2021 CBA ANNUAL CONFERENCE
CBA Boston Chapter Kick-off event-Innovation 2021: Lessons learn in the pandemic and opportunities afterwards
Date: Feb 20, 2021
Time: 8:45 am -1:00 pm (EST)
Register Now and Find the Connection
Registration Link: http://bit.ly/2NQzET
Agenda:
|
Time |
Topic | Speaker |
| 8:45am-9:00am | CBA-USA Boston Chapter Kick-off | Ru Zheng |
| 9:00am-9:30am | Challenge and Opportunity in US-China Collaboration during and post the pandemic | Guo-liang Yu |
| 9:30am-10:00am | An investor view of life science capital market in China | Alex Li |
| 10:00am-11:00am | COVID19 testing and vaccination market insights in US | Regina Au |
| 11:00am-11:30am | High risk group screening needs overlooked during pandemic | James Hamilton |
| 11:30am-12:00pm | FDA review insights and COVID19 Diagnostic product EUA application | Jinjie Hu |
| 12:00pm-12:45pm | Diagnostics of sales marketing strategy and organization health | Barbara Spector |
| 12:45pm-1:00pm | CBA-USA Boston Chapter Operation Plan for Programs and Seminars in 2021 | Ru Zheng |
Speakers Bios:
Ru Zheng, MBA, is the President of CBA-USA Boston Chapter. She is also the VP of Business Development of Antagen Pharmaceutical Inc., focusing on the development and commercialization of innovative biological drugs. She has more than 20 years of experience in life science and medical device industries. She served at Thermo Fisher Scientifics for almost a decade with diverse roles and progressing responsibilities leading teams in sales operation, business intelligence, product management, strategic pricing, strategic marketing and business development functions. She also worked in Boston Scientific managing supply chain initiatives, strategic sourcing and supplier management in United States. Ru is a certified Dale Carnegie Trainer, TypeCoach Professionals, and active community leader. She has served in the leadership team as officer, general manager (2008-2013), former president (2013-2014) and as board member (2014-2020) in New England Chinese Information and Networking Association. She has been volunteering to Youth Entrepreneurship Service Program there since 2006. Ru received her MBA with Global Financial Analysis concentration from Bentley University, and earned her B.A. majoring in International Business from Guangzhou University of Foreign Studies (Formerly Guangzhou Foreign Language Institute)
Dr. Guo-Liang Yu is the global CEO of Apollomics Inc. (Formerly CBT Pharmaceuticals), an innovative therapeutics company devoted to curing cancer by combining immunology and other caner fighting methods. Before Apollomics Inc., Dr. Yu was the Executive Chairman of Crown Biosicence Inc., a publically-listed personalized oncology platform company with ~600 employees globally. Crown Bioscience was acquired by JSR for $400 million in May of 2018. He co-founded Epitomics Inc., an antibody biotechnology company, and served as Chairman and CEO for 10 years prior to its acquisition by Abcam for $170 million. He was also a venture partner at OrbiMed Venture LLC. Dr. Yu’s success is driven by his scientific curiosity and passion for translating scientific discovery to real products. After graduating from Fudan University in Shanghai, China, he came to the United States in 1984 to pursue advanced studies. He obtained his Ph.D. from UC Berkeley, where he and Dr. Greider discovered telomerase and its mechanism in Dr. Blackburn’s lab. Drs. Blackburn and Greider received Nobel Prize in 2009 for their discovery. Dr. Yu later joined Dr. Frederick Ausubel’s lab at Harvard University to pursue the question of how plants defend themselves against pathogens without an immune system, and identified the plant disease resistance gene. In 1993, when genomics was still in its infancy, Dr. Yu joined Human Genome Sciences Inc. as one of the first few senior scientists, identifying human gene targets for drug discovery. Among several important drug targets he studied was BLys, the first successfully genomic target for the development of a lupus antibody drug Benlysta, which was approved by FDA in 2010. In 1998, Dr. Yu was attracted to identifying plant genes with economic value in agriculture and in bio-energy. He was Senior Vice President of R&D at Mendel Biotechnology Inc. where his team analyzed the function of a complete set of plant transcription factors, and ultimately identified several valuable traits such as enhanced crop yield, disease resistance, and drought tolerance. Dr. Yu has co-authored 43 peer-reviewed scientific articles that have been referenced by the scientific community over 6000 times. He is a co-inventor of more than 400 patents. Dr. Yu is the founding president of the Chinese Biopharmaceutical Association (CBA) and serves on the boards of several professional organizations in the United States and China, including BayHelix, Chinese-American Bio/Pharmaceutical Society (CABS), National Foundation of Cancer Research, Ray Wu Memorial Foundation, and University of Pacific. Dr. Yu is generous in coaching young entrepreneurs, and he has co-founded a dozen startup companies in biotech and the healthcare sector, including Immune-Onc Therapeutics, Inc.in Palo Alto.
Dr. Alex Li is a venture capital investor with investing experience in both United States and China. He specialized in the life science industry with focus on cutting edge technology and first-in-class therapeutic medicine. He currently serves on the boards of five innovated companies. TF Capital, one of the premium venture capital fund in China, have invested in near 100 companies, with successful exits like Zai Lab, Hua Medicine, Henlix, and Frontage, etc. Alex is one of the three investment decision committee members in TF Capital. Before Joining TF Capital, Alex was Managing Director of Fosun Pharma for three years. He managed the American Venture Capital Fund for Fosun Pharma with investments in both Boston and the Bay area. Before he dived into the venture investment, Alex worked as a research scientist in Biogen for seventeen years. He has worked on several high-profile projects in the field of drug discovery, precision medicine and clinical biomarkers. Alex obtained his Ph.D. degree in Biochemistry, Cellular and Molecular Biology (BCMB) from the University of Tennessee.
Outside his professional career, Alex has volunteered in SAPA since 2003. He served as SAPA-NE president from 2010-11. He currently serves as a Board Director of SAPA.
Regina Au is CEO, New Product Planning/Strategic Planning at BioMarketing Insight with 20+ years experience in the biotechnology, pharmaceutical, medical device, diagnostic and healthcare industries. She helps companies to maximize the benefits of their technology by conducting the business due diligence early in product development to de-risk the process and increase commercial success. This ensures that the technology is the right product for the right market in meeting a critical unmet need and that the market opportunity for the product meets the business goals of the company. She will translate these unmet needs into a marketing target product profile (TPP) with the R&D TPP. Ms. Au then develops marketing strategies to ensure market access and product adoption. She was a member of the Advisory Board for Regis College, Master of Regulatory and Clinical Research Management Program. Regina serves as an advisor for the Massachusetts Technology Transfer Center Platform Meetings for entrepreneurs and an Advisory Board member for a Delta V team at the Martin Trust Center for Entrepreneurship at MIT. Ms. Au is a member of the Editorial Board for the International Journal of Clinical Pharmacology & Pharmacotherapy and Industry Advisor for the European BioPharmaceutical Review Journal.
Regina was an Adjunct Professor at Northeastern University in the Masters in Biotechnology Program and at Regis College in the Master of Regulatory and Clinical Research Management Program. Regina has published numerous articles on market and technology trends such as “Immuno-oncology: Can the Right Chimeric Antigen Receptors T-Cell Design be Made to Cure All Types of Cancers and Will it be Covered?” in the Journal of Pharmaceutics, “Why Our Microbiome is Important to Our Physiology and Diseases” in the International Journal of Clinical Pharmacology and Pharmacotherapy, “From Genetic Engineering to Genome Engineering: What Impact Has it Made on Science and Society?” in Advances in Biology, Biotechnology and Genetics, and “The paradigm shift to an “open” model in drug development” in Applied and Translational Genomics. Her expertise is in a number therapeutic areas such as cardiology, interventional cardiology, infectious disease, immunology, gastroenterology, neurology, oncology and surgery.
Prior to BioMarketing Insight she worked for Merck & Co., Genzyme Corp., NMT Medical, and Radi Medical (St. Jude Medical) in various positions of increasing responsibility in new product planning, marketing and sales. She had P&L responsibility in managing six multimillion dollar product lines and has experience in upstream and downstream marketing including strategic marketing, product development, market development, product launches, and product management.
Dr. James Hamilton is Professor, Physiology & Biophysics, Boston University School of Medicine, and teaches in Programs of Nutrition and Metabolism. Professor Hamilton holds a BS in Chemistry from Juniata College and a PhD degree in Chemistry from Indiana University. As a graduate student he pioneered applications of C-13 NMR spectroscopy to human plasma that was published in three Science papers, and in other international journals. He founded the first NMR center at Boston University shortly after his recruitment in 1978, initially with a 200 MHz instrument, then a 300 and a 500 MHz NMR. With a new research focus on high-risk atherosclerotic plaques, he established the first high field (500 MHz) MRI center in 2001. At Boston University he has appointments in Physiology and Biophysics, Biomedical Engineering, and Radiology. He is the founding director of the Cardiovascular Center for High Field MRI at Boston University School of Medicine, a founding member of the Boston University Obesity Center, and a strong advocate for multidisciplinary and translational research. Research in his group is aimed at providing fundamental information relating to heart disease, diabetes, obesity, and diseases related to fatty acid metabolism. The overall goal is to develop novel methods in biomedical science by integrating physical-chemical and physiological approaches. This is achieved by assembling multi-disciplinary teams to translate rigorous basic research into clinical applications. Research in his lab has provided novel methods and insights into fatty acid transport in membranes and binding to albumin. His newest area of research focuses on brain vasculature, neural networks, and aging, and Alzheimer’s disease by application of novel MRI methods with histological validation with a strong focus on clinical translation of MRI of atherosclerotic plaque and thrombosis to prevent stroke and to provide informed decision making to physicians. Dr. Hamilton has received several recent awards, including the Wallace H. Coulter Translational Partners Grant Award (2007), the Brom and Sunstein “Ignition” Award for commercializable research (2008), the Biophysical Society Avanti Lipid Award (2010), and Outstanding Science Alumni Award, Juniata College (2011). He was elected as Fellow of the Massachusetts Academy of Sciences (MAS) in 2013, appointed to the MAS Board of Directors in 2014, and elected as a Fellow of the Obesity Society in 2014. His team’s research has been published very high-impact journals such as Science, Nature Medicine, Journal of Clinical Investigation, Proceedings of the National Academy of Sciences, Cell Metabolism and Neurology, with a total of 14700 citations and a h-index score 67. Continuous funding for 40 years has come from several major sources including the National Institutes of Health, American Diabetes Association, pharmaceutical companies, and foundations. His greatest research passion remains stroke, especially since almost half of stroke patients never fully recover and since he believes many if not most strokes are preventable. He began MRI imaging of plaques nearly two decades ago with studies of carotid endarterectomy specimens shipped to Boston from the lab of the world-renowned Dr. Michael De Bakey at Baylor College of Medicine and Chief of Medicine Tony Gotto, who later became Dean of Cornell-Weill Medical School. A decade ago, when their new MRI studies achieved major breakthroughs in detecting rupture-prone plaques the translational potential, he founded a company Vascuvis, now Elucid Bioimaging (elucidbio.com). The company has recently developed unique FDA-cleared imaging technology to evaluate plaque stability that is a better predictor of plaques at high risk for thrombosis and stroke than conventional methods. They are beginning clinical applications to stratify risk and monitor the effectiveness of therapies with omega-3 fatty acids. Dr. Hamilton once collaborated with Noble Laurate Roger Tsein. After Dr. Tsein’s Keynote lecture at an international imaging meeting on novel applications of his fluorescence probes for detecting atherosclerotic plaques in mice, he came to Dr. Hamilton’s poster on MRI of rabbit plaques. In a 30-minute meeting, Dr. Hamilton convinced Dr. Tsein of that they were preforming novel complimentary measurements by MRI in a better model of human disease. They corresponded frequently, met again at conference where Dr. Tsein gave the keynote lecture, and organized a collaboration. After publishing a paper in PLOS One, they worked on a grant and they were scheduled to meet in Boston. Unexpectedly and sadly, Dr. Tsein died of a stroke 2 weeks before they met. With the new health crisis with COVID, Dr. Hamilton became involved because cardiovascular links contribute to COVID, clearly to the “long hauler” syndrome if not to patient death. He clearly see the urgency of combing fields of expertise and am very passionate about contributing with the team of top-level microbiologists at Boston University Medical Center.
