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Pre-congress briefing 16 September 2008: Biotech Health
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08.00 | Registration and coffee
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09.00 | Chairman’s opening remarks
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| | Dr Avinoam Kadouri, Scientific Advisory Board, Sigma-Aldrich and SAFC, and Chief Executive Officer, Rainbow Biotechnologies
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09.10 | Keynote address: specialised biotech companies: how to maximise chances of success and avoid typical failure
- STRATEGY! STRATEGY! STRATEGY!
- Speed to market, PoC and the true relationship with cost
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| INNOVATIVE BUSINESS MODELS FOR BIOTECHS |
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09.55 | Panel session: biotech business models: CEO perspectives on new opportunities for making biotechs successful
- Principal challenges in taking charge of a biotech company: challenges and how they are addressed
- An assessment of opportunities for collaboration in research: case based perspectives
- Strategic business models: merits, limitations and what you can do to turn chance in your favour
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10.40 | Morning coffee
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11.15 | Challenges for small and medium biotechs in bringing biological cell therapy products to market
- Assessing the challenges directly from the market: business leader perspectives
- Key regulatory challenges in demonstrating compliance
- Risk minimisation and a focus on phase I/II, phase III, pre-marketing and post-marketing stages of the biologic lifecycle
- Alternative channels for stimulating biotech growth
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| FUNDING, PARTNERING AND DEFINING YOUR EXIT STRATEGY |
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11.45 | Innovative funding options for early stage development: alternative sources of funding and where to find them
- Reviewing potential sources of funding and the early-stage financing environment
- The role of pharma in the biotech financing process: how do they finance and how do they decide?
- The causes of biotech finding shortfalls and how to avoid them
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12.15 | Lunch
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13.45 | Current issues and developments in IP and patenting
- US and European patent law: changes, impact and what you need to do
- IP rights and the interface with regulatory systems
- Structuring your R&D for maximum IP capture
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| | Dr Giampiero De Luca, Senior Executive Vice President, Licensing and Intellectual Property and Chief Intellectual Property Counsel, Merck Serono
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14.15 | Positioning your biotech: designing a roadmap for delivery
- An overview of due diligence and technical assessment
- Identifying the important milestones and recognising the criteria of importance to potential partners and acquisition players
- Making your alliance work
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14.45 | Afternoon tea
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15.15 | Financing biotech: is M&A the only way – exit whose exit?
- What realistic options are there for financing biotech and what are the main drivers?
- How do these options affect the various stakeholders – is financing an “exit” or an “entrance”?
- Ablynx – a case study to illustrate some of the above
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15.45 | Panel session: understanding the drivers for big pharma and the requirements of biotech when assessing acquisition and partnering opportunities
- How to maximise the appeal of your business to potential investors and the importance of defining your goals and strategy
- The due diligence and technical assessment process
- The importance of demonstrating commercial ability and how to do it
- Preparing your business for investor analysis, due diligence and preparing for technical assessment
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| | Moderator: Dr Jeff Southerton, Executive Director, Worldwide Business Development, Pfizer Global R&D
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16.30 | Close of pre-conference briefing
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Congress day one 17 September 2008 - PLENARY MORNING SESSION
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| BIOLOGICS – THE BIG PICTURE |
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08.00 | Registration and coffee
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09.00 | Chairman’s opening remarks
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09.10 | Keynote address: commercialising embryonic stem cell therapies: lessons from the United States
- Potential for regenerative medicine and limitations of prior attempts at cell therapy
- Advantages of embryonic stem cells
- Service versus product business models
- Role of US Federal Government/NIH, the US FDA and the academic community
- Scope and content of the first Human Embryonic Stem Cells (HESC) IND application
- Realities of the current unsustainable product development paradigm for HESC-based therapies and necessary corrective actions
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09.55 | Keynote address: the changing world order of biotech and big pharma: an expert view on the emerging trends and realities for biological drug products and the wider pharmaceutical industry
- The inclusion of biologics into the wider pharmaceutical industry: drivers and what will this look like
- Changing attitudes of big pharma to biologics, and the impact on their business models
- New opportunities arising from a transforming landscape
- The challenging climate for the small and medium biotech: where will the next Biogen/Amgen come from?
