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China Pharmaceutical R&D Summit

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April 05 - 08, 2010 · Grand Hyatt Hotel · Shanghai, China
Inspiring the Future of Science & Innovation with Leadership Thinking and Global Vision

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Agenda

Agenda

Pre-Conference Workshops - Monday, April 5, 2010

8:30
Registration & Morning Coffee

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

4:30
Close of Workshop

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.

3:30
Q&A

4:00
Close of Workshop

New!
Workshop III:

Rapid Fire Company Showcase

The showcase will feature 10 companies that have been pre-selected by the VC Advisory Committee, and who will be presenting their companies' scope of business, strategies for growth, management board, and financial projections for potential funding and investment interest.

Attend this Showcase to find out which are the latest innovations in healthcare that are capturing the attention of VCs, law firms and investment companies today, and what these companies have that makes them attractive - is it technology innovation? Is it business strategy or product mix? Is it leadership and management capabilities? Or is it just the particular field the company is in?

Hear from the VC panel and how they critically critique these companies and learn what these VCs, law firms and investment companies are looking for in a business presentation.

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

3:30
Close of Showcase

Main Conference - Tuesday, April 6, 2010

Plenary Session

8:30
Chairperson's Opening Remarks
Steve Yang, Ph.D., Vice President and Head of R&D, Asia, Pfizer Global Research & Development

Keynote Presentations

8:45
Marc Cluzel, Ph.D., M.D. Sanofi-Aventis' Strategies for 2010 and Beyond - Reorganizing and Adapting R&D for the Changing Pharmaceutical Industry
Marc Cluzel, Ph.D., M.D., Executive Vice President, R&D, Sanofi-Aventis

9:15
Piao-Yang Sun, Ph.D. From Generic Drug to New Drugs: Hengrui's Experience
Retagliptin, a new DDPIV inhibitor, was discovered and developed by Hengrui for the treatment of Type II diabetes and is now in clinical trials in the United States since August 2009. This is a major milestone for Hengrui and the Chinese pharmaceutical industry as Retagliptin was the first home-grown NCE ever put into clinical trials in US. The experience of transforming a domestic generic drug business into a globally competitive pharmaceutical enterprise will be shared. Updates on Hengrui's clinical trials will also be discussed.
Piao-Yang Sun, Ph.D., Chief Executive Officer and Chairman of the Board, Jiangsu Hengrui Medicine Co. Ltd.

Investment Panel

9:45
The Future of Biotechnology Investing in China
Moderator:
Robert Nelsen, Managing Director, Co-Founder, ARCH Venture Partners
Panelists:
Nisa Lin, Partner, Qiming Venture Partners
Leon Chen, Ph.D., Partner, Fidelity Asia Ventures
James Li, Partner, Kleiner Perkins Caufield & Byers
Nancy Chang, Ph.D., Senior Managing Director, Orbimed Healthcare Fund Management
Ge Li, Ph.D., Chairman & CEO, Wuxi Apptec

10:30
Morning Refreshments & Opening of Exhibit & Poster Hall

China R&D Leaders' Roundtable

11:00
China's Pharmaceutical Industry from the Insiders' Eyes
  • The experiences and retrospective view of pharmaceutical companies in China
  • The perspectives, interests and future visions
  • How does drug discovery differ in domestic vs. global pharma companies?
  • How to best utilize collaboration between Chinese domestic pharma and returnee companies?

Moderator:
Steve Yang, Ph.D., Vice President & Head of R&D, Asia, Pfizer Global Research & Development
Panelists:
Li Chen, Ph.D., Head of Research & CSO, Roche R&D Center (China) Ltd.Xin Ma, Head of Global Drug Discovery - Innovation Center China, Bayer Schering Pharma
Peng Cho Tang, Ph.D., Chief Scientific Officer, R&D, Shanghai Hengrui Pharmaceuticals Co. Ltd.
Frank Jiang, M.D., Ph.D., Vice President & Head, China R&D, Sanofi-Aventis
Jimmy Wei, Ph.D., Vice President, Hutchison MediPharma
Peng Wang, Ph.D., Chief Scientific Officer, Simcere Pharmaceutical Group
Guoxin Zhu, Ph.D., Senior Director, Lilly Research Laboratories, Eli Lilly & Company

12:15
Networking Luncheon in Exhibit & Poster Hall

Impact of Healthcare Reform on China's Pharmaceutical Industry

1:30
Chairpersons' Opening Remarks
Kewen Jin, M.D., General Manager, Preclinical Services, Charles River Laboratories Greater China
Dan Zhang, M.D., MPH, Co-Founder & CEO, Fountain Medical Development Corporation

1:35
Healthcare Reform - Moving Beyond Reading of the Tea Leaves
Rajesh Parekh, Ph.D., Leader of Asia Healthcare Practice, McKinsey & Company

2:00
The Progress of Essential Medicines System Reform in China: Opportunity and Challenge
Shanlian Hu, Ph.D., Director and Professor, Department of Health Economics, School of Public Health, Fudan University

2:25
China's Healthcare Reform: Implications for the Industrial Sectors
Yuan-Li Liu, Ph.D., Director, China Initiative of Harvard University of Public Health

Panel Discussion

2:50
Impact of China's Healthcare Reform on the Burgeoning Industry - for MNCs, Domestic Pharma/Biotechs, Devices, Diagnostics Companies etc.
  • What does it mean to the total industry?
  • Does the company have the right portfolio to meet the needs?
  • How does the reform affect premium pricing for innovative drugs?
  • Which drugs will benefit most from China's reform?

