August, 2018 ~ Adjunct Professor, College of Pharmacy, Sunchon National University

January, 2023 ~ Managing Director, AniMusCure Inc., Suwon, Korea

< EDUCATION >

B.S. Pharmacy, College of Pharmacy, Sungkyunkwan University, Korea

M.S. Biochemistry, College of Pharmacy, Sungkyunkwan University, Korea

Ph.D. Biochemistry, College of Pharmacy, Sungkyunkwan University, Korea

< PROFESSIONAL EXPERIENCES >

- Assistant Manager, Kolon Pharmaceuticals Inc.

- Assistant Manager, Kolon Life Science, Ins., Seoul, Korea

- Research Fellow, Daewoong Pharmaceutical Co.

- Deputy Director, DanDi Bioscience, Inc.,

- Director, Selecxine, Inc.

- Managing Director, Genencell Co., Ltd.

Education:

• National Taiwan University, Pharmacy (1993-1997)
• National Taiwan University of Science and Technology, EMBA (2022-2023)

Working experience:

Current: Novartis SSO country head試驗監測部長/臨床研究部/全球藥物研發中心

• Head of Clinical Operations, Taiwan & Hong Kong, Eli Lilly Taiwan (2010-2019)
• Trial Monitoring (TMO) Country Head, Novartis Taiwan (2019-2023)
• Study & Site Operations (SSO) Country Head, Novartis Taiwan (2023~)

External Engagement:

• TransCelerate Taiwan Country Lead (2013~)
• Taiwan Clinical Research Association (TCRA) ex-president (2014); Executive Director (2015~)

Tina has over 20 years of experience in clinical operations. She was Head of Clinical Operations to manage Taiwan & Hong Kong for 10 years when at Eli Lilly before joined Novartis as the TMO Country Head in Taiwan, 2019. Tina is interested in external engagement activities through her journey in clinical operations, she is Transcelerate Taiwan Country lead since 2013 and was ex-president (2014) and current executive director in Taiwan Clinical Research Association

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.

Dr. Yun began her career at Hanmi Pharmaceuticals, took the major role in managing all activities associated with the clinical development programs for key assets including long-acting insulin, GLP-1 agonist and GLP-1/GCG dual agonist. She engaged in full courses of drug development, ranging from CDP/TPP development, clinical strategy formulation and operations, licensing out and co-development with partners. She also served as a strategic consultant in IQVIA, worked on consulting projects for key business decisions, including business planning and strategy formulation, asset valuation and pricing & reimbursement strategy for various drugs etc.

In September 2019, Dr. Yun joined to GI Innovation and has led clinical collaboration agreement of company’s immunooncology asset with global pharmaceutical companies, including MSD and AstraZeneca. She is now serving as a head of clinical development.

Dr. Yun is a registered pharmacist in Korea and was educated at School of Pharmacy, Sunkyunkwan University, where she received her PhD in pharmacology in 2012.

2022 Sungkyunkwan University School of Medicine, Ph.D. Clinical Epidemiology

2019 Master of Pharmacy, Sungkyunkwan University Graduate School

1996 Bachelor of Pharmacy, Sungkyunkwan University Graduate School

2023 ~                Head of Research and development in Quratis

2016 ~ 2022(former) Medical Manager in ChungKundang

2001 ~ 2016(former) GSK Medical

A highly skilled pharmacovigilance professional with vast experience in pharmacovigilance operations and regulatory intelligence in the APAC region and internationally. Strong leadership skills in both; project and people management with 18 years of working experience in the healthcare and pharmaceutical industry. Proven ability to set up new Pharmacovigilance (PV) operations, oversee PV compliance, audit, and quality management in the Asia Pacific region with positive track record of successful global PV audit and inspections. A qualified healthcare professional with post-graduate degrees in; Pharmacovigilance and Pharmacoepidemiology (specialized in Risk Identification and Quantification) and Business Administration.

Strong knowledge of relevant Codes of Conduct, aggregate reporting, compliance monitoring, safety databases and hands-on experiences in managing organization M&A as change agents.

Dr. Noh received his Ph.D. in pharmacy Kyung Hee University and joined Hanmi Pharma in 2009, bringing more than 15 years of experience in clinical research and development. He is responsible for leading clinical program with NMEs or NBEs in multi-therapeutic area: including metabolic diseases and rare disease as well as oncology and hematology. He has lot of experience for collaborating with global big pharma as well as biotech companies.

Previously, he served as an adjunct professor, department of regulatory science for Kyung Hee university and an expert member of external evaluation committee of KDDF.

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

Seoyeon Hyun is the Head of Clinical Development at ILIAS Biologics. In her role, she is responsible for overseeing the overall clinical development of the company's pipeline and leading global clinical trials for engineered exosome therapeutics.

With over 20 years of experience, she has handled various clinical development tasks, including Phase 1-3 clinical trials for new drug approvals as well as global clinical trials sponsored by multinational pharmaceutical companies. Before joining ILIAS Biologics in September 2021, she held a position overseeing new drug clinical development at a European biotech company, where she led multinational clinical trials in Europe. She has also served as a Clinical Research Manager at MSD and as a clinical project manager for new drug development at Boehringer Ingelheim and SK Chemicals.

