Workshop I:
Implementing Best Practices in Animal Research
9:00
Introduction of Workshop and Goals
Kathryn Bayne, MS, PhD, DVM, DACLAM, Global Director, AAALAC International
9:15
Trends in Animal Care and Use Programs in China Observed by AAALAC International
Kathryn Bayne, MS, PhD, DVM, DACLAM, Global Director, AAALAC International
9:45
Implementing An Effective IACUC
Dale Martin, DVM, Ph.D., DACLAM, DECLAM, Regional Director, Laboratory Animal Science and Welfare, Sanofi-Aventis
10:30
Networking Refreshment Break
10:45
The Animal Environment, Housing and Management
Fon Chang, DVM, Director, Veterinary Affairs & Animal Welfare Asia, AstraZeneca
11:30
Key Physical Plant Issues
William J. White, V.M.D., M.S., DACLAM, DipECLAM, Corporate Vice President, Veterinary and Professional Services, Charles River
12:15
Networking Luncheon
1:30
The Role of the Veterinarian
Kathryn Bayne, MS, PhD, DVM, DACLAM, Global Director, AAALAC International
2:15
Implementing An Effective Occupational Health and Safety Program
Fon Chang, DVM, Director, Veterinary Affairs & Animal Welfare Asia, AstraZeneca
2:45
Networking Refreshment Break
3:15
Animal Welfare Audits
Dale Martin, DVM, Ph.D., DACLAM, DECLAM, Regional Director, Laboratory Animal Science and Welfare, Sanofi-Aventis
3:45
Sustaining A High Quality Animal Care and Use Program
William J. White, V.M.D., M.S., DACLAM, DipECLAM, Corporate Vice President, Veterinary and Professional Services, Charles River
4:15
Other International Standards for Laboratory Animal Care and Welfare and Their Influence on China
Kathryn Bayne, MS, PhD, DVM, DACLAM, Global Director, AAALAC International
Workshop II:
What Every Small & Medium-Sized Company Needs to Know About IP Procurement and Enforcement
IP Procurement
9:00
Introduction to Legal System in PRC and Procurement of Intellectual Property Issues
Albert Chan, Ph.D., Partner, Law Offices of Albert Wai-Kit Chan, LLC.
10:30
Networking Refreshment Break
11:00
Patent Issues
Albert Chan, Ph.D., Partner, Law Offices of Albert Wai-Kit Chan, LLC.
12:00
Networking Luncheon
IP Enforcement
1:00
Strategies of IP Protection Concerning Pharmaceutical Inventions in China
This presentation gives a detailed introduction of the strategies of protection of pharmaceutical inventions in China, including the significant aspects that should be paid special attention to such as in filing patents for pharmaceutical inventions and proceeding with infringement litigations.
Linda Liu, Ph.D., President, Linda Liu & Partners
1:45
Patent and IP Litigation in US for Chinese Companies
We will have a brief summary of the U.S. court system, followed by a discussion of patent infringement cases, including court jurisdiction, personal jurisdiction, and venue. We will look at pretrial discovery and procedure, including tools for obtaining information for use in a lawsuit, the trial to a jury or a judge, strategy for Chinese companies as patent owners and accused infringers, damages and other remedies, appeals, and alternative dispute resolution forums.
Robert Katz, ESQ., Partner, Cooper & Dunham, LLP.
2:30
Networking Refreshment Break
2:50
Avoidance of IP Dispute Using Appropriate Corporate Structures
When doing business between U.S. and China, it is very important to have an appropriate corporation set-up to separate and limit the liabilities of the corporation owner. A proper corporate structure helps when dealing with contract rights and minimizing the risk of dispute, as will be illustrated with case laws.
Jack Chung, J.D., Attorney, Of Counsel, Litigation, Law Offices of Albert Wai-Kit Chan, LLC.
New!
Workshop III:
Rapid Fire Company Showcase
9:00
Chairperson's Introduction of Program and VC Advisory Committee
Charles Hsu, Venture Partner, Bay City Capital LLC.
