China BioPharma Congress 2009

	DAY One(Dec. 2nd) Workshop Day
AM	Workshop A: China BioPharma Regulatory Frameworks With enormous potentials, biotech industry in China has been selected by central and provincial government to attract global innovations in a bid to upgrade economic structure, however, fragmented and complex regulations has been holding back the international biotechs and investors largely. Any guideline available to improve the transparency in pricing and efficiency of regulatory processes? Any new initiatives to further improve IP protection and shorten time for clinical trials registration? What can we expect to accelerate the commercialization of new bio products in China? Will there be any incentives available in terms of tax exemption or funding support? This workshop is dedicated to the regulatory issues within biopharma development in China and will look at areas such as: 1. Current situation of pharmaceutical market in China 2. Interpreting current reforms of medical system in China 3. Brief on China’s efforts to improve the IPP and efficiency of regulatory process 4. New tax and funding incentives available to further attract global biotech innovation 5. New initiatives to accelerate the commercialization of New drugs
PM	Workshop B: Optimized Legal Practice for Cross-border Licensing of R&D and Production China is emerging not just as a drug manufacturing powerhouse but a leading source of drug discovery and innovation. Foreign big pharmas and biotech firms are looking to China as a No.1 destination for R&D, manufacturing and commercialization through licensing and collaboration. Intellectual property protection (IPP) is one of the primary requirements for licensing any patented drug manufacturing or drug R&D. IPP in China has still fallen short of western standards. With Over 1,800 novel molecules been patented in China, biotech companies in China are also keen to partner with Western companies for development and distribution of these valuable assets. How can Chinese companies prepare themselves for licensing and collaboration transactions with foreign entities? What preparations should be made by foreign companies to avoid pitfalls in these agreements? This workshop will discuss challenges faced by pharmaceutical companies in China especially issues and concerns relating to contractual agreement negotiation, patent protection, and strategies for protecting and IPRs in China. • The Basic Building Blocks of Agreements, From Simple to Complex • Advance Preparation Necessary to Properly Prepare for Negotiating an Agreement • IPR creation in China –Issues to watch out • The Terms of IP Licenses in Detail and Review Negotiating Strategies • Rules to Complete Your Deals Successfully
	DAY Two(Dec. 3rd)
0900	Registration & refreshments
0930	Welcome address by conference chairman
1000	CAPITALISING ON CHINA’S GROWING BIOPHARMACEUTICAL INDUSTRY
1030	Keynote: Globalization of China’s Biopharmaceutical Industry: Opportunities and Challenges Ahead  Regulatory updates on China’s biopharma industry  •Maintaining our competitiveness and moving up the value chains  •Positioning of China in global biopharma market  •Briefing on China’s latest R&D developments in core areas: vaccines, mabs, recombinant proteins etc  •Creating a stimulating environment for biotech fundings
1050	Panel Discussion: BioPharma’s Going-East Strategy: China-From Manufacturing Base to Innovation Center  •China VS India: crystal-balling the future of Asian biopharma industry  •Offshoring VS outsourcing: pros and cons  •Time for “In China, For China”?  •Conducting early-stage R&D in China: major concerns and challenges ahead  •Potential targets that attracts big pharmas
1120	Coffee Break & Networkings
1150	How for biotech/biopharma to gain a foothold in China’s biopharma sector? – A Legal Perspective  •How to avoid getting lost in China’s regulation frameworks  •Where and how to screen out a reliable local partners  •When is IPR creation needed and how to protect your patent portfolio  •How is partnering different in China than in the West?  •Understanding the negotiation process, the structure of the agreement and potential pitfalls  •What is optimal business model and structure in China?
1230	FOCUS ON STEM CELL RESEARCH: TRENDS AND CHALLENGES
	Panel Discussion: Looking Into the Drug Development Potential of Stem Cell Technology Big pharmas including Pfizer, GSK, AstraZeneca and Roche Holding start looking at stem cell technology as a source of new therapies, but when will be the first commercialization of stem cell-based therapy? US has removed barriers to responsible scientific research involving human stem cells at the beginning of 2009, however, what are other technical barriers holding back discovery of hESCs derived drugs? This panel will discuss the latest regulatory, ethical and technical issues in human stem cell research and commercialization.  •Embryonic Stem Cell Test in Screening of Medicine and Other Chemicals  •Regulatory, ethical and technical barriers lying ahead  •Targeted disease: What’s the most promising approach?  •Enhance intergovernmental collaboration and collaborations with research institutes  •Potentials of iPS cells for understanding personalized medicine & genetic variation and drug discovery  •Future of regenerative medicine: When will be its first debut?
1400	Chairman’s closing remarks
1430	Luncheon
1500	REGIONAL EXPANSION STRATEGY: COLLABORATION AND PARTNERSHIP
1530	Global Perspective: Shaping New Landscapes of Global Biopharma Industry through Integration and Consolidation  •How current crisis is challenging is biopharmas and biotechs  •Big pharmas’ forward integration strategy: A preferred new business model?  •Will partnership and M&A survive small biotechs?  •Looking beyond: China and India as next alternative destination for funding and reliable partners  •Cost control and enhancing efficiency through global R&D partnership networks
1550	Shifting R&D Outsourcing Strategy: From Line-centric Model to Integrated Model Big pharma/biotechs’ diffused outsourcing model, working with multiple CROs for different tasks, requires the least investment to develop capabilities and offer the ability to choose the "best-in-class" CRO for each task, however, are higher complexity and longer cycle times. After evaluating various options, Pfizer decided to shift its R&D outsourcing strategy from a line-centric model to an integrated sourcing model, which favors working with one CRO that is able to provide chemistry, biology, and ADME screening and testing services. Mr. Pan from Pfizer highlights the pros and cons of integrated sourcing model and their successful partnership with Wuxi Pharma Tech.
