7th International China Pharma R&D Summit 2012

Day 1

MAIN CONFERENCE DAY ONE • TUESDAY, 24 APRIL 2012

8.00 Registration and Morning Coff ee/Tea 签到及早茶

8.30 Chairman’s Opening Remarks 大会主席致开幕词

Li Chen, President and Chief Executive Officer, Hua Medicine, China

PLENARY KEYNOTE SESSIONS: GLOBAL AND REGIONAL PHARMA R&D
大会主题演讲：全球药物研发与区域合作发展现状

8.40 Keynote Address 主题演讲
Takeda’s R&D Collaboration Model for Targeted Medicine for Unmet Needs
武田制药的研发合作模式创新 - 贴近医患需求，积极推进靶向药物开发

Mary Haak-Frendscho, President and Chief Scientific Officer, Takeda San Francisco, USA

9.10 Global Keynote Address 全球主题演讲
Extending Innovation Network through Partnering 通过合作扩展创新网络

Joe McCracken, Global Head of Business Development and Licensing, Roche, USA

9.40 Industry Keynote Address 题演讲主
Effectively Tackling R&D Productivity Challenge: Integration of External Research
全球有效应对研发生产力挑战：整合外部研究

Open innovation models
Improving innovation for sustainability
Innovation in China
Industry-Academia and Industry-Biotech partnerships
Effectively managing the integration of external research
Abandoned R&D assets: value or burden?

Helmut Haning, Senior Vice President and Head Global Innovation Outsourcing, Bayer Healthcare Pharmaceuticals, Germany

10.10 Is China Ready to Lead in Global Drug Development?
全体小组讨论：中国是否已准备好领导全球药品创新与发展？

Is ROCE-led innovation transforming China’s pharma industry onto the world stage?
Partnering with China in vaccines research & development
Opportunities and challenges from biosimilars and biobetters from/for pharmerging markets

Moderator:
Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, Singapore

Panelists:
Frank Shen, Vice President Global Data Management and Statistics, Global Pharmaceutical R&D, Abbott, USA
Ling Chen, Vice President of R&D China Operations, GlaxoSmithKline, China
Ming Wang, Executive Director and Head of Diabetes Research, Amgen, USA
Youling Wu, Chief Executive Officer, ZheJiang Teruisi, China
Karen Atkin, Vice President of Research and Development, AstraZeneca, China

11.00 Morning Refreshments 上午茶歇
End of Plenary Session 药物创制和开发周联合会议时段结束

PLUS
Mini Workshops Organized and Sponsored by Molecular Devices

Completed Calcium Flux Solutions
钙流检测完全解决方案
Chuanxiu Yang PhD, Chief Application Scientist
杨传秀博士 , 首席应用科学家

Regulatory Snapshots
监管简介

Discussion Den
讨论会

11.30

Navigating the Regulatory Landscape in Key North Asian Countries
and US: R&D Efforts that Translate to Approvals
审视亚洲主要国家/地区、欧洲和美国的监管环境：获得批准的研发成果
Concise overviews from regulatory experts and opinion leaders to examine the latest updates and the regulatory scene in each country
Taiwan: Herng-Der Chern, Distinguished Research Fellow, Center for Drug Evaluation
Japan: Yuko Kikuchi, Clinical Regulatory, Strategy Planning & Management Section, Eisai
China: Rong Chen, Head of Regulatory Center for Excellence, GlaxoSmithKline

A Panel Discussion among the country presenters follows
Moderator:
Seth Goldenberg, President, Asia Pacific Bio Intelligence, former US FDA, USA

11.30

Partnering in
Biosimilars mAbs
在生物仿制药单克隆
抗体领域展开合作

Robert Chen, Director, Global Strategy & Partnering, Genor BioPharma, China

Opportunities in Emerging R&D Models in Asia
亚洲新兴研发模式的机遇

12.30

The Role of Asia in Drug Development 亚洲在药物开发中的作用
Moderator:
Jennifer Hu, Vice President, Head of Innovation Center China, Global Drug Discovery, Bayer Healthcare Pharmaceuticals, China

Panelists:
Yuan Hua Ding, Senior Director & Head, External R&D Innovation Asia, Pfizer, USA
Alain Bouckenooghe, Clinical R&D and Medical Affairs, Associate VP, Regional Head Asia/Pacific, Sanofi Pasteur, Singapore
Gao Qiang, Director of R&D, Sinovac Biotech, China