9:10
Yuling Luo, Ph.D., Founder, President & CEO, Advanced Cell Diagnostics, Inc., USA
9:30
Steven Engen, President, Solasia Pharma KK, Japan
10:10
Shawn Leung, Ph.D., Chief Executive Officer, SinoMab BioScience Limited, Hong Kong SAR, China
10:30
Xianping Lu, Ph.D., Chief Executive Office & Chief Scientific Officer, Shenzhen Chipscreen Biosciences, China
10:30
Morning Refreshment Break
11:00
Jingwen Liu, Ph.D., Chief Executive Officer, CVI Pharmaceuticals, Inc., USA
11:20
Ruhong Jiang, Ph.D., CEO & Co-Founder, Applied StemCell, Inc., USA
10:30
Jerry Liao, Ph.D., Director, Argusina, China
12:00
Networking Luncheon
1:30
Geert Cauwenbergh, Ph.D., Chief Executive Officer, RHEI, Belgium
1:50
Jin Li, Ph.D., Chief Executive Officer, Shenogen, China
2:10
Lee Huang, Ph.D., Chief Executive Officer, Sinobiopharma, China
2:30
VC Advisory Committee's Roundup of Presentations and Constructive Commentaries
VC Advisory Committee Members:
Charles Hsu, Venture Partner, Bay City Capital LLC
James Zhu, Partner, Perkins Coie
Anthony Chen, Partner, Jones Day Shanghai
Rob McCormack, Managing Director, Mustang Ventures
Track I:
Development Strategies and Challenges of Other Emerging Markets vis-à-vis China
4:00
Chairperson's Opening Remarks
Ruiping Dong, Ph.D., M.D., Vice President, Global Development & Medical Affairs, Bristol-Myers Squibb
4:05
Perspectives on China vis-a-via Other Emerging Asia Markets
- R&D Strengths and competitive advantage of representative countries
- Interactions between the various emerging markets
- Future development trends in Asia-Pacific emerging markets
Canwen Jiang, Ph.D., Vice President & Head, Genzyme R&D Asia
4:35
Key Factors to be Considered for Clinical Development in Emerging Markets
Emerging markets not only provide great opportunities for the pharmaceutical market but also opportunity for clinical development activities. Due to the diversity of emerging markets, we have to think about how to deal with differences in regulatory, disease epidemiology, and global vs. regional development.
Ruiping Dong, Ph.D., M.D., Vice President, Global Development & Medical Affairs, Bristol-Myers Squibb
5:05
BioManufacturing Updates from Singapore: An Overview
In the past decade, Singapore has built up substantial infrastructure in biotechnology R&D, while actively creating biomanufacturing capability and capacity on the island state. Many global biopharmaceutical companies have now designed, constructed and operated their biologics plants, including GSK BIO for vaccines, Roche/Genentech for monoclonal antibody and Lonza for stem cell products and CMO services for biologics. This overview presents an update on the state of biotechnology development of Singapore, from drug discovery to development to clinical trials to manufacturing for various potential products including therapeutic proteins and vaccines. Topics of interest include local strengths and weaknesses, outsourcing opportunities, and potential for global cross-border collaborations and partnering.
Steven Lee, Ph.D., Chief Executive Officer, A-Bio Pharma Pte. Ltd.
5:35
Biotechnology Updates from India: A Focus on Innovation
This presentation will present an overview of India's growing biotechnology industry. The traditional strengths in manufacture of biologics and vaccines as well as in process chemistry have been complemented by emerging strengths in clinical research, discovery biochemistry and translational research. This has led to the next phase of more vertically integrated business models within this sector and an increased focus on R&D and innovation. The presentation will discuss potential opportunities for cross-border collaborations and partnering.
Vijay Chandru, Ph.D., President ABLE; Chairman & CEO, Strand Life Sciences Pvt. Ltd.
Track III:
Academic Research & Scientific Advances
10:30
Chairperson's Opening Remarks
Tony Zhang, Ph.D., Managing Director, Head of R&D China, Eli Lilly and Co.
10:40
Functions of Structural Biology in Fundamental Research and Applications in Innovative Drug Discovery (tentative)
Abstract not available at time of print.
YiGong Shi, Ph.D., Professor & Dean, School of Life Sciences, Senior Vice Dean, School of Medicine, Tsinghua University
11:10
The Strength of Drug Discovery in China: Scientific Talents and Governmental Incentives
- Drug discovery is knowledge-based and highly competitive.
- The success of drug discovery is dependent on government's support and effective IP protection.
- Drug discovery relies on strong team-work of scientific talents across various areas.
