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Agenda

9:00-9:20 Keynote speech

- Destiny-Breast 09 Phase III clinical research and progress

  • Dr. Sara M Tolaney, Dana Farber Cancer Center, Harvard Medical School


9:20-9:50 Expert commentary

-To elaborate on the past and present of the DESTINY-Breast series of studies, predict the results of DB09 from DB03, who will be the overlord of advanced breast cancer research?

  • From clinical data perspective: Dr. Sheng Luo, Duke University

  • From clinical mechanism perspective: Dr. Youwen He, Duke University


9:50-10:30: Panel Discussion

  • Dr. Sheng Luo, Duke University

  • Dr. Sara M Tolaney, Dana Farber Cancer Center, Harvard Medical School

  • Dr. Youwen He, Duke University

  • Dr. Lei Fan, Fudan University Cancer Hospital

  • Dr. Yizhou Jiang, Fudan University Shanghai Cancer Center

  • Dr. Hengyu Li, The Changhai Hospital of Navy Military Medical University

  • Dr. Wenfeng Li, The Affiliated Hospital of Qingdao University

  • Dr. Jia Wang,The Second Hospital of Dalian Medical University


 

Our Guest Speakers


Dr. Sara M Tolaney, Dana Farber Cancer Center, Harvard Medical School

Sara Tolaney, MD, MPH is the Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, and is internationally recognized for her research and education leadership in breast cancer. She also serves as Associate Director of the Susan F. Smith Center for Women’s Cancers and is a Senior Physician at Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School.

Dr. Tolaney received her undergraduate degree from Princeton University and her medical degree from UC San Francisco. She subsequently completed her residency in Internal Medicine at Johns Hopkins University, and fellowships in hematology and medical oncology at Dana-Farber Cancer Institute. She obtained her Masters in Public Health from Harvard School of Public Health.

Her research focuses on the development of novel therapies in the treatment of breast cancer and developing more effective and less toxic treatment approaches. Her work has demonstrated that a relatively low risk regimen is beneficial in women with early stage node-negative HER2-positive cancers, and this works has been incorporated into national and international guidelines. She has developed several follow-up studies looking at novel approaches to early stage HER2-positive disease and has also played a significant role in development of cdk 4/6 inhibitors, antibody drug conjugates, and immunotherapy in breast cancer. She currently chairs several registration studies in these areas and also leads many investigator-initiated trials. She is the author of over 150 peer-reviewed publications with manuscripts included in many prestigious journals such as the New England Journal, Lancet Oncology, Journal of Clinical Oncology, and JAMA Oncology.



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. Youwen He, Duke University

Dr. You-Wen He received his M.D. from the Fourth Military Medical University in 1986 in China and his Ph.D. in Immunology from the University of Miami School of Medicine in 1996. He completed his postdoctoral training in Dr. Michael J. Bevan’s laboratory at HHMI/University of Washington and took an Assistant Professor position in the Department of Immunology at Duke University Medical Center in year 2000. Dr. He is currently a Professor of Immunology at Duke University Medical Center. His lab has been studying T cell biology in health and diseases. The current effort in his lab is focused on developing new strategies to treat cancers using immunotherapies. His lab is examining how antibodies/antagonists to complement receptors and the cytokine IL-10 are used to treat different tumors in animal models and human. Dr. He is also leading three highly personalized cancer immunotherapy clinical trials treating patients with glioblastoma multiforme and advanced solid tumors. He also studies the functional role of the fundamental intracellular process termed autophagy in T lymphocyte function.



Dr. Lei Fan, Fudan University Cancer Hospital

Dr. Fan Lei graduated from the Department of oncology, Shanghai Medical College, Fudan University; She has been studying for breast cancer since 2004. She went to Harvard University medical school for further training, and she also received systematic training in breast cancer comprehensive treatment and clinical research at the MGH cancer center. She focused on diagnosis and treatment of breast benign and malignant diseases and individualized comprehensive treatment of breast cancer. Her research is mainly engaged in clinical research of breast cancer and clinical application related basic research. She was supported by Avon research programs, GCI international projects and other international projects and already published more than 20 papers included in SCI, which are included in top magazines such as Lancet tumor.


