, and mobile health technologies with the Society of Clinical Data Management (SCDM).
As a faculty member in the Department of Biomedical Informatics at the University of Arkansas for Medical Sciences (UAMS), her research interests are in international data standards, EHR data integration for clinical studies, and implementation of eHealth and mHealth technologies for underserved and under-represented communities to improve healthcare access and health outcomes.