K-NIBRT

Institute

• CEO of Bio-Support

Academic background

• Sungkyunkwan University
• Okayama University

Work experience

• 2016 - PresentBio-Support Co., Ltd.
• 2003 - PresentBio-Support Co., Ltd.
• 2016 - 2021Korea Pharm. Tech. Education Center (KPTEC)
• 2018 - 2021PDA Korea(The Parenteral Drug Association)
• 2008 - 2021Pharmaceutical technology magazine [pharmtech]
• 1997 - 2002Bausch & Lomb Korea
• 1996 - 1997Institute of Technology (Haetae Dairy Co.)

Main Activities

• 2013 - 2021PDA Korea · Operating Committee (pharmtech)
• 2007 - PresentKPTEC's GMP and Validation Curriculum
• 2014 - PresentGMP Curriculum of the Korea Human Resource Development Institute for Health & Welfare
• 2019 - 2020Pharmacy Education Program Linked to Pharmaceutical Practice (College of Pharmacy, Ewha Womans University)
• 20182018 2nd Ministry of Food and Drug Safety GMP Inspector Capacity Reinforcement Workshop (organized by Ministry of Food and Drug Safety)
• 2018 - 2019Basic job training for examiners of the Ministry of Food and Drug Safety in the pharmaceutical field (organized by the Korea Human Resource Development Institute for Health & Welfare)
• 2015 - 2020Advisory member for GMP review and evaluation of medical products (Ministry of Food and Drug Administration Daejeon Branch)
• 20172017 Phamaceutical Design-Based QbD Workshop (ICH Q-Trio overview and understanding of ICH Q10 PQS) / Managing Department: Dongguk University Industry-Academic Cooperation Foundation / Host Institution: Ministry of Food and Drug Safety• (Pharmaceutical Quality Division)
• 20172017 Beginner's Course for Practical Training on Development Work (Facility standard ordinance and Introduction to GMP Manufacturing / Managing Department: The Pharmaceutical Advanced Institute of Korea
• 2015 - 20192015, 2016, 2017, 2018, and 2019’s Regulatory Affairs (RA) Basic Course (GMP and validation systems in each country related to drug licensing) / Korea Drug Research Association
• 2016Seminar to Explore Strategies for Promoting Export of Drugs for Animals / Animal and Plant Quarantine Agency
• 2016Pharmaceutical GMP Seminar at the 11th Medical Product GMP Evaluation Research Meeting / Ministry of Food and Drug Safety Daejeon Branch
• 201616th Asia Pacific Association of Surgical Tissue Banking(APASTB 2016)
• 2014, 2016Intensive Training on GMP for Veterinary Medicines / Korea Animal Health Products Association
• 2003 - 2014Korea Tissue Bank Professional Training Course (Bioburden Estimation) / Committee of IAEA National Training Center for Tissue Bank Operators
• 2014 - 「PIC/S Guidelines Special Lecture」 to Commemorate PIC/S Approval / PDA Korea
• 20132013 International GMP Guideline Curriculum (education target: GMP inspector of the Ministry of Food and Drug Safety) / Host Institution: Korea Human Resource Development Institute for Health & Welfare
• 2011Hanyang Cell Therapy Center
• 2010Study on the English Translation of Regulations for Joining the PIC/S (English translation of Q&A booklet related to the new GMP system) / Ministry of Food and Drug Safety
• 2010Study on Advanced GMP Standards and Operation for Veterinary Medicines / National Veterinary Research & Quarantine Service
• 2010R&D Integration Modeling & Simulation Support Service Task / Korea R&D Service Industry Association
• 2010GMP Inspector Workshop for the First Half of 2010 / Ministry of Food and Drug Safety
• 2009“Advanced GMP Professional Manpower Training Course for Biopharmaceuticals” of the 2010 (2nd) Year Bio-specialized Manpower Nurturing Project
• 2006“Expert Retraining Course on cGMP / Daejeon Technopark
• 20052006, 2007, 2008 International Conference (GMP and validation) / The Pharmaceutical Society of Korea
• Seoul National University Pharmacy Education Research Institute “GMP Course for Pharmacist Supervision Officer” / Ministry of Food and Drug Safety

