• The future of Asia’s biomedical industry in an era of globalization
• Cost pressure and heightened competition: Will Asia surpass the others to become a major production giant?
• Challenges that Asia faces in narrowing gaps in biomedical knowledge, and business expansion strategies for the region

• From an industrial enzyme company to a fully integrated biopharmaceutical company with strategic research initiative, how has Biocon’s business model evolved over the years to achieve leading biotech status?
• What’s keeping Biocon ahead of the competition?
• Is contract service a new diversified segment of business growth for Biocon?
• How do you see the current challenging economy impacting Biocon’s strategy?
   

• Biomedical science triumphs to business success – How long is the way to go?
• Will Asia be a future powerhouse for new technology and drugs for the world?
• How the recent major science breakthroughs will reshape the biomedical industry?
• Developing a talent strategy for more scientific-business hybrid minds

• The past, present and future of biomanufacturing
• Challenges and opportunities of biomanufacturing
• Leadership fundamentals for biomanufacturing
• East vs West: The culture differences

• Overview of operation excellence initiatives to enhance plant performance and flexibility
• Case studies with LEAN principles applied to biopharmaceutical manufacturing activities
• Organisational changes for optimal support to the products
• Next step - Beyond LEAN

• Quality-by-Design is a scientifi c risk-based framework to support innovation and effi ciency and can be applied to biotechnology development and manufacturing
• Quality-by-Design strategies include risk management formal experimental design and PAT
• FDA has a pilot program to develop a regulatory approach to Quality-by Design submissions for biotechnology products

• Current trends and status of QbD in process development and biologics manufacturing
• Adopting QbD the “smart” way - When and how much should you invest in QbD?
• Strategies to maximise process effi ciency and minimise cost in QbD integration

• Facility scope and design basis
• Incorporating process fl exibility and advances in technology
• Capital project execution model for building a facility in Asia
• Procurement strategies: Comparison of costs in Singapore to other areas of the world
• Innovative solutions to overcome project challenges

• Utilisation of advanced energy-saving technologies n lighting, heating, cooling, ventilation and biomanufacturing process systems and the potential costs reduction
• Adopting sustainability measures in the building of plant facility through incorporation of the LEED system
• Integrating energy-effi cient designs right from the very beginning
• Measuring the softer benefi ts for employees by investing in green buildings

• The importance of reduced development timelines to cope with the expanding early-stage pipeline
• High throughout approach to increase screening efficiencies and to enable selection of high-producing cell lines
• Optimising cell culture conditions to generate stable cell lines
• Understanding the changes in cellular expression physiology and cellular growth characteristics with increasing cell generations

• Assessing the impact of process parameters on glycoform distribution and product’s potency
• Discussing factors that contribute to glycosylation variability
• Suggestions to control glycosylation variability and ensure manufacturing consistency

• An introduction to yeast and fungal expression systems and protein engineering technologies
• Albumin fusion technology for the fl exible production of therapeutic proteins with extended circulatory half-life

• Addressing the need for chemically defined media formulations are the ultimate goal in biopharmaceutical production
• Current challenges associated with their development
• Use of peptone supplementation in order to achieve protein yields
• Insight to the modulators of performance and a pathway toward the development of chemically defined media supplements

• Analysing the variable factors that affect capacity requirement
• Solutions to increase downstream capacity
• Creating robust downstream processes to achieve efficiency and economy

• Addressing challenges for downstream processes due to high titer mAb production by the current mammalian cell culture systems
• Case study of a dynamic process with a full integration with upstream superior benefits
• Future applications

• Development timelines have shrunk due to increasing number of molecules in pipeline and speed to clinic paradigm
• Importance of platform processes and harmonized approaches
• Downstream yield as a cost driver: Efficient platform process enhances facility fit optimization while delivering good product quality
• Process characterization is the focus during late stage development

• Considerations in adopting single-use technology
• The challenges in implementing disposable systems for antibody manufacturing
• How does that affect the production process and the resulting yield?

• The extent of disposable technology implementation in manufacturing and the associated costs
• Evaluating the cost impact of disposables in broader aspects - Plant design, operation, compliance, capital investment and time-to-market
• How do we decide if it is worth investing in single-use technologies?

