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  • Plenary Lecture

  • Patient Voice

  • October 31st

  • November 1st

  • November 2nd

Plenary Lecture

Time

Plenary Lecture

October 31(WED)
09:30~10:00

  • chair : Yil-Seob Lee
  • Affiliation : GSK
  • Country : Korea

Bio-Health Innovation Plan for Korea

Ju Young KimMOHW

Korea

Bio Essay Ju Young Kim is currently working for Ministry of Health and Welfare as director of Division of Health Industry Promotion. He joined MOHW since 2009 and has taken important roles and experiences at several division. He holds Ph.D in Oriental medicine received from Kyungwon University.

Time

Plenary Lecture 2.

November 1(THU)
09:00~09:40

  • chair : Deborah Chee
  • Affiliation : KoNECT
  • Country : Korea

Transforming Clinical Research with the Patient, for the Patient

Andreas KoesterJ&J

USA

Bio Essay As Global Head of Janssen Clinical Innovation, Andreas is leading Janssen’s efforts to optimize the clinical trial process based on his 20+ years experience in pharmaceutical companies and CROs (Contract Research Organizations). Andreas is passionate about improving the way pharma runs clinical trials for the benefit of our two key partners: patients and investigators. Within J&J, he focuses on to developing capabilities and processes that streamline the clinical trial process and bring medical innovations to patients faster. Beyond Janssen, Andreas is active in the pre competitive space, e.g. as contributor to Transcelerate Biopharma and cocreator of the Investigator Databank. His background is in drug development, spanning first in human, proof of concept and large registration trials. He worked in leadership roles for trials that led to the approvals of Prezista®, Intelence® and Reminyl®. Andreas is a graduate of Leipzig Medical School and earned his Ph.D. in Clinical Pharmacology from Humboldt University in Berlin.

Patient Voice

Time

Patient Voice. Voice of Lymphoma Patient

November 1(THU)
09:40~10:00

  • chair : SungJa Cho
  • Affiliation : J&J
  • Country : Korea

Patient Voice. Voice of Lymphoma Patient

Wonyoung JangKorea Blood Cancer Association

Korea

Bio Essay I am working at the Korea Blood Cancer Association for 6 years. In September 2010, I was diagnosed with lymphoma in a regular checkup and received 6 times of chemo therapy (R-CHOP) and 20 times radiation therapy. I am doing fine without any special treatment, and I am working at the Korea Blood Cancer Association to help blood disease and cancer patients by utilizing of my experience.

October 31st

Time

S1: Recent Regulatory Updates in Clinical Trials

10:30~12:00

  • chair : Nakyung Kim
  • Affiliation : MFDS
  • Country : Korea
  • chair : Hea-Young Cho
  • Affiliation : CHA University
  • Country : Korea

[S1-1]Clinical Trial Regulation Implementation in Germany

Janet KoenigBfArM

Germany

Bio Essay She is the Head of Unit 33 Anaesthesiology, Algesiology, Rheumatology, Pulmonology, ENT in the Devision Licensing at the Federal Institute for Drugs and Medical Devices. She is also the German alternate member of the CHMP. She received her M.D. at University of Goettingen Germany (1998) and her Board Certificate in Surgery at University Hospital of Bonn, Germany

[S1-2]Regulatory Reform to Support Clinical Development of Innovative Products in China

Ling SuShenyang Pharmaceutical University and Lilly Asia Ventures

China

Bio Essay Dr. Ling Su is Professor and Director of the Institute of Drug Regulatory Science in Shenyang Pharmaceutical University. He has more than 25 years’ experience in pharma R&D, regulatory, consulting and teaching. Early in his career, he worked in the Chinese regulatory agency and in CDER, US FDA. Subsequently he spent 16 years in various R&D and management positions in the industry, including Epidemiologist, China Medical Director, Senior Regulatory Strategy Director at Merck Sharp & Dohme, Pharma Development and Medical Director at Roche, VP for Clinical Research Asia Pacific at Wyeth, and SVP and Head of Pharma Development China at Novartis. Prior to his current positions, he was a Strategic Advisor in life sciences in Sidley Austin, advising clients on medicinal product development and regulatory strategies. In 2012-2013, he was elected President of Drug Information Association (DIA).
He has been actively engaging in developing and teaching courses in the Yeehong Business School, Shenyang Pharmaceutical University, where he serves as the course program chair of “Clinical Research Management” and a course program committee member of the “Management of Pharma R&D”.
He is also a Venture Partner in Lilly Asia Ventures and a Research Fellow at the Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University.
He received BS degree in pharmacology from Shanghai Medical University, China, and MS degree in drug clinical development and PhD degree in epidemiology from University of North Carolina at Chapel Hill, USA.

[S1-3]Preparedness and Execution of Chinese Regulatory Reform

Chang LeePAREXEL

China

Bio Essay Dr. Lee brings both industry and regulatory agency experience to PAREXEL. He led Regulatory and/or Clinical Affairs at Capsugel, KV Pharmaceuticals, Morton Grove Pharmaceuticals, TAP Pharmaceutical Products Inc., Novartis OTC, and Igenix, and served as a Medical Officer at the FDA’s Center for Drug Evaluation. U.S. board-certified in Clinical Pathology, he is knowledgeable in global clinical and regulatory product development, including risk management, and has worked with many global regulatory authorities, including FDA, EMA, the Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, the Central Drugs Standard Control Organization (CDSCO) in India, and the China National Medical Product Administration (NMPA, the formally known as CFDA). In his role at PAREXEL, Dr. Lee works with the NMPA to support guideline development and Center for Drug Evaluation (CDE) education programs, and participates in new policy discussions, research projects and CDE meetings.

[S1-4]Regulatory Update for Clinical Trials in KOREA

Byoung Sam KimMFDS

Korea

Bio Essay He majored in pharmacy in Korea and holds a pharmacist license. He is a public servant at Korea’s Ministry of Food and Drug Safety(MFDS). He is currently in charge of approving clinical trials and establishing policies.

Time

S2: Facing ICH-E17 in North East Asia (Collaborated with KRPIA)

13:30~15:00

  • chair : Don Woong Choi
  • Affiliation : MFDS
  • Country : Korea
  • chair : Helen Heakyoung Cho
  • Affiliation : BMS
  • Country : Korea

[S2-1]A Consideration on Implementing E17 Guidance in Clinical Development

Akira WakanaMSD

Japan

Bio Essay He is a Director of biostatistics department at MSD K.K., a subsidiary of Merck & Co. in Japan. He focuses on statistical research in clinical development. He received his Ph.D. at Science University of Tokyo (2006). Especially, he is interested in statistical research on dose-response relationship in clinical trials.

[S2-2]Facing ICH-E17 in North East Asia: Academic Perspective

In Jin JangSeoul National University Hospital

Korea

Bio Essay In-Jin Jang is Professor of Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Director of Department of Clinical Pharmacology and Therapeutics, and Clinical Trials Center of Seoul National University Hospital. He obtained degrees of M.D. and PhD in 1987 and 1992 at Seoul National University, College of Medicine. He is a clinical pharmacologist who majors in pharmacogenomics, population PK/PD modeling/simulation and early clinical drug development methodologies. He worked as a visiting research fellow at Center for Drug Development Science, Georgetown University Medical Center from 1998 to 2000. At Seoul National University and Hospital, he is responsible for research and education in the field of pharmacology and clinical pharmacology, especially pharmacogenomics and PK/PD. He is in charge of therapeutic drug monitoring consultation, execution of phase 1 clinical trials and general management of Clinical Trials Center at Seoul National University Hospital.