- Shaping the future of biologics and the pharmaceutical industry: addressing the key dynamics and predictions for the future
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10.30 | Speed networking
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11.30 | Morning coffee
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12.00 | Keynote address: strategic opportunities, global regulatory harmonization and further perspectives on meeting unanswered regulatory and scientific challenges
- Changing strategic challenges that need to be faced in development
- Stakeholder perceptions of risk benefit: assessing risk benefit versus effectiveness
- Wider perspectives on bringing biological products into the clinic
- Risk benefit and it’s role in driving regulatory developments
- A new paradigm for regulatory global harmonization
- Unanswered challenges from a regulatory and scientific perspective
- FDA and European Commission specific developments
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| | Dr Kenneth B Seamon, Formerly of CBER, FDA and VP for Global Regulatory Affairs, Amgen and Senior Associate, University of Cambridge
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12.35 | Keynote address: a perspective on the biopharmaceutical industry in 2008 and beyond
- The worldwide biologics landscape, market dynamics and key growth areas
- Biologics pricing and cost-effectiveness
- The changing regulatory environment and key macro developments
- The impact of biosimilars on the biologics market
- Beyond 2008: best and worse case predictions for biologics
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| | Dr Uwe Bücheler, Senior Vice President, Biopharmaceuticals, Boehringer Ingelheim
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13.10 | Lunch
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Congress day one 17 September 2008 - BREAKOUT STREAM 1
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| REGULATING BIOLOGICS AND ACHIEVING COMPLIANCE |
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14.15 | Chairman's opening remarks
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| REGULATOR PERSPECTIVE |
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14.20 | A European regulators perspective on biologics
- The primary goals and responsibilities of European and national regulators
- Considerations arising from the European Regulation on Advanced Therapy Medicinal Products
- Activities of the CHMP Biologics Working Party
- Additional regulatory developments and future activities
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14.50 | Perspectives in regulating biological and biopharmaceutical products
- Current regulatory landscape pertaining to biologics in the United States
- The current status of biogenerics and future regulatory activity and hurdles
- Advice for increasing the efficiency of submissions, working with the authorities and data requirements
- What’s in the pipeline for the FDA?
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| | Dr Jim Kenimer, President and Chief Executive Officer, Biologics Consulting Group
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15.20 | Afternoon tea
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| INDUSTRY PERSPECTIVE |
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15.50 | An industry perspective on regulation of biological products
- Overcoming regulatory challenges: what are the common difficulties and how are they addressed
- Perspectives on the development of an appropriate regulatory system: suggestions for regulatory amendments
- Regulatory agency activities and interaction with industry
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16.20 | Panel session: regulators and industry: the challenges of operating in the current regulatory environment: overcoming the financial and regulatory hurdles to innovate and bring your product to market
- What are the current financial and regulatory hurdles, and how are they being overcome?
