The 4th Stat4Onc Annual Symposium (2021)

Symposium Objectives

The Stat4Onc Annual Symposium is a venue for interdisciplinary dialogue among clinical and quantitative scientists about cancer clinical trials. We seek participation by researchers from academia, industry, and regulatory agencies to share new research, discuss novel ideas, ask questions, and provide solutions for cancer clinical trials. Oncologists and statisticians can exchange views on trial design and conduct, drug development, and translation to patient care. Because of the current COVID-19 pandemic situation, the 4th Stat4Onc Annual Symposium will be help as an online conference. Topics for this symposium include big data and genomics, novel dose-finding designs, umbrella/basket designs, drug combinations, immune-based oncology, and engagement of under-representative population in oncology research.

Registration

Date : May 6-8, 2021

Venue : Online (Hosted by : Stanford University, Stanford, CA)

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Conference History

The idea of a unique conference that brings statisticians and oncologists together to discuss the challenges in oncology was initiated in 2015 during discussions between Yuan Ji (University of Chicago) and Professors Ying Lu (Stanford). The first symposium was held in 2017 at Stanford University . It was sponsored jointly by Stanford University and the University of Chicago. The second symposium was held in 2018 at the University of Chicago. At that time, we extended our partnership to include the University of Connecticut and chose OncoStat as the symposium name. The third symposium was held in 2019 at the University of Connecticut and renamed our symposium Stat4Onc. In 2020, we further extended our partnership to include the Oregon Health and Science University. This symposium is intended to be an annual event that rotates its location between Stanford University, the University of Chicago, the University of Connecticut and the Oregon Health Science University. Due to Covid-19 pandemic, the 2020 Symposium was postponed to 2021. For the safety of our participants and in view of current pandemic condition, the 2021 Symposium will be held online on May 6-8, 2021.


Click here to THE 3rd STAT4ONC ANNUAL SYMPOSIUM (2019)


Click here to THE 2nd STAT4ONC ANNUAL SYMPOSIUM (2018)


Click here to THE 1st STAT4ONC ANNUAL SYMPOSIUM (2017)


The 3rd Stat4Onc Annual Symposium

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Agenda

Time are all in Pacific Time. Program may change in later time.

See PROGRAM for detail.

Day 1 (May 6)

Time

Track 1

Track 2

8:15 AM - 12:15 PM Short Course 1 Short Course 2
13:00 PM - 13:30 PM Industry Leader Keynote
13:30 PM - 14:30 PM Poster Award, Post Viewing and Networking

Day 2 (May 7)

Time

Track 1

Track 2

8:15 AM - 8:30 AM Welcome and Formal Opening the Program
8:30 AM - 9:45 AM Keynote Session 1 and Discussion
10:00 AM - 11:30 AM Invited Session 1 Invited Session 2
12:15 PM - 1:30 PM Keynote Session 2 and Discussion
1:45 PM - 3:15 PM Invited Session 3 Invited Session 4

Day 3 (May 8)

Time

Track 1

Track 2

8:30 AM - 9:45 AM Keynote Session 3 and Discussion
9:45 AM - 11:30 AM Plenary Panel Discussions
12:15 PM - 1:30 PM Keynote Session 4 and Discussion
1:45 PM - 3:15 PM Invited Session 5 Invited Session 6

Organizers

Organizers


Co-Chairs

Ying Lu, Ph.D.

Stanford University, CA

Email

Yuan Ji, Ph.D.

The University of Chicago

Email

Shivaani Kummar, M.D.

Oregon Health and Science University, OR

Email

Ming-Hui Chen, Ph.D.

The University of Connecticut

Email

Scientific Program Committee

GRADUATE STUDENT/POSTDOC VOLUNTEER COMMITTEE


Webmaster: Heeju Lim (heeju.lim@uconn.edu)

Administrative Support: Elizabeth Munoz (ecmunoz@stanford.edu)

Partner


Sponsor

We are soliciting additional support for this event. Please contact Professor Ying Lu, ylu1@stanford.edu.

Call for Poster Submission

There will be poster viewing session from May 6-8, 2021. Topics related to interface between biostatistics and oncology are welcome. We encourage researchers, in particular young researchers and trainees in academia, industry and government to submit the title and one-page abstract of the posters for review on or before April 14, 5PM PT. Posters should depict scientific research projects with relevant data. Email confirming acceptance of abstracts for poster presentation will be sent on or before April 19, 5PM PT. Posters need to be submitted on or before April 26 5PM PT in pdf or ppt. Decisions of the top 5 selected for oral presentation will be sent by email on April 30th 5PM PT. Registration fee of the selected oral presentations will be refunded for one presenter per poster. Inquiries about the poster session can be made via email to min-hui.chen@uconn.edu.

Short Courses

Please note that the short courses will run parallel and one can register only one of them. Also, short courses are separated fee events and can be registered with or without the whole program.

