Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was a deputy director of the Evaluation Division II of PMDEC, later merged with other organization to form PMDA of the Ministry of Health and Welfare and Labor between 1997 – 2002, making his current position as Chief Executive his second appointment. Between Jan 2011 to Feb 2013, he was a Deputy Secretary General of Office of Medical Innovation, Cabinet Secretariat of Japan, and led health policy issues regarding life science.

Dr. Mayumi Shikano is currently Associate Director for Advanced Review with Electronic Data and Science Board of Center for Product Evaluation at Pharmaceuticals and Medical Devices Agency (PMDA). She is also responsible for the development of standards and guidelines by projects across multi offices in PMDA. Dr. Shikano graduated from the University of Tokyo, Faculty of Pharmaceutical Sciences in 1981. She received her Ph.D. from the University of Tokyo in 1992. Her career includes a researcher in Sagami Chemical Research Center and National Institute of Infectious Diseases before joining Pharmaceuticals and Medical Devices Evaluation Center, the predecessor of PMDA in 1998 as a reviewer.

Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in many of the Center’s strategic initiatives including decision support, data standards, program analysis, IT, informatics and governance. Ms. Slack serves on several Boards and Committees where she supports FDA’s needs and perspectives.

Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. She has over 20 years' experience as Biostatistics Reviewer, and currently she is responsible for the biostatistics review and consultation in the new drug and device review offices in PMDA. Also she works for Office of Advanced Evaluation with Electronic Data, the office which is responsible for the electronic study data submission in the PMDA. She is a member of Real World Data Working Group and Global Clinical Study Working Group that are projects across multi-offices in the PMDA. She received a master’s degree in Engineering from Tokyo Science University, and PhD in Health Science from Osaka University.

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on the standardized clinical protocol template, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme. Ron received a PhD in statistics from the University of Maryland and MBA from University of New Haven.

Naruhiko Hiramoto is a Director for Information System Coordination of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. Currently he is responsible for the information system development in the Information Technology Promotion Group in PMDA. Additionally, he works as a leader of e-submission gateway system development part of Advanced Review with Electronic Data Promotion Group.

Dr. Wilson has worked as a mathematical statistician at FDA for more than 33 years.  He is currently a Senior Staff Fellow with the Office of Biostatistics at the Center for Drug Evaluation and Research (CDER).  Steve received his doctorate in Biostatistics from the University of North Carolina, Chapel Hill, in 1984. His professional experience has also included positions with the East West Center, the Indonesian Central Bureau of Statistics, the University of North Carolina, the Federated States of Micronesia and the World Bank. His professional interests and activities are currently focused on issues related to the improvements in clinical trials science and practice, data standards, and the review of drug and biological therapies.