Dr. Jay Mei, founder of Antengene, previously served as the Global Clinical Lead of Clinical Development at Celgene Corporation. Dr. Mei has over 25 years of experience in the clinical development of oncology therapeutics globally and successfully led the development of multiple oncology products, including REVLIMID® in China, which received NDA approval in China and launched in 2013. Outside of the China market, Dr. Mei was responsible for the clinical trials of REVLIMID®, IDHIFA®, etc., in more than 30 countries.
Prior to his role at Celgene, Dr. Mei served in multiple clinical development positions at Novartis Oncology and J&J Pharmaceutical Research & Development. Dr. Mei completed eight years of cancer and clinical research at the U.S. National Cancer Institute (NCI). Dr. Mei has also been an author on over 70 publications and holds multiple patents.
Mr. John Chin has worked in the pharmaceutical industry for 30 years. Prior to joining Antengene, he was Country General Manager at Celgene China, leading a cross-functional team to support the development and approval of Celgene assets as well as approved brands commercialized by its partners in China. He spent 15 years at Celgene, held senior positions at Celgene and Aventis and previously worked at BMS and Merck.
As a commercial executive in pharmaceutical companies and established and early stage biotechnology companies, John has launched and managed some of the most important oncology therapies ever introduced into the U.S., Latin American and Chinese markets. While at Celgene from 2005 through 2019, he was instrumental in the commercial launch and lifecycle management of REVLIMID®, one of the industry’s most successful global hematology products. John also had key roles in the global management of the entire Celgene cancer portfolio.
Dr. Yang holds Ph.D. in Biostatistics from Boston University and Sc.D. in Clinical Epidemiology from the Netherlands Institute for Health Sciences. During the past 20 years, Dr. Yang held positions at Harvard and in multiple Pharmaceuticals and biotechnology companies, including Bristol Myers Squibb China, Wyeth, Vertex Pharmaceuticals, Acceleron Pharmaceuticals, MediVector Inc, Synageva BioPharma (Alexion), Forum Pharmaceuticals and Ziopharm Oncology in the function of biostatistics and clinical pharmacology to support clinical development programs and regulatory submissions. His responsibilities at these companies include study design for all phases of clinical trials, with statistical and clinical pharmacology input, statistical method selection, data management, clinical trial data analysis and interpretation, PK/PD analysis, manuscript publications, and regulatory submission for NDA/BLA/MAA. He participated in the clinical development approvals of multiple therapeutics, including Incivek® (telaprevir), Torisel® (temsirolimus) and Kanuma® (sebelipase alfa). With his guidance, these companies have successfully built biostatistics teams which optimize clinical trial program and improve efficiency.
Dr. Shan has over 15 years pharmaceutical experience in R&D and manufacturing in Europe and China. Most recently, he was Vice President at Ascletis Pharmaceuticals Ltd., lead interdisciplinary teams to deliver a number of IND and NDA programs, delivered one NDA filing and one IND filing at clinical phase III stage. As the site head for production plant, Dr. Shan was responsible for the construction and validation of the whole production facility which passed the CFDA GMP inspection in 2018. Prior to his position at Ascletis, Dr. Shan held several senior positions for companies, including Chempartner, Gateway Pharmaceutical Ltd and GE Healthcare. Dr. Shan holds a Ph.D. in Medicinal Chemistry from Aston University in the UK and an honorary research position at Imperial College London.
Mr. Thomas Karalis is a seasoned industry leader with over 30 years of experience working at several multinational biopharmaceutical companies in Australia and across multiple Asia Pacific countries/regions. Equipped with exceptional commercial leadership and strategic thinking, Tom has effectively initiated numerous critical initiatives in geographic expansion, enterprise design and portfolio transformation. Before joining Antengene, he was the General Manager for Celgene East Asia and Vice President & General Manager for Celgene Australia and New Zealand, where he made outstanding accomplishments in general management and commercial strategies.
Tom spent 8 years at Celgene, during which multiple regulatory and reimbursement milestones were achieved for core products in APAC markets leading to successful launches of REVLIMID® (lenalidomide), POMALYST® (pomalidomide) and ABRAXANE® (paclitaxel protein-bound particles for injectable suspension). Prior to Celgene, he served as General Manager for Abbott Nutrition (Philippines), BMS (Thailand, Vietnam, Singapore), and held senior positions at Eli Lilly (South Korea) and Pharmacia.
Ms. Sun acquired her bachelor degree in Medicine from Shanghai Second Medical University, and master degree in Public Health from University of New South Wales, Australia. She has over 10 years of experience in clinical trial in multinational pharmaceutical companies, including Roche, Shering-Plough, etc., she has hosted a number of domestic and international oncological clinical trials, and she is proficient in domestic clinical criteria and approval regulations. She is the former head of Oncological Clinical Operations Department of Tigermed (stock code 300347).