Seoyeon Hyun holds a bachelor’s degree from Ewha Womans University College of Pharmacy and a master’s degree in physical pharmacy from Seoul National University.

1. 2001.09~ present: HK inno-N. Manufacturing Team part manager.

; Quality assurance Team / Cell & Gene project Team / Technical development Team / Manufacturing Team

2. 2000.09~2001.09 : Green Cross Quality control team (Bio Pharm)
3. 1999.10~2000.09 : LG Chemical Quality assurance team (Quinolones antibiosis)

2014.10- Present  Team Leader/Director, Global Supply Chain Management in Celltrion

2012.01-2014.10   Manager, Material Management in Celltrion

Ms. Juhee Jeon graduated from Korea University with a Master’s of Science in Medical Microbiology (Virology & Immunology). She has been working in the field of medical information, drug safety in clinical trial, pharmacovigilance and GCP/GVP quality management at pharmaceutical companies and CROs for more than 18 years. Currently, she is responsible for managing drug safety monitoring and pharmacovigilance at Hana Pharm in Korea.

Hyejung Yang is the Clinical Research Manager and Clinical Research Team Lead at MedPacto Inc,. She has almost 12 years of experience in Clinical Research Project management by local pharmaceutical companies.

Shin-Il Kim is currently a CSO of Therabest Co., Ltd., a biopharmaceutical company that develops a platform for iPSC-derived immune cells. Prior to joining, he was a R & D director at aceRNA Technologies Co., Ltd., spun off from Center for iPS Cell Research and Application (CiRA) at Kyoto University.

Dr. Kim obtained his Ph.D. in molecular biology from University of Wisconsin-Madison in 2008. He then began his studies of TGF-b signaling in cancer models as a postdoctoral fellow at the University of California-San Francisco. In 2011, he moved to CiRA where Nobel Prize winner Shinya Yamanaka who first succeeded in establishment of iPS cells and became an assistant professor in 2017. He has extensive experience in the fields of genome engineering, iPSC differentiation, and cancer research.

BJ (Baek-Jae) Kim, Ph.D., is the IATA Country Manager Korea, based in Seoul, Republic of Korea. BJ leads a team of 3 (Mr. HT Lee, Ms. Anna Park, and Ms. Hyein Jeon) in the Korea field office work.

Prior to joining IATA in Aug 2019, BJ has about 25 years of aviation experience, including 6 years in United Airlines, 4 years in Air France, and 16 years in Qatar Airways as Airport Services Manager in ICN airport, the Republic of Korea.

BJ holds a Ph.D. and Master of Aviation Business Administration from the Korea Aerospace University (KAU) and a Bachelor's degree in Economics from Hankuk University of Foreign Studies (HUFS) in the Republic of Korea.

BJ is a citizen of the Republic of Korea. He is a Christian and married with 2 children. BJ enjoys hiking, mountain climbing, and other sports in his spare time.

Hyesung Shin, managing director of TiumBio Co., Ltd has worked more than 23 years of experience in clinical trial development and operations.

She had worked during 13 years for global pharmaceutical companies at Eli Lilly, Novo Nordisk and Novartis and 6 years at Abbott for medical devices clinical development and had experienced in Korean Biotech companies of BioPharm Solutions, Aptabio Therapeutics, TiumBio for new drug development and managing phase I/II Clinical Trial.

The works focused on managing clinical trial plan for new drug development, regulatory Filing for FDA/EMEA/MFDS IND, orphan drug Designation, vender management including CRO/Clinical Supplies/CDMO and development of  market strategy.

Head of Clinical Services in Novotech with >22 years’ experience in clinical research industry of CROs, Pharmaceutical company as well as academic research institute. Scientifically qualified as PhD majored in Preventive Medicine in Seoul National University. Experienced in all aspects of clinical research operations management. Broad range to cover Clinical Operations, Study Start-up, Regulatory Affairs, Project Management, Medical Affairs, Pharmacovigilance, Data Management, Business Operations as well as SMO. Joined Novotech in 2016 as head of Asia-Pac region and moved role to global coverage of clinical services in 2021.

Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain management. After working for a CRO, he joined N-SIDE where he supported the optimization of hundreds of trials from different indications and pharmaceutical companies, providing services ranging from risk-based optimization to clinical trial design and solving drug supply shortage problems. Amaury now leads a group of consultants, focusing on the extension of N-SIDE’s solutions.

Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Biological Threat Exclusion. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.  Mr. Smith has more than 17 years of public service with CBP, and has worked in a variety of environments, including on the southern land border, maritime, air passenger, and cargo locations.  He has also been able to assist in several past domestic and international CBP disaster recovery operations.

Gina Reneau is a Biological Threat Exclusion Coordinator (BTEC) for U.S. Customs and Border Protection (CBP) in the Office of Field Operations

Agriculture Programs and Trade Liaison/ Biological Threat Exclusion.  As a BTEC, Ms. Reneau is charged with supporting and developing CBP operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.  Ms. Reneau has more than 27 years of public service with CBP, and has worked in a variety of environments, including in air passenger, cargo, maritime, and express consignment locations.