E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII Working Group on Benefit-Risk Balance for Medicinal Products, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development and received the Senior Fellowship Award, Scientific Leadership in Pharmaceutical Medicine. He earned a BA from Harvard and MD from Stanford Medical School.

Dr. Inho Jo is currently a tenured Professor at Ewha Womans University College of Medicine and serves as the CEO of the Korean Fund for Regenerative Medicine (KFRM). He also holds the position of Editor-in-Chief for Tissue Engineering and Regenerative Medicine, a SCIE journal. He earned his B.A. and M.S. degrees in Pharmacy from Seoul National University, Korea, followed by a Ph.D. in Biophysical Sciences from SUNY at Buffalo in 1989 under the supervision of Prof. Chan Y Jung. After completing his Ph.D., Dr. Jo pursued a postdoctoral fellowship in Professor Morris J. Birnbaum’s lab at the Department of Cellular and Molecular Physiology at Harvard Medical School. Following this, he conducted additional research with Professor H. William Harris at the Nephrology Division of Boston's Children's Hospital, where he also served as an Instructor. Dr. Jo returned to Korea in 1997 and served as a director and general director of the Department of Biomedical Sciences at the Korean National Institutes of Health (NIH). Dr. Jo has published 175 papers and registered 26 patents both domestically and internationally. He has received several awards recognizing his research excellence, including the Research Excellence Award from Ewha Womans University, the Ewha Haengrim Research Award from Ewha Womans University Medical School, the 15th Univera Academic Award from the BioPharmacal Society, and the 2nd BioSolution Research Award from the Korean Tissue Engineering and Regenerative Medicine Society (KTERMS).

Educational Background
- Seoul National University, Ph.D
- KAIST, M.S.
- KAIST, B.S.

Professional Career
- KDDF, CSO
- CrystalGenomics, Pricipal Scientist
- KIST, Research Scientist
- Hanhyo Isnt.Tech., Research Scientist

Major research & Activity
- Drug Discovery & Development(Chemical / Oncology, Inflammation,Inflammation, Infectios Disease, Oncology)
-Project management & Evaluation of new drug development

Biography
An expert on regulatory affairs in Korea pharmaceutical industry with wide range of experience including pharmaceutical products and healthcare products.
- Strategic project manager with successful drug pipeline management including applications of NDA, DMF (API), IND, OTC, and other healthcare products.
- US Regulatory affairs experience in IND application, HA meetings, and orphan drug designation application with US FDA.
- Keeping wide and in-depth regulatory affairs intelligence based on experience in local, multinational pharmaceutical companies and health authorities (MFDS).
- Maintaining good and favorable relationship with MFDS reviewers and RA experts in pharmaceutical companies with scientific communication and credible feedback.

Professional Experience
Jan 2024 - Present Syneos Health Korea
Director, Regulatory Consulting
- Providing strategic and tactical regulatory guidance relating to global drug development. Leading and attending project staff meetings, project team meetings and training sessions.
- Interacting directly with customers and potential customers to explain regulations surrounding assigned regulatory functions; reviews processes and factors affecting project cost estimates.
- Planning and implementing the strategy for medicinal product registration activities for clients.
- Providing timely, accurate information to business management staff regarding hours to be budgeted for assigned regulatory tasks for Requests-for-Proposal (RFP). Reviewing RFPs and budgeted hours for regulatory deliverables and forwards issues to the Project Manager or Functional Manager. Periodically reviews project expenditures for compliance with budgets for assigned tasks.
- Facilitating communication with clinical staff, subject experts, medical writers, project manager, and team members with respect to technical sections of regulatory documents. Providing regulatory review guidance. Helping to resolve any sponsor/investigator issues with regard to technical and non-technical issues.

Apr 2022 - Dec 2023 Freyr Life Science Korea
Associate Director, MPR RA Korea
- Planning and implementing the strategy for medicinal product registration activities for clients
- Responsible for ‘Requests for Proposals’ (RFPs), project evaluations. Support in responding to RFPs for regional regulatory projects.
- Responsible for planning, executing, and coordinating all regulatory activities including pre- submission, scientific advice meetings, new drug applications, major lifecycle maintenance and customer’s market expansion activities
- Preparation of IND dossier and managing the submission of IND applications and health authority meetings.
- Responsible for delivery of regulatory projects, programs and solutions for all regional customer opportunities
- Cross functional ownership of regulatory projects including project evaluation, solutioning and delivery. First point of contact for pre-sales & solutioning for the region, and for customer escalations
- Provide and act on local / regional regulatory intelligence by responding to significant changes in the regional regulatory environment and communicating the impact appropriately among stakeholders

Sep 2020 - Apr 2022 MedPacto
Regulatory Affairs Director, Regulatory Affairs Team
- Preparing a regulatory documents related IND application, health authority meeting (meeting request letter, meeting information package), orphan drug designation application dossier
- Managing HA submissions of IND application and ODD application with a corporation with CROs
- Making a development strategy for new products for MedPacto’s new drug candidates with related stakeholders in company or partner companies
- Manage a communication with health authorities (US FDA, Korea MFDS) related with IND application of vactosertib in cooperation with CROs
- Managing high standard in compliance of RA and related internal and external projects in MedPacto pipeline products
- Leading RA team and supervising clinical supply management and clinical QA

May 2018 - Aug 2020 Bayer Korea
Leader of Consumer Health Regulatory Affairs Team
- Healthcare products registration and launch in Korea: OTC drug, Cosmetic, and Food


Supplements.
- Making a development plan for new products for consumer health division
- Managing high standard in compliance of RA and related internal and external projects in consumer health division
- Providing regulatory intelligence to HQ for new product development strategy and its impact.
- Leading RA team and make a training RA team members.

Jul 2017 - May 2018 Reckitt Benckiser Korea
Head of Regulatory Affairs Team
- Healthcare products registration and launch in Korea: OTC drug, Quasi-drug, Medical Device, Cosmetic, and hygiene products.
- Homecare products registration & launch: K-REACh registration and management of its ingredient with the regulation of Ministry of Environment.
- Managing PV report to MFDS and HQ with 3rd party (as Drug Safety Pharmacist)
- Managing QA process in cosmetic, food supplement, and homecare products

Jul 2013 - Jul 2017 Kowa Korea Company. Ltd.
Regulatory Affairs Team Manager
- Making a development plan for new products in Korea: OTC drug, new drug, and other healthcare products including quasi-drugs, medical device. Achieved successful OTC drug approvals and new drug development strategy for Rx drugs in accordance with HQ timeline.
- Managing PV reports to MFDS and HQ.
- Managing and improving drug import process: local QC testing & QA process.
- Providing regulatory intelligence to HQ for new product development strategy and its impact.
- Leading RA team and make a training RA team member.

