• Program & Speaker
  • Detailed Program

Detailed Program

  • June 28
  • June 29
  • June 30

June 28, 2017

Special Advisory Board Forum

Date & Time 10:00~12:00 Venue Jupiter, 30F
- Closed Meeting

Opening Ceremony

Date & Time 13:30 ~ 14:00 Venue Harmony, B1
- Opening

[GBC1] Keynote Speech & Plenary Session

Date & Time 14:00~18:00 Venue Harmony, B1
  • 14:00~14:30Reform of Regulations for Healthcare Convergence in 4th Industrial Revolution Dr. Min-Hwa Lee Chairman, KCERN / Professor, KAIST, Korea)
  • 14:30~15:00From Treatment to Cure: Striving for the Ultimate Goal in Healthcare Innovation Dr. Michael Goettler (Global President, Rare Disease for Pfizer's Innovative Health Business)
  • 15:00~15:30Small and Strong - Winning Models in Korea R&D Dr. Axel Baur (Senior Partner, Leader of McKinsey’s Asia Healthcare Practice, Mckinsey)
  • 15:30~16:00​Healthcare in the Age of Cognitive Computing Dr. Michael S. Weiner (Chief Medical Information Officer, IBM Healthcare)
  • 16:00~16:30Coffe Break
  • 16:30~17:00Prediction of Inherited Genomic Susceptibility for Major Cancers by Machine Learning Dr. Sung-Hou Kim (Professor, UC Berkeley, USA)
  • 17:00~17:30Modeling of Human Genetic Diseases Using Induced Pluripotent Stem Cells Prof. Yong-Mahn Han (Professor, KAIST, Korea)
  • 17:30~18:00Applications of 3D Printing in Biomedical Engineering Prof. Won-Soo Yun (Professor, Korea Polytechnic University / CEO, T&R Biofab Co., Ltd., Korea)

[GBC11] WHO PQ Workshop

Date & Time 14:00~17:45 Venue Vivace, B1
  • 14:00~14:15PQ Overview Ms. Carmen Rodriguez (Prequalification Team, World Health Organization (WHO))
  • 14:15~14:30PQ Pilot Process for Prequalification of Biosimilars Dr. Drew Meek (Prequalification Team, World Health Organization (WHO))
  • 14:30~14:45Vaccine Prequalification Overview Ms. Carmen Rodriguez (Prequalification Team, World Health Organization (WHO))
  • 14:45~14:55New Dossier Format- CTD to Replace PSF Ms. Carmen Rodriguez (Prequalification Team, World Health Organization (WHO))
  • 14:55~15:15The PQ Process: Quality Assessment and Programmatic Suitability for Prequalification Dr. Drew Meek (Prequalification Team, World Health Organization (WHO))
  • 15:15~15:30The PQ process: Inspection Mr. Mustapha Chafai (Prequalification Team, World Health Organization (WHO))
  • 15:30~16:00Coffee Break
  • 16:00~16:30GMP Biologicals :Lessons Learnt from Vaccine Inspections Mr. Mustapha Chafai (Prequalification Team, World Health Organization (WHO))
  • 16:30~17:00Clinical Assessment Mr. Olivier Lapujade (Prequalification Team, World Health Organization (WHO))
  • 17:00~17:15Post-Prequalification Monitoring of Prequalified Vaccines Dr. Drew Meek & Mr Olivier Lapujade (Prequalification Team, World Health Organization (WHO))
  • 17:15~17:30Collaborative Process for National Registration in Recipient Countries of Prequalified Products Ms. Carmen Rodriguez (Prequalification Team, World Health Organization (WHO))
  • 17:30~17:45Discussion and Q&A

Press Conference

Date & Time 16:30 ~ 17:30 Venue Allegro, B1
- Closed Meeting

 

June 29, 2017

[GBC2] Vaccine Forum

Date & Time 09:00~18:00 Venue Harmony I, B1
  • 09:00~10:00Innovation and Challenges in Vaccine Development Dr. Stephen Lockhart (Pfizer)
  • 10:00~11:00The History, Now and Future of Vaccine Development Dr. Rino Rappuoli (GSK)
  • 11:00~11:20Coffee Break
  • 11:20~12:20Current Status and Future of Regulatory Science of Biologics Dr. Ian Feavers (NIBSC, UK)
  • 12:20~13:40Lunch
  • 13:40~14:40Development of Zika Vaccines Dr. In-Kyu Yoon (International Vaccine Institute, Korea)
  • 14:40~15:40The Use of Novel Adjuvants to Enhance and Broaden the Immune Response Elicited by Human Vaccines Dr. Ralf Wagner (Paul-Ehrlich-Institut, Germany)
  • 15:40~16:00Coffee Break
  • 16:00~17:00Regulatory Challenges in the Design, Analysis and Interpretation of Immunobridging Vaccine Trials Using Correlates of Protection Dr. Catherlin Njue (Health Canada, Canada)
  • 17:00~18:00Development of an Ebola Vaccine in the Midst of an Unprecedented Epidemic Dr. Jayanthi Wolf (Merck, Sharp & Dohme (MSD)