12.30

Aligning R&D and
Drug Safety
协调研发与药品安全

James Yan, Executive Director, Hutchison
Medipharma, China

1.10

Networking Lunch 联谊午宴

2.10

Chairman’s Opening Remarks 大会主席致开幕词
Hiroshi Sugii, Vice President Clinical Development, Novo Nordisk, Japan

2.15

PHARMA IDOL: INNOVATION SHOWCASE 制药偶像: 创新展示
Concise 10 minute presentations of emerging innovations and technologies in Asia from academia and upcoming biotechs. These sessions will be judged a-la “American Idol” by industry leaders from VCs, Big Pharma and government agencies. 10 分钟简要发言，主题：学术界推出的亚洲新兴创新与
技术，以及未来的生物技术。这些会议将采用“美国偶像”形式，由来自风险投资公司、大型制药
公司和政府机构的行业领导者进行评判。

Application of Drug Rediscovery Strategies in Drug Discovery: Vicagrel as a Novel Anti platelet Agent
Prof Hongbin Sun, Director, Center for Drug Discovery, China Pharmaceutical University
The Development and Strategy of P1101, a PEGylated Proline Interferon Alfa-2b
Ko-Chung Lin, Chief Executive Officer, PharmaEssentia, Taiwan
HongKeun Oh, Professor and Dean, Graduate School of Alternative Medicine, Jeonju University, Korea

2.15

Understanding
the Virtual Drug
Development Model
在亚洲应用虚拟筛选
推动药物开发的利弊
分析

Stephen Porter, CEO,
VDDI Pharmaceuticals, USA

3.00

What is the Future of scientific Innovation in China?
中国科技创新的未来会怎样？

Moderator:
Sofie Qiao, President and Co-Founder, Linq Pharmaceuticals, USA

Panelists:
George Chen, Chief Medical Officer, BeiGene, China
Li Shi, Chief Executive Officer, Shanghai Zerun Biotechnology, China
Qing Dong, Chief Executive Officer, Shanghai Hengrui, China
Yuqiang Wang, Chief Executive Officer, Magpie Pharmaceuticals, China
Jasmine Cui, Chief Scientific Officer, Bioduro, former President, Sino-American Pharmaceutical Professionals Association (SAPA), China

3.00

Successful Licensing
Strategies for the
Chinese Biotech
中国生物技术的成功
许可策略

Allan Riting Liu, Vice President/Senior
Advisor, Wanbang
Biopharmaceutical Group, Vice President, Fosun
Pharmaceutical, China

3.40

Afternoon Refreshments 下午茶歇

PLUS
Mini Workshops Organized and Sponsored by Molecular Devices

Drug Screening Speed and Flexibility Innovation- HCS Technology and Application
药物筛选速度和灵活性的变革 - 高内涵技术和应用
Amy Zhang， Application Scientist
张薇，应用科学家

Funding for Innovation
资助创新

4.10

Investment Keynote 投资主题
Vijay Karwal, Managing Director, Royal Bank of Scotland, Hong Kong

4.40

Big Pharma Perspective: Evaluating which Innovation to Fund
医药业宏观展望：评估哪些创新项目值得投资
Stella Xu, Executive Director, Roche Pharma Partnering, China

4.40

R&D Project
Management &
Strategy
研发项目管理与策略

Kumar Penmetsa,
Senior Director, Project Management and Strategic Operations, Bristol Myers Squibb, China

5.10

Investment Appetite for Pharma R&D Innovation in Asia
亚洲医药研发创新的投资偏好

Who is investing in Asia? Where is the money going?
What are the criteria when choosing which companies to fund?
Lessons learned from select case studies

Moderator:
Jonathan Wang, Partner, Legend Capital, China

Panelists:
Leon Chen, Partner, Fidelity Asia Ventures, China
Yi Shi, Managing Director, Lilly Asia Ventures, China

5:55

End of Day One Followed by Networking Drinks
大会主席致词后第一天的会议议程结束，同时将举办联谊鸡尾酒招待会

Day 2

MAIN CONFERENCE DAY ONE • WEDNESDAY, 25 APRIL 2012

8:50 Chairman’s Opening Remarks 大会主席致开幕词

Frank Shen, Vice President Global Data Management and Statistics, Global Pharmaceutical R&D, Abbott , USA

Academia in Pharma R&D
医药研发学术界

Discussion Den
讨论会

9.00

Academic Keynote Address 学术主题演讲
Collaborative Research: Partnerships That Accelerate Innovation

