China R&D Summit
Event Information
Document Title
2009 Agenda
Zhangjiang Special Seminar
Monday, April 6, 2009
Only 100 seats available. Must be registered for Main Conference to qualify.
Zhangjiang Bio Pharmaceutical Development Forum: Globalization and Local Initiatives
12:00
Registration
1:00
Opening Address
Lin Xu, Secretary of Pudong New District Committee of CPC
Lin Xu, Secretary of Pudong New District Committee of CPC
1:10
Welcome Address
Xiaolong Liu, Executive Vice General Manager, Shanghai Zhangjiang (Group) Co. Ltd.
Xiaolong Liu, Executive Vice General Manager, Shanghai Zhangjiang (Group) Co. Ltd.
1:15
The Developments and Prospects of Biotech Pharma Industry
HongGuang Wang, Ph.D., Chief, China National Center for Biotechnology Development
HongGuang Wang, Ph.D., Chief, China National Center for Biotechnology Development
1:35
Vision of ZhangJiang Pharma Valley
LanZhong Wang, Majordomo of Development, Shanghai Zhangjiang (Group) Co. Ltd.
LanZhong Wang, Majordomo of Development, Shanghai Zhangjiang (Group) Co. Ltd.
1:55
IP Protection Situtation and New Policy in China
Qingkui Zhang, Minister, State Intellectual Property Office of the P.R. China
Qingkui Zhang, Minister, State Intellectual Property Office of the P.R. China
2:15
Q&A session
2:35
Networking Refreshment Break
2:45
New Drug Registration Policy and Case Analysis
Jianhua Ding, Section Chief, State SFDA
Jianhua Ding, Section Chief, State SFDA
3:05
Funding Support of Pudong Government
Speaker to be confirmed, Pudong New District Science and Technology Commission
Speaker to be confirmed, Pudong New District Science and Technology Commission
3:25
"CRO-VC-IP" Platform Model
Xiaochuan Wang, Chairman & CEO, Sundia
Xiaochuan Wang, Chairman & CEO, Sundia
3:45
The Emerging CRO Group of the World
Kevin Jin, Ph.D., General Manager, Charles River
Kevin Jin, Ph.D., General Manager, Charles River
4:05
Q&A session
Panel Discussion
4:20
Development and Globalization Strategies and Experiences from Small and Medium-sized Biopharmaceutical Companies
Panelists:
Samanthu Du, Shanghai Hutchison Pharmaceuticals
Tony Zhang, Eli Lilly & Co.
HD Biosciences Inc.
Pfizer
Kevin Jin, Charles River
Frontage Laboratories
Panelists:
Samanthu Du, Shanghai Hutchison Pharmaceuticals
Tony Zhang, Eli Lilly & Co.
HD Biosciences Inc.
Pfizer
Kevin Jin, Charles River
Frontage Laboratories
5:00
Discussion
5:15
Conclusion
5:20
Cocktail Reception
Simultaneous Translation available for Pre-Conference Seminar only
Co-Organized by
Tuesday, April 7, 2009
Keynote Plenary Session
8:35
Opening Address by IBC
8:45
Welcome Address
Yiping Li, Ph.D., Shanghai Pudong New District Governor
Yiping Li, Ph.D., Shanghai Pudong New District Governor
8:55
Chairperson's Opening Remarks
Li Chen, Ph.D., Head of Research and Chief Scientific Officer, Roche R&D Center (China) Ltd.
Li Chen, Ph.D., Head of Research and Chief Scientific Officer, Roche R&D Center (China) Ltd.
9:00
Restructuring for Innovation: How China Companies Can Learn from Roche's Global Initiatives
Innovation is at the heart of drug discovery and is measured by the creation of medically differentiated healthcare products for patients around the world. At Roche, we decided to create the first wholly-owned R&D Center for Roche in China in an attempt to drive innovation and our future growth. We came to China to gain access to the talented scientists and to help develop this talent into drug hunters who will contribute important medicines to the Chinese public. This presentation will discuss Roche's overall strategy for doing innovative drug discovery in China, as well as testing radically different approaches to develop new medicines.
Lee E. Babiss, Ph.D., President and Global Head of Pharma Research, F. Hoffmann La-Roche, Ltd.
Innovation is at the heart of drug discovery and is measured by the creation of medically differentiated healthcare products for patients around the world. At Roche, we decided to create the first wholly-owned R&D Center for Roche in China in an attempt to drive innovation and our future growth. We came to China to gain access to the talented scientists and to help develop this talent into drug hunters who will contribute important medicines to the Chinese public. This presentation will discuss Roche's overall strategy for doing innovative drug discovery in China, as well as testing radically different approaches to develop new medicines.
Lee E. Babiss, Ph.D., President and Global Head of Pharma Research, F. Hoffmann La-Roche, Ltd.
9:35
The Developing Pharmaceutical R&D Model in China: What Is Next?
Abstract to come.
Robert W. Armstrong, Ph.D., Vice President, Global External Research and Development, Eli Lilly and Company
Abstract to come.
Robert W. Armstrong, Ph.D., Vice President, Global External Research and Development, Eli Lilly and Company
10:10
The Global Partnering Strategy of Merck & Co. Inc
In a global economy, innovation is distributed worldwide. Merck & Co. Inc. has organized its research model to acknowledge the fact that ideas know no boundaries and to cherish science as an international language. The results of our global partnering efforts in drug discovery and development will be discussed.
Merv Turner, Ph.D., Chief Strategy Officer & Senior Vice President, Worldwide Licensing & External Research, Merck & Co, Inc.
In a global economy, innovation is distributed worldwide. Merck & Co. Inc. has organized its research model to acknowledge the fact that ideas know no boundaries and to cherish science as an international language. The results of our global partnering efforts in drug discovery and development will be discussed.
Merv Turner, Ph.D., Chief Strategy Officer & Senior Vice President, Worldwide Licensing & External Research, Merck & Co, Inc.
