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China Pharmaceutical R&D Summit
臨床および法規制サミットのアジェンダ
全3会議日程 一覧 (95K PDF)
2011年4月11日 (月) | 2011年4月12日 (火) | 2011年4月13日 (水)
8:00
Conference Registration Begins
8:30
Chairperson's Opening Remarks
Maria Xuemei Song, Ph.D, M.D, R. Pharmacist, M.A., President, VPS-CRO Group
Maria Xuemei Song, Ph.D, M.D, R. Pharmacist, M.A., President, VPS-CRO Group
特集プレゼン
8:40
SFDA CDE's Principles and Opinions Toward Cancer Drug Discovery and Clinical Research Methodologies in China
Senior Representative, Center for Drug Evaluation, SFDA (invited)
Senior Representative, Center for Drug Evaluation, SFDA (invited)
新薬開発と治験に関する中国の法規制環境の理解
9:10
Navigating the Changing Chinese Regulatory System
2010 is the first year of the implementation of the emerging strategic industries development. The Chinese government is planning to launch a series of helpful measures to support more and faster development of large-sized enterprises and innovative enterprises, as well as to leapfrog development timelines. Faced with the current changing regulatory landscape, many are confused. This presentation will help alleviate some of the concerns of managing your business in this rapidly changing environment.
Maria Xuemei Song, Ph.D, M.D, R. Pharmacist, M.A., President, VPS-CRO Group
2010 is the first year of the implementation of the emerging strategic industries development. The Chinese government is planning to launch a series of helpful measures to support more and faster development of large-sized enterprises and innovative enterprises, as well as to leapfrog development timelines. Faced with the current changing regulatory landscape, many are confused. This presentation will help alleviate some of the concerns of managing your business in this rapidly changing environment.
Maria Xuemei Song, Ph.D, M.D, R. Pharmacist, M.A., President, VPS-CRO Group
9:40
IND and Commercialization Strategies for Chinese Drugs and Biologics into US Market
A strategy to optimize drug/biologic development and marketing exclusivity in the US provides important commercial value to your product sourced/initially developed in China. Development of this strategy should start as early in product development as possible.
Paul Nemeth, Ph.D., CEO and Executive Vice President, CSR Pharma Services
A strategy to optimize drug/biologic development and marketing exclusivity in the US provides important commercial value to your product sourced/initially developed in China. Development of this strategy should start as early in product development as possible.
Paul Nemeth, Ph.D., CEO and Executive Vice President, CSR Pharma Services
10:10
Networking Refreshment Break and Opening of Exhibit & Poster Hall
プログラムのデザインと戦略
10:45
Ipsen Settlement in China: An Experience from a French Company with More than 80 Years History
After the sustainable and successful experience of a manufacturing unit in China for around 20 years, Ipsen, a French pharmaceutical company, decided to expand its scope of activity in China with a long-term perspective and a holistic approach. This talk will present a series of initiatives, from research to medical affairs, that are being put in place by teams comprising of French and Chinese employees.
Anne Verny, M.D., MBA, Vice President, Clinical Development, Ipsen
Ying Liu, M.D., Medical Director, Medical Development, Beaufour-Ipsen (Tianjin) Pharmaceutical
After the sustainable and successful experience of a manufacturing unit in China for around 20 years, Ipsen, a French pharmaceutical company, decided to expand its scope of activity in China with a long-term perspective and a holistic approach. This talk will present a series of initiatives, from research to medical affairs, that are being put in place by teams comprising of French and Chinese employees.
Anne Verny, M.D., MBA, Vice President, Clinical Development, Ipsen
Ying Liu, M.D., Medical Director, Medical Development, Beaufour-Ipsen (Tianjin) Pharmaceutical
11:15
A Hutchison MediPharma's Drug Development Footprint: From China Discovery Projects to Global Phase 3 Clinical Trials
Abstract not available at time of print.
Xun Zhang, Ph.D., Senior Vice President, Hutchison Medipharma, Ltd.
Abstract not available at time of print.
Xun Zhang, Ph.D., Senior Vice President, Hutchison Medipharma, Ltd.
11:45
Opportunity and Challenge of Global Clinical Trials in a Dynamic Regulatory Environment
Most large phase III registration trials require global participation. Currently, the regional and country specific regulatory requirements are very challenging. This talk will examine the opportunities for Asia countries, opportunities for Chinese study centers as well as for Chinese local CROs.
Oliver Kong, M.D., Senior Director, Clinical R/D Oncology, Celgene Corporation
Most large phase III registration trials require global participation. Currently, the regional and country specific regulatory requirements are very challenging. This talk will examine the opportunities for Asia countries, opportunities for Chinese study centers as well as for Chinese local CROs.