[S2-3]New Regulatory Dynamics in China

Hwei-Gene WangBMS

China

Bio Essay Dr. Heidi Wang is the Vice President and Head of Global Regulatory Science-China and Hong Kong, Bristol-Myers Squibb Company (BMS). She has led the team to obtain the first HCV direct acting agents (Daklinza and Sunvepra) approvals in China in April 2017. She also led the team to obtain the first Immuno-Oncology PD(L)-1 inhibitor (Opdivo) approval in China in June 2018. Prior to China, Dr. Wang had 22 years of experience working in BMS US headquarter, including conducting research in HIV and hepatitis B and C viruses and working on multiple regulatory submissions and approvals in the US and 30+ international markets, including China. With innovative thinking to overcome challenges, she led cross-functional teams to complete Daklinza and Sunvepra initial filings and approvals in 30+ international markets in a short timeframe. She had contributed to obtaining Sprycel initial US/EU approvals and Erbitux submissions and labelling approvals in the US.

Time

S3: Are You Ready for Implementation of RBM? (Collaborated with KSCD)

13:30~15:00

  • chair : Carlo Maccarrone
  • Affiliation : GSK
  • Country : Australia
  • chair : Hyewon Song
  • Affiliation : Sanofi
  • Country : Korea

[S3-1]Overview of TransCelerate RBM Methodology

Masato Kobayashi Astellas, TransCelerate representative

Japan

Bio Essay He was joined Astellas Pharma inc. in 1994. He has experienced researcher, CRA and Data Manager. Recently he has contributed to implement RBM methodology in Astellas and is working as RBM Japan Asia Project manager now, And he is involving Japan local activity of TransCelerate as one of member of RBM Communication of Practice.

[S3-2]Key Role of Centralized Monitoring - Going forward in RBM -

Yumi SugiuraBMS

Japan

Bio Essay Yumi Sugiura joined BMS Global strategies and solutions in Princeton, New Jersey as Central Monitor in June 2015, and since then has played a critical role in establishing and promoting the newly created central monitoring function while continuously contributing to the ongoing implementation of our Risk Based Monitoring (RBM) methodology. Yumi Sugiura has also helped to establish specifications for a robust suite of analytics reports used by central monitors to accurately capture outlier data reflective of poor site performance. Yumi has a thorough understanding of clinical trial processes and she is technically savvy with significant experience working in clinical data management system.

[S3-3]What Other CRA Capability Should be Required in a New RBM Process?

Barbara GrassiGSK

Italy

Bio Essay Barbara Grassi is VP, Global Head of In-Country Clinical Operations in GSK. She is also the Chair of the Pharma Clinical Quality Council in GSK and she has been leading the implementation of Risk Based Monitoring (RBM). She’s a physician, certified psychiatrist and has got 19-year experience of pharmaceutical company. She has had different jobs and accountabilities in Discovery, Clinical development and Medical. She is based in GSK Italy Verona, but since 2012 she has been working at regional level initially and then global.

Time

S4: Non-Clinical Studies Enabling Successful Clinical Development (Collaborated with KSNS)

13:30~15:00

  • chair : Joonghoon Park
  • Affiliation : Seoul National University
  • Country : Korea
  • chair : Dong Hwan Kim
  • Affiliation : Konyang University
  • Country : Korea

[S4-1]Translation of Non-Clinical Studies to Clinical Trials

Dong Hwan KimKonyang University

Korea

Bio Essay He is an Associate Professor at Konyang University in Korea. He received his D.V.M., M.S., and Ph.D. at department of Veterinary Sciences at Kyungpook national University in Korea. He also received his M.S. degree in technology management at State University of New York at Stonybrook. Before he moved to University, He worked at Korea Institute of Toxicology for two years and Dong-A Pharmaceutical Company for twenty years for safety evaluation of drug candidates. At 2004, he newly set up Korean Society of Non-clinical Studies which is one of the biggest Societies in this field. He charged in president of the Korean Society of Non-clinical Studies from 2014 to 2015. He is interested in safety evaluation of drug candidates and translational research. He teaches non-clinical pharmacodynamics and toxicology for drug development.

[S4-2]PKPD Considerations for New Drug Development

Hyun Joo Shim Dong-A ST Pharm

Korea

Bio Essay She is the vice-president of Dong-A ST. She received B.A. (1985: Food and Nutrition, 1989: Pharmacy) and M.A (1991: Pharmacology), Ph.D (2005, Pharmacokinetics) from Seoul National University, South Korea. She has worked for 27 years at the Dong-A research center and has contributed her considerable pharmacokinetic expertise to the development and successful launch of five Dong-A Pharmaceutical new drugs (Zydena, Sivextro, Suganon, stillen and motiliton). She also belongs to the National Science Expert Committee and is interested in women's science and technology mentoring..

[S4-3]Accelerating Clinical Development Using Cutting Edge Preclinical Technologies and E-data Submission

Takayuki AnzaiShowa University School of Medicine

Japan

Bio Essay Prof. Takayuki Anzai received his B.Agr. from Tokyo University of Agriculture and his Ph.D. at Showa University School of Medicine. His research area includes Regulatory Science, Environmental Risk Assessment for Pharmaceuticals, Nanomaterials, Electronic data management and so on. He has a long record of success. In 2005, he jointed Global CRO as a General Manager and Management Committee Member of Swiss Headquarters. He has the ultimate achievements in the product registration and consultation.

Time

S5: Real World Data for Clinical Development

15:30~17:00

  • chair : Chiyoung Ahn
  • Affiliation : MFDS
  • Country : Korea
  • chair : Rae Woong Park
  • Affiliation : Ajou University School of Medicine
  • Country : Korea

[S5-1]Effective Clinical Trial Planning Using Real World Data

Andrew RoddamGSK

UK

Bio Essay Andrew is currently Vice President and head of Epidemiology, RWE and Digital Clinical Platforms at GSK, and is a renowned expert in epidemiological research with specific interest in the utilisation of routine data for research purposes. Andrew obtained his DPhil in Statistics at the University of Oxford and completed a post-doc in Infectious Disease Epidemiology. He was a Senior Researcher at the CRUK Cancer Epidemiology Unit at the University of Oxford before taking up an appointment at Amgen where he was most recently Regional Head (EU, EEMEA) in the Center for Observational Research. In his current role, he oversees the teams responsible for the epidemiological input into the discovery and development of new medicines as well as the real-world data and analytics group and the team charged with delivering innovation in real-world study execution. Andrew is a participant on several expert groups and advisory committees both in the UK and internationally where his expertise in epidemiological methods and health informatics are highly regarded.

[S5-2]Utilization of RWD in Korea

Nam-Kyong ChoiEwha Womans University

Korea

Bio Essay Nam-Kyong Choi is an Assistant Professor of the Department of Health Convergence, College of Science & Industry Convergence at Ewha Womans University in Seoul, South Korea. Her research focuses on the development and application of epidemiologic and statistical methods for evaluating the safety and comparative effectiveness of medical products in large healthcare databases. She received her B.S. in Pharmacy from Ewha Womans University and M.Sc. and Ph.D. in Pharmacoepidemiology from the Seoul National University College of Medicine. She worked as a Visiting Professor in the Division of Pharmacoepidemiology Pharmacoeconomics, within the Department of Medicine at Brigham and Women’s Hospital and Harvard Medical School from 2015 to 2017.

