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活動剪影

Opening Remarks
Shan-Chwen Chang, MD, PhD
  • Executive Vice President, National Taiwan University
  • Distinguished Professor, Department of Internal Medicine, College of Medicine, National Taiwan University
Chiun Hsu, MD, PhD
  • Associate Dean, College of Medicine, National Taiwan University
Chun-Jung (Clement) Lin, PhD
  • Dean, School of Pharmacy, College of Medicine, National Taiwan University
  • Professor, School of Pharmacy, College of Medicine, National Taiwan University
Eunjoo Pacifici, PharmD, PhD
  • Chair & Associate Professor, Department of Regulatory and Quality Sciences, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, USA
Shianging (Shirley) Pan, MSc
  • Senior Technical Specialist, Division of Medicinal Products, Taiwan Food and Drug Administration (TFDA)
Keynote Lecture
Biosimilars: Opportunities and Challenges to a Sustainable Healthcare System
Moderator:
Jaw-Jou Kang, PhD
  • President, Taiwan Society of Regulatory Affairs for Medical Products (TsRAP)
  • Professor Emeritus, College of Pharmaceutical Sciences, National Yang Ming Chiao Tung University (NYCU), Taiwan
Speaker:
Sreedhar Sagi, MD, PhD
  • Head of Medical Affairs, Sandoz International Region, Sandoz
Session 1:
Regulatory Challenges for Biosimilars: Perspectives from Regulatory Authorities
Moderator:
Jaw-Jou Kang, PhD
  • President, Taiwan Society of Regulatory Affairs for Medical Products (TsRAP)
  • Professor Emeritus, College of Pharmaceutical Sciences, National Yang Ming Chiao Tung University (NYCU), Taiwan
Topics and Speakers:
  1. Regulation of Biosimilar Products in Taiwan
Chi-Hsun Chen, MD
  • Senior Clinical Section Chief, Division of New Drugs, Center for Drug Evaluation (CDE), Taiwan
  1. Current Regulation on Biosimilar in Japan
Keisuke Tanaka, PhD
  • Reviewer, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  1. Biosimilars Development and Approval – Current Status in The United States (December 2024)
Yow-Ming Wang, PhD
  • Associate Director, Biosimilars and Therapeutic Biologics, Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USA
Session 2:
Bio Industries' Points of View: Sharing Experiences and Challenges on Biosimilars
Moderator:
Frances Richmond, PhD
  • Professor Emerita, Regulatory and Quality Sciences, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, USA
Topics and Speakers:
  1. Overcoming Barriers in Biosimilar Development: Insights and Practical Recommendations
Lee-Cheng Liu, PhD
  • Founder, Chairman, and CEO of EirGenix, Inc., Taiwan
  1. Towards Streamlined Biosimilars Development – The Results of 20 Years of Success in the Clinic
Klaus Martin, PhD
  • Independent Consultant
  • CEO (part-time), Nodal Therapeutics, USA
  • Member, Scientific Advisory Board, JJP Biologics, Poland
  1. Biosimilar Development: Insights from a Biologic Developer
Mary Wilhelm, DRSc, RAC
  • Independent Consultant
  • Senior Director Regulatory Affairs, Ascendis Pharma, USA
  • Guest Lecturer, University of Southern California, USA
  1. Chemistry, Manufacturing, and Controls (CMC) Management for Biosimilar Production
Lequina Myles, DRSc, MBA, RAC, CSSBB, PfMP, PgMP, PMP
  • Vice President, Quality Assurance and Regulatory Affairs, and Business Unit Manager, Phenomenex, USA
  • Guest Lecturer, University of Southern California, USA
  • Guest Lecturer, Cedars-Sinai, USA
  • Adjunct Faculty, Mount Saint Mary's University, USA
Closing Remarks
Eunjoo Pacifici, PharmD, PhD
  • Chair & Associate Professor, Department of Regulatory and Quality Sciences, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, USA
Session 3:
Regulatory Science Issues for Biosimilars: Perspectives from Academia
Moderator:
Churn-Shiouh Gau, PhD
  • President, The Pharmaceutical Society of Taiwan (PST)
  • Director, Platform for Research and Inspiration in Regulatory Science, School of Pharmacy, College of Medicine, National Taiwan University
  • Adjunct Professor, School of Pharmacy, College of Medicine, National Taiwan University, Taiwan
Topics and Speakers:
  1. Biosimilar Research in Academia: Analytical Science and Epidemiological Research
Atsushi Yonezawa, PhD
  • Professor, Division of Integrative Clinical Pharmacology, Faculty of Pharmacy, Keio University, Japan
  1. Navigating Biosimilar Regulation: Academic Insights
Leena Suntornsuk, PhD
  • Professor, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Mahidol University, Thailand
  1. Immunogenicity and Biosimilars: Labeling Evolution and Regulatory Implications for Drug Safety
Lin-Chau Chang, PhD
  • Associate Professor, School of Pharmacy, College of Medicine, National Taiwan University, Taiwan
Session 4:
Accessibility and Utilization:
  1. Health Policy to Enhance Clinical Utilization<
  1. Clinical Experience Sharing
Moderator:
  1. Li-Ying (Grace) Huang, PhD
  • Director, Division of Health Technology Assessment, Center for Drug Evaluation, Taiwan
  • Board of Directors HTAi
  1. Mei-Ling Hsiao, MSc
  • Honorary President, Taiwan Society of Regulatory Affairs for Medical Products (TsRAP)
  • Distinguished Specialist, National Yang Ming Chiao Tung University (NYCU), Taiwan
  • Distinguished Specialist, National Cheng Kung University (NCKU), Taiwan
Topics and Speakers:
  1. The Swedish Reimbursement System for Medicines, with a Focus on Biosimilar
Niklas Hedberg, MSc
  • Chief Pharmacist, TLV, Sweden
  • Chair, EUnetHTA Executive Board
Fredrika Ryden, RPh
  • Senior Medical Investigator, The Dental and Pharmaceutical Benefits Agency (TLV), Sweden
  1. Strategies for Reimbursement of Biosimilars Under the Health Insurance System in Taiwan
Yu-Wen Huang, PhD
  • Director, Medical Review and Pharmaceutical Division, Insurance Administration, Ministry of Health and Welfare, Taiwan
  1. Clinical Adoption and Integration of Biosimilars in Healthcare Systems
Shao-Chin Chiang, PharmD
  • Director, Center for Advanced Pharmacy Education, Department of Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center, Taiwan
  • Assistant Professor, Department of Pharmacy, National Yang Ming Chiao Tung University, Taiwan
  • Director, Taiwan Society of Regulatory Affairs for Medical Products
  1. Implementation Experiences of Biosimilar Policies in Taiwanese Hospital Settings
Yuk-Ying Chan, MS
  • Chief of the Department of Pharmacy Administration at the Chang Gung Medical Foundation, Taiwan
Closing Remarks
Churn-Shiouh Gau, PhD
  • President, The Pharmaceutical Society of Taiwan (PST)
  • Director, Platform for Research and Inspiration in Regulatory Science, School of Pharmacy, College of Medicine, National Taiwan University
  • Adjunct Professor, School of Pharmacy, College of Medicine, National Taiwan University, Taiwan
Forum Agenda
議程