Books / Publications

• 2015GMP Q&A Guide for International Organizations and Major Countries / Issued by PDA Korea
• 2015Evaluation Guidelines for the Introduction of PIC/S Quality Risk Management (PI 038-1), Explanation, Pharmtech Vol. 8, No. 3, Issued by PDA Korea & KPTEC
• 2015PIC/S Inspection of Quality Control Laboratories (PI 023-2) Explanation, Pharmtech Vol. 8, No. 1, Issued by PDA Korea & KPTEC
• 2011Theory and Practice for Eligibility Evaluation: Validation of High-Pressure Steam Sterilization, Pharmtech Vol. 4 No. 1, Issued by PDA Korea & KPTEC
• 2003sureGMP Online Course: Risk Analysis

Major Consulting Experience

• 1st project manager of CGMP consulting for domestic drug manufacturers of Gilead
• GMP diagnosis project manager of Dong-A Pharm Cheonan Plant, Sam-A Pharm and Jinyang Pharm, etc.
• 1st project manager for mock inspection in preparation for US FDA CGMP inspection of Daewoong Pham Nabota Plant
• Consulting project manager for Kolon Pharm's Japan PMDA GMP due diligence preparation
• Project manager for conceptual design and validation consulting of cell therapy GMP manufacturing facility of Medipost
• Project manager for GMP and validation consulting of Dongwha Pharm's Chungju Plant
• Project manager for validation consulting of DHP Korea’s New Plant in Osong
• Project manager for GMP and validation consulting for Korean Red Cross Plasma Fractionation Center
• Consulting performance for advanced biopharmaceutical design/GMP and validation: Kolon Life Science Inc., Osong Medical Innovation Foundation Clinical Trial Drug Production Center, National Center for Stem Cell and Regenerative Medicine, Chungbuk Technopark Cell Therapy Center, Medipost Co., Ltd., Corestem, Inc., Eutilex, KangStem Biotech, SL Bigen, NKMAX, Samsung Medical Center, Daewoong Pharmaceutical Life Science Research Center, Anterogen, ExoCoBio, CuroCell, CJ Healthcare, CELLID, ENCell, and AnClon



※ Conducted about 300 design, GMP and validation consulting cases including the above projects.

institute

• CEO of FSH

Academic background

• Graduated from the Department of Nuclear Engineering, Seoul National University
• Korea University MBA (Strategy Major)

Work experience

• Representative Consultant of FSH KOREA (current)
• COO of ABC ChemBio and CSO of Smart Bio Pharm (current)
• Adjunct (advisory) Professor at Research Department, Seoul National University Bundang Hospital (current)
• CFO/COO of Chaperone (previous)
• Advisory Member of Strategy, Performance and Human Resources at Korea Internet & Security Agency (previous)
• Member of the Task Evaluation at the Ministry of Health and Welfare (previous)
• Advisory Member of Strategy, Performance and Human Resources at the Ministry of Environment (previous)
• Director of Accenture Consulting (previous)
• Strategy Consultant of OLIVER WYMAN (previous)
• Managing Director of NEMO Partners (previous)
• Strategic Management Consultant of SAP Korea (previous)

Major lecture career

• Lectures on Strategy, Organization, and HR Theory for Major Customers
• Strategic Management Lecturer of Hi CEO at the Korea Economic Daily
• In-house MBA Instructor of Woongjin
• Lecturer in the Field of Strengthening the Organizational Capacity at the Korea JoongAng Daily
• Lecturer in the Field of Performance Management at the Korea Consumer Agency
• Connection Plan between BSC and Six-sigma (The Federation of Korean Industries) *
• SAP BPS (Business Planning) Module Lecture
• Hyperion BSC Best Practice Seminar (Chosun Hotel)
• Lectures on Strategy and BSC at Korea Productivity Center
• Strategy and BSC Advanced Course Lectures at the Federation of Korean Information Industries

