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China Pharmaceutical R&D Summit
生物制剂和生物学名开发的议程
日程表(PDF) (95K PDF)
2011年4月11日 (一) | 2011年4月12日 (二)
8:00
Conference Registration Begins
8:30
Chairperson's Opening Remarks
Chris Chen, Ph.D., Chief Executive Officer, Shanghai Kanda Biotechnology Co. Ltd.
Chris Chen, Ph.D., Chief Executive Officer, Shanghai Kanda Biotechnology Co. Ltd.
特选简报
8:40
The Future of Monoclonal Antibodies How Should We Approach It?
Abstract not available at time of print.
William Strohl, Ph.D., Vice President, Biologics Research, Biotechnology Center of Excellence, Centocor
Abstract not available at time of print.
William Strohl, Ph.D., Vice President, Biologics Research, Biotechnology Center of Excellence, Centocor
中国的生物制剂／生物学名药开发
9:10
Development History of Licartin, a I-131 Labeled Anti-CD147 Launched in China for Liver Cancer
Abstract not available at time of print.
Xiaochun Chen, President, Pacific Meinouke
Abstract not available at time of print.
Xiaochun Chen, President, Pacific Meinouke
9:40
EGFR mAb Development : 10 Year Development Efforts
Abstract not available at time of print.
XianHong Bai, Ph.D., Chief Executive Officer, Beijing Baitai Biotech Co.
Abstract not available at time of print.
XianHong Bai, Ph.D., Chief Executive Officer, Beijing Baitai Biotech Co.
10:10
Networking Refreshment Break and Opening of Exhibit & Poster Hall
10:45
Etanercept and Beyond: Developing High Quality Bioproducts for the Emerging Markets
Abstract not available at time of print.
Zeling Cai, Ph.D., Senior Vice President, Shanghai Celgen Biopharmaceuticals Co. Ltd.
Abstract not available at time of print.
Zeling Cai, Ph.D., Senior Vice President, Shanghai Celgen Biopharmaceuticals Co. Ltd.
11:15
Research & Development of TPO An Innovative Biopharmaceutical Product in China
This talk will present the 3S Bio's strategy on how they choose their drug target and candidate in a rational way, and how they have executed the R&D of the candidate with strong technical and financial support to become a truly innovative biopharmaceutical product in China.
Yingfei Wei, Ph.D., Chief Scientific Officer, Shenyang Sunshine Pharmaceuticals
This talk will present the 3S Bio's strategy on how they choose their drug target and candidate in a rational way, and how they have executed the R&D of the candidate with strong technical and financial support to become a truly innovative biopharmaceutical product in China.
Yingfei Wei, Ph.D., Chief Scientific Officer, Shenyang Sunshine Pharmaceuticals
11:45
Interleukin 7 Receptor: A New Therapeutic Target Using a Biological Approach for the Treatment of Inflammatory Disease
Abstract not available at time of print.
Hongtao Lu, Ph.D., Head & Senior Director, Neuroimmunology Drug Discovery Performance Unit (DPU), GlaxoSmithKline
Abstract not available at time of print.
Hongtao Lu, Ph.D., Head & Senior Director, Neuroimmunology Drug Discovery Performance Unit (DPU), GlaxoSmithKline
12:15
Oral Insulin: Beyond Convenience
Oral insulin is considered the crown jewel of biopharmaceutical delivery and is the business focus of NOD Pharmaceuticals. The presentation summarizes current status of oral insulin development on a global stage and illustrated the different challenges facing the oral insulin project compared with insulin injections. The experiences and lessons of developing oral insulin in China are updated and shared.
William Lee, Ph.D., Chief Executive Officer, NOD Pharmaceuticals, Inc.
Oral insulin is considered the crown jewel of biopharmaceutical delivery and is the business focus of NOD Pharmaceuticals. The presentation summarizes current status of oral insulin development on a global stage and illustrated the different challenges facing the oral insulin project compared with insulin injections. The experiences and lessons of developing oral insulin in China are updated and shared.
William Lee, Ph.D., Chief Executive Officer, NOD Pharmaceuticals, Inc.
12:45
Networking Luncheon with Exhibit & Poster Viewing
中国的生物制剂临床开发策略
2:00
Clinical Development Strategies for Bioequivalence/Biocomparability Studies of Biologic Compounds in China
Abstract not available at time of print.
Rong Chen, M.D., Ph.D., Head of Regulatory Center of Excellence, GlaxoSmithKline China/HK
Abstract not available at time of print.