Dr. Kevin Lynch joined the Pharmaceutical Industry in 1993, continuing studies in Pharmaceutical Medicine. He gained his Membership of the Faculty of Pharmaceutical Medicine in 1998 by thesis, and was awarded Faculty Fellowship in 2004.
During 25 years in Clinical Development and Medical Affairs, Dr. Kevin Lynch has managed all aspects of drug development, including many Phase I through to Phase III and post-registration studies, as well as establishing departments responsible for Drug Safety, Medical Communications and Medical Affairs. He was Oncology Medical Director for Novartis Australia and New Zealand, with developmental responsibility for multiple breakthrough cancer treatments, including GLIVEC®, TASIGNA®, EXJADE®, ZOMETA®, FEMARA®, and SANDOSTATIN®.
In 2008 Dr. Kevin Lynch joined Celgene as Medical Director for Australia and New Zealand, and then as Director, Clinical Development and Medical Affairs, Asia-Pacific. With Celgene, he has worked successfully on the development and registration of drugs such as REVLIMID®, VIDAZA® and POMALYST®. In 2011 he moved to Switzerland as Vice President, Clinical Research and Development for Europe and returned to this region in 2014 as Vice President, Clinical Development and Medical Affairs for Asia-Pacific. He is co-author on more than 100 publications and abstracts at international meetings.
Dr. Lee Kang holds Ph.D. in Chemistry from Virginia Tech and MBA from the State University of New York (SUNY) at Buffalo. He has a combined 25 years of industrial experiences at Bristol-Myers Squibb, Pfizer, Sanofi, and Perrigo Companies in various capacities of pharmaceutical manufacturing, regulatory affairs, quality assurance, and supply chain management. Dr. Kang has guided the chemical manufacturing and controls (CMC) groups to support global clinical trials, with over 100 submissions of IND, IMPD, dealt with regulatory inquiries, and directly contributed to NDA and market launches for both brand-name drugs, such as Effexor® (venlafaxine), Enbrel® (etanercept), Plavix® (clopidogrel), Ambien® (zolpidem), and several generic drugs. He has held managerial positions with high exposure to regulatory agencies for activities such as tech transfer and preapproval inspections (PAI) by US FDA and UK MHRA. Dr. Kang has also directly overseen supply chain operations for sourcing medicinal products from China, India, and other Pacific Rim regions/countries. In recent years, Dr. Kang has provided consultancy to Chinese companies regarding GMP quality, risk management, M&A, and marketing.
Dr. Kang has been an adjunct visiting professor in School of Pharmacy, SUNY at Buffalo. Dr. Kang is a Certified Quality Auditor (CQA) by American Society of Quality (ASQ). Dr. Kang presents and publishes frequently and holds patents in medical devices.
Mr. Liu received his master degree from Hong Kong University of Science and Technology in engineering. He has served in various capacities at Agilent, Frost & Sullivan, CBRE and other Fortune Global 500 companies, with work experience covering management, strategy consultancy, IPO research, strategic location consulting and investment transactions, etc., and he has operated many projects like Samsonite IPO, site selection of LEGO China, etc.. Mr. Liu once served at CITIC (a Top 500 company) Investment Group and served as General Manager of Corporate Strategy and Business Development Department of CITIC Senior Living Co., Ltd., and invested 2.5 billion Yuan in the two projects integrating medical treatment and endowment in Chongming Island and downtown Shanghai.
Ms. Guo received her Bachelor’s degree in Statistics from Fudan University and M.S. degree in Management Science and Engineering from Columbia University in New York. Prior to joining Antengene, she was based in the U.S., with Navigant Life Science Practice. Her project experiences include portfolio strategy, market and product opportunity assessment, launch strategies, commercialization planning, brand optimization, etc. Prior to Navigant, she was with Sandoz (Novartis) Pipeline Strategy & Launch Management team, working cross-functionally with development, CMC, regulatory, commercial and intellectual property to optimize pipeline strategy and planning, Portfolio under her management includes therapeutic areas ranging from oncological therapies to cardiovascular disease, and central nervous system diseases.
Mr. Qian received his master degree in Management from Shanghai University. He once served in Hangzhou Municipal Government and Shaoxing Municipal Government, mainly engaged in investment promotion and policy research of biopharmaceutical industry. He is familiar with government investment policies and manage several foreign invested projects. He has successfully applied for a number of major national, provincial and municipal major science and technology projects and major talent projects.