PROGRAM
7/27
Protecting your Life Sciences Innovations:Challenges in the USA and Europe
Obtaining global protection for your innovation can be challenging, particularly when considering the different rules and legal systems in the USA and Europe. In this seminar we will explain the post-grant challenges to patents that can be launched in the USA and in Europe, highlighting the opportunities and potential pitfalls within the two legal systems. We will also discuss the Biologics Price Competition and Innovation Act (BPCIA) in the USA and the litigation that has followed. Finally, we will have a panel discussion on the impact of clinical trials on patentability of inventions, addressing the relevance of publication of clinical trial data to assessment of novelty and inventive step in both the USA and in Europe.
Date / Time: July 27 13:30-17:00 | Registration starts from 13:00
Venue:Room 504A, Nangang International Exhibition Center, Hall1 (TaiNEX 1) / No.1, Jingmao 2nd Rd., Nangang District, Taipei City (南港展覽館一館,5樓504A會議室)
Co-organizer: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Registration Link:https://forms.gle/mB3zEc32RYBT7oQy8
Agenda
Time | Activities |
---|---|
13:00-13:30 | Registration |
13:30-13:45 | Opening Remarks | Introduction of Finnegan and the speakers Ming-Tao Yang, Partner, Finnegan |
13:45-14:45 | Navigating your Life Sciences Post-Grant Challenges: Tips for best practice when you are challenging or being challenged in the EPO or USPTO |
14:45-15:45 | The Biologics Price Competition and Innovation Act (BPCIA) and the Changing Landscape for Biologics and Biosimilars |
15:45-16:00 | Break |
16:00-17:00 | Panel Discussion:The Impact of Clinical Trials on Patentability—novelty, non-obviousness, and inherency Moderator: Professor Su-Hua Lee, Ph.D. College of Law, NTU |
17:00 | End |
Speaker's Bio
Amanda K. Murphy
Maeve O'Flynn
Contact:
Laila Liu
Tel: (02)2783-6028ext.25
Email: bioasiataiwan@gmail.com
7/27
Pushing Frontiers in Drug Screening: Innovation in Human iPSC Technology, 3D Culture Models, and High-Throughput Screening for Accelerated Drug Discovery
Due to the high demand for innovations in drug screening, LumiSTAR Biotechnology (Taiwan), HCS Pharma (France), and Molecular Device (USA) co-organized a symposium at BIO Asia-Taiwan 2023 this year, focusing on cutting-edge technologies for high-throughput phenotypic screening.
This session will showcase the revolutionary potential of Human iPSC (induced pluripotent stem cell) technology, advanced 3D culture models, and high-content/high-throughput screening techniques along with state-of-the-art imaging analysis technologies.
Attendees will gain insights into how these advancements are driving accelerated drug discovery. Join us to engage with leading experts and stay at the forefront of the rapidly evolving field of drug screening.
Date / Time: July 27 13:30-17:00
Venue:Room 403, Nangang International Exhibition Center, Hall1 (TaiNEX 1) / No.1, Jingmao 2nd Rd., Nangang District, Taipei City (南港展覽館一館4樓403會議室)
Organizer: LumiSTAR Biotechnology, HCS Pharma, Molecular Devices
Registration Link: https://www.accupass.com/go/
Agenda
Time | Event/Presentation |
---|---|
13:30-14:00 |
Registration |
14:00-14:10 |
Opening Remarks & Group Photo |
14:10-14:50 |
Transforming Drug Discovery: Leverage the Power of LumiRDT™ with Advanced Human iPSC Technology and High-throughput Screening |
14:50-15:30 |
BIOMIMESYS® Hydroscaffold, a Ready-to-use Organ-specific Extracellular Matrix for Relevant Phenotypic Screening |
15:30-16:10 |
Overcoming the Barriers to 3D Organoid Adoption: A Complete Workflow to Enable Large-scale Production of Organoids and their Use in Automated High-throughput Applications Angeline Lim, Senior Applications Scientist, Molecular Devices (USA) |
16:10-16:15 |
Closing Remarks |
16:15-17:00 |
Refreshment & Networking |
7/28
Digital Health: Data Use & Cybersecurity
In this symposium, Baker McKenzie will discuss the focus and trend on digitalization and data and its impact in the healthcare industry, the challenges when healthcare industry incorporates data privacy into compliance programs, and the views about the best practice. Baker McKenzie will also introduce the key legal and regulatory issues, from the ideation stage to market, that innovators of AI/ML products should consider, as well as the latest cybersecurity trends internationally and share the experiences in Baker McKenzie's leading cases in healthcare sector with key takeaways.
