The 3rd Stat4Onc Annual Symposium

Panel Discussion Speaker Biography

Daniel Catenacci, M.D.

Bio:

Daniel Catenacci, MD, Associate Professor of Medicine, is an adult GI medical oncologist, and Director of the gastrointestinal oncology program at the University of Chicago. He serves as the Assistant Director of Translational Research in the Comprehensive Cancer Center.

In addition to his clinical practice, Dr. Catenacci is an active basic and clinical researcher, focusing on the treatment of gastroesophageal (esophagus, gastroesophageal junction, and stomach) cancers. His bench-to-bedside translational research has an overarching goal to validate and improve personalized treatment, immunotherapy, and precision medicine for gastroesophageal cancer and other GI cancers. A major focus of his research is on the quantification of tumor genetic molecular heterogeneity both between individuals with gastroesophageal cancer, but importantly also within a given individual within one tumor site, and from one tumor site to another, and how this impacts personalized targeted therapeutic approaches. Additionally, Dr. Catenacci designs and executes novel clinical trials to implement treatment strategies based on these laboratory and clinical discoveries. Dr. Catenacci serves as Associate Editor for the Journal of American Medical Association Network Open (JAMA Netw Open) and is on the editorial board of the Journal of Clinical Oncology Precision Oncology (J Clin Oncol PO).

Andrea Gross, M.D.

Bio:

Dr. Andrea Gross is a board-certified pediatrician who earned her medical degree at the University of Connecticut and completed pediatric residency and a chief resident year at Cincinnati Children’s Hospital Medical Center. She completed a pediatric hematology/oncology fellowship at Children’s National Medical Center and is currently an Assistant Research Physician working in the Pediatric Oncology Branch at the National Cancer Institute under the mentorship of Dr. Brigitte Widemann. Dr. Gross has been the lead associate investigator on the phase 2 trial of selumetinib for patients with NF1 and inoperable plexiform neurofibromas since 2015.

Yuan Ji, Ph.D.

Bio:

Dr. Yuan Ji graduated from Fudan University with a bachelor in Mathematics, University of Wisconsin – Madison with a PhD in Statistics. He spent 9 years at The University of Texas M. D. Anderson Cancer Center as Assistant and Associate Professor in Biostatistics and Bioinformatics. Currently, Dr. Yuan Ji is Professor of Biostatistics at The University of Chicago. He is an NIH-funded PI focusing on innovative computational and statistical methods for translational cancer research. Dr. Ji is author of over 120 publications in peer-reviewed journals, conference papers, book chapters, and abstracts. He is the inventor of many innovative Bayesian adaptive designs such as the mTPI and mTPI-2 designs, which have been widely applied in dose-finding clinical trials. His recent work on precision medicine was elected as one of the top 10 ideas of the Precision Trials Challenge hosted by The Harvard Business School in 2015. He is also a co-founder of Laiya Consulting, Inc., focusing on innovative and adaptive designs for clinical trials in new drug development, including the development of novel early-phase statistical platform allowing seamless and efficient clinical trials with master protocols.

Rui (Sammi) Tang, Ph.D.

Bio:

Dr. Rui (Sammi) Tang is a leading expert of biostatistics/bioinformatics in the biotech/pharmaceutical industry and she is currently the US site Biostats Team leader heads up Biostats and Programming team at Servier Pharmaceuticals US. Servier is the leading French independent pharmaceutical company, and the second largest French pharmaceutical company worldwide. It has branches in 149 countries, and 22,000 employees worldwide. Prior to join Servier she was the Therapeutic Area head of Oncology, Transplants, Ophthalmology and prematurity neonates programs at Shire pharmaceutical.

Prior to that she was at Vertex pharmaceutical leading Oncology and Hematology pipelines. Before that she also has worked at Amgen for about 8 years, Mayo clinical biostatistics and Merck shortly. Previously 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 at Amgen. 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 30 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 2000 members internationally. She serves in the SCT (Society of Clinical Trials) scientific program committee and development committee since 2013 to help organize the annual international conference. She is leading teams in the DIA (Drug Information Association) Adaptive design working group 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.

Susan Tannenbaum, M.D.

Bio:

For more than 10 years until two years ago, Susan Tannenbaum was the Medical Director of the Clinical and Translational Breast Program, now fully NAPBC accredited for the last 4 years. In that position she moved forward multiple clinical and translational projects and studies. For the last two years she has held the positions of Division Chair of Hematology and Oncology as well as Medical Director (Section Head) of the Neag Comprehensive Cancer Program with a focus on expanding the Cancer Center presence throughout the University and region. Again, she has acted as PI on multiple translational studies. An ever present focus of her time and effort is devoted to working closely with basic scientists as a Principal Investigator on novel genomic and immunologic trials which include; a vaccination Phase I Study of OncoImmunome for the Treatment of Stage III/IV Ovarian Carcinoma, a 2016-Retrospective study and now planned prospective study, to investigate clinical utility of BIOARRAY Therapeutics genomic panel as a predictor of pathological response in triple negative breast cancer, and an upcoming project, Determination of the potential clinical utility of the QCDx liquid biopsy technology utilizing genomics in circulating tumor cells via a novel imaging platform in breast cancer patients. A major focus of this and prior studies utilizing near-infrared technology to determine pathologic response in neoadjuvant treatment, utilized clinical trials in the neoadjuvant treatment of breast cancer.

Sue-Jane Wang, Ph.D.

Bio:

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. Dr. Wang has joined FDA for more than 20 years. Currently, she is also helping the Biometrics Division that provides regulatory statistical services to cardio- renal, neurology, psychiatry and medical imaging drug product developments. 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, analytical validation of biomarker for qualification. She is a member of FDA- NIH Biomarker Working Group. Dr. Wang has been active in complex trial design, pharmacogenomics, biomarker, diagnostic imaging, theranostics research 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.