• The science and concept behind optimisation technology; key developments to date  
• Opening up a route to generating highly optimised versions of currently marketed biologics and vaccines
• Classification system for understanding optimisation technologies

• An overview of Synagis and Numax – the first DME product to reach the market?
• The role of DME in RSV
• Experience with DME providing a successful lifecycle management strategy

• Applying DME in the discovery and development process to enhance biologic lead candidates
• Rationale for targeting already marketed biologics to develop optimised versions for internal pipeline
• Targeting an optimised G-CSF

• Outlining the current industry techniques for optimisation of protein therapeutics and monoclonal antibodies
• High yield protein expression strategies, generation of stable cell lines and automation
• Major technologies to create therapeutic antibodies; chimeric, humanised and human

• Challenging landscape of scattered technologies and expertise on optimising mammalian clones for yield and development time
• Different needs in the biotech sector depending on company size and experience
• UTR clone consortium business model provides flexibly "state of the art" integrated solutions for rapid development of commercial GMP clones

• Optimisation needs and approaches for therapeutic antibodies and nanobodies
• Gaining access to the technologies and techniques which best suit
• Comparison of display technology and methodologies

• Comprehensive and rapid solutions for stable, high yield mammalian cell lines used in recombinant protein manufacturing
• Reducing traditional cell line development with an increase in expression
• Increasing recombinant protein expression in mammalian cells in suspension and in serum-free

• Use of optimisation technologies in biopharmaceutical discovery

• Gaining a competitive advantage by engineering binding and effector function of me-better antibody leads

• Case studies on improving solubility, expression, specificity and efficacy on biologics leads

• Presentation of the RapMAT^TM technology
• Generating antibodies using RapMAT^TM with affinities in the low pM range
• Comparison of different approaches for affinity maturation

• The rationale for generating highly optimised versions of currently marketed biologics and vaccines
• Optimisation as a broadly applicable method for product lifecycle management of biologics 
• Technology to usher in the wave of next-generation biologics to combat biogeneric and competitive threats

• Identifying medicines that bring the greatest benefit to patients by ensuring early - access to these medicines 
• Working towards the goal of achieving the G10 recommendations regarding Public Health objectives aimed to offer European citizens an equal >access to medicines at an affordable overall cost 
• Supplementing the key role of health professionals by improving the quality of, and access to, information on authorised medicines and related >health areas to European patients
  

• Factors driving the emergence of an environment for biogenerics
• Progress towards the introduction of biogenerics in US and Europe; what are the major targets?
• Regulations and political structures for the regulation of biogenerics and approval

• Market demand for off-patent biologics
• Cost-of-goods associated with biologics production
• Optimisation initiatives aimed at improving the cost-effectiveness of biogenerics production

• Why biosimilars development is being pushed in Europe
• Overview of the success of biosimilar approvals in European markets
• Identification of future trends shaping biosimilar regulatory environment evolution

• Biologic expectations as the primary growth driver out to 2010
• Competitive forces acting on different drug types
• Strategies aimed at meeting unmet patient need and pricing leverage

• A market for therapeutic proteins and mAbs and how will it alter in the future
• The most promising new therapeutic proteins and mAbs on the market
• Unmet needs and key issues affecting the therapeutic protein and mAbs market
  

• Competitive forces driving significant growth over small molecules and therapeutic proteins
• Strategies to overcome key, current and future challenges 
• Anticipating future trends and critical success factors
  

• Current environment based on exposure to generics and next generation products
• Which conventional and next-generation product types offer the best opportunities?
• What are the latest developments within this field?
  

• Small molecule products maintaining a role in large pharmaceutical sales growth
• Standing up to heavy exposure to generic competition
• Strategies that compliment sales growth driven by innovative small molecule products
  

• The goal of the comparability exercise to ensure quality, safety and efficacy
• Determining comparability using a combination of analytical testing, biological assays and data
• Obtaining datacase-by-case basis – recent examples

• Comparability for biological products in light of lessons learnt
• Product quality attributes impacting safety and efficacy
• Decision points on when to move your comparability assessment from analytical to non-clinical / clinical

• Current landscape of analytical methods for comparability studies. Benefits of the biophysical analytical approach
• Orthogonal approach towards a better comparability
• Further applications of biophysical methods

• The task of planning and demonstrating comparability
• Process changes during protein and monoclonal antibody production
• Demonstrating comparability through state-of-the-art technology

• What special challenges are being faced by biotechnology companies?
• How are companies being affected by new regulations?
• What strategies are being adopting and what are the prospects for the future?