10:45
Grand Opening of Exhibit & Poster Hall and Networking Refreshment Break held in Exhibit & Poster Hall
Sponsored by
Sponsored by
China as the Innovation Center for Global Pharmaceutical R&D
11:30
Chairperson's Opening Remarks
Zhu Shen, Ph.D., MBA, Chief Operating Officer, BioForesight
Zhu Shen, Ph.D., MBA, Chief Operating Officer, BioForesight
11:35
Regional Innovation Networks To Address Diseases of Poverty: A Win-Win Solution for Both The Public And Private Sector
Rob Ridley, Ph.D., Director of the UNICEF/UNDP/World Bank / WHO Special Programme for Research & Training in Tropical Diseases, World Health Organization (WHO/TDR)
Rob Ridley, Ph.D., Director of the UNICEF/UNDP/World Bank / WHO Special Programme for Research & Training in Tropical Diseases, World Health Organization (WHO/TDR)
Panel Discussion
12:00
NCE Discovery & Development in China
Zhengyu Yuan, Ph.D., President & CEO, MicuRx Pharmaceuticals Inc.:
Ming Guo, Ph.D., General Manager, Ascenta (Shanghai) R&D Center
John Oyler, Ph.D., CEO, Bioduro
Weiguo Su, Ph.D., Senior Vice President, Hutchison Medipharma Limited
Jacques Y. Roberge, Ph.D., Vice President, Chemistry, Egret Pharmaceuticals
- What are the key advantages (besides cost) of carrying out R&D in China?
- Main hurdles in carrying out NCE R&D in China – Potential Solutions?
- What will China's NCE R&D look like in 5 years?
- What will be a healthy ratio of CRO and NCE R&D activities in China?
Zhengyu Yuan, Ph.D., President & CEO, MicuRx Pharmaceuticals Inc.:
Ming Guo, Ph.D., General Manager, Ascenta (Shanghai) R&D Center
John Oyler, Ph.D., CEO, Bioduro
Weiguo Su, Ph.D., Senior Vice President, Hutchison Medipharma Limited
Jacques Y. Roberge, Ph.D., Vice President, Chemistry, Egret Pharmaceuticals
12:50
Networking Luncheon in Exhibit & Poster Hall
Panel Discussion
2:00
New and Evolving Areas for Partnering – What Opportunities Does China Present to Global Companies?
Jing Shan (Jennifer) Hu, Ph.D., Director Licensing & External Research, Merck & Co., Inc
Panelists:
Mark Lotter, Ph.D., Chief Executive Officer, Novamed Pharmaceuticals, Inc.
Allan (Riting) Liu, Ph.D., Business Development Director, Corporate Technology Center, Shanghai Fosun Pharmaceutical (Group) Co
Jia Qian, Ph.D., Deputy General Manager, North China Pharmaceutical Corporation
Sam Liao, Head, Business Development & Licensing, Asia, Novartis Vaccines & Diagnostics, Inc.
Stella Xu, Ph.D., Global Licensing Director, Roche Pharma Partnering Asia
- Licensing Chinese rights for regulatory approval and distribution to Chinese companies
- How to form partnerships between innovative early stage company with mature Chinese company who can do clinical to manufacturing
- Where can Chinese companies use their expertise? - manufacturing, cell line development?
- New opportunities for partnerships in vaccines, diagnostics, medical devices, drug delivery etc.
Jing Shan (Jennifer) Hu, Ph.D., Director Licensing & External Research, Merck & Co., Inc
Panelists:
Mark Lotter, Ph.D., Chief Executive Officer, Novamed Pharmaceuticals, Inc.
Allan (Riting) Liu, Ph.D., Business Development Director, Corporate Technology Center, Shanghai Fosun Pharmaceutical (Group) Co
Jia Qian, Ph.D., Deputy General Manager, North China Pharmaceutical Corporation
Sam Liao, Head, Business Development & Licensing, Asia, Novartis Vaccines & Diagnostics, Inc.
Stella Xu, Ph.D., Global Licensing Director, Roche Pharma Partnering Asia
Panel Discussion
2:50
Intellectual Property Issues in Partnering/Licensing
Lewis Ho, Consultant, Simmons & Simmons
Chyau Liang, Ph.D., Partner, Osha Liang LLP
- Compare what's happening in China vs. US/EU
- Extension of patents in China
- Patent enforcement rights and challenges
- How to uphold secondary patents in Chinese courts?
Lewis Ho, Consultant, Simmons & Simmons
Chyau Liang, Ph.D., Partner, Osha Liang LLP
3:30
Networking Refreshment Break in Exhibit & Poster Hall
Sponsored by
Sponsored by
Banking on China's Life Sciences Futures
Panel Discussion
4:00
VC Investments in China: So Many Leads, So Few Deals – Why? Where are the Drug Discovery Innovations and Investments?
Venture Capital interest in life sciences in China has taken off very recently—even five years ago, convincing a U.S.-based VC to invest in China was almost impossible. Since the Wuxi Pharmatech IPO, the TPG investment in ShangPharma and the Charles River acquisition of BioExplorer, interest has skyrocketed, but few deals are actually getting done. There are a lot of lessons to be learned from the history of biotech investing in Europe and the U.S., but few of the current Chinese entrepreneurs or VC's were involved in those experiences. There are also unique factors in China which many U.S.-based VC's are not factoring in.
Introductory Remarks - Life Sciences Investing in China: Obvious and Not-So-Obvious Influences
Dr Hsu will highlight a few items for VC's and entrepreneurs to think about in planning new Chinese life sciences ventures.
Charles Hsu, Venture Partner, Bay City Capital LLC., USA
Panelists:
Leon Chen, Ph.D., Partner, Fidelity Asia Ventures
Charles Hsu, Venture Partner, Bay City Capital LLC.
Yi Shi, Managing Director, Lilly Asian Ventures
Nisa Leung, Partner, Qiming Venture Partners
Carl Firth, Ph.D., MBA, Head of Asia Pacific Healthcare, Investment Banking, Merrill Lynch
Dajun Yang, Ph.D., Partner, Morningside
Venture Capital interest in life sciences in China has taken off very recently—even five years ago, convincing a U.S.-based VC to invest in China was almost impossible. Since the Wuxi Pharmatech IPO, the TPG investment in ShangPharma and the Charles River acquisition of BioExplorer, interest has skyrocketed, but few deals are actually getting done. There are a lot of lessons to be learned from the history of biotech investing in Europe and the U.S., but few of the current Chinese entrepreneurs or VC's were involved in those experiences. There are also unique factors in China which many U.S.-based VC's are not factoring in.
Introductory Remarks - Life Sciences Investing in China: Obvious and Not-So-Obvious Influences
Dr Hsu will highlight a few items for VC's and entrepreneurs to think about in planning new Chinese life sciences ventures.