Oliver Kong, M.D., Senior Director, Clinical R/D Oncology, Celgene Corporation
12:15
FIH Study in China: from IND Application to Study Completion
First-in-human study is a critical step to translate scientific findings during discovery stage into potential clinical application. With more and more firms establishing an R&D center in China, it is worthwhile to exam the status of FIH study in China, including SFDA regulations, GCP center performance and its development in near future, safety handling issue and IRB consideration.
Dan Zhang, M.D., MPH, Co-Founder & CEO, Fountain Medical Development
First-in-human study is a critical step to translate scientific findings during discovery stage into potential clinical application. With more and more firms establishing an R&D center in China, it is worthwhile to exam the status of FIH study in China, including SFDA regulations, GCP center performance and its development in near future, safety handling issue and IRB consideration.
Dan Zhang, M.D., MPH, Co-Founder & CEO, Fountain Medical Development
12:45
Networking Luncheon with Exhibit & Poster Viewing
1:55
Chairperson's Remarks
Dan Zhang, M.D., MPH, Co-Founder & CEO, Fountain Medical Development
Dan Zhang, M.D., MPH, Co-Founder & CEO, Fountain Medical Development
2:00
Phase IIB Clinical Study of Sifuvirtide in China
A multicenter randomized Phase II clinical study was conducted to appreciate the efficacy, safety and pharmacokinetics of combination therapy of Sifuvitide with other anti- retrovirus drugs in treatment-experienced HIV-infected patients. The results showed that Sifuvirtied showed good safety profiles and the efficacy of combination therapy of Sifuvitide with other anti- retrovirus drugs can be substantially improved.
Jingzong Qi, Ph.D., Vice President, Business Development, FusoGen Pharmaceutical Company
A multicenter randomized Phase II clinical study was conducted to appreciate the efficacy, safety and pharmacokinetics of combination therapy of Sifuvitide with other anti- retrovirus drugs in treatment-experienced HIV-infected patients. The results showed that Sifuvirtied showed good safety profiles and the efficacy of combination therapy of Sifuvitide with other anti- retrovirus drugs can be substantially improved.
Jingzong Qi, Ph.D., Vice President, Business Development, FusoGen Pharmaceutical Company
2:30
Creating Readiness for Global Trials in China
Abstract not available at time of print.
Juan Qiao, Ph.D., Director of Clinical Sciences, Primary Care Business Unit, Pfizer (China) R&D Center
Abstract not available at time of print.
Juan Qiao, Ph.D., Director of Clinical Sciences, Primary Care Business Unit, Pfizer (China) R&D Center
3:00
Long-Term Strategy to Ensure Persistent Clinical Research Development in China
In China, we have already about 20 year's operation experience on conducting global clinical studies. Recently, as always, changes come to the clinical research arena very frequently, working environments both internally and externally have been changed; sponsor operation strategy changed a lot as well. How to maintain a persistent development and overcome the current challenges is key to our future business success.
Jennifer Huang, Ph.D., Research Director, Global Clinical Trial Operation, MSD China
In China, we have already about 20 year's operation experience on conducting global clinical studies. Recently, as always, changes come to the clinical research arena very frequently, working environments both internally and externally have been changed; sponsor operation strategy changed a lot as well. How to maintain a persistent development and overcome the current challenges is key to our future business success.
Jennifer Huang, Ph.D., Research Director, Global Clinical Trial Operation, MSD China
3:30
Networking Refreshment Break with Exhibit & Poster Viewing
基調講演 (3つのカンファレンス共通のセッション)
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 (月) | 2011年4月12日 (火) | 2011年4月13日 (水)
総会: 中国における変革と技術革新
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.
基調講演
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
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
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
臨床および法規制サミット
1:55
Chairperson's Opening Remarks
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
世界の立証研究の実際
2:00
Patient Chart Review for CML in China
This talk highlights the process of conducting an epidemiological study for CML among 15 hospitals in China in 2006-2007. Data from real world practice can help to enhance clinical guidelines while conducting such a study can help to foster good engagement with local thought leaders in the respective disease areas in China. Epidemiological studies in China can generate real world data not only for outcomes research, but also as background information for regulatory filing.
Hong Li, Ph.D., Group Director, Global Health Economics & Outcomes Research, Bristol-Myers Squibb Company
This talk highlights the process of conducting an epidemiological study for CML among 15 hospitals in China in 2006-2007. Data from real world practice can help to enhance clinical guidelines while conducting such a study can help to foster good engagement with local thought leaders in the respective disease areas in China. Epidemiological studies in China can generate real world data not only for outcomes research, but also as background information for regulatory filing.
