K-NIBRT

Institute

• Professor at K-NIBRT, Yonsei University

Academic background

• Bachelor's Degree at Dankook University
• Master's Degree at Dankook University

Work experience

• 2023-현재Professor at K-NIBRT, Yonsei University
• 2022-2022KDDF, Korea Drug Development Fund
• 2021-2022Consultant at Delver, Inc.
• 2017-2021Hanmi Pharmaceutical, Co., Ltd.
• 2016-2017YD Diagnostics, Corp.
• 2016-2016ISU ABXIS, Co., Ltd.
• 2015-2016KOPRI, Korea Polar Research Institute

Books & Publications

• 2023.01.Biopharmaceutical job bible by job specialist, Letuin Books

Research Field

• PQS, Pharmaceutical Quality System
• Quality Management System
• Risk Management
• Regulatory Science
• Data Integrity
• Validation & Qualification
• Education & Training
• Inspection (FDA, EMA, MFDS, etc.) & Audit
• Quality Control

Institute

• Ehwa Womans University College of Pharmacy

Education

• Ph.D. UC Berkeley, Dept. of Molecular & Cellular Biology
• Ph.D. UCSF, Dept. of Biochemistry & Biophysics
• Ph.D. Univ. of Utah, Molecular Biology
• B.S. Sungkyunkwan University(SKKU), Pharmacy

Biosketch

• Hotcherl Jeong is currently an Invited Professor of Pharmacy, Ewha Womans University and Adjunct Professor of K-NIBRT, Yonsei University.
  
  His long-term research interests involve genetics/genomics and pharmacogenomics. He earned his B.S. in pharmacy from Sungkyunkwan University and his Ph.D. in molecular biology from University of Utah under Dr. John Roth. He was awarded the National Honor Society of Phi Kappa Phi Award for outstanding graduate work. Then, he pursued his postdoctoral work at UCSF under Dr. Ira Herskowitz and UC Berkeley under Dr. Jasper Rine. All three advisors are internationally recognized leaders in the field of genetics. After a seven-year stint in industry (in both US and Korea), he transited into academia in 2014. Since 2011, he has taught courses on molecular biology, biotechnology, and pharmacogenomics at Ewha, Yonsei, and various training programs.

Institute

• Yonsei University Professor of K-NIBRT Project

Education

• Ph. D., Integrated OMICS for Biomedical Science, Yonsei University, Seoul, Korea
• MS degree, Department of Biochemistry, Chungbuk National University, Cheongju, Korea
• Bachelor degree, Department of Food Science and Technology, Chungbuk National University, Cheongju, Korea

Experience

• 2011 – 2023Yonsei University, College of Pharmacy, Lab of pharmacology, Incheon, Korea
  - Established of expression and purification process for cosmetic ingredient protein
  - Experienced with all stages of production and purification of monoclonal antibody in CHO cells
• 2006 – 2010Korea Research Institute of Bioscience & Biotechnology (KRIBB), Daejeon, Korea
  - Purification of pure proteins using various chromatography method
  - Crystallization and data collection
  - Determination of three-dimensional structure

Institute

• K-NIBRT Professor

Research field

• Fatty acid separation and purification
• Development of health functional food
• Education for Bioindustry GMP (2012-2022)

Education

• Doctor degreeNational Andong National University Biological Resources Engineering(2020.08)
  Ph.D: A Study on The Health Functional Material of Purple Sweet Potato Using Bioconversion Process
• Master degreeGyeongsang National University College of Bio-Environmental Engineering(2006.02)
  Master's Thesis: Quality Characteristics of Chlorella-Added White Bread and soybean Curd
• Bachelor Degree of Food SciencesGyeongsang National University Department of Food Science and Technology(1998.02)

Career

• 2008.11 - 2022.03Gyeon-buk Bio industry Research institute
• 2006.02 - 2008.11Dong-bu Han Nong Chemical
• 2001.05 - 2006.02GMF: [God Made Food]
• 1987.04 - 2001.05Dae-kyung Engineering

Certificate

• 2022.03Life-long educator
• 2022.01Technology Transfer Agent
• 2015.10ISO9001 14001 International judge
• 2007.106-Sigma GB Belt
• 1997.10Industrial Safety engineer

Other activities

• 1989.03-2022.05Blood donations 112th
• 2008.03-2022.03Member of Nationnal equipment introduction Deliberation Committee
• 1995.03 - 2022.03Marine Corps Volunteer Activities
• 2017.12Korea Heart Saver Award

Awards

• Commendation from the Minister of Health Award 2012
• Commendation from the Minister of Agriculture and Forestry Award 2017
• Food and Drug Administration Award 2007
• National Agricultural Cooperative Federration Award 2019
• National equipment Utilization Portal Supporter Award 2017