[GBC3] Recombinant Protein Products Forum

Date & Time 09:30~17:30 Venue Harmony II, B1
  • 09:30~10:10History, Current Status and Future of Recombinant Protein Products Dr. Elwyn Griffiths (Health Canada, UK)
  • 10:10~10:50Current Trends and Future of Biosimilars Dr. Jian Wang (Health Canada, Canada)
  • 10:50~11:00Q&A
  • 11:00~11:20Coffee Break
  • 11:20~12:00Roadmap Based Approach to Precision Oncology  Dr. Soonmyung Paik (Yonsei University College of Medicine, Korea)
  • 12:00~12:10Q&A
  • 12:10~13:30Lunch
  • 13:30~14:10Creating Next Generation ADCs with Industry Leading DAR Precision and Plasma Stability Dr. Jeiwook Chae (LegoChem Biosciences, Inc., Korea)
  • 14:10~14:50Emerging Strategies for Engineering Monoclonal Antibodies with Improved PK/PD Dr. Douglas L. Sheridan (Alexion, USA)
  • 14:50~15:30Modulation of the Quality of mAbs and Fc-fusion Proteins in CHO Cell Culture Prof. Gyun Min Lee (KAIST, Korea)
  • 15:30~15:40 Q&A
  • 15:40~16:00 Coffee Break
  • 16:00~16:40 Continuous Bioprocessing: Technology and Regulatory Challenges and Mitigation Strategies Dr. Marc Bisschops (Pall Lifesciences, USA)
  • 16:40~17:20Immunogenicity Considerations in Review and Approval of Therapeutic Proteins Dr. Klara Tiitso (European Medicines Agency, UK)
  • 17:20~17:30 Q&A

[GBC4] Cell & Gene Therapy Products Forum

Date & Time 09:30~17:40 Venue Harmony III, B1
  • 09:30~10:00Present and Future of Cell and Gene Therapy Product Development Dr. Maria Cristina Galli (Istituto Superiore di Sanità, Italy)
  • 10:00~10:30Current Status of Advance Therapies in Japan Prof. Teruhide Yamaguchi (Kanazawa Institute of Technology, Japan)
  • 10:30~10:50 Coffee Break
  • 10:50~11:30Clinical and Regulatory Considerations for CAR-T Cell Therapies Prof. Bambi Grilley (Baylor Collge of Medicine, USA)
  • 11:30~13:00 Lunch
  • 13:00~14:00Initiating Cell and Gene Therapy: New Progress for the Pharmaceutical Industry Dr. Joseph Tarnowski (GSK R&D, USA)
  • 14:00~15:00Development of Anticancer Therapies Based on Chimeric Antigen Receptor (CAR)-T cells:
    CAR-T Cells in Clinical Trials of Hematologic Malignancies
    Dr. Jae Hong Park (Memorial Sloan Kettering Cancer Center, USA)
  • 15:00~15:40Regulatory Policy Directions for Cell and Gene Therapy Products:
    Regulation of CAR-T Cell Therapies from Singapore Perspectives
    Dr. Lee Lee Ong (Health Sciences Authority, Singapore)
  • 15:40~16:00 Coffee Break
  • 16:00~16:40Update on Regulatory Aspect of Regenerative Medical Products in Japan Dr. Masakazu Hirata (PMDA, Japan)
  • 16:40~17:20FDA's Role in Advancing Development of Cellular Products Dr. Diane Maloney (FDA, USA)
  • 17:20~17:40Regulatory Policy Directions for Cell and Gene Therapy in Korea   Dr. Jeewon Joung (MFDS, Korea)