Nov 2010 - Jan 2013 Korea Otsuka Pharmaceuticals
Development Team Leader
- Making a development strategy and NDA approval in cooperation with HQ, AP region and local stakeholders (marketing, business development, market access).
- Providing a regulatory intelligence for HQ & other stakeholders.
- Managing multi-national & local clinical trial IND applications with clinical team and 3 country development team (China, Japan, Korea) for development strategy and protocol development.
- Post-approval change managements: labeling, CMC, API manufacturing site and artworks.

Apr 2007 - Oct 2010 Bristol-Myers Squibb Company Korea

Regulatory Affairs Manager
- Project managing of pipeline products for MFDS approval of new drug and biological products including IND submission, NDA filing and its post-approval variations.
- NDA & DMF: ONGLYZA (Saxagliptin), FORXIGA (Dapagliflozin), REYATAZ (Atazanavir)
- IND: more than 30 IND application to MFDS, and many pre-IND meeting with MFDS Brivanib(HCC), YERBOY(Ipilimumab), BELATACEPT, other biological products for cancer
- Post-approval variations: REYATAZ, BARACLUDE, and other mature products
- Reporting regulatory intelligence to HQ. Made the strategic amendment for it.

Jun 2003 - Mar 2007 Yuhan Corporations
Senior Associates of Regulatory Affairs
- Product registration of new drug(REVANEX), generic drugs, OTC drugs, cosmetics.
- Making strategy for drug registration in cooperation with other teams (clinical trial team, institute, and manufacturing site) for new drug, generic products
- Fostering and maintaining the good relationship with MFDS(KFDA) and other Health Authorities
- Maintaining the product license in terms of label revisions, CMC updates and post-marketing surveillance reports in accordance with the regulatory authority’s regulations

Dec 1999 - Mar 2003 The Korea Pharmaceutical Information Center
Drug Information Team Manager
- The building and management of drug information database for the drug store’s prescription management program and the publication of Drug Information Handbooks and other books

Jul 1996 - Feb 1999 The Ministry of Food and Drug Safety
MFDS Officer (reviewer)
- NDA review including the safety & efficacy review and other variation applications.
- Reviewing and making approval of IND applications & approval.
- Site inspections for GCP and GMP compliance check
- The management of drug safety information (Pharmacovigilance) and drug re-evaluation.

Languages
English - Speaking, Reading, Writing
Korean - Speaking, Reading, Writing - Native

Professional Certifications & Licensures
Regulatory Affairs Certified (RAC US, by RAPS)
- May-2014

Education
2017 Dongguk University - Korea, Republic of
Masters - MBA

1997 Graduate school of ChungAng University - Korea, Republic of
Masters - Pharmaceutical Microbiology

1994 ChungAng University - Korea, Republic of
Bachelor - Pharmacy

1994 - Korea, Republic of
Licensed Pharmacist

Dr. Bell is VP of Translational Medicine and Regulatory Affairs at Neuraly, Inc, a US subsidiary of D&D Pharmatech (Korea). He obtained his PhD in molecular biology at the University of Buffalo, then completed a post-doctoral fellowship at the National Institutes of Health where he was a recipient of the Fellows Award for Research Excellence. In 2000, while at Human Genome Sciences, he was the inventor and project lead for Albugon (Albiglutide), one of the first long-acting GLP-1R agonists. Albugon was licensed by GSK and approved for the treatment of diabetes in 2014 (Tanzium®). At CoGenesys, a spin-out of HGS, Dr. Bell assumed responsibility for Regulatory Affairs and was Director of Medical and Scientific Affairs. With products for oncology, heart failure, and diabetes, the company filed 3 INDs in 18 months and initiated Phase 1 and 2 trials before being acquired by Teva Pharmaceuticals. With a 25-year career at both small and large biotech, big Pharma, and a CRO, Dr. Bell has participated in discovery and early clinical development for >20 products in the US, Canada, Europe, Russia, Ukraine, Poland, Hungary, and parts of Africa.
Most recently, Dr. Bell joined Neuraly to help develop two innovative GLP-1R agonists. NLY01 is being developed as a potential treatment of neurodegenerative diseases and was recently shown to reduce motor function deficit in young patients with early, untreated Parkinson’s disease. DD01 is being developed to treat obesity-related disorders like MASH. The company is also developing TLY012, a novel and potent anti-fibrotic with potential use in the treatment of multiple diseases including liver fibrosis/cirrhosis, chronic pancreatitis, and scleroderma. Since joining, the company has cleared 6 INDs, obtained two orphan drug designations for TLY012, was granted Fast Track designation for DD01, and successfully executed multiple Phase 1 and Phase 2 trials in the US, Canada, and Germany.

2004 Internship, Asan Medical Center, Korea
2006-2011 Resident, fellow, Asan Medical Center, Korea
2012 Staff, Seoul National University Bundang Hospital
2013-2020 Clinical instructor, Assistant professor, Asan Medical Center, Korea
2017.8-2018.07 Visiting scholar, University of Washington, US
2021- Associate professor, Asan Medical Center, Korea

Expansion of tumor-infiltrating lymphocytes in non-small cell lung cancer: Clinical potential and efficacy in EGFR mutation subsets. Lee H, Lee M, Lim CL, Park HS, Song IH, Jeong BK, Kim DK, Kim YH, Choi S, Lee GD, Lee SB, Jung S, Gong G, Kim SB, Yoo C, Kim JY, Lee HJ. Clin Immunol. 2024 Jun 20;265:110289.
Persistence and enrichment of dominant T cell clonotypes in expanded tumor-infiltrating lymphocytes of breast cancer. Ham B, Kim SY, Kim YA, Han D, Park T, Cha S, Jung S, Kim JH, Park G, Gong G, Lee HJ, Shin J. Br J Cancer. 2024 May 15. doi: 10.1038/s41416-024-02707-6. Online ahead of print.
Expansion of tumor-infiltrating lymphocytes from head and neck squamous cell carcinoma to assess the potential of adoptive cell therapy. Choi S, Hossain M, Lee H, Baek J, Park HS, Lim CL, Han D, Park T, Kim JH, Gong G, Kweon MN, Lee HJ. Cancer Immunol Immunother. 2024 Apr 17;73(6):101.
Analysis and Development of Antigen-specific T Cells Derived from Peripheral Blood Mononuclear Cells of Healthy Donors. Kim J, Jung S, Jeong BK, Kim KA, Jisu J, Bang WS, Ham B, Kim JY, Kim YA, Lee HJ. Anticancer Res. 2024 Apr;44(4):1377-1387.
Factors associated with engraftment success of patient-derived xenografts of breast cancer. Lee J, Lee G, Park HS, Jeong BK, Gong G, Jeong JH, Lee HJ. Breast Cancer Res. 2024 Mar 21;26(1):49.
Proteomic analysis of breast cancer based on immune subtypes. Jeon Y, Lee G, Jeong H, Gong G, Kim J, Kim K, Jeong JH, Lee HJ. Clin Proteomics. 2024 Feb 29;21(1):17.
Tumor-infiltrating lymphocyte therapy: Clinical aspects and future developments in this breakthrough cancer treatment. Lee H, Kim K, Chung J, Hossain M, Lee HJ. Bioessays. 2023 Jul;45(7):e2200204.