Research publications

• 2021.03GMP that bioindustry majors must know 11
• 2021.03Cell culture experiment handbook for functional material development
• 2018.10Research and development of soy sauce using 100% shiitake mushrooms with excellent anticancer activity
• 2016.10Development of foods that facilitate bowel movements using purple sweet potatoes

Patent

• 2017.03Oriental melon grain syrup with contains ginger and manufacturing method
• 2022.0Grain powder composition with good solubility in the mouth
• 2018.10Research and development of soy sauce using 100% shiitake mushrooms with excellent anticancer activity

Institute

• Associate Professor of Dongguk University College of Pharmacy

Education

• Ph.D. Purdue University Industrial & Physical Pharmacy
• M.S. Chung-And University Pharmacy
• B.S. Chung-And University Manufacturing Pharmacy

Major Career

• 2012~PresentDongguk University College of Pharmacy
• 2009 - 2012Pusan National University College of Pharmacy
• 2008 - 2009LG Life Science Team Leader
• 2006 - 2008Wyeth(currently, Pfizer) Senior Research Scientist
• 1994 - 2001LG Household & Healthcare Senior Scientist

Education

• 2009. Sep – 2014. Feb Korea Advanced Institute of Science and Technology, Daejeon, Korea Ph.D degree in Biological Sciences
• 2003. Mar–2005. Feb Korea Advanced Institute of Science and Technology, Daejeon, Korea Master's degree in Biological Sciences
• 1996. Mar-2003. Feb Yonsei University, Seoul, Korea Bachelor's degree in Biotechnology

Representative career

• 2021. Sep-Current K-NIBRT Education Center, Songdo, Korea Joint Professor
• 2020. Mar-CurrentYonsei University, Wonju, Korea Division of Biological Science and Technology Assistant Professor
• 2018. May-2020.Jan Bioprocessing Technology Institute (BTI) at A*STAR and National University of Singapore (NUS), Singapore Systems biology group Research Scientist
• 2005. Jan-2015. Jan Biopharmaceutical companies (LG Chem, Hanwha Chemical, Aprogen) Research topics: 1.Production cell line development (Target protein: mAbs, BsAb and Fc-fusion protein) 2.Early-stage & Late-stage cell culture process development

Research area

• Data-driven and model-guided cell culture media design
• Transient gene expression platform (cell lines, media, and reagents)
• Continuous biomanufacturing (real-time monitoring, media optimization)
• Optimization of large-scale production using computational fluid dynamics
• Digital twin of bioprocessing using CFD, PAT, and in silico modeling

Education

• Ph. D., The Rutgers University, New Brunswick, New Jersey, U.S.A.
• Master of Art, University of Northern Iowa, Cedar Falls, Iowa, U.S.A.
• Bachelor of Pharmacy, College of Pharmacy, Ewha Womans University, Seoul, Korea

Professional Experience

• Global Bio-Connection_SSP, Korea and USA (2019-Present): CEO
• Korea Biotechnology Industry Organization: Seoul, Korea (2019-Present): Advisor
• Samsung Bioepis, Drug Product Team, Inchon, Korea (2017-2019): Senior Advisor
• Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA (1996-2017): Principal Scientist
• R.W. Johnson Pharmaceutical Research Institute, Raritan, NJ, USA (1981-1996): Scientist
• Seoul National University Hospital, Seoul, Korea: Korean Registered Pharmacist

Awards and Honors

• CE Pharm Award 2010 from the international meeting of CE Pharm (2010)
• Several Amgen Bravo Acclaim awards, 3-star, 2-star, 1-star
• Amgen Development Hall of Fame Award (2002)
• Corporate Quality ACES Awards (2006, 2007)

Professional Contributions and Accomplishments

• Associate Director of an International CA Separation Science Society (CASSS)
• Organization committee member for Latin America Capillary Electrophoresis (LACE) and CE Pharm meeting (1999-Present)
• Co-Chair for CE Pharm meeting (2001, 2003, 2004, 2006)
• Member of American Chemical Society
• Invited speaker for LACE (2006)
• Invited speaker for Pittsburg Conference (2007)
• Invited speaker for Asia Pacific Pharmaceutical Congress: Therapeutic Protein development and production (2008)
• Invited speaker for Beckman Coulter and Dionex seminar series (2002, 2004)
• Invited speaker for CE Pharm meeting (1999, 2002, 2005, 2007)
• Authored 3 book chapters
• 16 publications in peer reviewed journal

Institute

• K-NIBRT Professor

Academic background

• Kyung Hee University
• Master's Degree at Kyung Hee University Graduate School
• Doctor's Degree at Kyung Hee University Graduate School