Growing importance of sponsored research in accelerating drug discovery and development
Role of the public sector in helping to leverage industry investments in academic research
Examples of successful collaborative research projects from the Massachusetts life sciences supercluster
Models for shared public-private investment in collaborative research

Susan Windham- Bannister, President, Massachusetts Life Science Center, USA

9.15

Biocomparability
in Biosimilars:
Conducting BA/BE
studies
生物仿制药的生物相
容性：开展生物利用
度/生物等效性研究

Chichang Lee, VP of
Preclinical and
Cell line Development,
ZheJiang Teruisi,
China

9.40

What is the Expanding Role of Academia in Drug Discovery and Development?
学术界在药物发现与开发领域发挥了哪些日益重要的作用？

Moderator:
Ralf Altmeyer, Director General, Institut Pasteur, China

Panelists:
Kumar Penmetsa, Senior Director, Project Management and Strategic Operations, Bristol Myers Squibb, China
Prof Hongbin Sun, Director, Center for Drug Discovery, China Pharmaceutical University
Kewei Wang, Professor and Chair, Department of Molecular and Cellular Pharmacology, Peking University School of Pharmaceutical Sciences, China
Susan Windham-Bannister, President, Massachusett s Life Science Center, USA

10.25

Morning Refreshments 上午茶歇

Drug Development and Partnering Strategies that Work in Asia
适合于亚洲的药物开发与合作战略

10.55

Examining the Pros and Cons of the Virtual Pharma Model in the Context of Asia 亚洲环境中虚拟制药模式的利弊分析
John Oyler, Chief Executive Officer and Founder, Beigene, China

11:15

Drug Discovery Acceleration through Enabling Chemistry Technology

Advances in high throughput chemistry
New flow chemistry platforms
Photochemistry and the use of Target Identification Proteomics for the discovery of pharmacologically relevant drug targets

Stevan W Djuric, Senior Director, Global Pharmaceutical Research and Development, Abbott, USA

11.35

Emerging Business Models in Pharma R&D in Asia
亚洲医药研发的新兴商业模式

What model works best with Asian partners?
How do you broaden the choices when looking for Asian partners?
How do emerging markets fi t into big pharma growth strategies?

Moderator:
Li Chen, President and Chief Executive Officer, Hua Medicine, China

Panelists:
Roxanne De La Riva, Head of Genentech Research and Early Development (gRED) Procurement, Genentech, USA
Chia-Lin Wang, President, Development Center for Biotechnology, Taiwan
Binhui (Ben) Ni, Head of Scouting & Partnership, Sanofi Aventis, China
Jun Bao, Director, Worldwide Business Development, Head of China, GlaxoSmithKline
Dr Chen Chen, Chief Executive Officer, Sundia MediTech, China
Ralf Altmeyer, Founder, Advance Biochina, China

11.35

Dealing with Legal
and IP Issues in
Entering the US
Market
打入美国市场需要应
对的法律和知识产权
问题

Gary Arlen Smith,
Founder, Enterprise
Law, USA

12.20

Spotlight Presentation: Perkin Elmer
How Informatics Can Help the Externalization of R&D
Clive Higgins, Vice President of Marketing, PerkinElmer, USA

12.40

Networking Lunch 联谊午宴

1.45

PHARMA IDOL: INNOVATION SHOWCASE 制药偶像：创新展示

Multi-functional Agent for Treatment of Parkinson’s Disease
Yuqiang Wang, Chief Executive Officer, Magpie Pharmaceuticals, Professor and Dean, Jinan University College of Pharmacy, China
Clinical Development of Tanibirumab and its Next Generation, DIG-KT
Jin-San Yoo, Chief Executive Officer, PharmAbcine, Korea

Interested in presenting? Email elle.quan@ibcasia.com.sg now, limited slots available.