Charles Hsu, Venture Partner, Bay City Capital LLC., USA
Panelists:
Leon Chen, Ph.D., Partner, Fidelity Asia Ventures
Charles Hsu, Venture Partner, Bay City Capital LLC.
Yi Shi, Managing Director, Lilly Asian Ventures
Nisa Leung, Partner, Qiming Venture Partners
Carl Firth, Ph.D., MBA, Head of Asia Pacific Healthcare, Investment Banking, Merrill Lynch
Dajun Yang, Ph.D., Partner, Morningside
5:15
"A Taste of Shanghai" Cocktail Reception and Special Event at the Exhibit & Poster Hall
Co-sponsored by
Co-sponsored by
Main Conference - Day Two
Wednesday, April 8, 2009
Track I - Innovative Discovery & Development
Session Sponsor:
8:50
Chairperson's Opening Remarks
Guoxin Zhu, Ph.D., Director, Discovery Chemistry Research & Technology, Lilly Research Laboratories Eli Lilly & Company
Guoxin Zhu, Ph.D., Director, Discovery Chemistry Research & Technology, Lilly Research Laboratories Eli Lilly & Company
9:00
Discovery & Development of SHR1020 for Cancer Treatments in China
Structural modification of SU11248 (SUTENT) has resulted in discovery of 2 series of compounds with equal or better potency than SU11248. The discovery & development of SHR1020 will be discussed as well as its potentials as an affordable new anticancer drug for greater Chinese population beyond the urban areas.
Peng-Cho Tang, Ph.D., Chief Scientific Officer, Shanghai Hengrui Pharmaceutical Co., Ltd.
Structural modification of SU11248 (SUTENT) has resulted in discovery of 2 series of compounds with equal or better potency than SU11248. The discovery & development of SHR1020 will be discussed as well as its potentials as an affordable new anticancer drug for greater Chinese population beyond the urban areas.
Peng-Cho Tang, Ph.D., Chief Scientific Officer, Shanghai Hengrui Pharmaceutical Co., Ltd.
9:30
Chiglitazar—A Configuration-Restricted PPAR Pan Agonist Currently in Human Trials
T2D type of insulin sensitizer is PPARg agonist and the only treatment so far targeting mechanistically and directly against insulin resistance. Based on the functional importance of each subtype of PPAR, identification of synthetic ligands to simultaneously target multiple PPAR subtypes would be beneficial. Although such efforts have been overshadowed by the discontinuation of several PPARα/γ dual agonists in clinical development, probably due to the safety concerns, it lacks evidence from humans that ligands targeting multiple subtypes would actually cause additive adverse effects derived from the activation of individual PPAR subtypes. This presentation will focus on Chiglitazar, which is a configuration-restricted PPAR pan agonist with weight on PPARg currently under phase IIb trial in China.
Xian-Ping Lu, Ph.D., President and Chief Scientific Officer, Shenzhen Chipscreen Biosciences, Ltd.
T2D type of insulin sensitizer is PPARg agonist and the only treatment so far targeting mechanistically and directly against insulin resistance. Based on the functional importance of each subtype of PPAR, identification of synthetic ligands to simultaneously target multiple PPAR subtypes would be beneficial. Although such efforts have been overshadowed by the discontinuation of several PPARα/γ dual agonists in clinical development, probably due to the safety concerns, it lacks evidence from humans that ligands targeting multiple subtypes would actually cause additive adverse effects derived from the activation of individual PPAR subtypes. This presentation will focus on Chiglitazar, which is a configuration-restricted PPAR pan agonist with weight on PPARg currently under phase IIb trial in China.
Xian-Ping Lu, Ph.D., President and Chief Scientific Officer, Shenzhen Chipscreen Biosciences, Ltd.
10:00
Accelerated Translation from Lead Optimization to Clinical Development: A Critical Overview of Human Microdosing and Exploratory IND (Phase 0) Studies
Optimizing exploratory drug development by conducting first-in-human studies earlier could be an attractive option for pharmaceutical companies to select more successful drug candidates. Traditional Phase 1 clinical development plan could be preceded by Phase 0 that involves early first-in-human (FIH) screening studies with sub-pharmacological or low pharmacologically active doses of one or several novel drug candidates that are difficult to differentiate on the basis of the preclinical lead optimization studies. The most promising compound would be selected for Phase 1 on basis of the human pharmacokinetic and pharmacodynamic data from Phase 0. This presentation will outline the US and EU regulatory guidance for human screening studies and the potential advantages and limitations of this approach. Case studies of using microdoses and single pharmacologically active doses for early decision making in exploratory drug development will also be presented.
Nenad Sarapa, M.D., Senior Director, Johnson & Johnson Pharmaceutical Research and Development
Optimizing exploratory drug development by conducting first-in-human studies earlier could be an attractive option for pharmaceutical companies to select more successful drug candidates. Traditional Phase 1 clinical development plan could be preceded by Phase 0 that involves early first-in-human (FIH) screening studies with sub-pharmacological or low pharmacologically active doses of one or several novel drug candidates that are difficult to differentiate on the basis of the preclinical lead optimization studies. The most promising compound would be selected for Phase 1 on basis of the human pharmacokinetic and pharmacodynamic data from Phase 0. This presentation will outline the US and EU regulatory guidance for human screening studies and the potential advantages and limitations of this approach. Case studies of using microdoses and single pharmacologically active doses for early decision making in exploratory drug development will also be presented.
Nenad Sarapa, M.D., Senior Director, Johnson & Johnson Pharmaceutical Research and Development
10:30
Networking Refreshment Break in Exhibit & Poster Hall
Sponsored Presentation
11:00
Genotype-correlated Phenotypic Drug Discovery- OncoPanel™
Oncopanel comprises of a compendium of a large panel of human tumor-derived cell lines from different origins with broad genetic heterogeneity and a sensitive High Content Analysis method for comparing proliferation or cytotoxicity across genotypes. We have developed a panel of 240 human cell lines with genetic information available on the genome copy number, mRNA expression data and gene mutation. The media and culture conditions, cell fixation and High Content Analysis are standardized and optimized so that the genetic heterogeneity of the cell line will be responsible for the results obtained. We generate simultaneous data for each compound at 10 concentrations in triplicates resulting in precise IC50/EC50 values for analysis and comparison. Results from a case study will be presented to depict the very robust data quality. Also, data with known inhibitors will be presented using a smaller subset of the cells.