Work experience

• 2014 – 2016 Administrator of Ministry of Food and Drug Safety Gyeongin Branch
• 2013 – 2014Administrator of Director of Ministry of Food and Drug Safety Daegu Branch
• 2000 – 2013Director of Ministry of Food and Drug Safety
• 1982 – 2000Korea National Institute of Health (researcher) and Ministry of Food and Drug Safety (researcher)
• 2000 – 2002Visiting scientist at the College of Pharmacy at Utah State University
• 1994 – 1995Visiting scientist to the FDA
• Acquired national pharmacist license
• Acquired national oriental medicine pharmacist license
• Acquired administrator’s certificate

Lecture history

• Visiting Professor, Department of Cosmetics/Songdo Bio, Incheon at Incheon Jaeneung University
• Adjunct Professor in the Department of Pharmacy/Pharmaceutical Science at Kyung Hee University

Institute

• Laboratory Chief at Biofors Global Co., Ltd.
• Served as a senior researcher at LG R&D Center
• Served as a researcher at the Korea Research Institute of Chemical Technology
• Served as an adjunct professor at Incheon National University

Academic background

• Completed Ph.D. in bio-regulatory science at Korea University
• Completed the venture CEO course at KAIST Graduate School of Business
• Master of Microbiology at Chungnam National University Graduate School
• Bachelor of Biology at Chungnam National University

Book

• Bioprocess Design and Economic Analysis ISBN Number: ISBN9788970749426

Education

• 1981~1985ChungNam National Univ. Bachelor in Biology, BS
• 1985~1987ChungNam National Univ. Master in Microbiology, MS
• 2000~2001KAIST. Graduate School of Management., AVM
• 2006~2009Korea Univ. PhD in Bioregulatory Affair & Science

Carrier

• 1985~1986Korea Research Institute of Chemical Technology, Researcher 1986~1992, LG Research Institute of HG&CM, Principal Researcher
• 1992~1997Jinsung system Co., VP
• 1997~2005Phorom Digital System Co., Ltd. CEO
• 2005~2010Biotron Inc.,/Hanil Science Co. Ltd. VP
• 2009~2010Gangneung Polytech Univ., Adjunct Prof.
• 2006~PresentIncheon Univ., Adjunct Professor
• 2011~2012Jaeneung Univ. Adjunct Prof.
• 2010~PresentBiofors Global Inc. CTO of Process R&D Institute.
• 2014~PresentQbD Consulting Partner of SMatrix & BPTC

Book

• Bioprocess Design and Economic Analysis (ISBN Number: ISBN9788970749426)
• Authorized Book : Kevin KB Rhee, BioProcess Design and Economic Evaluation, Gumin Press, 2014(Korean)

Major Research Area

• Bioprocess Modeling and Assessment by SuperPro Designer & SchedulePro
• Conventional and Stem Cell Bio-Process Engineering
• Bio-regulatory Affair & Science-cGMP, QbD, Risk Assessment
• Enzyme and Preservative Application to Household goods and Cosmetics
• Nano-Biotechnology and Nano-Medical-Engineering
• Bio-Refinery for Renewable Energy
• Bio-Process from Microalgae

International Invited Presentation

• 2007KSBB, Korea-Bioprocess regulation
• 2008TERMIS, International-Regenerative medicine and Bioreactors for Stem Cell
• 20092009
• 2010U. of National Colombia – Renewable Bioenergy in Latin America
• 2010U. of Caldas-Regenerative Medicine and Biotechnology
• 2010U. of Manizales SUMA-Nano-Biotechnology
• 2010BioMalaysia 2010 – Renewable Bioenergy and Microalgae Application
• 2011BioMalaysia 2011 – Planning of New Bio Factory and Vaccine Manufacturing
• 2012International Symposium at Northwest State Univ. of Russia-Stem cell and Nanomedicine
• 2013Deajeon Techno Park – QMS in Bio Fermentation Process
• 2013Deajeon Techno Park – Systematic approach for providing of Production Facilities of BioProducts
• 2014KSBB, Korea-Bioprocess Modeling and Economic Evaluation for Sustainable Energy
• 2014BIT’s 5th Annual World DNA and Genome Day-2014, Dalian, China
• 2014Korea Bio Association-About Global Trend of cGMP
• 2014Korea Bio Association-Program organizer and Speaker - QbD as 21st Century cGMP
• 2014The Korean Society for FD&C Regulatory Sciences-Efficient QbD Process
• 2014Korea Bio Association-About Global Trend of cGMP
• 2014KSBB-Efficient QbD Process
• 2015Korea Bio Association-About Global Trend of cGMP & QbD
• 2015DaeJeon TechnoPark-QbD
• 2015Korea BioAssociation- Validation of Utilities on BioProcess Facilities