Dr. Jinjie Hu is the president and principle consultant of Axteria BioMed Consulting (ABC). She also joined serve as Chief Regulatory Officer in charge the regulatory strategy and lead all related activities of regulatory submissions at Laboratory of Advance Medicine. Prior to establishing ABC, she was a senior consultant at Biologics Consulting Group (BCG) for more than 5 years. She has almost 12 years of experience with the Food and Drug Administration, Center for Biologic Research and Review as senior reviewer for multiple analytes In Vitro Diagnostic Devices (IVD) products and CGMP inspection for biologic products. She leaded and chaired many review committees for 510 (k), IDE, PMA, IND and BLA and conducted many domestic and international manufacturer inspections. Jinjie has very successful track records in supporting companies submitting companion diagnostic products, combination products, and applications for 510(K), de novo, PMA, Clinical Laboratory Improvement Amendments (CLIA) waivers, IDE, IND and device Master File. As a trained manufacturer facility reviewer and CGMP inspector, she performed many pre-approval inspections and helped company to resolve deficiency issues meeting CGMP and QSR. She has been serving as scientific advisor, dossier reviewer and manufacturer facility inspector for the In Vitro Diagnostic Pre-Qualification Program at WHO since 2009. As the chair for the International Network Committee of the FDA Alumni Association, she provides leadership to collaborate with developing and emerging regulatory agencies for regulatory capacity building and training for many international regulatory agencies. Jinjie received her B.S. in Cell Biology from Beijing Normal University and her Ph.D. in Comparative Pathology from UC Davis, and completed her post-doctoral training at NIAID, NIH.
Ms. Barbara Spector is President of Smart Moves, a Talent Management and Leadership Development firm based in Northern California. The firm has been in business for the last 24 years. As a Business Consultant, Corporate Trainer, and Master Business Coach, she has a track record of improving leadership focus, sales management effectiveness, organizational alignment, teamwork, facilitated succession planning, along with providing programs that accelerate more accurate employee selection and retention.
Over the years, Barbara and her team have helped companies across the USA and Canada to make great decisions whenever they have been faced with the challenge of hiring great people, retaining great people, executing on a sales process and developing their leaders bench strength. Her success lies in providing critical and insightful information that enables business owners and executives to make better decisions regarding their people issues.
SmartMoves has a national client base spanning the entire spectrum of industries with small, medium and enterprise sized companies. Some notable clients have included U.S. Bancorp, HCA Hospital Corporation of America, Corning, NEC, Sun Microsystems, Woodruff Sawyer Insurance and Amedisys, just to name a few. Ms. Spector has served on the faculty at Syracuse University’s graduate school of Sales and Marketing Management. She held the position of Vice President of Sales and Marketing at Management Research Institute. Thereafter she held the position of Executive Vice President and Partner at Productivity Concepts before founding her own firm in 1997. Ms. Spector is an active member in SHRM, as well as the American Society of Training and Development. She often speaks on the subject of Effective Hiring, Sales Leadership and Training, Leadership Development and Retention, for various business and trade associations nationally. Barbara earned her Bachelor’s degree with Fine Art and Psychology from Boston University, and her Master Business Coach certificate from B-Coach Executive Coaching Program.
How to Develop and Advance Your Career
Date: Jan 23, 2021 (Saturday)
Time: 9:00-11:30 am (EST)
Registration link: https://bit.ly/2K0TgTJ
Draft Agenda: all presentation topics are tentative.
Section 1: Presentation Host: Hao Li
- 9:00 – 9:05 am Introduction of CBA. Dr. Hang Lu, CBA President-Elect
- 9:05 – 9:35 am Opportunities and Career Development in the US FDA and USPHS as a Chemist. Commander Geoffrey Wu, Ph.D., Acting Deputy Director, OLDP, OPQ, CDER, FDA. (Click here to view the presentation)
- 9:35 – 10:05 am Project Management: a career option in pharmaceutical / biotech industry and not-for-profit organizations. Dr. Nora Yang, Chief Scientific Officer at Stratify Therapeutics, LLC. (Click here to view the presentation)
- 10:05 – 10:35 am Chance favors the prepared mind. Dr. Yun-Fu Hu, Chief Medical Officer at Genetron Health. (Click here to view the presentation)
- 10:35 – 11:05 am Overview of Employment-Based Immigration. Mr. Richard W. Chang, J.D., Partner, Wasserman, Mancini & Chang, P.C.
Section 2: Panel Discussion Host: Kevin Li
11:05 – 11:30 am including four speakers and two additional panelists
- Dr. Xin Xu, Principal Investigator and Director of Pharmacokinetics, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health
- Dr. Kevin Li, Executive Director of Regulatory Affairs and Head of US Regulatory Affairs, TopAlliance Biosciences, Inc., a subsidiary of Junshi Biosciences
Speaker bio:
Commander Geoffrey Wu, Ph.D., PMP, CPH, Acting Deputy Director, OLDP, OPQ, joined FDA’s OTR in 2010, has served as research scientist, science staff, chemistry reviewer, special assistant to the Office Director, staff supervisor (Division Director equivalent), Associate Director for Sciences and Communication (ADSC), acting Division Director, and acting Deputy Office Director. He is a scientist officer in the United States Public Health Service. Throughout his FDA tenure, he has been deeply involved, leading or co-leading regulatory review and research for Controlled Correspondence, ANDAs, and supplemental ANDAs and NDAs. Between 2013 and 2017, he served as a founding member on the OPQ Emerging Technology Team (ETT). He was a core member in multiple policy development efforts, such as emerging technology, continuous manufacturing, and comparability protocols. Dr. Wu has training and education in pharmacy, pharmaceutical science, protein chemistry, polymer chemistry, and process analytical technology. He has more than 20 peer-reviewed publications, and been invited to multiple national and international conferences to present or discuss the above related topics. His Ph.D. thesis from the University of Utah focused on self-assembly of hybrid hydrogels containing coiled-coils and drug-free macromolecular therapeutics to induce apoptosis by coiled-coiled mediated crosslinking of antigens.
N. Nora Yang, Ph.D., MBA, has twenty plus years of executive and scientific leadership experience in pharmaceutical, biotech, venture capital industries, and government. She is a leading expert on improving the efficiency and effectiveness of therapeutic development, particularly at the intersection of science and business. She currently serves as the Chief Scientific Officer at Stratify Therapeutics, LLC. Previously, she served as the Director of Portfolio Management and Strategic Operations at the National Center for Advancing Translational Sciences at the National Institutes of Health (NIH). She was recruited to NIH to develop novel public-private partnerships to establish new models of financing biomedical research that maximize benefits for underserved patient populations, while incentivizing industry partners and private investors. Under Dr. Yang’s management, the Therapeutic for Rare and Neglected Diseases (TRND) program portfolio at NIH created more than $2.5 billion dollars of commercial value within 8 years for its collaborating organizations and their investors. Prior to joining NIH, Dr. Yang led global teams for the successful development of novel therapies at Eli Lilly & Co and Amgen Inc. Her successful therapeutic development track record includes taking four (4) investigational drugs through successful New Drug Application (NDA) and Biologics Licensing Application (BLA) filings to global market launches and twelve (12) investigational drugs through Investigational New Drug (IND) filings to phase 3 clinical trials. Nora holds both a Master’s and a PhD degree in chemistry from the University of California, San Diego with her PhD research conducted at the Salk Institute for Biological Studies. She also holds a Master’s degree in management from Stanford University, Graduate School of Business.
Yun-Fu Hu, Ph.D., RAC, ASQ CQA, has served as Chief Medical Officer at Genetron since April, 2020. Dr. Hu brings over two decades of experience in regulatory and managerial capacities related to medical devices and pharmaceutical industries. Dr. Hu had more than ten years of service at US Food and Drug Administration (“FDA”), where he had served as Deputy Director and other positions at Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, Center for Device and Radiological Health. During his tenure at FDA, Dr. Hu supervised a staff of scientists, engineers, consumer safety officers and medical officers in premarket reviews and post-market compliance of IVD products and LDTs for genetic testing, molecular cancer diagnostics, companion diagnostics, radio dosimetry, digital pathology and artificial intelligence devices. Some of the notable authorizations by Dr. Hu’s group at FDA include: the first NGS-based LDT as CDx (Foundation Medicine FoundationFocus CDxBRCA); the first NGS-based CDx kit (ThermoFisher Oncomine Dx Target Test); the first NGS-based LDT for tumor profiling (MSK-IMPACT) and later on FoundationOne CDx); the first liquid biopsy test for NSCLC (Roche Cobas EGFR Mutation Test v2); and FDA’s only two approved cancer screening tests in the last decade (Exact Sciences’ Cologuard and Epigenomics’ Epi ProColon). He was a member of the steering committee to stand up the FDA’s Oncology Center of Excellence (OCE) under the 21st Century Cures and served as the Center’s first Acting Associate Director of In Vitro Diagnostics.
Prior to joining FDA, Dr. Hu has more than ten years of product development experience in diagnostic and pharmaceutical industries, including his prior employments at GlaxoSmithKline and Becton Dickinson Diagnostic Systems.
Richard W. Chang, J.D., is a partner at the law firm of Wasserman, Mancini & Chang, an “AV” rate firm that is also one of the oldest immigration law firms in the country. Richard W. Chang received his Juris Doctorate (JD) and his International Law Certificate at the Columbus School of Law at the Catholic University of America. He graduated from the University of Illinois at Urbana-Champaign (UIUC) with a Bachelors degree in History – East Asian Concentration. Richard W. Chang was one of the authors of the Asian Pacific American Coalition (APAC) Cultural Center Proposal at UIUC that helped the Asian Pacific American (APA) student groups land a $30,000 grant for APA programs. He is a former Vice-President for Communications for the Asian Pacific American Bar Association (APABA) in Washington DC. Richard W. Chang co-founded the DC Chapter of the National Association of Asian American Professionals (NAAAP-DC) in 1998. He is a former board member of the Asian American Action Fund (AAA-Fund), Richard Chang was a contributing author for the Taiwan-AIT article in “The Visa Processing Guide” published by the American Immigration Lawyers Association (AILA). Richard was the co-host of the Free Immigration Law program on World Today Comcast Cable Channel 678 in Montgomery County, Maryland since 1997. He was named one of America’s Best Lawyers in 2020 & 2021 in Immigration by Best Lawyers at Bestlawyers.com (U.S. News and World Reports). He was also named as one of the Top 100 Northeast Lawyers (Immigration Category) by Amtrak’s ARRIVE Magazine and AVVO (Nov/Dec 2011)
Panelist Bio:
Xin Xu, Ph.D., is a Principal Investigator and Director of Pharmacokinetics at National Center for Advancing Translational Sciences (NCATS), NIH. Prior to joining NCATS, she had over 20 years of industrial experience in drug metabolism and pharmacokinetics. Dr. Xu has extensive experience in IND and NDA filings of novel therapeutics, ranging from small molecules to biologics, such as monoclonal antibody, nanobody, engineered human protein, protein-drug conjugate and gene therapy. Dr. Xu obtained her B.Sc. degree from School of Pharmacy, Peking University Health Science Center, Beijing, China. She earned her Ph.D. degree in Pharmacokinetics from Faculty of Pharmacy, University of Toronto, where she also did her post-doctoral training in controlled release formulations. Dr. Xu has authored 239 publications (119 journal papers/ book chapters, and 120 conference presentations/abstracts). She is the co-inventor for five patents.
Kevin Li, Ph.D., is the Executive Director of Regulatory Affairs and Head of US Regulatory Affairs at TopAlliance Biosciences, a subsidiary of Junshi Biosciences. Prior to TopAlliance, Dr. Li was a director of regulatory affairs at AstraZeneca BioVentures and the head of regulatory affairs at Centus Biotherapeutics, a joined venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics. In that role Dr. Li has directed the regulatory affairs group for the preparation and defending of global marketing applications for Equidacent® (a proposed biosimilar to Avastin), leading up to the final approval by European Union in September 2020. Prior to AstraZeneca, Dr Li was a product quality reviewer at Office of Biotechnology Products (OBP) and Office of Life Cycle Product at CDER/FDA, responsible for reviewing the chemistry, manufacturing and control (CMC) section of Abbreviated NDA (ANDA), investigational new drug (IND) and biologic license applications (BLA) for biologics and drugs. Before that, Dr. Li was an analytical scientist at MedImmune, with responsibilities range from method development to project and people management. Dr. Li received his undergraduate degree from Peking University and Ph. D. from University of Illinois at Urbana-Champaign.
