wei zhang · event background – ignore china at your own risk! the new healthcare reform has put...

PBPF2010 – China’s Definitive Event Forging Pharma - Biotech - Academia - CRO Worldwide Partnerships! Join our Pioneer Forum to Speak your Mind and Take your Partners!

• Exploring the new R&D metrics in post-blockbuster era• Adapting to China’s evolving pharmaceutical and biotech/bioservice market

• Examining the latest trends in partnering & licensing deals in specialty Asia markets such as China, India, Japan, Malaysia, etc • Creating successful M&A and strategic alliances in global partnerships and capturing the anticipated value• Screening, evaluating, negotiating, implementing the right external innovation opportunities and effectively managing IP• Unlocking value of co-development, co-commercialization and clinical trial opportunities for oncology • One-on-one business meeting based on your WISHING LIST, taking away with the latest edition CRO booklet

Organizer :

Frank Jiang, M.D., Ph.D.

Sanofi-aventis

Wei ZhangDirector General,Department of Drug RegistrationState Food and Drug Administration (SFDA)

Mace Rothenberg, M.D.

Senior Vice President, Clinical Development and Medical Affairs

Pfizer Oncology

Senior Vice President & Oncology Franchise Head

Merck & Co Inc.

Lily Lee, Ph.D.

Senior Vice President , Head of Pharmaceutical R&D Asia

Johnson&Johnson

Gary Gilliland, M.D.

Vice President, Head of Asia Research & Development

International Marketing Partner:

Bradley Marchant, M.D.Executive Director, Head of Clinical Development Asia, Emerging Markets

Pfizer

Venturing into new scientific and therapeutic areas such as biomarker & personalized medicine, next generation antibody therapies and more

•

Amgen

Roger Perlmutter, M.D., Ph.D.Executive Vice President, Research and Development

Endorsers:

Exclusive Law Firm Sponsor:

Presentation Sponsors:

Exhibiting Sponsors:

Showcasing CROs:

Big Pharma’ s latest initiatives for biotech innovation

Last year ended with a frenzy of new drug deals, and big pharma’s appetite for new deals continues to grow in 2010.

"The world economy is recovering, and so is China;The world bio-pharma industry is advancing, so is China."

Who should attend?Presidents, Vice Presidents, Directors, Senior Managers, Managers and Scientific Officers in charge of:

Global Licensing / Business Development / Corporate Strategy / Strategic Alliance / Mergers and AcquisitionsResearch & Development / External Innovation / External Research / Global Sourcing Clinical Trials / Pre-clinical DevelopmentIntellectual Property & PatentsSales and Marketing

This is a must-attend event for all top level executives and decision makers who are involved in pharma R&D, outsourcing and long term growth strategy: We anticipate forum participants and presenters representing a broad array of institutions, with the largest number of delegates from multinational pharmaceutical & life sciences companies, biotechs and CROs. Geographically, besides the delegates from Mainland China, a large number will be traveling from other Asian countries (Japan,Taiwan, India, Singapore, Australia, Korea, Malaysia, Thailand, Philippines), Europe, and the United States. This diversity will allow a strong exchange of opinions and ideas.

Better researched program, higher profiled speakers, more dedicated organizers!

Event Background – Ignore China at your Own Risk!

The new healthcare reform has put China in the spotlight. China's pharmaceutical market capacity is projected to exceed 310 billion RMB by 2011 and $220 billion by 2020, overtaking France, Germany, Japan to become the second largest following the United States. The Chinese central government continues to push through reform and encourage pharmaceutical innovation to meet healthcare demand growth. The preferential drug pricing policies for innovative drugs and tax incentives also support China in becoming a world R&D base. China is uniquely positioned to compete in the global innovative medicines industry.

Biopharma Leading the Pack China’s biopharma industry is entering its “Golden Age” and the primary drivers will be antibodies, vaccine and protein therapeutics. In June 2009, the State Council issued several policies of accelerating the development of bio industry in China and pointed out that the biopharma field is the vital one for the development of modern biotechnology. NDRC arranged additional 442 million yuan RMB central investment to support biological medicine, bio-breeding, the construction of special biomedical engineering high-tech industrialization project and special construction project of national biological industry base conditions for public service. The Chinese central government plans to continue investments in the biopharma sector to help it become one of the leading industries in China by 2020.