Susan Wang, Ph.D., Technical Director, Pharmacology DMPK, MDS Pharma Services
Oncopanel comprises of a compendium of a large panel of human tumor-derived cell lines from different origins with broad genetic heterogeneity and a sensitive High Content Analysis method for comparing proliferation or cytotoxicity across genotypes. We have developed a panel of 240 human cell lines with genetic information available on the genome copy number, mRNA expression data and gene mutation. The media and culture conditions, cell fixation and High Content Analysis are standardized and optimized so that the genetic heterogeneity of the cell line will be responsible for the results obtained. We generate simultaneous data for each compound at 10 concentrations in triplicates resulting in precise IC50/EC50 values for analysis and comparison. Results from a case study will be presented to depict the very robust data quality. Also, data with known inhibitors will be presented using a smaller subset of the cells.Susan Wang, Ph.D., Technical Director, Pharmacology DMPK, MDS Pharma Services
11:30
Target the STAT Signaling Pathway
STATs (Signal Transduction and Activation of Transcription) are a family of 7 proteins, STAT1, 2, 3, 4, 5A, 5B, and 6. They are critical signal transducers of various cytokines and play important roles in regulating proliferation, differentiation, migration, and survival/death of many types of cells, particularly immune system cells. The STATs are critical for various immune system diseases and cancer. We have developed cell-based assays to identify drug candidates targeting the STATs signaling pathways. Both positive and negative regulators of the STATs pathway have been identified. These regulators are potential drug candidates for treating cancer and inflammation.
Qiang Yu, Ph.D., Chief Executive Officer, Shanghai Ambrosia Pharmaceutical Co. Ltd.
STATs (Signal Transduction and Activation of Transcription) are a family of 7 proteins, STAT1, 2, 3, 4, 5A, 5B, and 6. They are critical signal transducers of various cytokines and play important roles in regulating proliferation, differentiation, migration, and survival/death of many types of cells, particularly immune system cells. The STATs are critical for various immune system diseases and cancer. We have developed cell-based assays to identify drug candidates targeting the STATs signaling pathways. Both positive and negative regulators of the STATs pathway have been identified. These regulators are potential drug candidates for treating cancer and inflammation.
Qiang Yu, Ph.D., Chief Executive Officer, Shanghai Ambrosia Pharmaceutical Co. Ltd.
Sponsored Presentation
12:00
The Impact of CRO Companies in China NCE R&D
Western pharmaceutical companies are turning more and more to CRO companies in India and China to develop their new drugs. These same CRO companies in China can provide the basic infrastructures for China NCE R&D. A China company does not need to build its in-house capabilities, but instead use the capabilities from CROs to develop a new drug. This talk will summarize the capabilities available in China, and showcase what GenScript can offer in more detail.
Nick Yan, Ph.D., Vice President, GenScript Corporation
Western pharmaceutical companies are turning more and more to CRO companies in India and China to develop their new drugs. These same CRO companies in China can provide the basic infrastructures for China NCE R&D. A China company does not need to build its in-house capabilities, but instead use the capabilities from CROs to develop a new drug. This talk will summarize the capabilities available in China, and showcase what GenScript can offer in more detail.Nick Yan, Ph.D., Vice President, GenScript Corporation
12:30
Networking Luncheon in Exhibit & Poster Hall
From Licensing to Co-Development in R&D
2:00
Chairperson's Opening Remarks
Guoxin Zhu, Ph.D., Director, Discovery Chemistry Research & Technology Lilly Research Laboratories Eli Lilly & Company
Guoxin Zhu, Ph.D., Director, Discovery Chemistry Research & Technology Lilly Research Laboratories Eli Lilly & Company
2:05
Building, Growing & Sustaining a Biotech Business – a European/North American Experience
Evolving from very early stage discovery or service provider into a biotech can represent a jump into the unknown: financing, business structure and requirement, BD&L, regulatory environment. In this presentation, we will delineate the expectations, requirements and means required for such endeavours.
Didier Coquoz, Ph.D., Chief Executive Officer, DRDC Pharma S.A.
Evolving from very early stage discovery or service provider into a biotech can represent a jump into the unknown: financing, business structure and requirement, BD&L, regulatory environment. In this presentation, we will delineate the expectations, requirements and means required for such endeavours.
Didier Coquoz, Ph.D., Chief Executive Officer, DRDC Pharma S.A.
2:30
Case Study: Strengths, Weaknesses, Opportunities and Threats in Australia-China Partnership
Avexa is a medium sized Australian biotech company which has partnered with Chinese companies for the past five years. A new program has been initiated in the new therapeutic area of HCV since the partnership. This talk will focus on the objectives that Avexa has in seeking outsourcing in China and in exploring the future of cGMP manufacturing in China. Management of intellectual property as well as opportunities for funding for an Australia-China project (between ISL in Australia and MOST in China) will be reviewed. We will also discuss the increasing opportunities in the drug discovery area with other examples from Australia such as Cytopia.
John Deadman, Ph.D., Senior Vice President, Chemistry, Discovery, Avexa Australia
Avexa is a medium sized Australian biotech company which has partnered with Chinese companies for the past five years. A new program has been initiated in the new therapeutic area of HCV since the partnership. This talk will focus on the objectives that Avexa has in seeking outsourcing in China and in exploring the future of cGMP manufacturing in China. Management of intellectual property as well as opportunities for funding for an Australia-China project (between ISL in Australia and MOST in China) will be reviewed. We will also discuss the increasing opportunities in the drug discovery area with other examples from Australia such as Cytopia.
John Deadman, Ph.D., Senior Vice President, Chemistry, Discovery, Avexa Australia
Sponsored Presentation
2:55
Conducting Preclinical Research in China
China is becoming a significant partner in global pharmaceutical research and development. By fostering internal research and encouraging investment by global pharmaceutical and contract research companies, China has demonstrated that the world of new drug development is truly flat. Doing business in China is no different from doing business in other areas of the world. It is founded on understanding culture and building relationships. This session will explore the perspectives of the provider and the customer on doing preclinical research in China through case studies of successful partnerships.
