KOREA LIFE SCIENCE WEEK
HOME SEMINAR & CONFERENCE > Advanced Regenerative Medicine Development Strategy

The 7th Global Cell & Gene Therapy Strategy Forum

SESSION 1 | Global CGT Development Trends

Jun Takahashi, M.D., Ph.D.

Professor, Center for iPS Cell Research and Application (CiRA), Kyoto University

(10:20–11:00) iPS cell-based therapy for Parkinson's disease
  • •Professor, CiRA, Kyoto University (2012–Present)
  • •Director, CiRA, Kyoto University (2022–2026)
  • •Led the clinical development of iPS cell-derived dopaminergic neuron transplantation for Parkinson’s disease
  • •Led a physician-initiated Phase I/II clinical trial at Kyoto University Hospital, with results published in Nature in 2025
  • •His research contributed to the development of AMCHEPRY, the world’s first approved iPS cell-derived therapy for Parkinson’s disease in Japan
Alafiz Prasla

Senior Manager, Regulatory Affairs, Thermo Fisher Scientific

(11:00–11:30) Evolving FDA CMC Expectations for Cell and Gene Therapies: Practical Insights for Global Product Development and Regulatory Strategy
  • •Regulatory Affairs CMC professional with 13+ years of experience in biologics and cell and gene therapy products
  • •Former Sr. Director of Regulatory Affairs CMC at Aldevron and Regulatory Affairs CMC Manager at Lonza
  • •Extensive experience in global CMC strategies and regulatory submissions, including INDs, IMPDs, BLAs, and MAAs
  • •Expertise in FDA CMC requirements, Module 3 documentation, aseptic manufacturing, process validation, and global regulatory compliance
Wenyan Leong, Ph.D.

Director, APAC Commercial, CGT, Terumo BCT

(11:30–12:00) Tomorrow’s Therapies Depend on Today’s Decisions: Automation and Scale in CGT Manufacturing
  • •Cell and gene therapy professional specializing in clinical translation, scalable manufacturing, and commercialization
  • •International experience across Singapore, the United States, and Japan in commercial strategy, strategic partnerships, and market development
  • •Ph.D. in Biomedical Engineering with expertise in tissue engineering, pluripotent stem cell differentiation, and cell-based regenerative medicine
  • •Author of 10 publications and holder of three patents in cell-based regenerative medicine

SESSION 2 | Advancing Regenerative Medicine through Regulatory Improvement

Jung Hwa Kang

CEO, ImmunisBio

(13:20–13:50) From Medium to Low Risk: Background and Strategic Response Regarding the Deregulation of Advanced Regenerative Medicine
  • •CEO of ImmunisBio and Adjunct Professor at Hanyang University
  • •Member of national advisory committees on bioinnovation, regulation, and science & technology policy
  • •Chief Advisor to the Global TOP Gene and Cell Therapy Research Group and Policy Committee Member of CARM
  • •Recipient of the Prime Minister’s Commendation, the IR52 Jang Young-sil Award, and multiple ministerial awards
  • •Ph.D. in Natural Science and Pharmacy; former Visiting Professor at The Ohio State University
Dong Jin Ryu

Professor, Inha University Hospital

(13:50–14:20) Autologous Adipose-Derived Stem Cell Therapy for Knee Osteoarthritis: What We Have Learned and Where We Go Next

SESSION 3 | A New Paradigm in Advanced Regenerative Medicine: In Vivo Gene Therapy

Chae Ok Yun

Vice-President, CARM / CEO, Gene-medicine

(14:35–15:05) Needle-Free Brain Delivery Platforms: A New Paradigm for CNS Treatment
Sunny Song

VP, Head of New Therapeutics Global BD&L / President, Samyang Biopharm USA

(15:05–15:35) Revolutionizing Gene Therapeutics through Non-Viral, Repeat-dose Capable, Low-Toxicity & Tissue-Selective Delivery Platforms
  • •Global business development, licensing, and strategic partnership leader with 20+ years of experience across biotech, pharma, and techbio
  • •Former senior roles at Thermo Fisher Scientific, Danaher, Agilent, and WuXi Biologics
  • •Leads global business development and licensing for new therapeutics at Samyang Biopharm and Samyang Biopharm USA
Ki Joon Cho

Deputy Director of R&D, MVRIX Co. Ltd. Research Center

(15:35–16:05) Precision Delivery as the Key to In Vivo CAR-T

Special Lecture

Sol Ruiz, Ph.D.

Head of Biologics and ATMP, AEMPS

(16:15–16:55) Regulation of ATMP in the EU - Spain
  • •Head of Biologics, Biotechnology and Advanced Therapies at the Spanish Medicines Agency since 2015
  • •Chair of the EMA Biologics Working Party (2014–2023) and Vice-Chair (2007–2014)
  • •Co-opted member of the EMA Committee for Medicinal Products for Human Use (CHMP) and Spanish representative to the Committee for Advanced Therapies (CAT)
  • •Chair of the EMA Vaccines Working Party since 2025, with extensive expertise in EU regulation of biologics and advanced therapy medicinal products