Recombinant Protein Products Forum

GBC 3

Recombinant Protein Products Forum

09:00 ~ 18:00 GB II 5F

Summary
A recombinant protein product includes peptide or protein produced by genetic engineering as an active ingredient. We share the global issues and the regulatory trends on cancer immunotherapy and biosimilars.
Date
June 28(Thu), 09:00 ~ 18:00
Venue
GB II 5F Venue Guide

Schedule

Time Title Presentation File
Recombinant Protein Products
[Session 1] Development and Regulation of Immunotherapy Drugs | Chair : Dae Ho Lee (Asan Medical Center)
09:00~09:10(10')

Welcome Remark

/ Director General, MFDS

-
09:10~09:50(40')

The Tumor-Agnostic Development of Pembrolizumab in MSI-H cancer

Andrew Joe / MSD

09:50~10:30(40')

Clinical Development of TTAC-0001 (Tanibirumab) and its Combination Trial with Keytruda + TTAC-0001

Jin-San Yoo / PharmAbcine, Inc

-
10:30~10:50(20')

Coffee Break

-
10:50~11:30(40')

How Biomarkers Can Help Physicians Overcome the Challenges of Developing Immuno-oncology Therapies

Brian Lamon / BMS

-
11:30~12:10(40')

New Trend of Immune Cancer Therapy : Application of Microbiome

Suenie Park / Hallym University

12:10~12:50(40')

Global Regulatory Landscape of Drug - Companion diagnostics and Revision Proposal of Domestic Guideline

Young Kee Shin / Seoul National University College of Medicine

[Session 2] Global Regulatory trends of Biosimilars | Chair : Dae-chul Kim (NIFDS)
14:10~15:00(50')

Biosimilars: Progress and Promise

Hae-Young Ahn / Ahn Bio Consulting

15:00~15:30(30')

Regulation of Biosimilars in the European Union – an Overview of Current Issues and Initiatives

Klara Tiitso / European Medicines Agency

15:30~15:50(20')

Coffee Break

-
15:50~16:20(30')

Regulation of Biosimilars in Canada: Update on Current Issues and Activities

Stephanie Hardy / Health Canada

16:20~16:50(30')

Updates on Biosimilars and Post-Approval CMC Changes in Japan

Yasuhiro Kishioka / PMDA

16:50~17:20(30')

Role of regulatory authorities in promoting the access to biosimilars

Hyena Kang / WHO