Erik Pulkstenis, Ph.D.
Dr. Erik Pulkstenis is Chair of the CDISC Board of Directions. Dr. Pulkstenis is Vice President and Global Head of Data and Statistical Sciences in support of clinical development strategy, data science, statistical analysis and reporting/analytics at AbbVie. Previously, he headed Clinical Biostatistics & Data Management at Medimmune, led the Biostatistics Department at Human Genome Sciences, and served at C.L. McIntosh & Associates consulting with medical device manufacturers with respect to study design, regulatory strategy, and FDA Advisory Committee preparation. From 2013 to 2019 Dr. Pulkstenis served on the American Statistical Association Biopharmaceutical Section Executive Committee and currently serves on the ICH E20 Adaptive Design Expert Working Group. He received an M.S. and Ph.D. in statistics from the Pennsylvania State University.
Pam Howard, MS
Pam Howard is Past Chair of the CDISC Board of Directors. Ms. Howard is Vice President of Biostatistics and Programming and Medical Writing at ICON. Prior to this role, she held a number of senior positions within ICON, including Vice President, Data Management, Vice President, Clinical Operations and Global Business Lead for Metrics and Process Improvement Initiatives. Ms. Howard has always had an interest in standards, and has actively promoted the application of standards, in particular, to promote data-driven decision making, to increase the quality and productivity of clinical projects, and decrease their costs. She recently completed a diploma and certificate in Company Direction from the Institute of Directors, Ireland. Ms. Howard received her MS in Biostatistics from the University of Reading, UK, an MS in Biotechnology from University College Galway, Ireland and a BS in Industrial Chemistry from the University of Limerick, Ireland.
Wenjun Bao, Ph.D.
Dr. Wenjun Bao is a Chief Scientist and Sr. R&D Manager for JMP Life Sciences of SAS Institute Inc. She has rich experiences in clinical, biochemistry, molecular biology and bioinformatics research. She has been a research grant review committee member for the NIH since 2005 and research advisor for scientists in universities and government agencies. Dr. Bao is an adjunct professor at Fudan University in Shanghai and a Chinese CDISC Coordinating Committee Member.
Jonathan Chainey, BSc
Jonathan Chainey is an Executive Director and Global Head, Data Standards & Governance within Data Sciences, Product Development at Roche. He leads a global team accountable for the cross-functional governance and adoption of Roche’s CDISC-aligned global data standards across all Roche sponsored early & late phase clinical trials. Prior to his election to the CDISC Board of Directors, Jonathan served as chair of the CDISC Advisory Council.
Over the past 25 years Jonathan has worked within the biopharmaceutical industry in the U.K., Switzerland, and United States in a range of disciplines 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).
Jonathan has a scientific background and education including a BSc (Hons) Pharmacology, University of Bath, U.K. He is a British citizen and currently located in the San Francisco Bay Area, California.
Karen Curran, MBA
Karen Curran is Vice President, Global Strategic Partnerships at IQVIA. She has over 25 years’ experience with clinical research organizations leading global teams across Standards & Innovation, Data Management, Statistics, Statistical Programming and Medical Writing. Karen provides strategic direction and guidance on building and optimizing processes and outsourcing strategies for sponsors that result in successful long-term partnerships. Karen has been actively involved with organizations supporting the industry; she is currently the 2022 PHUSE US Connect Chair, she was the co-chair of the 2021 conferences and Panelist on Leaders in Innovation session, was the 2019 and 2020 Chair of the Leadership stream focusing on industry best practices around global strategies and innovation.
Karen was an early adopter of CDISC and has consulted with companies on best practice solutions since 2004. Prior to IQVIA, she held roles as the Vice President and General Manager at CSG, and the Vice President of Global Strategic Partnerships at Covance. Karen received her BS in Mathematics from Shippensburg University, and her MBA from Penn State University.
David Hardison, Ph.D.
Dr. Hardison has spent over three decades striving to make a difference for patients by helping organizations develop capabilities that leverage data, digital and science to improve diagnoses, treatments, and care delivery throughout the global healthcare ecosystem.
He recently retired from ConvergeHEALTH by Deloitte where he served as Vice President of Health Sciences and focused 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 also served in several industry leadership positions.
Dr. Hardison was awarded a B.S. with High Honors in Mathematics and Computer Science from Vanderbilt University. His Ph.D. is in Biostatistics from the UNC Gillings School of Global Public Health.
Brooke Hinkson has over 25 years of clinical research experience in various settings including a clinical research organization, healthcare provider, technology vendor, and biopharmaceutical companies. She is the Executive Director, Global Clinical Data Standards at Merck & Co., Inc., Kenilworth, NJ, USA in support of enabling process optimization, technology-enabled information management, and compliance with regulation and guidance for clinical study data. For over the past two decades, Brooke has extensive experience defining clinical data standards strategies and standards operating models to support the adoption, definition, use, sharing and governance of standards. Brooke has a passion for change and a desire to treat information as a strategic asset and leverage standards to accelerate delivering therapies to patients.
