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CASE Direct #2:Destiny-Breast 03 Case Study


About this event


Every year, we watch world-class clinical trial presentations at ASCO and ESMO and appreciate the marvelous works done by leading global Principal Investigators (PI). As a professional in clinical trial space, do you want to learn what’s behind the success of these clinical trials and these masters? Have you also dreamt of just being like them and present your own clinical research results on ASCO and ESMO?

eChinaHealth and AOCRAS jointly launch the “CASE Direct” series webinars of world-class clinical trials case analysis. We borrow from case study methods prevailing in business schools, to dissect deeply on global clinical trials, and dialogue directly with the prominent global PI of these trials, to explore the "insider story and secret recipes” behind these global clinical trials and the masters.

The hottest area of drug development in recent years is the research and development of ADC drugs. There is not only the spectacular 226 million yuan failure of Bio-Thera's clinical trial, but also the amazing glory of RemeGen's $2.6 billion global licensing of its ADC drug. Nevertheless, the brightest star in the ADC field is undoubtedly the impeccable DESTINY series clinical trial and amazing results of Enhertu (DS-8201), developed by Daiichi Sankyo.

Our Inauguring webinar of the CASE Direct series focuses on DESTINY-Gastric01 case study and a direct dialogue with the trail PI, Dr. Kohei Shitara of Japan Cancer Center Hospital. Our second webinar focuses on DESTINEY-Breast03 case study and a direct dialogue with the trail PI, Dr. Sara Hurvitz of PI University of California, Los Angeles. Our third webinar focuses on DESTINY-Breast 09 case study and a direct dialogue with the trail PI, Dr. Sara Tolaney of Dana Faber Cancer Institute and Harvard Medical School.



Agenda


9:00-9:20: Keynote speech

- Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2+ Metastatic Breast Cancer: Subgroup Analyses From the Randomized Phase 3 Study DESTINY-Breast03



• Dr. Sara A. Hurvitz, University of California, Los Angeles


9:20-9:50: Expert commentary

- Success is not chance, failure is not accident: secrets of DB03 success

• Professor Sheng Luo, Duke University


9:50-10:30: Panel discussion

- Dr. Sheng Luo, Duke University

- Dr. Sara A. Hurvitz, University of California, Los Angeles

- Dr. Ying Yuan, MD Anderson Cancer Center

- Dr. Qiao Li, Cancer Hospital, Chinese Academy of Medical Sciences

- Dr. Jian Zhang, Fudan University Cancer Hospital



 

Our Guest Speakers


Prof. Sara A. Hurvitz, University of California Los Angeles (UCLA)

Sara A Hurvitz, MD, is Professor of Medicine at the University of California, Los Angeles (UCLA); co-director of the Santa Monica-UCLA Outpatient Oncology Practice; Medical Director of the Clinical Research Unit of the Jonsson Comprehensive Cancer Center at UCLA; and Director of Breast Oncology. Dr. Hurvitz earned her MD from the University of Southern California. She served internship/residency at UCLA, was Chief Resident of internal medicine and completed a hematology-oncology fellowship at UCLA in 2006. Dr. Hurvitz received board-certification in internal medicine, hematology, and medical oncology.

Dr. Hurvitz has won numerous awards over the past few years, among them the Marni Levine Memorial Breast Cancer Research Award 2008 through 2015. She has an active clinical practice specializing in the treatment of women with breast cancer. She is involved in designing, implementing and leading multiple national and international clinical trials testing new targeted therapies and also leads the preclinical evaluation of novel breast cancer targets in the Translation Oncology Research Laboratory at UCLA.



Dr. Sheng Luo, Duke University

Dr. Luo is professor of Biostatistics & Bioinformatics at Duke University. He received his PhD in Biostatistics from The Johns Hopkins University. He is Fellow of American Statistical Association (ASA) and Elected Member of International Statistical Institute. Dr. Luo is a leading expert in statistical methods of the design and analysis of clinical trials and observational studies. He has more than 100 peer-reviewed articles published in high-impact clinical and statistical journals. Dr. Luo has served as PI of multiple NIH grants on statistical methodology development. He is also PI of multiple projects regarding novel latent variable modeling and various neurodegenerative disorders rating scale development, validation, and translation funded by Parkinson’s Foundation, CHDI Foundation, and Movement Disorders Society.