• What drove Genentech to set up a manufacturing plant in Asia: Market, cost, or both?
• Several years ago, Genentech set out a series of goals for product development, called the 5x5 strategy. Genentech is currently ahead of schedule for meeting these goals. What is the reason for its success
• Looking forward to 2010 - What are some of the things that will shape the industry and competition?

• How will the credit crunch affect R&D strategy in the pharmaceutical industry?
• How do you see the R&D business model/strategy evolving in the pharma industry under the current economy?
• How has Novartis restructured its R&D model to address challenges from increasing cost and unmet efficiencies? What are the implications?
• Novartis has set up an NITD in Singapore, an R&D centre in China and a manufacturing plant in Singapore. What is Asia’s role in Novartis’ global growth strategy?

•  How Takeda’s business model has evolved over the years
• How has Takeda’s recent investment and buyout strategies affected its overall business portfolio and commercial performance?
• With all the pharmas looking south, what’s Takeda’s strategy for its business expansion in Asia?

• The future of Asia’s biomedical industry in an era of globalization
• Cost pressure and heightened competition: Will Asia surpass the others to become a major production giant?
• Challenges that Asia faces in narrowing gaps in biomedical knowledge, and business expansion strategies for the region

• From an industrial enzyme company to a fully integrated biopharmaceutical company with strategic research initiative, how has Biocon’s business model evolved over the years to achieve leading biotech status?
• What’s keeping Biocon ahead of the competition?
• Is contract service a new diversified segment of business growth for Biocon?
• How do you see the current challenging economy impacting Biocon’s strategy?

•  Biomedical science triumphs to business success – How long is the way to go?
• Will Asia be a future powerhouse for new technology and drugs for the world?
• How the recent major science breakthroughs will reshape the biomedical industry?
• Developing a talent strategy for more scientific-business hybrid minds

• Evaluating the impact of globalization on the growth of the pharmaceutical industry in Asia
• How are the R&D partnership models of multinational pharma changing with growing innovation capability and scientific talent in Asia?
• How will the increasing number of R&D and licensing partnerships between western companies and Asia biopharm companies drive the global gravity shift to Asia?

• Making a wise R&D partnership decision: When, where, with who and how?
• Conducting R&D in Asia: Challenges and opportunities
• Comparing China, India, Singapore and South Korea for R&D operation sites
• Evaluating return on investment for each of the various different partnership models
• Significant R&D milestones achieved through R&D partnerships in Asia

• Market access challenges and market penetration strategies
• The talent war: How to attract talent with management skills and scientific background
• How is the major pharmaceutical business model changing with rising affluence in emerging markets like China and India?

• Private Public Partnerships (PPP) in Asia: Using Novartis Institute of Tropical Diseases as an example to describe how such partnerships address development of drugs for neglected diseases, particularly for developing nations
• A fully integrated R&D Center for pharmaceutical research in Asia: Approach, objective and outcome of partnerships in Asia
• Future direction of Novartis pharmaceutical research in Asia: To enter untapped markets with unmet medical needs

• Venturing - An imperative in the modern pharmaceutical industry?
• The “Bio” - “Pharma” symbiosis
• Creating win-win outcomes through Pharma Corporate Venturing

• Strategic approaches to building a strong pipeline of innovative drugs to gain competitive edge in the global market place
• Maximising R&D productivity and quality through developing complementary strengths within and between partners
• Existing partnerships with emerging biomedical players in Asia: Where are the emerging opportunities for strategic partnerships?

• Building a pool of entreprenurial talents in Asia to drive research commercialisation into product development
• Optimizing partnerships and strategic alliances
• Early stage investing opportunities for life science investors

• Biotechnology and academia capabilities in Korea
• Funding and initiatives in promoting partnership between industry and academia
• Biomedical science business environment in Korea

• Funding talent nurturing and building business environment for biomedical sciences in India
• How to manage intellectual property generated from research partnerships with academic centers in India
• Where are the partnership opportunities?

• China biomedical sciences academia capabilities
• Current academia and industry partnership in China
• Where are the partnership opportunities in China?

• Industry re-engages with academia for drug discovery and development
• Partnership models between multiple collaborators to promote IP sharing
• “Industry ready” systems can be achieved in academia

• What drove Genentech to set up a manufacturing plant in Asia: Market, cost, or both?
• Several years ago, Genentech set out a series of goals for product development, called the 5x5 strategy. Genentech is currently ahead of schedule for meeting these goals. What is the reason for its success?
• Looking forward to 2010 - What are some of the things that will shape the industry and competition?

