BPD 成都站 - 生物药工艺发展大会

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Meeting Overview

49+

Industry Speaker

999+

Professional Visitors

15+

Special Topic

Featured Event

Highlights

•Focus on the Southwest Region and strengthen practical CMC case exchanges
•Double the scale to expand BPD Chengdu's industry influence

This Year's Agenda Framework

11 6 (Day 1)

Hall 1: International Collaboration in Biologics and ADC Manufacturing

09:00-10:30

Domestic and international collaborations in biopharmaceuticals

Interview: Domestic and International Collaborative Innovation in Biologics (Ye Junmin et al.) | Pilot Segmented Production Accelerates Rare Disease Drug Approval (Zhang Xun)

10:30-11:00

Tea Break & Networking

11:00-12:30

Pharmaceutical Registration and Submission

Pharmacovigilance and Regulatory Management of Biologics Throughout the Product Lifecycle (Zhu Dianxi) | Post-Marketing Origin Change Management for European and Chinese Registration (Zhang Yunxia) | Interview: Differences in Domestic and International Submission and Regulation of Biopharmaceuticals

12:00-14:00

CMC Exclusive Offshore Roundtable (Invitation Only for C-Level Executives)

13:30-15:00

ADC Process Development

Advances in Antibody Lysine Conjugation Technology (Zhong Ping) | Challenges in Bispecific ADC Drug Development (Yu Yong) | Innovation in Subcutaneous ADC Administration (Zhang Haoyu)

15:00-15:30

Tea Break & Networking

15:30-17:00

ADC/Antibody Process Development

Upstream Cell Culture Development for ADC Drugs (Wang Zhenshou) | Interview: Differentiating ADC/Antibody Drug Design from a Commercial Production Perspective (Hosted by Lei Gang)

17:30-19:00

BPD Night - Networking Mixer

Session 2: CGT and Nuclear Medicine Innovation

09:00-10:30

Challenges in CGT Commercialization

Interview: Commercialization Challenges of CGT Drugs (Moderated by Zhang Huiyuan) | Development of In Vivo CAR-T Products Based on Lentiviral Vectors (Wang Bifeng)

10:30-11:00

Tea Break & Networking

11:00-12:30

CGT Innovative Development

Universal Off-the-Shelf Cell Therapy Products (Zhang Huiyuan) | Pharmaceutical Research on Gene-Modified iPSC Products (Yang Jiayin) | Opportunities in Stem Cell Regenerative Medicine (Xiang Jin) | Plasmid Production Processes and AAV Development (Chen Lijia)

12:00-14:00

CMC Exclusive Offshore Roundtable (Invitation Only for C-Level Executives)

13:30-15:00

Innovative Development of Radiopharmaceuticals

Interview: Nuclear Medicine Innovation and Commercialization Pathways (Hosted by Yang Xiaorong) | CMC Considerations for Radiopharmaceuticals (Liu Jiafeng) | Preclinical Evaluation Strategies for Radiopharmaceuticals (Xu Linghua)

15:00-15:30

Tea Break & Networking

15:30-17:00

Innovative Development of Radiopharmaceuticals (Continued)

Importance of Radiation Dosimetry in Early Clinical Development (Zhang Xiaoxia) | Preclinical Evaluation Strategy for Radiopharmaceuticals (Xu Linghua) | Q&A

17:30-19:00

BPD Night - Networking Mixer

11 7, Day 2

Venue 1: Innovative Drugs and Peptide Development

09:00-10:30

Innovative Drug Development

Interview: Differentiated Breakthroughs and Industrial Synergy in Innovative Drugs (Moderated by Zeng Li) | GLP-1 Multi-Target Drug Design (Song Wenxin)

10:30-11:00

Tea Break & Networking

11:00-12:30

Peptide Innovation Development Case Study

Pharmaceutical Change Studies for Peptide Biologics (Li Shuli) | CMC Development Strategy for Biological Combination Products (Yang Fengyun) | Pharmaceutical Similarity Studies for Peptide Drug Biosimilars (Xing Wancai)