Dr. Ying Yuan, MD Anderson Cancer Center

Ying Yuan, PhD, is a Bettyann Asche Murray Distinguished Professor and Deputy Chair in the Department of Biostatistics at the University of Texas MD Anderson Cancer Center. Dr. Yuan has published over 100 statistical methodology papers on innovative Bayesian adaptive designs, including early phase trials, seamless trials, biomarker-guided trials, and basket and platform trials. The designs and software developed by Dr. Yuan’s lab (www.trialdesign.org) have been widely used in medical research institutes and pharmaceutical companies. Dr. Yuan is the Chair of Data Safety Monitoring Board (DSMB), overseeing over 100 ongoing randomized clinical trials at MD Anderson Cancer Center. Dr. Yuan was elected as the American Statistical Association Fellow, and wrote book “Bayesian Designs for Phase I-II Clinical Trials” published by Chapman & Hall/CRC.


Zhang Jian, Chief Physician of Fudan University Shanghai Cancer Center

Chairman of YBCSG Academic Yangtze River Band Breast AllianceStanding Committee Member, Professional Committee of Breast Cancer, Chinese Anti-Cancer AssociationVice Convener of Youth Committee of Breast Cancer Professional Committee, Chinese Anti-Cancer AssociationAlternate Chairman of Professional Committee of Clinical Research on Cancer Drugs of Shanghai Anti-cancer AssociationVice Chairman of Youth Committee, Professional Committee of Breast, Chinese Research Hospital AssociationVice Chairman of National Association for the Monitoring of Clinical Use of Antineoplastic DrugsVice Chairman of Youth Committee of National Expert Committee on Integrated Prevention and Treatment of Breast CancerVice Chairman of Professional Committee of Oncology Pharmacy, Shanghai Anti-cancer AssociationStanding Committee Member of CSCO Expert Committee on Tumor Support and Rehabilitation TherapyStanding Committee Member of CSCO Youth Expert CommitteeMember of CSCO Breast Cancer Expert CommitteeAdjunct Clinical Reviewer of the First Batch of Chemical Drugs, CDE, China Food and Drug AdministrationAssociate Editor, Diseases& ResearchEditorial Board Member, Translational Breast Cancer Research, Gland Surgery

The first/co-first/corresponding author has published more than 40 SCI papers (Lancet Oncol, etc.)He won the first prize of the First National Science and Technology Achievement Award for Maternal and Child Health,First Prize of Shanghai Medical Science and Technology Award, Second Prize of Science and Technology Award of Chinese Anti-Cancer Association



Prof. Qiao Li

Associate Chief Physician, Master Tutor Medical Oncology Department, Cancer Hospital, Chinese Academy of Medical Sciences Eight-year Doctor of Clinical Medicine, Peking Union Medical College In 2016, he was selected for the Young Backbone Program for Excellent Talents in Beijing Vice Chairman of Youth Committee, Professional Committee of Breast, Chinese Research Hospital Association Vice Chairman of Youth Academic Committee of Beijing Breast Disease Prevention and Control Association Standing Committee Member and Chairman of Specialized Committee of Integrated Prevention and Control of Breast Cancer, Beijing Association for the Promotion of Chronic Diseases of Traditional Chinese and Western Medicine Standing Committee Member of Specialized Committee of Cancer Chemotherapy, China Medical Education Association Member of Specialized Committee of Internal Medicine, Beijing Society of Breast Disease Prevention and Control Director of Chronic Disease Prevention and Control Branch of National Health Industry Enterprise Management Association Reviewing experts such as JCO Chinese version, Chinese Journal of Breast Disease (electronic version), Young and Middle-Aged Editorial Board Member of Journal of Clinical and Pathology, and Chinese Journal of the Frontiers of Medical Science.


 


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