Speakers of the Session

3:30
Networking Refreshment Break with Exhibits & Poster Viewing

Concurrent Tracks

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 II:

Organizational Development and Talent Management

4:00
Chairperson's Opening Remarks
Carol Zhu, MBA, Director, Organization Development and Communication, GSK R&D Center

4:05
Compensation and Benefits in China's Pharmaceutical Industry
In 2009, Mercer released China's first "Pharmaceutical R&D Report and Clinical Research Organization Industry Report". In this presentation, we will share the latest findings and insights of this report and help interpret strategies on how to attract and retain R&D talents in this competitive market.
Speaker TBD, Mercer Greater China

4:35
Building Innovation Culture in R&D Center
Pharmaceutical R&D has tried different ways to increase productivity and reduce costs. The goal of establishing a R&D center in China is not that of cost savings, but to increase productivity and promote innovation. Yet, how can these R&D centers do research differently from the old model of big pharma as a way to increase productivity? What are the key elements to create an innovation culture? What kind of roles will leaders play to maintain the agility of the organization? How to motivate young researchers to be innovative and creative every day? These are all important questions for organizational development.
Carol Zhu, MBA, Director, Organization Development and Communication, GSK R&D Center

Panel Discussion

5:05
Innovations and Best Practices in Talent Attraction, Retention and Leadership Development
  • People development: Talent retention and resource management How to keep talent? How to train talent? How to build resources in collaboration with local universities? How can drug development link with talent development in China?
  • Best practices in leadership development, retention & engagement, organizational change, innovation in benefits

Moderator:
Jerome Bucher, Partner in Charge, Heidrick & Struggles
Panelists:
Elaine Lin, HR Director - China/HK, Baxter
Carol Zhu, Ph.D., Director, Organization Development and Communication, GSK R&D Center
Jennifer (LiHua) Jin, MSc., Executive Director, Human Resources, Beijing Novartis Pharma Co., Ltd.
Lan Kang, MSc., MBA, Client Partner, Korn/Ferry International

Main Conference

6:00
Opening Night Cocktail Reception with Exhibits & Poster Viewing

7:00
IBC's China Pharma R&D Awards Dinner
Join us for a fun-filled networking evening that brings together speakers, attendees, sponsors and exhibitors to honor and recognize individuals and companies who have contributed to the advancement of China's pharmaceutical industry.
The following awards will be presented:
  • IBC China Scientific Discovery of the Year Award: recognizing the most significant discovery in life science in China
  • IBC China Drug Discovery of the Year Award: recognizing the most significant achievement in new drug R&D milestones.
  • IBC China R&D Award: recognizing outstanding individuals whose contributions changed the landscape, reputation, and ecosystem for drug R&D in China
Awards Selection & Endorsing Associations:

Main Conference - Wednesday, April 7, 2010

Plenary Session

Featured Presentations: Public-Private Partnerships In Discovery & Development Of Unmet Medical Needs

8:50
Chairperson's Opening Remarks
Tony Zhang, Ph.D., Managing Director, Head of R&D China, Eli Lilly and Co.

9:00
Robert Ridley, Ph.D. Development of Regional Innovation Networks in Asia, Africa and the Americas for R&D into Infectious Diseases Treatment and Diagnostics for Developing Countries
Abstract not available at time of print.
Robert Ridley, Ph.D., Director, Special Program for Research, TDR, World Health Organization

9:30
Forging Triangular Partnerships in Global Healthcare - How Foundations, Academia and Industry Can Help Bring New Therapies Faster-to-Market
Abstract not available at time of print.
Kanwarjit Singh, M.D., MBA, Senior Program Officer, Global Health, Bill & Melinda Gates Foundation

10:00
Networking Refreshment Break with Exhibits & Poster Viewing

Concurrent Tracks

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

12:10
Talk TBD

12:40
Networking Luncheon with Exhibits & Poster Viewing

Luncheon Presentation

(Lunch boxes will be provided in the session room)

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

(Lunch boxes will be provided in the session room)

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

Main Conference - Thursday, April 8, 2010

Plenary Session

Keynote Presentations

8:50
Chairperson's Opening Remarks
Guoliang Yu, Ph.D., Chief Executive Officer, Epitomics, Inc.

9:00
Martin Mackay, Ph.D. Right Targets. Right Patients. Right Now.
Dr. Martin Mackay will describe a philosophical shift in research strategy to conquer the diseases that plague society. With a global force of scientists, laboratories and a virtual network in Asia, Pfizer is taking a unique approach to health care solutions for China and the world
Martin Mackay, Ph.D., President, PharmaTherapeutics R&D, Pfizer Inc.

