| 09:30-10:00 |
Registration |
| 10:00-10:20 |
Welcome Remarks & Congratulatory Remarks: Byoung Jun Bae President (CARM) / Kyung-il Choi Director General (MoHW) |
| Moderator: Kyoung Hwan Roh, Director (Artblood) |
| SESSION 1. Global CGT Development Trends |
Chairperson: Joo Ha Kwon Chair of Policy Committee Vice President / CEO (CARM / MEDVIA) Giselle Choi Regulatory Affairs Specialist (Thermo Fisher Scientific Korea) |
| 10:20-11:00 |
iPS cell-based therapy for Parkinson's disease |
Jun Takahashi M.D., Ph.D. Professor (Center for iPS Cell Research and Application, Kyoto University) |
| 11:00-11:30 |
Evolving FDA CMC Expectations for Cell and Gene Therapies: Practical Insights for Global Product Development and Regulatory Strategy |
Alafiz Prasla Senior Manager, Regulatory Affairs (Thermo Fisher Scientific) |
| 11:30-12:00 |
Tomorrow’s Therapies Depend on Today’s Decisions: Automation and Scale in CGT Manufacturing |
Wenyan Leong, Ph.D. Director (Terumo BCT) |
| 12:00-13:20 |
Lunch Time |
| SESSION 2. Advancing Regenerative Medicine through Regulatory Improvement |
Chairperson: Mee Hyun Jung Advisor, Policy Committee (CARM) (Executive Director, ENCell) |
| 13:20-13:50 |
From Medium to Low Risk: Background and Strategic Response Regarding the Deregulation of Advanced Regenerative Medicine |
Jung Hwa Kang CEO (ImmunisBio) |
| 13:50-14:20 |
Autologous Adipose-Derived Stem Cell Therapy for Knee Osteoarthritis: What We Have Learned and Where We Go Next |
Dong Jin Ryu Professor (Inha University Hospital) |
| 14:20-14:35 |
Break Time |
| SESSION 3. A New Paradigm in Advanced Regenerative Medicine: In Vivo Gene Therapy |
Chairperson: Hong Seok Ji CEO (GeneCraft) |
| 14:35-15:05 |
Needle-Free Brain Delivery Platforms: A New Paradigm for CNS Treatment |
Chae Ok Yun Vice-President / CEO (CARM / Gene-medicine) |
| 15:05-15:35 |
Revolutionizing Gene Therapeutics through Non-Viral, Repeat-dose Capable, Low-Toxicity & Tissue-Selective Delivery Platforms |
Sunny Song VP, Head of New Therapeutics Global BD&L, President (Samyang Biopharm USA) |
| 15:35-16:05 |
Precision Delivery as the Key to In Vivo CAR-T |
Ki Joon Cho Deputy Director of R&D (MVRIX Co. Ltd. Research Center) |
| 16:05-16:15 |
Break Time |
| Special Lecture |
| 16:15-16:55 |
Regulation of ATMP in the EU - Spain |
Sol Ruiz, Ph.D. Head of Biologics and ATMP (AEMPS) |
| 16:55-17:00 |
Closing |