Bio Essay
Dr. Wooseok Han is the Chief Scientific Officer at Cyrus Therapeutics, based in Seoul, Korea. He began his industrial career in 2005 at Chiron in Emeryville, California, which was soon acquired by Novartis. Over the next 15 years, Dr. Han developed his expertise as a medicinal chemist in the fields of oncology and infectious diseases at Novartis Institutes for BioMedical Research (NIBR), working in both Emeryville, California, and Cambridge, Massachusetts.
Prior to joining the industry, Dr. Han completed a postdoctoral fellowship at The Scripps Research Institute in the Boger group, focusing on the total synthesis of complestatin. He earned his Ph.D. in organic chemistry from the University of Toronto. Before pursuing his career overseas, Dr. Han worked at the Hansol Paper Institute of Technology for five years. He holds a B.S. in Chemistry from Yonsei University and an M.S. in Organic Chemistry from the Korea Advanced Institute of Science and Technology (KAIST) in South Korea.

Education
1998-2003 Ph.D. University of Toronto
1990-1992 M.S. Korea Advanced Institute of Science & Technology
1985-1989 B.S. Yonsei University

Professional Careers
2020-present Executive Vice President / CSO, Cyrus Therapeutics, Korea
2006-2020 Principal Scientist, Global Discovery Chemistry, Novartis Institutes for BioMedical Research, U.S.A.
2005-2006 Scientist, Biopharma, Chiron Corporation, U.S.A.
2003-2005 Post-doctoral Research Fellow, Department of Chemistry, The Scripps Research Institute, U.S.A.
1992-1997 Scientist, Chemical Research, Hansol Paper Institute of Technology, Korea

Awards
Spotlight NRG Award, Novartis Institutes of BioMedical Research, U.S.A. in 2018
Fusion Team NRG Award, Novartis Institutes of BioMedical Research, U.S.A. in 2013
Catalyst Award, Novartis Institutes of BioMedical Research, U.S.A. in 2008
Innovative Idea Glow Cue Trophy, Novartis Institutes of BioMedical Research, U.S.A. in 2008
Inventor Recognition Award, Novartis Institutes of BioMedical Research, U.S.A. in 2006
IR52 Jand Young Shil Award, The Minister of Science & Technology, Korea in 1994

Representative Publications
1. Synthesis and Structure?Activity Relationship of Tetra-substituted Cyclohexyl Diol Inhibitors of PIM Kinases, Han, W.; Ding, Yu.; Chen, Z.; Nishiguchi, G. A.; Atallah, G.; Bellamacina, C.; Lindvall, M.; Zang, R.; Feucht, P.; Zavorotinskaya, T.; Dai, Y.; Garcia, P.; Burger, M. T. J. Med. Chem. 2020, 63, 14885
2. Two Distinct Mechanisms of Small Molecule Inhibition of LpxA Acyltransferase Essential for Lipopolysaccharide Biosynthesis, Han, W.; Ma, X.; Balibar, C. J.; Rath, C. M. B.; Benton, B.; Bermingham, A.; Casey, F.; Chie-Leon, B.; Cho, M-.K. ; Frank, A. O.; Frommlet, A.; Ho, C-.M.; Lee, P. S.; Li, M.; Lingel, A.; Ma, S.; Merritt, H.; Ornelas, E.; de Pascale, G.; Prathapam, R.; Prosen, K. R.; Raper, D.; Ruzin, A.; Sawyer, W.; Shaul, J.; Shen, X.; Shia, S.; Steffek, M.; Subramanian, S.; Vo, J.; Wang, F.; Wartchow, C.; Uehara, T., J. Am. Chem. Soc. 2020, 142, 4445
3. Discovery of a Selective and Potent Inhibitor of Mitogen-Activated Protein Kinase-Interacting Kinases 1 and 2 (MNK1/2) Utilizing Structure-Based Drug Design, Han, W.; Ding, Yu.; Xu, Y.; Pfister, K.; Zhu, S.; Warne, B.; Doyle, M.; Aikawa, M.; Amiri, P.; Appleton, B.; Stuart, D. D.; Fanidi, A.; Shafer, C. M., J. Med. Chem. 2016, 59, 3034
4. Discovery of Imidazo[1,2-a]-pyridine Inhibitors of Pan-PI3 Kinases that are Efficacious in a Mouse Xenograft Model, Han, W.; Menezes, D.; Xu, Y.; Knapp, M. S.; Elling, R.; Burger, M. T.; Ni, Z-. J.; Smith, A.; Lan, J.; Williams, T. E.; Verhagen, J.; Huh, K.; Merritt, H.; Chan, J.; Kaufman, S.; Voliva, C. F.; Pecchi, S., Bioorg & Med Chem Lett. 2016, 26, 742
5. Structure Guided Optimization, in Vitro Activity, and in Vivo Activity of Pan-PIM Kinase Inhibitors, Burger, M. T.; Han, W.; Lan, J.; Nishiguchi, G.; Bellamacina, C.; Lindval, M.; Atallah, G.; Ding, Y.; Mathur, M.; McBride, C.; Beans, E. L.; Muller, K.; Tamez, V.; Zhang, Y.; Huh, K.; Feucht, P.; Zavorotinskaya, T.; Dai, Y.; Holash, J.; Castillo, J.; Langowski, J.; Wang, Y.; Chen, M. Y.; Garcia, P. D., ACS Med. Chem. Lett. 2013, 4, 1193

Thesis
Ph.D. Development of [18F]Halofluorination and [18F]Fluoride Ion Displacement Reactions for the Synthesis of F-18 Labeled Radiopharmaceuticals.
(with Prof. John A. Katzenellenbogen)

M.S. Photocyclization Reactions of 5,7-Dimethoxycoumarin with Tetramethyl-ethylene and Thymidine. (with Prof. Sang Chul Shim)

B.S. Photochemical Reactions of Molybdosilisic Acid with Organic Compounds.
(with Prof. Hyunsoo So)