PHARMA IDOL Judging and Awarding of Pharma Idol Innovation
Showcase Winner 制药偶像创新展示获奖者评判及颁奖

Judges:
Yuan Hua Ding, Senior Director & Head, External R&D Innovation Asia, Pfizer, China
Paul Bolno, Vice President, Worldwide Business Development, Head of Asia, GlaxoSmithKline, China
Jonathan Wang, Partner, Legend Capital, China

1.20

Innovative Drug
Development in
China
中国创新药物开发

Jingzong Qi, Vice
President & Director
of Clinical Research
Center, FusoGen
Pharmaceuticals, China

Clinical Development & Partnerships in Asia
亚洲临床开发与合作

2.25

Late Phase Clinical Development: Successful Partnering in Clinical
Development 后期临床开发：临床开发中的成功合作
江苏恒瑞医药股份有限公司，临床副总裁
Helen Jiang, Vice President Clinical, Jiangsu Hengrui Medicine Company, China

2.00

Leading a China
Team Towards
Drug Development:
Medical Director’s
Perspective
带领中国团队进行药物
开发：医疗主任的观点

Jean Denis Shu,
Medical Director, Sanofi
Pasteur, China

2.55

Clinical Development Expert Panel 临床开发专家小组：

Challenges experienced by the companies in conducting clinical development in Asia, particularly in China
Practical recommendations to ensure success and quality outcomes

Moderator:
Zaiqi Wang, Head of Clinical Development, Merck China

Panelists:
Amy Jiang, Quality Operations Head, R&D China, Sanofi Aventis
Sally Sha, Director Business Development, Tigermed, China
Helen Jiang, Vice President Clinical, Jiangsu Hengrui Medicine Company, China

3:40

Afternoon Refreshments Îçºó²èÐª

OUTLOOK FOR PHARMA R&D IN ASIA AND GLOBALLY 亚洲及全球医药研发展望

4:10 Biobetters Panel Discussion: Future Opportunities in Biosimilars and Biobetters
生物改良药小组讨论：生物仿制药和生物改良药的未来机遇

Determining the commercial value of biosimilars: Are the opportunities real?
China’s 5 year plan and what it means to the biosimilar/biologics industry
Are in & out-licensing agreements working out in the world of biobett ers?

Moderator:
Zhenping Zhu, President & Chief Executive Officer, Kadmon China

Panelists:
Shirley Zhao, General Manager, Genzyme China
Satheeshkumar Sriharan, Chief Representative / Country Head- China, Dr Reddy’s Laboratories, China
Ying Fei Wei, Consultant, 3SBio, Chief Executive Officer, Elixirin, USA

4:55 Closing Visionary Panel Discussion 结束前瞻性小组讨论

How is Collaboration Changing the Face of Pharma R&D in Asia and Beyond?
Where is the next innovation going to come from?
Will there be no more internal R&D for the pharma of the future?

Moderator:
Xian-Ping Lu, Chief Executive Officer, & Chief Scientific Officer, Shenzhen Chipscreen Biosciences, China

Panelists:
William Lee, Chief Executive Officer, NOD Pharmaceuticals, USA
Xiaodong Yang, President and Chief Executive Officer, Apexigen, USA
James Yan, Executive Director, Hutchison Medipharma, China
Zhengyu Yuan, President and Chief Executive Officer, MicuRx Pharmaceuticals, USA

5:40 End of Conference 会议闭幕

Workshops

Pre-Conference Day Workshop:
23 April 2012, Monday

This full-day workshop will run from 09:00 – 17:00,
with mid-morning and afternoon refreshment breaks
and lunch. Registration begins from 08:30

会前研讨会：2012年4月23日，
星期一 (上午9:00 — 下午5:00)

A: U.S. Market Entry: A Regulatory,
Legal, and Medical Communication Perspective
进入美国市场：从监管、法律和医学交流角度进行分析

Objectives:
To understand the opportunities and challenges for entering the U.S. Market from a Regulatory, Business Development, Law, and Communications perspective. It is important to take these issues into consideration together to create a successful market entry strategy.

Who Should Attend:
Anyone interested in entering the U.S. market to understand the challenges involved and how to position themselves to succeed in entering the U.S. market.

Outline:

Introduction: Case Study of Entering U.S. Market
Regulatory Considerations for R&D: Strategies to Save Time and Money Towards Future FDA Approval
Protecting your IP in the U.S.: When to File for IP with Changing U.S. Law
Filing for Regulatory Approval: Approaches for Handling New FDA
Communications Strategies: Medical Communications to Support Commercial Success
Developing Partnerships: Mergers and Acquisitions, Joint Ventures, Capital Raises
Clinical Trials: Strategies for Successful Trials
Launching your Product: Case Study, Getting your Product into the Hands of Clinicians

Led By:

Seth J. Goldenberg, President, Asia Pacific Bio Intelligence, former U.S. FDA
Seth is a former Regulatory Chemist with the FDA and current President of APBI. He holds a PhD in Pharmacology from the University of Washington and a M.S. from the School of Biomedical Engineering at Drexel University. He has a strong record in drug development, FDA, business development, product licensing, grant writing, scientific patents, medical communications, and collaborations with academia and industry. Dr Goldenberg understands not only what it takes to carry out scientific study, but also the importance of communicating it with the global scientific community to foster partnerships and collaboration.