[S5-3]Enhancing Clinical Development through the Use of RWD

Bruce CrawfordSyneos Health

Japan

Bio Essay Bruce is responsible for Real-World Evidence & Insights in Japan and APAC and is based in Tokyo, Japan. With approximately 25 years consulting experience, Bruce has considerable expertise in health economic and outcomes evaluations, and helps clients link clinical and market data to further the successful development and marketing of their products. Bruce has directed numerous projects dealing with prospective study design, patient-reported outcomes, cost-effectiveness analyses, reimbursement and epidemiologic studies. Bruce has been involved in research, training and meetings with the US Food and Drug Administration, Japanese Pharmaceuticals and Medical Devices Agency, Thailand FDA, and Thailand National List of Essential Drugs committee. Over the past 18 years he has worked on projects throughout Asia, covering 12 countries. Prior to joining Syneos Health, Bruce led the IMS RWE team for Japan while supporting APAC and established the Boston and Tokyo offices of Mapi Values (name changed to Adelphi Values), which he managed for almost 16 years. Previous to that he worked in managed care and for a major CRO as a health economist. Bruce held an appointment as Clinical Instructor of Epidemiology and Biostatistics at Tufts University School of Medicine (2002-2007) and Adjunct Associate Professor of Pharmacoeconomics at Massachusetts School of Pharmacy and Health Sciences (2000-2006). Bruce recently held an appointment of Adjunct Project Professor of Health Technology Assessment and Public Policy at Tokyo University Graduate School of Public Policy (2012-2013) and as Adjunct Instructor at Kyoto University, School of Medicine and Public Health in the Department of Pharmacoepidemiology (2013-2014).

Time

S6: Patient Journey In Clinical Trials - From Enrollment To Trial Completion

15:30~17:00

  • chair : Hailey Chae
  • Affiliation : PPD
  • Country : Korea
  • chair : Catherine Yi-San Lee
  • Affiliation : Pfizer
  • Country : Taiwan

[S6-1]The Common Registry Data Packet: TransCelerate’s Initiative to Improve Data in Clinical Trial Registries / eLabels: Understanding the Benefits for Patients, Sites and sponsors

Keris HuangMSD, TransCelerate representative

Taiwan

Bio Essay Keris Huang is the Clinical Research Director, Global Clinical Trial Operations Taiwan and Hong Kong of Merck Sharp & Dohme (M.S.D.). She received her B.S.(1993) & M.S.(1995) both from Taipei Medical University. She has around 20 years of experience in pharmaceutical industry. She is very supportive on building better clinical trial environment in Taiwan and is ex-President and current Board member of Taiwan Clinical Research Association. She is also interested in different e-initiatives and is the current AP sub-team lead for TransCelerate eLabel workstream

[S6-2]Patient-Centric, Patients-First Approach to Feasibility

Gaurav BhatnagarPPD

USA

Bio Essay Gaurav Bhatnagar is vice president of strategic feasibility within global clinical development. He leads the strategic vision and development of feasibility services, managing the implementation of data-driven analysis using internal and external data sources and driving innovation across the division. He is accountable for the operational delivery of feasibility assessments and services that support protocol and trial optimization, centralized country and site selection, and investigator-initiated feasibility activities. Gaurav joined PPD in 2017 after 16 years in the global CRO industry where he established a track record of enhancing end-to-end clinical trial delivery processes. Following roles of increasing responsibility, he most recently served as a global head of data analytics and process transformation within clinical operations. He is an experienced industry leader in global data and safety monitoring, clinical development productivity and quality, product development, and strategic planning for innovation. A risk-based monitoring (RBM) expert, he pioneered the development of advanced and predictive analytics capability for RBM studies that enabled clinical trial site performance/patient safety and identification of highest-risk sites. Gaurav holds a Bachelor of Science in pharmacy from Gulbarga University, and a Master of Science in pharmacology from the Birla Institute of Technology and Sciences in Pilani, both in India, and a Master of Business Administration from The Fuqua School of Business at Duke University in North Carolina.

[S6-3]The Digital Patient Journey

Catherine Yi-San LeePfizer

Taiwan

Bio Essay Catherine Lee is the Area Head of Global Site and Study Operations in Asia for Pfizer Inc with over 25 years of experience in clinical research. Catherine is responsible for supervising the medical and operational resources in the Asia Pacific region, excluding Japan, to ensure effective delivery of key clinical-site management milestones and overseeing the clinical/medical, operational and scientific oversight activities for Pfizer clinical trials. Catherine is a registered pharmacist with Master degree in Pharmacology and EMBA. Catherine is passioinate about drug development and advance science with clinical research site to accelerate the availability of therapies for patients.

Time

S7: New Approaches to Pharmacovigilance & Their Applications to Clinical Development?

15:30~17:00

  • chair : Soo Youn Chung
  • Affiliation : KIDS
  • Country : Korea
  • chair : Stewart Geary
  • Affiliation : Eisai
  • Country : Japan

[S7-1]ICH E19: Update and Expectation from Industry

Seong Choon ChoeBoryung Pharmaceutical Company

Korea

Bio Essay Dr. Seong-Choon Choe is a highly accomplished medical/clinical/developmental expert with over 16 year-experience. He has extensive experience managing medical, R&D, commercial organization and business development in Korean subsidiary of multinational big pharmaceutical companies as well as Korean pharmaceutical company. He is also an expert in leading and contributing in cross functional and global projects. With a proven track record in achieving medical-marketing, R&D excellence, he is also an active player in engaging the industry associations and academic societies to promote the value of R&D. Currently he is more focused on clinical development of NCEs in developed countries as well as in emerging countries He has a strong scientific background and previously served as a professor of cardiology (M.D., Ph.D.) for 3 years and served as reviewer in many governmental organizations (such as KoNECT, KDDF, and etc.) and member of task force team in academia-industry-government collaborative organizations. He is also fluent in both Korean and English.

[S7-2]Pharmacovigilance for Oncology Combination Studies with Checkpoint Inhibitors

Stewart GearyEisai

Japan

Bio Essay Stewart Geary, M.D, has worked at Eisai since 1996 in pharmacovigilance, clinical safety and regulatory science. He is a DIA Fellow and is currently a member of the Executive Committee of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Boards for the publications Applied Clinical Trials and Pharmaceutical Medicine. He recently joined the CIOMS Working Group on Drug-Induced Liver Injury and served on the CIOMS VII Working Group on the Development Safety Update Report, the CIOMS VIII Working Group on Signal Detection, the CIOMS Working Group on Standardized MedDRA Queries and the CIOMS IX Working Group on Medicinal Product Risk Management. Dr Geary graduated from Harvard College summa cum laude with a bachelor’s degree in chemistry in 1985. He spent a year doing basic research on insulin-like growth factor receptors at Harvard Medical School before attending Stanford Medical School from which he earned an MD degree in 1990. He went on to complete a residency in Urology at the Stanford University Medical Center in 1996. He lectures at several universities on Pharmaceutical Medicine and has published on the Japanese pharmaceutical industry and on global pharmaceutical regulations.