D. Thomas Oakley, MBA, President and Chief Executive Officer, Bridge Laboratories
China is becoming a significant partner in global pharmaceutical research and development. By fostering internal research and encouraging investment by global pharmaceutical and contract research companies, China has demonstrated that the world of new drug development is truly flat. Doing business in China is no different from doing business in other areas of the world. It is founded on understanding culture and building relationships. This session will explore the perspectives of the provider and the customer on doing preclinical research in China through case studies of successful partnerships.D. Thomas Oakley, MBA, President and Chief Executive Officer, Bridge Laboratories
3:20
Networking Refreshment Break and Last Chance for Exhibit & Poster Viewing
Sponsored Presentation
3:50
How to Optimize the Pre-Clinical Drug Discovery Value Chain from Assay Development to Screening and High-Throughput Screening, from Compound Profiling to In Vivo Testing?
Focussing on in vitro pharmacology and ADME-Tox, Cerep provides solutions allowing cost-effective drug discovery by identifying at early stages the most promising drug candidates and eliminating compounds likely to fail in development.
Thierry Jean, Ph.D., Chairman & CEO, Cerep
Focussing on in vitro pharmacology and ADME-Tox, Cerep provides solutions allowing cost-effective drug discovery by identifying at early stages the most promising drug candidates and eliminating compounds likely to fail in development.Thierry Jean, Ph.D., Chairman & CEO, Cerep
Collaborations with Academics and Non-Profits
4:15
The Power of Collaboration: From Butterfly Wings to ALIMTA®
ALIMTA® (Pemetrexed Disodium) is a new pyrrolopyrimidne-based antifolate that was approved by US FDA as the first line treatment (in combination with cisplatin) for the malignant pleural mesothelioma (MPM) and as the 2nd line treatment (single agent) for non-small cell lung carcinoma (NSCLC). ALIMTA® was discovered from a very fruitful academia-pharma collaboration between the Princeton University and Eli Lilly and Company. Through 10 years of collaborative efforts, three clinical candidates (Lometrexol, ALIMTA® and LY309887/GARFTII) were discovered and brought to clinical development. The history of the discovery, clinical development of ALIMTA® and the impacts/learning from this very productive academia-pharma collaboration will be discussed.
Chuan Joe Shih, Ph.D., Distinguished Lilly Scholar, Discovery Chemistry Research & Technology, Eli Lilly and Company
ALIMTA® (Pemetrexed Disodium) is a new pyrrolopyrimidne-based antifolate that was approved by US FDA as the first line treatment (in combination with cisplatin) for the malignant pleural mesothelioma (MPM) and as the 2nd line treatment (single agent) for non-small cell lung carcinoma (NSCLC). ALIMTA® was discovered from a very fruitful academia-pharma collaboration between the Princeton University and Eli Lilly and Company. Through 10 years of collaborative efforts, three clinical candidates (Lometrexol, ALIMTA® and LY309887/GARFTII) were discovered and brought to clinical development. The history of the discovery, clinical development of ALIMTA® and the impacts/learning from this very productive academia-pharma collaboration will be discussed.
Chuan Joe Shih, Ph.D., Distinguished Lilly Scholar, Discovery Chemistry Research & Technology, Eli Lilly and Company
4:40
Perspective in China: Genetic Engineered Mouse for Disease Models
Our center is the host for National Resource Center for Mutant Mice and Consortia for Chinese Mouse KO Project which houses more than 500 strains of mice. Currently, we are aiming to generate more than 150 "floxed" strains for conditional gene-targeting and 20 tissue-specific Cre transgenic strains. These mice will help to establish many disease models for both basic research drug company R&D.
Gao Xiang, Ph.D., Director & Professor, Model Animal Research Center of Nanjing University
Our center is the host for National Resource Center for Mutant Mice and Consortia for Chinese Mouse KO Project which houses more than 500 strains of mice. Currently, we are aiming to generate more than 150 "floxed" strains for conditional gene-targeting and 20 tissue-specific Cre transgenic strains. These mice will help to establish many disease models for both basic research drug company R&D.
Gao Xiang, Ph.D., Director & Professor, Model Animal Research Center of Nanjing University
5:05
AT-Bio. Case Study of Globalization of China's Drug Development
Combining the drug development capabilities in China with the drug discovery and international business. Management capabilities in Australia to develop small molecule therapeutics for global markets. AT-Bio is an Australian joint venture of the Tianjin Institute for Pharmaceutical Research (TIPR). This presentation will discuss the relationship development, business structure, IP management, regulatory management and opportunities.
Jim Murray, MBA, Chief Executive Officer, AT-Bio Pty Ltd., Australia
Combining the drug development capabilities in China with the drug discovery and international business. Management capabilities in Australia to develop small molecule therapeutics for global markets. AT-Bio is an Australian joint venture of the Tianjin Institute for Pharmaceutical Research (TIPR). This presentation will discuss the relationship development, business structure, IP management, regulatory management and opportunities.
Jim Murray, MBA, Chief Executive Officer, AT-Bio Pty Ltd., Australia
5:30
Close of Day Two
Track II - Clinical Trials, Safety, Quality & Adaptive Designs
8:50
Chairperson's Opening Remarks
Frank Fan, MD., MBA, Medical Director, Wyeth Hong Kong
Frank Fan, MD., MBA, Medical Director, Wyeth Hong Kong
Panel Discussion
9:00
Understanding the Regulatory Challenges for Discovery & Development in China
Weiping Li, M.D., Head of Regulatory Affairs, Johnson & Johnson China
Mark Engel, Ph.D., President, Excel PharmaStudies, Inc.
Richard Jiang, Ph.D., Head, Regulatory Affairs, Roche R&D Center (China) Ltd.
Joanne Jiang, Ph.D., VP of Business Development, Fountain Medical Development
- Data harmonization
- Enabling collaboration across countries
- Challenges in SFDA requirements for IND submissions
- How to expedite NDA approval timelines
- Ideas/comments on current registration process in China
- How SFDA can monitor pharmacovigilence, safety, new product registration
- SFDA regulations on FIH trials
- How to interact with regulatory authorities
Weiping Li, M.D., Head of Regulatory Affairs, Johnson & Johnson China
Mark Engel, Ph.D., President, Excel PharmaStudies, Inc.
Richard Jiang, Ph.D., Head, Regulatory Affairs, Roche R&D Center (China) Ltd.