Job Opportunities (Click the links below for details)
CBA Hosted a Successful Webinar on COVID-19
CBA抗击新冠病毒系列讲座成功开讲
正当我们满怀喜悦步入新的十年、迎接2020年的到来时，一场突如其来的新型冠状病毒肺炎疫情向我们的家人、亲友无情袭来。不断蔓延的疫情牵动着所有在美华人的心。CBA（美国华人生物医药科技协会）首先停止准备已久的华府春节酒会的一切活动，立即号召会员及华人科学家积极行动起来投入到支援祖国同胞的抗疫战斗中去！他们组织CBA的骨干企业为国内新冠肺炎患者急需的创新药物和疫苗献计献策，同时捐献试剂药品和防护器材到抗疫战场的第一线！他们还组织募捐活动，为灾区加油、加油！
新冠病毒十分狡猾，它与SARS病毒有类似之处，但又完全不一样，对疫情的防控带来很大的挑战。因此，CBA决定利用我们的知识专长设计一套抗击新冠肺炎的知识系列讲座，帮助广大群众对此病毒有个正确的认识，普及一些防控和保护自己的常识和方法。考虑到主要听众在国内，所以借助webinar就可同时向全美和中国开放。方向既定，CBA在一周内就于2月19日晚上推出CBA抗击新型冠状病毒知识系列线上讲座第一讲 “新型冠状病毒解读和流行病防控战略”。两位资深主讲人分别是美国国立卫生研究院（NIH）国家癌症研究所（NCI）肿瘤病毒RNA生物学实验室主任、资深研究员，国际知名肿瘤病毒学专家郑志明博士和美国国立卫生研究院国家过敏和传染病研究所（NIAID）微生物学和传染病部（DMID）属下的生物防御，生物研究资源和转化研究办公室主管官员符海青博士。
郑博士是我国第一批送到美国来深造的学者。81年就到Yale大学专攻病毒学。84年学成回国服务。回国后任武汉大学医学院病毒研究所所长和临床病毒学研究室主任。曾任中华医学会医学病毒学会副主任委员. 可以说，他是我国在Yale大学第一位受过正规训练的医学病毒学家。对武汉的过去和现在的医学病毒研究十分了解。他是带着强烈的乡情、厚重的乡音来到CBA讲座现场。郑博士首先详细地介绍了新型冠状病毒的结构和进入人体的机制以及导致肺炎的机理，然后通过和SARS病毒传染的比较，指出新型冠状病毒传染性非常强，防御机制非常重要。他指出在设计核酸检测试剂盒时，最好要把SARS的基因片段和新冠病毒S蛋白的基因片段都包括在内，这样不仅能确定病毒的存在，而且能确定特异的新冠病毒的存在。他又指出，新冠病毒虽然传染性很强，但也有它的弱点。它在高温和干燥的条件下不易生存。郑博士在讲到家乡人民正在遭受新冠病毒的肆虐而备受煎熬时，他的眼睛霎时湿润了，他希望通过online把他对家乡的思念和关切传递到大洋彼岸的千家万户，把他对正在奋战的白衣天使和战友的敬意和问候传递到抗疫最前线！
符海青博士具有20多年的生物诊断及精准医学技术开发，新药研发，项目管理，产业化等工作经验，既有工业界的实践经验，又有政府机构项目管理的经验。特别是自2004年以来，她帮助建立了1.4亿美元的集中生物防御试剂资源中心。通过生物防御试剂计划，符博士主持NIAID在传染病研究中试剂和分析标准化的建立，管理多项疫苗和新药开发项目的全过程；参与管理美国国家生物防卫重点项目（包括炭疽，天花病，各种细菌病毒）的诊断，疫苗及新药研发。符博士前后参与和主持了20项生物防御和突发性（爆发性）微生物传染病的抗病毒和抗生素新药研发NIH的国家重点项目，管理超过7亿美元的政府投资科研资金及项目。 符博士通过分析1918-1919 Influenza感冒病毒在美国的大规模传染为例，系统讲述了美国政府如何吸取教训从而推出PHEMCE（Public Health Emergency Medical Countermeasures Enterprise）。美国政府的此举，其实对中国很有借鉴意义。人民大众的健康和安全问题必须动员和依靠整个社会一起来办。符博士还详细介绍了如何在疫苗和药物研发方面进行有计划、有步骤、有措施、有保障的大量的投入，从而防御流行病大规模爆发。符海青博士还重点介绍了广谱抗病毒药的必要性以及Gilead的Remdesivir作为广谱抗病毒药或许对新型冠状病毒的大有作为。符海青博士还通过Ebola病毒案例的分析，特别指出对于防御类似新型冠状病毒COVID-19的全球性爆发，各国政府的合作以及持续性投入必不可少。
演讲结束后，两位专家还回答了网上听众提出的各种问题。CBA明确地制订了讨论规则：我们欢迎与社会大众互动，但凡是涉及中美两国的国家政策的问题不讨论；凡是涉及网上的各种流言、猜测不讨论。所以，整个讲座完全集中在科学问题上。
CBA抗击新型冠状病毒知识系列线上讲座第二讲在2 月 26 日 周三晚上 8:30成功举行。演讲嘉宾美国圣诺制药公司创始人, 总裁兼首席科学家陆阳博士和康希诺生物股份公司首席运营官巢守柏博士。陆博士是CBA-USA创始人之一并出任第二任会长。陆博士是国际核酸干扰药物研制领域的著名专家和企业家，曾领导应用核酸干扰技术研发SARS、流感和埃博拉药物的工作，曾主持国家十二·五“重大新药创制”的大平台项目。陆博士的演讲题目是RNAi技术是开发治疗新冠肺炎创新药物的有效方法。巢博士在加入康希诺生物之前是阿斯利康的高级副总裁，领导阿斯利康的生物风投业务部门，与中国和其他亚洲国家的领先生物技术公司合作，为全球市场开发生物仿制药和创新生物制品。他是美国华人生物医药科技协会第十八任会长。巢博士的演讲题目是预防新冠肺炎病毒的疫苗研发。
陆总首先介绍了核酸干扰技术作为分子医学的一个重要组成部分及在抗体和小分子药物中的作用机理，强调是一种新兴的药物，市场上已有FDA批准的药物。陆总强调此类药物开发的关键是干扰核酸的输送，圣诺制药公司己成功开发了多肽纳米技术或载体来达到这亇目的，已有多个在研管线产品和四亇临床试验在中美两地进行中。陆总详细叙述了核酸干扰药物开发在抗SARS和流感病毒感染中的经验和在发展抗新冠病毒药物中如何优化此类药物开发过程中每个步骤的思路，尤其是靶点设计，体外和体内动物实验或模型的有效性确认，制剂系统的优化和雾化气道输送器械的开发。
康希诺生物2017在中国首次成功获批在紧急情况下可使用的Ebola疫苗，这种疫苗就是用腺病毒为载体的。巢总详述了新兴传染性疾病给人类所带来的挑战和人类如何利用过往的抗SARS病毒, 中东病毒，Ebola病毒等感染性疾病的经验来开发合适的疫苗抵抗新冠肺炎病毒感染病。巢总叙述了新冠疾病在中国和世界范围的现在流行状况，并详述了灭活病毒疫苗，减毒病毒疫苗，DNA疫苗，重组旦白疫苗，病毒载体相关疫苗和mRNA疫苗的特点和应用在抗新冠病毒感染中的可能性和要克服的障碍。巢总进一步叙述了美中两地多个公司和机构在抗新冠肺炎病毒疫苗中的进展。并总结到疫苗不可能在三个月内出现，但可通过技术创新，优化从早期研究，临床前工作，生产过程，临床试验，监管程序和步骤等整个过程而加快开发进程，并强调疫苗是最经济和有效的预防大规模传染性疾病的手段。巢总最后也强调新兴传染病的防治是对全人类的挑战，需要政府，工业界，基金等各方面共同努力和协作来应对这种对人类的挑战。
讲座最后，二位老总回答了听众的问题，强调在抗新兴传染病的药物和疫苗开发中，重要的是全球合作，政府，工业界和各类基金的全力合作，优化开发步骤，从而一起来有效地应对这类对人类的挑战。
这个讲座得到广大听众的热烈反响，觉得受益匪浅。听众的反馈也是对CBA最好的鼓励和鞭策。讲座刚刚开始，要知还有什么精彩故事，且等下周三晚上8：30网上不见不散！
CBA抗击新冠病毒系列讲座之五&六
CBA抗击新冠病毒系列讲座之五
──FDA在紧急或危机情况下的反应
继共同学习新型冠状病毒的基础知识、分析针对COVID-19的新药临床试验之后，美国华人生物医药科技协会（CBA）的系列讲座迎来了听众们关心的内容之一——FDA在紧急或危机情况下的反应。
3月18日晚，美国东部时间9点，在CBA元老之一，biomarker组负责人杨宏钧博士的主持下，CBA前任会长、现BLA咨询公司创始人李利博士以“Introduction of Key Federal Laws and Policies in Responding to Public Health Crisis in the US”为题，开始为听众们介绍联邦政府的法规及在一些公共卫生事件中的反应和应用。他先提纲挈领地为听众列出了几个关键的联邦紧急情况管理的法律，如1988年的Robert T. Stafford 灾难救援及紧急救助行动，还有911之后，鉴于全球性威胁而催生的2004年“生物盾牌行动（The Project Bioshield Act）”， 以及2018年在1988 的的法案基础上做的相应修订，最后是2019年的“The Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA)”。 然后，李会长详细地分别分析了几个法案在新形势下的应用，特别强调1988年的Robert T. Stafford 灾难救援及紧急救助行动法案在2020年的应用，的执行速度非常快捷，一旦宣布，立即执行。而2004年的生物盾牌行动，则旨在帮助生物医药公司、科研单位研发一些有针对性的防止生物恐怖武器等的方法及疫苗等。谈及2019年的PAHPAIA， 他介绍了这一由HHS管理的法案，帮助全美的医院及州立卫生系统在灾难中的人员调度安排等具有一定灵活性，而全美有31000家医院参与这一系统。最后，李会长分别介绍了紧急使用法案（EUA）的标准及炭疽EUA和神经毒气EUA，以及“动物法则”及其在疫苗研发中的作用。
紧接着，Axteria BioMed 咨询公司的总裁胡劲捷博士接过了话题。胡博士以前一直在FDA工作多年，之后也曾于其他咨询公司任职，具有丰富的实战经验。她从介绍FDA的紧急使用法案指南开始，指出这一法规适用于CLIA实验室及一些商业公司，近期FDA于2020年3月16日发布最新条例之后，也一直在做相应修改。关于这一系列改动的关键信息是：FDA不反对将测试用于临床，但其前提条件是这些测试方法已经进行了评估，同时申请方应同期准备EUA的申请文件，在推向市场后15天之内上交至FDA。胡博士比较了以前Ebola及Zika疫情期间使用的EUA，评价说本次COVID-19的EUA相对条件最为宽松。她也指出，EUA不是一个长期计划，仅是短期行为，而且需要提供使用指南（IFU）。 在分析商业EUA检测方法时，胡劲捷博士指出，EUA仅要求最少的检测方法，而且可以是不同种类例如分子检测、抗原检测或血清学检测等；她也着重讲了分子检测的样品、最低检测线及临床评价，强调现在临床评价的困境在于没有已知的阳性标本，所以接受人为创建的标本（Contrived clinical specimen）。胡博士还详细分享了FDA评议EUA的流程，并结合自己公司近期准备的一个EUA案例的具体时间线，为听众分享了准备过程及来自FDA的反馈；同时为大家介绍在与FDA评审员的数轮互动沟通中，怎样阐述并介绍自己的产品，逐渐走向理解及认同，并最后取得可能的成功申报。
两位嘉宾的精彩讲座之后，随后与听众交流的是来自FDA-CDRH的分子、遗传及病理分部的胡云福博士。他对两位嘉宾的讲座进行了点评，并且也从FDA的角度介绍了现在法规部门在全力推进审批进度以适应疫情。胡博士也针对听众提出的问题一一解答，尤其是听众对于“人为创建标本（contrived clinical specimen）”的疑惑给予了详细答疑。
CBA抗击新冠病毒系列讲座之六
──全球疫情爆发对生物医药产业的影响及我们的应对策略
CBA抗击新冠疫情系列讲座的压轴大戏请来了四位前会长们，于3月25日美东时间晚9时准时与听众们探讨疫情对相关领域的影响及如何从个人角度及企业层面顺应疫情的变化并调整应对策略。
CBA的创始会长余国良博士首先开启话题，分析了新冠疫情对于全球经济的影响。作为多家公司的创始人、投资人及慈善家，余会长对于生物医药产业在疫情中所受影响有全局宏观的了解及独到的心得体会，他指出生物医药的研发需要持续地进行融资和与投资者的交流，现在鉴于疫情影响导致股市低迷，公司估值降低；投资者对公司的要求就会更苛刻、决策会更慢并且更趋谨慎。 另外一批投资机构如公司LP（limited partner）可能也会暂停，等资本市场回归再进行。在资本市场已经趋冷的形势下， COVID-19实际上是雪上加霜，可能给行业带来悲观情绪。但是余博士同时也鼓励所有听众，虽然我们这次经历了相对比较严重的疫情，只要疫情一旦结束，大家又会尽快回到经济发展的轨道上。各个国家批准的经费可以更多地投入到生物医药行业，不论资金来自资本还是政府。这次疫情也让社会意识到健康产业的重要性和大家专业人士对整个社会的贡献，所以资金来源可能相对比其他行业更为乐观。在与参会嘉宾的讨论中，余博士认为医药行业的投资方向可能会有一些微小的调整，如病毒的诊断可能会受到较大促进，推进一些已经有一定基础的企业的发展；同时开发疫苗或治疗的公司，可能都会被资本市场看好；另外，其他交叉行业、如互联网等可能和生物技术公司建立更多的合作。
