PROGRAM
2022 Focus Symposia & Workshop
BIO Asia–Taiwan 2022
Focus Symposia & Workshop Agenda
Taiwan
Cell and Gene Therapy Development Success, from Benchtop to
Marketing Authorization
DateJuly 27-31｜On-demand
VenueOnline Event Platform
Opening Remarks
Session Chair
Patrick JP Burke
Sr. Director, Business Development, Amarex Clinical Research, LLC
Towards Closed and Automated Manufacturing of CAR T-cell therapy
Luc Henry, DPhil CEO, Limula SA
Overcoming the Challenges of Cell & Gene Therapy Data Collection
Herman Wong, B.S.
Sr. Vice President, Information Technology, Amarex Clinical Research, LLC
From Magical Mystery Tour to. ... Here Comes the Sun: A Stem Cell Story From the Southern Hemisphere.
Maroun Khoury, Ph.D.
Acting CEO / CSO, Cells for Cells SA
Approaches to Overcoming Regulatory and Clinical Limitations of Cell and Gene Therapies
Chia-Hua Maggie Ho, DPhil.
Chief Operating Officer, Amarex Taiwan, LLC
Company Info
Company Name:Amarex Taiwan, LLC
Address:2F., No.19-10, Sanchong Rd., Nangang Dist, Taipei 115, Taiwan
Website:www.amarextw.com
Contact
Name:Ming-Fen Hsu
Title:Sr. Clinical Development Manager
Email:mingfenh@amarextw.com
Phone:(02) 26553391
Introduction
Amarex Taiwan, LLC began as a concept in 2003 following several years of steady growth of services provided by Amarex Clinical Research, LLC (U.S.) to Taiwanese pharma, biotech, and device companies. Shortly thereafter Amarex Taiwan was established as an affiliate organization to better serve its clients in the Pan-Pacific Region. Amarex Taiwan’s services include clinical site management, safety monitoring, and regulatory compliance for Phase I through IV trials with sites in Taiwan and the Pan-Pacific Region. In close collaboration with our U.S. affiliate, we provide regulatory services and all other trial support services including regulatory strategy development, protocol writing, data management, data analysis, and clinical study report writing. During the COVID-19 pandemic, Amarex helped companies to obtain EUA and rapid clinical trial approval from the U.S. FDA and other Regulatory Agencies around the World; including EU Competent Authorities, MHRA, Health Canada for drug, biological product, medical device and diagnostic products intended to treat and/or diagnose COVID-19.
The Australian Biotechnology Ecosystem
DateFriday 29 July, 2022 08:30-12:00
VenueRoom 703, Hall 2, Taipei Nagang Exhibition Centre
Registration Registration link
Registration and Morning Coffee
Welcome Remarks
Ms Jenny Bloomfield, Australian Representative in Taiwan
Opening Remarks
Dr Chung-hsiu Wu
Director, Biotechnology and Pharmaceutical Industries Promotion Office, MOEA
Chairman, Taiwan Bio Industry Organisation
Australia: A powerhouse for science and innovation in Biotechnology
Rhett Miller
Head of Greater China International Health Team
Trade and Investment Commissioner, Austrade
Part 1- Presentation: Australia Clinical Trials Capabilities
| Topic | Speaker |
|---|---|
| George Clinical – Your CRO Partner for Australia and across the Globe | James Cheong Chief Executive Officer George Clinical |
| US Team capability, Phase I capability and Experiences (ANZ), NVT/PPC integration | John Moller Chief Executive Officer Novotech |
| Southern Star Research: Early Phase Clinical Study Specialists | Chris Stellatos, Director Southern Star Research |
| Neuroscience Trials Australia (NTA): The CRO for all your neuroscience trials in Australia and beyond | Kathy Skoff Senior Business Development Manager Neuroscience Trials Australia |
| Nucleus Network : Your Premier Early Phase Clinical Trial Solution Provider Across Australia and USA | Jeffery Wong Director of Business Development Nucleus Network |
| Local knowledge, global network: Bioanalytical solutions for Australia and beyond | Angela Luttick EVP, Commercial 360biolabs |
| Conducting Clinical Trials in Australia: Corporate Structuring & R&D Incentives | Blair Lucas, Partner Acclime Australia |
Q&A
Part 2- Presentations: Australian Innovative Biotech Company Presentation
| Topic | Speaker |
|---|---|
| MiCheck® Prostate for Detection of Aggressive Prostate Cancer | Dr Brad Walsh Chief Executive Officer Minomic International |
| Discovery, development, and market authorisation of microbiome-based therapies | Thomas Mitchell Chief Executive Officer BiomeBank |
| Data driven development of microbiome-based therapeutics | Trent Muno SVP Therapeutics Microba Life Sciences |
| Your Australian Future: Global Talent Visa Program | Pip Butler Director Global Talent, Hong Kong and North Asia Global Australia Taskforce |
Q&A
Tea Break
Part 3: Taiwan Precision Medicine Company Presentation
| Topic | Speaker |
|---|---|
| Code to cure, an enterprise cloud-native BioMed-IT platform to empower biotech and precision medicine industries to innovate at scale and speed | Allen Chang Chief Executive Officer ATGENOMIX |
| One-stop services for cell-based products and bioassays | Shing-Mou Lee Chief Executive Officer & Lab Head TACT, Executive Director EMO Biomedicine |
| Universal antibody lock makes antibody drugs safer and effective | Yun-Chi Lu Chief Executive Officer PrecisemAb Biotech |
| A novel nanobody-based trispecific T cell engager (Nb-TriTE) for cancer immunotherapy | Shao-Chih Chiu Chief R&D Officer Shine-On BioMedical |
| Biologic drug industry pain points and how we can help to fill the gap | Alan Chang, Ph.D., Chief Executive Officer Taron Solutions |
| Research results of lung cancer urine detection technology | I-Shu Lee, Ph.D. Chief Executive Officer VITAE Biomedical |
Q&A
Event Closing
生物相似性藥品研討會：法規、健保支付與臨床應用
DateFriday 30 July, 2022 13:30-17:00
VenueRoom 702, Hall 2, Taipei Nagang Exhibition Centre
Registration separately Registration Link
報到
開場致詞
Speaker
楊志新 理事長
中華民國癌症醫學會
The Value of Biosimilars
Speaker
姜紹青 藥師
臺灣臨床藥學會學術主委/和信醫院藥劑科副主任
Moderator
謝右文 理事長
臺灣臨床藥學會
The must-knows for Biosimilars
Speaker
張端瑩 醫師
臺大醫院腫瘤部
Moderator
趙毅 主任
臺北榮民總醫院 腫瘤醫學部
Can we switch to biosimilar? How and when?
Speaker
謝燿宇 主任
衛生福利部雙和醫院 血液腫瘤科
Moderator
褚乃銘 主任
和信治癌中心醫院 血液與腫瘤內科
Break
我國生物相似性藥品健保給付政策現況與願景
Speaker
張惠萍 簡任技正
衛生福利部中央健康保險署醫審及藥材組
Moderator
譚家惠 秘書長
臺灣藥物經濟暨效果研究學會
Regulatory Considerations for Biosimilars
Speaker
陳紀勳 資深臨床小組長
財團法人醫藥品查驗中心
Moderator
蕭美玲 理事長
台灣醫藥品法規學會
Panel Discussion (with interactive response system)
Speakers
All Speakers
Moderator
楊志新 理事長
中華民國癌症醫學會
閉幕致詞
Speaker
楊志新 理事長
中華民國癌症醫學會