PROGRAM
Jul.23
From Data-Driven Insights to Clinical Value: Advancing Cancer Care
Toward Healthier Taiwan
Room 701E, Hall 2
Date / Time : July 23 13:30-16:30
Venue : Taipei Nangang Exhibition Center, Hall 2 (Room 701E)
Co-organizer : Taiwan Bio Industry Organization, PwC Taiwan
Language : English and Chinese, No Translation Available
Time | Topic | Speaker |
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13:30-13:50 | Opening remark & photo | Eric Crowley Acting Commercial Section Chief of the American Institute in Taiwan |
13:50-14:10 | Taiwan’s Cancer Policy Landscape: Vision and Current Progress | Moderator Nick Meadows Director at PwC Australia Kuan-Hung Lin Partner and Health Industry Medtech Leader, PWC Taiwan |
14:10-14:35 | Leveraging Clinical Data to Inform Drug Evaluation and Reimbursement | Kung-Yee Liang Chairman of Taiwan Health and Bio Databank |
14:35-15:00 | Advancing Rare Cancer Care: From Guideline Alignment to Mortality Reduction | Yu-Feng Wei Director of the Department of Internal Medicine, E-Da Cancer Hospital |
15:00-15:20 | Coffee Break | |
15:20-16:10 |
Panel Discussion
▪ Closing Cancer Treatment Gaps to Improve Outcomes in Hard-to-Treat Cancers
▪ Debut of CDF: How to leverage RWD and Digital Tools for Reimbursement Decisions
▪ Advancing Sustainable Investment in Healthcare
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Moderator : Technology Committee of Taiwan Electrical and Electronic Manufacturers (TEEMA) |
16:10-16: 30 | Q & A | All Attendees |
16:30- | Closing |
Date / Time :July 24 14:00-17:00
Venue : Taipei Nangang Exhibition Center, Hall 1 (Room 402C)
Co-organizer: LumiSTAR Biotechnology, Molecular Devices
Jul.24
Treg Symposium 2025
Engineering Immune Peace: Translating Treg Science into Clinical Reality
Room 403, Hall 1
Date / Time : July 24 08:00-17:00
Venue : Taipei Nangang Exhibition Center, Hall 1 (Room 403)
Co-organizer : Taiwan Bio Therapeutics INC.
Session Synopsis:Jul.24
Promega Session-Innovating Biologics: Accelerating Drug Discovery and Development with Functional Bioassays
Room 503, Hall 1
Date / Time : July 24 13:00–17:30
Venue : Taipei Nangang Exhibition Center, Hall 1 (Room 503)
Co-organizer : Promega Corporation
Time | Topic | Speaker |
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13:00-13:30 |
Registration |
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13:30 |
LayPing Lee |
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13:35-14:20 |
Illuminating Biologics Drug Discovery with Innovative Assays |
Dr. Frank Fan |
14:20-15:20 |
The Bioluminescent Toolbox for Vaccine Characterization and mRNA Quality Control |
Dr. Jamison Grailer |
15:20-15:50 |
Promega Bioassays: Enabling Reliable Methodology for Research and Industrial Advancement |
Dr. Mei-Wei Lin |
15:50-16:00 |
Break |
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16:00-16:30 |
Bioassays Development for Product Release and Characterization - From a CDMO Perspective |
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16:30-17:20 |
Bioluminescent Platform Technologies for Functional Characterization of Advanced Cancer Therapeutics |
Dr. Jamison Grailer |
17:20 |
Closing |
Dr. Frank Fan |
Jul.25
AI for Bio-Pharma Integrated Practice of Design, Quality, and Manufacturing
Room 402AB, Hall 1
Date / Time : July 25 14:00-17:00
Venue : Taipei Nangang Exhibition Center, Hall 1 (Room 402AB)
Co-organizer: Genetics Generation Advancement Corp, Taiwan Bio Industry Organization
Language : English and Chinese, No Translation Available
Time | Topic | Speaker |
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14:00-14:20 |
Guest Registration |
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14:20-14:35 |
Opening Remarks |
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14:35-15:20 |
AI-Driven Innovation in Drug Discovery |
Keng-Chang Tsai CEO, Cyrus Biotechnology |
15:20-15:50 |
Accelerating Drug Innovation and Lab Automation through AI |
Peng Hua |
15:50-15:55 |
Q&A |
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15:55-16:10 |
Leveraging AI-Driven Process Optimization to Transform Biopharmaceutical Manufacturing |
Jack Lim |
16:10-16:15 |
Q&A |
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16:15-17:00 | AI Platform Demonstration |
Session Synopsis:
As the global AI era unfolds, artificial intelligence is rapidly transforming the biopharmaceutical landscape—from drug design and quality control to manufacturing processes. This forum, themed “AI for Bio-Pharma Integrated Practice of Design, Quality, and Manufacturing”, will spotlight the multifaceted applications and successful use cases of AI in the biopharmaceutical industry.