Employment
1999. 11 ? present CEO, FutureChem Co., Ltd.
2017. 9 ? present CEO, FutureChem Healthcare Co., Ltd.
2018. 1 ? present CEO, SI Healthcare Co., Ltd.
2022. 9 ? present Emeritus Professor, Department of Chemistry, Sogang University, Seoul, Korea.
2009. 1 ? 2020. 8 Professor, Department of Chemistry, Sogang University, Seoul, Korea.
2009. 9 ? 2014. 12　 Director of Converging Research Headquarter for Frontier Medical Instruments
2009. 7 ? 2014. 6 Head of Converging Research Center for PET Radiopharmaceuticals
2010. 3 ? 2011. 2　 Adjunct Professor, College of Medicine, Ulsan University
2002. 3 ? 2003. 2 Invited Professor, Department of Nuclear Medicine, Seoul National University Hospital, Seoul, Korea.
2003. 9 - 2004. 8 Visiting Professor, Department of Chemistry, University of Illinois, Urbana, Illinois, U.S.A.
2002. 6 - 2004. 2 Outside Director of Hansol Chemicals
1995. 9 - 2008. 12 Professor, Department of Chemistry, Inha University, Inchon, Korea.
1994. 4 - 1995. 9 Director of PET Center, Department of Nuclear Medicine, Samsung Medical Center, Seoul, Korea.
1992. 2 - 1994. 5 Research Associate, Department of Chemistry, University of Illinois, Urbana, Illinois, U.S.A.
1988. 2 - 1992. 2 Senior Research Scientist, Medicinal Chemistry Laboratory, Korea Institute of Science and Technology, Seoul, Korea.
1986. 10 - 1988. 2 Postdoctoral Research Fellow, Department of Chemistry, University of California, Berkeley, California, U.S.A.
1979. 2 - 1982. 6 Research Scientist, Catalyst Chemistry Laboratory, Korea Institute of Science and Technology, Seoul, Korea.

He spent all his carrier developing methodologies of fluorine-18 and technetium-99m since 1982. He collaborates extensively with other researchers in Korea and internationally. He published around 220 scientific papers, and 7 book chapters and filed more than 100 patents. Since he retired from Sogang University, Department of Chemistry on Aug. 31, 2020, he is actively working as the CEO of three companies as well as an Emeritus Professor of Sogang University. As his company has a Research Institute of Labeling, he can develop radiopharmaceuticals continuously.

Education
- Chartered Financial Analyst
- MBA, INSEAD (France/Singapore)
- Bachelor’s degree in Oriental Pharmacy, Kyung Hee University (Korea)
Experience
- Team Lead, Strategic Planning, CJ Biosciences
- Head of Business Development, ImmuneOncia Therapeutics
- Manager, Business Development, SK biopharmaceuticals
- Consultant, Clinical Development, Eli Lilly and Company
- Associate, Regulatory and Medical Affairs, Ferring Pharmaceuticals

Hyun Jung Helen Lee MD, MHCM is a board-certified OBGYN physician and an experienced
pharmaceutical professional with 28 years’ experience in health care and pharmaceutical industry.
She has experienced in oncology drug development in Global, US and Asia regions working in early and
late stages from phase I to III and has the first hand regulatory experience as a medical lead for the
submission to the FDA/EMA and other regulatory agencies like PMDA.
As a Global Head of clinical development for solid tumor in Shire/Baxalta, she successfully led Onivyde
program receiving market authorization in pancreatic cancer from EMA in 2016. She worked as a Global
Lead for clinical development of Pacritinib in Baxalta/Baxter leading NDA and MAA submissions for
myelofibrosis indication of Pacritinib in 2015. She worked as a medical lead for the submission of head
and neck cancer indication for Erbitux in Eli Lilly leading clinical and registration strategy and
successfully received approval from the FDA in 2011.
She also has experience in oncology medical affairs in Global, US and Asia region leading the
development and execution of new and marketed products’ clinical and lifecycle plans such as Pacritinib,
Erbitux, Alimta and Sutent. She also has extensive product launch and commercialization experience in
those oncology drugs.
She has a deep expertise in setting up and executing innovative corporate and R&D strategies.
She was one of the initial members of Baxter Oncology Business Unit and played the main role in
creating blueprint and developing the strategy of Baxter Oncology working with cross functional teams
and leading its execution successfully. After joining Samyang Biopharm, she established the first US
subsidiary of Samyang Biopharm as President/CEO from scratch in Cambridge, MA in 2018 and grew it
to the organization of 10 full time employees and 10 part time dedicated consultants in-licensing two
innovative oncology drugs in 2019. As CEO of R&D in CHA Biotech, she launched one of the most
innovative cancer treatment platform of CAR-NK therapy in 2023.
She was featured in the 2020 PharmaVOICE 100, a listing of 100 of the most Inspiring People in Life
Sciences Industry in the USA.
She holds a M.D. from Yonsei University Medical School and a M.S. in Health Care Management
(MHCM) from Harvard School of Public Health.

PRESENT EMPLOYMENT and PREVIOUS WORK EXPERIENCE
Chief Operating Officer: March 2022 to Present Elevar Therapeutics
Duties and responsibilities include:
Oversee all corporate activities related to NDA preparation, including clinical development, quality assurance, CMC, regulatory affair, and program management.

Lead Pharmacologist: January 2015 to February 2022 GS-0405-15; full time
Division of Infectious Disease Pharmacology (DIDP)
Office of Clinical Pharmacology (OCP); Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

Acting Deputy Division Director: April 2018 to August 2018 GS-0405-15; full time
Division of Generic Drug Bioequivalence Evaluation (DGDBE)
Office of Study Integrity and Surveillance (OSIS); Office of Translational Sciences (OTS) Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

Clinical Pharmacology/Biopharmaceutics Reviewer: September 2002 to December 2014 GS-0405-14; full time

EDUCATION
Postdoctoral Researcher, December 1999 ? September 2002 The Ohio State University, Columbus, Ohio
? Major research projects involved: PK-PD based cancer chemotherapy, application to drug combination therapy and drug delivery into solid tumors
? Development of better treatment schedule of paclitaxel
? Combination therapy using suramin, a growth factor inhibitor, and anticancer drugs such as paclitaxel, 5-FU, gemcitabine, and mitomycin C against solid tumors including renal and bladder cancers

Ph.D. in Pharmaceutics, December 1999 The Ohio State University, Columbus, OH
? Dissertation: Intracellular pharmacokinetics of paclitaxel: Relationship with pharmacodynamics and therapeutic implication
? Advisor: Dr. Jessie L.-S. Au, Professor in Pharmaceutics