- How industry and the regulators can cooperate to develop a more conducive operating environment: what you can do to make things easier
- Suggested future regulatory developments and alternative approaches
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| | Confirmed: Dr Jim Kenimer, President and Chief Executive Officer, Biologics Consulting Group Confirmed: Dr Kenneth B Seamon, Formerly of CBER, FDA and VP for Global Regulatory Affairs, Amgen and Senior Associate, University of Cambridge
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17.05 | Close of congress day one followed by networking drinks
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Congress day one 17 September 2008 - BREAKOUT STREAM 2
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| OPTIMISING CLINICAL TRIALS FOR BIOLOGICS |
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14.15 | Chairman's opening remarks
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14.20 | Current challenges in the clinical development of biologics
- How to manage clinical trials for biologics and advanced therapeutics
- Determination of a suitable starting dose for clinical studies in humans
- Making the choice between healthy volunteers and patients for first in human studies
- The development of combination products (device-biologics)
- Unique clinical challenges in regenerative medicine and cellular therapies
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| | Dr Hartwig Gajek, Medical Director, Global Clinical and Medical Affairs, Baxter BioScience
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14.50 | Lessons learned in the transfer of biologics from R&D into phase III clinical trials/manufacturing sites
- Defining a technology transfer protocol: principles and framework
- Using process excellence in technology transfer
- Working with contractors to improve process development and associated issues
- Roles and responsibilities of the sponsor and contractor for GMP compliance
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15.20 | Afternoon tea
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15.50 | Assessing the challenges for biotech in developing a clinical outsourcing strategy
- Developing the basis of an outsourcing strategy
- Guidance in working productively with contract research organisations, geographical issues and working in low cost environments
- Selection of candidates, managing the proposal, negotiating and the contract process
- Reviewing outsourcing performance and techniques for developing fruitful strategic relationships
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16.20 | Panel/question session: developing an adequate and well-controlled clinical strategy for trialling biopharmaceutical products
- Lessons learned in clinical strategy development
- Key indicators for failure, common pitfalls, and early recognition of warning signs
- Effective management of clinical resources
- Summarizing the critical factors for developing your clinical strategy
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| | Confirmed: Dr Hartwig Gajek, Medical Director, Global Clinical and Medical Affairs, Baxter BioScience Confirmed: Dr Gerhard Klement, Chief Executive Officer and President, Reliant Life Sciences
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17.05 | Close of congress day one followed by networking drinks
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Congress day two 18 September 2008 - BREAKOUT STREAM 1
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| STRATEGIC CHALLENGES AND OPPORTUNITIES |
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08.00 | Registration and coffee
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09.00 | Chairman’s opening remarks
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| | Dr Mark Horn, Director, Finance and R&D Portfolio Management, Wyeth
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| MANAGING AND OPTIMISING YOUR PRODUCT PIPELINE |
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09.05 | The challenge of developing a biologics development portfolio
- The importance of building an international presence in R&D and commercialisation of biologics
- Considerations for strength and diversity of your product pipeline
- Reviewing productivity targets and balancing priorities
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09.35 | Delivering on R&D virtualisation to fill your product pipeline
- Delivering on R&D virtualisation and the importance of leveraging wealth and diversity in the current climate
- Developing strategies for virtualizing drug discovery through the formation of innovative entrepreneurial units
- How is virtualization delivered? The advantages, dangers and limitations of virtualization
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10.05 | A non-profit research institute's perspective on outsourcing R&D
- Understanding the new global dynamics of the biopharmaceutical industry and assessing increasing globalization of the research market
- Primary considerations for sourcing and researching and where to look
- Formulating an external research strategy based on your company requirements
- Effectively managing external relationships
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10.35 | Panel session: considerations for building a successful pipeline including recent developments and perspectives
- Understanding how pharma and large biotechs are working on building product pipelines: case studies and discussion
- An overview of recent major developments and perspectives on what this means for the industry
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| | Moderator: Dr Mark Horn, Director, Finance and R&D Portfolio Management, Wyeth Confirmed: Dr Bruce Pratt, Vice President, Science Development, Genzyme Corp
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11.05 | Morning coffee
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| THE FUTURE FOR BIOSIMILARS |
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11.35 | Biosimilar regulation in the US, Europe and beyond
- Current European and FDA guidelines on biosimilar regulation
- Determining the level of development and clinical trials likely to be required
- Future outlook for biosimilars and key areas of opportunity and how to exploit them
- The link between biotech in Europe, the USA and beyond
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12.05 | The impending arrival of biosimilars
- The intellectual property quagmire of biosimilars, patent and data protection issues in Europe, US and other leading markets
- The Patient Safety Imperative: Evolving regulatory requirements for safe and effective follow-ons
- The biosimilar experience to-date and anticipated future direction
- The expected participation of emerging markets in the biosimilar landscape
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12.35 | Panel session: biosimilars in 2008 – how far have we come?