Growing Importance of CROs

Bioservice is another fast-rising segment in the Chinese biopharma industry. Currently there are several hundred CROs operating in China offering integrated or specialized services and China's CROs devoted to late-stage research will boom along at an 18% annual growth rate, with revenue projected to grow from $145 million to $240 million by 2012. Increasingly, CROs are evolving from one-off study vendors to become viable, strategic long-term partners in tune with the goals and objectives for companies both big (to help improve productivity) and small (to help maximize licensing opportunities by achieving proof-of-concept without high infrastructure costs). The role of CROs as a regulatory resource has also grown significantly due to the current regulatory landscape in China.

Rising Licensing & External Innovation Partnership OpportunitiesNew drug discovery is increasingly important, but the R&D process has never been more complex. Big pharma's thirst for external innovation is set to persist amidst the blockbuster drought. Also global economics, market pressures from payers and patients and a need to reduce internal infrastructure costs are forcing pharmaceutical companies to seek more international technology transfer and cross-border licensing opportunities. Technology transfer, especially licensing and cooperative development, has become a vital business development strategy for pharma industry. The Chinese Government is also making great efforts to support technology transfer and promote technological innovation. The Provisions for Registration of Drug Technology Transfer effect from August 19, 2009 will bring along a new wave of technology transfer in China. Greater Genetic Competition

Although the Chinese Government is taking initiatives to create a regulated market for fair competition of generics and innovative medicines, China’s pharmaceutical market is still generics dominated with over 5,000 generic companies. Expiring patents are even a bitter pill for big pharmas. A record number of drug patents will expire over the next few years, which should heighten competition from generic drugs and force down prices. In 2011, $58 billion of sales are at risk from patent expiries.

Centered around the topic of "New R&D Metrics", PBPF2010 will track various focus points on open innovation and licensing opportunities, preclinical and clinical developments, biomarker & personalized medicine, next generation antibody and protein therapeutics, and point to the best opportunities for R&D partnering & outsourcing, providing you with the unique platform to review, examine and take advantage of these key issues. It will also help to fuel your company's dynamic growth in China.

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Bring your Team to Make the Most of the Event & Get Big Discounts on Registration !

Evolving Pharmaaceutical Market

To register, please visit www.genviews.com Phone: (8621) 6651 1606 Email: [email protected]

07:30

08:30

Where is China’s pharmaceutical and biotechnology/bioservice industry headed under new healthcare reform? China’s expanding role in global drug discovery and development and contributions to global biotech industryMNCs doing business in China: addressing the regulatory, clinical and reimbursement issuesThe internationalization of novel drug: unique US-China opportunities

Sino-American Pharmaceutical Professionals Association (SAPA)

09:00 Opening Keynote Speech: Meeting Future Medical Needs with Open InnovationGiven greater complexity of the next-generation drugs & therapies, companies’weak internal pipelines and stagnant R&D spending, big pharmas are looking outside of companies for innovation and actively collaborating with biotechs or academics on promising compounds and innovative technology platforms. External partnerships will be important for developing innovative drugs moving forward.

Examining evolution and challenges of big pharmas’R&D metricsComparing different models for approaching innovation in ChinaHow external innovation and partnership boost novel drug development?

MODULE ONE: NEW R&D METRICS AND OPEN INNOVATION

Unlocking value of novel drug co-development, co-commercializationLooking outside: what are the new opportunities in open innovation?

Lily Lee, Ph.D.Senior Vice President, Head of Pharmaceutical R&D AsiaJohnson & Johnson

09:30 Screening, Evaluating, Negotiating and Implementing the Right External Growth Opportunities

What’s the key criteria for evaluating external partners?

How to effectively assess and mitigate collaboration risks?How to successfully negotiate the partnership and structure the deal?How to increase productivity, speed and efficiency in your external innovation program? Walking the tightrope of trust, motivation and control with external partners

Frank Jiang, M.D., Ph.D.Vice President, Head of Asia R&DSanofi-aventis

10:30 Coffee & Refreshments - Speed Networking Break

11:00 Partnering to Accelerate Cancer Research in Asia Merck together with Eli Lilly and Pfizer are pulling together to accelerate research on Asia's most common cancers by forming the Asian Cancer Research Group, a “pre-competitive collaboration” devoted to sharing resources and expertise. Profit can't be far from the trio's motives: lung and gastric cancers. In this presentation, Gary will talk about how to leverage on external innovation and partnership to accelerate cancer research and drive future robust growth of oncology business in Asia.