Dr. Yizhou Jiang, Fudan University Shanghai Cancer Center

Dr. Yi-Zhou Jiang, researcher of Fudan University Shanghai Cancer Center, graduated from Fudan University. His research efforts have been focused on molecular subtyping and precision treatment of breast cancer. His work has centered on the following: 1. Defining molecular profiling of triple-negative breast cancer using multiple-omic data (including genomic, transcriptomic, proteomic and metabolomic profiling). Using high-throughput technology to determine genetic alterations in breast cancer during neoadjuvant chemotherapy and metastasis. 2. Proposing precision treatment strategies of triple-negative breast cancer. Based on our subtyping system, establishing the prognostic models and identifying potential therapeutic targets for triple-negative breast cancer. 3. Identifying the molecular mechanisms by which breast cancer cells can survive chemotherapy and HER-2 targeted therapy, leading to recurrences, relapses, and metastasis. In recent five years, Dr. Yi-Zhou Jiang has published 28 articles in journals including Cancer Cell, Cell Metabol, Cell Res, Nat Commun, Science Adv, Mol Cancer, Cancer Res and Clin Cancer Res as the first or corresponding author. These findings were included in guidelines from the European Group on Tumor Marker and validated in clinical trials.



Dr. Jia Wang,The Second Hospital of Dalian Medical University

Jia Wang, MD, PhD, is the vice director of the department of Breast Surgery, 2nd hospital of Dalian Medical University.

Dr. Wang received her medical degree from China medical university. She subsequently completed her residency in Pathology at affiliated hospital of Kagoshima University Japan. She received her PhD degree from Kagoshima university, and got post-doctoral fellowships in medical oncology at Kyushu university Japan. She went back to her motherland at October 2013. From that time, serves as a breast surgeon until now.

Her research focuses on the development of evaluating the response of neoadjuvant chemotherapy of breast cancer by artificial intelligence and early predicting neoadjuvant chemotherapy drug-resistant populations. She has developed a phase II randomized clinical trial of Eribulin combined with carboplatin in the treatment of Her2-negative operable or locally advanced breast cancer after resistance to anthracycline and Taxane.


Dr. Hengyu Li, The Changhai Hospital of Navy Military Medical University

Li Hengyu is the executive director of breast and thyroid surgery of Changhai Hospital, doctor of surgery and postdoctoral in biology. His majority is diagnosis and treatment of breast and thyroid diseases, in particular, comprehensive treatment of breast tumor surgery, specializes in breast cancer plastic surgery, breast cancer chemotherapy, targeting and immunotherapy. Surgery for thyroid tumors. He published nearly 40 SCI papers, including nearly 20 SCI papers published by communication, the first and co-first authors, and authorized 6 national invention patents. He is also the Secretary General and vice chairman of the Yangtze River academic belt alliance; Young member of breast oncology group, oncology branch, Chinese Medical Association; Anti cancer association breast cancer Specialized Committee National Youth Committee and Shanghai Municipal Committee; Member of the youth Expert Committee of the Chinese society of Clinical Oncology (CSCO), reviewers of many SCI magazines. He participated in many international and domestic multi center research projects such as AFFINTY.



Dr. Wenfeng Li, The Affiliated Hospital of Qingdao University

Professor Li Wenfeng is the deputy chief physician of breast oncology department of the Affiliated Hospital of Qingdao University. She graduated from Shanghai Cancer Hospital of Fudan University with a doctor's degree in oncology. She is member of China Anti-Cancer Association breast cancer Specialized youth Committee and member, Standing Committee of Shandong Anti-Cancer Association cancer psychology Committee. She also worked as a visiting scholar in the cancer center of Houston Methodist Hospital.

Professor Li has worked in the field of oncology for 20 years and specializes in the treatment of breast cancer and lung cancer, especially in breast cancer chemotherapy, radiotherapy, endocrine therapy, targeted therapy and other comprehensive treatment. She extensively studied in terms of genetic susceptibility, recurrence and metastasis risk assessment, and multidisciplinary treatment of young/early-onset breast cancer. She has participated in a number of national, provincial and ministerial projects, won a third prize for scientific and technological progress in Shandong Province, and published more than 20 high-quality works in academic journals.


 

#cancer #breastcancer #destiny #cancertreatment #cancerresearch #cancerhealth

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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.


