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This conference will address the difficulties Pharmaceutical companies are experiencing in getting biological products to the market place. This contentious area is highly regulated with different standards and expectations in different parts of the globe. As a consequence some parts of the world are favoured over others for the manufacturing of biologicals. In general there is currently a huge bottleneck in production with companies having to choose between contracting out or going it alone.

There will be talks on current regulations including current best practice, consequences of non-compliance, validation programmes and 21 CFR part 11. These will be supported by case studies. Current trends in biomanufacture and validation will also be presented with talks on managing capacity, cleaning validation, quality systems, the use of disposables and the challenges of scale-up.

Pre-clinical and clinical development will also be covered with an emphasis on overcoming the hurdles of immunogenicity of testing human proteins in animals.

As biological products reach the end of their market exclusivity, opportunities for generics abound for the clued-up Pharma company. This conference will also cover biological generics, particularly the challenges companies face concerning the demonstration of biological equivalence.

A unique opportunity to learn from leading industry experts including:
· Dr John Birch, Chief Scientific Officer, Lonza
· Dr Elise Brownell, Project Director, Bayer
· Dr David Glover, Chief Medical Officer, Cambridge Antibody Technology
· Dr Frank Brennan, Project Director Biopharmaceuticals, Huntingdon Life Sciences
· Prof Dr Rolf Werner, Corporate Director, Biopharmaceuticals, Boehringer Ingelheim
· Prof Klaus Cichutek, Vice President, Paul Ehrlich Institute
· Peter Ketelaar, Manager, New Business Development, DSM Biologics

“An extraordinarily important subject”
Prof Mike Hoare, Head & Director, IMRC for Bioprocessing, University College London

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Keith Chidwick

Dr Keith Chidwick, Pharmaceutical Assessor, MHRA

9:10 OVERVIEW

Dr David Glover

Dr David Glover, Chief Medical Officer, Cambridge Antibody Technology

  • Successes in the market place
  • Hurdles to be overcome
  • Manufacturing issues
  • Safety concerns - immunogenicity - novel technology
  • Lack of regulatory guidelines
  • Regulatory requirements

    Clinical trial challenges

  • 9:40 MANUFACTURING STRATEGIES IN A GROWING MARKET SECTOR

    Dr Amber Gibson

    Dr Amber Gibson, Analyst, Datamonitor

  • Commercial potential of the therapeutic research and development pipeline
  • Areas of growth
  • Areas of unmet need
  • Shortfall of biologics manufacturing capacity
  • Implications for future market growth
  • Optimizing biogeneric defence strategies
  • 10:20 TECHNOLOGY TRANSFER

    Prof Dr Rolf Werner

    Prof Dr Rolf Werner, Corporate Director, Biopharmaceuticals, Boehringer Ingelheim

  • Activities and timelines
  • Technology adaptation
  • Scale-up for commercial production
  • Proprietary know-how
  • Product identity and bio-equivalence
  • 11:00 Morning Coffee

    11:20 MANUFACTURING BIOPHARMACEUTICALS FOR EARLY STAGE CLINICAL TRIALS

    Andrew Lewin

    Andrew Lewin, Director, Business Development, Cobra Biomanufacturing

  • Case report – gene therapy products
  • Unsuitability of current antibiotics
  • Antibiotic free process
  • Scaling up experiences
  • Building an intellectual property portfolio
  • 12:00 APPROACHING CLINICAL TRIALS FOR ANTIBODY THERAPEUTICS

    Dr Cristina Glad

    Dr Cristina Glad, Executive Vice President, BioInvent

  • Strategic planning
  • Regulatory standards
  • Development, scale-up, manufacturing and validation
  • Product characterisation and stability
  • Technology transfer
  • 12:40 Networking Lunch

    14:00 DEVELOPMENT AND REGULATION OF GENE TRANSFER MEDICINAL PRODUCTS

    Prof Klaus Cichutek

    Prof Klaus Cichutek, Vice President, Paul-Ehrlich Institut

  • Definition of biotechnology-derived products
  • Current clinical studies
  • Clinical trial regulation
  • Changes according to GCP directive
  • 14:40 WORKING TO FDA RULES FOR MANUFACTURE IN EUROPE

    Dr Mark Carver

    Dr Mark Carver, Head, Research & Development, Avecia Biologics

  • A growing need
  • Manufacture of recombinant proteins
  • Technology transfer of production platform
  • ICHQ7a
  • Process development process validation and manufacture
  • FDA requirements

    Recognition of MCA

    Future developments and trends

  • 15:20 EARLY PRE-CLINICAL TESTING PRIOR TO PHASE 1 TRIALS

    Dr Frank Brennan

    Dr Frank Brennan, Project Director, Biopharmaceuticals, Huntingdon Life Sciences

  • Design of pre-clinical safety testing programmes
  • Case studies - Monoclonal antibodies - Vaccines - Recombinant proteins - Gene therapy and somatic cell products
  • Key issues in the safety assessment of these products
  • 16:00 Chairman’s Closing Remarks followed by Afternoon Tea
    Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Prof Mike Hoare

    Prof Mike Hoare, Head & Director, IMRC for Bioprocessing, University College London

    9:10 GENERIC BIOTECHS: A REALITY OR DREAM?