- Considerations for getting a biosimilar to market: how is it going to happen
- How the biologic generics and biosimilars wave will hit the current market: advice for protecting your products or exploiting the opening
- Emerging capabilities in developing nations
- Key remaining complexities and biosimilars research and manufacturing
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| | Confirmed: Dr Patrick Vink, Senior Vice President and Global Head of Biologics, Mylan
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| PRICING AND REIMBURSEMENT |
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13.05 | Considerations for biologics pricing in the changing pharmaceutical industry
- Primary versus speciality care, and the decision making process
- Addressing regulatory hurdles for efficacy and safety: influencing decisions
- How will big pharma and biotech balance primary and speciality care, and what new partnerships might evolve as a result?
- How will these changes affect the “rules” for pricing biologicals?
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| | Dr Mick Kolassa, Chief Executive Officer and Managing Partner, Medical Marketing Economics
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13.35 | Lunch
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| EXAMINING THE VALUE PROPOSITION OF NEW FIELDS AND TECHNOLOGIES |
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14.35 | Next generation antibodies with enhanced effector functions and dual target recognition capabilities
- A critical overview of advanced antibody development to-date
- The importance of enhancing effector function in the current antibody development climate
- Novel classes of bi- and dual-specific antibodies in development
- Understanding the future of antibody development and the revolutionary potential of next generation antibodies: what will be possible and how you can capitalize
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| | Dr Tariq Ghayur, Senior Principle Scientist and Research Fellow, Abbott Laboratories
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15.05 | Case study: how biotech and pharma are extracting value from RNAi technology
- Understanding the basic biology of RNAi through product development
- Recent advances in RNAi and antisense technology and their implications for therapeutic treatment
- Case studies for delivering ROI on RNAi technology: who the successful players are and what sets them apart
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15.35 | Afternoon tea
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16.05 | Partnering biologics with personalised medicine: strategies for achieving mid and long-term return on investment
- Segmentation of disease categories and the advances that facilitate greater understanding
- Adopting your business model to accommodate products more finely targeted to patient groups within disease categories
- Why approaches towards development of personalized therapeutic biologics can compliment a more streamlined approach to R&D
- The road ahead for personalized medicine and what you need to know to benefit
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| | Dr Glenn Miller, Vice President and General Manager, Genzyme Analytical Services
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16.35 | Vaccines: latest developments and market opportunities
- Overview of the global vaccines market and its changing landscape
- Investment areas for developing new vaccine products
- New technologies and further advances for vaccines
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17.05 | Panel session: addressing unmet medical needs through biotherapeutics development
- What the future holds for biological drug products, the evolution of the pharmaceutical industry and what this means for your business
- Identifying future market potential and potential return on your investment
- Diagnostic development and the role of biologics
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| | Confirmed: Dr Tariq Ghayur, Senior Principle Scientist and Research Fellow, Abbott Laboratories Confirmed: Dr Glenn Miller, Vice President and General Manager, Genzyme Analytical Services
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17.40 | Close of congress day two followed by networking drinks
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Congress day two 18 September 2008 - BREAKOUT STREAM 2
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| BIOLOGIC PRODUCT DEVELOPMENT |
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08.00 | Registration and coffee
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09.00 | Chairman’s opening remarks
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| ADDING VALUE TO BIOLOGICS DEVELOPMENT |
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09.05 | Preclinical tools for assessing product safety
- The development of different approaches to preclinical safety evaluation
- Understanding the impact of recent events on the pre-clinical safety assessment of biologics
- Presenting the analysis of a critical review from industry and regulators of safety assessment procedures
- Adopting the lessons learned in a cohesive strategy for assessing product safety at the preclinical development stage
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09.35 | Segmenting your portfolio to reduce time from target to clinic and reduce resources from clinic to commercial
- Understanding the value to the patient and innovator on reducing time to market
- Understanding the key drivers contributing to biopharmaceutical product development and approval
- Example strategies to address reducing time from target to clinic
- Example strategies to address reducing resources from clinic to commercial
- Business practices to integrate how the strategies are applied across the portfolio
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| | Dr Sue E Steven, Senior Director, Business Support, Process Development, Genentech
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10.05 | Early development of therapeutic biologics