Date / Time: July 28 9:00-12:00/ On-demand
Venue:Room 505A, Nangang International Exhibition Center, Hall1 (TaiNEX 1) / No.1, Jingmao 2nd Rd., Nangang District, Taipei City (南港展覽館一館5樓505A會議室)/ Online event platform
Co-organizer: Baker McKenzie, Taipei (國際通商法律事務所)
Registration Link:https://forms.gle/LhvG88fvxoEdfFGc9
Agenda
Contact:
Laila Liu
Tel: (02)2783-6028ext.25
Email: bioasiataiwan@gmail.com
7/28
TCI Event
TBD
7/29
TMU x BE x SCHS Demoday
活動資訊
TMU x BE x SCHS Demoday 即將於台北時間 2023年 7月 29 日星期六上午12時舉辦 Demo Day
實體活動地點:台北南港展覽館1館 4樓401會議室(台北市 11568 南港區經貿二路 1 號)
歡迎對醫療科技與創業投資有興趣的產業相關夥伴一起來共襄盛舉!
Registration Link:https://www.accupass.com/go/TMUxBExSCHS-DemoDay
Agenda
Time | Activities |
---|---|
11:30-12:00 |
Registration|報到 |
12:00-12:30 |
Opening & Guest Remarks|開場 & 貴賓致詞 |
12:30-12:35 |
Intro|加速器介紹 |
12:35-14:15 |
Pitch Session|新創發表 |
14:15-14:30 |
Break|中場休息/投票 |
14:30-14:50 |
Panel Discussion 1|座談會1 |
14:50-15:20 |
Panel Discussion 2|座談會2 |
15:20-15:30 |
開票&頒獎 |
15:30-16:30 |
閉幕&交流時間 |
【BE粉專】:https://www.facebook.com/beaccelerator
【北醫生醫加速器粉專】:https://www.facebook.com/tmubiomedaccelerator/
【IRCAD-Taiwan秀傳亞洲遠距微創手術中心粉專】:https://www.facebook.com/ircadtaiwan
7/29
TCI Event
時間 | 內容 | 講者 |
---|---|---|
10:10-11:00 |
萬病之源始於腸,保腸護命新解方 |
高雄市立小港醫院院長 郭昭宏醫師 |
11:10-12:00 |
感染病原基因定序應用與發展 |
台大醫院感染科 盛望徽醫師 |
12:00-13:30 |
Break |
|
13:30-14:30 |
心血管用藥指引應用與發展 |
台北榮總心臟內科 胡瑜峰醫師 |
時間 | 內容 | 講者 |
---|---|---|
15:15-15:25 |
產學及臨床成功案例分享 |
國立台灣大學 楊泮池校長 |
15:25-15:45 |
柑橘幼果論文成果發表 |
中山醫學大學 徐慶琳教授 |
15:45-17:00 |
無限創研 論文計畫 |
大江生醫 博士團隊 |
時間 | 內容 | 講者 |
---|---|---|
15:00-15:20 |
大江生醫董事長致詞 |
大江生醫董事長 林詠翔 |
15:20-16:00 |
AI未來科技結合原料採購應用分享 |
|
16:10-17:00 |
全球採購策略佈局發布 |
大江生醫採購主管 李秋月 |
7/29
Trends in Next Generation Sequencing: Quality Management and Industrial Development
With the introduction of information technology, artificial intelligence, 5G, and extensive data analysis in the biomedical industry, Next Generation Sequencing (NGS) technology has become increasingly important. However, the issues of how to build a laboratory quality managment system of genetic testing in Taiwan to connect with global standards, utilize the benefits of big data, promote the clinical benefits of precision medicine, and pave the way for National Health Insurance coverage of NGS need further discussions by key stakeholders..