[S7-3]Innovative Technology for Case Intake to Enable Process Improvements and Focus on Data Analysis

Jamie PortnoffForesight

USA

Bio Essay Ms. Jamie Portnoff is Global Head of the Business Transformation Practice with 18 years of experience in Life Sciences. In the past 13 years Ms. Portnoff has delivered a broad range of business solutions to companies of all sizes with PV operations in the US, Europe, India and Japan, including multiple PV operational and organizational integrations. Prior to Foresight, Ms. Portnoff was a Project Manager at Patni Life Sciences. She also worked within PV for Elan Pharmaceuticals and Hospira. Ms. Portnoff received her Bachelor of Science degree in Communications Studies from Northwestern University. She is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professionals Society (RAPS).

November 1st

Time

S8: Data Driven Approaches in Drug Development

10:30~12:00

  • chair : Sam Muk
  • Affiliation : KDDF
  • Country : Korea
  • chair : Soo Kyung Shin
  • Affiliation : IQVIA
  • Country : Korea

[S8-1]Practical Application of New Solutions for Drug Development: From Strategic Development Decisions to Patient’s Perspective

Kate Lawrey IQVIA

Singapore

Bio Essay Kate is an Associate Director in the IQVIA Asia Therapeutic Strategy Group, responsible for the management and delivery of Next Generation of Clinical Development (NGCD) Solutions for Asia-Pacific, as well as APAC Regional Site ID Oversight. Previously, Kate was a Therapeutic Strategy Lead, responsible for the development and review of effective Clinical Trial delivery strategies. Prior to joining IQVIA, Kate worked at Janssen Cilag, as both a Product Manager and a Healthcare Solutions Project Manager, in both Hong Kong and Australia. As a Healthcare Solutions Project Manager, she was responsible for the development and delivery of patient support programs, as well as access and adherence programs for patients in need. In 2013, Kate completed her Master of Business Administration (MBA) at Melbourne Business School in Australia. Prior to starting the MBA, Kate worked at The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) on projects and programs encompassing obstetric education and development, focusing on opportunities for Specialist and GP Obstetricians in rural and remote Australia.

[S8-2]Healthcare Big Data: Real World Data for Clinical Trials

Kyu-pyo KimAsan Medical Center

Korea

Bio Essay Kyu-pyo (KP) is a medical oncologist and clinical pharmacologist at the Asan Medical Center/Univ of Ulsan, College of Medicine. KP is responsible for the Cancer Precison Medicine Clinic at Asan and has been involved with the Health Big Data Center at Asan to utilize the clinical research datawarehouse and common data model tools for realization for cancer patients. He also practices in GI oncology with a focus on pancreatobiliary cancers. KP also supervises the operation of the early phase unit at the Clinical Trial Center. KP has been involved in various Ph 1 trials of both cancer and healthy volunteers and has experience with pharmacometrics including PK/PD modeling. He has also worked as a public servant within the Ministry of Health and Welfare and KHIDI.

[S8-3]Healthcare Blockchain

Seyoung JungSeoul National University Bundang Hospital

Korea

Bio Essay Seyoung Jung is a doctor (family physician) and a researcher at Seoul National University. SJ is responsible for healthcare ICT research/ development project of the hospital especially for cloud based hospital information system, population health management, and blockchain based medical information sharing. He is also participating Korean governmental projects related healthcare AI, blockchain, and personal health record.

Time

S9: Patient Centric Clinical Development

13:30~15:00

  • chair : Jessica Liu
  • Affiliation : Tigermed
  • Country : China
  • chair : Jun Li
  • Affiliation : J&J
  • Country : China

[S9-1]Patient Centric Protocol Optimisation

David YoshiiPAREXEL

Japan

Bio Essay tient recruitment, site alliances, and other site related strategies at PAREXEL. His career spans over 20 years in drug development in various global leadership roles. He joined PAREXEL in 2011 and is currently based in the Tokyo office.

[S9-2]Implementing Novel Patient-centric Solutions: Case Studies

Fuqu WangJ&J

USA

Bio Essay Fuqu Wang is Director, Janssen Clinical Innovation (JCI), an entrepreneurial global team within Janssen that is working to identify and test novel solutions to transform the clinical research industry. Fuqu has more than 10 years of R&D experience in the pharmaceutical industry, spanning discovery research, project management and clinical development. Fuqu is passionate about patient-centric innovation for clinical research and emerging markets. Fuqu holds a BS in Biology from Peking University in China, and a PhD in Molecular & Medical Pharmacology from University of California, Los Angeles in the US.

[S9-3]Tissue Chips for Personalized Medicine in Risk Assessment during Drug Life Cycle Management

Tagle DaniloNational Institutes of Health (NIH)

USA

Bio Essay Danilo Tagle is Acting Deputy Director, and Associate Director for Special Initiatives in the Office of the Director at NCATS (National Center for Advancing Translational Sciences) at the National Institutes of Health (NIH) where he coordinates efforts towards developing microphysiological systems or organs on chips for drug development. He also coordinates efforts on 3D bioprinting for drug discovery, on the use of neuromodulation devices for conditions recalcitrant to drugs, and the clinical utility of secreted RNA for biomarker (liquid biopsy) and therapy development. Prior to joining NCATS in 2012, he was a program director for neurogenetics at the National Institute of Neurological Disorders and Stroke at NIH where he was involved in developing programs concerning genomics-based approaches for basic and translational research in inherited brain disorders. He was also an investigator and section head of molecular neurogenetics at the National Human Genome Research Institute at NIH and has been involved in the highly collaborative effort toward the positional cloning of genes for Huntington’s disease, ataxia-telangiectasia and Niemann-Pick disease type C. He has served on numerous committees, advisory boards, and editorial boards. Dan obtained his Ph.D. in molecular biology and genetics from Wayne State University School of Medicine in 1990. He was an NIH National Research Service Award postdoctoral fellow in human genetics in the laboratory of Francis S. Collins, M.D., Ph.D., at the University of Michigan. Dan has authored more than 150 scientific publications and has garnered numerous awards and patents.

Time

S10: Clinical Development Strategy for Precision Medicine

13:30~15:00

  • chair : Young Suk Park
  • Affiliation : Samsung Medical Center
  • Country : Korea
  • chair : Hyerim Lee
  • Affiliation : MSD
  • Country : Korea

[S10-1]Application of NGS in Clinical Trials, Clinical Research and Practice

Kyoung-Mee KimSamsung Medical Center, Sungkyunkwan University School of Medicine

Korea

Bio Essay She is a Professor at Sungkyunkwan University. She received her M.D from Ewha Women’s University. She is interested in integration of genomic alterations with pathologic and clinical findings, and focused on exploring molecular targets and biomarkers predicting therapeutic responses.

[S10-2]Innovative IO Strategy in the Era of Precision Medicine

Hyerim LeeMSD

USA

Bio Essay Hyerim Lee, PhD is Director in Oncology Global Medical Affairs, responsible for the biomarker and diagnostics at Merck (known as MSD outside the United States and Canada). She has over 15 years of experience in oncology translational medicine from biomarker discovery to clinical implementation in non-profit and industry settings. Hyerim earned a BA degree in Chemistry and a PhD degree in Biophysical Chemistry in Columbia University and completed a post-doctoral fellowship in Molecular Biology at Sanford-Burnham Medical Research Institute in San Diego.

[S10-3]Refractory Cancer Basket Trials and Cancer Genomics

Hyo Song KimYonsei Cancer Center

Korea

Bio Essay Dr. Hyo Song Kim is a highly accomplished medical/clinical/developmental expert with over 10 year-experience. She has extensive experience managing medical and new drug development. During past years, personalizing treatment of metastatic solid tumors has been her primary research goal with emphasis on gastric cancer and rare cancer She has a strong scientific background and previously served as a professor of Medical Oncology (M.D., Ph.D.) for 8 years in Yonsei University College of Medicine and served as principle investigator and sub-investigator of clinical trials for rare solid tumors.