Education

• 2008Bachelor's degree in Biotechnology, Yonsei University
• 2013Ph.D. in Biotechnology, Yonsei University

Professional Experience

• 2021 ~ 2023 Visiting Professor, College of Pharmacy, Yonsei University ( Specializing in the Graduate Program for Pharmaceutical Industry Cooperation, with a focus on new drug research)
• 2020 ~ 2021 Senior Researcher, STU Bio (Research and Development, Pharmaceutical Synthesis)
• 2019 ~ 2019 Lecturer, School of Dentistry, Yonsei University (Organic Chemistry)
• 2016 ~ 2019 Research Manager, Industry-Academia Cooperation Office, Yonsei University (Successfully secured projects for nurturing future scholars)
• 2013 ~ 2020 Postdoctoral Researcher, Industry-Academia Cooperation Office, Yonsei University (Engaged in pharmaceutical design and synthesis across various research projects in the Molecular Pharmacology Laboratory)

Major Research Achievements

• Optimization techniques for leading compounds
• AI-based research on new drug design
• In silico/in vitro studies for ADME optimization of small molecules

Participation in Research Projects

• Production and properties study of anti-HIV candidate substances targeting HIV-NC
• Design and synthesis of novel small molecules inducing functional regulation of bone marrow-derived mesenchymal stem cells for cardiovascular disease treatment
• Construction of a library of inhibitors targeting human Leucyl-tRNA synthetase and development of anticancer agents
• Chemical biology research on the effects of small molecules regulating the function of the ion exchange channel pendrin for congenital deafness and hypertension treatment
• Investigation of the pharmacological characteristics of small molecules inhibiting the function of the ion exchange channel pendrin for congenital deafness treatment (Research Fellow Project)
• Development of a PDS correction agent for congenital deafness treatment
• Optimization study for KCNQ4 activators for the development of a therapy for noise-induced hearing loss.

Technology Transfer

• 2021Research collaboration and license agreement (연세의료원-아보메드)

Research Paper

• 2023Structural optimization of novel Ras modulator for treatment of Colorectal cancer by promoting β-catenin and Ras degradation
• 2022Inhibition of phospholipase D1 induces immunogenic cell death and potentiates cancer immunotherapy in colorectal cancer
• 2022Indirubin-3′-alkoxime derivatives for upregulation of Wnt signaling through dual inhibition of GSK-3β and the CXXC5-Dvl interaction
• 2021Structure-based modification of pyrazolone derivatives to inhibit mTORC1 by targeting the leucyl-tRNA synthetase-RagD interaction
• 2020Inhibition of Pendrin by a small molecule reduces Lipopolysaccharide-induced acute Lung Injury
• 2020PRMT5 promotes DNA repair through methylation of 53BP1 and is regulated by Src-mediated phosphorylation
• 2020Identification and Validation of VEGFR2 Kinase as a Target of Voacangine by a Systematic Combination of DARTS and MSI biomolecules
• 2019Novel pendrin inhibitor attenuates airway hyperresponsiveness and mucin expression in experimental murine asthma
• 2017Improving potency and metabolic stability by introducing an alkenyl linker to pyridine-based histone deacetylase inhibitors for orally available RUNX3 modulators
• 20152-(Trimethylammonium)ethyl (R)-3-methoxy-3-oxo-2-stearamidopropyl phosphate promotes megakaryocytic differentiation of myeloid leukaemia cells and primary human CD34+ haematopoietic stem cells
• 2013New synthetic aliphatic sulfonamido-quaternary ammonium salts as anticancer chemotherapeutic agents
• 2011, 2013Synthesis and biological evaluation of novel aliphatic amido-quaternary ammonium salts for anticancer chemotherapy
• 2010Structure Based Optimization of Chromen-Based TNF-alpha Converting Enzyme (TACE) Inhibitors on S1' Pocket and Their Quantitative Structure Activity Relationship (QSAR) Study

Patents

• Composition and method for the prevention or treatment of respiratory diseases
• Novel rodanin derivatives, their manufacturing method, and pharmaceutical compositions for AIDS prevention or treatment containing them as active ingredients
• Novel diamine compounds or pharmaceutically acceptable salts thereof, their manufacturing method, and pharmaceutical compositions for cancer treatment containing them
• Novel thio- or urea derivatives, their manufacturing method, and pharmaceutical compositions for AIDS prevention or treatment containing them as active ingredients
• Preparation of diamine derivatives as anticancer agents

