Synopsis

This webinar discusses the expansion of International Market for Ensartini and RNAi Therapeutics in Oncology, from Skin Cancers to Liver Cancers. Additionally, it aims to understand the Evolving U.S. regulatory requirements for diversity in clinical cancer trials.

Script

Speakers and Panelists Bio:

Dr Xiaoxiang

Dr. Xiaoxiang Chen, Founder, Interim CEO, President of R&D, Tenacia Therapeutics, Executive member of USCACA, Vice Chair of CSCO New Drug Development Committee

Dr. Xiaoxiang Chen has led the successful clinical development and registration into the China market of more than 20 global innovative products across multiple therapeutic areas.

Since May 2022, Xiaoxiang has started to found a new Biotech, Tenacia Therapeutics. Prior to that, he is the Co-founder, Chief Development Officer for Harbour Biomed since Nov 2017, in full charge of product development process from pre-clinical development, CMC(until April 2021, clinical development and regulatory affair until BLA approval. Before joining Harbour BioMed in Nov of 2017, in his role as Medical Lead of Emerging Markets at Boehringer Ingelheim, Dr. Chen had overall medical responsibilities, including clinical development, regulatory affair, medical affair, in more than 80 countries and regions, including China, Taiwan, Hong Kong, South Eastern Asia, India, the Middle East and Africa. Previously, he served as Boehringer Ingelheim’s Vice President, Head of Medicine Group of Greater China. Prior to Boehringer Ingelheim, Dr. Chen served as director, Clinical research & development organization of Wyeth Asia Pacific, also the global medical lead for clinical development of chronic pain & anti-infection. Dr. Chen received his Medical Degree from Nanjing Medical University.

Yi Long

Yi-Long Wu, MD, FACS,Guangdong Lung Cancer Institute,Guangdong Provincial People’s Hospital,Guangzhou, China

Prof. Yi-Long Wu is a tenured professor of Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences and Guangdong Lung Cancer Institute. He is the Past President of Chinese Society of Clinical Oncology (CSCO), the Chief of the WU JIEPING Oncology Medical Foundation, the vice-director of the Precision Medicine of the Chinese Medical Doctor Association, the President of Chinese Thoracic Oncology Group(C-TONG), Board of Directors of the International Association Study of Lung Cancer(IASLC,2013-2017), a past Member of the International Affairs Committee of American Society of Clinical Oncology (ASCO).

He graduated from Sun Yat-sen University of Medical Sciences in 1982 and completed his thoracic surgery training in Germany in 1989. His main research interests are the multidisciplinary synthetic therapy on lung cancer in translation medicine and evidence-based medicine in oncology. He is leading the Chinese lung cancer research field and has been the Principal Investigator or Co-PI of more than 200 international or national multicenter clinical trials. He received several awards, including the national science and technology award, the Chinese medical science and technology award. He has contributed 22 books on cancer and has published more than 300 articles in peer-reviewed journals including J Clin Oncol, Lancet Oncol, Lancet, New Engl J Med,Cancel Cell, Ann Oncol and J Thorac Oncol. He also serves on the editorial boards of Nature Review Clinical Oncology, Annual of Oncology, Journal of Hematology and Oncology, Journal of Immunotherapy of Cancer, The Oncologist, Science Bulletin, Deputy Editor of Lung Cancer.

Dr Giovanni

Dr. Giovanni Selvaggi,Chief Executive Officer & Chief Medical Officer,Xcovery

Dr. Selvaggi held global positions of increasing responsibility in clinical development at various global pharmaceutical companies prior to joining Xcovery in March 2019.  Dr. Selvaggi joined the pharmaceutical industry in 2010 as Medical Director in the MAGE-A3 lung cancer vaccine program at GSK. He then played an instrumental role in the successful development and approval of ceritinib (Zykadia) in ALK-translocated NSCLC at Novartis in 2013. Most recently, Dr. Selvaggi was part of the immunotherapy team at Bristol-Myers Squibb, serving as a program lead in thoracic malignancies, with a focus on SCLC and mesothelioma, leading to the approval of nivolumab (Opdivo) in third line SCLC indication with NDA in 2018. Dr. Selvaggi received his medical degree at the University of Torino School of Medicine, in Torino, Italy, in 1992 and served as staff physician of thoracic oncology at the University Hospital in Torino, participating in several clinical trials in lung cancer and mesothelioma over a span of 16 years.