Time

S11: Changing Ethics in Clinical Trials (Collaborated with KAIRB)

13:30~15:00

  • chair : Sun Young Rha
  • Affiliation : Yonsei University College of Medicine
  • Country : Korea
  • chair : Jerry Menikoff
  • Affiliation : U.S. Department of Health & Human Services
  • Country : USA

[S11-1]Understanding the Revisions to the Common Rule

Jerry MenikoffU.S. Department of Health & Human Services

USA

Bio Essay Jerry Menikoff is the director of the Office for Human Research Protections, which is within the U.S. Department of Health & Human Services. He received his A.B. from Harvard College (1973), and his J.D. from Harvard Law School (1977). He also received an M.D. from Washington University in Saint Louis (1986). He has written about and studied issues in the intersection of law and bioethics generally, and most recently has worked on issues regarding the ethics and regulation of research with human subjects. Among his books are Law and Bioethics: An Introduction (Georgetown Univ. Press 2001) and What the Doctor Didn’t Say: The Hidden Truth about Medical Research (Oxford Univ. Press 2006).

[S11-2]Opportunities and Challenges of Single IRB vs Central IRB

Yong-Jin KimKyungpook National University Hospital

Korea

Bio Essay Yong-Jin Kim is a pathologist and working for Kyunpook National University Hospital (KNUH) in Daegu, Korea. He has been actively involved in IRB; the chair of IRB of KNUH and a board member of KAIRB (Korean Association of IRB). He has been running the Daegu Joint IRB since 2013 as a chair, which is composed of five university hospitals and one general hospital located in Daegu. This is the first Joint IRB in Korea.

[S11-3]Conflict of Interest Management Plan

Dae Ho LeeUniversity of Ulsan College of Medicine, Asan Medical Center

Korea

Bio Essay Dae Ho Lee, MD, PhD, is Professor of Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. He earned MD degree in 1994, MS degree in 2001 and PhD degree in 2007 from Seoul National University. He completed an internship, internal medicine residency and hemato-oncolgy fellowship at Seoul National University Hospital. He then moved to National Cancer Center Korea. In 2006, he joined the faculty at Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Korea. He has been involved in basic, translational and clinical research in lung cancer with particular interests in clinical trials including early phase I and in biomarkers and related basic studies. Based on his experiences in clinical trials, he has participated in many activities related to clinical research, such as member of IRB, consultant of MFDS, HIRA and NECA and so on. He still plays an active role as a board member or consultant in many committees of governmental organizations as well as academic societies.

Time

S12: Building Industrial Capabilities in Early Phase Development (Collaborated with KSPM)

15:30~17:00

  • chair : SungJa Cho
  • Affiliation : J&J
  • Country : Korea
  • chair : Jongho Ahn
  • Affiliation : MSD
  • Country : Korea

[S12-1]Early Phase Clinical Pharmacology Studies – Timing, Contents, and Impact

Joshep KimPAREXEL

USA

Bio Essay Dr. Joseph Kim is a clinical pharmacologist/pharmacometrician with 20 years of clinical drug development experience in big pharma and CROs. He is currently a senior director at PAREXEL Quantitative Clinical Development group in Durham, North Carolina and providing consulting services regarding all stages of clinical drug development including study design, PK, PK/PD modeling and simulation, regulatory interactions and overall Clinical Drug Development strategies. Before join to PAREXEL, Joseph worked as Director of Clinical Pharmacology Modeling and Simulation group at GlaxoSmithKline R&D, USA for 13 years and previously, he had worked as a consulting scientist at Pharsight Inc. in Cary, North Carolina. Joseph has been working on more than 25 First-in-Human studies and many more clinical studies from Phase I through Phase IV. His drug development work involves a variety of therapeutic areas, such as infectious disease, Oncology, metabolic disease, auto-immune disease, neurologic disease and rare diseases. His research population includes pediatric and elderly populations. Joseph has extensive experience in IND, NDA, PIP, and application of PK, PK/PD modeling and simulation in clinical drug development. Joseph is a frequently invited speaker for international scientific conferences.

[S12-2]How to Design Clinical Trial with Considering Statistical Methodology

Byung-Ho NamHerings Global

Korea

Bio Essay Dr. Nam is a CEO at HERINGS, a clinical research company. He has been working at HEIRNGS as a CEO since March 2017. He received his B.A. from Seoul National University, his M.S. from University of Michigan, and his Ph.D in Biostatistics. from Boston University (2000). He joined at the National Cancer Center, Korea in 2005 and worked for 12 years as a professor and head of clinical research coordination center. Before He joined at the NCC, He was a faculty member at the Boston University and involved at the Framingham Heart Study as a chief biostatistitian. His main interest area is clinical trial designs, developing risk prediction models mainly for cancer and cardiovascular disease

[S12-3]Leveraging Companion Diagnostics in Early Phase Oncology Development

Brian LamonBMS

USA

Bio Essay Since joining BMS in 2014, Dr. Lamon has held positions of increasing responsibility as a leader in Oncology Clinical Development, Translational Medicine, Medical Affairs, and Business Development. Dr. Lamon is currently the External Clinical Collaborations and BMS ONO I-O Joint Development Team Leader, in Oncology Clinical Development. In this role, he is responsible for setting the clinical development strategy for external collaborations, and for the BMS/ONO I-O joint development of assets in Japan, South Korea, and Taiwan. Prior to Dr. Lamon’s current role, he led the Oncology Search & Evaluation team responsible for the identification and evaluation of external clinical stage assets for licensing, clinical collaborations and M&A. Before joining BMS, Dr. Lamon was Assistant Dean of Research Development and Assistant Professor, Department of Pathology and Laboratory Medicine at Weill Medical College of Cornell University, New York, NY. He has a Ph.D. in Pharmacology from New York Medical College and completed a postdoctoral fellowship and advanced certificate program in Clinical Investigation at Weill Medical College of Cornell University.

Time

S13: Role of Clinical Trial Centers in Global Collaboration (Collaborated with KACTC)

15:30~17:00

  • chair : In Jin Jang
  • Affiliation : Seoul National University Hospital
  • Country : Korea
  • chair : Yoon-Duk Han
  • Affiliation : Pfizer
  • Country : Korea

[S13-1]Quility Improvement of a CTC by Certification Program

Min-Gul KimChonbuk National University Hospital

Korea

Bio Essay He is an Assistant Professor at Chonbuk National University, He received his M.D. from Chonbuk National University (2004) and his Ph.D. at Seoul National University (2014). He is interested in pharmacokinetic research field, especially phase 1 clinical trial and population pharmacokinetics. Recently, he is interested in clinical trial research using ICT technology.

[S13-2]Overseas Engagement of Clinical Research to Develop Academic Seeds : Efforts of Osaka University Hospital

Daisaku NakataniOsaka University Hospital

Japan

Bio Essay Daisaku Nakatani is an Associate Professor, working at Osaka University Hospital, Department of Medical Innovation. He collaborates with clinical or basic researchers to develop new drugs and devices. He started to manage global clinical studies of his collaborators with a grant from the Japan Agency for Medical Research and Development.