• How will the credit crunch affect R&D strategy in the pharmaceutical industry?
• How do you see the R&D business model/strategy evolving in the pharma industry under the current economy?
• How has Novartis restructured its R&D model to address challenges from increasing cost and unmet efficiencies? What are the implications?
• Novartis has set up an NITD in Singapore, an R&D centre in China and a manufacturing plant in Singapore. What is Asia’s role in Novartis’ global growth strategy?

• How Takeda’s business model has evolved over the years
• How has Takeda’s recent investment and buyout strategies affected its overall business portfolio and commercial performance?
• With all the pharmas looking south, what’s Takeda’s strategy for its business expansion in Asia?

•  The future of Asia’s biomedical industry in an era of globalization
• Cost pressure and heightened competition: Will Asia surpass the others to become a major production giant?
• Challenges that Asia faces in narrowing gaps in biomedical knowledge, and business expansion strategies for the region

• From an industrial enzyme company to a fully integrated biopharmaceutical company with strategic research initiative, how has Biocon’s business model evolved over the years to achieve leading biotech status?
• What’s keeping Biocon ahead of the competition? 
• Is contract service a new diversified segment of business growth for Biocon?
  • How do you see the current challenging economy impacting Biocon’s strategy?
   

• Biomedical science triumphs to business success – How long is the way to go?
• Will Asia be a future powerhouse for new technology and drugs for the world?
• How the recent major science breakthroughs will reshape the biomedical industry?
• Developing a talent strategy for more scientific-business hybrid minds

• What motivates Western pharma and biotech companies to move drug development to Asia
• Are there preferred countries and why?
• How do regulatory agencies in US, EU and Japan look at this development?
• Is there more to placing clinical development in Asia?
• Strategies for global growth

• Cost breakdown in performing clinical trials in Asia versus US and Europe - How great are the differences?
• Analysing which countries are rising in cost and which are delivering consistent return on investment
• Identifying high-cost areas and discussing short and long term strategies to minimise these expenses
• Impact of availability of trained staff and patient recruitment on cost budget
• Is Asia losing out on cost-effectiveness?

• The checklist for choosing CROs in Asia Pacific
• Assessing the pros and cons of engaging local CROs
• Comparison between local and international CROs
• Where and when should you partner local CROs?

• Analyzing the different needs of a small biotech versus big pharma
• What should a small biotech consider in selecting a CRO?
• Partnership model and case study

• Analyzing the different needs of a small biotech versus big pharma
• What should a small biotech consider in selecting CRO?
• Partnership model and case study

• Challenges in transiting to paperless clinical trials and how best to start implementing it
• Evaluating the advantages of using EDC and analysing the return on investment
• Validation of an EDC system

• Analysing the cost of investing in data management system versus outsourcing
• When should sponsors outsource data management?
• What do sponsors look out for in outsourcing data management? What do they expect from the service providers?

• Electronic Data Capture uptake in Asia
• Trial build and deployment
• Interfacing solutions, Site setup and support
• End user training

• Learnings from running Clinical Trials in Asia 1995 to 2008
• The opportunity before us and the challenges
• Changing the patient, the site and the trial monitoring paradigm by 2011

• Challenges in performing clinical studies in India
• Upholding ethical standards in India - Obtaining proper informed consent from Indian patients
• Addressing IP protection issues and the impact on India’s clinical development

• Navigating the regulatory approval process
• Developing investigational sites and internal clinical research professionals
• Sustaining competitiveness in global drug clinical development

•  Pros and cons of conducting clinical trials in Taiwan
• With a well-developed clinical research system already in place, how can we further expedite and improve the efficiency of studies conducted in Taiwan?
• Conducting clinical trials in a changing society

• Current status and development of Eisai’s global clinical research
• How does the clinical research industry in Japa compare to other Asian countries?
• Challenges in moving clinical studies to emerging

• Overcoming language and cultural barriers in IND and NDA applications
• Utilisation of foreign clinical data and challenges in bridging studies
• Positioning Korean trials in global studies