接下来，CBA第9任会长、方恩医药创始人及CEO张丹博士指出：这次疫情是全球人民共同经历的一场挑战，经济活动等都受到直接影响，打乱了正常的药物研发及产品开发的计划，对各个企业的应急措施是一大考验。从产品开发讲， 临床试验受影响，试验配套受影响，这种情况下怎么来应对？张丹会长结合他自身作为一家跨国CRO创始人的经验，与听众们分享他们所看到的客户和政府举措。 他认为：1）每个公司遇到的挑战是不一样的，应对方案也不同。无论怎样，受试者安全是第一位，所以需要重新审视我们的方案，和PI沟通形成共识。2）新冠疫情下，融资难度增加。但全球都在开始用各种方式来支持我们这一类企业的发展（税收、贷款和国家主导的银行部门）。张丹博士以自己公司为例，国内国家银行主动提供流动性的支持，关键时刻政府开始伸出援手，和相应政府机构进行有效交流，获得有力支持。所以需要拓展各种获取支持的渠道，目前中美的经济活动并未停止。跨境的BD合作目前尤其重要，如跨欧美、中国大陆等等。3）FDA和EMA上周都颁布了针对新冠疫情的指南，也看出政府对这种情况下新药研发的支持，所以各个初创企业要充分领会这个指南，看能否对自己的药物研发有支持。特别需要指出的是，在药物安全性方面，FDA是扩大了灵活性。对于新冠感染造成的不良影响，也给与了足够的空间。国内也有相应的工业界共识，并上报国家进行考虑，让大家在面对新冠病毒造成的影响时有案可查，有据可循。4）新冠疫情也促使大家考虑在新药研发时走全球化布局及考虑，并充分利用外援技术进行支持，远程监察，解决CRA无法现场监察的困境。张丹博士也认为这次各国应对措施不同，期望这些经验可以保留下来。在回答听众的问题时，张丹博士认为国内一般医院目前恢复较快，可能6月底大部分恢复，年底可望完全恢复。
紧接着，CBA第8任会长、亚盛医药创始人及CEO杨大俊博士开始了他的经验分享。杨会长结合自己公司在中、美、澳大利亚不同区域的情况，指出这次新冠疫情对临床试验产生的较大影响，许多患者不能得到及时的试验处理，而这些肿瘤患者都面临生命威胁。可喜的是，从1月开始，中国就发布了一些危机处理的方案，指导医院、临床试验点及患者。另外，许多组织如中国药促会等也在2月初发布了应对指南，着重于远程监察的实施，为医院及临床试验点提供具体的参考。作为多个专业委员会的委员，杨大俊博士与张丹博士很早就给中国CDE提出建议，CDE也迅速反应，给予了极大的支持。虽然CDE的官方文件尚未出台，但是根据药促会及抗癌协会等专业协会的建议，“病人的安全及获益”始终是强调的重点；而且，这次疫情对各个参与方都是巨大的挑战，不论是临床试验的发起者、CRO或者参与的医院。在这样的特殊情况下，杨博士强调客观、详实的记录是最重要的，这样即使有“方案违背”，也可以有据可循；当然，杨博士再次强调，应该在保证患者安全性的前提下，面对挑战并顺应形势，尽可能减少疫情对临床试验的影响。在回答听众的问题时，杨博士指出，现在临床试验受影响最大的是两个方面，一是新的研究的启动，中国2月初就不再开启新的试验，好在现在3月份重启了，但是鉴于需保持“社交距离”，许多步骤改为线上操作。二是病人的给药，可能有一些推迟甚至出现超过窗口期，但是如果延迟在1-2月之内，还可以补救处理。
最后，CBA第10任会长、新原力公司CEO李玉玲博士和听众分享了药物研发企业在药物的供应量和药企经历的挑战及怎样在挑战中争取到机会。李会长首先介绍了药物的生产和物流：全球供应链物流的影响，在一月份，疫情紧张之际，由于航班取消，公司货物不能寄送至欧洲，影响了物质的供应，幸运的是缓解计划可用。如果一个公司没有足够的储备，就可能会受到不可估量的影响。 所以这个需要吸取的教训就是，做研究及临床计划时，需要考虑足够的贮备量。另外，也要确保物流链的可靠，否则会有极大风险。李博士也从公司负责人角度分享自己经营公司的理念，如何维持公司的运作，同时要关心员工的健康及安全，并且及时分享一些医疗教育性的讲座帮助员工应对疫情和加强自身专业背景的提高。 李博士还分享了利用远程办公，组织了一次跨越6个不同时区、5个国家4个洲的洲际会议的经验，强调要使这样的会议高效进行，必须做好详尽的准备工作。所以，实施这样的应对措施也是对每个人的一个学习提高机会。针对听众问到的应对将来类似危机的经验时，李博士再次强调要在供应链上预留足够余地。
这次讲座中，几位会长及公司主席们结合自身丰富经验、总结并为听众们提出诚恳建议。杨大俊博士也多次强调，在保证病人福祉的前提下，开启远程监察，线上多于线下，也是行业转型的机会；同时在布局方面不要集中在大的医学中心，可以考虑各种层次的医院相结合，也许可以形成新的商业模式。
至此，由CBA元老杨宏钧博士策划、CBA前任会长李利博士倾力参与及现任会长邢传华博士大力支持、数位CBA核心成员辛勤劳动支持的“抗击新冠疫情系列讲座”圆满完成。李利会长在讲座结尾大力感谢了各位积极参与的嘉宾及辛苦工作的CBA核心成员，同时指出，中国境内新冠疫情控制良好，但美国及欧洲的疫情形势越来越严峻，所以CBA也还将密切关注疫情，首先要保护好自己和家人亲友，同时继续在自己的专业领域发挥作用。新冠病毒引发的疫情是对全人类的威胁和挑战。病毒不分肤色，与COVID-19的战争可能是长期的，CBA的成员应该在这场战役中用好我们的专业特长，积极投入到保卫家园、保卫人民、保卫全人类的战斗中去！全球防疫，必须从我做起！
The 1st CBA Biomarker and Diagnostics Study Group Meeting: Recap
The 1st CBA Biomarker and Diagnostics Study Group Meeting: Recap
Gaithersburg, MARYLAND, May 6, 2018.
The launch of CBA Biomarker and Diagnostic Discussion Group has taken place. 19 scientists and professionals from Washington DC and Philadelphia areas attended the kick-off meeting for a study group to facilitate the applications of the biomarkers and innovative diagnostic technologies in precision medicine.
In the Spring of 2018. Dr. Harry Yang, Dr. Judy Yu, Dr. Peixuan Zhu and Dr. Chuanhua Julia Xing and the CBA president elected, Dr. Frank Li formed the idea of a CBA Biomarker and Diagnostics Study Group to facilitate the scientific learning, education, and exchange in areas of research achievements, technology improvements, clinical trial development, regulatory policy and guideline updates etc. related to precision medicine. The establishment of this group should strengthen and advance scientific discussion and communication in area of biomarker and companion/complementary diagnostics among the scientists, clinicians and biopharmaceutical communities in Washington D.C. area.
The mission of this group is aligned with the CBA’s mission to promote the precision medicine and biomarker strategy among regions by taking advantage of the rich resources in this region. With the rapid advancement of the genomics and sequencing technology, precision medicine became a hot topic in the biomedical research and development field, where precision diagnosis plays the fundamental role for the precision medicine and P4 medicine era.
At the 1st CBA Biomarker and Diagnostics Discussion Group Meeting held on Saturday, May 6th, 2018, 19 scientists and professionals from NIH, Johns Hopkins, MedImmune, AstraZeneca, GeneDx, PacBio, XPrecision and other biotech companies joined onsite or online. One member of the group drove 2hrs from Philadelphia to attend the meeting. All attendees are very passionate for this leading topic on precision diagnosis. The CBA President-Elect Dr. Frank Li opened up the meeting with enthusiasm, “Congratulations! This is the first study group focused on biomarkers under CBA umbrella. It is a new experiment of exploring the way of development for a non-profit and professional organization. I hope each of you will enjoy studying together as a group and share knowledge and expertise for your experience.” He also pointed out that the discussion content of this group will only include the knowledge in the public domain. The rest of the meeting focused on self-introduction by each attendee. The background introduction of each individual led to enthusiastic conversations in work experience, technical and business expertise.
The discussion was also covered the upcoming 23rd CBA Annual Conference on June 9th 2018.Many world-class experts such as Prof. Lieping Chen, Dr. Richard Pazdur, Dr. Gang Wang, Dr. Bing Yao, etc. will talk about their brilliant scientific achievement in Immuno-Oncology, Drug Discovery and Development, Advanced Translational Medicine, AI & Big Data in Biopharmaceutical and Healthcare, etc. which include the new trend and progresses in Biomarker and Diagnostics area. All members are warmly expecting another great and fruitful conference with a high enthusiasm.
Future activity plans were also discussed such as seminar/webinar, publications and resources sharing, projects and collaboration, communication/outreaching, regulation and legal guidelines, etc., which will tentatively open to all CBA active and lifetime members.
The group members are now working on finalizing the short-term and mid-term goals and topics to discuss, scheduling monthly meeting agendas and speakers, setting up information sharing space etc. Stay tuned for upcoming progress!