[GBC5] Blood Products Forum

Date & Time 09:00~12:40 Venue Vivace, B1
  • 09:00~09:40Innovation in Blood Banking and Transfusion Medicine Dr. Hyun Ok Kim (Yonsei University College of Medicine, Korea)
  • 09:40~10:20Current Status and Production Trends of Plasma Fractionation in the World Prof. Thierry Burnouf (Taipei Medical University, Taiwan)
  • 10:20~10:40 Coffee Break
  • 10:40~11:20 Development of Plasma Therapies in Relation to Emerging Infectious Diseases Dr. Glenn Smith (TGA, Australia)
  • 11:20~12:00Establishment of a Reliable Supply of Blood and Blood Products in Canada (Video Conference) Dr. Francisca Agbanyo (Health Canada, Canada)
  • 12:00~12:40How to Support the Reliable Supply of Source Plasma/Plasma Derivatives during National Emergencies Dr. Moon Jung Kim (Seonam University College of Medicine, Korea)

[GBC6] Human Tissues Forum

Date & Time 13:30~17:50 Venue Vivace, B1
  • 13:30~13:50Human Tissue Safety Control Policies of Korea Ms. Eunhee Moon (MFDS, Korea)
  • 13:50~14:30The Development of a National Canadian Tissue System: Perspective and Lessons Learned Mr. Ken Lotherington (Canadian Blood Services, Canada)
  • 14:30~15:10Considerations When Screening and Testing Donors of Human Tissue Mr. Jason LoVerdi (American Association of Tissue Banks, USA)
  • 15:10~15:30 Coffee Break
  • 15:30~16:10Criteria and Mechanisms of Managing Tissue Bank Establishments Mr. Brian Bobka (AlloSource, Inc, USA) & Jennifer Drago (Advanced Quality Resources, a Division of Eye and Tissue Resources, USA)
  • 16:10~16:50Standards for Tissue Banking, 14th Edition: Overview of Changes Mr. Jason LoVerdi (American Association of Tissue Banks, USA)
  • 16:50~17:50Panel Discussion

WHO PQ (1:1Meeting)

Date & Time 09:00~12:20 Venue Business Center, 2F
- Closed Meeting

Blood Products

Date & Time 14:00~16:00 Venue Business Center, 2F
- Closed Meeting

June 30, 2017

[GBC7] GMP Forum

Date & Time 09:20~11:50 Venue Harmony I, B1
  • 09:20~10:00Process Validation GMP Guideline for Biopharmaceuticals Dr. Richard Parker (MHRA, UK)
  • 10:00~10:40FDA’s New Initiative: Quality Metrics - Why, What, How and Issues Prof. Seongkyu Yoon (University of Massachusetts Lowell, USA)
  • 10:40~11:10Coffee Break
  • 11:10~11:50A Study on the Quality by Design Approach for Biopharmaceutical Process Development Dr. Kyunghee Jung (Osong Medical Innovation Foundation/Clinical Drug Manufacturing Center, Korea)

[GBC8] Regulatory Workshop

Date & Time 09:00~12:30 Venue Harmony II, B1
  • 09:00~09:05 Photo
  • 09:05~09:10 Opening Remarks Mr. Moo-young Yoo (MFDS, Korea)
  • 09:10~09:30 Sophistication of Biopharmaceutical Regulations Mr. Nam Soo Kim (MFDS, Korea)
  • 09:30~09:50 Regulation of Biopharmaceuticals in Singapore Dr. Lee Lee ONG (Health Sciences Authority, Singapore)
  • 09:50~10:10 Regulation on Biopharmaceuticals and Challenges (Indonesian Perspective) Mr. Ramjani Simalango (National Ageny for Drug and Food Control, Indonesia)
  • 10:10~10:30 Registration of Biopharmaceutical Products in the Philippines Ms. Norlene I. Chua (FDA, Phillipines)
  • 10:30~10:50 Coffee Break
  • 10:50~11:10 National Regulatory System in Iraq Dr. Mohammed Ismael Majeed (Vaccine and Serum Institute, Iraq)
  • 11:10~11:30 SFDA Experience on the Regulation of Biopharmaceutical Products Dr. Ali Mohammed Al-Samil (SFDA, Saudi Arabia)
  • 11:30~11:50 Regulation of Biological Products in PERU Ms. Vicky Roxana Flores Valenzuela (DIGEMID, Peru)
  • 11:50~12:10 Advanced Therapy Products in Brazil: Where We Are Ms. Renata Miranda Parca ( ANVISA, Brazil)
  • 12:10~12:30Regulatory Framework for Biological and Biotechnological Products Mr. Pablo Diaz Molina (Public Health Institute of Chile, Chile)

