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Pre-congress briefing: biosimilars and biodefense - Monday 19th June 2006
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| SIMILAR BIOLOGICAL MEDICINAL PRODUCTS |
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| 08.00 | Registration
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| 09.00 | Chairman’s opening remarks
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| 09.15 | Manufacturing issues: practicability
- Issues of limited clinical case studies comparing the product to the reference product
- Contract manufacturing – in house vs. outsourcing
- Regulatory implications and guidelines
- Obtaining an understanding of how process changes can affect the structure and biological activity of the product
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| 09.45 | Methods of assessing immunogenicity of biosimilar products and their limitations
- The limitations of available assays for predicting the immunogenicity of biologicals
- Available assays for the measurement of antibodies in patient sera and their limitations
- Challenges of assays used for assessment of unwanted immunogenicity
- Strategy for determination of unwanted immunogenicity
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| | Meenu Wadhwa, Leader,Cytokine and Growth Factor Group,Division Of Immunology and Endocrinology, NIBSC
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| 10.15 | Morning coffee
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| 11.15 | How European responsiveness compares to the USA
- The new framework for similar biological medicinal products in Europe
- What developments have been made in the USA?
- Products approved under the public health service act USA
- How far has Europe come?
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| | Thomas Bols, Director Government Affairs, Europe, Amgen
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| BIODEFENSE |
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| 11.45 | Biodefense market
- What is the current situation with the biodefense market?
- What are the major changes?
- What is the future direction?
- Is there a large difference between the USA and Europe?
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| 12.15 | Public private partnerships in biodefense and public health research
- Strategic goals and objectives for public health
- What are the research funding mechanisms?
- What are the technology areas of interest?
- The key to successful partnerships
- Public private partnerships for biodefense
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| | Trevor Marks, Business Development Manager, Health Protection Agency Porton Down
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| 12.45 | Lunch
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| 14.15 | Legal and contractual challenges within biodefense
- Overview of the Project BioShield Act of 2004
- Negotiating a US government contract
- Challenges of contract administration
- Addressing liability concerns
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| 14.45 | Clinical aspects of safety trial design in biodefense
- Clinical development of biodefense vaccines
- Animal rule regulation
- Design of phase I and II vaccine studies
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| 15.15 | Afternoon tea
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| 16.00 | Panel session: biodefense strategies for the future
- Where is the industry going?
- What opportunities lie ahead in this field?
- When should you make the decision to buy?
- Is there a difference in advancement between the USA and Europe
- Advances in the biodefense industry
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| 17.00 | Close of pre-congress briefing
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| 17.05 | Pre-congress welcome cocktail reception
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Conference day one - Tuesday 20th June 2006 - Plenary morning
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| 12.12 |
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| 08.00 | Registration
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| 08.30 | Welcome address
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| 08.45 | Chairman’s opening remarks
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| | Brendan Fish, Director, Bioprocess Sciences, Cambridge Antibody Technology
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| BIOPHARMACEUTICAL OPERATIONS AS A COMPETITIVE ADVANTAGE |
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| 09.00 | Biopharmaceutical operations industry trends
- Current trends and impacts on biopharmaceutical operations
- The 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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| 09.30 | Case study: cancer vaccine development on the fast track
- A case study in facilities planning for clinical support and scale-up
- Facilities development issues and implications
- Planning policy
- Innovation and implementation
- Increasing the speed to market while decreasing costs
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| 10.00 | Panel session: manufacturing strategies for the future
- 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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| | Confirmed: Sandra Fox, President, HighTech Business Decisions Confirmed: Andrew Sinclair, Co-Founder, Managing Director, UK, Biopharm Services Confirmed: Brendan Fish, Director, Bioprocess Sciences, Cambridge Antibody Technology
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| 10.30 | Morning coffee
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| 11.30 | Process development of biologics: putative impacts of process changes and site transfers
- The costs and benefits of process changes and production site transfers throughout the process
- Finding the “golden way” for process development and production.
- Risk assessment
- Aspects at odds with process changes and their putative impacts: comparability, use of development data as basis for final process validation and cost effectiveness and flexibility
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| 12.00 | Biomanufacturing outsourcing strategies
- The decision of in-house vs.outsourcing manufacturing operations
- How to adapt your company's manufacturing strategy through periods of growth
- Types of contractors available for outsourcing, contractorselection,and pricing practices
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| | Sandra Fox, President, HighTech Business Decisions
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| 12.30 | A New Mixed Mode Chromatography Platform for Large Scale Protein Separation
- New chromatography selectivities
- Complement/ orthogonal to ion exchange or other conventional Chromatography methods
- Scalable to production of therapeutic proteins
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| 13.00 | Lunch
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Conference day one - Working session one - FORMULATION AND DELIVERY
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| 14.15 | Chairman’s opening remarks
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| | Philipp Hess, President and Founder, Philipp Hess Associates
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| 14.30 | Design of biopharmaceuticals: an approach to integrated formulation development
- The need for progress in pharmaceutical development
- Customised pharmaceutical development approaches to fulfill market needs.