–Yixing Han reports
Source: ©CBA- Biomarker and Diagnostics Study Group
CBA抗击新冠病毒系列讲座之五 《FDA在紧急或危机情况下的反应》
继共同学习新型冠状病毒的基础知识、分析针对COVID-19的新药临床试验之后，美国华人生物医药科技协会（CBA）的系列讲座迎来了听众们关心的内容之一——FDA在紧急或危机情况下的反应。
3月18日晚，美国东部时间9点，在CBA元老之一，biomarker组负责人杨宏钧博士的主持下，CBA前任会长、现BLA咨询公司创始人李利博士以“Introduction of Key Federal Laws and Policies in Responding to Public Health Crisis in the US”为题，开始为听众们介绍联邦政府的法规及在一些公共卫生事件中的反应和应用。他先提纲挈领地为听众列出了几个关键的联邦紧急情况管理的法律，如1988年的Robert T. Stafford 灾难救援及紧急救助行动，还有911之后，鉴于全球性威胁而催生的2004年“生物盾牌行动（The Project Bioshield Act）”， 以及2018年在1988 的的法案基础上做的相应修订，最后是2019年的“The Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA)”。 然后，李会长详细地分别分析了几个法案在新形势下的应用，特别强调1988年的Robert T. Stafford 灾难救援及紧急救助行动法案在2020年的应用，的执行速度非常快捷，一旦宣布，立即执行。而2004年的生物盾牌行动，则旨在帮助生物医药公司、科研单位研发一些有针对性的防止生物恐怖武器等的方法及疫苗等。谈及2019年的PAHPAIA， 他介绍了这一由HHS管理的法案，帮助全美的医院及州立卫生系统在灾难中的人员调度安排等具有一定灵活性，而全美有31000家医院参与这一系统。最后，李会长分别介绍了紧急使用法案（EUA）的标准及炭疽EUA和神经毒气EUA，以及“动物法则”及其在疫苗研发中的作用。
紧接着，Axteria BioMed 咨询公司的总裁胡劲捷博士接过了话题。胡博士以前一直在FDA工作多年，之后也曾于其他咨询公司任职，具有丰富的实战经验。她从介绍FDA的紧急使用法案指南开始，指出这一法规适用于CLIA实验室及一些商业公司，近期FDA于2020年3月16日发布最新条例之后，也一直在做相应修改。关于这一系列改动的关键信息是：FDA不反对将测试用于临床，但其前提条件是这些测试方法已经进行了评估，同时申请方应同期准备EUA的申请文件，在推向市场后15天之内上交至FDA。胡博士比较了以前Ebola及Zika疫情期间使用的EUA，评价说本次COVID-19的EUA相对条件最为宽松。她也指出，EUA不是一个长期计划，仅是短期行为，而且需要提供使用指南（IFU）。 在分析商业EUA检测方法时，胡劲捷博士指出，EUA仅要求最少的检测方法，而且可以是不同种类例如分子检测、抗原检测或血清学检测等；她也着重讲了分子检测的样品、最低检测线及临床评价，强调现在临床评价的困境在于没有已知的阳性标本，所以接受人为创建的标本（Contrived clinical specimen）。胡博士还详细分享了FDA评议EUA的流程，并结合自己公司近期准备的一个EUA案例的具体时间线，为听众分享了准备过程及来自FDA的反馈；同时为大家介绍在与FDA评审员的数轮互动沟通中，怎样阐述并介绍自己的产品，逐渐走向理解及认同，并最后取得可能的成功申报。
两位嘉宾的精彩讲座之后，随后与听众交流的是来自FDA-CDRH的分子、遗传及病理分部的胡云福博士。他对两位嘉宾的讲座进行了点评，并且也从FDA的角度介绍了现在法规部门在全力推进审批进度以适应疫情。胡博士也针对听众提出的问题一一解答，尤其是听众对于“人为创建标本（contrived clinical specimen）”的疑惑给予了详细答疑。
CBA抗击新冠病毒系列讲座之六
──全球疫情爆发对生物医药产业的影响及我们的应对策略
CBA抗击新冠疫情系列讲座的压轴大戏请来了四位前会长们，于3月25日美东时间晚9时准时与听众们探讨疫情对相关领域的影响及如何从个人角度及企业层面顺应疫情的变化并调整应对策略。
CBA的创始会长余国良博士首先开启话题，分析了新冠疫情对于全球经济的影响。作为多家公司的创始人、投资人及慈善家，余会长对于生物医药产业在疫情中所受影响有全局宏观的了解及独到的心得体会，他指出生物医药的研发需要持续地进行融资和与投资者的交流，现在鉴于疫情影响导致股市低迷，公司估值降低；投资者对公司的要求就会更苛刻、决策会更慢并且更趋谨慎。 另外一批投资机构如公司LP（limited partner）可能也会暂停，等资本市场回归再进行。在资本市场已经趋冷的形势下， COVID-19实际上是雪上加霜，可能给行业带来悲观情绪。但是余博士同时也鼓励所有听众，虽然我们这次经历了相对比较严重的疫情，只要疫情一旦结束，大家又会尽快回到经济发展的轨道上。各个国家批准的经费可以更多地投入到生物医药行业，不论资金来自资本还是政府。这次疫情也让社会意识到健康产业的重要性和大家专业人士对整个社会的贡献，所以资金来源可能相对比其他行业更为乐观。在与参会嘉宾的讨论中，余博士认为医药行业的投资方向可能会有一些微小的调整，如病毒的诊断可能会受到较大促进，推进一些已经有一定基础的企业的发展；同时开发疫苗或治疗的公司，可能都会被资本市场看好；另外，其他交叉行业、如互联网等可能和生物技术公司建立更多的合作。
接下来，CBA第9任会长、方恩医药创始人及CEO张丹博士指出：这次疫情是全球人民共同经历的一场挑战，经济活动等都受到直接影响，打乱了正常的药物研发及产品开发的计划，对各个企业的应急措施是一大考验。从产品开发讲， 临床试验受影响，试验配套受影响，这种情况下怎么来应对？张丹会长结合他自身作为一家跨国CRO创始人的经验，与听众们分享他们所看到的客户和政府举措。 他认为：1）每个公司遇到的挑战是不一样的，应对方案也不同。无论怎样，受试者安全是第一位，所以需要重新审视我们的方案，和PI沟通形成共识。2）新冠疫情下，融资难度增加。但全球都在开始用各种方式来支持我们这一类企业的发展（税收、贷款和国家主导的银行部门）。张丹博士以自己公司为例，国内国家银行主动提供流动性的支持，关键时刻政府开始伸出援手，和相应政府机构进行有效交流，获得有力支持。所以需要拓展各种获取支持的渠道，目前中美的经济活动并未停止。跨境的BD合作目前尤其重要，如跨欧美、中国大陆等等。3）FDA和EMA上周都颁布了针对新冠疫情的指南，也看出政府对这种情况下新药研发的支持，所以各个初创企业要充分领会这个指南，看能否对自己的药物研发有支持。特别需要指出的是，在药物安全性方面，FDA是扩大了灵活性。对于新冠感染造成的不良影响，也给与了足够的空间。国内也有相应的工业界共识，并上报国家进行考虑，让大家在面对新冠病毒造成的影响时有案可查，有据可循。4）新冠疫情也促使大家考虑在新药研发时走全球化布局及考虑，并充分利用外援技术进行支持，远程监察，解决CRA无法现场监察的困境。张丹博士也认为这次各国应对措施不同，期望这些经验可以保留下来。在回答听众的问题时，张丹博士认为国内一般医院目前恢复较快，可能6月底大部分恢复，年底可望完全恢复。
紧接着，CBA第8任会长、亚盛医药创始人及CEO杨大俊博士开始了他的经验分享。杨会长结合自己公司在中、美、澳大利亚不同区域的情况，指出这次新冠疫情对临床试验产生的较大影响，许多患者不能得到及时的试验处理，而这些肿瘤患者都面临生命威胁。可喜的是，从1月开始，中国就发布了一些危机处理的方案，指导医院、临床试验点及患者。另外，许多组织如中国药促会等也在2月初发布了应对指南，着重于远程监察的实施，为医院及临床试验点提供具体的参考。作为多个专业委员会的委员，杨大俊博士与张丹博士很早就给中国CDE提出建议，CDE也迅速反应，给予了极大的支持。虽然CDE的官方文件尚未出台，但是根据药促会及抗癌协会等专业协会的建议，“病人的安全及获益”始终是强调的重点；而且，这次疫情对各个参与方都是巨大的挑战，不论是临床试验的发起者、CRO或者参与的医院。在这样的特殊情况下，杨博士强调客观、详实的记录是最重要的，这样即使有“方案违背”，也可以有据可循；当然，杨博士再次强调，应该在保证患者安全性的前提下，面对挑战并顺应形势，尽可能减少疫情对临床试验的影响。在回答听众的问题时，杨博士指出，现在临床试验受影响最大的是两个方面，一是新的研究的启动，中国2月初就不再开启新的试验，好在现在3月份重启了，但是鉴于需保持“社交距离”，许多步骤改为线上操作。二是病人的给药，可能有一些推迟甚至出现超过窗口期，但是如果延迟在1-2月之内，还可以补救处理。
最后，CBA第10任会长、新原力公司CEO李玉玲博士和听众分享了药物研发企业在药物的供应量和药企经历的挑战及怎样在挑战中争取到机会。李会长首先介绍了药物的生产和物流：全球供应链物流的影响，在一月份，疫情紧张之际，由于航班取消，公司货物不能寄送至欧洲，影响了物质的供应，幸运的是缓解计划可用。如果一个公司没有足够的储备，就可能会受到不可估量的影响。 所以这个需要吸取的教训就是，做研究及临床计划时，需要考虑足够的贮备量。另外，也要确保物流链的可靠，否则会有极大风险。李博士也从公司负责人角度分享自己经营公司的理念，如何维持公司的运作，同时要关心员工的健康及安全，并且及时分享一些医疗教育性的讲座帮助员工应对疫情和加强自身专业背景的提高。 李博士还分享了利用远程办公，组织了一次跨越6个不同时区、5个国家4个洲的洲际会议的经验，强调要使这样的会议高效进行，必须做好详尽的准备工作。所以，实施这样的应对措施也是对每个人的一个学习提高机会。针对听众问到的应对将来类似危机的经验时，李博士再次强调要在供应链上预留足够余地。
这次讲座中，几位会长及公司主席们结合自身丰富经验、总结并为听众们提出诚恳建议。杨大俊博士也多次强调，在保证病人福祉的前提下，开启远程监察，线上多于线下，也是行业转型的机会；同时在布局方面不要集中在大的医学中心，可以考虑各种层次的医院相结合，也许可以形成新的商业模式。
至此，由CBA元老杨宏钧博士策划、CBA前任会长李利博士倾力参与及现任会长邢传华博士大力支持、数位CBA核心成员辛勤劳动支持的“抗击新冠疫情系列讲座”圆满完成。李利会长在讲座结尾大力感谢了各位积极参与的嘉宾及辛苦工作的CBA核心成员，同时指出，中国境内新冠疫情控制良好，但美国及欧洲的疫情形势越来越严峻，所以CBA也还将密切关注疫情，首先要保护好自己和家人亲友，同时继续在自己的专业领域发挥作用。新冠病毒引发的疫情是对全人类的威胁和挑战。病毒不分肤色，与COVID-19的战争可能是长期的，CBA的成员应该在这场战役中用好我们的专业特长，积极投入到保卫家园、保卫人民、保卫全人类的战斗中去！全球防疫，必须从我做起！
CBA 2020 San Francisco Conference Successfully Concluded
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CBA 2020 San Francisco Conference Successfully Concluded
Technology Commercialization in Biopharmaceutical and Healthcare
Chinese Biopharmaceutical Association – USA successfully held the first joint conference with Chinese Bioscience Association (CBA San Francisco Chapter) in the theme of “Technology Commercialization in Biopharma and Healthcare” in San Francisco, USA on January 12, 2020. The invited CBA speakers from China and US delivered fantastic speeches. The venue was full-filled, and the guests have enjoyed this unique opportunity to exchange ideas and communicate and network each other in person. The conference includes three sessions: CBA Entrepreneurs in Action, Dialogue with Investors, and Recent Regulatory Updates and Case Studies in the US and China.
Opening Remark
The current president, Dr. Chuanhua Julia Xing delivered an opening remark. Dr. Xing first introduced the glorious tradition of CBA in innovation and entrepreneurship. Many CBA former presidents and members established their own companies. More than 10 CBA former presidents and entrepreneurs participated in this meeting. Many of them are leaders and have IPO companies in the biomedical industry, representing the internationally highest level in innovation and entrepreneurship. The conference is the first joint meeting held by the two coasts of the CBA in the US. CBA’s representative companies will give a remarkable tour, supplemented with representative investment capitals and the latest regulations. Then Dr. Xing briefly introduced the history and recent achievements of CBA. CBA was founded 25 years ago in Maryland, with more than 8,000 members now and more than 80% of them having a doctorate degree. It is one of the leading groups in the Chinese science and technology community, has flourished in innovation and entrepreneurship recent years. The CBA-San Francisco Chapter was formulated with the Chinese Bioscience Association in 2017. There are also a few milestones in development in last year: the CBA-Canadian Chapter, CBA – Hangzhou office and the CBA Clinical and Regulatory Affairs Study Group (CCRA) were established, the precision medicine and biomarker group successfully hold the first symposium, and the 2019 annual conference at the Guangzhou jointly with the China Bio-industry Conference was one of the influential events in biopharma and healthcare industry in 2019.