ALL TIME ARE BASED ON PACIFIC DAYLIGHT TIME


Short Course 1 (May 6, 8:15AM-12:15PM PT)

Short Course 2 (May 6, 8:15AM-12:15PM PT)

Speakers and Panelists

Industry Leader Keynote

Keynote Speakers

Invited Speakers and Panelists (Subject to Change)

alphabetic order by last name

James Reimann, PhD

Genentech/Roche

james James Reimann is Vice President and Global Head of Data Strategy & Delivery at Genentech/Roche. Until November 2020, James was VP and Global Head of Oncology Biostatistics & Patient Centered Outcomes Research (PCOR) and had spent 20 years as a Biostatistician in Oncology research. In his current role, he oversees "data as an asset" for the entire Genentech/Roche pipeline, including capabilities coming from a variety of disciplines (CDM, Data Standards & Governance, Data Curation & Integration, Data Privacy & Sharing), reflecting a shift towards viewing patient data as a strategic asset in the age of digital health. He holds a PhD in Statistics from the University of California, Berkeley.

Industry Leader Keynote

Title : Stories on Innovation from 20 Years in Oncology Biostatistics

Date : May 6, 2021

Time : 1:00 PM– 1:30 PM PT


Peter Bross, MD

Center for Biological Evaluation and Research, US Food and Drug Administration

peter Peter Bross is acting Chief of Oncology Branch and clinical team leader in the FDA Center for Biological Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT) and previously worked as a clinical reviewer in the Division of Oncology Drug Products in the Center for Drug Evaluation and Research (CDER). Over 20 years at FDA, Dr. Bross has gained expertise in the design and analysis of clinical oncology trials of cellular, tissue and gene therapies, especially cancer vaccines, combination therapies, and companion diagnostics. As a regulatory reviewer, he has reviewed new molecular entities for marketing approvals in solid tumors and hematological malignancies, including oncolytic viruses, cellular immunotherapies, targeted kinase inhibitors, proteasome inhibitors and an antibody-drug conjugate. He has presented FDA perspectives at professional meetings and review findings at FDA advisory committee meetings and has authored several manuscripts. Dr. Bross is a graduate of University of Virginia Medical School and trained in Hematology and Oncology at The George Washington University and has been at FDA since 1999.

Keynote Session 1.

Title : FDA Initiatives to Expedite Oncology Drug Development

Date : May 7, 2021

Time : 8:30 AM – 9:45 AM PT


Dr. Brigitte Widemann

Pharmacology & Experimental Therapeutics Section and NCI’s Pediatric Oncology Branch

widemann Dr. Brigitte Widemann is a pediatric oncologist with the primary interest of developing effective therapies for children and adults with genetic tumor predisposition syndromes, such as neurofibromatosis type 1 (NF1), and rare solid tumors through innovative clinical trial design. Dr. Widemann currently serves as the head of the Pharmacology & Experimental Therapeutics Section and as Chief of NCI’s Pediatric Oncology Branch. Anticancer drug discovery and development are moving towards a more rational and targeted approach. The application of new molecularly targeted agents to the treatment of childhood cancers and neurofibromatosis type 1 (NF1) is a research objective of the Pharmacology & Experimental Therapeutics Section (PETS). In addition to studying the pharmacology, pharmacokinetics, pharmacodynamics, and toxicities of these novel agents, it is also a goal of the PETS to evaluate novel clinical trial designs and trial endpoints, which may be more applicable for molecularly targeted agents.

Keynote Session 2.

Title : Challenges and solutions in advancing therapies for children and adults with rare tumors or genetic tumor predisposition syndromes

Date : May 7, 2021

Time : 12:15 PM– 1:30 PM PT


Laura Esserman, MD and Christina Yau, PhD

University of California, San Francisco (UCSF)

laura Dr. Laura Esserman is Professor of Surgery and Radiology at the University of California, San Francisco (UCSF) and director of the UCSF Breast Care Clinic. Her work in breast cancer spans the spectrum from basic science to public policy issues, and the impact of both on the delivery of clinical care. Dr. Esserman is recognized as a thought leader in cancer screening and over-diagnosis, as well as innovative clinical trial design. She led the creation of the University of California-wide Athena Breast Health Network, a learning system designed to integrate clinical care and research as it follows 150,000 women from screening through treatment and outcomes. The Athena Network launched the PCORI-funded Wisdom Study, which tests a personalized approach to breast cancer screening in 100,000 women. She is also a leader of the innovative I-SPY TRIAL model, designed to accelerate the identification and approval of effective new agents for women with high risk breast cancers.

christina Christina Yau, PhD, is Association Professor of Surgery at the University of California, San Francisco. She is a bioinformatician with extensive experience in analyzing high dimensional biological data, such as gene expression and inferred pathway activity data, to address important questions in translational cancer research. She actively participated in the Cancer Genome Atlas (TCGA) Research Network efforts to comprehensively characterize the molecular portraits of human cancers. She is a member of the I-SPY 2 Data Access and Publication Committee and Biomarker Working Group.