- The (more challenging) development of platforms for the assessment of immunogenic potential and formulation tolerability
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| | Amer Jaber, Vice President Lifecycle Management, Global Product Development, Serono International S.A
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| 15.00 | Speed networking
This is a revolutionary, exciting, quick and non-pressurised way to meet fellow conference delegates and industry peers in a one hour session. These brief meetings are the starting point for conservation and networking throughout the conference. This is where long lasting and fruitful relationships begin. Please make sure you bring lots of business cards!
- Meet….move on…meet…move on…meet!
- Exchange business cards with fellow conference delegates, speakers and moderators
- The best networking session you’ve ever experienced
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| 16.00 | Afternoon tea
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| 16.30 | Single use stirred tank bioreactor: a new concept
- Design aspects of the new concept of a single use stirred tank bioreactor
- Design comparison with other disposable and classical bioreactors
- Detailed evaluation of new results of sample cell line cultivation in classical stainless steel bioreactors versus the results in the single use bioreactor
- Scalability and typical applications for single use bioreactors
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| 17.00 | Application of automated cell culture systems to biopharmaceutical development: reducing the process development bottleneck
- Automated high throughput microbioreactor systems
- Production clone selection
- Media optimisation
- Bioprocess optimisation
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| | James Hope, Vice President, Operations, Bioprocessors Corp.
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Conference day one - working session two - CLINICAL TRIAL ISSUES
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| 14.15 | Chairman’s opening remarks
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| 14.30 | Adding value to early stage clinical development of biologics within the framework of the directive
- Achieving quality criteria to enter clinical studies
- Achieving GMP requirements in early stage development
- Turning a hurdle into a benefit for product value
- Applying scientific advice
- Strategic approaches to the Clinical Trial Directive
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| | Niamh Kinsella, Assoicate Director of Regulatory Affairs, ERA Consulting
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| 15.00 | Speed networking
This is a revolutionary, exciting, quick and non-pressurised way to meet fellow delegates and industry peers in a one hour session. These brief meetings are the starting point for conversation and networking throughout the conference. This is where long lasting and fruitful relationships begin. Please make sure you bring lots of business cards!
- Meet….move on…meet…move on…meet!
- Exchange business cards with fellow conference delegates, speakers and moderators
- The best networking session you’ve ever experienced
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| 16.00 | Afternoon tea
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| 16.30 | Clinical quality management for 2006
- Key learning’s 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
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| 17.00 | Pre-clinical and clinical development of avian flu vaccines
- Issues of working with transgenics
- How can the timelines be decreased to meet the demand of a possible pandemic
- Cell line technologies
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| | Confirmed: Otfried Kistner, Senior Director Virology / Viral Vaccines, Baxter AG
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| 17.30 | Close of day one followed by networking boat trip
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Conference day two - Wednesday 21st June 2006
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| 08.00 | Registration
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| 09.00 | Chairman’s opening remarks
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| REGULATION |
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| 09.15 | Critical considerations in the development, technology transfer and validation of a biopharmaceutical product design
- A case study of a lyophilized Protein Product
- Technology transfer issues
- Validation
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| | Feroz Jameel, Prinicpal Scientist Drug Product and Process Development, Amgen Inc
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| 09.45 | The PER.C6® cell line based production platform: process design and change control
- The PER.C6® production platform features
- The production platform and change control during typical CMO projects
- The URS (user requirement specification) approach of documenting process design and managing (future) change control
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| FACILITIES DEVELOPMENT AND DESIGN ISSUES |
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| 10.15 | Process transfer and scale-up of HUMIRATM
- Capacity planning and timing of investments
- Facility design and automation
- Process design for scale up
- Process performance across sites and scale of operation
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| | Peter F. Moesta, Divisional Vice President, Biologicas Manufacturing, Global Pharmaceutical Operations, Abbott Laboratories
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| 11.00 | Morning coffee
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| 11.45 | Case study: start-up of a new large scale facility for microbial and cell culture contract manufacturing
- Formation of multi disciplinary project teams
- Lay-out of building
- Qualification strategy
- Maintenance strategy
- Staffing and training of personnel
- Introduction manufacturing processes in facility
- lessons learned
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| STEM CELL RESEARCH AND ITS IMPACT ON THE INDUSTRY |
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| 12.15 | The gap between the advanced basic research of stem cells and its Industrial therapeutic applications
- How to learn from the classical biotech
- New methodologies
- The missing tools and Instruments
- How to cope with GMP constrains
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| 12.45 | 3-D stromal cell cultures for the expansion of hematopoietic stem cells
- Hematopoietic stem cells and the challenges in bone marrow transplantation
- Pluristem’s breakthrough in BMT: the use of an artificial physiological like
- structure for supporting stem cells expansion
- Stem cell industry model
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| 13.15 | Lunch
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| SCALE-UP, PURIFICATION AND EXTRACTION |
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| 14.15 | High-level protein-producing mammalian cell factories: potential of targeting signals
- Exploiting mRNA targeting to facilitate translation
- A means to increase mAb production
- A means to decrease timeline
- A means to produce difficult to express proteins
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| | Beate Stern, Department of Biomedicine, University of Bergen
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| 14.45 | Case study: hydrocylone, the cell retention system for continuous fermentation
- Development of an integrated perfusion system for production scale bioreactor
- In situ sterilisation
- Scalability
- Suitable for stir tank bioreactors
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| 15.15 | Afternoon tea
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| 16.00 | Panel session: overcoming scale-up issues in downstream processing
- What can be done to decrease timelines?