12:30-13:30

Lunch & Learn

13:30-16:00

Sterility Assurance and Inspection

USP Release Testing in the Aseptic Era (Xie Guoxiu) | Assessment of New Applications for Environmental Monitoring Technology (Xue Jun) | Sterility Assurance for Monoclonal Antibody Biologics (Jiang Yu) | Q&A

Venue 2: Quality, Commercialization, and Small Nucleic Acids

09:00-10:30

Quality and Process Change Management

Antibody Drug Quality Management (Li Yan) | Process Change Management for Innovative Biologics During Clinical Development (Zhang Zhe-wen) | Q&A

10:30-11:00

Tea Break & Networking

11:00-12:30

Innovation Drug Development Enablement and Commercial Manufacturing

Empowering Drug Development and Manufacturing with New Technologies (Zhang Peng) | Continuous Process Verification at Commercial Scale (Zhou Jinli) | Q&A

12:30-13:30

Lunch & Learn

13:30-16:00

Small Nucleic Acid Innovative Development

Challenges in Oligonucleotide Drug Quality Research (Lu Feilong) | Application of Cryo-EM Technology in Small Nucleic Acid Drug Development (Chen Jinhao) | Advances in Small Nucleic Acid Drug Delivery Technologies (Wang Haojun) | Interview: Innovations and Industrialization Challenges in Nucleic Acid Delivery

Previous Schedule

11 6

Venue 1

09:00-10:30

09:00-10:00

Interview: Domestic and International Collaborative Innovation in Biologics

Host: Ye Junmin, CSO at Xinyi Tai; Guests: Zheng Zirong, CTO & Senior Vice President at Dingkang Bio; Huang Jingjing, CEO & Founder at Silingyuan Pharma; Liu Juhong, Chief Consultant at International Registration Consulting Company; Song Hongtao, CMC Vice President at Canmoya.

10:00-10:30

Pilot Phase Production Accelerates Rare Disease Drug Launch

Guest: Zhang Xun, Senior Vice President of Regulatory Affairs at BeiHeng Kangcheng

10:30-11:00

11:00-12:30

11:00-11:30

Theme: Pharmaceutical Regulatory Management Across the Full Lifecycle of Biologics

Guest: Zhu Dianxi, Senior Director of Pharmaceutical Regulatory Affairs, Roche Pharmaceuticals

11:30-12:00

Post-Marketing Change of Origin for Medicinal Products: Management of China-EU Registration Submissions

Guest: Zhang Yunxia, Eli Lilly, RA Expert

12:00-12:30

Interview: Differences in Domestic and International Registration and Regulation of Biologics

Host: Zhu Dianxi, Senior Director of Pharmaceutical Registration, Roche; Guests: Zhang Yunxia, RA Expert, Eli Lilly; Zhang Xun, Senior Vice President of Regulatory Affairs, BeiHai KangCheng

12:00-14:00

13:30-15:00

13:30-14:00

Antibody Lysine Conjugation: Advances in Site-Specific Technologies and Process Development Considerations

Guest: Zhong Ping, Director of Process Development at WuXi AppTec Advanced Solutions

14:00-14:30

Challenges and Considerations in the Development of Bispecific Antibody-Drug Conjugates (BsADCs)

Guest: Yu Yong, Vice President of Process Development, Biologics R&D Center, Kelun-Biotech

14:30-15:00

Redefining Subcutaneous ADC Delivery: Formulation Strategies, Clinical Progress, and Future Advantages

Guest: Zhang Haoyu, Deputy Director of Technology Transfer, Product Development Department, Henlius

15:00-15:30

15:30-17:00

15:30-16:00

Considerations for Upstream Cell Culture Development in ADC Drug Manufacturing

Guest: Wang Zhenshou, Director of Cell Culture Process Development at ARIAD Pharmaceuticals