• Best strategies to conduct efficient clinical trials in Philippines
• Dealing with long application timeline
• Leveraging on the country’s developed medical facilities and infrastructure to enhance study performance

• Current status and development of clinical research industry in Vietnam
• Challenges in performing clinical trials in Vietnam
• Due diligence and lessons learnt

• Procedures in getting approval and conducting clinical studies in Thailand
• Site profile and consideration factors
• Challenges in conducting clinical trials in Thailand

• What drove Genentech to set up a manufacturing plant in Asia: Market, cost, or both?
• Several years ago, Genentech set out a series of goals for product development, called the 5x5 strategy. Genentech is currently ahead of schedule for meeting these goals. What is the reason for its success?
• Looking forward to 2010 - What are some of the things that will shape the industry and competition?

• How will the credit crunch affect R&D strategy in the pharmaceutical industry?
• How do you see the R&D business model/strategy evolving in the pharma industry under the current economy?
• How has Novartis restructured its R&D model to address challenges from increasing cost and unmet efficiencies? What are the implications?
• Novartis has set up an NITD in Singapore, an R&D centre in China and a manufacturing plant in Singapore. What is Asia’s role in Novartis’ global growth strategy?

• How Takeda’s business model has evolved over the years
• How has Takeda’s recent investment and buyout strategies affected its overall business portfolio and commercial performance?
• With all the pharmas looking south, what’s Takeda’s strategy for its business expansion in Asia?

This year’s opening keynote session will feature Asia’s industry top mind and legendary woman entrepreneur Kiran Mazumdar-Shaw from Biocon and Nobel Laureate Kurt Wüthrich to share their perspectives on the biomedical business and science in Asia and around the world.

• The future of Asia’s biomedical industry in an era of globalization
• Cost pressure and heightened competition: Will Asia surpass the others to become a major production giant?
• Challenges that Asia faces in narrowing gaps in biomedical knowledge, and business expansion strategies for the region

• From an industrial enzyme company to a fully integrated biopharmaceutical company with strategic research initiative, how has Biocon’s business model evolved over the years to achieve leading biotech status?
• What’s keeping Biocon ahead of the competition? 
• Is contract service a new diversified segment of business growth for Biocon?
• How do you see the current challenging economy impacting Biocon’s strategy?
   

• Biomedical science triumphs to business success – How long is the way to go?
• Will Asia be a future powerhouse for new technology and drugs for the world?
• How the recent major science breakthroughs will reshape the biomedical industry?
• Developing a talent strategy for more scientific-business hybrid minds

• Prevailing financial headwinds and effect on the life sciences industry globally and particularly in Asia
• How public markets are faring in 2009 – Globally and in Asia. Will life sciences companies look towards Asia-Pacific markets for listing?

• Reviewing some of the alternative sources for funding of life sciences/ healthcare sector
• Are these investors actively looking into opportunities in the Asia Pacific and which countries and sectors are attracting the most investment?

• Trends in life sciences early stage deal values and numbers-globally and in Asia
• Role of pharmas and government-linked funds in sustaining early stage biotechs and the partnering/ funding models being used
• What opportunities do early stage deals offer to VCs and business angels in the current economic climate

• How do private equity firms view the potential of Asian life sciences and healthcare companies in the current economic climate?
• What investment strategies do private equity firms use for Asian life science/healthcare investments and how are these different than those used in the US and Europe?

• How companies, even high risk small companies, from emerging biotech regions in Asia can effectively tap into the pool of funding available and the pitfalls to be avoided
• The key areas of focus for investors and which make for a successful company

• M&A or IPO - How to decide on the best exit strategy for your company and whether dual tracking is advisable
• Considering alternative fi nancing : Convertible bonds, mixture of debt & equity
• Licensing and partnering with big pharma as liquidity options – What sort of models are being adopted in Asia?
• Value of having strategic investors vs financial sponsors

• How are the Asia Pacific growth boards faring in the current climate and what measures have been taken to encourage listing of more life sciences companies?
• Discussing the public markets of China , Hong Kong, Singapore, Japan and Australia.
• What trends are emerging? Reverse takeovers, crossborder listings, new regulations

• What drove Genentech to set up a manufacturing plant in Asia: Market, cost, or both?
• Several years ago, Genentech set out a series of goals for product development, called the 5x5 strategy. Genentech is currently ahead of schedule for meeting these goals. What is the reason for its success?
• Looking forward to 2010 - What are some of the things that will shape the industry and competition?