Hong Li, Ph.D., Group Director, Global Health Economics & Outcomes Research, Bristol-Myers Squibb Company
2:30
Conducting HE&OR Studies in China: Novartis Experience
Abstract not available at time of print.
Jennifer Sung, Executive Director, Global Health Economics & Outcomes Research, Novartis Pharmaceuticals
Abstract not available at time of print.
Jennifer Sung, Executive Director, Global Health Economics & Outcomes Research, Novartis Pharmaceuticals
3:00
Real World Evidence Study in China
RWE data plays a big role in exploring the standard treatment, identifying the unmet medical needs and giving advice to the payer etc. It is a key component of the product life cycle management plan. Considering that the current China healthcare database system is not well developed, pharmaceutical companies are facing a daunting challenge when designing and conducting high quality RWE studies.
Helen Lin, MBA, Medical Science & Medical Affairs Director, R&D, AstraZeneca China
RWE data plays a big role in exploring the standard treatment, identifying the unmet medical needs and giving advice to the payer etc. It is a key component of the product life cycle management plan. Considering that the current China healthcare database system is not well developed, pharmaceutical companies are facing a daunting challenge when designing and conducting high quality RWE studies.
Helen Lin, MBA, Medical Science & Medical Affairs Director, R&D, AstraZeneca China
3:30
Networking Refreshment Break and Last Chance for Exhibit & Poster Viewing
臨床薬理学、安全性、ファーマコビジランス
4:00
Clinical Pharmacology in New Drug Innovation: Science-Driven Programs and Study Designs
- Key clinical pharmacology questions addressed for development of an NCE in the West
- China Regulation pertaining to clinical pharmacology and real-life experiences
- Future opportunities
4:30
Safety Monitoring of Clinical Trials in General and in China
Developmental risk management plan should be prepared with the first-in-man study and continue throughout the clinical development program. As drug safety is an evolving science in China, a concerted effort by the academia, SFDA and industry is required to ensure patient protection and quality safety data collection from clinical trials conducted in the country.
Rebecca Wang, M.D., FRCP, FACC, Head, Product Safety Operation, Asia Pacific, Shanghai Roche Pharmaceuticals, Ltd.
Developmental risk management plan should be prepared with the first-in-man study and continue throughout the clinical development program. As drug safety is an evolving science in China, a concerted effort by the academia, SFDA and industry is required to ensure patient protection and quality safety data collection from clinical trials conducted in the country.
Rebecca Wang, M.D., FRCP, FACC, Head, Product Safety Operation, Asia Pacific, Shanghai Roche Pharmaceuticals, Ltd.
5:00
How to Develop Risk Management Plan in Clinical Trials in China
China SFDA issued Special Review Procedure in 2009 to encourage the innovation and control the risk effectively during the drug development in China. According to this procedure, Risk Control Plan (Risk Management Plan) is required when the sponsor submits the clinical trial application in China. This presentation will cover the SFDA's requirement on risk management plan, the sharing of practices and challenges, etc.
Xiaojun Guo, M.D., Senior Patient Safety Manager, R&D China, AstraZeneca
China SFDA issued Special Review Procedure in 2009 to encourage the innovation and control the risk effectively during the drug development in China. According to this procedure, Risk Control Plan (Risk Management Plan) is required when the sponsor submits the clinical trial application in China. This presentation will cover the SFDA's requirement on risk management plan, the sharing of practices and challenges, etc.
Xiaojun Guo, M.D., Senior Patient Safety Manager, R&D China, AstraZeneca
5:30
Close of Day Two
2011年4月11日 (月) | 2011年4月12日 (火) | 2011年4月13日 (水)
8:50
Chairperson's Opening Remarks
Li Ding, MSc., Head of Trial Operations-China & Asia Pacific, Clinical Science & Operations, Sanofi-Aventis
Li Ding, MSc., Head of Trial Operations-China & Asia Pacific, Clinical Science & Operations, Sanofi-Aventis
世界同時開発
Panel Discussion
9:00
Global Simultaneous Development and Bridging of China Data with Global Data
Moderator:
Frank Shen, Ph.D., Asia Pacific Head of GPD Biometrics, Actemra China Development Leader, Roche Global Products Development Asia Pacific
Panelists:
William Wang, Ph.D., Associate Director, Biostatistics and Research Decision Sciences, Merck & Co., Inc.
