Experienced healthcare editor with a demonstrated history of B2B journalism covering drug development, manufacturing, and the pharma industry. Skilled in editing, news writing, KOL interviews and financial journalism. Special focus on pharmaceutical manufacturing, clinical trials, rare disease and women's healthcare. Bilingual Glasgow/London-based English and French-speaking media professional with a Master of Arts (M.A.) in English from the University of Bristol.

Maggie LIM has been in the clinical research industry for the last 26 years; she graduated from Singapore National University Pharmacy and took up Clinical Pharmacy postgraduate in Canberra Australia while working as a pharmacist in Singapore General Hospital.
She took an interest in Clinical Research and joined Eli Lilly as a CRA and study manager, specializing in early phase clinical pharmacology studies.
When the opportunity came to join GSK as a regional Asia-Pacific GCP trainer came in 2007, she covered training for R&D medical and clinical teams for 5 years before joining Global Clinical Quality Assurance in 2012,  and has since been managing a team of auditors delivering the QA strategized audits for the region.

YoungWook Kim serves as the Associate Director of Investigator Engagement for Korea within the Clinical Research Investigator Engagement, Delivery & Capabilities at Eli Lilly and Company. In this role, he is entrusted with the comprehensive oversight of investigator site management for clinical research across Lilly Korea. His responsibilities encompass a broad range of critical capabilities, including portfolio management, study feasibility assessment, site selection, patient enrollment, and monitoring.

Holding a Bachelor's degree in Pharmacy from Sahmyook University, he has cultivated a distinguished career that spans over 15 years in the pharmaceutical industry, with a particular focus on clinical operations. His professional journey has seen him undertake various roles, from CRA to Clinical Development Consultant, Clinical Operations Portfolio Manager, Clinical Information Process Automation, and Clinical Project Management. His experience covers a diverse geographical spectrum, including Korea, Emerging Markets, and Lilly Headquarters.

His extensive experience and deep commitment to the field are driven by a passion for enhancing the delivery of clinical research, with the ultimate goal of improving patient outcomes and advancing healthcare. His expertise and dedication are reflected in his approach to fostering innovation and efficiency in clinical research processes.

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.

Director, Clinical Development, Connext Co. Ltd.

Previously worked as CDO, MedGene Therapeutics Inc.;

Project Manager & Senior Director, KCRN Research;

Principal Scientist, G+FLAS Lifesciences;

Postdoc & Research Fellow, NCI, NIH;

Ph.D. in Biochemistry & Molecular Biology, Environmental Toxicology, Michigan State University;

BS & MS, Seoul National University

She has been an expert in drug development, clinical trials, projects, and quality control since 2001 and has worked in domestic pharmaceutical companies and global CRO, as well as university. She graduated from Seoul National University with B.S and Doctor degree and obtained Ph.D. from the CHA university.

And she served as a branch manager(country head), global task manager and quality manager in a Global CRO, PAREXEL International and as a professor at the University of CHA univeristy for five years from 2014, she has served as the head of the New Drug Development Division at Bioteches since 2020. she is currently leading clinical development as the head of development and vice president of Spark Biopharma.

• EDUCATIONS 

2016.09 - PhD in Regulatory affairs, Department of Pharmaceutical Industry Management,

Chungbuk National University

2003.02 - M.S. in Biochemistry and Cell biology, Department of Biochemistry,

Konyang University

2001.02 - B.S. in Chemistry, Department of Chemistry,

Konyang University

• EXPERIENCES 

1. Korea Research Institute of Bioscience and Biotechnology (KRIBB)
2. Neopharm. Co., Ltd.
3. Bischem. Co., Ltd.
4. Biopharm solutions. Co.Ltd.
5. Veraverse Co.Ltd. - Currently employed