Pandu Kulkarni, Ph.D.
Dr. Pandu Kulkarni is the Chief Analytics Officer R&D and Vice President of Statistics, Data, and Analytics at Eli Lilly and Co. Dr. Kulkarni leads a large division of people composed of statisticians from discovery to commercialization, advanced analytics, data management, data standards and technology. He joined Eli Lilly in 2000 and has held numerous leadership positions, including technical and management positions within, and outside of, Statistics.
Before joining Lilly, Dr. Kulkarni was a tenured professor at the University of South Alabama. He has worked with NASA, Air Force, and given numerous invited presentations and workshops across the globe to provide training and continuing medical education. He has published over 50 articles in statistics and medical areas in peer-reviewed journals.
He earned his Ph.D. in Statistics at LaTrobe University, Australia.
Dominic Labriola, Ph.D.
Dominic F. Labriola is Chief Data and Analytics Officer of Madrigal Pharmaceuticals. Dr. Labriola has over 35 years’ experience as a drug developer, overseeing and contributing to the global registration of 20 medicines in multiple therapeutic and more than 20 years serving in executive leadership roles at Bristol Meyers Squibb. His interactions with global regulatory agencies have given him a unique understanding of the drug approval process and the importance of quality data to support those filings. An expert in trial designs and leveraging innovative approaches, he possesses a particular appreciation for the importance of data standards to support clinical research.
Dr. Labriola earned his Ph.D. from the University of Delaware.
Lisa Lin, MBA
Lisa Lin is a Study Data Standards Manager at FDA CBER (Center for Biologics Evaluation and Research). Currently she is responsible for all study data standards projects in CBER, including study data validation, evaluation and testing of the SEND standard for CBER, data standards and analysis tool training and support for CBER reviewers.
Before joining CBER, Lisa worked at CDER (Center of Drug Evaluation and Research) as a Data Standards Lead. She played an important role of leading CDER on study data standards development and implementation and her contribution includes the Development of Technical Rejection Criteria, Technical Conformance Guide, FDA Business Rules, FDA Data Standards Catalog, various technical specification guides, eData mailbox, training and support of analysis tools, consultation on Pre-NDA/Pre-BLA/IND meetings. Before joining FDA, Lisa contributed extensive experience and strong technical background working on CDISC data standards and clinical trial data analysis and submissions in several pharmaceutical companies. She received her MBA from West Chester University.
Hiroshi Masumoto, Ph.D.
Hiroshi Masumoto is Vice President of Data Intelligence at Daiichi Sankyo. Hiroshi leads the function, supervising clinical epidemiology, biostatistics, data management, and clinical data system and standards. His focus is to contribute to informed decision-making and value proposition through data-driven sciences. Hiroshi has broad experience and expertise in the pharmaceutical industry, including non-clinical research, global project management, corporate strategy and brand strategy. He received his Ph.D. in Bio-Organic and Medicinal Chemistry and BS in Pharmaceutical Chemistry from the University of Tokyo.
Rhona O'Donnell, BSc
Rhona O’Donnell has over 20 years’ experience in the clinical trials industry. She is currently VP, Data Management Systems and Standards at Novo Nordisk, overseeing clinical data standards, clinical data systems and data transformation across the Novo Nordisk value chain. Previously, Rhona held the position of VP, Data Management & Clinical Risk Management at ICON, working with multiple Sponsor partners across Data Management and Clinical Risk Management over the course of 19 years. Her experience spans global data management project delivery, EDC/clinical database and data transformation strategy and management, delivery model design, departmental financial and commercial management, clinical risk management, technical system selection and implementation as well as extensive experience in change control and process improvement projects.
Rhona studied Experimental Physics at University College Dublin and is currently serving as a voluntary board member for ECO-Unesco an environmental education and youth organization based in Ireland.
Mihoko Okada, Ph.D.
Dr. Mihoko Okada became President of the Institute of Health Data Infrastructure for All in May 2018. Prior to this role, she was a Professor of Health Informatics at Kawasaki University of Medical Welfare for 20 years, after serving as an Associate Professor of Statistics at Niigata University. Dr. Okada was the President of the Japan Association for Medical Informatics from 2013 to 2016 and has been with the ICH M2 EWG (Electronic Transfer of Regulatory Information) since 1998 and is currently an M2 Co-Rapporteur.
Christina Reith, BSc, MBChB, PhD, FRCP, FFPM
Dr. Christina Reith is a Senior Clinical Research Fellow at the University of Oxford’s Nuffield Department of Population Health (NDPH), where she primarily works on large-scale clinical trials and individual participant data meta-analyses in relation to cardiovascular disease. She is also involved in teaching on the NDPH MSc courses for both Global Health Science & Epidemiology and Clinical Trials, is a UK General Medical Council Educational Supervisor for Pharmaceutical Medicine specialty training, and acts as a College Advisor for students at the University of Oxford's Green Templeton College.