Rong Chen, M.D., Ph.D., Head of Regulatory Center of Excellence, GlaxoSmithKline China/HK
2:30
Strategy for Anti-Drug Antibody (ADA) Detection in Non-Clinical and Clinical Safety Evaluation of New Biologics
In nonclinical/clinical studies, most biologics elicit some level of anti-drug antibody (ADA) response, which might affect PK and PD profiles, and lead to potentially serious side effects or loss of efficacy. Therefore, the immunogenicity is one of the major concerns during R&D of biologics. Herein, strategy and approaches for ADA testing are discussed.
Haifeng Song, Ph.D., Professor, Department of Pharmacology & Toxicology, Institute of Radiation Medicine, Academy of Military Medical Sciences
In nonclinical/clinical studies, most biologics elicit some level of anti-drug antibody (ADA) response, which might affect PK and PD profiles, and lead to potentially serious side effects or loss of efficacy. Therefore, the immunogenicity is one of the major concerns during R&D of biologics. Herein, strategy and approaches for ADA testing are discussed.
Haifeng Song, Ph.D., Professor, Department of Pharmacology & Toxicology, Institute of Radiation Medicine, Academy of Military Medical Sciences
3:00
Sponsored Presentation Available
IBC's Sponsored Presentations offer supplier and service companies the opportunity to present product and service offers directly to the audience at the conference. For more information, contact:US/Europe: Sherry Johnson, sjohnson@ibcusa.com, Asia Pacific: Kell Yang, kell.yang@ibcasia.com.sg
IBC's Sponsored Presentations offer supplier and service companies the opportunity to present product and service offers directly to the audience at the conference. For more information, contact:US/Europe: Sherry Johnson, sjohnson@ibcusa.com, Asia Pacific: Kell Yang, kell.yang@ibcasia.com.sg
3:30
Networking Refreshment Break with Exhibit & Poster Viewing
主题演讲 (3个会议的共通会议)
4:00
Chairperson's Remarks and Introduction of Keynotes
Tony Zhang, Ph.D., Vice President, Global External R&D, Asia, Eli Lilly & Co.
Tony Zhang, Ph.D., Vice President, Global External R&D, Asia, Eli Lilly & Co.
4:05
Key Factors to Be Successful in Emerging Markets
Ruiping Dong, M.D., Ph.D., Senior Vice President, Head of Emerging Markets R&D, Merck Research Laboratories
Ruiping Dong, M.D., Ph.D., Senior Vice President, Head of Emerging Markets R&D, Merck Research Laboratories
4:35
Innovation in Protein Therapeutics Research and Development
Clive R. Wood, Ph.D., Senior Vice President, Head of Global Biologics, Bayer Healthcare
Clive R. Wood, Ph.D., Senior Vice President, Head of Global Biologics, Bayer Healthcare
5:05
How to Introduce the Concept of "Change" in Biopharmaceuticals
Sam Waskal, Ph.D., Chairman & CEO, Kadmon Pharmaceuticals
Sam Waskal, Ph.D., Chairman & CEO, Kadmon Pharmaceuticals
5:35
Cocktail Reception in Exhibit & Poster Hall
2011年4月11日 (一) | 2011年4月12日 (二)
总会: 中国的变革和技术革新
8:45
Chairperson's Opening Remarks and Introduction of Keynote Speaker
Xian-Ping Lu, Ph.D., CEO & Chief Scientific Officer, Shenzhen Chipscreen Biosciences, Ltd.
Xian-Ping Lu, Ph.D., CEO & Chief Scientific Officer, Shenzhen Chipscreen Biosciences, Ltd.
主题演讲
8:50
Innovation in China Chinese Government's Initiatives and Investment in the 12th 5-Year Plan
Hongguang Wang, Ph.D., Director General, China National Center for Biotech Development, Ministry of Science & Technology China
Hongguang Wang, Ph.D., Director General, China National Center for Biotech Development, Ministry of Science & Technology China
Panel Discussion
9:20
Dialogue Between the Stakeholders of Innovation in China Where Does Innovation Originate From? Locally or Globally?
Panelists:
Hongguang Wang, Ph.D., Director General, China National Center for Biotech Development, Ministry of Science & Technology China
Xian-Ping Lu, Ph.D., CEO & Chief Scientific Officer, Shenzhen Chipscreen Biosciences, Ltd.
Frank Jiang, M.D., Ph.D., Vice President & Head, China R&D, Sanofi-Aventis
- Chinese government's innovation initiatives
- Chinese government's investment in biotechnology firms in 12th 5 year planning phase
- Role of MNCs in business growth/innovation in China
- How can MNCs and domestic companies bridge the gap and leverage on each other's expertise, funding and resources?