Simon Day, Ph.D., Statistical Expert, Statistics Methods and Research, Roche Products Limited, United Kingdom
Bob Powell, Ph.D., Scientific Advisor, Roche Shanghai R&D Center
Ruiping Dong, M.D., Ph.D., Senior Vice President, Head of Emerging Markets R&D, Merck Research Laboratories
Ling Su, Ph.D., Senior Vice President and Head of Development Greater China, Novartis Pharma
Moderator:
Frank Shen, Ph.D., Asia Pacific Head of GPD Biometrics, Actemra China Development Leader, Roche Global Products Development Asia Pacific
Panelists:
William Wang, Ph.D., Associate Director, Biostatistics and Research Decision Sciences, Merck & Co., Inc.
Simon Day, Ph.D., Statistical Expert, Statistics Methods and Research, Roche Products Limited, United Kingdom
Bob Powell, Ph.D., Scientific Advisor, Roche Shanghai R&D Center
Ruiping Dong, M.D., Ph.D., Senior Vice President, Head of Emerging Markets R&D, Merck Research Laboratories
Ling Su, Ph.D., Senior Vice President and Head of Development Greater China, Novartis Pharma
10:00
Sponsored Presentation Available
10:30
Networking Refreshment Break
治験サイトマネジメントと運営管理
11:00
Best Practice Site Management The Trials & Tribulations of Starting Clinical Trials in a New Geographic Region, & How to Avoid Them
In recent years, there has been an explosion of new clinical trials in China. In many ways this mirrors the initial expansion into CEE and South Africa that several of us were involved in during the early 1990s. This session will draw upon those experiences to examine the potential pitfalls of conducting trials in Emerging Regions how to ensure an appropriate balance of efficiency and productivity on site whilst ensuring that you maintain the necessary quality, and how to manage staff turnover in a region with limited availability of qualified staff.
Diane Driver, Senior Director, Global Head Clinical Site Management & Monitoring, UCB Celltech, United Kingdom
In recent years, there has been an explosion of new clinical trials in China. In many ways this mirrors the initial expansion into CEE and South Africa that several of us were involved in during the early 1990s. This session will draw upon those experiences to examine the potential pitfalls of conducting trials in Emerging Regions how to ensure an appropriate balance of efficiency and productivity on site whilst ensuring that you maintain the necessary quality, and how to manage staff turnover in a region with limited availability of qualified staff.
Diane Driver, Senior Director, Global Head Clinical Site Management & Monitoring, UCB Celltech, United Kingdom
11:30
Site Management and Monitoring in the New Healthcare Environment
Investigator sites involved in clinical trial activities must be managed and monitored to ensure that the activities are performed in compliance with the protocol, all applicable operating guidelines and study plans, with GCP, the applicable regulatory requirements, and the basic principles of Operational Quality Standard. We will discuss the changes in healthcare environment and the impact on site management and monitoring practice.
Li Ding, MSc., Head of Trial Operations-China & Asia Pacific, Clinical Science & Operations, Sanofi-Aventis
Investigator sites involved in clinical trial activities must be managed and monitored to ensure that the activities are performed in compliance with the protocol, all applicable operating guidelines and study plans, with GCP, the applicable regulatory requirements, and the basic principles of Operational Quality Standard. We will discuss the changes in healthcare environment and the impact on site management and monitoring practice.
Li Ding, MSc., Head of Trial Operations-China & Asia Pacific, Clinical Science & Operations, Sanofi-Aventis
12:00
Collaborations between East-West Laboratories for Better Regulatory Compliance during Drug Discovery & Development
Pharmaceutical industry has led global initiatives to develop consensus around acceptable benchmark practices applicable to standardizing laboratory and good management systems for regulated R&D programs. Collaboration between West and East has become increasingly important for the quality of data, implementations, and products approved for public use by regulatory agencies.
Michael Zhou, Director, Bioanalytical Chemistry/DMPK, Synta Pharmaceuticals
Pharmaceutical industry has led global initiatives to develop consensus around acceptable benchmark practices applicable to standardizing laboratory and good management systems for regulated R&D programs. Collaboration between West and East has become increasingly important for the quality of data, implementations, and products approved for public use by regulatory agencies.
Michael Zhou, Director, Bioanalytical Chemistry/DMPK, Synta Pharmaceuticals
12:30
A New Integrated CRO Model for Managing Pharmaceutical Trials in Asia
This presentation will present a new integrated approach to working with CROs, which offers cost and structural benefits. This case study will also examine the new roles implemented in clinical operations in Asia.
Donald Russell, Ph.D., Senior Director, International Clinical Operations, Eli Lilly & Co.
This presentation will present a new integrated approach to working with CROs, which offers cost and structural benefits. This case study will also examine the new roles implemented in clinical operations in Asia.
Donald Russell, Ph.D., Senior Director, International Clinical Operations, Eli Lilly & Co.
1:00
Close of Clinical & Regulatory Summit
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