[S13-3]Evolution of Clinical Trials Centers in Korea

Min Soo ParkYonsei University College of Medicine

Korea

Bio Essay Min Soo Park graduated from Yonsei University College of Medicine in Seoul, Korea, and was trained in Pediatrics and Neonatology at Severance Hospital, Yonsei University. He received his Master of Science in Clinical Pharmacology at University of Aberdeen, UK, and his Ph.D. in Medicine at Ajou University, Korea. He served as Vice President of Korea National Enterprise for Clinical Trials (KoNECT) between 2008-2014. And he established the Clinical Trials Center of Severance Hospital and served as Director from 2004 to 2016. Currently he is Professor in Pediatrics and Clinical Pharmacology at Yonsei University College of Medicine. As the Chair of Korea Clinical Trials Global Initiative (KCGI), funded by Korea Ministry of Health and Welfare, he operates the Global Centers of Excellence Program and the Convergence Technology Development Program to boost and accelerate global clinical development of new drugs.

Time

S14: A Step forward in IIT

15:30~17:00

  • chair : Young-suk Lim
  • Affiliation : Asan Medical Center
  • Country : Korea
  • chair : Il Ju Choi
  • Affiliation : National Cancer Center
  • Country : Korea

[S14-1]Opportunities and Challenges in Conducting IIT in Korea

Il Ju ChoiNational Cancer Center

Korea

Bio Essay He is a Prof. at the Graduate School of Cancer Science and Policy at the National Cancer Center Korea. He graduated Seoul National Univ. College of Medicine in 1990 (MD) and received PhD from the same Univ. in 2001. He works as a gastroenterologist at National Cancer Center Koea. His major topic of interest is gastric cancer prevention and treatment. He’s now doing several RCTs on the topic of H. pylori treatment for gastric cancer prevention.

[S14-2]Infrastructure of IIT in Singapore

Ivanus ManopoSingapore Clinical Research Institute

Singapore

Bio Essay Ivanus Manopo is a certified PMP® senior clinical project manager from SCRI with extensive experience in the clinical research. He is currently involved with MOHH projects to transform Singapore’s healthcare landscape into Smart Healthcare System. Ivanus received a Bachelor of Applied Science in Biotechnology in 2002 from NUS and a diploma in Entrepreneurship Development in 2006. He started in pre-clinical research with Temasek Life Science Laboratories and authored 8 peer reviewed international journals. He furthered his career in a vaccine development company, which was acquired by Takeda. Before joining SCRI, he was working as laboratory project manager in Quintiles East Asia. His exposure to both commercial trial and IIT has made him a valuable member to the project management team in SCRI.

[S14-3]Medical Innovation Led by Academia in Japan and Scope of Global ARO Network

Masanori FukushimaTranslational Research Center for Medical Innovation (TRI), Foundation for Biomedical Research and Innovation at Kobe

Japan

Bio Essay With comprehensive experience spanning over the past quarter-century as a medical oncologist at Aichi Cancer Center and Kyoto University Hospital, Dr. Fukushima has engaged in the practice and dissemination of standard cancer treatment and reform of Japan’s medical care system, and is active to date contributing to building up the infrastructure of clinical trial, particularly focusing on translational research. He has supervised the national translational research promotion programs conducted by the government of Japan, and currently, assuming the Board of Director for CDISC, and Program Officer of Rare / Intractable Disease Project of Japan, aiming to contribute to the standardization and harmonization of global data sharing in clinical trials; ultimately for the disease control over the world.

November 2nd

Time

S15: How Smart will Clinical Trials Centers be? (Collaborated with KCGI)

09:00~10:30

  • chair : Min Soo Park
  • Affiliation : Yonsei University College of Medicine
  • Country : Korea
  • chair : Jae-Wook Ko
  • Affiliation : Samsung Medical Center
  • Country : Korea

[S15-1]Smart Clinical Trials Management System

Dong-Wan KimSeoul National University Hospital

Korea

Bio Essay Dr. Dong-Wan Kim is a Professor of Medicine at the Seoul National University Hospital (SNUH), Seoul, Korea. Dr. Kim received his MD and PhD degree from the SNU and completed a residency in internal medicine at the SNUH. After completing his fellowship at the SNUH, he has been working at the SNUH and the SNU College of Medicine as a staff member since 2003. He spent a year at the Duke Comprehensive Cancer Center as a Visiting Research Fellow in 2007. Dr. Kim’s specialty is medical treatment for lung cancer and his research interests include clinical and translational research on thoracic malignancies. He has extensive experience in conducting clinical studies including first-in-human phase I studies with molecular targeted agents and immune-oncology trials. Also, he is the author of more than 150 academic papers in peer reviewed international journals.

[S15-2]Smart Clinical Development Support System

Min-Gul KimChonbuk National University Hospital

Korea

Bio Essay He is an Assistant Professor at Chonbuk National University, He received his M.D. from Chonbuk National University (2004) and his Ph.D. at Seoul National University (2014). He is interested in pharmacokinetic research field, especially phase 1 clinical trial and population pharmacokinetics. Recently, he is interested in clinical trial research using ICT technology.

[S15-3]AI-based Clinical Trial Resources Information System (ACTRiS)

Janghee HongChungnam National University College of Medicine and Hospital Clinical trials Center

Korea

Bio Essay He is a Professor at Chungnam National University Hospital. He received his B.A. from Chungnam National University of at Daejeon (1997) and his Ph.D. at Chungnam National University (2002). He has been conducting more than 15 new clinical trials every year on average, as investigator more than 10 years. These trials involve drugs and biologic products regarding a wide range of therapeutic areas, and span over various kinds of trial types such as first-in-human (FIH) studies, pharmacokinetic-pharmacodynamic studies, drug-drug interaction (DDI) studies, new formulation evaluations, clinical pharmacogenomic (PGx) studies, and bioequivalence /bioavailability (BE/BA) studies.

Time

S16: Securing Quality and Compliance in Clinical Trials

09:00~10:30

  • chair : Sora Lee
  • Affiliation : Syneos Health
  • Country : Korea
  • chair : Helen Wong
  • Affiliation : MSD
  • Country : Hong Kong

[S16-1]ICH GCP (R2): Quality Management System & Risk Management

Helen WongMSD

Hong Kong

Bio Essay Helen Kit-Yi Wong is the Regional Director, Clinical Quality Management Asia-Pacific at Merck Sharp & Dohme (MSD). She is based in Hong Kong. Helen has 20 years experiences in the pharmaceutical industry. She has worked in various areas in MSD including Regulatory Affairs, Pharmacovigilance, Clinical Operations, Operational Excellence, Quality and Process Improvement. She is now working in the Clinical Quality Management (CQM) function and leading a CQM team serving the MSD country clinical operations in Asia-Pacific. Helen graduated with First Class Honors and a Bachelor’s degree in pharmacy from the University of Sydney, Australia and a Master’s degree in Health Administration from the University of New South Wales, Australia. She is a certified Lean Six-Sigma (LSS) Black Belt and LSS Green Belt trainer. She has also been a Section Editor of Hong Kong Pharmaceutical Journal (HK Pharm J) since 2000.