Dr. Dannis Chang, PharmD, President of Chinese Bioscience Association 2020, delivered an inspiring speech about the mission, vision and the current activities of the organization. Chinese Bioscience Association was founded in 1997 in the heart of San Francisco, and currently has 1000+ active members ranging from C-suites, founders, business executives, professors, scientists, post-docs and college students. Throughout the presentation, Dr. Chang walked the audience through the history of Chinese Bioscience Association with a dedicated goal to bridge the knowledge and cultural gaps in the healthcare across the globe by building and fostering upon strong partnerships from an educational perspective with various organizations in the life sciences arena. He also showcased the successful milestones that took place in 2019. The October Annual Conference, themed “From Disruptive Innovations to Real World Clinical Applications”, had attracted more than 300 attendees from all over the world. The outstanding workshops and symposiums with various topics such as CNS Drug development, CRISPR, gene therapy, Artificial Intelligence, Regulatory Considerations in Drug Development, made this event a great success. The Annual Summer Picnic for members to socialize was a blast as always. All the future events are update on the website: www.cbasf.org. Dr. Chang also thanked for the joint conference and would like to keep it as a tradition to distribute the spirit of innovation and science from San Francisco to the whole field.
PART 1 CBA pro-active entrepreneurs
VIP Host: Guo-Liang Yu, Ph.D., Chairman and CEO, Apollomics, Inc.
Dr. Guo-Liang Yu reviewed the history of CBA as the founder of the association and shared his brilliant experiences as an entrepreneur. From a group of elites to more than 8000 members, he can’t imagine that after 25 years, CBA has a high reputation in delivering powerful influence internationally now in innovation, entrepreneurship and scientific communication, etc.. Dr. Yu is also a mentor to entrepreneurs. He received his Ph.D. from UC Berkeley and then a postdoctoral fellow at Harvard Medical School. He has set up and invested in many start-up companies. Now he is the Chairman of both Apollomics and InnoForce.
VIP Speaker: Yuling Li, Ph.D., CEO, InnoForce
Innoforce CEO and former CBA president, Dr. Yuling Li emphasized that the scientific discovery across the eastern and western pharmaceutical industry is very cutting-edge. Product development is particularly important and has exceptional opportunities. Innoforce starts from China and drives the value of producing high-quality medicines, combining the experience from East and West. There is already a lot of research in the scientific community, so the product development behind science is particularly important at this stage. Their wish is to provide efficient and affordable therapeutic products for Chinese people. They pay particular attention to product quality, cooperation and partnership, innovation and products, and business models adaptive to the local economy. The company was established in Hangzhou last year, growing at a rapid speed with an internationally leading team. Their goal is to become the best in Hangzhou and then in China.
VIP Speaker: Patrick Lu, Ph.D., Founder, President and CEO, Sirnaomics Inc.
Dr. Lu was the second president of CBA. He pointed out that CBA has always valued the importance of entrepreneurship and encouraged its members to become an entrepreneur and serve the common mission and vision. CBA enjoys a common philosophy, cultural background, and the development of technology and products to serve the community and patients. RNAi is a new and innovative technology in the field of biopharmaceuticals and has been able to drive the development of many clinical projects. Until now, there have been many molecular therapeutic companies based on RNAi. Sirnaomics was founded 13 years ago, with the research facilities in Suzhou and Guangzhou, and offices in Boston and Hong Kong, and headquartered in Gaithersburg, Maryland. The drug delivery system is the key to RNAi therapeutics. They focus on tumors therapy that would deliver the drugs to the liver and lungs.
VIP Speaker：Ziping Wei, Ph.D., Founder and CEO, Bliss Biopharmaceutical Co., Ltd
Dr. Wei was the president of CBA in 2014-2015. She shared her thoughts with the audience: According to statistics, the average age of entrepreneurs in biopharma is 55 years old. Successful entrepreneurs not only need passion, that is, choose the things they love to start a business; they also have a long-term perspective, considering many challenges and difficulties later. Successful entrepreneurs need to be determined and believe that they can do this and build a comprehensive and effective leadership team. Product safety is critical, and speed is vital without compromising quality. We are developing more products while raising funds too.
VIP Speaker: Stephen Turner, Ph.D., Founder and CTO, Pacific Biosciences, Inc.
Pacific Biosciences is of about 400 employees and located in Menlo Park, California. Dr. Turner is a founder of the company and co-inventor of the third generation of sequencing and is also an entrepreneur advisor to CBA. Stephen talked about how to build the gene tags and sequencer infrastructure step-by-step when the molecular detection technology was infant before 1997. Then they invented the most advanced single-molecule sequencing technology, SMRT sequencing. SMAT sequencing has the read more than ten times longer than that of Illumina’s platform, and therefore results in high accuracy in detecting various types of mutations. He also shared their road to commercialization.
Round Table Panel Discussion
Each guest participated in a Q & A session with the audience on entrepreneurship and fundraising.
PART 2 Dialogue with Investors
VIP Host：Sujuan Ba, Ph.D., Co-Founder and CEO for AIM-HI Accelerator Fund; CEO, National Foundation for Cancer Research & Asian Fund for Cancer Research
VIP Speaker： Lynn Yunxia Yang, General Manager, Sequoia Capital
The investment in medical and health care has continued to grow in China in the past six years, the top VCs in China have invested in 37 companies, 60% of them are in biotechnology field including innovative drugs, medical services, digital medicine, medical devices, and genomic testing, etc.. Sequoia Capital China is involved in almost every type. The innovative drugs have attracted more capitals. The trend of biotechnology finance is that top investors and managers will communicate, recognize and attract each other. Demarginated technology is prevailing.
VIP Speaker: Zhe Li, Ph.D., Co-Founder and Partner, Proxima Ventures Ltd
There is a big gap between the Chinese and American healthcare industries. Chinese companies are actively introducing innovations from overseas, and China’s capital market has always provided opportunities for innovative companies. Proxima Ventures is committed to building a unique ecosystem to accelerate innovation, Proxima wants to establish multiple clinical applications for the leading hospitals, and to provide helpful assistance to the investment portfolios. For example, they are helping companies apply innovative technology to lung indicators, introducing oversea talents to the companies and entrepreneurs to develop globally innovative products.
VIP Speaker: Angel Huang, J.D., Shanghai Partner-in-charge and M&A Chair for Asia, Jones Day
In the Chinese market in 2019, the number of transactions has been growing, and biotechnology transactions have grown faster than before because of the active Chinese scientists in the United States. Investment in new areas back to the Mainland is continually increasing, and new open areas are expected to pass through foreign investment laws. 2020 prediction: transactions outside China are waiting for a direction and existence.
VIP Speaker: Lin Sun Hoffman, Ph.D., J.D., Founding Partner, Liu Chen & Hoffman LLP
Photo: Dr. Hoffman is from Liu Chen & Hoffman LLP. The firm mainly serves legal service in the area of intellectual property (IP), corporate law, cross-border investment, and contract, etc. The attorneys in the team have a diverse academic background and work experience. Dr. Sun Hoffman discussed issues and concerns during cross border collaborations
Chengmei Law Firm in the United States mainly serves laws about intellectual property (IP), company, cross-border investment, and contract, etc.. The lawyers in the team have a diverse academic background and work experience. Dr. Hoffman discussed the query of investment licenses. These include investment and Chinese license, IP, subordinate license, domains, asset ownership, alternating control power, and more.
VIP Speaker: Rose Wang, Strategic Advisor, AIM-HI Accelerator Fund
AIM-HI Accelerator Fund takes a new approach to invest in early-stage oncology startups. By establishing an evergreen investment ecosystem, a bridge has been built for the development of oncology drugs from discovery to clinical trials. They have established a new investment model: a combination of venture philanthropy (funded for a non-profit National Cancer Research Association for 46 years) and an influential investment to accelerate the development of innovative research on cancer.
Round Table Panel Discussion
The audience enthusiastically asked questions and actively interacted on the spot.
PART 3 New regulatory trends, case studies in China and the US
VIP Speaker: Ke Liu, M.D., Phd., Associate Director for Cell and Gene Therapy & Chief of Oncology Branch, CBER, FDA
Dr. Liu introduced several FDA accelerate approval approaches for macromolecules and anticancer drugs to ensure that patients can use new drugs as soon as possible, including Accelerated Approval (1992), Priority Review (1992), Fast Track (1997 ), Breakthrough Therapy (2012), and Regenerative Advanced Therapy (2016).
VIP Speaker: Dan Zhang, M.D., Founder and CEO, Fountain Medical Development Ltd.
China is a member of ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). Dr. Zhang updated the latest status of ICH implementation in China and its impact on the global biopharmaceutical industry.
VIP Speaker: Xiaobin Victor Lu, Ph.D., Senior VP, Head of Regulatory Affairs, Innovative Cellular Therapeutics Inc.
VIP Speaker: Frank Li, PHD., Founder and CEO, BLA Regulatory
Round Table Panel Discussion
In the regulatory section, Dr. Frank Li specifically mentioned FDA-approved Brukins from BeiGene. Two studies were conducted for mantle cell lymphoma using 118 patients. About three-quarters are Asians, 21% of participants are white, and 10% to 15% are from the United States. The Ph-2 study is fully supported using Chinese clinical data to obtain accelerated FDA approval, which is a milestone for the approval of Chinese originated medicines in the United States. Dr. Ke Liu pointed out specially that this approval was important to support the efficacy and the clinical trials to confirm efficacy and safety after approval. Dr. Xiaobin Victor Lu also pointed out that the approval of Brukins will encourage Chinese pharmaceutical companies to continue the clinical trials in China, considering factors to meet the requirements of the FDA. The clinical trials in China help win approvals from both China and the US, and shorten the time for approval between the two countries.
Networking Distinguished guests ample networking among participants.
This conference acknowledged the sponsorship and support from Sirnaomics and Jones Day
Dr. Tamera Weisser, Head of Jones Day ’s Biopharmaceutical Intellectual Property Department, gave a welcome speech at the conference and introduced Jones Day ’s legal business achievements in the field of medicine.
Dr. Kaixian Chen accepted to be a CBA Scientific Advisor
Dr. Kaixian Chen (陈凯先), a member of Chinese Academy of Sciences, has recently accepted the invitation to join our organization as a CBA Scientific Advisor.
Dr. Kaixian Chen has committed himself to research in the areas of organic chemistry, medicinal chemistry and drug design for many years. Through theoretical calculation and molecular modeling, his group has developed and improved many methods and techniques for drug design, studied in depth structure-function relationships of many biological macromolecules, structure-activity relationships as well as mechanism of action of a significant number of biologically active small molecules. Focusing on a series of important drug targets, his team has conducted high throughput virtual screenings, lead discovery researches, prediction and design of biological active small molecules. Through these studies, Dr. Chen has promoted the interdisciplinary exchanges and integrations among medicinal chemistry, life sciences, computer science and informatics, achieving a contribution towards innovative drug research in China.
CBA is very honored to have Dr. Chen join us at the 20th Annual Conference of CBA (2015, China). Dr. Chen’s thought-provoking lecture attributes tremendously to the success of this 20th anniversary event of CBA.
Since its founding over 20 years ago, CBA has been serving as a bridge between US and China in the field of bio-med research with the goal of bringing new pharmaceutical agents to commercial development and healthcare market. Among many US-based professional societies and associations, CBA stands out as one of the most active, vibrant and engaging organizations. Dr. Kaixian Chen’s wealth of scientific knowledge and experience in scientific communities will be a great asset to CBA’s future growth and our continued involvement in scientific research and biopharmaceutical development.
Again, we are very honored and excited to have Dr. Kaixian Chen as a valuable addition to the CBA team. We look forward to working with Dr. Chen to take CBA to a higher level in the future.
Sincerely,
CBA Leadership Team
CBA-USA Successfully Held the Fourth Biopharmaceutical Development Workshop on February 19, 2017 in Maryland, USA
CBA-USA Successfully Held the Fourth Biopharmaceutical Development Workshop on February 19, 2017 in Maryland, USA
2016-2017 Workshop series-4
Entrepreneurs in Biopharmaceutical field
Sharing experience and advising your real start-up plan
CBA-USA successfully organized the fourth seminar of biopharmaceutical development workshop on February 19, 2017. This event is co-sponsored by Chinese Culture and Community Service Center (CCACC), Chinese Students and Scholars Association at the National Institute of Health (NIH-CSSA) and American Society for Quality-Washington DC and Maryland Metro, Section 509. Nearly 80 professionals attended the forth work shop at CCACC in Gaithersburg, Maryland.
