Archives: Speakers

Dr. Hwang is a board certified MD licensed in South Korea. He is an experienced pharmaceutical physician with 11+ years of industry career. He worked for multinational companies including MSD, Gilead Sciences as well as a biotech company, MedPacto. His role covers from country medical director, regional therapeutic lead, medical monitor, and trial director. He is a member of DIA, ASCO, Korean Cancer Study Group, and serves as Director of General Affairs in Korean Society of Pharmaceutical Medicine. He is now working for MediRama as Chief Scientific Officer providing clinical development consultation, trial strategy development, and overall trial oversight service for biotech companies.

Sang Ho, MA is Vice President, at the Bilix which Biotech in south korea. He is expert member of MFDS (Ministry of Food & Drug Safety) & judge member of KDDF. (Korea Drug Development Fund) His current research area is acute & chronic inflammatory disease & drug delivery system. Pursuing this R&D agenda he has recently been working with global CRO & CMO. He wrote his Ph.D. on the specific chemistry for drug development at the Graduate Institute in south korea. Since 2006, he has been a senior researcher of JW Pharma & GC Pharma for more than 14 years. And he joined Bilix in 2019 and is currently the head of the research institute and Chief Development Officer.

Clare has been doing clinical trials in clinical operations and project management for the more than 18 years. Her first 15 years were with the CROs. She started off her career in LabCorp (formerly known as Covance) as a CRA who manages sponsor studies in Singapore and Malaysia. Later on, she joined PPD and over the years, she became the regional head for Singapore, Malaysia, Vietnam and Indonesia. Clare then returned to LapCorp and headed the Early Clinical Development team in Asia Pacific to run Immuno-Oncology, Rare Diseases and Epidemiology studies in the region. Clare is now with Tessa Therapeutics, working on cell therapy studies, focusing on CAR-T treatment.

Yohan Bae is Executive Director, Clinical Development Division at Kangstem Biotech Co. Ltd since he joined in Mar 2020. He has almost 30 years of drug development experience ranging local and global regulatory affairs, clinical development, and patient access for pharmaceutical and medical device. Before he joined in Kangstem Biotech, Mr. Bae has worked for large international pharma and medical device companies such as Alcon, Bristol-Myer Squibb, and Boehringer-Ingelheim. He holds a master’s degree in Pharmacology from Pharmacy College, Kyunghee University.

EDUCATION :

l  Duksung Women’s University, College of Pharmacy

l  Sookmyung Women’s University. Graduate School of Clinical Pharmacy

PROFESSIONAL EXPERIENCE

l  Current: Celltrion, Head of Clinical Development Division

l  Dec 2013 ~ : Celltrion

l  C&R Research

l  PPD Korea

Education Ph.D. in Microbiology Rutgers University, New Jersey, USA(1992) M.S. in Molecular Biology Fairleigh Dickinson University, New Jersey, USA(1988) B.S. in Pharmacy Chung-Ang University, Seoul, Korea(1978) PROFESIONAL EXPERIENCE 2020.09-present CEO, POSVAX CO, Ltd 1996-2020 Professor, Virology Lab, College of Pharmacy, Chung-Ang University, Seoul, Korea 1995-1996 Senior Scientist, Han Mi Pharmaceutical Company, Central Research Institute, Seoul, Korea 1992-1995 Post Doctoral Scientist, Pfizer company, New York, USA PROFESIONAL ACTIVITES 1997-present Committee member of Central Pharmaceutical Affairs Council, KFDA Osong, Korea 2009-present Committee member of Preventive Vaccine (Human papillomavirus), Centers for Disease Control and Prevention, Osong, Korea 2007-2008 Consultant, SK Chemical-LS, Seoul, Korea 2005-2007 Outsider Director, DongShin Pharmaceutical Company, Seoul, Korea 2005-2006 Professional Committee member of Life Science, KOSEF, Seoul, Korea 2004-2005 Chairman of Microbilogy and Immunology Division The Pharmaceutical Society of Korea, Seoul, Korea 1999-2006 Consultant, Dong-Gu Bio Pharmaceutical Company, Seoul, Korea

Rainbow has 16 years’ experience in clinical research and drug development in both pharmaceutical and CRO settings. She has thorough understanding of overall product development process from pre-IND through post-marketing, including knowledge of core cross-functional concepts on preclinical, translational medicine, CMC and major requirements at different development stages. She has in-depth knowledge of regulatory requirements and process in Asia Pac especially Greater China and Japan. She has proven capabilities and records in contributing to the business growth and partnership opportunities with emerging biotech in Asia Pac. Furthermore, she has extensive experience in managing pre-clinical through late phase global clinical studies across continents including North American, European and Asia Pac regions. Her therapeutic areas’ experience including Oncology and Hematology, CNS disorder, Respiratory, Cardiovascular, Vaccines, Infectious diseases, Fertility, Internal Medicine and Biosimilars on biologics and chemicals. In addition to her product lifecycle management, clinical project management and customer management expertise, she demonstrates diverse capabilities in various aspects into future state. She possesses strategic vision for her department growth and sustainability, has proven line management skills and is keen in people career development with excellent 360 scores. She also possesses business acumen, customer centricity and result-driven capabilities from business and delivery perspectives. She is strong in innovation, strategies and continuous process improvements such as leading machine translation solutions, risk based monitoring pilot, precision patient recruitment strategies in Merck and leading cross functional initiatives in resourcing optimization and hiring recommendation, customer portfolio lead community as well as bid defense coach program in her years in CRO.