Joanne Jiang, Ph.D., VP of Business Development, Fountain Medical Development
10:00
Comparison of New Drug Application Procedures and Regulations Between USA and China
Differences and similarities between USA and China in new drug application (IND) procedures and regulations will be analyzed in the presentation. Although the IND procedures in USA are more transparent and effective than those in China, the SFDA is improving their regulations to stimulate innovative R&D and ensure drug quality.
Lee Jia, Ph.D., Project Manager, Developmental Therapeutics Program (DCTD), National Cancer Institute/NIH
Differences and similarities between USA and China in new drug application (IND) procedures and regulations will be analyzed in the presentation. Although the IND procedures in USA are more transparent and effective than those in China, the SFDA is improving their regulations to stimulate innovative R&D and ensure drug quality.
Lee Jia, Ph.D., Project Manager, Developmental Therapeutics Program (DCTD), National Cancer Institute/NIH
10:30
Networking Refreshment Break in Exhibit & Poster Hall
Therapeutic Clinical Trials
11:00
Psychiatry Clinical Research in Asia
Doing psychiatry trials in Asia pose a number of challenges, and raises many questions. We are dealing with a difficult group of patients, being considered "vulnerable" (in GCP context). Are the patients protected as well as in Western world, when it comes to avoid undue pressure, and informed censcent? Do we / Should we recruit the very poor patients? We are also dealing with patients where we collect rather soft endpoints (rating scales), rather than hard endpoints. Could ethnical and cultural factors impact our endpoints? Are psychiatric disease the same in Asa as in Wetsern World? Are psychiatric diesase classifications the same? Local treatment principles? Can our various rating scales be used at all and are the patients comparable at all? These, and other questions, will be discussed, and some data presented to answer the questions.
Lars Nelleman, MD, Medical Director, Lundbeck A/S
Doing psychiatry trials in Asia pose a number of challenges, and raises many questions. We are dealing with a difficult group of patients, being considered "vulnerable" (in GCP context). Are the patients protected as well as in Western world, when it comes to avoid undue pressure, and informed censcent? Do we / Should we recruit the very poor patients? We are also dealing with patients where we collect rather soft endpoints (rating scales), rather than hard endpoints. Could ethnical and cultural factors impact our endpoints? Are psychiatric disease the same in Asa as in Wetsern World? Are psychiatric diesase classifications the same? Local treatment principles? Can our various rating scales be used at all and are the patients comparable at all? These, and other questions, will be discussed, and some data presented to answer the questions.
Lars Nelleman, MD, Medical Director, Lundbeck A/S
11:30
A New Approach to Regulatory Approval in 3 Key Asian Markets
China, India and Korea all require local clinical trial data for their national regulatory approval. This presentation examines a recent collaboration between China, Korea and India to provide the clinical data required according to their individual national guidelines in ONE clinical trial.
Ole Molsknov Bech, Ph.D., Vice President, Int. Operations Clinical Development Centre, Novo Nordisk China
China, India and Korea all require local clinical trial data for their national regulatory approval. This presentation examines a recent collaboration between China, Korea and India to provide the clinical data required according to their individual national guidelines in ONE clinical trial.
Ole Molsknov Bech, Ph.D., Vice President, Int. Operations Clinical Development Centre, Novo Nordisk China
12:00
Clinical Development of a New Therapeutic Agent For Pulmonary Fibrosis In China
There is an urgent unmet medical need for developing safe and efficacious agents against life-threatening fibrotic diseases such as idiopathic pulmonary fibrosis (IPF). We have obtained an IND for F647, classified as Class 1.1 new chemical drug in China, and subsequently conducted a Phase I and two randomized, double-blind, multi-centered Phase IIa trials. The results show that F647 may help to stabilize and improve pulmonary functions of end-stage IPF patients.
Jun Wu, Ph.D., Chief Executive Officer, Shanghai Genomics Inc. and Executive Managing Director and CSO, GNI Ltd
There is an urgent unmet medical need for developing safe and efficacious agents against life-threatening fibrotic diseases such as idiopathic pulmonary fibrosis (IPF). We have obtained an IND for F647, classified as Class 1.1 new chemical drug in China, and subsequently conducted a Phase I and two randomized, double-blind, multi-centered Phase IIa trials. The results show that F647 may help to stabilize and improve pulmonary functions of end-stage IPF patients.
Jun Wu, Ph.D., Chief Executive Officer, Shanghai Genomics Inc. and Executive Managing Director and CSO, GNI Ltd
12:30
Networking Luncheon in Exhibit & Poster Hall
Safety & Quality Evaluations
2:00
Chairperson's Opening Remarks
Frank Fan, M.D., MBA, Medical Director, Wyeth Hong Kong
Frank Fan, M.D., MBA, Medical Director, Wyeth Hong Kong
2:05
General Statistical Considerations in the Safety Evaluation of Medical Products
Scientifically sound safety evaluation is fundamental in the assessment of the risk/benefit profile of a medical product. In this talk, we will discuss the general (statistical) issues/considerations in designing and analyzing clinical trials with safety as a primary focus. We will further discuss the use of meta-analysis for safety evaluations.
William W. Wang, Ph.D., Associate Director, Biostatistics and Research Decision Sciences, Merck & Co. Inc.
Scientifically sound safety evaluation is fundamental in the assessment of the risk/benefit profile of a medical product. In this talk, we will discuss the general (statistical) issues/considerations in designing and analyzing clinical trials with safety as a primary focus. We will further discuss the use of meta-analysis for safety evaluations.
William W. Wang, Ph.D., Associate Director, Biostatistics and Research Decision Sciences, Merck & Co. Inc.
2:30
Hypothesis Testing in Early Drug Development – Time for Significant Change
Decision-making in early drug development based on incomplete information has large opportunity costs and relying solely on p-values for making drug development milestone decisions is an inefficient approach. Statistical tools that exploit the totality of accumulated knowledge for internal decision-making in early drug development will be discussed.
Narinder Nangia, Ph.D., Director, Statistics, Abbott Laboratories
Decision-making in early drug development based on incomplete information has large opportunity costs and relying solely on p-values for making drug development milestone decisions is an inefficient approach. Statistical tools that exploit the totality of accumulated knowledge for internal decision-making in early drug development will be discussed.