16:00-17:00

Interview: Differentiated Design, CMC Development, and Quality of ADC/Antibody Drugs from the Perspective of Commercial Manufacturing

Moderator: Lei Gang, Head of Molecular Drug Creation Department, New Drug Research Institute, Kanghong Pharmaceutical; Guests: Yang Yong, Director of Quality Center, Salubris (Chengdu); Tang Defang, Deputy General Manager, Chengdu Jingze; Wang Yunxue, Deputy General Manager of Operations, Feifan (Chongqing) Biotech

17:30-19:00

Room 2

09:00-10:30

09:00-10:00

Interview: Commercialization Challenges, Material Optimization, and Substitution for CGT Drugs

Moderator: Zhang Huiyuan, Chengnuo Medical, Executive Partner & Director of Quality; Guests: Guo Junjie, Chengdu Ousai, Co-founder & COO; Wang Bifeng, Xiji Bio, Vice President; Chen Lijia, Jinweike Bio, Vice President

10:00-10:20

Process Development and Quality Control of In Vivo CAR-T Products Based on Lentiviral Vectors

Guest: Wang Bifeng, Vice President, Xiji Biotech

10:20-10:30

Questions & Answers

10:30-11:00

11:00-12:30

11:00-11:20

Development Strategy and Risk Control for Off-the-Shelf Cell Therapy Products

Guest: Zhang Huiyuan, Chengnuo Medical, Executive Partner & Director of Quality

11:20-11:40

Key Considerations for Pharmaceutical Development of Gene-Modified iPSC Products

Guest: Yang Jiayin, Co-founder & CTO, Sanqi Biology

11:40-12:00

Topic: Opportunities and Challenges of Stem Cells in Regenerative Medicine

Guest: Xiang Jin, Research Fellow at the Pharmacology Institute of Sichuan Academy of Traditional Chinese Medicine Sciences and R&D Advisor to Baitaisen Biotech

12:00-12:20

Theme: First-in-Class Plasmid Production Process and AAV Gene Therapy Product Development

Guest: Chen Lijia, Vice President of Jinweike Bio

12:20-12:30

Questions & Answers

12:00-14:00

13:30-15:00

13:30-14:00

Interview: Innovation and Commercialization Pathways in Radiopharmaceuticals

Host: Yang Xiaorong, Vice President of Tianjin Hengrui Medicine; Guests: Liu Jiafeng, VP of R&D Technology Center at Guodi New Drugs; Zhang Xiaoxia, Founder of Developo; Hu Linghua, Deputy General Manager of Radio Imaging Evaluation Center at YihaoSi

14:00-14:30

CMC Considerations for Radiopharmaceuticals

Guest: Liu Jiafeng, Vice President of R&D Technology Center, Guodi New Drugs

14:30-15:00

Theme: Nonclinical Evaluation Strategy for Radiopharmaceuticals

Guest: Xu Linghua, Deputy General Manager of the Radiology Imaging Evaluation Center at Yihao Si

15:00-15:30

15:30-17:00

15:30-16:00

Importance of Radiation Dosimetry in Early Clinical Development

Guest: Zhang Xiaoxia, Founder of Developo

16:00-16:30

Theme: Preclinical Evaluation Strategy for Radiopharmaceuticals

Guest: Xu Linghua, Deputy General Manager of the Radiology Imaging Evaluation Center at Yihao Si

16:30-17:00

Radiopharmaceutical Innovation Development: Q&A

17:30-19:00

11 7

Venue 1

09:00-10:30

09:00-10:00

Interview: Differentiated Breakthroughs in Innovative Drugs and Industry Synergy

Host: Zeng Li, CEO of Hejing Pharma; Guests: Li Yingfu, Founder and Chairman of Haibowei Pharmaceuticals; Song Wenxin, Deputy General Manager of Minwei Bio; Lou Dengfeng, Vice President of Strategy and Planning at Chengdu Xidao; Wang Wenzhi, Deputy General Manager of PedBio.