Education

• Ph.D., University of Virginia, U.S.A.
• M.S.E., University of Pennsylvania, U.S.A.
• B.S., Sungkyunkwan University

Professional Experience

• 2023-presentProfessor, K-NIBRT
• 2020-2022Chief Research Scientist, Bioneer
• 2016-2020Technical and Scientific Advisor, Prime4Dia
• 2014-2016Assistant Professor, King Saud University, Saudi Arabia
• 2014Senior Researcher, Sungkyunkwan University
• 2009-2013Training Fellow, NIH Biotechnology Training Program, U.S.A.
• 2011Visiting Scholar, Georgia Institute of Technology, U.S.A.
• 2006-2008Researcher, Korea Institute of Industrial Technology

EDUCATION

• 2022.09-2024.08Ph.D degree in pharmaceutics, Dongguk university
• 2017.03-2019.02Master’s degree in pharmaceutics, Dongguk university
• 2011.03-2017.02Bachelor’s degree in biological sciences, Dankook university

WORK EXPERIENCE

• 2022.09-2023.08Lecturer, pharmacy, Dongguk university

Major Research Achievements

• Pre-formulation & Formulation
• Lyophilization process

EDUCATION

• 2011Yonsei University, Department of Biotechnology, Republic of Korea Ph.D. in Medicinal chemistry
• 1996Korea University, Department of Biotechnology, Republic of Korea M.S. in Biochemistry
• 1994Korea University, Department of Biotechnology, Republic of Korea B.S. in Biotechnology

Major Research Achievements

• 2023–2024Yunovia Pharm. Managing Director, Head of Innovative Solution Group
• 2016–2023Ildong Pharma. Managing Director, Head of Innovative Solution Group
• 2012–2016CalIBR(California Institute for Biomedical Research, CA, US) Research Scientist
• 1996–2012Daewoong Pharma. Research fellow, Department of Drug discovery

Research Paper(last 3-years only)

• 2023Synthetic Strategies for Improving Solubility: Optimization of Novel Pyrazolo[1,5-a]pyrimidine CFTR Activator That Ameliorates Dry Eye Disease. Journal of Medicinal Chemistry (ACS publicatin
• 2023Discovery of ID110521156, a Small Molecule GLP-1 Receptor Agonist, for the Treatment of Type 2 Diabetes and Obesity. ADA 83th Scientific sessions poster (American Diabetes association)
• 2022Novel CFTR Activator Cact-3 Ameliorates Ocular Surface Dysfunctions in Scopolamine- Induced Dry Eye Mice. International Journals of Molecular Sciences (MDPI)
• 2021Discovery of 5-(N-hydroxy carbamimidoyl) benzofuran derivatives as novel indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors. Bioorganic & Medicinal Chemistry Letters (Elsevier)

Patents(last 3-years PCT only)

• WO 2024/085661A1Novel triheterocyclic compounds
• WO 2024/063576A1Novel quinazoline compound as KRAS inhibitor
• WO 2024/063578A1Novel tetraheterocycle compound
• WO 2024/019541A1Heteroaryl derivative compound and use thereof
• WO 2024/014885A1Novel Bicyclic heteroaryl compound and use thereof
• WO 2023/182869A1Novel salt of GLP-1receptor agonist compound, preparation method thereof and pharmaceutical composition thereof
• WO 2023/113474A1Novel salt of1-sulfonyl pyrrole derivative, Method for preparing same, and Pharmaceutical composition including same
• WO 2023/113458A1Novel salt of1-sulfonyl pyrrole derivative, preparation method thereof and pharmaceutical comprising thereof
• WO 2023/067388A1Uses of CFTR modulatorand/or PDE4 inhibitor compounds
• WO 2022/231357A1Pharmaceutical comprising GPR40 agonist and SGLT-2 inhibitor
• WO 2022/195522A1Inhibitors of ANO6 and their uses thereof
• WO 2022/157686A1Inhibitors of Anoctamin6 protein and their uses thereof
• WO 2022/123319A1Biased agonists of opioid receptors
• WO 2022/084741A1CFTR modulator compounds, compositions, and uses thereof

EDUCATION

• 2002.03-2005.08B.S., Department of Life Sciences, Korea University
• 2006.03-2013.08Ph.D., Department of Life Sciences, POSTECH
• 2013.09-2016.02Post-doctoral associate, Department of Life Science, POSTECH
• 2017.03-2018.06Research Scientist, Rosetta Exosome Inc.
• 2021.11-2024.07Post-doctoral associate, Department of Pediatrics, Division of Hematology/Oncology, University of Minnesota

Education

• B.Sc. in Microbiology, Chungbuk National University
• Master's in Public Health(M.P.H), Graduate School of Public Health, Yonsei University