CBA currently has over 3000 registered individual members (www.cba-USA.org).The goal of this series of CBA workshops is to provide opportunities for biomedical professionals to gain a deeper understanding of drug development and marketing approval. At the same time, the CBA workshop is a unique networking platform for local biomedical professionals. Speakers and attendees will have opportunities to discuss the current state-of-art practice, future directions, and career development in biopharmaceutical field.
The forth workshop focused on how to successfully start, run and grow your biopharmaceutical companies. We invited four entrepreneurs from biopharmaceutical industry, ranging from small start-ups to multinational biotech and contract research organization (CRO). The speakers presented their distinguished backgrounds and past achievements, as well as successful and failed stories during entrepreneurship. Further, valuable advice and guidance were shared for future entrepreneurs. Markedly, family support is critical for running a successful business.
Dr. Dazhi Lai, founder of SPEED Biosystems, started his reagent service company after being frustrated as a postdoctoral researcher in Yale University and the NIH. He mentioned that entrepreneurship not only gives him financial reward, but also promotes his spirituality. Next, Mr. Charles Li, senior director of Poochon Scientific LLC, presented their sophisticated business model of how to identify customers, expand market and practically analyze profit. The third speaker is previous CBA president Patrick Y. Lu. Currently, he is founder, president and CEO of Sirnaomics, Inc.in Rockville, Maryland and chairman of board of directors of Suzhou Sirnaomics Pharmaceuticals, Ltd. in Biobay, SIP, China. Dr. Lu showed his impressive 20 years’ drug discovery and development trip to potentially the first RNAi based therapy, which could be used for treatment of many diseases. At the same time, Dr. Lu has published many top-class research articles and applied for many patents. The last speaker Dr. Dan Zhang is chairman of board of directors of Fountain Medical Development. He also served as CBA president previously. Dr. Zhang shared his unique experience in working with both governments and venture capitals in China. His company is one of the largest CROs in China. Dr. Zhang shared his insight into current biopharmaceutical industry in China. During lunch and network time, participants had good communications with each other. At the end of the workshop, Drs. Frank Li and George Chang hosted the panel discussion and lottery.
CBA is dedicated to bridging the Chinese and US biopharmaceutical industries. We will continue to organize the bimonthly workshop. CBA will organize career development workshop and job fair in April. The 2017 CBA annual conference will be in June. We will post more information in the following month. Please stay tuned. If you have any advice for this event, please feel free to contact contact@cba-usa.org.
CBA 抗击新型冠状病毒知识系列讲座-3–Remdesivir药物及其临床研究
CBA 抗击新型冠状病毒知识系列讲座-3 Remdesivir药物及其临床研究
演讲嘉宾：Angela Zeng，M.D.,Ph.D. Yebin Zhou，Ph.D. Dan Zhang，M.D.，MPH
抗疫情，CBA在行动！美国华人生物医药科技协会除了给奋战在抗疫第一线的医务人员捐助防护器材、发动会员和群众为受灾群众募捐以外，决定用自己的专长组织举办抗击新型冠状病毒知识系列讲座，由属下的Biomarker Group和Clinical Regulatory Affair Group联合负责举办。自2月19日开讲以来，已成功地举办了两次了，受到广大群众的热烈反响。
3月4日将举办第三讲。这一讲的主题是Remdesivir药物及其临床研究。讲座将采用英文的ppt和中文的演讲。讲座结束前，还有与听众互动环节。
时间：3 月 4 日 周三晚上 8:30-9:30（美东时间）; 3月5日 周四上午9:30-10:30 (中国时间)。
讲座形式：线上讲座（webinar） 请事前注册（Register in advance for this meeting is required）：https://zoom.us/webinar/register/WN_DtB3BOVtR7e8jtkzyr-xBg
注册后，你将收到确认的电子邮件，还会告诉你参会的具体信息。After registering, you will receive a confirmation email containing information about joining the meeting.
讲座内容： 1. 新冠病毒的药物研发与公众科普
Yebin Zhou, Ph.D. Dr. Zhou was trained as a geneticist and immunologist at University of Alabama at Birmingham. He completed his postdoc training in autoimmune research at MedImmune, AstraZenecca. Since then, Dr. Zhou has joined AbbVie as a senior scientist in Immuno-Oncology. In his spare time, Dr. Zhou also enjoyed writing popular science online.
2. Remdesivir临床试验的解析及新冠肺炎疫情应对的探讨
Angela Zeng, M.D., Ph.D., Vice president of CBA, Clinical Study Physician in Ascentage Pharma. Dr. Zeng is a well-trained surgeon and medical scientist. She has near 20 years’ experience in clinical medicine and currently serves as a study physician leading global clinical trials for early development of new drugs.
3. 中美新冠病毒临床试验之比较
Dan Zhang, MD, MPH, the Executive Chairman of Fountain Medical Development (FMD), a clinical CRO with 1700 employees operating in China, Hong Kong, Taiwan, South Korea, Japan, UK, India, Philippines, Armenia & USA. He also served as General Secretary of “Thousands of Talents Program”.Before founding FMD in 2007, Dr. Zhang was the Head of Clinical Development and Head of Safety Assessment at Sigma-Tau Research Inc., a leading Italian Pharmaceutical Company. Prior to that, he was the Vice President at the Quintiles Transnational Corp., the world largest clinical CRO, and Chairman of Quintiles Medical Development (Shanghai) Company Ltd.
对抗疫情，CBA在行动
2020初始，新型肺炎疫情的进展速度超出了大家的预期。位于美国首都华盛顿的美国华人生物医药科技协会（CBA），本计划在大年初一举行一年一度的庆祝中国新年的盛装酒会。考虑到在大华府地区久负盛名的CBA Chinese New Year Gala规模大（近200人聚会），层次高（嘉宾包括联邦，州，郡和驻美使馆的官员和议员，各大公司主管以及著名艺术家），专业强（成员都是生物医药方面的专家），我们果断取消了这次酒会。这样的果断决定得到了全体嘉宾的由衷支持和感谢！
截至1月27日，美国疾控中心（CDC）宣布美国境内已经确诊了5例病人感染了新型冠状病毒，并且病毒已经确认会人传人。
为应对新型冠状病毒感染肺炎疫情，全球科研机构和制药公司正加紧相关疫苗研发和抗病毒药物试验。作为华人生物医药界首屈一指的行业协会，CBA的成员们更是快速行动。曾任CBA第二任会长，美国Sinaomics Inc及苏州圣诺制药总裁兼首席执行官陆阳博士表示： “现在是治疗由新型冠状病毒2019-nCoV引起的SARI以减轻这种致命疾病进一步扩散的关键时刻。核酸干扰RNAi作为一种自然进化的抗病毒机制，已在各种体外和体内模型中得到证实。我们团队在以前的SARS爆发中有使用RNAi技术对抗呼吸道病毒感染的经验，这将为我们对抗SARI提供有力的武器。我们结合独特的siRNA药物设计和化学修饰、呼吸道siRNA递送制剂以及手持式雾化器，为开发针对2019-nCoV感染的新型siRNA治疗和预防方法提供了一条清晰的途径。” 圣诺制药在中美两地的团队正全力以赴，联手推动基于RNAi药物途径对抗新型冠状病毒（2019-nCoV）引起的严重急性呼吸道感染（SARI）。
在香港上市的康希诺生物，是国内领先的疫苗研发公司，康希诺生物，长期以来是CBA最为重要的合作伙伴之一，该公司在烈性传染病疫苗方面的研发方面经验丰富，他们的重组埃博拉病毒病疫苗已经获批准上市，他们在疫苗领域的研究必将加快新型冠状病毒的研发步伐。康希诺的现任COO，CBA第二十任会长，巢守柏博士表示： “基于我们的腺病毒载体疫苗平台，我们正在全力进行2019-nCoV疫苗的开发。除了公司内部研发外，我们也在积极寻找外部支持和协作开发。我们会努力把该疫苗尽快推进到人体临床阶段，为控制疫情做出贡献”。
RNAImmune的创始人和CEO，沈栋博士是CBA的二十二任任会长，他表示： “RNAImmune的科学家正在以最新冠状病毒为靶点，主攻新型冠状病毒信使核糖核酸疫苗的设计和研发”。沈栋还介绍到 “此次新型冠状病毒感染疫情对抗工作具有三方面难点：病毒传染性强，变异快，并且隐形潜伏期长，因此颇具挑战性，预计要到5月之后气温回升会对病毒感染有抑制作用。因为新型冠状病毒变异快而疫苗生产需要需要一定周期，很多情况下并不适用，公司团队正在通过最新冠状病毒基因序列，通过机器学习和人工智能找到针对此病毒的最佳疫苗设计，并通过细胞和动物模型筛选，找到最有效最安全的信使核糖核酸疫苗”。 目前沈栋本人与世界顶级传染病学家奥利瓦尔（Kevin Olival）和马道夫（Larry Madoff）等研究人员合作，钟南山弟子何嘉曦(Kevin He)也在团队中，还有曾成功研发非典SARS疫苗的圣诺制药公司加盟，中美员工加班加点，努力尽快将疫苗试剂投入临床使用。到现在，团队已经成功设计出“信使小核酸疫苗(message RNA) ” 并且申请专利，疫苗研发已处于优化阶段，正在走“绿色通道”申报，相信很快可以投入临床使用。沈栋同时强调了本次疫苗研发工作的社会责任：“和世界上其他公司不同的是，RNAimmune公司的冠状病毒新疫苗，完全公益，不赚取一分钱，这是RNAimmune的郑重承诺，也是在美华人科学家对抗击冠状病毒疫情的贡献和应尽的职责”。
在疫情肆虐的非常时期，为了尽快地得到控制，美国FDA会有一套变通的做法，包括允许使用一些还没有被FDA批准的药物，或者用在还没有被批准的适应症上。但FDA的具体规定如何呢？CBA第二十三任会长，美国BLA Regulatory公司的李利博士加班加点，果断地把FDA的Emergency Use Authorization (EUA)法规翻译成中文，并无偿提供给国内的制药企业和政府机关参考和借鉴。该法规的中文文本可以联系CBA免费索取。
CBA也在积极的和其它组织一起合作捐赠以及购买口罩、防护服等紧缺物资支持有需求的医院，特别是湖北，浙江等省的县级医院。此外，CBA正在组织NIH，GSK，以及制药公司的病毒专家和公共卫生教育专家进行线上讲座。如果CBA的会员和朋友有意进行爱心捐助，contact@cba-usa.org。
CBA的其他会员也在各自的领域里积极工作，我们期待他们的成果，并且会在CBA的平台上通知给大家。无论身处疫情第一线的国内亲人，还是侨居海外的华人，面对灾难我们的心是连在一起的。武汉加油！中国加油！在未来的几天，CBA还会继续发表与新型冠状病毒相关的系列文章，敬请关注。
CBA 2020 Anti-COVID-19 Webinar Series-6
Global Pandemic Prevention and Start from Me
Time: March 25th (Wednesday) 9:00-10:30pm (US Est. Time), March 26th (Thursday) 9:00-10:30am (Beijing Time)
Language: ppt-English; Speaking-Chinese
Everyone is invited to a Zoom webinar.
When: Mar 25, 2020 09:00 PM Eastern Time (US and Canada)
Topic: CBA Coronavirus Webinar Series #6: Global Pandemic Prevention and Start from Me. Register in advance for this webinar: https://zoom.us/webinar/register/WN_vu0OzzCcQ7e84_2bfwoV9w
After registration, you will receive a confirmation email containing information about joining the webinar.
This session will cover:
1. The Global Pandemic Impact to China’s Healthcare Industry
Speaker：Dan Zhang
2. Panel Discussion：Epidemic Prevention and The Return to Work
Panelists: Guoliang Yu, PhD；Dajun Yang，PhD；Yuling Li，PhD；Dan Zhang，MD
Dr. Guoliang Yu: Founding President of CBA, CEO of Apollomics Pharma., former partner at OrbiMed.
Dr. Dajun Yang: The 8th President of CBA, Chairman and CEO of Ascentage Pharma.
Dr. Yuling Li: The 10th President of CBA; CEO of Innoforce; Sr. VP of Apollomics.
Dr. Dan Zhang: The 9th President of CBA, Chairman of FMD; former Chairman of Quintiles-China.
Join Us and Defeat COVID-19 Together!
CBA 抗击新型冠状病毒知识系列讲座-2
CBA 抗击新型冠状病毒知识系列讲座-2 抗击新型冠状病毒创新药物的研发
演讲嘉宾：Dr. Patrick Lu, Sirnaomics Inc. Dr. Shoubai Chao, CanSino Biologics Inc.