[S16-2]How to Embed cQMS into Daily Work

Hannah ChenJ&J

China

Bio Essay Hannah joined Johnson & Johnson Bioresearch Quality and Compliance (BRQC) in September 2012. Current position (since September 2016): QP&S ASPAC Strategy Lead, to develop strategy for providing quality and compliance support to inspection, and to the Quality Management System in China R&D and Asia Pacific region.
2012.9-2016.9 JNJ As QA director for Asia Pacific and China R&D in BRQC, Hannah leading a team of 10 auditors in AP region covering: non-regulated, GLP, GCLP, GCP and PV audits.
1997.5-2012.9 GSK Hannah worked for GSK for more than 15 years, including 10 years in the area of auditing, and conducted a variety of GCP audits in many AP countries, as well as in US, Europe, Latin America and African countries.
2010-2012 Hannah has been working closely with China FDA since 2009, provides consultation and involves in the development of guidance documents in GCP area. She established the China QA Forum in May 2010. Since 2015 China QA forum has been collaborating with CFDA Institute of Executive Development to provide auditors’ training.
Hannah obtained her Medical Degree from Capital University of Medical Sciences in China and worked as a Pediatrician for years before joined industry in 1996.

[S16-3]The Role of Quality Assurance in Multi-Center Trials

Choy Kiew CheongIQVIA

Singapore

Bio Essay Choy Kiew Cheong is General Manager Quality Assurance (QA) of AsiaPac at IQVIA, based in Singapore. She leads a team of 16 QA professionals across AsiaPac including China, Korea and Japan. Choy Kiew joined IQVIA in September 2017. Prior to this she worked in AstraZeneca for over 27 years in roles of increasingly responsibility including leading the Japan Clinical Operations function, and heading up the QA AsiaPac function based out of China. Choy Kiew is a statistician by training. She received her Master of Science degree in Medical Statistics from the London School of Hygiene and Tropical Medicine in the UK.

Time

S17: Trends in Gene & Cell Therapy

09:00~10:30

  • chair : Hun Che Cho
  • Affiliation : Korea Drug Research Association
  • Country : Korea
  • chair : Ho-Sang Jeong
  • Affiliation : MFDS
  • Country : Korea

[S17-1]Gene and Cell Therapy: How It Started, Where We Are, and What Is Next?

Young Jik KwonUniversity of California

USA

Bio Essay Dr. Young Jik Kwon is a professor at UC Irvine in the Pharmaceutical Sciences, Chemical Engineering & Materials Science, Biomedical Engineering, and Molecular Biology & Biochemistry departments. Following his undergraduate education in Biological Engineering at Inha University, Dr. Kwon received his Ph.D in Chemical Engineering from the University of Southern California with a focus on retroviral gene delivery in 2003 and did post-doctoral training in department of chemistry at UC Berkeley on polymeric vaccine carriers. He started his academic career in Biomedical Engineering at Case Western Reserve University in 2005 and moved to UC Irvine in 2007. He currently oversees research at the BioTherapeutics Engineering Laboratory (BioTEL) at UC Irvine and his current projects mainly focus on gene therapy, drug delivery, cancer-targeted therapeutics, combined molecular imaging and therapy, and cancer vaccines.

[S17-2]Global Trend & Case Study in Cell Therapeutics

Antonio LeeMEDIPOST

Korea

Bio Essay Dr. Antonio Lee is the Global Head of Business Development at MEDIPOST (KOSDAQ: 078160; Seoul, Korea) and also serves as the CEO and Managing Director at MEDIPOST America Inc., a wholly-owned U.S. subsidiary of MEDIPOST. Since 2011, Dr. Lee has been involved in the global commercialization and clinical development strategy, regulatory affairs and marketing of human Umbilical Cord Blood (hUCB)-derived Stem Cell technology and products developed by MEDIPOST, including the World’s First regulatory-approved allogeneic stem cell product - CARTISTEM®, for the treatment of knee Osteoarthritis (OA). Dr. Lee also serves as the Chair of the Board of Directors for MEDIPOST’s North Asian Joint-Venture entities – ‘ORLIFE Pharmaceuticals, Shandong, China’ and ‘EVASTEM Therapeutics, Tokyo, Japan’

[S17-3]Current Status of Gene Therapy

Jae-Gyun JeongViroMed Co., Ltd.

Korea

Bio Essay He is a Principal Research Scientist at ViroMed Co., Ltd. He received his BA (1997), MS (1999), and Ph.D. (2003) from Seoul National University. During undergraduate period, his major was microbiology and his thesis of Ph.D. was the development of gene therapy for rheumatoid arthritis. He joined ViroMed at 2002 and has been involved in the development of various gene therapy products; plasmid DNA-based, adenovirus-based, retrovirus-based ex vivo gene therapy, and so on. He started his career as a Research Scientist and has been in charge of the Director of R&D department for 5 years, from 2012 to 2017. From this year, he moved to the global clinical development team and is currently involving in the phase III clinical trials in the United States.

[S17-4]Recent Perspective of Korean Gene & Cell Therapy Regulations

Kyungtak NamMFDS

Korea

Bio Essay Kyungtak Nam is working as a senior scientific officer at Biopharmaceuticals Review Management Division, Biopharmaceuticals & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation (NIFDS), Ministry of Food and Drug Safety (MFDS). In 2002, he joined the MFDS as a reviewer. He has been in charge of review of the safety and efficacy of biopharmaceuticals including vaccines, plasma-derived products, recombinant protein products, cell therapy products and gene therapy products for more than 10 years. Since then, he has been involved in a variety of biopharmaceutical-related tasks such as establishing biopharmaceuticals related policies, post-approval management, and national lot release and so on. Currently he is in charge of approval of advanced biopharmaceuticals.

Time

S18: Adaptive Design of Clinical Trials in Oncology Drug Development

11:00~12:30

  • chair : Jin Hyoung Kang
  • Affiliation : KCSG
  • Country : Korea
  • chair : Eric Groves
  • Affiliation : IQVIA
  • Country : USA

[S18-1]Why Adaptive Clinical Trials in Oncology Drug Development?

Hanlim MoonCUREnCARE Research

Korea

Bio Essay Hanlim Moon is a highly regarded industry oncologist with more than thirty years’ experience in oncology clinical research internationally. During her career she has fulfilled several senior corporate leadership positions, has lead clinical and pre-clinical research divisions, large and small medical teams, been a head of business development and worked as an independent consultant on a substantial array of high-value oncology projects. Experience includes portfolio development, early clinical programs, P3 registration activities and late-phase studies to support marketed therapeutics. Dr Moon is widely regarded as one of the leading industry physicians in the Asia-Pacific-Australasia region. She is particularly adept at dealing with regional norms and local requirements for the effective conduct of clinical research. The broad network of academic and industry contacts that she boasts reflects her skills as a collaborator and mentor. She is specialized in the clinical approaches to the development of therapies in both solid and hematological cancers.