We are honored to bring together leading experts from both Taiwan and abroad, including representatives from the National Research Institute Of Chinese Medicine, Dassault Systèmes, and MasterControl. Together, they will explore how AI is becoming a critical driving force in the industry, unlocking new potential and future opportunities.
The forum will feature three key topics:
Harnessing AI to Decode Bio Signatures: A New Frontier in Precision Drug Development
Accelerating Drug Innovation and Lab Automation through AI: Enhancing pharmaceutical quality management and process innovation
Leveraging AI-Driven Process Optimization to Transform Biopharmaceutical Manufacturing: How electronic batch records are reshaping manufacturing and quality systems
On behalf of the Bionet Group, we sincerely invite professionals from pharmaceutical companies, biotech firms, CRDMOs, and academic research institutions to join us for this insightful event.
Date / Time : July 25 14:00-17:00
Venue : Taipei Nangang Exhibition Center, Hall 1 (Room 404)
Organizer : Department of Industrial Technology, MOEA
Co-organizer : Metal Industries Research & Development Centre, AG CORP, KENTRON
Time | Topic | Speaker |
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14:00-14:30 |
Admission |
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14:30-14:35 |
Opening Remarks & Group Photo |
Representative from Department of Industrial Technology, MOEA |
14:35-15:05 |
Dov Shamir, PhD
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15:05-15:35 |
Challenges of U.S. Market Expansion: An International Entrepreneur’s Perspective |
Vivian Feng CEO of AG CORP |
15:35-16:05 | John Lynn Co-Founder of QUAY |
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16:05-16:35 |
Navigating U.S. FDA Regulations and Government Grants (e.g., SBIR/STTR) |
Kenny Wang
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16:35-17:00 |
Panel Discussion |
Moderator: Vivian Feng, CEO of Accelerator Guardian Corp. Panelists: Dov Shamir, John Lynn, Kenny Wang, Pearl Chen |
Session Synopsis:
This session explores essential strategies for healthcare innovators seeking to enter the competitive U.S. market. We'll examine regulatory pathways through the FDA, reimbursement considerations, partnership opportunities, and investment landscapes unique to the American healthcare ecosystem. Experts will share insights on navigating complex stakeholder relationships, addressing market-specific challenges, and positioning your innovation for successful commercialization. Whether you're developing medical devices, biotech solutions, digital health tools, or other healthcare innovations, you'll gain practical knowledge to develop a robust U.S. market entry strategy.
Jul.25
Digital and Automated Cell Manufacturing: From QbD to AI and Robotics
Room 503, Hall 1
Date / Time : July 25 13:30–17:00
Venue : Taipei Nangang Exhibition Center, Hall 1 (Room 503)
Co-organizer : Purple Win Co., Ltd.
Time | Topic | Speaker |
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13:30–14:00 |
Registration |
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14:00–14:10 |
Opening Remarks |
Session Chair |
14:10–15:10 | ||
15:10–15:30 |
Coffee Break |
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15:30–15:40 |
2nd Opening Remark |
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15:40–16:40 |
Development of robotic automation system for cell manufacturing |
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16:40–17:00 |
Closing Discussion |
Date / Time : July 26 09:00–12:00
Venue : Taipei Nangang Exhibition Center, Hall 1 (Room 401)
Co-organizer : Taiwan Biomedical Innovation Association, Taiwan Bio Industry Organization, NHRI Institute of Population Health Sciences
Language: Chinese only
Time | Topic | Speaker |
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09:00-09:20 |
Registration |
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09:20-09:25 |
Opening Remarks |
Dr. Yun Yen Chairman, Taiwan Biomedical Innovation Association |
09:25-09:30 |
Special Address |
Dr. Huey-Herng Sheu
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09:30-09:35 | Group Photo | |
09:35-10:00 |
Global trend of colorectal cancer by age, gender and risk factors |
Dr. Hung-Yi Chiou Director, NHRI Institute of Population Health Sciences |
10:00-10:25 |
Diabetes mellitus/hyperglycemia on colorectal cancer risk and oncological outcomes: from basic studies to clinical perspectives |