点评嘉宾：Dr. Hang Lu
庚子伊始，正值中国传统佳节春节来临之际，一场突如其来的“2019 新型冠状病毒”疫情向 我们无情袭来，不断蔓延的疫情更是牵动了无数 CBA 成员和朋友们的心，许多我们熟知 CBA 的骨干企业及个人，已经直接或间接地投入到了这场没有硝烟的战斗中！ 抗疫情，CBA 在行动！作为 CBA 抗疫行动的一部分，CBA Biomarker Study Group 和 CBA Clinical and Regulatory Affair Study group 决定联合举办抗击新型冠状病毒肺炎知识系列讲座（CBA Anti-COVID-19 Webinar Series）；这个系列讲座将就大家关注的新型冠状病毒的科学知识，流行病防控战略和机制，抗病毒药物制备和临床试验，病毒检测方法和应用， 特殊时期 FDA 的药政法规，防控工作的中长期规划等一系列问题，邀请本地的专家、学者、政府官员、企业家、工程技术人员来分享他们的真知灼见，并回答大家的问题。这个讲座将对 CBA 及社会公众开放，听众可用 Zoom 来加入。本讲座由商图信息（BIOMAP）负责中国国内推广。 御风雪呼唤抱薪者，抗疫情更需你我他。欢迎大家积极参加，并把您的宝贵意见反馈给我们。让我们携起手来，风雨同舟，共克时艰，将点滴爱心汇成江河，呼唤春风化雨，散尽阴霾，共盼灿烂阳光的到来！
时间： 2 月 26 日 周三晚上 8:30-9:30（美东时间）; 2月27日周四上午9:30-10:30 (中国时间)。
讲座形式：线上讲座（webinar）
Webinar 链接的详细信息如下:
Register in advance for this meeting is required: 请事前注册：
https://zoom.us/meeting/register/tZAkfuyhqj8rMVV-GvB1aKLE_WEUV3SFUA
After registering, you will receive a confirmation email containing information about joining the meeting. 注册后，你将收到确认的电子邮件，还会告诉你参会的具体信息。
讲座内容：
报告1：RNAi技术是开发治疗新冠肺炎创新药物的有效方法
报告人：陆阳 博士
Patrick Lu, PhD, CEO and Chairman of Sirnaomics Inc., the 2nd President of CBA. Dr. Lu and his team have developed RNAi technology to fight against respiratory tract viruses during the outbreak of SARS, H1N1 and its further development can work towards Coronavirus.
报告2：预防新冠肺炎的疫苗研发和防疫的中长期规划
报告人：巢守柏 博士
Shoubai Chao, PhD, COO of CanSino Biologics Inc., the 20th President of CBA. Dr. Chao and his team have been working on the recombinant Ebola vaccine that has been approved in China. Now he is focusing on the vaccine for SARS-CoV-2.
点评嘉宾：陆杭 博士
Dr. Hang Lu is CBA VP of Science Project and the director of BioAssay at Emergent BioSolutions and has been working in vaccine development at Emergent BioSolutions and Merck for ~ 20 years. He has contributed to the development of several traditional and new generation vaccines from the preclinical to post approval in USA.
请关注下一讲：关于Remdesivir的临床研究 （3月4日8：30 pm of Eastern Time）
CBA抗击新冠病毒系列讲座精彩继续（二）
3月4日美国东部时间晚8：30，CBA第三期线上公益讲座如期举行。此次讲座围绕大家广泛关注的一个新药瑞德西韦（Remdesivir）展开。众所周知，瑞德西韦是吉利德（Gilead）制药研发的一款药物，在前期主要用于埃博拉（Ebola）病毒和中东呼吸综合征（MERS）等疾病的临床研究，在今年的COVID-19疫情中被快速用于临床试验，因此得到了全球医疗及制药相关领域的关注。此次讲座邀请了三位嘉宾，分别是周叶斌博士，Angela Zeng博士和张丹博士。
周叶斌博士现为供职于AbbVie的免疫学专家，也在业余时间利用个人微信公众号平台从事生物医药的科普工作。周博士首先深入浅出地介绍了药物研发的一般过程，然后介绍了几款被认为可能可以治疗新冠病毒的药物，比如克力芝（Kaletra）、氯喹、瑞德西韦和PD-1，并分析了每个药物的优劣以及可能存在的问题。周博士也和参与的听众分享了他自己微信科普平台的信息，会后也会继续与感兴趣的同道深入讨论。
紧接着，复旦大学医学、理学博士，前约翰霍普金斯医学院肿瘤学教职员，现任亚盛医药临床研究医生的曾琪博士详细解析了目前全球范围内已开展或即将启动的瑞德西韦的临床研究。曾博士在简要回顾SARS-CoV-2基础结构的基础上，首先分析了瑞德西韦可能的作用机制；然后她进一步分析目前中国开展的两个三期随机对照临床试验（Phase-3）的录入和排除标准，试验的设计特点及试验终点的评估。在报告中，她分别谈到了轻中度与重度患者在用药后试验效果的的评判标准；最后她提出了对瑞德西韦临床试验中的一些可以改善的方面，比如从伦理学角度是否可以直接采用单臂设计？是否可以在试验中期进行分组交叉以及所涉及的中期数据分析、中期揭盲等问题，指出即将启动的适应性设计（Adaptive design）可以针对性地解决相关疑虑。曾琪博士还简略介绍了现行开展的COVID-19临床试验的适应证及涉及面，同时提出了自己对现状的思考供听众们讨论。
最后， CBA 第八任会长, 方恩医药发展有限公司董事长兼首席执行官张丹博士以瑞德西韦为例，为大家讲述药物注册法律法规方面的知识。作为一个跨中、港、台、韩国、日本、英国、美国等多领域的临床CRO的首席执行官，在2007年创建方恩医药之前，张丹博士还曾任世界最大CRO公司昆泰的副总经理等职，在新药研发的申报方面具有多年的丰富经验。张总结合自身的实践经验，精辟、简洁地为大家分析了瑞德西韦开展的5个临床研究的精准设计，同时呼吁国内的临床试验尽快募集病员，推进试验。从注册战略角度，张丹博士为大家分析了如何设计临床试验更加合理，指出在此次疫情爆发的情况下，可以利用政策方面的优势，比如“同情心使用原则”和“紧急使用授权原则”，尽快推动临床试验的开展并收集数据进行分析。他也同时提到“动物法则”在缺乏临床试验资料的紧急情况下的使用，为在线的听众们提供了非常实用的思考与建议。
讲座后，大家踊跃提问，气氛热烈。此次讲座，让公众对广泛关注的药物瑞德西韦从研发过程、临床试验和注册法规方面都有了更多认识。
3月11日第4期讲座录音
3月11日美国东部时间晚9点，美国华人生物医药科技协会（CBA）抗击新型冠状病毒知识系列线上讲座第四讲在听众们的一片期待中如期准时开始。这次讲座在CBA前会长李利博士的主持下，第一位演讲嘉宾是中国生物工程学会精准医学专委会联席主任杨宏钧博士，他也是CBA的老战士，多年来一直活跃于中美两国的生物医药事业的舞台上，对中美两国生物医药领域的创新创业、商务发展、交流合作及人才培养等诸多领域做出杰出贡献。杨博士的演讲以“A Comparison of Detection Methods of SARS-CoV-2 ”为题，详细比较了现行可用的几种检测方法在COVID-19疫情爆发中的应用。他首先带领听众简略回顾了SARS-CoV-2的基因结构及形态学特征，强调spike 蛋白的重要性，然后简略介绍了qRT-PCR、宏基因组新一代测序（mNGS）、胸部 CT、抗体免疫检测、CRISPR‘s Sherlock 系统及ddPCR共六种检测方法。接下来，杨博士为在线听众们一一解析了6种方法的优缺点，如RT-PCR的敏感度受探针和引物的设计，病人发病的时期，鼻、咽拭子采样、分离、标本的储存及运送过程，试剂的活性，操作人员的培训和熟练程度，实验室的整个管理等诸因素的影响都有很大的关系。他以一个1049例患者进行RT-PCR及胸部CT的比较，阐述了RT-PCR的假阴性问题，提出应将RT-PCR与CT相结合从而降低漏检率。在分析抗体免疫检测时，杨博士分析了不同抗体IgM及IgG产生的时间先后，结合自身经验总结胶体金试纸条的测试快捷、简单，可以在15分钟就得到结果，而且还不需要专职人员操作，适合大范围患者群体的初筛。而宏基因组新一代测序 （mNGS），在精准测序的基础上，与大数据相结合，把所有环境微生物中的相关基因组信息整合在一起，从而尽快找出疾病的起源，但是这一先进的技术过程较复杂，耗时相对较长，所以仅适用于高度疑似病例的确诊。在介绍CRISPR’s SHERLOCK 系统时，杨博士详细介绍了CRISPR是近年基因编辑技术发展的新亮点，而SHERLOCK系统是哈佛大学张锋院士应用CRISPR检测病毒的最新方法。该方法曾在检测寨卡病毒时取得空前的成功。这次，张锋院士又把该方法应用于新冠病毒的检测。针对RNA及dsDNA病原的不同特征，杨博士借助形象的示意图，简明、清晰地介绍了这个检测系统的原理，并且高度评价这个检测方法的高度灵敏性，甚至可以检测到低至10-18M的样本量，同时兼具高度的特异性，尤其是该方法还突破了现有核酸检测指南的规定，以最具新冠病毒特征的Spike蛋白的RNA片段为检测目标。遗憾的是这一创新的检测手段尚未经过临床验证，也未获得FDA批准，我们只能期待不久的将来可以应用于这类应急
这次讲座的第二位嘉宾是北美华人临床化学家协会候任会长王永强博士。王博士曾担任研发经理、CAP认证实验室临床实验室主任等。他以“Viral Sample Management and Biological Safety”为题，分析指出COVID-19临床样本的社区采样很关键，而且采样后应保存于4摄氏度容器，并需要在采样后4小时内送检，否则容易发生RNA降解。王博士也再次强调医护人员应加强自我保护。在讲到临床实验室的检测时，王博士介绍了FDA通过的EUA中的体外诊断（IVD）及CLIA认证的LDT即实验室自行开发的技术；他详细为听众们介绍了CLIA（临床实验室改善修改条例）的法规标准及强化的领域（如实验人员资质要求，质控标准及执行标准等）；同时，王博士也详尽介绍了在欧洲应用非常广泛的ISO15189标准，同时这也是在160多个国家共用的国际性的标准；这个系统在保证通用原则不变的情况下，也给各个单独的实验室提供了一定的灵活性。最后，王博士重点强调了CAP（美国病理学家学院）的系统及认证，指出如果同时具备CAP及ISO5189认证，那就表明此实验室已经进入全球顶端1%的范围，由此可见此两种认证的高标准。
在两位主讲者的讲座之后，另外两位嘉宾也加入了讨论。李游博士现任Thrive公司法规部主任，他曾供职于FDA并负责体外诊断、医疗器械等的审核。讨论中，李博士指出紧急使用法规（EUA）比平时的审评需要更少的数据，目前采用的指南，仅需敏感性、临床样本认证，纳入/排除标准等。他也客观分析了现在美国的新冠病毒检测受到一定条件限制，多数实验室仅有二级生物安全级别，但是只有达到生物安全级别三级以上的实验室才能进行检测，而全美仅有100多家满足条件的实验室。CBA的郭雁副会长有着生物技术研究和开发20多年的经验，她作为讨论嘉宾也指出，这次中国的科学家在很短时间内提供了病毒序列，是值得我们感谢的地方。她也补充说CRISPR技术的主要创始人张锋教授证实此技术可以直接检测RNA，不同于平时所用的方法，因此极具发展前景。
一个半小时的讲座，内容丰富、实例详尽。在最后，几位嘉宾也与线上听众互动答疑，充分讨论。听众们的参与热情很高，也非常期待后续讲座的更多精彩内容，在最后的两次讲座中，CBA结合听众的兴趣，特地安排了紧急状态下的药政法规的特殊授权及处理的专题，是广大医药界人士所关心的话题；同时，CBA还专门邀请了四位前会长们，结合他们自身创建的已经上市的医药公司的经验，共同探讨“防疫”与“复工”的双重挑战，周三晚9点，CBA与您继续相约。