- Significantly increased incentives offered by the Chinese government to drug discovery and innovation.
- The experiment of building up a functioning drug discovery platform at the Shenzhen Graduate School of Peking University
Zhen Yang, Ph.D., Professor, Peking University, Shenzhen Graduate School
11:40
New Drug Candidates Discovery Based on Chemical Modification
Chemical modification is a powerful approach to generation of new drug candidates. The presentation will describe new drug candidates of Fluoroquinolone, oxazolidione and Pleuromutilin discovered by the chemical modification approach in our lab.
Yu-she Yang, Ph.D., Professor, Medicinal Chemistry, Shanghai Institute of Materia Medical
Sponsored Presentation
12:10
MPI Research: Leveraging Experience and Strength with Partners in China
As pharmaceutical and biologics move from their research to their developmental stage the need for experimental pharmacology, safety pharmacology, specialized disease state models and biomarkers will be great to meet the expectations of the regulatory and commercial market place of the future, ie: personalized medicine and evidence based medicine. Efforts by MPI Research and partners like Medicilon, PharmaLegacy and Frontage, among others, will allow for a much greater leverage of talent to serve clients worldwide. Examples will be given that demonstrate the value of an international leveraged outsourced model. The potential for dual or triple registration (OECD, SFDA, and FDA) capabilities will also offer a significant commercial advantage to client marketing strategies.
Tina Rogers, Ph.D., DABT, MBA, EVP and Director of Research, MPI Research
12:40
Networking Luncheon with Exhibits & Poster Viewing
Luncheon Presentation
12:45-
1:30
Outsourcing to China: A Global CRO Perspective
China presents unique challenges and opportunities to the pharmaceutical and biotechnology industry and an experienced partner can help companies navigate those challenges and gain the most benefits from this market. Hear from a leading global CRO, the first to offer discovery through post-approval services in China, as they discuss the reasons for their recent acquisitions in China, the practical implications of integrating these companies and the ultimate benefits to local and global companies.
Simon Britton, Vice President, Clinical Development, Asia Pacific, PPD, Inc.
Academic Research & Scientific Advances, continued
2:00
Neuronal Potassium Channels as Therapeutic Drug Targets for Treatment of Neuropsychiatric Disorders
Neuronal hyperexcitability defines the fundamental mechanism of neurological diseases as well as psychiatric disorders. This presentation focuses a subfamily of neuronal voltage-gated KCNQ/Kv7 potassium channels that have emerged as novel drug targets for a number of neuropsychiatric disorders. The recent development of higher throughput automated electrophysiology has promoted rapid screening and evaluation of ion channel modulators. Modulation of KCNQ/Kv7 channel activity can present a powerful means of modulating neuronal activity for new therapy.
Kewei Wang, Ph.D., M.D., Changjiang Professor, Neurobiology, Neuroscience Research Institute, Peking University School of Medicine
2:30
Novel Compounds Discovery from Natural Resources: A View of SCM (Scientific Chinese Medicine)
Our current studies were to test the hypothesis that two novel single compounds from Chinese herbs SCM-198 and ZYZ-802 would have antioxidant, anti-apoptotic effects and cardioprotection on acute myocardial infarction (MI) in vitro and in vivo. Our study provides novel evidence that two natural compounds SCM-198 and ZYZ-802 have cardioprotective action via anti-oxidant and anti-apoptotic mechanisms on MI in vitro and in vivo.
Yi Zhun Zhu, M.D., Ph.D., Department of Pharmacology, Dean, School of Pharmacy, Fudan University
Sponsored Presentation
3:00
Role of Integrated CRO in China Pharmaceutical R&D
Abstract not available at time of print.
Chun-Lin Chen, Ph.D., Chief Executive Officer, Shanghai Medicilon Inc.
3:30
Networking Refreshment Break with Exhibits & Poster Viewing
4:00
Assembly of Pharmaceutically Important Heterocycles via Copper-Catalyzed Coupling Reactions
In this talk we will summarize our efforts on the development of new reaction conditions for Ullmann-type coupling using amino acids as promoters, and their applications in the synthesis of heterocycles likes substituted indoles, 1,2-disubstituted benzimidazoles, N-substituted 1,3-dihydrobenzimidazol-2-ones, substituted benzothiazoles, 3-acyl oxindoles and 2,3-disubstituted benzofurans.