Narinder Nangia, Ph.D., Director, Statistics, Abbott Laboratories
2:55
The Issue of Quality – Ensuring Data Integrity, Quality in Clinical Trials
Abstract to come.
QingAn Jiao, M.D., Clinical Research Unit Director, China R&D, Sanofi-Aventis
Abstract to come.
QingAn Jiao, M.D., Clinical Research Unit Director, China R&D, Sanofi-Aventis
3:20
Networking Refreshment Break and Last Chance for Exhibit & Poster Viewing
Mini-Workshop: Adaptive Designs
One of the largest challenges pharmaceutical companies face in bringing new drugs to market is the clinical trial process. Adaptive design allows for modifications to the on-going trial based on the observed data from the trial. It is recognized that adaptive designs,can improve the efficiency of clinical research and increase the probability of success.
With the growing need to conduct global clinical trials smarter, one way to make this process more efficiently (and also is currently receiving significant attention from the industry and regulatory agencies) – is adaptive trial design.
Join this mini-workshop to get introduced to the concept and taxonomy of adaptive designs through trial examples; learn case studies and explore the challenges in the implementations of adaptive designs and its implications towards clinical operations in China.
3:50
Adaptive Clinical Trials- Innovation of the Decade in Clinical R&D
- Drug development challenges - increased R&D investment with decreased output
- Why now - New science, technology and statistical method
- Key difference between traditional and adaptive designs
- Ethical and cost advantages of adaptive design
- Risk in clinical execution and regulatory acceptance
4:15
Biostatistics and Adaptive Trial Design: From Computer Side to Bedside
- A quick overview of Biostatistics
- Adaptation by design: fixed adaptation vs. continuous/dynamic adaptation
- Consideration for Adaptation in Exploratory and Confirmatory Trials
- Hypes & hopes with adaptive design
- How to plan for sample size
- How to control type I errors
- Clinical operation challenges
- Case Studies
4:40
Adaptive Design: the temptation, the barrier, and the strategy br>
- Who wants to be "non-adaptive"
- Challenges with being adaptive
- Statistic validity
- Logistics
- Trial integrity
- Recommendations from PhRMA WG and Regulatory Reviewers
5:05
Mini Panel Discussion
5:30
Close of Day Two
Main Conference - Day Three
Thursday, April 9, 2009
Biologics Development in China
8:50
Chairperson's Opening Remarks
Guo-Liang Yu, Ph.D., President & CEO, Epitomics Inc.
Guo-Liang Yu, Ph.D., President & CEO, Epitomics Inc.
9:00
Antibody technology: where do we go from here?
Progress in therapeutic antibodies parallels the technology advancement in antibody engineering. This presentation will discuss the technological trend in therapeutic antibody discovery and development: 1) Fc engineering to create therapeutics with more potent biological activities; 2) Glycoengineering to improve the pharmaceutical properties; 3) New sources and formats of antibodies; 4) In silico tools to analyze antibody sequences for humanization and immunogenicity prediction; 5) Alternative antibody expression technologies; and 6) Accessing intracellular and CNS targets
Zhiqiang An, Ph.D., Chief Scientific Officer, Epitomics Inc
Progress in therapeutic antibodies parallels the technology advancement in antibody engineering. This presentation will discuss the technological trend in therapeutic antibody discovery and development: 1) Fc engineering to create therapeutics with more potent biological activities; 2) Glycoengineering to improve the pharmaceutical properties; 3) New sources and formats of antibodies; 4) In silico tools to analyze antibody sequences for humanization and immunogenicity prediction; 5) Alternative antibody expression technologies; and 6) Accessing intracellular and CNS targets
Zhiqiang An, Ph.D., Chief Scientific Officer, Epitomics Inc
9:25
Next Generation Antibody Technology & Beyond
Abstract to come.
Herren Wu, Ph.D., Vice President, Head of Antibody Discovery and Protein Engineering, and Global Head of Technology, MedImmune, Inc.
Abstract to come.
Herren Wu, Ph.D., Vice President, Head of Antibody Discovery and Protein Engineering, and Global Head of Technology, MedImmune, Inc.
9:50
Current Status and Future of Biologics Development in China
Abstract to come.
Xiaojin Yin, Ph.D., VP, President of R&D, Simcere Pharmaceutical
Abstract to come.
Xiaojin Yin, Ph.D., VP, President of R&D, Simcere Pharmaceutical
10:10
Launching Kogenate-FS™, the Largest Therapeutic Protein Manufactured by the Industry, in China.
Bayer has marketed recombinant Factor VIII (rFVIII) with a trade name Kogenate-FSTM since 1993. rFVIII is a therapeutic protein for the treatment of Hemophilia A, which is an X-linked recessive bleeding disorder that affects 1 in 10,000 males throughout the world. rFVIII is a human protein with 2332 amino acids and a molecular weight of more than 300 KD. So far the rFVIII is the largest protein genetically engineered by biotech industry. Due to the complexity and instable of the protein, there are many difficulties and challenges to manufacture rFVIII. This presentation provides a broad view of how Bayer Healthcare has manufactured the rFVIII in Berkeley, California, USA. It covers the history of Bayer biotech center at Berkeley, California; characteristics of rFVIII molecule; challenges in manufacturing processes, key process technologies developed at Bayer Berkeley, and complexity in quality assurance and quality control system. At the end, the presentation shows the history of Bayer’s commitment to Hemophilia patients worldwide including China. It covers the development of new generations of Kogenate-FSTM currently in clinical trial, communications to the regulatory authority, KOLs and patient community, and recently donations and investments to the Chinese patients. All these have contributed to a successful launch of Kogenate-FSTM in China in 2007.
DQ Wang, Ph.D., Department Head, Bayer Corporation
Bayer has marketed recombinant Factor VIII (rFVIII) with a trade name Kogenate-FSTM since 1993. rFVIII is a therapeutic protein for the treatment of Hemophilia A, which is an X-linked recessive bleeding disorder that affects 1 in 10,000 males throughout the world. rFVIII is a human protein with 2332 amino acids and a molecular weight of more than 300 KD. So far the rFVIII is the largest protein genetically engineered by biotech industry. Due to the complexity and instable of the protein, there are many difficulties and challenges to manufacture rFVIII. This presentation provides a broad view of how Bayer Healthcare has manufactured the rFVIII in Berkeley, California, USA. It covers the history of Bayer biotech center at Berkeley, California; characteristics of rFVIII molecule; challenges in manufacturing processes, key process technologies developed at Bayer Berkeley, and complexity in quality assurance and quality control system. At the end, the presentation shows the history of Bayer’s commitment to Hemophilia patients worldwide including China. It covers the development of new generations of Kogenate-FSTM currently in clinical trial, communications to the regulatory authority, KOLs and patient community, and recently donations and investments to the Chinese patients. All these have contributed to a successful launch of Kogenate-FSTM in China in 2007.