- Dealing with scale up issues in the face of a possible flu pandemic
- What new developments are being made?
- What is the future?
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| | Moderator: Avinoam Kadouri, Chief Executive Officer, Rainbow Biotechnologies Confirmed: Christian Leist, Head of Bioprocess & Technology Development, Novartis Pharma Ltd
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| 16.45 | Application of HTP microfluidic culture systems to media and process optimisation
- Current workflow limitations in developing media and bioreactor processes.
- Scale-down models for validation in bioreactors
- New microfluidic technologies revealing synergies and predicting optimal conditions for bioreactor performance
- Results of factorial or central composite experiments
- A cost effective way to validate media formulations and bioreactor parameters for scale-up
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| 17.15 | PAT and paralleling: meeting the challenge of speed and quality in bioprocess development
- Biological profiling of production clones as a precondition to reduce costs by increasing success rate in bioprocess development
- Identification, monitoring and closed loop control of critical process parameters to achieve predictable product quality
- Combination of platform technologies to speed up bioprocess development
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| | Christian Leist, Head of Bioprocess & Technology Development, Novartis Pharma Ltd
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| 17.45 | Close of congress
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Diosynth Biotechnology site visit
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| 08.00 | Buses depart from the Hotel Okura to Diosynth facilities
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| 09.30 | Arrival at facility/morning coffee
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| 09.50 | Chairman’s opening remarks
George Koch, Chief Scientific Officer, Head of US Operations and Process development, Diosynth Biotechnology |
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| 10.00 | Rapid development of fed-batch conditions for therapeutic protein production using CHO cells
- Maximising total cell time via rational design of balanced feed media
- Optimising bioreactor conditions to maximize productivity
Arun Tholudur, Senior Scientist, Cell Culture and Fermentation Development, Diosynth Biotechnology |
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| 10.30 | Product development and outsourcing of tumor targeting
IL13-PE38QQR, a protein-cytotoxic agent fusion molecule
- Experiences with clinical trial management
- Setting-up for successful regulatory discussions and how to quickly realise commercialisation
- Fast track process development to support cGMP manufacturing of a complex fusion protein for pivotal clinical trials
Zafeer Ahmed, Vice President Development and Production, NeoPharm
Scott Shepard, Director, Cell Culture and Fermentation Development, Diosynth Biotechnology |
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| 11.15 | Diosynth's approach to process validation, site transfer and pre-approval inspection preparation
- Validation of biological processes
- Do’s and don’ts for site transfer
- FDA pre-approval inspection preparation
Aad van de Leur, Customer Project Leader, Diosynth Biotechnology |
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| 11.45 | Product and clinical development of rhC1INH from the milk of transgenic rabbits for the treatment of hereditary angioedema
- Transgenic animals as a production platform
- Experiences with clinical trial management
- Setting-up for successful regulatory discussions and how to quickly realise commercialisation
- How to set-up and maintain a successful network of collaborators for clinical and commercial supply
Bertjan Ziere, Senior Director Operations and Pre-clinical Development, Pharming Technologies BV |
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| 12.15 | Lunch
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| 13.00 | Diosynth Biotechnology facility overview
Erik van den Berg, Director Marketing and Sales, Diosynth Biotechnology
Europe |
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| 13.15 | Facility tour
- A new parenteral fill/finish Organon facility
- Small scale cell culture commercial manufacturing facility
- A new large scale microbial and mammalian manufacturing facility
- Large scale down stream processing facility
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| 15.00 | Buses depart to Amsterdam with drop-off at the Hotel Okura and Schiphol International airport
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