 

#china #cancer #breastcancer #us #destiny #clincaltrails #casestudy #db03


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Inauguring webinar of the CASE Direct series



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-Gastric 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.


Webinar Agenda

Welcome Remarks:

• Dr. Jianqiang Cai, Deputy Director of China National Cancer Center


CASE Analysis:DESTINY-Gastric trial

• Dr. Sheng Luo, Duke University

• Dr. Kohei Shitara, Japan Cancer Center Hospital


Panelists:

• Dr. Hong Zhao, Cance


r Hospital, Chinese Academy of Medical Sciences

• Dr. Ying Yuan, MD Anderson Cancer Center

• Dr. Tang Li, St. Jude Children’s Research Hospital


Closing Summary:

• Dr. Sheng Luo, Duke University


 

Our Speakers


• Dr. Jianqiang Cai, Deputy Director of China National Cancer Center

Professional Societies: Stan


ding Member, Oncology branch of Chinese Medical Association Vice Director, Experts Committee on Liver Cancer, The Chinese Medical Doctor Association Vice Director, Experts Committee for Prevention and Control of Hepatobiliary and Pancreatic Diseases, Chinese Preventive Medicine Association Director, Experts Committee on Sarcoma, Chinese Anti-Cancer Association Chief Editor, Electronic Journal of Liver Tumor Magazine

Professional Direction: Comprehensive treatment of abdominal tumors and translational medicine research.


• 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. Kohei Shitara, Japan Cancer Center Hospital

Dr Kohei Shitara is a Chief of Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa in Japan.

He received his medical degree from Tohoku University School of Medicine in 2002. Dr Shitara is an active member of ASCO and ESMO. He is also a member of the Japanese Society of Internal Medicine, the Japanese Society of Medical Oncology (JSMO), the Japanese Society of Clinical Oncology (JSCO), and the Japanese Gastric Cancer Association. He also acts as one of the organising members for Japanese gastric cancer treatment guidelines.

Main research interests include development of new anti-cancer agents, optimal chemotherapy regimen for gastrointestinal cancer, and translational research. He is the primary investigator or study coordinator of several sponsor initiated trials or investigator initiated trials for gastric or colorectal cancer: He act as one of steering committee members of several ongoing global studies in the field of GI cancers.


• Dr. Hong Zhao, Cancer Hospital, Chinese Academy of Medical Sciences

Vice Director & Professor, Department of Hepatobiliary Surgery, Cancer Hospital, Chinese Academy of Medical Sciences

Zhao Hong is Vice Director of Department of Hepatobiliary Surgery and Laboratory of abdominal surgical oncology in Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. He is also Professor of Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. He graduated from the Chinese Peking Union Medical College received his MD in 2003.

Professional direction: surgical treatment of colorectal cancer liver metastasis, neuroendocrine tumor, hepatocellular carcinoma.

Professional Societies: Secretary General of Neuroendocrine Tumor Society, China International Exchange and Promotive Association for Medical and Health Care, Member of Advisory Board of ENETS, Member of Chinese Association of Young Scientists And Technologists, Member of liver metastasis committee, colorectal Society, Chinese Anti-Cancer Association, Member of Colorectal Cancer Liver Metastasis Society, China International Exchange and Promotive Association for Medical and Health Care, Deputy Chair of Youth scholar committee, Oncology Society of Beijing

Medical Association, Secretary General of Youth scholar committee of Liver cancer Society, China

International Exchange and Promotive Association for Medical and Health Care.


• 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.


• Dr. Tang Li, St. Jude Children’s Research Hospital

Dr. Li Tang is an Associate Member in the Department of Biostatistics at St. Jude Children's Research Hospital. She is the Associate Director of the National Cancer Institute (NCI)-funded Biostatistics Shared Resource (BSR) of St. Jude. Every year, the BSR at St. Jude has over 100 clinical studies either in design and development, active accrual or analysis stages at any given time. Dr. Tang has extensive experience and research expertise in the design and analysis of clinical trials and clinical observational studies. As part of her methodology research, Dr. Tang focuses on new methods and their applications to data arising from pediatric oncology studies and from emerging infectious diseases research, including microbiome analysis and predictive analytics.


 

#cancer #oncology #destiny #clinicaltrials #gastric #cancertreatment #ds03

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