Dawei Ma, Ph.D., Research Professor, State Key Laboratory of Bioorganic and Natural Product, Shanghai Institute of Organic Chemistry; Founder, Target Drug
4:30
Drug Delivery System Development in China
Creating new, more effective medicines using biotechnology products such as proteins, DNA and RNA require enabling technologies that can get these compounds to their site of action. However, effective technology to deliver drugs to their putative disease targets is a work in progress. China is developing technologies and drug delivery systems, such as liposome etc., but there are still various obstacles from the excipient to the facility that needs to be resolved. This presentation will share some of our inhouse research and development on drug delivery technologies to enable more effective delivery of drugs to their targets.
Youxin Li, Ph.D., Professor, College of Biosciences, Jilin University; VP, R&D, Luye Pharmaceuticals Group, Ltd.
5:00
Working with the Scientific Community for Innovative Drugs
Abstract not available at time of print.
Alex Zhang, Ph.D., Head, China Discovery Research, Sanofi-Aventis
5:30
Close of Academic Research & Scientific Advances Session
Track IV:
Clinical Development Strategies
10:30
Chairperson's Opening Remarks
Frank Jiang, M.D., Ph.D., Vice President & Head, China R&D, Sanofi-Aventis
Conducting Trials in China
10:40
Case Study: Conducting Proof-of-Concept Studies in China
Abstract not available at time of print.
Karen Atkin, M.D., Vice President, R&D, AstraZeneca China
Panel Discussion
11:10
Conducting FIH Studies in China
- Is China Ready Now?
- Regulations
- Ethical review
- Medical governance
- Benefits & risks
- Safety management
Moderator:
Min Irwin, M.D., Ph.D., Medical Director of BSP China, Bayer Healthcare Co. Ltd.
Panelists:
Yali Cong, Ph.D., Professor of Medical Ethics, Health Science Center, Peking University Medical School
Zhengyu Yuan, Ph.D., President & CEO, MicuRx
Seymour Mong, Ph.D., Director, Development, Jiangsu Hengrui Medicine Co.
David Shao, Ph.D., CFA, Senior Vice President, China Aoxing Pharmaceutical Company, Inc.
12:10
Drug Safety and Post-Marketing Surveillance
- Public health need - PMS is vital to achieve safe and rational use of medicines
- Benefit/risk assessment - a crucial concept at the very basis of many regulatory decisions
- Decisions appropriate to needs and resources- emphasis on "adapting" rather than "copying"
Junqi Zheng, M.D., Ph.D., MPH, Director, Medical Affairs and Business Development, Venturepharm Groups
12:40
Networking Luncheon with Exhibits & Poster Viewing
Luncheon Presentation
12:45-
1:30
Outsourcing to China: A Global CRO Perspective
China presents unique challenges and opportunities to the pharmaceutical and biotechnology industry and an experienced partner can help companies navigate those challenges and gain the most benefits from this market. Hear from a leading global CRO, the first to offer discovery through post-approval services in China, as they discuss the reasons for their recent acquisitions in China, the practical implications of integrating these companies and the ultimate benefits to local and global companies.
Simon Britton, Vice President, Clinical Development, Asia Pacific, PPD, Inc.
Clinical Development Tools: Project Management and CDM
Panel Discussion
1:45
Project Management in the New Paradigm: Global Clinical Development in Asia
The new paradigm of clinical development calls for lower cost and faster timeline along with delivery of quality data. Many global clinical studies have taken the initiatives to include China, Hong Kong, Taiwan and Korea. Some of the key questions that this session will attempt to highlight, include:
- What are the challenges present in these areas in terms of clinical operation?
- How can project management be best practiced to optimize trial conduct and data quality in these emerging markets?
- Which areas have project managers created most value besides driving project timelines?
- Are there any weaknesses in current operation process that can be eliminated by stronger enforcement of project management matrix?
Moderator:
Joanne Jiang, Ph.D., MBA, Vice President, Fountain Medical Development
Panelists:
Nenad Sarapa M.D., FCP, Head of Clinical Pharmacology-Oncology, Hoffmann-La Roche, Inc.
Ivan Zhai, M.D., MBA, Chief Operating Officer, R&D PharmaStudies Ltd.