• How will the credit crunch affect R&D strategy in the pharmaceutical industry?
• How do you see the R&D business model/strategy evolving in the pharma industry under the current economy?
• How has Novartis restructured its R&D model to address challenges from increasing cost and unmet efficiencies? What are the implications?
• Novartis has set up an NITD in Singapore, an R&D centre in China and a manufacturing plant in Singapore. What is Asia’s role in Novartis’ global growth strategy?

• How Takeda’s business model has evolved over the years
• How has Takeda’s recent investment and buyout strategies affected its overall business portfolio and commercial performance?
• With all the pharmas looking south, what’s Takeda’s strategy for its business expansion in Asia?

• The objectives, expected benefi ts, gains and outcomes for stakeholders of the biomedical sector conducting translational medicine research
• The approaches adopted to achieve these outcomes
• The gaps and opportunities for Asia partnerships in translational research

• Rationale for incorporating translational medicine in pharmaceutical R&D strategy
• The translational medicine approach adopted by Schering Plough
• Impact of translational medicine on drug development process in major pharmaceutical companies

• Recent initiatives and progress of implementation in Singapore Translational Clinical Research
• Challenges and key milestones achieved in conducting translational research in Singapore
• Case examples of partnerships between pharmas, biotechs, and healthcare organisations

• Challenges in sourcing for funds to commercialize research
• Initiatives to drive scientists and clinicians to be more involved in translating research discoveries into clinics
• Where are the opportunities for industry collaboration?

• Major drivers for the heightened growth of translational medicine research in China
• Major players and unique strength and capabilities in translational medicine research?
• Future outlook of research and industry landscape China

• Recent government initiatives to encourage local biomedical industry to translate bench discoveries into bedside applications
• Major players in India and unique strength and capabilities in translational medicine research?
• Current state of development and future outlook of India’s translational research landscape

• Strengths and weakness of translational research in Korea
• Who are the major translational research players and what are their approaches?
• Current state and future direction to drive drug development for new markets

• Evaluating the advantages in collaborating with local scientific talents in China
• Key lessons learnt in establishing translational medicine research work in China
• Case examples of unique applications of translational medicine in neurodegeneration drug discovery and development

• Clinical application or establishment of translational platform
• Artificial lymph node, humanized mice, or NKT cellmediated adjuvant cell therapy on lung/head and neck tumor
• Areas for Translational research collaboration

• Addressing the technology and quality gap between the Asia and Western CMOs - Can Asia CMOs ever match up in quality and yet maintain their competitive pricing?
• Business models and strategies for Asian CMOs to match the expectations of their partners
• How can Asia CMOs better position themselves to cope with the increasing demand for clinical supplies of biologics?
• Opportunities and risks of a biologics CMO in Asia

• Manufacturing strategies for an emerging biological company
• Analyzing the economics behind make vs. buy and the cost of outsourcing vs. in-house manufacturing and facility modifi cation
• How can CMO translate their expertise into quality production with quick turnaround time and low manufacturing cost?
• How to decide on the most effective outsourcing strategy from bulk API to fi ll/fi nish to packaging and distribution
• Engaging a CMO in US, Europe or Asia: What are th pros and cons?

• Process and selection criteria for choosing the right CMO
• Addressing the challenges of GMP compliance in light of tightening scrutiny and monitoring of Asian suppliers
• Evaluating how technology can be successfully transferred to Asian CMOs and its implications on Asia’s biomanufacturing industry
• Should CMOs provide and incorporate development services into their operations? How big can this market potential get?

• Selection of CMO
• Technology transfer and scale-up issues
• Overcoming cultural hurdles and ensuring effective communication

• Gaining a competitive edge through various models of strategic business partnership
• Advantages and limitations of the co-operative partnership between a large and small CMO
• Will we see more of such collaborative moves in the near future?

• How can a small CMO in Asia stand out among the many others in Asia and globally?
• Creating a competitive niche - Proprietary technologies, specialties, fi ll/fi nish and packaging services, and clientele base
• Partnering with vendors to provide a full-service platform for clients
• Partnering with other small CMOs versus big CMOs