Keynote Speakers
Robert Hemmings, Consilium Salmonson and Hemmings
Dr. Robert Hemmings is a partner at Consilium. Consilium is my consultancy partnership with Tomas Salmonson, a long-standing member of the EMA’s CHMP and formerly the chair of that committee. Tomas and I support companies in the development, authorisation and life-cycle management of medicines.
Previously Dr. Hemming worked at AstraZeneca and for 19 years at the Medicines and Healthcare products Regulatory Agency, heading the group of medical statisticians and pharmacokineticists. He is a statistician by background and whilst working at MHRA he was co-opted as a member of EMA’s CHMP for expertise in medical statistics and epidemiology. At CHMP Dr. Hemming was Rapporteur for multiple products and was widely engaged across both scientific and policy aspects of the committee’s work. He was fortunate to chair the CHMP’s Scientific Advice Working Party for 8 years and have also chaired their expert groups on Biostatistics, Modelling and Simulation and Extrapolation. Dr. Hemmings wrote or co-wrote multiple regulatory guidance documents, including those related to estimands, subgroups, use of conditional marketing authorisation, development of fixed-dose combinations, extrapolation and adaptive designs. Dr. Hemmings have a particular interest in when and how to use data generated in clinical practice to support drug development.
Tze Leung Lai, Stanford University
Dr. Tze Leung Lai is the Ray Lyman Wilbur Professor of Statistics and by courtesy, also of Biomedical Data Science, and Computational & Mathematical Engineering at Stanford University, where he is the Director of Financial and Risk Modelling Institute (FARM), Co-director of the Center for Innovative Study Design (CISD) and core member of the Comprehensive Cancer Institute, Center for Innovation in Global Health, Center for Precision Mental Health and Wellness, and Center for Population Health Sciences in the School of Medicine, and an advisory committee member of the Bing Overseas Program (BOSP) in Hong Kong. Before moving to Stanford in 1987, he was the Higgins Professor of Statistics at Columbia University where he received his Ph.D. and an Assistant Professor appointment in 1971 and was promoted to Professor in 1977. He received the COPSS (Committee of Presidents of Statistical Societies) Award in 1983 and was elected to Academia Sinica in 1994. He is also the honorary dean of the Center for Financial Technology & Risk Analytics at Fudan University, a visiting chair professor of Southwestern University of Finance and Economics, and an advisory committee member of the Yau Center for Mathematical Sciences at Tsinghua University, the Center for Statistical Science at Peking University, the Department of Statistics and Actuarial Science at The University of Hong Kong (where he received his B.A degree, First Class Honors, in Mathematics in 1967), and the Institute of Statistical Science, Academia Sinica in Taiwan. He has published over 300 papers and 12 books, and has supervised 73 Ph.D. these at Columbia, Stanford, and Stony Brook and University of Padova in Italy (where he visited).
TFrank W Rockhold, Duke University
Dr. Frank Rockhold is a fulltime Professor of Biostatistics and Bioinformatics at Duke University Medical Center (Scholars at Duke), Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Managing Partner of HunterRockhold, Inc. His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance. He has held faculty appointments at six different universities. Dr. Rockhold 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 and a past member of the PCORI Clinical Trials Advisory Panel. He is currently on the board of the Frontier Science and Technology Research Foundation and a technical advisor to EMA.
Dr. Rockhold has diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, safety and pharmacovigilance and has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. Dr. Rockhold is widely published in major scientific journals across a wide variety of research topics.
Dr. Rockhold 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. Dr. Rockhold is an Elected Fellow of both the American Statistical Association and the Society for Clinical Trials, a Fellow of the Royal Statistical Society, an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.
Sue-Jane Wang, Food and Drug Administration (remotely via video)
Dr. Sue-Jane Wang is an Associate Director, Office of Biostatistics (OB) in the Office of Translational Sciences, CDER, US FDA. She is also the OB Biostatistics Liaison to Office of New Drugs for the FDA/CDER Biomarker Qualification Program. Her tenure at FDA is more than 20 years. Currently, Dr. Wang is also helping the Biometrics Division that provides regulatory statistical services to cardio-renal, neurology, psychiatry and medical imaging drug product developments. She is well-recognized nationally and internationally of her significant contributions to biopharmaceutical regulatory statistical community on adaptive designs, biomarkers and pharmacogenomics. In her roles, Dr. Wang has been contributing to FDA guidance developments as an Office Lead or a guidance working group member including, e.g., pre-market evaluation on clinical pharmacogenomics, adaptive design, enrichment strategies, drug development tools, co-development of an In Vitro companion diagnostic device with a therapeutic product, multiple endpoints, and biomarker qualification guidance for industry and FDA staff. She is a member of FDA-NIH Biomarker Working Group and FDA/CDER/OB Safety and Benefit-Risk Working Group. Dr. Wang has been active in complex trial design, pharmacogenomics, biomarker, medical imaging efficacy and safety issues in drug development, theranostics research and regulatory considerations, and professional editorship. She has been awarded for her professional recognitions including, e.g., a Fellow of the American Statistical Association, an FDA Level Scientific Achievement (Individual) Award on Excellence in Analytical Science.
Daisaku Sato, Pharmaceuticals and Medical Devices Agency
Dr. Daisaku Sato is Chief Management Officer / Associate Centre Director for Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA). From June 2016 to July 2018, he was Director, Pharmaceutical Safety Division, Pharmaceutical Safety and Environmental Health Bureau, the Ministry of Health, Labour and Welfare (MHLW), Japan. Before back to MHLW, from 2013 to 2016, he was Director, Office of New Drug V for oncology drug review and Director, Office of Cellular and Tissue based Products at PMDA, respectively. Dr Sato worked for more than 25 years as a technical administrator at MHLW, Japan. From 2011 to 2013 he was Director, Office of Compliance, Pharmaceutical and Food Safety Bureau, MHLW and was responsible for pharmaceutical law enforcement and GMP inspectorate. He also experienced various drug regulatory responsibilities in pharmacovigilance, clinical research, health research funding, blood safety, food safety, international harmonisation (such as ICH) and normative activities at MHLW. During his service of the Ministry, he worked at Division of Drug Management and Policy, WHO (Geneva) on secondment from 1994 to 1996.
He is a registered pharmacist and was received Ph.D. degree (pharmaceutical sciences) from the University of Tokyo. Dr Sato has been a member of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations since 2014.