Keynote Session 3.

Title : Evolving I-SPY 2 to optimize patient outcomes

Date : May 8, 2021

Time : 8:30 AM– 9:45 AM PT


Amanda Bruegl, MD

Oregon Health and Sciences University

amanda Amanda Bruegl is a Citizen of Oneida Nation and is a Gynecologic Oncologist in the department of OB/Gyn at Oregon Health and Science University. She completed her fellowship in gynecologic oncology at MD Anderson Cancer Center and has been at OHSU since that time. She is the Associate Director of the Education Core for the Northwest Native American Center of Excellence, a recipient of the Robert Wood Johnson Harold Amos Minority Faculty Development Award, and has research interests in gynecologic cancer prevention in American Indian/Alaska Native women.

Keynote Session 4.

Title : Engaging Underrepresented Minority Groups in Oncology Research Success and Challenges

Date : May 8, 2021

Time : 12:15 PM– 1:30 PM PT


Program

Date : May 6-8, 2021

Venue : Online (Hosted by : Stanford University, Stanford, CA)

Link information will be provided one week prior to the conference date.



Schedule of Events (Subject to change)

ALL TIME ARE BASED ON PACIFIC DAYLIGHT TIME

Time

Events

May 6  
8:15 AM - 12:15 PM Parallel Sessions
Short Course 1:  Real-World Data and Evidence in Drug Development and Regulatory Submission: Statistical Considerations
  • Speakers: Richard Baumgartner (Merck), Jie Chen (Overland Pharmaceutics), and Tze Leung Lai (Stanford University)
Short Course 2:  Innovative Designs for Early Phase Oncology Trials
  • Speakers: Yuan Ji (U Chicago) and Sue-Jane Wang (US FDA)
12:15 PM - 13:00 PM Lunch Break/Post Viewing
13:00 PM- 13:30 PM Industry Leader Keynote: Learnings from 20 years in Oncology Biostatistics
  • Chair : Ming-Hui Chen (U Conn)
  • Speaker : James Reimann (Genentech)
13:30 PM - 14:30 PM Poster Award, Post Viewing and Networking
May 7  
8:15 AM - 8:30 AM Welcome and Formal Opening the Program
8:30 AM - 9:45 AM Keynote Session 1: Topics in Innovative Trial Designs, FDA Regulatory Perspectives
  • Chair : George Sledge (Stanford)
  • Speaker : Peter Bross (US FDA)
  • Discussants : Keaven Anderson (Merck), Ruixiao Lu (Quantum Leap Healthcare/UCSF), Chris Takimoto (Gilead)
9:45 AM - 10:00 AM Transition to Parallel Sessions
10:00 AM - 11:30 AM Parallel Sessions
Invited Session 1: Biomarker Driven Methodology for Clinical Applications
Invited Session 2:  Innovations in Trial Design for Drug Evaluations
11:30 AM - 12:15 PM Lunch Break/Post Viewing
Speedy Poster Presentation: Winners of Poster Submissions
  • Chair : Manisha Desai (Stanford)
  • Presenter: the Winner of the Poster Competition
12:15 PM - 1:30 PM Keynote Session 2:  Challenges and solutions in advancing therapies for children and adults with rare tumors or genetic tumor predisposition syndromes
  • Chair : Shivaani Kummar (OHSU)
  • Speaker : Brigitte Widemann (Pharmacology & Experimental Therapeutics Section and NCI’s Pediatric Oncology Branch)
  • Discussants : Lillian Siu (U Toronto) and Sue-Jane Wang (FDA)
1:30 PM - 1:45 PM Transition to Parallel Sessions
1:45 PM - 3:15 PM Parallel Sessions
Invited Session 3: Innovative Designs and Analytic Methods for Small Sub Groups
Invited Session 4: Real World Data and Real World Evidence in Oncology Research
May 8  
8:30 AM - 9:45 AM Keynote Session 3: Evolving I-SPY 2 to optimize patient outcomes
  • Chair : Ying Lu (Stanford)
  • Speakers : Laura Esserman and Christina Yau (The University of California, San Francisco)
  • Discussants : Patricia LoRusso (Yale)
9:45 AM - 11:30 AM Plenary Panel Discussions on Master Protocols on Complex Trial Designs
- Finding the Right Treatment for Patients
11:30 AM - 12:15 PM Lunch Break/Post Viewing
12:15 PM - 1:30 PM Keynote Session 4: Engaging Underrepresented Minority Groups in Oncology Research Success and Challenges
  • Chair : John Witte (UCSF)
  • Speakers : Amanda S. Bruegl, MD (OHSU)
  • Discussants : Neby Bekele (Exelixis)
1:30 PM - 1:45 PM Transition to Parallel Sessions
1:45 PM - 3:15 PM Parallel Sessions
Invited Session 5: Racial Disparities in Clinical Research in Oncology - Challenges and Opportunities
Invited Session 6 - Panel discussions : Evaluation and Level of Evidence for Combination Cancer Treatments