10:00-10:30

Topic: Target Combination Strategies for Multi-Target Drug Design in the GLP-1 Class

Guest: Song Wenxin, Deputy General Manager, Minwei Bio

10:30-11:00

11:00-12:30

11:00-11:30

Pharmaceutical Change Studies for Polypeptide Biologics

Guest: Shuli Li, Gan & Lee Pharmaceuticals, Director of R&D Analysis

11:30-12:00

Theme: CMC Development Strategy and Key Considerations for Biological Complex Formulations

Guest: Yang Fengyun, Director of Formulation Development at Gansu R&D Pharmaceutical

12:00-12:30

Pharmaceutical Similarity Study of Peptide-Based Drug Analogues

Guest: Xing Wancai, Gan & Lee Pharmaceuticals, Director of R&D Analysis

12:30-13:30

13:30-16:00

13:30-14:00

USP Release Testing in the Sterile Era: Breakthrough Practices of Next-Generation High-Throughput Nucleic Acid Sequencing and Mycoplasma Nucleic Acid Amplification Technologies

Guest: Guoxiu Xie, Director at WuXi Biologics

14:00-14:30

Assessment of Emerging Technologies in Environmental Monitoring: Opportunities and Challenges

Guest: Xue Jun, Senior Sterility Assurance Engineer, Manufacturing Science & Technology Department, Eli Lilly

14:30-15:00

Aseptic Assurance for Monoclonal Antibody Biologics

Guest: Jiang Yu, Director of Manufacturing at Suzhou Zhonghe

15:00-15:30

Topic: Q&A on Biologics Formulation Development, Sterility Assurance, and Inspection

Speakers: Jiang Yu, Director of Formulation Production at Suzhou Zhonghe; Xie Guoxiu, Department Head at WuXi Biologics; Xue Jun, Senior Sterility Assurance Engineer in the Manufacturing Science & Technology Division at Eli Lilly.

Room 2

09:00-10:30

09:00-09:30

Theme: Quality Management of Antibody Drugs

Guest: Li Yan, Director of the Biological Products Inspection Institute, Sichuan Provincial Institute for Drug Control

09:30-10:00

Topic: Managing Process Changes During Clinical Development of Innovative Biologics

Guest: Zhang Zhe-wen, Deputy Director of the Biological Drug R&D Institute at CSPC

10:00-10:30

Quality and Process Change Management Q&A

10:30-11:00

11:00-12:30

11:00-11:30

Theme: New Technologies Empowering Drug Development and Production

Guest: Zhang Peng, Head of Science and Technology Department, Small Molecule New Drug R&D Center, Pharmaron

11:30-12:00

Topic: Continued Process Verification at Commercial Scale

Guest: Zhou Jinli, Senior Manager, Manufacturing Science & Technology, Eli Lilly

12:00-12:30

Innovative Drug Development Enablement and Commercial Manufacturing: Q&A

12:30-13:30

13:30-16:00

13:30-14:00

Challenges and Strategies in Oligonucleotide Drug Quality Research

Guest: Lu Feilong, Head of the Innovative Drug Division and Chief Quality Officer at Guowei Biotechnology

14:00-14:30

"One Lens, Multiple Insights: Cryo-EM Applications in Small Nucleic Acid Drug Characterization and Development"

Guest: Jin Hao Chen, WuXi Biologics, Director

14:30-15:00

Advances in Delivery Technologies for Small Nucleic Acid Drugs

Guest: Haojun Wang, Anlong Bio, Head of Pharmaceutical Sciences

15:00-15:30

Interview: Challenges in Nucleic Acid Innovation Delivery and Industrialization

Moderator: Wan Jinqiao, Chairman of Xianyan Biosciences; Guests: Huang Yi, Head of Innovative Drug Division at Guowei Bio; Song Wenxin, Vice President at Minwei Bio