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.