Professional Experience

• 2020 – 현재 Director, Quality Services APAC, Merck Life Science
• 2015 – 2020QA Manager, Bristol Myers Squibb
• 2013 – 2015Quality & Compliance Supervisor, Janssen Korea
• 2010 – 2013QC team lead, LG Life Sciences
• 2007 – 2010Hanmi Fine Chemical

Education

• 1991 Jeonju Sangsan High School
• 2000 Bachelor of Engineering, Food Engineering Woosuk University
• 2003 Master of Biotechnology, Sejong Graduate School
• 2016 Ph.D. of Biotechnology Sejong Graduate School

Professional Experience

• 2021. 02 ～ present: Incheon TP Chief Researcher Bioprocess Human Resource Development Center (Center Construction and Equipment Establishment)
• 2016. 01～2021.02: Binex Corporation General Manager Cultivation Team (Biopharmaceutical Production: 200 ~ 1000 L)
• 2010. 11～2016.12: Binex Corporation Team Leader (R&D CenterDevelopment and Technology Transfer of Animal Cell Culture Processes)
• 2007. 07～2010.06: BioR&D Senior Researcher (Research Institute (Development and Technology Transfer of Cultivation Processes))
• 2003. 11～2004.04: Aprogen Co., Ltd Researcher Research Institute (Cell Line Development)
• 2010. 03～2010.08: Nazarene University Instructor (lecture)
• 2007. 09～2008.08: Sejong University Instructor (lecture)

Research Paper - Master

• - ANovel Cell Culture System Developed for High Density Culture of Anchorage Dependent and Anchorage Independent Cells

Research Paper - Ph.D

• - Production of Therapeutic Recombinant Proteins byCultivation of rCHO Cells in a Depth Filter Perfusion sustem anda Single-Use Pneumatic Bioreactor Syustem
• Ⅰ: Evaluation of a novel pneumatic bioreactor system for culture of recombinant Chinese hamster ovary cells. (Biotechnology and Bioprocess Engineering, 2013, vol.18, no.4,)
• Ⅱ: Producrtion of recombiniant human growth hormone by rCHO cells in a depth filter perfusion system. (Biotechnology and Bioprocess Engineering, 2014,vol.19, no.6,)

Education

• 1987 Bachelor of Pharmacy, Yeungnam University
• 1989 Master of Pharmacy, Graduate School, Yeungnam University
• 1999 Doctor of Pharmacy, Graduate School, Chungbuk University
• 2010 Master of Social Pharmacy, Sookmyung Women's University Graduate School of Clinical Pharmacology

Professional Experience

• 22.12.30 ~ present Korea Center for Regulatory Science Center Director General (BioHealth Regulatory Science Project )
• 20.03.30. ~ 22.12.20 Director General of the Biopharmaceuticals and Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation (NIFDS), Ministry of Food and Drug Safety(MFDS), overseeing the approval review and national marketing authorization of biopharmaceuticals such as vaccines, antibody therapies, and cell therapies
• 18.02.06. ~ 20.03.29 Director of Research Planning and Coordination Division, National Institute of Food and Drug Safety Evaluation (NIFDS), Ministry of Food and Drug Safety(MFDS), overseeing the planning and management of R&D
• 15.11.09. ~ 18.02.05 Director of the Dental and Gastroenterological Device Division, National Institute of Food and Drug Safety Evaluation (NIFDS), Ministry of Food and Drug Safety(MFDS), responsible for medical device approval evaluation
• 11.01.05. ~ 15.11.08 Director Pharmaceutical Standardization Division, National Institute of Food and Drug Safety Evaluation (NIFDS), Ministry of Food and Drug Safety(MFDS), responsible for pharmaceutical approval evaluation

Research Paper - Master

• - Interaction between Histamine Antagonists and Muscarinic Receptors (II) (Effects on Muscarinic Receptors in the Brain)

Research Paper - Ph.D

• - The Effect of NMDA Receptor Antagonists on 5-Hydroxytryptamine-Induced Mouse Head-Twitch Response

Education

• 2013. 08 – 2020.08 Ph.D Biotechnology Yonsei University, Republic of Korea Supervisor: Prof. YoungSoo Kim Prof. Gyounghee-Han Prof. Jun-Seok Lee
• 2010. 08 – 2013. 03 M.S. Brain and Cognitive Engineering Korea University, Republic of Korea Supervisor: Prof. Seong-Whan Lee
• 2002. 02 – 2008. 03 B.S. Bio-resources Science Dankook University, Republic of Korea Supervisor: Prof. Dae-Kyung Kang

