2023

Bios

Morning Keynote:

Mark Chang, PhD, is the founder of AGInception, devoting to AI research. He is an elected fellow of the American Statistical Association with over 25 years of experience as a statistician in the biopharmaceutical industry and academia. He held various positions from Scientific Fellow to Senior Vice President. As adjunct professor in Boston University he has guided his PhD students on thesis topics of Adaptive Clinical Trial Design and Artificial Intelligence. He has broad research interests, including adaptive clinical trials, AI, principles of scientific methods, paradoxes, issues and methods in modern biostatistics interests in general, and software development. His recent publications include Artificial Intelligence for Drug development, precision medicine, and healthcare (2020) and Foundation, Architecture, and Prototyping of Humanized AI (2023). Dr. Chang served on editorial boards for statistical journals and actively engaged in statistical communities for promoting biostatistics. He is a co-founder of the International Society for Biopharmaceutical Statistics. Dr. Chang earned his Master and PhD degrees from the University of Massachusetts in Amherst, MA.

Morning Session 1:

Gu Mi is currently a Senior Statistical Project Leader in Oncology Early Development at Sanofi. He started career at Eli Lilly in 2014 after graduating from Oregon State University with a Ph.D. in Statistics. In October 2020, he joined Sanofi’s Biostatistics and Programming team and has been leading several early-phase oncology projects across solid tumors and hematologic malignancies, with a focus on novel cell-based therapies. He also serves as a group leader for internal cross-functional working groups such as basket trial designs and dose optimization. Externally, he is a member of the DahShu IDSWG Oncology sub-teams, and had served as an organizer/session chair for pharmaceutical/statistical conferences on multiple occasions.

He is active in promoting statistical innovations in drug development, with research papers, book chapters and presentations on topics related to translational research, enhancements of adaptive designs and dose-escalation methods, decision-making in basket trials and practical dose optimization designs. Some of his recent research works were published at Pharmaceutical Statistics, Contemporary Clinical Trials, and Statistics in Biopharmaceutical Research. He is also an Associate Editor for the Journal of Biopharmaceutical Statistics and serves as a statistical board member for multi-disciplinary journals.

Lisa LaVange, PhD, is Professor and Chair Emerita of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. She is former director of the department’s Collaborative Studies Coordinating Center (CSCC), overseeing faculty, staff, and students involved in large-scale clinical trials and epidemiological studies coordinated by the center.  From 2011 to 2017, Dr. LaVange was director of the Office of Biostatistics in the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). There, she oversaw more than 200 statisticians and other staff members involved in the development and application of statistical methodology for drug regulation. She was a leader in developing and assessing the effectiveness and appropriateness of innovative statistical methods intended to accelerate the process from drug discovery to clinical trials to FDA approval and patients’ benefit, with a particular focus on rare diseases.  Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry. Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and was the 2018 ASA President, as well as the 2007 Eastern North American Region (ENAR) of the International Biometrics Society (IBS) President. She received the Chair’s Award for Outstanding Contribution to Global Health (in the Americas Region) from the Drug Information Association (DIA).

Morning Session 2:

Tianyu Sun is currently working as biostatistician focusing on Real-World Evidence Analytics at Moderna. He is partnering with cross-functional groups to support the development and execution of comparative effectiveness studies, disease surveillance studies, and externally controlled trials. Full list of publications: https://scholar.google.com/citations?user=fB8A030AAAAJ&hl=en&oi=sra.

Dr. Wei Wei is currently a senior manager in the Statistics and Quantitative Science department at Takeda Pharmaceutical Company. Before joining Takeda, Dr. Wei was an assistant professor at the department of Biostatistics at Yale School of Public Health and served as the lead statistician for numerous early phase oncology clinical trials at Yale Cancer Center. Dr. Wei's research is centered around developing novel Bayesian and causal machine learning methodologies within the realm of master protocol, dose optimization and utilization of external data.

Afternoon Keynote:

Dr. Rui (Sammi) Tang is a leading expert of biostatistics in the biotech/pharmaceutical industry and she is currently the VP, Global Head of Biometrics at Servier Pharmaceuticals.

Prior to join Servier she was the Biostatistics Therapeutic Area Head for multiple teams at Shire Pharmaceuticals including oncology, Transplants, Ophthalmology and prematurity neonates and has worked at several other organizations, including Vertex, Amgen, Mayo Clinical and Merck. At Amgen, she served as the biostatistics lead of Companion Diagnostics and the Global Statistics Lead for multiple oncology clinical programs from early phase to late phase. Sammi has great experience in CDRH, CBER, CDER, health Canada, EMA and Asian regulatory agencies interactions. Sammi’s research interests are primarily in the area of adaptive clinical trial design and biomarker subgroup related statistical issues in precision medicine. She has authored more than 50 articles in peer-reviewed scientific journals on methodology, study design, data analysis and reporting and is a co-inventor of several patents. Besides her daily work, she actively promotes data science through many of her volunteer activities: Sammi is co-founder of DahShu which is a 501(c)(3) non-profit organization, founded to promote research and education in data sciences with almost 5000 members internationally. She is leading teams in the Innovative design scientific working group (IDSWG) of oncology drug development and small population working group for rare disease statistical methodology development. She is also an active member in ASA(American Statistics Association) and ICSA(International Chinese Statistics Association) to serve the biostatistics and data science professional community.

Sammi graduated from the University of Michigan Technology University with a PhD in statistics Genetics.

Afternoon Session:

Sarah Conner is a Principal Biostatistician at Vertex Pharmaceuticals. Since joining Vertex in 2021, Sarah has worked on various clinical trials and real-world analyses for rare disease. Prior to Vertex, Sarah graduated from Boston University with her PhD in Biostatistics, with a research focus in survival data and non-proportional hazards.

Ting Wang is a senior principal biostatistician in Biogen. He received Ph.D. degree in Biostatistics from University of North Carolina at Chapel Hill in 2020, and then joined Biogen Biostatistics. He has worked on the design and analysis of several late phase clinical trials in multiple sclerosis and immunology. His research interests include design and analysis of innovative clinical trials, precision medicine and Bayesian inference.

George Kong is Director of Biostatistics at Biogen. He has been working in the field of clinical development for over 20 years across therapeutic areas of immunology, neurology, oncology, and virology. His interest includes drug development strategy, innovative trial design, and regulatory statistical methodology in clinical trials. He received his PhD degree in statistics from Michigan State University.