- Bioanalytics and immunogenicity of therapeutic biologics
- Pharmacokinetics of therapeutic biologics in preclinical development
- Perspectives on preclinical safety
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10.35 | Developing a product with process intelligence at the forefront of your agenda
- Definition of a product development strategy with process in mind
- Requirements for early clinical trial material balanced with new process options
- Mandatory and optional CMC and non-clinical investigations
- The real challenge between cost and quality during product development
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11.05 | Morning coffee
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| DEALING WITH IMMUNOGENICITY AND ACHIEVING COMPARABILITY |
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11.35 | Immunogenicity: understanding the implications for product development and designing an effective risk assessment strategy
- Why immunogenicity of biological medicines is such a big problem, and understanding the consequences
- Strategies and tools for assessing immunogenicity
- An expert perspective on the main pitfalls and failures in the assessment of immunogenicity: how to avoid them
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12.05 | Development of new animal models for preclinical assessment of immunogenicity of protein therapeutics
- Challenges in the development of new protein therapeutics
- Shortcommings of current murine animal models for preclinical immunogenicity studies
- New murine models for preclinical immunogenicity testing of new protein drug candidates for the treatment of hemophilia A
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12.35 | Unwanted immunogenicity
- Critical overview of assays for immunogenicity
- Available guidelines/guidance for unwanted immunogenicity
- Issues relating to Biosimilars
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| | Dr Robin Thorpe, Head, Biotherapeutics Group, National Institute for Biological Standards and Control
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13.05 | Panel session: perspectives on biologic risk assessment, prediction and minimisation of immunogenicity
- Understanding strategic attitudes towards the assessment of immunogenicity
- Discussing risk-based approaches to immunogenicity
- Appreciating the regulator approach to immunogenicity concerns: focussing on the scientific basis for regulator’s assessment of immunogenicity and corrective action
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| | Moderator: Dr Harald Kropshofer, Global Coordinator and Head, Immunosafety of Biotherapeutics, F Hoffman La Roche Confirmed: Dr Robin Thorpe, Head, Biotherapeutics Group, National Institute for Biological Standards and Control
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13.35 | Lunch
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14.35 | Demonstrating comparability: a regulatory perspective
- Principles of assessing the comparability of biological products
- A brief outline of the regulatory requirements and guidelines
- Case studies that demonstrate the impact of process change
- Learning from the experiences of the regulators
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| | Dr Mark L Slisz, EU and US RAC, Principal Regulatory Scientist, Global Regulatory Affairs, Eli Lilly
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| QUALITY BY DESIGN IN BIOLOGICS PROCESS DEVELOPMENT |
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15.05 | The reality of Quality by Design for the biotechnology industry
- Review of the various elements of QbD such as determination of critical quality attributes and design space
- Novel analytical technology to evaluate the product attributes and PAT tools for on-line assessment of product quality
- Review of comparability protocols to support filing of the design space data
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15.35 | Afternoon tea
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16.05 | Structure activity relationship and comparability in conjunction with critical quality attributes
- Analytical methods for assessment of critical quality attributes
- Relationship between structure activity and critical quality attributes
- Adopting lessons learned and assessing tangible benefits
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16.35 | The application of design space and risk management approaches in biologics process development and manufacturing
- How to define design space and carry out studies to qualify it
- How to design experiments using multi-parameter limits
- A case study approach to assessing the advantages and constraints of design space
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| | Dr Joerg Schmidt, Senior Scientist, Head, Exploratory Pilot Plant, Biotechnology Development, Novartis
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17.05 | Panel session: the practicalities of implementing QbD initiatives
- Qualifying the link between process change, quality, efficacy and safety
- Monitoring the real impact of process change
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| | Moderator: Dr Kripa Ram, Vice President, BioProcess/Manufacturing, MedImmune Confirmed: Dr Joerg Schmidt, Senior Scientist, Head, Exploratory Pilot Plant, Biotechnology Development, Novartis
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17.40 | Close of congress day two followed by networking drinks reception
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Post-day briefing – 19 September 2008
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08.00 | Registration and coffee
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09.00 | Chairman’s opening remarks
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| MANAGEMENT STRATEGY AND OPERATIONAL EFFICIENCY |
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09.10 | Opening address: the coming of age of biopharmaceutical manufacturing
- Current trends, impacts and strategic role of biopharmaceutical operations
- Where is manufacturing going over the next ten years?