DQ Wang, Ph.D., Department Head, Bayer Corporation
10:30
Networking Refreshment Break
Expectation and Perspectives of Multinational Pharmaceutical Companies
11:00
Successful Development of Monoclonal Antibodies through Translational Research
Roskos Lorin, Ph.D., Vice President and Global Head, Pharmacokinetics, Pharmacodynamics and Bioanalysis, MedImmune, Inc.
Roskos Lorin, Ph.D., Vice President and Global Head, Pharmacokinetics, Pharmacodynamics and Bioanalysis, MedImmune, Inc.
11:20
Protein Therapeutics R&D at Novo Nordisk
Baoping Wang, Ph.D., Vice President & Head, Beijing Novo Nordisk Pharmaceuticals Science & Technology Co.
Baoping Wang, Ph.D., Vice President & Head, Beijing Novo Nordisk Pharmaceuticals Science & Technology Co.
11:40
GSK's Biologics Development in China
Lixin Li, Ph.D., GlaxoSmithKline, China
Lixin Li, Ph.D., GlaxoSmithKline, China
Mini Panel Discussion
12:00
The Trends of Biologics Development in China
Speakers from the morning session, plus
Julius Li, MSc., MBA, Chief Executive Officer, AutekBio Inc.
- Differences in development status between China and US/EU/Japan: generic or innovative based
- Market size and growth rate, comparing to developed markets
- Which platform technologies are more widely/less used? Why? How are they compared to that in US/EU?
- Challenges in China: regulatory, policy, payment for biologics, technology, talents...
- How will the Chinese biologic development be part of the international value chain, particularly in new drug development, in marketed drug manufacturing?
Speakers from the morning session, plus
Julius Li, MSc., MBA, Chief Executive Officer, AutekBio Inc.
12:30
Networking Luncheon
Challenges of Biologics Development and Manufacture
2:00
Developing A World-Class Mammalian Cell Culture Platform to De-Bottleneck mAb Development
Bottleneck of developing novel antibodies is to produce the first 100g of clinical materials. Currently it takes up to 18 months and costs up to $5 million, which poses significant technical and financial challenges to startup companies. Shanghai Celgen has developed a world-class CHO cell line/culture development platform that can routinely generate 1+g/L cell culture processes to expedite mab development.
Chris Chen, Ph.D., Chief Operating Officer, Shanghai Celgen Biopharmaceuticals
Bottleneck of developing novel antibodies is to produce the first 100g of clinical materials. Currently it takes up to 18 months and costs up to $5 million, which poses significant technical and financial challenges to startup companies. Shanghai Celgen has developed a world-class CHO cell line/culture development platform that can routinely generate 1+g/L cell culture processes to expedite mab development.
Chris Chen, Ph.D., Chief Operating Officer, Shanghai Celgen Biopharmaceuticals
2:20
Bioanalytical Strategies for Quantifying Monoclonal Antibody Therapeutics in Matrix
Specific, sensitive and robust analytical methods that quantify antibody therapeutics in serum are critical for the evaluation of drug efficacy and safety in preclinical and clinical stages. Here we introduce our strategies of screening anti-idiotype antibodies as ELISA reagents, and then developing and validating the assay for PK/Tox study report.
Shaoxiong Wang, Ph.D., Senior Scientist, Translational Sciences, Amgen Inc.
Specific, sensitive and robust analytical methods that quantify antibody therapeutics in serum are critical for the evaluation of drug efficacy and safety in preclinical and clinical stages. Here we introduce our strategies of screening anti-idiotype antibodies as ELISA reagents, and then developing and validating the assay for PK/Tox study report.
Shaoxiong Wang, Ph.D., Senior Scientist, Translational Sciences, Amgen Inc.
2:40
Vivatuxin - A Successful Story of East West Partnerships to Capture Chinese Growing Antibody Market
Vivatuxin, a radiolabeled TNT chimeric monoclonal antibody, represents the first therapeutic antibody approved by SFDA for the treatment of malignant lung cancer. Clinical trials of Vivatuxin for liver cancer and brain cancer are underway. Experience of the preclinical and clinical development of Vivatuxin will be shared. This is a case study of successful and unique east west collaboration in R&D of novel antibody-based pharmaceuticals.
Dianwen Ju, Ph.D., Chief Executive Officer, MediBiotech, Co. Inc.
Vivatuxin, a radiolabeled TNT chimeric monoclonal antibody, represents the first therapeutic antibody approved by SFDA for the treatment of malignant lung cancer. Clinical trials of Vivatuxin for liver cancer and brain cancer are underway. Experience of the preclinical and clinical development of Vivatuxin will be shared. This is a case study of successful and unique east west collaboration in R&D of novel antibody-based pharmaceuticals.
Dianwen Ju, Ph.D., Chief Executive Officer, MediBiotech, Co. Inc.
3:00
Networking Refreshment Break
Panel Discussion
3:30
Understanding the Regulatory Pathway, IP and Investment Climate for Biologics in China
Panelists:
James J. Zhu, Ph.D., Partner, Perkins Coie LLC
Hongbo B. Lu, Ph.D., Vice President, Senior Research Analyst, Healthcare, Piper Jaffray & Co.
Darren Ji, Ph.D., MBA, Chief Executive Officer, PharmaLegacy
Jiwan Qiu, Ph.D., Chief Executive Officer, T-MAb Biotechnology Co. Ltd.
Panelists:
James J. Zhu, Ph.D., Partner, Perkins Coie LLC
Hongbo B. Lu, Ph.D., Vice President, Senior Research Analyst, Healthcare, Piper Jaffray & Co.
Darren Ji, Ph.D., MBA, Chief Executive Officer, PharmaLegacy
Jiwan Qiu, Ph.D., Chief Executive Officer, T-MAb Biotechnology Co. Ltd.
4:15
Close of Conference
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