Employment history

• 1. Incheon Technopark / 2023. 04. ~ Present Biocenter / Senior researcher
• 2. Yonsei University / 2022. 01. ~ Present K-NIBRT Project / Adjunct Professor
• 3. Incheon Technopark / 2021. 02. ~ 2023. 04. Bioprocessing Technology Training Center / Senior researcher
• 4. Yonsei university / 2020. 09. ~ 2021. 01. Laboratory of Chemical Biology, Department of Pharmacy / Post-doctor researcher
• 5. Korea Institute of Science and Technology / 2013. 09. ~ 2018.04. Diagnosis, Treatment of Care System of Dementia / Researcher
• 6. Korea university / 2013. 03 ~ 2013. 05. Pattern Recognition and Machine Learning Lab, Department of Brain & Cognitive engineering / Researcher
• 7. Seoul National University Hospital / 2010. 01. ~ 2010. 08. Department of Clinical Pharmacology / Researcher
• 8. Korea Institute of Science and Technology / 2009. 01. ~ 2009. 12. Center for Water Cycle Research / Researcher
• 9. National Institute of Agricultural Sciences / 2008. 01.~ 2008. 10. Department of Agricultural Environment / Researcher

Publication list

• 1. Soo Min Cho, Sejin Lee, Seung-Hoon Yang, Hye Yun Kim, Michael Jisoo Lee, Hyunjin Vincent Kim, Jiyoon Kim, Seungyeop Baek, Jin Yun, Dohee Kim, Yun Kyung Kim, Yakdol Cho, Jiwan Woo, Tae Song Kim & YoungSoo Kim. (2016) Age-dependent inverse correlations in CSF and plasma amyloid-β(1–42) concentrations prior to amyloid plaque deposition in the brain of 3xTg-AD mice. Scientific Reports
• 2. Seung-Hoon Yang, Dongkeun Kenneth Lee, Jisu Shin, Sejin Lee, Seungyeop Baek, Jiyoon Kim, Hoyong Jung, Jung-Mi Hah & YoungSoo Kim. (2016) Nec-1 alleviates cognitive impairment with reduction of Aβ and tau abnormalities in APP/PS1 mice. EMBO molecular Medicine

Education

• Ph. D., The Rutgers University, New Brunswick, New Jersey, U.S.A.
• Master of Art, University of Northern Iowa, Cedar Falls, Iowa, U.S.A.
• Bachelor of Pharmacy, College of Pharmacy, Ewha Womans University, Seoul, Korea

Professional Experience

• Global Bio-Connection_SSP, Korea and USA (2019-Present): CEO
• Korea Biotechnology Industry Organization: Seoul, Korea (2019-Present): Advisor (자문위원)
• Samsung Bioepis, Drug Product Team, Inchon, Korea (2017-2019): Senior Advisor (고문)
• Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA (1996-2017): Principal Scientist
• R.W. Johnson Pharmaceutical Research Institute, Raritan, NJ, USA (1981-1996): Scientist
• Seoul National University Hospital, Seoul, Korea: Korean Registered Pharmacist

Awards and Honors

• CE Pharm Award 2010 from the international meeting of CE Pharm (2010)
• Several Amgen Bravo Acclaim awards, 3-star, 2-star, 1-star
• Amgen Development Hall of Fame Award (2002)
• Corporate Quality ACES Awards (2006, 2007)

Professional Contributions and Accomplishments

• Associate Director of an International CA Separation Science Society (CASSS)
• Organization committee member for Latin America Capillary Electrophoresis (LACE) and CE Pharm meeting (1999-Present)
• Co-Chair for CE Pharm meeting (2001, 2003, 2004, 2006)
• Member of American Chemical Society
• Invited speaker for LACE (2006)
• Invited speaker for Pittsburg Conference (2007)
• Invited speaker for Asia Pacific Pharmaceutical Congress: Therapeutic Protein development and production (2008)
• Invited speaker for Beckman Coulter and Dionex seminar series (2002, 2004)
• Invited speaker for CE Pharm meeting (1999, 2002, 2005, 2007)
• Authored 3 book chapters
• 16 publications in peer reviewed journal

Education

• 1996 Bachelor's degree in Biological Engineering from Inha University
• 1998 Master's degree in Biological Engineering from Inha University.
• 2004 Ph.D. in Biological Engineering from Inha University.