• PUBLICATIONS

1. Lee KB, Bae JH, Kim JS, Yoo YC, Kim BS, SKwak ST, KimYS, ”Anticoagulant Activity of Sulfoalkyl Derivatives of Curdlan”, Arch Rharm Res. 2001,24:109-13.
2. Bae JH, Yoo YC, Kwak ST, Seo EY, Moon EH, Lee MJ, Lee KB, “Antiviral and anticoagluant activity of sulfoalkyl derivatives of curdlan “, Korean J.Lab Anin. Sci. 2001,02. 119-124.
3. Bae JH, Kim GS, Yoo YC, Lee HY, Lee KB, ”The investigation of Synovial Fluid and Serum for Biochemical Markers of Joint diseases in the horse (Review)”, J Vet Clin. 2001,02:304-310.
4. Bae JH, Yoo YC, Hong GH, Moon EH, Song GS, Lee KB, “Biochemical analysis of synovial fluid and serum to diagnose early joint diseases in equine”, Korean J.Lab Anin. Sci. 2004.05:37-43.
5. Yeop YJ, Bae JH “Effect of an extraction solvent on the antioxidant of pine tree”, J. Soc. Cosmet. Scientists Korea. 2005.02.
6. Jung M, Lee S, Park HY, Youm JK, Jeong S, Bae JH, Kwon MJ, Park BD, Lee SH, Choi EH, “Anti-ageing effects of a new synthetic sphingolipid (K6EAA-L12) on aged murine skin”, Exp Dermatol. 2011, 20(4):314-9.
7. Sul GD, Park HJ, Bae JH, Hong KD, Park BD, Chun J, Jeong SK, Lee SH, Ahn SK, Kim HJ, “Preventive effects of multi-lamellar emulsion on low potency topical steroid induced local adverse effect.”, Ann Dermatol. 2013,25(1):5-11.
8. Rho JK, Choi YJ, Kim SY, Kim TW, Choi EK, Yoon SJ, Park BM, Park E, Bae JH, Choi CM, Lee JC, “MET and AXL inhibitor NPS-1034 exerts efficacy against lung cancer cells resistant to EGFR kinase inhibitors due to MET or AXL activation”, Cancer Res. 2013, 10.
9. Hong JY, Bae JH, Lee KE, Kim M, Kim MH, Kang HJ, Park EH, Yoo KS, Jeong SK, Kim KW, Kim KE, Sohn MH, “Antibody to FcεRIα Suppresses Immunoglobulin E Binding to High-Affinity Receptor I in Allergic Inflammation”, Yonsei Med J. 2016,57(6):1412-9.

• PATENTS

1. Lee KB, Bae JH “Method for extracting high purified hyaluronic acid for arthritis therapy from cocks comb”, 2003.05.
2. Park BD, Yeom JG, Jeong SK, Bae JH, Kwon MJ, Kwak HS, Sin DM, Choi YH, “New anti-skin aging and wrinkle-treating agents and cosmetic compositions containing the same” , 2007.03.30.
3. Park BD, Kwak HS, Jeong SK, Bae JH, “Human antimicrobial peptides promoter, method for preparing thereof and composition comprising the same as active ingredient”, 2008.04.01.
4. Choi HS, Bae JH, Park HJ, Jeong SK, “Compostion comprising mycolic acid derivatives for anti-inflammatory activity”, 2009.10.12.
5. Park BD, Yeon SJ, Kim UD, Bae JH, Kim MH, Kang HJ, Park EH, “Conjugate comprising soluble fragment of FcεRI and composition for treating allergy diseases mediated by IgE comprising the conjugate”, 2012.05.23.
6. Park BD, Yeon SJ, Bae JH, Park EH, Kim UD, Kim MH, Kang HJ, Ryu GS, “FcεRI specific human antibody and composition for treatment or diagnosis of allergy disease comprising thereof”, 2012.05.30.
7. Jeong SK, Kim BW, PARK BM, Jeon JE, Bae JH, “Heterocyclic compounds”, 2013.11.18.
8. Park BD, Kim Y, Yang MG, Jeong SK, Bae JH, “Wound dressing comprising pseudo-dermal lipid”, 2014. 01. 07.
9. Jeong SK, Bae JH, Park BM, “Composition for preventing hair loss or promoting hair growth”, 2015. 01.19.
10. Jeong SK, Bae JH, Kim DH, “Composition for improving condition of scalp”, 2015.07.20.
11. Jeong SK, Bae JH, Kim DH, “Composition for improving condition of damaged hair”, 2015.07.20.
12. Yoon CH, Bae JH, Han CK, Kang HJ, Kim MH, Seo JB, “Fused ring heteroaryl compounds as ALK4/5 inhibitors”, 2018.10.
13. Yoon CH, Bae JH, Han CK, Kang HJ, Kim MH, Seo JB, “Fused ring heteroaryl compounds as RIPK1 inhibitors”, 2019.09.
14. Yoon CH, Bae JH, Han CK, Kang HJ, Kim MH, Seo JB, “Fused ring heteroaryl compounds as STING agonist” , 2020.01.