Advisory / Project

• PM for Establishing Innovative Medical Technology R&D Development Strategy at Seoul National University Hospital
• Advisory member for Seoul National University Bundang Hospital's Integrated Purchasing and Logistics System Construction Project
• PM of the Mid-to-long-term Strategy and Information Strategy Establishment Project in the Research Field of Seoul National University Hundang Hospital
• PM of the Mid-to-long-term Strategy Establishment in the Research Field of the Borame Medical Center
• Advisory Member of the Medical Device Research and Development Project of the Borame Medical Center
• PM of the Mid-to-long-term Strategy and Information Strategy Establishment Project of Asan Institute for Life Sciences
• PM of Information Strategy Establishment Project at Seoul Asan Hospital
• Investigation the Actual Condition of Medical Information System in the Russian Far East and Preparation for Policy Support Measures
• Community Care Service Model Development Task Planning
• Consultation on R&D Tasks for Medical Devices in Seoul National University Bundang Hospital
• PM of the Information Strategy Establishment Project at the National Medical Center
• Advisory Member for the Establishment of a Domestic Joint Venture for a T-Pharmaceutical
• Advisory Member of Consulting the Strategy for Overseas Expansion of A-Digital Hospital in Korea
• Advisory Member on Feasibility Study for Overseas Expansion of Medical Devices and Sale of Overseas Distribution Rights
• Consultation on the Sale of Overseas Copyright Rights of B Pharmaceutical Co.
• Advisory Member in the Mid-to-long-term Strategy Establishment, New Business Development, Strategic Performance Management, and Human Resources of Korea Internet & Security Agency
• Consultation on the Mid-to-long-term Strategy Performance Management Project of the Korea Education and Research Information Service

• ※ Conducted a number of projects in the fields of vision, strategy, performance management, and human resources at domestic hospitals, large corporations, SMEs, and government agencies.

Institute

• Yonsei University College of Medicine, Dept. of Microbiology

Education

• 1991Doctor of Medicine, Yonsei University College of Medicine
• 1993Master of Medical Science, Yonsei University College of Medicine
• 1999Ph.D. in Medical Science, Yonsei University College of Medicine

Main Career

• 2009- Present Yonsei University College of Medicine, Dept. of Microbiology, Professor
• 2002-2004Johns Hopkins University Oncology Centre, Instructor
• 1999-2002Johns Hopkins University Dept. of Pharmacology, Postdoctoral fellow
• 1998-1999Yonsei University College of Medicine, Dept. of Microbiology, Research Instructor

Research

• Tumor associated Herpes virus (Epstein-Barr virus, Kaposi's Sarcom Associated Herpes virus), Interferon regulatory factor 5, Nur77
• Molecular Imaging of cancer
• Tumor development and cytokine promoter polymorphism
• miRNA and siRNA

Career

• 2020 - Present CEO of DELVER Inc.
• 2019-2020Bio Division, Reyon Pharmaceutical Co., Ltd.
• 2016-2019Product Development Division, Polus Inc.
• 2012-2015R&D Division, Celltrion Inc.

Main Activities

• More than 10 years of experience in the field of biopharmaceuticals.
• Specialized in animal cell/microorganism-based biopharmaceutical production process development.
• Specialized in biopharmaceutical production process validation.
• Specialized in establishing biopharmaceutical global product strategy and approval strategy.
• Specialized in global regulatory compliance in the US and Europe.
• Specialized in life cycle project management for biopharmaceutical development.
• Specialized in Quality by Design (QbD).
• Experience in developing new drugs and biosimilar products such as gene and cell therapy, monoclonal antibodies, and therapeutic proteins (insulin analogues, GCSF, somatropin, etc.).
• Consulting with biopharmaceutical development companies (cell therapy, mAb, scFv, toxin, and therapeutic proteins)
• Educational lecture on biopharmaceutical manufacturing process validation at Incheon National University Innovative Human Resources Development Center

Institute

• CEO of MEDICELL

Academic background

• Bachelor of Pharmacy at Chung-Ang University
• Master of Biopharmacology at Graduate School of Tokyo University
• Doctor of Biopharmacology at Graduate School of Tokyo University

Work experience

• Vice President of Scale-Up Partners
• CEO of STEMON Co., Ltd.
• Technical Expert of Wonik Investment Partners Co., Ltd.
• Managing Director of Focus Asset Management Co., Ltd.
• Executive Director of ID Ventures Co., Ltd.
• Director of Leading Investment Co., Ltd.
• Director of CTC Bio Co., Ltd.
• CEO of Incubia Co., Ltd.
• Manager of CJ Pharmaceutical Division
• Manager of Life Science Division of SK Chemicals Co., Ltd.
• Research Fellow Harvard Medical School (blood tumor)
• Acquired national pharmacist license

Lecture history

• Adjunct Professor at Department of Bio Management, Incheon National University
• Adjunct Professor at Venture Techno Management School, Konkuk University

Work experience

• 2018 - Present Advisor of Mentoring Project at Incheon Creative Economy Innovation Center
• 2012 - PresentAdvisor at Bio Medical Connect Center (BMCC)