2:30
Clinical Data Management in China: Opportunities and Challenges
On the backdrop of new regulatory environment, EDC being more widely adopted, and more global trials coming to China, we set out to build a CDM team under the greater development plan of building a R&D center in China at Sanofi-Aventis. Experience will be shared.
Li Ding, MSc., China Site Head, Clinical Data Management, Sanofi-Aventis
3:00
Reducing Risk in Asia with the Right CRO Partner
For drug developers, finding the right outsourcing partners can be critical in Asia due to the multitude of clinical trial variables. In particular, sponsors are looking for CROs that employ process-driven clinical research methods and have demonstrated expertise of the Asian landscape. Understand the key considerations for conducting clinical trials in Asia and how to evaluate a CRO's processes and expertise to help reduce overall trial risk.
Jessica Liu, Ph.D., Senior Director, Clinical Operations- Asia Pacific Rim, INC Research
3:30
Networking Refreshment Break with Exhibits & Poster Viewing
Building Clinical Development Centers in Pharmas and Academia for Global Clinical Trials
4:00
Simultaneous Global Development - What Does It Mean for China?
Pharmaceutical companies are increasingly pursuing development strategies that support the earliest possible registration across major markets. Including China as part of simultaneous global development (SGD) means Chinese patients get earlier access to new medicines. This presentation will review the opportunity and challenges of SGD including a case study.
Bradley Merchant, M.D., Head of Clinical Development, Asia, Pfizer, Inc.
Panel Discussion
4:30
Building a Clinical Trial Unit in Academic Medical Centers
The quality of a clinical trial will be important to explore the real efficacy and safety of a new drug. Building a Clinical Trial Unit in Academic Medical Centers is an innovative approach to expedite the clinical trial process and guarantee the quality of clinical trials. Hear from 2 of the leading AMCs in China on how they can and have helped manage phase I to IV studies in China.
Moderator:
Frank Fan, M.D., Medical Director, Wyeth (H.K.) Limited
Panelists:
Jack Xu, M.D., Senior Vice President, Clinical Operation, Shanghai Clinical Research Center
Yangfeng Wu, M.D., Ph.D., Professor, Peking University Public Health School, Director, CCDRS, Peking Universtiy Clinical Research Institute
Panel Discussion
5:00
Building a State-of-the-Art Clinical Development Center in China and Ensuring Efficient Site Management
- Developing the center as part of a global network
- Talent development
- Innovation
- Global Site Management strategies
Moderator:
Frank Jiang, M.D., Ph.D., Vice President & Head, China R&D, Sanofi-Aventis
Panelists:
Paul Dai, M.D., Director, Clinical Development, Beijing Novartis Pharma Co., Ltd.
Ole Molsknov Beck, Ph.D., Vice President, International Operations Clinical Development Center, Novo Nordisk China
Zheng Gu, M.D., Senior Medical Director, Sanofi-Aventis China
Ling Su, Ph.D., Vice President, Clinical Research & Development Asia Pacific, Wyeth Research
5:45
Close of Clinical Development Strategies Session
3:15
FOB Roadmap for Bio-Pharmaceutical Industry in China
Although recent global financial crisis and re-bounce makes some emerging economies such as China as new spotlights, to share the pie with giants in biopharmaceutical industry is still a great challenge. Huge estimated profit of global FOB market, however, provides an excellent opportunity for Chinese biopharmaceutical companies to overcome the major challenges, mainly the weak pipeline of new biologics. In this presentation, the major cost saving and timeline for "me-too" and "me-better" bio-drug development are compared, and strategies for implementing platform technologies from high-titer cell culture, integrated DSP, pre-clinical and clinical design of biologics to flexible manufacturing perspectives that Genor currently is using for FOB mAb therapeutics are shared.
Joe Zhou, Ph.D., Chief Executive Officer, Genor BioPharma
4:25
Overcoming Bottlenecks in China's Biologics Development and How Do You Bridge the Gap?
Moderator:
Guoliang Yu, Ph.D., Chief Executive Officer, Epitomics, Inc.
Panelists:
Yu Zhao, Ph.D., Vice President, Tianjin International Joint Academy of Biotechnology and Medicines
Joe Zhou, Ph.D., Chief Executive Officer, Genor BioPharma
Chris Chen, Ph.D., Chief Operating Officer, Shanghai Celgen Biopharmaceuticals