• ORAL PRESENTATION

1. Diagnosis method for degenerative joint disease of equine, The Korean society of veterinary science, 2001. 03.
2. Effects of anti-microbial peptides stimulating molecules on epidermal permeability barrier function, The Korean Society for skin barrier research, 2007. 06.
3. Effects of physiologic lipid mixture on epidermal anti-microbial peptides in experimental atopic dermatitis model, Asian Dermatological Congress, 2008.10.
4. Overseas company visit program (France and Germany) – IR, 2024,09

• IND SUBMISSION 

1. FDA IND approval for Phase 2 (Alzheimer’s disease)
2. FDA IND approval for Phase 2 (Diabetic Macular Edema)
3. FDA IND approval for Phase 2 (Alzheimer’s disease

-   MS (PhD course completion), RN, APN of Oncology

-   Experience in clinical trials for 22 years;

• developed whole clinical regulatory package for new anti-cancer immunotherapy in ImmunoneOncia Therapeutics Inc. (current)
• developed whole clinical regulatory package and gained the approval for biosimilars from EMA, FDA and PMDA in CELLTRION Inc.
• developed the systemized data capturing module and clinical study conducting program in National Cancer Center Korea

-   Published 30 articles and 53 congress presentations (including The Lancet, Lancet Oncology, Lancet Hematology, etc)

Education

Professional Experiences

Publications (Selected or Past 5 years)

○ A new algorithm for detecting Low-complexity regions in protein sequences, bioinformatics, pp 160-170, vol. 21, 2005

○ Asthma-Predictive Genetic Markers in Gene Expression Profiling of Peripheral Blood

Mononuclear Cells, ALLERGY ASTHMA & IMMUNOLOGY RESEARCH, pp 265-272, vol. 3, 2011

○ Differential gene expression profile in PBMCs from subjects with AERD and ATA: a gene

marker for AERD, Molecular Genetics and Genomics, pp 361-371, vol 287, 2012

○   A Highly Sensitive and Specific Genetic Marker to Diagnose Aspirin-Exacerbated Respiratory Disease Using a Genome-Wide Association Study, DNA AND CELL BIOLOGY, p1604-1609, vol 31, 2012

○ Genome-wide association study of aspirin-exacerbated respiratory disease in a Korean

population, Hum Genet, March 2013, Volume 132, Issue 3, pp 313–321

○ Elevation of Eosinophil-Derived Neurotoxin in Plasma of the Subjects with Aspirin-Exacerbated Respiratory Disease: A Possible Peripheral Blood Protein Biomarker, PLOS ONE, vol 8, 2013.

○ Exonic Variants Associated with Development of Aspirin Exacerbated, Respiratory Diseases,

PLOS ONE 9(11), 2014.

○ Genome wide identification and expression profile in epithelial cells exposed to TiO₂ particles, Environ Toxicol, 2015 Mar;30(3):293-300

○ Association between TAAR6 polymorphisms and airway responsiveness to inhaled

corticosteroids in asthmatic patients, Pharmacogenetic Genomics, 2015 Jul;25(7):334-42

○ Development of a genetic marker set to diagnose aspirin-exacerbated respiratory disease     in a genome-wide association study, Pharmacogenomics J. 2015 Aug;15(4):316-21

○ Clinical Characteristics of Exacerbation-Prone Adult Asthmatics Identified by Cluster

Analysis, Allergy Asthma Immunol Res, 2017 Nov;9(6):483-490

○ lung function trajectory types in never-smoking adults with asthma: clinical features and

inflammatory patterns, Allergy Asthma Immunol Res. 2018 Nov;10(6):614-627

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.

Jeffery Wong is the Senior Director of Business Development at Nucleus Network, one of the world’s largest Phase I Clinical Trial Service provider with operations spreading across both Australia and the USA.

A strong business development professional, Jeffery graduated from RMIT University, holds a Masters in Business and Biotechnology with a major in Pharmaceutical Sciences. During his 18 years with Nucleus Network, Jeffery has seen the growth of Nucleus Network from a 24 bed not for profit organisation to its current capacity of over 200 phase I beds spread across the globe.

Jeffery has a passion in supporting industry members to achieve their clinical development goals and leverages on his extensive knowledge in business development, project operation, clinical study design and regulatory affairs.

Karen Montgomery-Douglas | Commercial Development Manager | BSc (Biomedical), Grad. Dip. Medical Laboratory Science

Karen brings over 20 years’ experience in sales and business development in the clinical trials and laboratory sectors. With a strong background in managing global and Asia-Pacific sales strategies, Karen drives growth and fosters client relationships across the pharmaceutical and biotechnology industries. She has demonstrated leadership in developing robust business processes to support commercial objectives.