Asia as the emerging pharmaceutical R&D hub with abundant scientific resourcesThe Asia dimension: opportunities for strategic alliances and partnerships

Assembling an IP landscape for the external innovation and map the associated IP

Obtaining and leveraging on best IP data to find the best partner

12:30 Luncheon

Registration-Coffee & Tea

Meet... Move on... meet... move on... meet!Exchange business cards with fellow forum participants and industry peersDon’t forget to bring lots of business cards, a box or two will do!

12:00 Managing IP in External Innovation Partnerships and LicensingNowadays big pharma’s interest of external partnering and licensing is mounting, however, for external innovation partnerships and licensing deals to work, companies need to have a solid, yet agile IP strategy in place. This session will help you receive the required skills and tools to protect your intellectual property in your global external innovation partnering and licensing activities.

Using systematic tools before, during and after an external innovation partnershipSpecific considerations for IP protection of branded biologic productsManaging confidential information and trade secrets in cross boarder licensing transactionsEffective strategies for patent linkage, patent enforcement and patent litigation

Sponsored by:

Accessing best-in-class science via more flexible, less risky partnerships across AsiaCase study of Merck-Eli Lilly-Pfizer alliance on cancer research

Simultaneous Global Drug Development: What Does it Mean for China?

11:30

Selecting Asian partners into global external innovation program

Global biopharmaceutical industry embracing its“golden age”The trend of globalized biotech R&D International cooperation opportunities for biopharmaceutical and clinical diagnosis techniques innovation

AGENDA DAY ONE – THURSDAY, SEPTEMBER 16, 2010

Gary Gilliland, M.D., Ph.D.Senior Vice President, Head of Oncology FranchiseMerck Research Laboratories

Bradley Marchant, M.D. Head of Clinical Development Asia, Emerging MarketsPfizer

10:00 Tapping Global Innovation - Unveiling Current and Future Biopharmaceutical Development Strategies

Roger Perlmutter, M.D., Ph.D.Executive Vice President, Research and DevelopmentAmgen


14:00

MODULE TWO: LATEST TRENDS IN R&D PARTNERING AND LICENSING DEALS

Wei ZhangDirector General, Department of Drug RegistrationState Food and Drug Administration (SFDA)

14:30 Innovation Partnering in Asia: Aligning with the Changing Pharma/Biotech Landscape

Big Pharma’s evolving alliances strategies and appetite for biotech acquisitionsReviewing the realistic benchmarks for future licensing around the industryWhat therapeutic areas have high commercial value, promising for licensing deals? Examing the early or late-stage licensing deal prospects Rising in-out licensing opportunities across Asia

The changing paradigm of Asia strategic alliances deal flowHow to improve partnering capability across Asia?

How to build a strong oncology business in Asia through strategic alliances?

Richard Wang, Ph.D.Director, Strategic Alliance Asia &Portfolio and Operation ManagementInnovation Center ChinaAstraZeneca Global R&D

15:00 New Dynamics of Strategic Alliances in Asia: Where are Big Pharmas all Going?

The regulatory hurdles and other major challenges facing Japanese pharmaceutical industry

15:30 How Japanese Big Pharmas Restore Robust Growth by Implementing Overseas M&A and Licensing Strategies?

How are Japanese big pharmas positioned for regional and global competitions?What is Takeda seeking from partnering and licensing?Sealing the right deal with the right partner at the right timeValue estimation of bio-medical patents from licensing deals

18:10 Luxury Cocktail Party

18:00

Government’s role and initiatives to boost drug innovation in ChinaLatest updates on drug registration regulations- Drug registration policy - Classification of drugs - Drug registration application - Application documents for new drug registration - Technical review guidance for registration documents - New drug registration process - OTC new drug registration process - New drug registration statistics - Classification of combination drug-device products - New regulatory changes<Provisions for Registration of Drug Technology Transfer>: impacts & implications to domestic & MNC pharmaceutical companies Responding to the industry needs: What’s in the pipeline for regulatory improvements?

- Academia partnering- Biotech partnering- Diagnostic partnering

Overseas M&A strategy: key pre-acquisition due diligence procedures to increase the probability of successCreating value through a smooth merger integration

Frank Grams, Ph.D.Executive Director Roche Pharma Partnering, Asia

How to successfully structure and negotiate China specific partnerships?