1620	Panel Discussion: Exploring Optimal Partnership Networks to Increase Productivity and Efficiency of R&D  •Tapping into China’s Unmet Biopharma Industry through M&A and Alliances  •Motivations driving the surge of pharma-biotech M&A s in 2009  •Bargain chips of biotechs in China and their counterparts respectively  •Risk sharing as an evolving drug development business model in China  •Framework for structuring and executing strategic alliances
1650	CUTTING EDGE BIOTECHNOLOGIES SHOWCASING
1720	Enabling Drug Discovery with Next Generation Sequencing A new generation of non-Sanger-based sequencing technologies has delivered on its promise of sequencing DNA at unprecedented speed, thereby enabling impressive scientific achievements and novel biological applications. Mr. Roderic Fuerst from Roche shares with us Roche’s cutting edge high speed DNA sequencing solution and its promising potential in accelerating drug candidate screening and discovery.
1650	Application of High-Content Screening & Analysis in Stem Cell Research High Content screening is an automated cell biology method drawing on optics, chemistry, biology and image analysis to permit rapid, highly parallel biological research and drug discovery. Mr. Ken Berger from Thermer Science shares with us the common and latest application of HCS in chemical genetics, stem cell differentiation, and, in combination with RNAi, identification & annotation of genes.
1430	Chairman’s Closing Remarks
1430	Day One Ends
	DAY Three(Dec. 4th)
0850	BIOPHARMA FINANCING AND INVESTMENT	NOVEL DRUG PIPELINE SHOWCASE This one-day parallel stream is featured with presentations demonstrating 15-20 most promising drug candidates' pipelines delivered by scientists representing biotechs, pharmas and research institutes from China and Asia.
0900	Welcome address by conference chairman
0930	Diversifying Financing Channels to Propel the Commercialization of China’s Biopharma Industry  •China’s stimulus measures to promote biological industry  •Favorable taxation and loan arrangements to boost R&D in China  •Public funding schedule available for biopharma/biotechs  •Target areas/projects of governmental funding  •Encouraging participation of VCs, private capitals and foreign investors
1000	Panel Discussion: PPP model for regional R&D innovation networks  •Necessity of government funding: Overseas cases sharing  •PP Partnership: what is the best risk and profit sharing model?  •Mechanisms exist for cost recovery / profit  •Extending Capability through Pre-competitive Networks  •A Regional Network Model to promote local innovation	NOVEL VACCINES AND ADJUVANTS
1030	Coffee Break & Networkings	HUMANIZED MONOCLONAL ANTIBODIES
1050	The Role of Philanthropy and Partnerships in Global Health  •The mission and objectives of the Gates Foundation  •The structure of the organisation  •The areas of focus of the Foundations activities  •The various partnership models for engaging with the Foundation	HUMANIZED MONOCLONAL ANTIBODIES
1120	investors’ panel: How the Financial Crisis is Reshaping the Global Landscape of Biopharma Investment? Is It Accelerating the Rising of China and Asia? What to Expect in 2010?  •Impact of the financial crisis on global biopharma investments  •Weighing returns against risks: what are the major risks?  •Identifying novel technologies as potential investing targets in China  •Biotech firms’ optimal financing strategies and alternative financing options  •Exit strategy available in China and beyond	RECOMBINANT DNA DRUGS
1150	Chairman Closing Remarks	RNAi & DRUG DISCOVERY POTENTIALS
1230	Luncheon
	DEVELOPING AND MANUFACTURING BIOSIMILARS IN CHINA
1400	Overcoming the challenges in developing biosimilars in China  •Current status and upcoming trends in biosimilars development in China  •Analysing the differences between biosimilar protein therapeutics and biosimilar antibody therapeutics  •What are the challenges of biosimilar research and development at pre-clinical and clinical stages?
1430	Biosimilars regulatory issues in US: When will the road be clear?  •Current status and development of biosimilars regulation in US  •What does the US FDA really think?  •Technical challenges for the approval of biosimilars  •What is the next step after the approval of Omnitrope?
1500	Best practices in securing EMEA approval for your biosimilars  •Overview of the development of EMEA guidelines on follow-on biologics  •Procedures for the registration of your biosimilars in EU  •Managing the requirements for comparability assessment, non-clinical and clinical data
1530	Coffee Breaks & Networkings
1600	Panel discussion: Just how lucrative is the biosimilars business as compared to that of innovative biologics?  •Evaluating the cost of producing generic biologics versus innovative biologics  •With the highly extensive characterisation studies required and lengthy approval time, what is the profit margin for biosimilars?  •How much ROI can biomanufacturers achieve from producing and marketing biosimilars?  •What are the strategies that be adopted to enhance economy?
1630	Chairman Closing Remarks
1640	Close of Conference