9:40
Michel Vounatsos China: A Key Emerging Market for the New Merck
In 2011, China will be the number 3 worldwide pharmaceutical market. Emerging markets are a key priority for the new Merck while facing the exciting opportunity of integrating two cultures. How will Merck realize its sustainable commitment to the Chinese market?
Michel Vounatsos, President, MSD China

10:10
Networking Refreshment Break

Biologics & Biosimilars Development

Innovative Biologics - Global Development

10:45
Research and Development of Next Generation of Antibody-based Therapeutics: The Challenges and Opportunities
Recent clinical success with antibody-based therapeutics has led to an upsurge in the development of these agents. Since 1994 the US FDA has approved 23 therapeutic antibodies. In addition, there are several hundreds of antibodies currently being tested in late-stage pre-clinical and clinical settings worldwide for a variety of disease indications. This presentation will discuss the current status and future trends, focusing on emerging novel technologies and their impact, in the discovery and development of next generation antibody-based therapeutics.
Zhenping Zhu, M.D., Ph.D., Vice President and Global Head, Protein Sciences and Design, Novartis Biologics

11:15
Strategy for Biologics
  • Biologic products and projects at Nycomed
  • R&D strategy
  • Developing a biologics strategy

Sigurd Okkels, Ph.D., Vice President & Head of Biologics Department, Discovery to Preclinical Development, Nycomed GmbH

11:45
RNAi Therapeutics in China: A Frontier for Targeted Medicine
RNAi therapeutics has demonstrated clinical benefits in several ongoing human trials in US. The development of siRNA therapeutics in China is still at a very early stage. However, with combined efforts from scientists in academic institutions and entrepreneurs in biopharmaceutical industries, and increasing funding from different levels of Government, the impressive progress has been made. The current development of RNAi therapeutics in China will be discussed and some of the unique technology approaches will be addressed.
Patrick Lu, Ph.D., Founder, President & CEO, Sirnaomics, Inc.

12:15
Change of Biopharmaceutical R&D in Asia
Abstract not available at time of print.
James Cai, M.D., Senior Vice President, Clinical Development, aTyr Pharmaceutical

12:45
Networking Luncheon

Innovative Biologics in China

2:00
A Joint Effort to Develop a Novel Anti-Cancer Antibody Drug in China
Due to the potential of the Chinese market, the large talent pool, coupled with the recently improved R&D capability and infrastructure, companies from around the world are conducting innovative drug R&D in China or collaborating with local Chinese companies. This presentation will serve as an example of a joint effort between a US-based biotech firm and a Chinese drug company in developing a novel antibody drug for the treatment of cancer, leveraging on the proprietary rabbit monoclonal antibody technology and a novel humanization technology.
Peng Wang, Ph.D., Chief Scientific Officer, Simcere Pharmaceutical Group
Xiuwen Liu, Ph.D., Director of Research, Epitomics Inc

2:25
Innovative R&D Approach for Innovative Biologics R&D in China
The Chinese biopharmaceutical industry is blooming in recent years primarily due to the growing market needs, increasing financial and policy support, improving technical capabilities, and accumulated talent pools. On the other hand, there is still a significant gap between the Chinese biopharmaceutical companies and the advanced multinational companies in the field of R&D. This presentation indents to discuss various innovative and flexible R&D approaches that could effectively meet the needs for the Chinese drug discovery and development environment.
Yingfei Wei, Ph.D., Chief Scientific Officer, 3S Bio

Follow-on Biologics and Bio-Betters in China

2:50
An MNC's Perspective on the Overall Capabilities of China's Biosimilars/FOB Development - A Comparison with US/EU
This presentation is intended to focus on understanding the current competitive landscape of China's biosimilars/FOB market and addressing the critical gaps in China's biologics R&D and manufacturing capabilities. A comparison with US/EU will be given in respect to regulatory affairs, market dynamics and technical know-hows. Further discussion will be centered around the trends and opportunities of the biosimlars/biobetters in China.
Yining Zhao, Ph.D., Associate Research Fellow, Strategy & Operation, Pharmaceutical Sciences, Pfizer, Inc.

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

3:40
Networking Refreshment Break

4:00
The SFDA's Policies and Regulations Towards Biosimilars/Bio-Betters in China
Following EU biosimilar guidance being published, WHO and the US are also drafting their respective guidance on biosimilar/follow-on biologics and planning to publish by 2009 or early 2010. What then, is China SFDA's attitude and proposal in this area? Are there any challenges in implementing a biosimilar guidance for China? This presentation will help to integrate all the information and give an in-depth analysis on the biosimilar issues in China.
Weiping Li, MSc., MBA, Director, Regulatory Affairs, XIAN-Janssen Pharmaceutical, Johnson & Johnson China

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

5:00
Close of China 2010 Pharmaceutical R&D Summit

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