Con Konstantopoulos | Founder and Co-CEO | BSc (Pharmacology, Physiology)

Con leverages over 25 years of expertise in international pharmaceutical supply chains. His strategic approach and innovative thinking have positioned Akesa as a leader in delivering bespoke solutions for clinical trials, enhancing outcomes and forging global partnerships.

Antoine Remiot is N-SIDE's Director of BD and Partnerships. Over the past years, Antoine has been sharing his enthusiasm for lean clinical supply chain management, waste reduction, and sustainability with various pharma partners he supported in their change management journey toward digitalization.
Antoine is passionate about leveraging data and AI to improve clinical supply efficiency. He gained expertise in forecasting, planning, IRT configuration, and end-to-end clinical supply chain optimization through his work on hundreds of trials on multiple indications.

Chris joined Novotech as Clinical Team Leader in 2013, to manage Hong Kong office from inception. He led expansion of Hong Kong team, positioning the company as one of active players in clinical research industry. He also had exposed to China and Taiwan for around a year. Since 2022, he has been heading the clinical operations team across Southeast Asia and Hong Kong and additionally oversees Clinical Lead function at department level for 2 years.

Chris has over 16 years industry experience in multiple settings including CRO, pharmaceutical and academic. In his career, he led various initiatives to improve efficiency and delivery, including the most recent one on implementing changes for trial subject recruitment. He is now driving the capability expansion and site relationship in Southeast Asia countries.

Chris holds a Master of Social Sciences from the University of Hong Kong

Renee’s long professional journey in the pharmaceutical/biotechnology industry enabled her to work or support across multiple GxP areas. She has experiences in production quality control, clinical operations, operational quality management, pharmacovigilance, and clinical research quality assurance -  where majority of her exposure is and where she finds her drive.

Currently at CSL Ltd, Renee provides quality and qualification oversight of third parties involved in their clinical trials globally, manages audit program for specific clinical studies, performs audits, and supports regulatory authority inspections. She was previously with GSK, Quintiles, Eli Lilly, Pfizer, and Ciba-Geigy.

Renee obtained her Bachelor of Science in Pharmacy degree from the University of the Philippines Manila and resides in Melbourne, Australia.

Joy has over 20 years of experience in the pharmaceutical industry, working across a diverse range of cross-functional environments in Clinical Research & Development and Clinical Quality Management. Her expertise spans Good Clinical Practice (GCP), Good Vigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP), and Clinical Good Manufacturing Practice (cGMP).
Currently, Joy serves as the Head of Clinical Quality Assurance Operations for Asia Pacific and the Global Compliance Area Lead for Clinical Vendor Quality Management at CSL Limited, based in Australia.

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.

Dr. Vasee Moorthy is Senior Advisor, Research for Health Department, WHO Science Division, Geneva, Switzerland. Since 2008, he has held progressively senior roles at WHO in malaria vaccine policy development, Ebola vaccine phase 1-2 trials, global norms in sharing research data and results during public health emergencies, WHO R&D Blueprint for action to prevent epidemics, global consensus on clinical trials policy norms, WHO COVID-19 Research & Innovation Roadmap and the WHO Solidarity Trial of therapeutics supporting clinical trials networks in over 40 Member States in all WHO regions, and most recently, the adoption of resolution (WHA75.8) on clinical trials. Prior to joining WHO, Dr. Moorthy worked as a medical researcher at the University of Oxford, UK (2005-2008); with an NGO, PATH, in USA (2003-2005); running a clinical trials programme at MRC Laboratories in The Gambia (1999-2003), and as a government medical officer in Kwazulu/Natal, South Africa (1996-1997). He received a B.A. and M.A. from the University of Cambridge in Natural Sciences, a B.M.B.Ch medical degree and a Ph.D in malaria immunology and clinical trials both from the University of Oxford.

Hyun Kyoung Kim is a Project Director with over 16 years of clinical trial experience in various roles in global CROs. Hyun has earned her B.S. degree in Biochemistry from Northeastern University, USA. Hyun joined Novotech as a project director and she has supported multiple types of emerging biotech clients from Korea and US to operate the clinical trials outside of Korea toward other Asia countries and US with strategical and realistic visions for successful deliverables. Prior to joining Novotech, Hyun was a project manager for various global clinical trials in Asia, Europe, and North America from the protocol development to CSR and also a clinical operations manager for global pharmaceutical company dedicated team. She also bring experiences as a global feasibility manager, who assesses country-level feasibility at earlier stage of the protocol development process.

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.

HLB Therapeutics

Clinical Development Team Lead/2023 - 2024

KoBioLabs

Clinical Development Team Lead/ 2018 – 2023

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.