M.S. in Pharmacokinetics, February 1992 Seoul National University, Korea

? Thesis: Pharmacokinetics and pharmacodynamics of furosemide after intravenous and oral administration to spontaneously hypertensive rats and DOCA-salt induced hypertensive rats
? Advisor: Dr. Myung G. Lee, Professor in Pharmacokinetics

B.S. in Pharmacy, February 1990 Seoul National University, Korea

LEADERSHIP and COMMUNICATION TRAINING
Advanced Leadership Program, JP Consultants, August 2018 ? June 2019
Team Leader Competence Program, JP Consultants, September 2016 to June 2017
Excellence in Government (EIG) Fellows Program, Center for Government Leadership, October 2013 to June 2014Uncivil servant: holding federal employees accountable; FDA: July 15 - 16, 2015

SELECTED INVITED PRESENTATIONS

The Korean Society of Pharmaceutical Sciences and Technology: Interdisciplinary Approach in the 4th Industry Era for Drug Development (December 2021) “Role of Clinical Pharmacology in Streamlined Drug Development Pathways: Cases and Lessons”

ASCPT Pre-Conference Workshop: Translational and Clinical Pharmacology Advances in Anti-infective Development (March 2020). “Regulatory Considerations and Streamlined Pathways for Anti-Infectives”

Seoul National University Hospital ‘The New Drug Clinical Development Specialist Course’ (October 2019) “Expedited Drug Development Programs for Serious Conditions:
Role of Clinical Pharmacology”

ASM/ESCMID Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance (September 2019). “Drug Development to Meet the Challenge of Antimicrobial Resistance: Role of Clinical Pharmacology”

Graduate School of Pharmaceutical Sciences, Ewha Womans University (January 2018) “Introductory Regulatory Sciences: Application of Clinical Pharmacology in drug development”

NIAID Workshop: ‘PKPD for Development of Therapeutics Against Bacterial Pathogens’ (June 2017). “Application of PKPD for Regulatory Decisions in Anti-Infective Drug Development: Perspectives and Challenges”

1st Ewha Health Care and Global Pharma Industry Forum 2016 (September 2016). “ Antibacterial Drug Development for Patients with Unmet Medical Need”

American Society for Microbiology Microbe 2016 (June 2016) “Recommendation of antibacterial drug dosing regimens for patients with renal impairment based on safety and efficacy data as well as pharmacokinetic data: Examples from the FDA-approved labels.”

Ajou Research Institute for Innovative Medicine, 1st International Workshop for Model-based Drug Development (May 2015). “Application of Modeling and Simulation in Antibacterial Drug Development”

Clinical Trials Transformation Initiative (CTTI): Statistical Issues Think Tank II (November 2014). “Application of Pharmacokinetics/Pharmacodynamics in New Anti-Infective Drug Development: Current Challenges and Future Perspectives”

PUBLICATIONS

Hiwot Hiruy, Shukal Bala, James M. Byrne, Kerian Grande Roche, Seong H. Jang, Peter Kim, Sumathi Nambiar, Dan Rubin, Yuliya Yasinskaya, Laura H. Bachmann, Kyle Bernstein, Radu Botgros, Sue Cammarata, Ricardo L. Chaves, Carolyn D. Deal, George L. Drusano, Erin M. Duffy, Ann E. Eakin, Steve Gelone, Thomas Hiltke, Edward W. Hook, Ann E. Jerse, Candice J. McNeil, Lori Newman, Seamus O’Brien, Caroline Perry, Hilary E. L. Reno, Raul A. Romaguera, Junko Sato, Magnus Unemo, Teodora E. C. Wi, Kimberly Workowski, Graeme A. O’May, Sunita J. Shukla, and John J. Farley. FDA, CDC and NIH Co-sponsored Public Workshop Summary?
Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea. Clin. Infect. Dis. accepted 2024

Seong Jang, Bill Strickland, Lynda Finis, Jeffrey J. Kooijman, Janneke J. T. M. Melis, Guido
J. R. Zaman and Jan Van Tornout. Comparative biochemical kinase activity analysis identifies rivoceranib as a highly selective VEGFR2 inhibitor. Cancer Chemother. Pharmacol. 91:491-499, 2023

Xiaohui Wei, Shabnam Naseer, Edward A Weinstein, Dmitri Iarikov, Sumathi Nambiar, Kellie S Reynolds, Seong H Jang. Cefiderocol Dosing for Patients Receiving Continuous Renal Replacement Therapy. Clin. Pharmacol. Ther. 112(5):1004-1007, 2022

Luning Zhuang, Kunyi Wu, Seong Jang, Kellie Reynolds, Shrimant Mishra, and Dmitri Iarikov. Application of Population Pharmacokinetic Modeling, Exposure-Response Analysis, and Classification and Regression Tree Analysis to Support Dosage Regimen and Therapeutic Drug Monitoring of Plazomicin in Complicated Urinary Tract Infection Patients with Renal Impairment. Antimicrob. Agents Chemother. doi:10.1128/aac.02074-21, 2022

Ursula Waack, Abhay Joshi, Seong H Jang, Kellie S Reynolds. Variations in Pharmacokinetic-Pharmacodynamic Target Values Across MICs and Their Potential Impact on Determination of Susceptibility Test Interpretive Criteria. J. Antimicrob. Chemother.
76:2884-2889, 2021

Seong H. Jang. Regulatory Considerations and Streamlined Development Programs for Antibacterial Drugs for Serious Bacterial Diseases. Clin. Pharmacol. Ther. https://doi.org/10.1002/cpt.2144, 2021

Shabnam Naseer, Edward A Weinstein, Daniel B Rubin, Kalavati Suvarna, Xiaohui Wei, Karen Higgins, Avery Goodwin, Seong H Jang, Dmitri Iarikov, John Farley, Sumathi Nambiar. US Food and Drug Administration (FDA): Benefit-Risk Considerations for Cefiderocol (Fetroja®). Clin. Infect. Dis. 72:e1103-e1111, 2021

L Zhuang, Y Yu, X Wei, J Florian, SH Jang, KS Reynolds, and Y Wang. Evaluation of Hemodialysis Effect on Pharmacokinetics of Meropenem/Vaborbactam in End-Stage Renal Disease Patients using Modeling and Simulation. J. Clin. Pharmacol. 60: 1011-1021, 2020

ML Rizk, SM Bhavnani, G Drusano, A Dane, AE Eakin, T Guina, SH Jang, JF Tomayko, J Wang, L Zhuang, and TP Lodise. Considerations for Dose Selection and Clinical Pharmacokinetics/Pharmacodynamics for the Development of Antibacterial Agents.
Antimicrob. Agents Chemother. 63: e02309-18. 2019