Dr. Jaw-Yuan Wang
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10:25-10:40 |
Coffee Break |
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10:40-11:05 | Evolution and Execution of Colorectal Treatment | Dr. Po-Li Wei Superintendent, Taipei Cancer Center, Taipei Medical University |
11:05-11:30 | Ovulation may promote carcinogenesis in the proximal colon | Dr. Tang-Yuan Chu Director, Center for Prevention and Therapy of Gynecological Cancers, Hualien Tzuchi General Hospital |
11:30-11:50 | Panel Discussion | Moderator: Dr. Yun Yen Panelists: Dr. Hung-Yi Chiou Dr. Jaw-Yuan Wang Dr. Po-Li Wei Dr. Tang-Yuan Chu |
11:50-12:00 | Kulia Labs' Demo | Winn Hong CEO, Kulia Labs |
12:00- | Closing Remarks | Dr. Yun Yen Chairman, Taiwan Biomedical Innovation Association |
Jul.26
The Regulation of Biological Medicines
in US and Taiwan Pharmacopeia
Room 505AB, Hall 1
Date / Time : July 26 12:30–17:10
Venue : Taipei Nangang Exhibition Center, Hall 1 (Room 505AB)
Co-organizer : Taiwan Society of Regulatory Affairs for Medical Products, Taiwan Bio Industry Organization, The Pharmaceutical Society of Taiwan
Guiding Government Agency:Taiwan Food and Drug Administration, Ministry of Health and Welfare
Language : English and Chinese, No Translation Available
Time | Topic | Speaker |
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12:30–13:00 |
Registration |
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13:00–13:05 |
Opening remark |
Jaw-Jou Kang President, TsRAP |
13:05–13:15 |
VIP remarks |
DG Chih-Kang Chiang |
13:15–13:20 | Group Photo | |
13:20–14:00 |
Overcoming Barriers to the Availability of Biosimilars |
Moderator Churn-Shiouh Gau President, PST Chris Colwell VP, International Government & Regulatory Affairs, USP |
14:00–14:40 |
Evolving Vaccine Standards to Support Quality Throughout the Product Lifecycle: From Raw Materials to Drug Product |
Dipankar Das |
14:40–15:00 |
Coffee Break |
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15:00–15:30 | Sharing experiences of potency assay in biosimilars | Moderator Jaw-Jou Kang President, TsRAP Po-Chih Wu TFDA Division of Research and Analysis |
15:30–16:00 | Live Biotherapeutic Products: Global Regulatory Perspectives and Taiwan’s Approach. | Shirley Pan TFDA Division of Drug Regulation |
16:00-16:30 | New Rules, New Roadmap: The Impact of Regulatory Shifts on Biosimilar Developers | Lee-Cheng Liu Founder/Chairman & President, Eirgenix |
16:30-17:00 | General Discussion | Chris Colwell VP, International Government & Regulatory Affairs, USP Dipankar Das Biological Science, USP Po-Chih Wu TFDA Division of Research and Analysis Shirley Pan TFDA Division of Drug Regulation Lee-Cheng Liu EirGenix Chun-Ying Wu Chairman, Taiwan Microbiota Consortium 葉明功 中華藥典委員會委員TWP |
17:00–17:10 | Conclusion | Jaw-Jou Kang President, TsRAP |
Jul.26
Strengthening the Harmonization, Trust, and Excellence of Taiwan’s Drug Review System Through Global Experience
Room 504AB, Hall 1
Date / Time : July 26 13:00–17:10
Venue : Taipei Nangang Exhibition Center, Hall 1 (Room 504AB)
Co-organizer : Taiwan Society of Regulatory Affairs for Medical Products, Taiwan Bio Industry Organization
Language : English and Chinese, No Translation Available
Time | Topic | Speaker |
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13:00–13:30 |
Registration |
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13:30–13:40 |
Opening remark |
Jaw-Jou Kang President, TsRAP |
13:40–13:50 |
VIP remarks |
DG Chih-Kang Chiang |
13:50–13:55 | Group Photo | |
13:55–14:25 |
Global Harmonization, Convergence and Regulatory Reliance – Key Takeaways from RAPS 2024 |
Moderator 沈麗娟 理事 台灣醫藥品法規學會 蔡懿玲 助理教授/副秘書長 臺北護理健康大學健康事業管理學系 台灣醫藥品法規學會 |
14:25–14:45 | ||
14:45–15:05 | Jaylesh Jani Regulatory Submission Management - Rest of World Team Lead |
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15:05–15:15 | Q & A | All speakers |
15:15–15:35 | Coffee Break | |
15:35–16:05 | TFDA Perspectives on Harmonization and Regulatory System Strengthening Focus on Harmonization and Reliance |
Moderator 高純琇 常務理事 台灣醫藥品法規學會 林意筑 副組長 食藥署藥品組 |
16:05–17:00 | Panel Discussion: Opportunities and Challenges for Taiwan in Regulatory Convergence, Benchmarking and Reliance |
Panelists: 林意筑 食藥署藥品組副組長 陳惠芳 台大/清華/陽明交大兼任教授、前食品藥物管理署副署長 洪筱玲 台美生技協會會長 李珮瑜 IRPMA Reliance Taskforce Leader 陳昱萍 中華民國學名藥協會法規政策發展委員會副主委 蔡懿玲 台灣醫藥品法規學會副秘書長 |
17:00–17:10 | Conclusion | 高純琇 常務理事 台灣醫藥品法規學會 |