[GBC9] Gap Analysis to Market Biopharmaceuticals Overseas

Date & Time 14:00~17:30 Venue Harmony II, B1
  • 14:00~14:30Contract Manufacturing - An Experience from Germany and Malaysia - Case Study Dr. Joachim Walter (Walter Biotech Consultancy, Germany)
  • 14:30~15:00Gap Analysis in Quality Systems in Vaccine Industries in Korea Dr. TED YI (Janssen Korea, Johnson and Johnson)
  • 15:00~15:30 Coffee Break
  • 15:30~16:00Scientific and Regulatory Challenges in Development and Commercialization of Biosimilars Dr. Anurag S. Rathore (Indian Institute of Technology Delhi, India)
  • 16:00~16:30Soft Factors Comparison of Biomanufacturing Between Asia and Europe Dr. Bjorn Hammarberg (ABD Life Sciences Ltd, Hong Kong)
  • 16:30~17:30 Panel Discussion

[GBC10] Biostatistics Forum

Date & Time 09:30~18:00 Venue Harmony III, B1
  • 09:30~10:00 Biostatistical Review of IND and NDA in Korea Dr. Jusun Nam (MFDS, Korea)
  • 10:00~10:30 Statistical Review of Clinical Trials: A Regulatory Perspective Dr. Catherlin Njue (Health Canada, Canada)
  • 10:30~11:00 Leading Statistical Strategy and Innovation in Drug Development Dr. Han-Joo Kim (Yuhan Corporation, Korea)
  • 11:00~11:30 Statistical Aspects in Regulatory Affairs Dr. Sang-Joon Lee (Celltrion, Korea)
  • 11:30~13:00 Lunch
  • 13:00~13:40 Usage of Noninferiority Design : Points to Consider from Regulatory Agency and Pharmaceutical Companies Prof. Seung-Ho Kang (Yonsei University, Korea)
  • 13:40~14:20 Usage of Adaptive Design : Points to Consider from Regulatory Agency and Pharmaceutical Companies Dr. Suktae Choi (Celgene Corporation, USA)
  • 14:20~15:00Adaptive Dose Finding : An Efficient Way Forward to Improve Drug Development Dr. Jiawei Wei (Novartis Pharmaceuticals, China)
  • 15:00~15:40 Vaccine Safety Monitoring, Reporting and Analysis Dr. Yun Chon (International Vaccine Institute, Korea)
  • 15:40~16:00 Coffee Break
  • 16:00~16:40Use of Real World Evidence in Drug Development Dr. Jeff Lange (Amgen, USA)
  • 16:40~17:20Drug Safety Monitoring using the National Health Insurance Claims Database Prof. Nam-Kyong Choi (Ewha Womans University, Korea)
  • 17:20~18:00Utilization of Real-World Data on Post Marketing Drug Safety Assessment in PMDA Mr. Atsushi Noguchi (PMDA, Japan)

[GBC12] Cosmetics Forum

Date & Time 14:00~17:50 Venue Harmony I
  • 14:00~14:10Opening Remarks Mr. Dong-hee Lee (MFDS, Korea)
  • 14:10~14:30The Forth Industrial Revolution and the Future of Cosmetics Mr. Ohsang Kwon (MFDS, Korea)
  • 14:30~14:50Latest Cosmetics Development Trends of Korea Dr. Soonam Park (Seoul National University of Science&Technology, Korea)
  • 14:50~15:30A Risk Assessment-Based Approach to Safety Evaluation of Cosmetic Products Dr. Seok (Soga) Kwon (P&G Singapore, Singapore)
  • 15:30~15:45Coffee Break
  • 15:45~16:20 Make-up show
  • 16:20~17:00Latest Cosmetics Development and Regulatory Trends of Europe Ms. Karyn Yeoran Yun (L’Oreal Korea, Korea)
  • 17:00-17:40Latest Cosmetics Market and Regulatory Trends of China Ms. Hyunjung Kim (MFDS, Korea)
  • 17:40~17:50Q&A

Biosimilar Reviewer Workshop

Date & Time 09:30~17:00 Venue Vivace I, B1
- Closed Meeting

Regulatory Meeting

Date & Time 15:00~17:30 Venue Allegro, B1
- Special Event

WHO PQ (1:1Meeting)

Date & Time 09:00~12:20 Venue Business Center, 2F
- Closed Meeting

MFDS-WHO Meeting

Date & Time 14:00~16:00 Venue Mercury, 30F
- Closed Meeting

Vaccine

Date & Time 09:00~12:00 Venue Vivace II, B1
- Closed Meeting

Cell & Gene Therapy Products

Date & Time 09:00~12:30 Venue Apollo, 30F
- Closed Meeting

Human Tissues

Date & Time 09:30~12:00 Venue Mercury, 30F
- Closed Meeting