- How can MNCs assist in innovation initiatives by domestic companies?
Panelists:
Hongguang Wang, Ph.D., Director General, China National Center for Biotech Development, Ministry of Science & Technology China
Xian-Ping Lu, Ph.D., CEO & Chief Scientific Officer, Shenzhen Chipscreen Biosciences, Ltd.
Frank Jiang, M.D., Ph.D., Vice President & Head, China R&D, Sanofi-Aventis
10:20
Networking Refreshment Break with Exhibit & Poster Viewing
Panel Discussion
10:50
Transformation & Innovation: Moving Up the Value Chain
Panelists:
Robert Armstrong, Ph.D., Vice President, Global External Research, Eli Lilly
Bin Li, Ph.D., Executive Director, Senior Equity Research Analyst, China Healthcare, Morgan Stanley
George Baeder, Senior Partner, Monitor Group
Li Chen, Ph.D., Chief Executive Officer, Hua Medicine
- What's the next stage for China's life sciences industry?
- What are the pros and cons of the different approaches of global pharma?
- How can China transform itself and expand from manufacturing and service to product and technology innovation?
- Lessons learned from other industries
- Global pharma R&D Productivity challenge and how China can help?
Panelists:
Robert Armstrong, Ph.D., Vice President, Global External Research, Eli Lilly
Bin Li, Ph.D., Executive Director, Senior Equity Research Analyst, China Healthcare, Morgan Stanley
George Baeder, Senior Partner, Monitor Group
Li Chen, Ph.D., Chief Executive Officer, Hua Medicine
Showcase: IBC-BayHelix Class of 2010
12:00
ASLAN Pharmaceuticals - An Asia-Enabled Pharmaceutical Company that Develops Novel Medicines for Global Markets
Carl Firth, Ph.D., MBA, Chief Executive Officer, ASLAN Pharmaceuticals
Carl Firth, Ph.D., MBA, Chief Executive Officer, ASLAN Pharmaceuticals
Hua Medicine An Innovator's Approach to Accelerated Development
John Choi, M.D., Ph.D., Co-Founder and Chief Strategy & Business Officer, Hua Medicine
Moderator: Li Chen, Ph.D., Chief Executive Officer, Hua Medicine
Additional presenters to be announced. To present in the Showcase, please contact Mimi Langley at mlangley@ibcusa.com
John Choi, M.D., Ph.D., Co-Founder and Chief Strategy & Business Officer, Hua Medicine
Moderator: Li Chen, Ph.D., Chief Executive Officer, Hua Medicine
Additional presenters to be announced. To present in the Showcase, please contact Mimi Langley at mlangley@ibcusa.com
12:30
Networking Luncheon in Exhibit & Poster Hall with Presentation of 2nd Annual IBC-BayHelix China Pharma R&D Awards
- China Scientific Discovery of the Year Award
- China Drug Discovery of the Year Award
- China R&D Award
生物制剂和生物学名开发
1:55
Chairperson's Opening Remarks
Guoliang Yu, Ph.D., President & CEO, Epitomics, Inc.
Guoliang Yu, Ph.D., President & CEO, Epitomics, Inc.
国际的生物制剂开发之策略和成功案例
2:00
Endosialin/TEM1 Targeting via MORAb-004 Antibody: a Novel Anti-Tumor Stroma Approach
Studies have found endosialin to play a key role in tumor growth and neovessel formation in numerous cancer types. We are currently evaluating the therapeutic efficacy of MORAb-004, a human monoclonal IgG targeting TEM-1, in a Phase I clinical trial. In the presentation, target validation, preclinical models and potential MOA of the antibody will be discussed.
Yuhong Zhou, Ph.D., Senior Director of Antibody Development, Morphotek, Inc.
Studies have found endosialin to play a key role in tumor growth and neovessel formation in numerous cancer types. We are currently evaluating the therapeutic efficacy of MORAb-004, a human monoclonal IgG targeting TEM-1, in a Phase I clinical trial. In the presentation, target validation, preclinical models and potential MOA of the antibody will be discussed.
Yuhong Zhou, Ph.D., Senior Director of Antibody Development, Morphotek, Inc.