Toshikazu BanGeneral Manager, Global BD & Licensing Takeda Pharmaceutical Company Ltd

AGENDA DAY ONE – THURSDAY, SEPTEMBER 16, 2010

16:00 Coffee & Refreshments

Targeted cancer therapies have achieved phenomenal growth and many mAb-based therapies have demonstrated superior patient benefits while at the same time becoming blockbuster products. In the next 20 years, mAbs will continue to play an exciting role as the backbone of individualized combination therapies that will redefine cancer diagnosis and treatment. In this presentation, Doug will focus on how to make this vision a reality through partnering among big pharma, biotech and academia. This partnering will be key in providing novel mAbs that

Douglas F. Hager, Ph.D.Vice President, BD & Licensing, Global OncologyNovartis Pharmaceuticals Corporation

16:30

Gaining a Clearer Perspective into Partnering & Licensing Opportunities of Therapeutic Antibodies for Cancer

One-on-one business meetings based on your WISHING LIST

Christoph Geserick, Ph.D. Director of Innovation Management, Global Drug DiscoveryBayer Schering Pharma

17:00

Case Study of Bayer Schering Pharma’s Early Stage Partnering Strategy

Ying Luo, Ph.D.Chairman and General ManagerShanghai Genomics

17:30

Co-Development of Novel Therapeutic Products in China -- A Chinese Biotech Company’s Partnering Perspective

Are the foundation of individualized therapeu ticsolutions that are both effective and well toleratedProvide a basis for effective new antibody drug conjugatesDraw upon the vigorous innovative spirit of researchers in AsiaFocus on therapies for cancers distinctively common in Asia


08:00 Registration – Coffee & Tea

MODULE THREE: VENTURING INTO NEW SCIENTIFIC AND THERAPEUTIC AREAS

09:30

What are the Challenges and Opportunities of Antibody Drug R&D and Commercialization in China?

China’s emerging role as an innovative anti-cancer drug R&D hub

How to capture growth in China’s new wave of biotech boom?

Insights into CPGJ’s mAb R&D and commercialization plan

10:30

Keeping Abreast with Fully Human Monoclonal Antibody Technology Advancements

Using biomarkers to accelerate drug development

Li Chen, Ph.D.Chief Scientific OfficerRoche R&D Center, China

12:00 New Frontiers in Biomarker and Drug Development

Implementing biomarker & personalized medicineEffectively translating biomarkers into diagnostics

12:30 Luncheon

Yajun Guo, ProfessorDirector, SMMU Cancer Institute, National Engineering Research Center for Antibodyedicine, PRC Chief Scientific Adviser, CPGJ


08:45

11:00

Coffee & Refreshments

14:00 Strategic Dialogue I: How to Effectively Rise to Innovative Drug Discovery and Preclinical Development Challenges?

MODULE FOUR: INNOVATIVE DRUG DISCOVERY AND CLINICAL TRIALS OUTSOURCING OPPORTUNITEIS IN ASIA

Major drivers and challenges for innovative drug discovery and developmentHow CROs can help in innovative drug discovery and preclinical development?

Selecting relevant tools for high throughput screening and preclinical testing

Integrating scientific processes with regulatory & business requirements

Quintessential steps after lead candidate identification

Application of biopharmaceutics to prototype formulation designApplying principles of pharmaceutical GXP to ensure compliance

Speakers include:

Ling Su, Ph.D. Vice President, Clinical Research & Development, Asia PacificWyeth, a Pfizer company

Chengming Gu, M.D., Ph. DMedical Affairs Director, Asia PacificBaxter BioScience

Xiaochuan Wang, Ph.D. Chairman and CEOSundia MediTech Company, Ltd

Yun He, Ph.D.Senior Vice President & Chief Scientific OfficerBioduro, a PPD Company

Welcome Address:

09:00

10:00

Emerging Opportunities for the Treatment of Chronic Diseases

AGENDA DAY TWO – FRIDAY, SEPTEMBER 17, 2010

Zhinan Chen, Professor Director, Cell Engineering Research Center, Department of Cell Biology The Forth Military Medical. University

Speech opportunity available *

Tina Huang, Ph.D. Senior Vice President, Operation, Preclinical Services Pharmaron

Immunology, immunogenicity, cell and molecular biology

Interactive Panel Discusstion: Next Generation Antibody Therapies - How Emerging Technologies Will Transform Antibody R&D

Genetics, proteomics, epitomics, system biology for antibody discovery Hybridoma technology and antibody gene manipulationNanosensors, microarray, biochips and cytokine antibody arrays Generation of immune and synthetic libraries, and high throughput screening