Michael Platt, President, MedVal Communications, USA
Michael comes to MedVal from Fission Communications, a New York-based medical education and communications company he co-founded in 2001. He has over 16 years of industry experience and a broad knowledge of the pharmaceutical, biotechnological, and healthcare marketing fields, as well as additional expertise in cardiology, allergy and asthma, infectious disease, gastroenterology, urology, rheumatology, oncology, and HIV.

Gary Arlen Smith, Managing Partner, Enterprise Law Associate, USA
Gary is founder and principal of Enterprise Law Associates, LLC, a boutique law firm serving life science and technology companies in all stages of their life cycles from pre-startup through exit. Prior to founding ELA, Gary was Vice President and General Counsel of Tengion, Inc., served as Vice President and General Counsel of Enzon Pharmaceuticals, Inc., was engaged in private law practice for 15 years and was a partner in the law firms Morgan, Lewis & Bockius and Ballard Spahr and Saul Ewing.

___________________________________________________

Post-Conference Day Briefing:
26 April 2012, Thursday

This full-day workshop will run from 09:00 – 17:00,
with mid-morning and afternoon refreshment breaks
and lunch. Registration begins from 08:30

会后通报会：2012年4月26日，
星期四 (上午9:00 — 下午5:00)

B: Turning Strategies into Tactical Plans to
Optimize Market Entry – Balancing Commercial,
Regulatory and Investments to Deliver
Successful Business Models
运筹最佳上市时机 — 生物仿制药推向市场的思考与机遇

Workshop Agenda:

An overview of the challenges and opportunities in the biosimilars market
~ Tactics employed by originator companies to counter biosimilars
~ Selecting country of origin in certain market tenders to facilitate registration
~ Impact of second generation molecules being launched prior to availability of first generation biosimilars
~ Requirement and access to an EU CPP for qualification in tendering
Biosimilars in the Asian pharmerging markets, positioning and opportunities
~ China ~ Philippines ~ Bangladesh ~ India ~ Malaysia ~ Taiwan ~ Vietnam ~ Singapore ~ Hong Kong ~ Thailand ~ South Korea ~ Indonesia ~ Pakistan
What are the various market entry strategies for Biosimilars in the above markets?
Tailoring targeted launch strategies
Strategic pricing strategies used by originators to retain volume sales and reduce attraction of biosimilars
~ Implications of such actions in MENA, LATAM and APAC emerging markets
What intellectual property challenges lie ahead?
~ Potential for an Invalidation Strategy for 8,063,182 Roche patent on etanercept expiring 11/22/28
~ Cabilly II and III: An insurmountable hurdle or a reason for negotiation?
What is the recommended legal due-diligence needed before entry into pharmerging countries?
The importance of an essential drug’s list and inclusion
The acceptance by regulators of a global development programme for biosimilars to speed access to markets and harmonise requirements

Led By:

Alan Sheppard, Global Head of Generics, Thought Leadership, IMS Health
Alan has over 35 years’ experience within the pharmaceutical industry covering the full spectrum of innovative medicines, generics, biologicals, vaccines and OTC medicines. His previous career positions include Executive VP, Europe Generics, Dr Reddy’s Laboratories and VP, Global Corporate Strategy, Pliva. Alan was a long serving member of the Prescription Medicines Code of Practice Authority Appeals Board, Fellow of the Institute of Management, Member of Chartered Marketing and Fellow of the International Doctors’ Association.

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc
Co-founded in 2007, with a proven pipeline of products developed since 1984, HMP develops and licenses-out to the trade, worldwide, complex generic drug products, copy bio products and biosimilars. Rich is a member of the Editorial Board of the Journal of Generic Medicines, a member of the Licensing Executives Society and is widely published in generics and biosimilars.

Janet M McNicholas, Partner, K&L Gates LLP
Janet has headed the biotechnology patent practice at McAndrew, Held and Malloy, the Life Sciences Patent Group of Cooley Godward in Palo Alto and served as patent counsel for XOMA, a biotechnology company known as a leader in the development of therapeutic antibodies. Prior to practicing law, Janet conducted research in immunology, molecular biology, biochemistry and genetics at Stanford University and at the California Institute of Technology through a postdoctoral fellowship.