Michale

Michael Molyneaux, M.D, MBA

Dr. Michae V. Molyneaux has been the Chief Medical Officer at Sirnaomics, Inc (02257, HK)since 2015. Dr. Molyneaux is currently responsible for Medical Affairs, Clinical Operations, and Regulatory Affairs activity within the Company and has led clinical activities for IND filings in multiple therapeutic areas including fibrosis and oncology as well as leading the efforts for three orphan drug designations for STP705 under US FDA. He has practiced clinical medicine since 1998 having received his Medical Doctorate from Dalhousie University and he began doing clinical trial research in 2005 and was a Principal Investigator for Phase 2 and 3 studies working with companies such as Shire, Pfizer, Smith & Nephew, GSK, and AstraZeneca. He completed his MBA at Olin School of Business at Washington University in St. Louis Missouri in 2012. He is currently a Diplomate with the American Board of Family Medicine and a Fellow of the Canadian College of Family Physicians and a Licensed Physician in good standing in the state of California.

Dr Patricia

Dr. Patricia Keegan MD, Chief Medical Officer, TopAlliance

Dr. Patricia Keegan, is the Chief Medical Officer at TopAlliance Biosciences, Inc., a subsidiary of Shanghai Junshi Biosciences. Junshi Biosciences and TopAlliance Biosciences are focused predominantly in the development of immunotherapeutics for the treatment of cancer, with the lead candidate drug (toripalimab, an anti-PD-1 blocking antibody) the first PD-1 antibody approved in China in 2018, with multiple new indications since, and is under BLA review at the US FDA for the treatment of nasopharyngeal cancer.  Prior to joining TopAlliance Biosciences, Inc. since August 2020. Prior to joining TopAlliance, Dr. Keegan held multiple positions at the U.S. Food and Drug Administration over 30 years. Her most recent position was Acting Associate Director of Medical Policy Oncology Center for Excellence (OCE), Office of the commissioner; as well as 16 years as the Division Director of Oncology Products; 4 years as Deputy Director Division of Clinical Trial Design and Analysis; and 8 years as Chief and Medical officer at Oncology Branch. Prior to joining FDA, Dr. Keegan was a Clinical Assistant Professor of Medicine in Hematology and Medical Oncology at University of North Carolina at Chapel Hill. Dr. Keegan received her Bachelor of Science in Biology from University of Illinois Champaign-Urbana. She earned her medical degree from Loyola University Stritch School of Medicine, where she also completed a residency in internal medicine and completed a fellowship in medical oncology at Roswell Park Memorial Institute, Buffalo, New York.

Dr Lily

Dr. Lily Li, VP of Strategic Collaboration , Betta Pharmaceutical

In this role, she leads the BD effort of expanding the company’s innovative pipeline through in-licensing, co-development and strategic investment.

Lily has 15 years of experience in drug development, business development and alliance management. Prior to joining Betta, she worked at the world’s leading pharmaceutical companies including Merck and AstraZeneca. Since joining Betta, Lily has led the BD team establishing strategic partnerships with over 10 global and domestic companies including the most recent $135M USD deal with Agenus. Three of these programs are currently under NDA review and expected to be launched in China in 2022.

Lily received her Bachelor of Science degree from Peking University, China and her PhD in Chemistry from Washington University in St. Louis, US. She was elected in the Zhejiang Recruitment Program of Global Expert in 2018.

Dr Dewan

Dr. Dewan Zeng, VP, Head of Search and Evaluation, BeiGene USA, Inc

In her 24 years of pharmaceutical career, Dewan played critical roles in advancing global clinical development programs and establishing strategic partnerships between pharmaceutical and biotech companies. Currently, Dewan is Vice President, Head of Search and Evaluation, Business Development at BeiGene. She leads a team of professionals in US, Europe and China to evaluate innovative products and technologies to strengthen BeiGene’s portfolio.

Prior to joining BeiGene, Dewan led global clinical development teams at Pfizer, Gilead and CV Therapeutics. She led programs from Phase 1 to Phase 3 pivotal studies and supported approval and launch of three pharmaceutical products in US, Europe and China. Dewan has BS degree in Biochemistry from Peking University, PhD in Biochemistry from University of Virginia, and MBA in Global Business Strategy from Cal State University East Bay. She completed her post-doctoral training at UCSF. She has over 50 publications in peer-reviewed journals and is the inventor of 8 issued patents in the US and globally. She enjoys skiing, golf and gourmet cooking.

 

Organizer:

Anti cancer association

eChinaHealth

Novotech

 

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