Antibody conjugates, fragments, novel adaptors and molecular scaffolds Nanotechnology and drug delivery technologies of antibodies

Panelists TBA *

Antibody imaging, labeled antibodies and radioimmunotherapy

Collaborative efforts in biomarker development

Module Chairman:

Jingsong Wang, M.D.Director of Immunology, Discovery Medicine & Clinical PharmacologyBristol-Myers Squibb

Examining the application trends of diagnostics & molecular biomarkers


14:45

Strategic Dialogue II:21st Century Medicines and the Personalized Medicine Opportunity

Translational medicine helps to improve decision-making during drug development and in the clinic. This session will provide insight into technological advancements spurring the discovery of new biomarkers such as genes, proteins, and metabolites. Translational approaches to biomarker identification and qualification for use will be presented. Experiences with human clinical trials that implement pharmacogenetic biomarkers of safety and efficacy will be described.

15:15

Translational Medicine: Accelerating Compounds to the Clinic

16:00 Coffee & Refreshments

The patent of Lipitor and many other top earning drugs will expire in 2011. The traditional blockbuster strategy must be combined with a model based on targeted therapeutics in order for profitability to continue. Personalized medicine represents such paradigm shift from “blockbuster” to the direction of the right treatment for the right patient, opening the possibility of new approaches to drug development as well as unleashing the potential of significantly more effective diagnosis and therapeutics. Biomarkers that support personalized molecular medicine develop patient-specific tests that predict and monitor the effectiveness of treatment and can identify the recurrence of disease. Our panel of experts will highlight the most exciting scientific endeavor in the areas of biomarkers and personalized medicine and opportunities this new paradigm presents.

The stirring paradigm shift towards personalized therapeutics

17:00 Strategic Dialogue III: Key Success Factors for Conducting Oncology Clinical Trials in AsiaWith the oncology market now valued at $55 billion, pharmaceuticals and biotech manufacturers are under pressure to find innovative ways of speeding development times in order to claim their share of this lucrative area. However, oncology trial complexity can waste invaluable resource and slow regulatory approval. Our panel of experts will address the unique patient recruitment, trial design, project management and operational challenges during oncology trials with an emphasize on Asia sites and practical solutions put forward for your benefits.

Planing and selecting Asian countries into your global oncology clinical studies

Improving patient selection & retention and investigator recruitment strategies for your oncology trials

Implementing regional know-how for conducting oncology trials in Asia: planning, training, and partnership

Smarter design and project management to keep your oncology trials on trackOvercoming operational challenges in large phase III/IV oncology trialsEffective data collection and management to facilitate oncology trials regulatory approval processes in Asia

Speakers include:

Mace Rothenberg, M.D.Senior Vice President of Clinical Development and Medical Affairs Pfizer Oncology

Challenges and opportunities in capturing growth in personalized medicine marketBuilding effective partnerships for the development of personalized medicineDigital pathology and advanced biomarkers paving the way to personalized medicineApplying genomics/pharmacogenomics biomarker tools for discovery/clinical studiesAddressing the unique biomarker opportunity in oncology

Speakers include:

Michael Shi, Ph.D. Director of Biomarker, OncologyNovartis Pharmaceuticals Corporation

Frank Zhang, Ph.D.Co-founder and CEOGenScript Corporation

Daniel Lee, Ph.D.Senior DirectorNeurodegeneration Research & Translational MedicineGlaxoSmithKline (China) R&D Co., Ltd.


16:30

Mace Rothenberg, M.D.Senior Vice President of Clinical Development and Medical Affairs Pfizer Oncology

17:45

18:00 End of PBPF2010

Personalized Therapies and Best Clinical Practices for Lung Cancer

Taiping Chen, Ph.D.Executive DirectorCrown Bioscience, Inc.

Emily Tan Executive DirectorPharmaNet Development Group, Inc.

Global bio-pharmaceutical R&D challenges & solutions aiming to reduce time to market and cost

Jinhua WangSenior Director, Clinical Operations Head,GCO-MAO Asia PacifcGlobal Clinical Operations, Johnson & Johnson

Christopher UngVice President, Strategic Business and Operations, OncologyQuintiles

Jeffrey Kasher, Ph.D. Vice President and COO Global Clinical DevelopmentEli Lilly and Company

AGENDA DAY TWO – FRIDAY, SEPTEMBER 17, 2010

wei zhang · event background – ignore china at your own risk! the new healthcare reform has put...

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