Professional Experience

• 2021.11. ~ present Head of R&D Headquarters at Hu evergreen pharm (Director) (Overall R&D Management)
• 2015.04.～2021.09. Principal Researcher in the Innovative CAR-T GMP center at AbClon (Responsible for GMP Manufacturing, Head of Manufacturing Process Team)
• 2009.10.～2014.12. Senior Researcher in the Process Development Team at Procell Therapeutics (Team Leader for Process Development)
• 2004.03.～2009.09. Senior Researcher in the NK Cell Therapy Team and Protein Engineering Team at Mogam Biotechnology Research Institute (Cell Cultivation and Analysis)

Research Paper - Master

• - Process Studies for Enhancement of 10-DAB Production in Taxus Cell Suspension Culture

Research Paper - Ph.D

• - Studies of recombinant Leukotactin-1 on Protection of Hematopoietic Stem and Progenitor Cells from Cytotoxicity of Cancer Therapy

Education

• Major in Life Sciences, Ewha Womans University
• Tumor Immunology, Seoul National University College of Medicine

Research career

• Senior Researcher, National Designated Tumor Immunology Research Center (TIMRC), Seoul National University College of Medicine
• Principal Researcher, National Designated Digestive Efficacy Evaluation Center (NCEED), Inha University College of Medicine
• Research Professor, Inha University College of Medicine
• Adjunct Professor, K-NIBRT Yonsei University

Education

• 2025Bachelor of Engineering / Academic Credit Bank
• 2005Associate degree / Dongyang Mirae University

Work Experience

• 2023. 07 ~ PresentIncheon Technopark Bio Center
• 2015. 11 ~ 2023. 07Bi-nex Engineering Team
• 2010. 12 ~ 2015. 11Okong Facilities Management Department

License and Certificate

• 2024Maintenance of facilities
• 2015Industrica Engineer Electricity
• 2012Industrica Engineer Craftsman Air-Conditioning and Refrigerating Machinery
• 2012Completion of Max Capa expert training course through facility improvement(Korea Standards Association)
• 2012Completion of the fair safety report evaluation curriculum (Korea Occupational Safety and Health Agency)
• 2011Finished training course for refrigeration and refrigeration machine manufacturing facilities and inspection institution (Korea Gas Safety Corporation)
• 2008Completion of the Electrical Basic Course of the Small and Medium Business Training Institute
• 2008Completion of Hydraulic Basic Course at Small and Medium Business Training Institute

Education

• 2008Bachelor of biological engineering , Inha University
• 2011Master of Science (M.S.) in Bioengineering, Seoul National University

Career

• 2023 – PresentConsultant, Merck, Consulting APAC Viral Vector Technology - Global Focused Modality
• 2021 – 2023Consultant, Merck, Global Upstream Integrated Systems, Mixing, System Field Services, USP Bio Continuous Processing Go-to-Market Strategy Lead, APAC Single-Use Go-to-Market Strategy Lead - Global Strategy Deployment
• 2019 – 2020Senior Technology Manager, Merck, Technology Consulting for TFF, Clarification, and Cell & Gene Therapy Processes, Global Go-to-Market Lead for Clarification, Cell & Gene Therapy Champion
• 2015 – 2019Technology Manager, Merck, Technology Consulting for TFF, Clarification, Vaccines, and Viral Gene Therapy Processes, APAC Go-to-Market Lead for Clarification
• 2013 – 2015Field Marketing Specialist, Merck, Technology Consulting for TFF, Clarification, and Virus Removal
• 2010 – 2013Research Scientist, ISU ABXIS, Downstream Process Development and Technology Transfer for Monoclonal Antibodies (mAbs) and Recombinant Proteins

Master’s Thesis

• Characterization of β2-Microglobulin Amyloid Formation Depending on pH

Published Papers

• Risk Assessment for Biopharmaceutical Single-Use Manufacturing: A Case Study of Upstream Continuous Processing, Biologicals, 84 (2023) 101713

Education

• 1987 Bachelor's degree in Biotechnology from Dongguk University.
• 1990 Master's degree in Biotechnology from Dongguk University Graduate School.
• 2002 Ph.D. in Biotechnology from Kangwon National University Graduate School.

Professional Experience

• 2022 Completed Health and Social Policy Course at Seoul National University Graduate School of Public Health
• 2021~2022 Committee Member of the Pharmaceuticals Specialty Committee, Ministry of Food and Drug Safety
• 2021 Director of Industry Promotion at the Korea Health Industry Development Institute
• 2020 Director of International Healthcare at the Korea Health Industry Development Institute
• 2019 Director of the Seoul Biohub Center at the Korea Health Industry Development Institute
• 2016~2018 Head of the Pharmaceutical and Bio-industry Division at the Korea Health Industry Development Institute
• 2017 Planner at the Medium to Long-term Strategy Planning Division for the Pharmaceutical Industry, Ministry of Health and Welfare
• 2017~2022 Committee Member of the Internal Regulatory Review Committee, Ministry of Food and Drug Safety