Using NGS technology to promote precision health has been a shared goal for many nations in recent years, and Taiwan must not fall behind. Taiwan Society of Pathology and PwC Legal Taiwan co-host this symposium to bring together participants from the industry, government, research institutes, and medical field. Join us for this unique opportunity for the advancement of precision medicine in Taiwan.
時間 |
議程 |
講者 |
|
---|---|---|---|
08:40 – 09:00 |
Registration |
||
09:00 – 09:20 |
Opening Remarks |
Chung-Liang Shih, Director General, National Health Insurance Administration |
|
09:20 – 10:00 |
Topic 1 |
Moderator |
|
10:00 – 10:40 |
Topic 2 |
Moderator |
|
10:40 – 11:00 |
Break |
||
11:00 – 11:30 |
Topic 3 |
Moderator |
|
11:30 – 12:00 |
Closing Remarks |
Moderator |
|
12:00 – 12:30 |
Tour of BIO Asia-Taiwan Exhibition Floor |
||
12:30 – 14:00 |
Group Lunch |
7/29
BIO-ASIA Regulatory Forum
COVID疫情催化下,伴隨著科技進化的推波助瀾,改變了醫療服務及醫藥產業的營運模式。在後疫情時代,法規監管機構做為民眾使用藥品的守門員,為確保民眾即時使用到安全、有效、具品質保證之醫藥品,法規規範與管理也進行了大幅度的調整。您想了解美國FDA與歐盟EMA,因應疫情,推行的新法規政策,以及面對這些新的法規規範,生技醫藥產業可能的因應策略與未來趨勢?同時,為回應疫情,數位醫療科技的相助帶來了臨床試驗的轉型,分散式臨床試驗(Decentralized Clinical Trial, DCT)將對未來的醫藥產業、醫療機構及民眾帶來什麼樣的變化?
台灣醫藥品法規學會非常榮幸邀請到長期深耘國際醫藥產業的王慧君執行長、Linus Kao副總裁,以及食品藥物管理署長官,分享對醫藥品監管法規趨勢的見解,及美、歐、台灣監管機構對DCT的政策措施等。竭誠歡迎對醫藥品法規及臨床試驗議題關切之會員及各界先進踴躍報名參加!
主辦單位:台灣醫藥品法規學會
會議時間:2023年7月29日(星期六)下午1點30分
會議地點:亞洲生技大會現場 504A會議室(南港展覽館一館5樓)
報名連結:https://forms.gle/d6FGS6pg2AK5rSox5
Agenda
時間 Time |
主題 Topic |
講者 Speaker |
主持人 Moderator |
|
---|---|---|---|---|
13:00 – 13:30 |
報到 |
|||
13:30 – 13:40 |
開幕 |
康照洲 理事長 |
||
13:40 – 14:30 |
State of the Art in Drug Authority Engagement |
黃文英 董事長暨總經理 |
||
14:30 – 15:00 |
US/EU DCT Rregulation and Development |
康照洲 理事長 |
||
15:00 – 15:20 |
茶敘Tea and Coffee Break |
|||
15:20 – 15:50 |
台灣藥品臨床試驗執行分 散式措施指引 |
張婷雅 科長 |
高純琇 主任 |
|
15:50 – 16:50 |
綜合討論 |
與談人: 王慧君 執行長 |
康照洲 理事長 |
|
16:50 – 17:00 |
閉幕 |
康照洲 理事長 |
聯絡人:鍾明翰、譚筱曉,TEL:(02)2747-3625,E-MAIL:tsrap@tsrap.org.tw,更多訊息請參考學會官網 (http://tsrap.org.tw/)