SH Jang, Z Yan, and JA Lazor. Therapeutic Drug Monitoring: A Patient Management Tool for Precision Medicine. Clin. Pharmacol. Ther. 99:148-150, 2016

SH Jang, PM Colangelo, and JVS Gobburu. Exposure?Response of Posaconazole Used for Prophylaxis Against Invasive Fungal Infections: Evaluating the Need to Adjust Doses Based on Drug Concentrations in Plasma. Clin. Pharmacol. Ther. 88:115-119, 2010

VA Bhattaram, C Bonapace, DM Chilukuri, JZ Duan, C Garnett, JVS Gobburu, SH Jang, L Kenna, LJ Lesko, R Madabushi, Y Men, JR Powell, W Qiu, RP Ramchandani, CW Tornoe, Y Wang and JJ Zheng. Impact of Pharmcometric Reviews on New Drug Approval and Labeling Decisions-Survey of 31 New Drug Applications Submitted between 2005 and 2006. Clin.
Pharmacol. Ther. 81:213-221, 2007

Seong H. Jang, M. Guillaume Wientjes, Dan Lu, and Jessie L.-S. Au. Drug Transport and Delivery in Solid Tumors. Pharm. Res. 20:1337-1350, 2003

Seong H. Jang, M. Guillaume Wientjes, and Jessie L.-S. Au. Inter-dependent Effect of P- glycoprotein-mediated Drug Efflux and Intracellular Drug Binding on Intracellular Paclitaxel Pharmacokinetics: Application of Computational Modeling. J. Pharmacol. Exp. Ther.
304:773-780, 2003

Dong Li, Seong H. Jang, Jonghan Kim, M. Guillaume Wientjes, and Jessie L.-S. Au. Enhanced Drug-Induced Apoptosis Associated with P-glycoprotein Overexpression is Specific to Antimicrotubule Agents. Pharm. Res. 20:45-50, 2003

Jessie L.-S. Au, Seong H. Jang and M. Guillaume Wientjes. Clinical Aspects of Drug Delivery to Tumors. J. Control. Release 78:81-95, 2002

Seong H. Jang, M. Guillaume Wientjes, and Jessie L.-S. Au. Kinetics of P-glycoprotein- Mediated Efflux of Paclitaxel. J. Pharmacol. Exp. Ther. 298:1236-1242, 2001

Jessie L.-S. Au, Seong H. Jang, Jenny Zheng, Chiung-Tong Chen, Saeheum Song, Leijun Hu, and M. Guillaume Wientjes. Determinants of Drug Delivery and Transport to Solid Tumors. J. Control. Release 74:31-46, 2001

Seong H. Jang, M. Guillaume Wientjes, and Jessie L.-S. Au. Determinants of Paclitaxel Uptake, Accumulation and Retention in Solid Tumors. Invest. New Drugs 19:113-123, 2001

Seong H. Jang, M. Guillaume Wientjes, and Jessie L.-S. Au. Enhancement of Paclitaxel Delivery to Solid Tumors by Apoptosis-Inducing Pretreatment: Effect of Treatment Schedule. J. Pharmacol. Exp. Ther. 296:1035-1042, 2001

Hyo-Jeong Kuh, Seong H. Jang, M. Guillaume Wientjes, and Jessie L.-S. Au. Computational Model of Intracellular Pharmacokinetics of Paclitaxel. J. Pharmacol. Exp. Ther. 293:761-770, 2000

Hyo-Jeong Kuh, Seong H. Jang, M. Guillaume Wientjes, Jean R. Weaver, and Jessie L.-S. Au. Determinants of Paclitaxel Penetration and Accumulation in Human Solid Tumor. J. Pharmacol. Exp. Ther. 290:871-880, 1999

Jessie L-S. Au, Dong Li, Yuebo Gan, Xiang Gao, Andrew L. Johnson, Jeffrey Johnston, Nancy J. Millenbaugh, Seong H. Jang, Hyo-Jeong Kuh, Chiung-Tong Chen, and M.

Guillaume Wientjes. Pharmacodynamics of Immediate and Delayed effects of Paclitaxel: Role of Slow Apoptosis and Intracellular Drug Retention. Cancer Res. 58:2141-2148, 1998

Eunsun Cho, Seong H. Jang, Jong W. Lee, Nak D. Kim and Myung G. Lee, Metabolic Changes of Acetaminophen after Intravenous Administration to Rats Pretreated with a Hepatoprotective Agent, YH-439, Res. Com. Mol. Pathol. Pharmacol. 91: 3-16, 1996

Seong H. Jang, Min H. Lee and Myung G. Lee, Pharmacokinetics of Acetaminophen after Intravenous and Oral administration to Spontaneously Hypertensive Rats and Normotensive Wistar rats. J. Pharm. Sci. 83: 810-814, 1994

Seong H. Jang, Myung G. Lee and Nak D. Kim, Pharmacokinetics and Pharmacodynamics of Furosemide after Intravenous and Oral Administration to Spontaneously Hypertensive Rats and DOCA-salt Induced Hypertensive Rats. Biopharm. Drug Dispos. 15: 185-206, 1994

Woo H. Yoon, Eun J. Yoon, Seong H. Jang, Sun H. Lee, Hee J. Lee, Jeong M. Park, Kyung
E. Choi and Myung G. Lee, Pharmacokinetics of Ciprofloxacin After Intravenous Administration of Ciprofloxacin-TOF in rabbits. Int. J. Pharm. 102: 249-255, 1994

Sun H. Lee, Woo H. Yoon, Seong H. Jang, Kye S. Han, Kyung-Hoon Jeong, In S. Kim and Myung G. Lee, Pharmacokinetics of a 22kDa Variant of Unlabeled Monomeric Human Growth Hormone in Rabbits. Int. J. Pharm. 90: 81-86, 1993

Seong H. Jang, Sun H. Lee, Si H. Ryoo, Soon H. Kim and Myung G. Lee, Dose-independent Pharmacokinetics of Recombinant Human Interferon-αA in Rabbits. Int. J. Pharm. 84: 273- 278, 1992

Young M. Choi, Sun H. Lee, Seong H. Jang and Myung G. Lee, Effects of Phenobarbital and 3-Methylcholanthrene Pretreatment on the Pharmacokinetics and the Pharmacodynamics of Bumetanide in Rat. Biopharm. Drug Dispos. 12: 311-324, 1991.

