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)

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Registration Link: http://bit.ly/2NQzET 

Agenda:

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.