• Adding value to early stage clinical development of biologics
• Achieving quality criteria to enter clinical studies
• Achieving GMP requirements in early stage development

• Key learnings from common audit findings
• Building the function and use of vendors for internal and external quality management
• Common misunderstandings in clinical quality management
• Identifying the added value of quality management

• Recent advances and challenges associated with prediction and reduction of protein immunogenicity
• Effective early assessment and minimisation of therapeutic protein immunogenicity and patient safety
• Strategies to reduce the immunogenicity of second generation biotherapeutics

• Protein immunogenicity reliably in the absence of clinical data
• When and how to do successful de-immunisation of biotherapeutics
• Humanisation vs. de-immunisation vs. tolerance-induction; pros and cons

• Outlining the requirements for final product formulations
• Developing adequate test procedures to assure product purity, activity, stability and safety
• Justified formulation development and compliance with regulations

• Protein stability and common degradations such as aggregation
• Protein formulation and how to design and characterise protein formulations
• Strategy and design of protein formulation under various pre-clinical and clinical timelines

• Case study: fully human anti-IL-18 mAb for treatment of autoimmune diseases
• Development of high concentration therapeutic monoclonal antibody protein formulations
• Monitoring procedures for improved delivery and protein product quality assurance

• Design aspects of the new concept of a single use stirred tank bioreactor
• Detailed evaluation of new results of sample cell line cultivation
• Scalability & typical applications for single use bioreactors

• Conception of a chromatography packing station with disposable mixing tank
• Disposable mixing technology for such application
• Validation and advantages in cleaning, storage and operation
• How to integrate such skid in your process

• Strategies to improve product yield and in turn cost effectiveness of recombinant and antibody production processes
• Process scenarios for recombinant products and antibodies
• High throughput tools and techniques for the rapid, cost effective design and development of production and downstream processes

• 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 facility

• Virus clearance studies performed as part of the strategy for assuring that biotherapeutic products are free of virus contamination
• Scope of viral clearance studies varying with the phase of development of the product
• Early and late phase studies as part of the overall process validation plan
• Integration of the virus clearance study with process validation planning during the development of biopharmaceutical products

• The current regulatory framework for virus safety studies 
• New regulatory initiatives in Europe for biotechnological products in development
• Industry viewpoints

• Design of single use systems for ease of use; cassette, hollow fiber and new technologies used in single use TFF
• Scale and performance limitations of disposable technologies
• Appropriate application case studies for single use TFF

• Manufacturing biologics - the perspective from a CMO
• Strategic importance of manufacturing in product development
• Case studies on successful approaches to manufacture

Roundtable 1

17.00 Marketing and authorisation strategies

• Regulatory requirements in key European markets
• Formulate authorisation strategies that generate revenues sooner to offset development costs
• Manage and minimise authorisation bottlenecks

Chairman:

Dr Emmanuelle Voisin, Principal, Voisin Consulting

Roundtable 2

17.00 Technology transfer from R&D to manufacturing 

• Project planning and key manufacturing and specification requirements
• Risk analysis as a tool for right first time
• Process development phases and maintaining comparability

Chairman:

Dr Claudia Roth, Process Development and Implementation, Vetter Pharma

• Current observations about operations in the biopharmaceutical industry 2007
• An interactive workshop to identify the key threats facing the industry in the next 10 years
• Discussion of the future of operations excellence
• A discussion of the biopharma operations excellence roadmap developed in September 2006 in Boston, MA

• BioChemical manufacturing
• Quality control
• Organisational design

• Challenge: the board asks you to reduce costs by 40%, what do you do?
• Training on workshop structure

• The group will be subdivided into teams, and presented with key industry challenges in either manufacturing or development
• Each team will discuss the challenges and identify best practices in those areas
• Each team will present their findings for discussion to the group

• The group will be subdivided into teams, and presented with key industry challenges in either quality or supply chain
• Each team will discuss the challenges and identify best practices in those areas
• Each team will present their findings for discussion to the group