Experience
More than 10 years of experience within the EU regulatory system, including regular interactions with FDA, Health Canada, Swiss Medic, PMDA, and other health/medicines authorities and agencies.
Served at the European Medicines Agency (EMA) as a member of the Committee for Medicinal Products for Human Use (CHMP) for >6 years.
Member and Chair of CHMP’s Oncology Working Party (ONCWP).
Dr. Sarac has also served as a member of the Committee for Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP) at the EMA.
He has attended +100 meetings in CHMP, CAT, and SAWP, and countless Oral Explanations in CHMP and CAT.
At Parexel, he is responsible for providing strategic, clinical, and technical advice to clients, especially regarding clinical development strategy, marketing authorization, scientific advice submissions, pre-IND, IND, NDA, BLA, MAA, ODD, PRIME, Fast track, Breakthrough designation, high-stake FDA/EMA meetings, etc.
Location
Located in Copenhagen, Denmark (EU)

Education

Dec. 1997 Post-doc. in Chemistry: The University of Chicago, Chicago, IL.
Dec. 1995 Ph.D. in Chemistry and Chemical Biology: Harvard University, Cambridge, MA.
Graduate Student under the direction of Professor E. J. Corey (Novel laureate 1990 in Chemistry).
Feb. 1988 M.S. in Organic Chemistry: Sogang University, Seoul, Korea
Feb. 1986 B.S. in Chemistry (major) and Physics (minor): Sogang University, Seoul, Korea

Employment History and Research Experience

Jan. 2024 ? current: Avelos Therapeutics, Inc. CEO/CTO, Seoul, Korea
Responsible for R&D and corporate operation
Overviewing and running all R&D programs for the areas of Oncology.
Oct. 2021 ? Dec. 2023: Avelos Therapeutics, Inc. CTO, EVP of Corporate, Seoul, Korea
Avelos Therapeutics Inc. focuses Drug discovery research in human Cancer.

July 2019 ? Sep. 2021: Hana Pharm: CTO, EVP of R&D and BD, Gyunggi-do, Rep. of Korea
Hana Pharm. is specialized in CNS medicines: anesthesia and pain killer in Korea.
Responsible for leading the research and global BD, reporting to the CEO
Overviewing and running all R&D programs: Oncology, Pain disease and Contrasting agent.
Managing Chemical Process unit and Improved modified drug units
January 2018 ? June 2019: Yuhan USA, CEO/President
June 2017 ? June 2019: Yuhan Corporation: CSO, EVP of R&D, Gyunggi-do, Rep. of Korea
Yuhan Corp. is #1 pharmaceutical company in Korea by sales.
Responsible for leading the research and R&D BD function reporting to the CEO
Established and Managed Yuhan USA as advanced bases for global research business in US.
Managed New Drug discovery unit, Chemical Process unit and Improved modified drug unit
Led partnering strategy, partner identification, due-diligence and term-sheet negotiation
? Completed a worldwide licensing transaction for two major projects to Janssen for NSCLC ($50M upfront and $1.2B total milestone and Gilead for NASH programs ($15M upfront and $780M total milestone) in 2018, with profit share option in specific indications; Set up decision for a global licensing deal for NASH program with BI ($40M upfront and $870M total milestone) in 2019.
December 2014 ? May 2017: Mogam Biotechnology Institute/Green Cross Corp, Gyunggi-do, ROK
February 2012 ? Nov. 2014: Green Cross Corp.: Gyunggi-do, Rep. of Korea
Green Cross Corp. is #2 pharmaceutical company (#1 Biopharmaceutical company) in Korea by sales.
Director/Investigator; Team Leader of Chemistry and Chemical Biology
Overviewed all chemical drug discovery programs
Clinical and non-clinical research, CRO, CMO and cGMP manager
? Achieved China licensing agreement with Lee’s Pharm to develop and commercialize the investigational anticoagulant.
? Licensed out for clinical development of SGLT2 inhibitor to Daewoong Pharmaceutical company; Approved for marketing in Korea.

December 2002 ? 01/2012: PTC Therapeutics, Inc.: South Plainfield, NJ 07080
Group Leader; Department of Chemistry
? Licensed out for clinical development of SMA inhibitor to Roche; Approved for marketing in US, Europe and Korea.
January 1998 ? 12/ 2002: Bayer Corp.: Pharmaceutical Division; West Haven, CT 06516
Sr. Research Scientist; Department of Chemistry Research

EDUCATION
Ph.D. Department of Life Science, Gwangju Institute of Science and Technology (GIST), Gwangju, Korea (2013)
M. S. Department of Life Science, GIST, Gwangju, Korea (2004)
B. S. Department of Biology and Food Science, HandongUniversity, Pohang, Korea (2003)

EXPERIENCE
Principal Scientist; LigaChem Biosciences, Inc. Korea (Dec. 2016 ? present)
Senior Researcher; Korea Institute of Ceramic Engineering & Technology Korea (Oct. 2015 ? Nov. 2016)
Postdoctoral Fellow; Scripps Korea Antibody Institute, Korea (2013 ? 2015)

LICENSING-OUT
[1] DLK1-targeted antibody-drug conjugate. 2020.12. Pyxis Oncology. Project Lead
[2] ADC platform technology. 2022.12. Amgen. Project Lead
[3] TROP2-targeted antibody-drug conjugate. 2023.12. Janssen Biotechnology. Project Lead

Profile:
Baljit (Boo) Samra is a senior executive at Parexel, where he oversees clinical operations across 14 countries in the Asia-Pacific region, including China, Japan, Korea, Taiwan, Australia, and Southeast Asia. Leading a team of over 1,600 employees, Boo focuses on ensuring quality delivery, productivity, and customer and site satisfaction.

Work Experience:
Boo joined Parexel in 2020 after serving as the Chief Operating Officer at Duke Clinical Research Institute (DCRI) and as a strategic advisor to academia, CROs, biotech, and private equity firms. He is also an advisory board member for organizations in biotech, artificial intelligence, and digital technology sectors. Boo’s comprehensive expertise includes clinical trial strategy, planning, and execution; mergers and acquisitions; and digital health technologies. His first tenure at Parexel (2002-2016) included leadership roles in IT, quality, operations, general management, and strategic account leadership. His global experience extends beyond the Asia-Pacific region to include India, Europe, and the United States.?