2:30
High Affinity Mirror-Image Oligonucleotides (Spiegelmers) as Alternatives to Antibodies in Drug Development: Clinical Data on MCP-1 Inhibitor NOX-E36 and SDF-1 Inhibitor NOX-A12
Using its proprietary drug discovery platform NOXXON has identified mirror-image oligonucleotides (Spiegelmers) against MCP-1 (NOX-E36) and SDF-1 (NOX-A12). Both compounds demonstrated an exceptional safety profile in regulatory toxicity studies and in multiple ascending dose Phase I studies. An update on clinical experience with Spiegelmers will be presented.
Sven Klussmann, Ph.D., Chief Scientific Officer, NOXXON Pharma AG, Germany
Using its proprietary drug discovery platform NOXXON has identified mirror-image oligonucleotides (Spiegelmers) against MCP-1 (NOX-E36) and SDF-1 (NOX-A12). Both compounds demonstrated an exceptional safety profile in regulatory toxicity studies and in multiple ascending dose Phase I studies. An update on clinical experience with Spiegelmers will be presented.
Sven Klussmann, Ph.D., Chief Scientific Officer, NOXXON Pharma AG, Germany
3:00
The Story of Abgenix: from XenoMouse to Panitumumab and Beyond
Abgenix was a highly successful biopharmaceutical company and created enormous value by successfully making the transition from its technology focus into a fully integrated product development company. Its success sets a precedent and role model for developing and executing innovative business models and strategies in the biotech industry.
Xiaodong Yang, M.D., Ph.D., President & CEO, Apexigen Inc.
Abgenix was a highly successful biopharmaceutical company and created enormous value by successfully making the transition from its technology focus into a fully integrated product development company. Its success sets a precedent and role model for developing and executing innovative business models and strategies in the biotech industry.
Xiaodong Yang, M.D., Ph.D., President & CEO, Apexigen Inc.
3:30
Networking Refreshment Break and Last Chance for Exhibit & Poster Viewing
4:00
Strategy for Cost-Effective Development of Biosimilar Monoclonal Antibodies for Rapid Introduction to Emerging Market
This presentation will review cell line platforms, process development and optimization, regulatory filing practice for commercially viable mAbs beyond R&D applications, in an attempt to develop a sound strategy for rapid introduction of mAbs to one of the most promising emerging market, namely China. Moreover, a unique business model designed to enter the market with cost-effective biosimilar products will be discussed.
Steven S. Lee, Ph.D., Chief Executive Officer, A-Bio Pharma Pte. Ltd., Singapore
This presentation will review cell line platforms, process development and optimization, regulatory filing practice for commercially viable mAbs beyond R&D applications, in an attempt to develop a sound strategy for rapid introduction of mAbs to one of the most promising emerging market, namely China. Moreover, a unique business model designed to enter the market with cost-effective biosimilar products will be discussed.
Steven S. Lee, Ph.D., Chief Executive Officer, A-Bio Pharma Pte. Ltd., Singapore
4:30
Development of Cell Therapy in China
To ensure patients' safety and evaluate the effectiveness of cell therapies, the Ministry of Health has led the government's efforts to establish a regulatory framework. Compared to the cell therapy regulations established in the US, EU and Japan, however, the regulations and their reinforcement are still evolving. For example, autologous cell therapy, regulated as a new medical technology in China, represents challenges for both development and commercialization. We will briefly discuss the current regulations in the US and share our experience in China.
Canwen Jiang, M.D., Ph.D., Vice President & Head of R&D Asia, Genzyme
To ensure patients' safety and evaluate the effectiveness of cell therapies, the Ministry of Health has led the government's efforts to establish a regulatory framework. Compared to the cell therapy regulations established in the US, EU and Japan, however, the regulations and their reinforcement are still evolving. For example, autologous cell therapy, regulated as a new medical technology in China, represents challenges for both development and commercialization. We will briefly discuss the current regulations in the US and share our experience in China.
Canwen Jiang, M.D., Ph.D., Vice President & Head of R&D Asia, Genzyme
5:00
Peptide Therapeutics & Peptide API Manufacturing in China/Asia
As a third party approved peptide CMP/CRO, many CPC's products are currently under Phase I/II/III clinical trials in US, Japan and Europe. CPC also participates in many NCE from China and passed PAI inspection for Leuprolide.
Shawn Lee, Ph.D., President & CEO, CPC Scientific, Inc.
As a third party approved peptide CMP/CRO, many CPC's products are currently under Phase I/II/III clinical trials in US, Japan and Europe. CPC also participates in many NCE from China and passed PAI inspection for Leuprolide.
Shawn Lee, Ph.D., President & CEO, CPC Scientific, Inc.
5:30
Close of Biologics & Biosimilars Development
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