[S18-2]Benchmark and Ongoing Adaptive Trials in Oncology

Jee Hyun KimSeoul National University Bundang Hospital

Korea

Bio Essay She is a Professor of Medicine at Division of Hematology and Medical Oncology, Seoul National University College of Medicine and Seoul National University Bundang Hospital. She received her MD (1995) and PhD (2004) from Seoul National University College of Medicine. She is a clinical researcher of breast cancer and hepatocellular carcinoma. She is interested in developing novel therapeutics and is conducting many clinical trials in breast and liver cancer. She is currently serving as Director of clinical trial center at Seoul National University Bundang Hospital. She is an active member of Korean Cancer Study Group, a nation-wide cooperative oncology group of Korea founded in 1998. She is now serving as Secretary General of KCSG. Her research interest also includes geriatric oncology and she conducted many studies to develop prediction tool of outcomes in older patients with cancer. She is currently a national representative of Korea in International Society of Geriatric Oncology, dedicated to promote geriatric oncology in Korea

[S18-3]Practical Considerations for Adaptive Trials

Eric GrovesIQVIA

USA

Bio Essay Dr Groves is Board Certified, in oncology and internal medicine with 30+ years of experience in drug development as corporate officer/senior manager, clinician and researcher. Noteworthy are his accomplishments in clinical and preclinical development, research and general management, for agents with oncologic, infectious disease, immunologic, dermatologic and pain therapy applications. He has the experience of five successful US registrations, four for Europe, multiple INDs, creation of new clinical and project management groups for pharmaceutical companies, start-up to multi-national. At IQVIA, Dr Groves has provided drug development guidance to a wide variety of clients both small biotech and large pharma. He has had leadership roles in development partnerships with Eisai, AstraZeneca, Merck-Serono, and Baxalta focusing on oncology and for Novartis on bone and muscle building agents. He has supported IQVIA internally, providing oncologic and development advice to IQVIA efforts to form various partnerships. Prior to joining IQVIA, Dr Groves was at Ligand Pharmaceuticals Inc, Sanofi, Sterling and Cetus in various senior management positions.

Time

S19: Answering Clinical Questions Using Medical Big Data

11:00~12:30

  • chair : Kenneth Paik
  • Affiliation : Massachusetts Institute of Technology
  • Country : USA
  • chair : Hayoung Park
  • Affiliation : Seoul National University
  • Country : Korea

[S19-1]Data Ecosystems and Data Sharing to Enable Practical Medical Analytics

Kenneth PaikMassachusetts Institute of Technology

USA

Bio Essay Dr. Paik is a clinical informatician with a decade of experience in machine learning and digital health. In addition to ongoing research in critical care informatics, he also plays a key role in development and organization of the MIT Clinical Data Consortium, an academic-industry group focused on collaborative development activities for improving the quality and availability of clinical data. Dr. Paik also leads global health innovation project initiatives for organizations including UNFPA, UNHCR, IOM, and MSF, designing and deploying mobile health solutions in regions of humanitarian crisis such as Haiti, Lebanon, Syria, and Uganda. He completed his fellowship training in biomedical informatics at Massachusetts General Hospital and Harvard Medical School. He graduated from Amherst College and received his M.D. from the Georgetown University School of Medicine.

[S19-2]Medical Big Data in the Field

Hyung Jin YoonSeoul National University College of Medicine

Korea

Bio Essay Hyung-Jin Yoon graduated from Seoul National University College of Medicine and got Ph.D. at the same university. He was trained as a physician in Seoul National University Hospital and his major was nephrology. Since 2010, he is an associate professor in Department of Biomedical Engineering Seoul National University College of Medicine and is currently serving as the director of Office of Clinical Bioinformatics, Biomedical Research Institute, Seoul National University Hospital. His research interests are in the area of medical big data and quantitative analysis of lifestyle factors such as physical activity of human.

[S19-3]How AI Technologies Can Enhance Our Understanding of Health and Disease

Mornin FengSaw Swee Hock School of Public Health, National University of Singapore

Singapore

Bio Essay Dr. Mengling Feng (http://www.mornin-feng.com) is currently an Assistant Professor at Institute for Data Science, National University of Singapore, and the Senior Assistant Director of National University Hospital championing the big data analytics efforts. Dr Feng is also an affiliated scientist with the Lab of Computational Physiology, Harvard-MIT Health Science Technology Division. His research is to develop machine learning algorithms to extract actionable knowledge from large amount of data to enable better quality of healthcare. His research brings together concepts and tools across deep learning, optimization, signal processing, statistical causal inference and big data management. Dr. Feng’s work was recognized by both well-established journals, such as Science Translational Medicine, JAMA and top international conferences, such as KDD, AAAI, MICCAI and AMIA. His team recently ranked number 2 in an international challenge on AI tools for medical image analysis. Dr. Feng works closely with clinicians aiming to develop and deploy the right AI solutions for more effective and cost-efficient care.

Time

S20: Clinical Trials in Rare Diseases

11:00~12:30

  • chair : Sin Gon Kim
  • Affiliation : Korea University Hospital
  • Country : Korea
  • chair : Seong Choon Choe
  • Affiliation : Boryung Pharmaceutical Company
  • Country : Korea

[S20-1]PARTNER’S Platform to Activate Clinical Trials for Rare Diseases Using Nation-Wide Big Data

Kyong Hwa ParkKorea University College of Medicine

Korea

Bio Essay She is a Professor at Korea University College of Medicine. She received her MD (1998) and PhD (2005) at Korea University. She is interested in conducting translational and clinical research in breast and ovarian cancer patients, especially focusing on hereditary breast and ovarian cancer syndrome. She believes that research can cure and even prevent cancer with the collaborative work of doctors, patients, family, and patient advocates. A new web-based platform for clinical research and communication for the rare disease will be introduced.

[S20-2]Rare Disease Research: Opportunities and Challenges

Tagle DaniloNational Institutes of Health (NIH)

USA

Bio Essay Danilo Tagle is Acting Deputy Director, and Associate Director for Special Initiatives in the Office of the Director at NCATS (National Center for Advancing Translational Sciences) at the National Institutes of Health (NIH) where he coordinates efforts towards developing microphysiological systems or organs on chips for drug development. He also coordinates efforts on 3D bioprinting for drug discovery, on the use of neuromodulation devices for conditions recalcitrant to drugs, and the clinical utility of secreted RNA for biomarker (liquid biopsy) and therapy development. Prior to joining NCATS in 2012, he was a program director for neurogenetics at the National Institute of Neurological Disorders and Stroke at NIH where he was involved in developing programs concerning genomics-based approaches for basic and translational research in inherited brain disorders. He was also an investigator and section head of molecular neurogenetics at the National Human Genome Research Institute at NIH and has been involved in the highly collaborative effort toward the positional cloning of genes for Huntington’s disease, ataxia-telangiectasia and Niemann-Pick disease type C. He has served on numerous committees, advisory boards, and editorial boards. Dan obtained his Ph.D. in molecular biology and genetics from Wayne State University School of Medicine in 1990. He was an NIH National Research Service Award postdoctoral fellow in human genetics in the laboratory of Francis S. Collins, M.D., Ph.D., at the University of Michigan. Dan has authored more than 150 scientific publications and has garnered numerous awards and patents.

[S20-3]The Rare Diseases and Pediatric Clinical Research Networks in Europe

Jacques DemotesECRIN

France

Bio Essay Jacques Demotes-Mainard, MD-PhD-MBA, is a neurologist and professor of Cell Biology. He worked as a clinical neurologist and basic neuroscientist, then as Director of a clinical research centre (CIC INSERM Bordeaux). Since 2014 he is Director General of the Paris-based ECRIN, the European research infrastructure supporting multinational clinical trials. Also advisor for the Biology and Health research department of the French Ministry of Higher Education, Research and Innovation. Chaired the working group who drafted the 2012 OECD Council Recommendation on the Governance of Clinical Trials.

[S20-4]Orphan Drug Development: A Regulatory Perspective

Changwon ParkMFDS

Korea

Bio Essay He is an Director of Oncology & Antimicrobial Products Division at National Institute of Food and Drug Safety Evaluation(NIFDS). He received the B.A. degree in Pharmacy from the SungKyunKwan University, Korea, in 1991, and the Ph.D. degrees in Pharmacy from Same University in 1997. He joined the National Institute of Toxicological Research in 1991 and has been evaluating on the safety and efficacy of drug until now

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