    Cecil Nick

    Cecil Nick, Senior Regulatory Consultant, Parexel

    9:40 MANAGING YOUR WAY OUT OF THE SUCCESS TRAP

    Geoff Tomlinson

    Geoff Tomlinson, Principal, PRTM

  • Drivers of post-launch capacity shortages in biologics manufacture
  • Issues arising from shortages
  • Importance of early identification of potential issues
  • Framework for response - Supply management - Product flow management - Demand management
  • Key success factors of implementation
  • 10:20 LARGE SCALE PEPTIDE MANUFACTURING

    Dr Vincent Bille

    Dr Vincent Bille, Peptide Business Unit & Formulation Business Unit Manager, UCB –Bioproducts

  • Scale up issues
  • Solid-phase, liquid-phase and fragment condensation synthesis
  • Separation technologies
  • Large-scale preparative HPLC
  • Bulk lyophilization
  • Regulatory challenges
  • 11:00 Morning Coffee

    11:20 AVOIDING THE CLEANING ISSUE

  • Benefits of disposables over conventional manufacturing materials
  • Overview of disposable technology
  • First hand experiences of the use of disposables
  • Going it alone versus contract manufacturing
  • Economic factors
  • Satisfying the regulators
  • Peter Ketelaar

    Peter Ketelaar, Manager, New Business Development, DSM Biologics

    Miriam Monge

    Miriam Monge, European Marketing Manager, STEDIM

    12:00 OPTIMISING MAMMALIAN CELL CULTURE PROCESSES

    Prof John Birch

    Prof John Birch, Chief Scientific Officer, Lonza Group

  • Drivers for optimization: speed, yield
  • Expression technology: GS gene expression system
  • Metabolic engineering to improve cell performance
  • Optimisation of fermentation processes
  • 12:40 Networking Lunch

    14:00 PROCESS DEVELOPMENT STRATEGIES

    Richard Francis

    Richard Francis, Manager, Operations Support, Protherics

  • Generic process applications
  • Cycle time reduction
  • Improving purification
  • Increasing speed and reducing costs
  • Regulatory considerations relating to protein purification
  • 14:40 VALUE-ADDED PROJECT MANAGEMENT FOR BIOPHARMACEUTICAL DEVELOPMENT

    Dr Elise Brownell

    Dr Elise Brownell, Project Director, Bayer

  • How is value-added project management defined?
  • What are the key critical path activities and risks in early biopharmaceutical development?
  • What tools can a project manager use to manage expectations?
  • 15:20 Afternoon Tea

    15:40 ADDING VALUE TO PRODUCT DEVELOPMENT THROUGH OUTSOURCING

    Dr Joseph Santangelo

    Dr Joseph Santangelo, Associate Director, Chemistry Manufacturing Control, Microscience

  • Working within the constraints of a small biotech company
  • Outsourcing - reducing costs or reducing risks?
  • Project planning and the role of the outsource partner
  • Responsibilities and expertise of the biotech company
  • Responsibilities and expertise of the outsource partner
  • Adding value - a case study
  • 16:20 DEIMMUNISATION™

    Dr Frank Carr

    Dr Frank Carr, Chief Executive Officer, Biovation

  • DeImmunisation™ involves the identification and removal of human helper T cell epitopes from therapeutic antibodies and proteins
  • Biovation has developed a toolbox of technologies to identify such T cell epitopes, ranging from an in silico peptide-MHC ‘docking’ technology (‘Peptide Threading’) to in vitro human T cell assays
  • Epitopes are subsequently eliminated by amino acid substitutions within the molecule
  • The optimised therapeutic molecule has a greatly reduced risk of immunogenicity
  • DeImmunisation™ modified biologics are being evaluated in clinical trials
  • 17:00 Chairman's Closing Remarks and close of Conference

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    Workshops

    Immunogenicity of Recombinant Biological Therapeutics – A Practical Approach
    Workshop

    Immunogenicity of Recombinant Biological Therapeutics – A Practical Approach

    The Hatton, at etc. venues
    21st March 2003
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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