Education:
Boo holds a degree in Chemistry from the University of Manchester Institute of Science and Technology (UMIST) in the United Kingdom

Featured Experiences
[Experiences in Clinical Trials / Head of Clinical Research, Global Clinical Trial Manager]

? Leadership position for country/region Clinical Operations under Clinical Services division in AIMS
? Acts as primary liaison with clients (Pharmaceutical company, Biotech located in US, Korea, AUS
? Leads and directs cross-functional team leaders and third parties/vendors
? Advisory on early-stage clinical design and Development Master Plan, including Targeted potential product
? Support to develop the pathway to License In and Out
? Develop strategies for clinical trial protocols, operational design, and planning, taking into client's requirements and the medical aspects of the market
? Consultation on quality control process including audit and inspection during the full life-cycle of clinical trials
? Overseeing and proactively driving activities of project progress and plans for client
? Taking responsibility for the timely development of clinical trial budget/milestones, investigator grants, and executing Clinical Trial Agreement during the start-up stage of a Clinical Trial
? Working collaboratively with key stakeholders and establishing project/country/site activation plans including risk assessments and mitigation planning for the clients, countries, and sites
? Led strategic initiatives work with other functional management to develop clinical implementation process. It involves having functional responsibility over the operations performance, dealing with external issues relating to meeting client
? Deliverables, project revenues, resource management, staff development and training
? Taking responsibility for global clinical trial lead (phase 1-3)
? Drive the planning, formation, and execution of timelines, while identifying and tracking the team's critical path
? Execute and control project activities, including scope, schedule, budget, and risk associated with each assigned project.

- Global Clinical Trial Development & management consulting service for over 20 cases
- Collaboration with IVI (International Vaccine Institute) / GCTM
- Collaboration with The Catholic University of Korea, Seoul ST. Mary’s Hospital
- Phase1b,2a / Global Study / Agent for Breast Cancer / GCTM
- Phase1 / Global Study / Agent for Multiple Myeloma / GCTM
- Patient Preference Study / Agent for Multiple Myeloma / Local CTM
- Specimen Sample Evaluation Study / Agent for Multiple Myeloma / Local CTM
- Phase 3 / Global study / Agent for HCC / Global Project Lead, GCTM
- Phase 1b, 2a, / Global Study / Agent for RCC / Country CTM
- Phase4 / Local study / Agent for Vascular Dementia / CRA Lead, Sr. CRA
- Phase4 / Local study / Agent for Ulcerative colitis / CRA Lead, Sr. CRA
- Phase4 / Local study / Agent for Liver cirrhosis / CRA Lead, Sr. CRA
- Phase2 / Local study / Agent for Gastritis / Sr. CRA
- Phase3 / Local study / Agent for Benign Prostatic Hyperplasia / CRA Lead, Sr. CRA
- Phase3 / Local study / Agent for Hypertension (ARB)
- Phase3 / Global Study / Agent for Hyperlipidemia with high cardiovascular risk / CRA
- Phase3 / Global Study / Agent for Hypertension (ARB) / CRA
- Phase 1 / Global Study / Agent for NSCLC (T790M+) / CRA
- Phase 1 / Global Study / Agent for NSCLC (EGFRm+) / CRA
- Observation Study / Global Study / Agent for Prostatic cancer / CRA
- Observation Study / Global Study / Agent for Osteoporosis / CRA
- Observation Study / Global Study / Agent for Colorectal cancer (After OP) / CRA
- Observation Study / Global Study / Agent for Colorectal cancer (After Neoadjuvant) / CRA
- Phase3 / Global Study / Agent for Gastric cancer / CRA
- IIT / Multi-site Local Study / Agent for NSCLC / CTM
- IIT / Multi-site Local Study / Agent for NSCLC / CRA
Training Experience ? Certificate of completion for Quality Assurance (KONECT, 2023)
? Completion of GCP Training, Organizers (KONECT, 2023)
? Certificate of Medical Data Analysis and Query Building with MedDRA Coding(The MedDRA Support Service Organization, 2022)
? Certification of attendance for ASCO 2022 in USA (ASCO, 2022)
? Certificate of MedDRA Coding Advanced course (The MedDRA Support Service Organization, 2022)
? Certificate of MedDRA Coding Basic course (The MedDRA Support Service Organization, 2022)
? Certificate of HIPPA training for Research monitor (Washington Univ. Medical center, 2021)
? Certification of attendance for FDA study data technical rejection criteria (Captain, US Public Health Service, 2021)
? Certificate of Project manager advanced course (KoNECT, 2019)
? Certificate of clinical research associate, advanced course with GCP training (KoNECT, 2018)
? Certification of attendance for Best of ASCO2017 in Korea (KOREAN SOCIETY OF MEDICAL ONCOLOGY & Korean Cancer Study Group, 2017)
? Certificate of Project manager course (KONECT & Yonsei Univ. Medical Center, 2017)
? Completion of GCP Training, Organizers (SillaJen Inc., 2017)
? Completion of GCP Training, Organizers (C&R Research, 2016)
? Certificate of completion for clinical research associate (KoNECT, 2019)
? Certificate of KCSG Clinical Trial Workshop Advanced course (Korean Cancer Study Group, 2013)
? Completion of GCP Training, Organizers (IQVIA, 2012)
? Completion of GCP Training, Organizers (CITI, 2011)

Education:
2004 Bachelor’s degree in Business Administration of Management, SungKyunKwan University
2009 Master degree of International Business, University of Melbourne, Australia

Professional Experiences:
2009 ? 2015 Medical Specialist in Lilly Korea
2015 ? 2022 Clinical Development Consultant in Lilly Korea
2017 ? 2018 APAC Global Study Training Management Short Term Assignment in Lilly
2022 ? Current Sr. Manager, Clinical Research Lead in Lilly Korea

1. Huh KY, Chung WK, Park J, Lee S, Kim MG, Oh J, Yu KS. Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms. Clin Transl Sci. 2023 Aug 25. doi: 10.1111/cts.13617. (First author)
2. Huh KY, Lee H, Lee S, Yu KS, Kim KH, Kim H. Exploration of smart adherence-monitoring methods in vitamin D-deficient patients: A pilot feasibility clinical study. Clin Transl Sci. Jul 18 2023;doi:10.1111/cts.13594 (First author)
3. Huh KY, Chung WK, Lee H, Choi SH, Yu KS, Lee S. Safety, Tolerability, and Pharmacokinetics of a Novel Macrocyclic Gadolinium-Based Contrast Agent, HNP-2006, in Healthy Subjects. Invest Radiol. Jul 21 2023;doi:10.1097/rli.0000000000001007 (First author)
4. Huh KY, Moon SJ, Jeong SU, Kim MJ, Yang W, Jeong M, Kim MG, Lee S. Evaluation of a blockchain-based dynamic consent platform (METORY) in a decentralized and multicenter clinical trial using virtual drugs. Clin Transl Sci. May 2022;15(5):1257-1268. doi:10.1111/cts.13246 (First author)
Huh KY, Hwang JG, Shin W, Baek S, Choi J, Lee N, Cho YM, Lee H. A double-blind, placebo-controlled, single-ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15136, a novel long-acting glucagon analogue, in healthy subjects. Diabetes Obes Metab. Mar 2022;24(3):411-420. doi:10.1111/dom.14590 (First author)