- What are the latest developments within this field?
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09.40 | Keynote address: biopharmaceutical manufacturing trends: long term viable manufacturing solutions
- Manufacturing biologics: the perspective from a biopharmaceutical manufacturer
- Strategic importance of manufacturing in product development
- Case studies on successful approaches to manufacture
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10.10 | A paradigm shift in cell culture based biomanufacturing processes
- Historical overview of successful biomanufacturing in cell culture technology and state of the art biomanufacturing
- technology
- The paradigm shift in design, multi-use facilities and making use of efficient and flexible biotech plants
- Underlining the global manufacturing challenges that we all face
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10.40 | Panel session: predicting innovation in biomanufacturing
- Where do the main bottlenecks and challenges remain within biomanufacturing?
- What novel approaches can be applied to address current shortcomings?
- How can the major stakeholders of pharma, biotech and CMOs interact?
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11.10 | Morning coffee
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| ECONOMIC MANUFACTURING STRATEGIES |
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11.40 | Use of operational excellence as a strategic weapon to optimise biopharma production
- The future of fermentation/purification/packaging networks
- Creating the ideal manufacturing facility
- Investing in or divesting capacity to meet longer term demand
- What strategies are being implemented to improve manufacturing across the industry? Building for the future
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12.10 | Avoiding investment into large bioreactor capacity by continuous process improvement
- Focus on secure supply whilst continuously reducing both capital investment and operating expenses
- Increase manufacturing output of existing operations by strengthening the continuous improvement process
- Mitigate the investment risk of building up bioreactor capacity by increasing process stability
- Achieve operational excellence in capacity management with best practice sharing and lean six sigma
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12.40 | Strategic and economic challenges of increasing biopharmaceutical supply
- Experience with biomanufacturer management
- Fast track process development to support cGMP manufacturing of a complex fusion protein for pivotal clinical trials
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13.10 | Lunch
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| COST MODELING FOR ECONOMIC MANUFACTURE |
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14.10 | Developing a framework of cost of goods and cost modelling
- Benefits and applications of cost modelling for biological bioprocessing
- Preparing cost-models for new biopharmaceutical projects, outsourcing initiatives and proposed technologies
- A framework for a Cost of Goods (COG) model
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| TECHNOLOGY TRANSFER FOR OUTSOURCING |
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14.40 | Technology transfer to ensure an effective biomanufacturing process
- Critical factors and timelines for a successful technology transfer
- Transfer process know-how into efficiency improvements during design and construction
- Transfer know-how, efficiency improvements and GMP requirements into regulatory strategy to gain approval
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15.10 | Afternoon tea
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15.40 | Case study: technology evaluation and process development strategy for the production of biopharmaceuticals
- Technology transfer to ensure an effective manufacturing process
- Critical factors and timelines for a successful technology transfer
- Technical and regulatory requirements for upscaling to different scales at multipurpose facilities
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16.10 | Pharmaceutical outsourcing strategies promoting economic manufacture
- Emerging fields in the pharmaceutical outsourcing market for biological products. Why outsource manufacturing and
- risk costly technology transfer delays?
- Analysing best practice outsourcing strategies to ensure implementation into future processes
- Critical assessment of biomanufacturing outsourcing focusing on key current issues such as patent protection and related legislative changes
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16.40 | Close of biomanufacturing strategy briefing day
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