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Following the success of SMi’s 2003 Conference, this event will address the continuing difficulties Biopharmaceutical companies are experiencing in getting biological products to the market place and will look at how the industry should cope with the recent slow down and the pressures to keep pipelines full.

This contentious area is highly regulated with different standards and expectations in different parts of the globe. The event will evaluate today’s regulations including current best practice, consequences of non-compliance, validation programmes and an update on regulation in the industry, including the FDA’s view on risk assessment and risk management.

The difficulties companies are experiencing in preclinical and clinical development will be discussed with an emphasis on overcoming the hurdles of immunogenicity testing and discussion on why clinical development times in this sector have slowed.

In general there is currently a huge bottleneck in production with companies having to choose between contracting out or going it alone. This event will feature an update on disposable technology in the manufacture of biologics, as well address the difficulties associated with manufacturing capacity and the challenges of scale-up in the biopharmaceutical industry.

A unique opportunity to learn from leading industry experts including:
. Dr Lester Crawford, Deputy Commissioner, Food & Drug Administration (FDA)
· Dr Efi Cohen-Arazi, Vice President, Corporate Manufacturing, Amgen
· Dr Anne-Marie Georges, Director, Regulatory Affairs, Legal & Information, GlaxoSmithKline Biologicals
· Dr David Glover, Chief Medical Officer, Cambridge Antibody Technology
· Dr Steven Projan, Assistant Vice President, Protein Technologies, Wyeth
· Dr Günter Jagschies, Vice President, Bioprocess Separations, Amersham Biosciences
· Dr Ronald Ellis, Senior Vice President, Research & Development & General Manager, Shire Biologics
· Prof John Birch, Chief Scientific Officer, Lonza
· Dr Hans-Joachim Wallny, Group Head Bioassay, Biotechnology Development, Novartis
· Dr Peter Robins, Consultant Regulatory Scientist, Eli Lilly

The essential event on:
· THE CHALLENGES FACING BIOPHARMACEUTICAL MANUFACTURERS IN 2004: Accounting for the continuing industry slowdown and discussing the consequences for manufacturing demand
· THE REGULATORY HURDLE: An update on the impact of the Clinical Trials Directive, getting approval from the Ethics Committee and securing a competitive label in the long run
· MANUFACTURING GENERIC BIOLOGICS: A discussion of generic drugs in the pipeline and predictions for the future impact of generic biopharmaceuticals
· DEVELOPMENTS IN THE MANUFACTURE OF VACCINES: Covering the current position of the FDA, contract manufacturing in the industry and value added activities in the production process
· DISPOSABLE MANUFACTURING & TECHNOLOGY TRANSFER: Innovations to improve efficiency in the production process

“Excellent conference bringing together a variety of development and manufacturing disciplines and approaches to biopharmaceutical manufacturing.”
Judith Sernatinger, Director, Cambridge Quality, Biogen

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Keith Chidwick

Dr Keith Chidwick, Pharmaceutical Assessor, MHRA

9:10 COMBATING THE BIOLOGIC MANUFACTURING PROBLEM

Peter Ketelaar

Peter Ketelaar, Manager, New Business Development, DSM Biologics

  • Accounting for the (continuing?) slowdown: pipeline development and consolidation in biotech
  • Consequences for manufacturing demand: clinical and commercial material
  • From capacity crunch in 2001/2002 to overcapacity now
  • How can pharma and biotech increase the number of drugs in the pipeline?
  • Getting through the bottleneck
  • The challenges for contract manufacturing organizations
  • 9:40 CHALLENGES IN THE DEVELOPMENT AND PRODUCTION OF VACCINES

    Dr Ronald Ellis

    Dr Ronald Ellis, Senior Vice President, Research & Development & General Manager, Shire Biologics

  • New technologies for producing vaccines
  • Defining strategy early in the development program
  • Assuring that early technical development meets regulatory needs
  • Clinical strategy
  • 10:20 CHALLENGES FOR BIOTECH COMPANIES

    Dr David Glover

    Dr David Glover, Chief Medical Officer, Cambridge Antibody Technology

  • Identifying the major hurdles
  • Regulatory guidelines and requirements
  • Scientific issues
  • Producing material for testing
  • Clinical trial design and other issues
  • Funding a quality programme
    Chances of success
  • 11:00 Morning Coffee

    11:20 THE REGULATORY CHALLENGE

    Dr Charles Zezza

    Dr Charles Zezza, Consultant Regulatory Scientist, Eli Lilly

  • Start with the end in mind
  • What are your ‘needs’ and ‘wants’?
  • Securing a competitive label
  • Preparing a ‘perfect’ dossier
  • 12:00 THE CLINICAL TRIALS DIRECTIVE AND ITS APPLICATION TO BIOLOGICAL MEDICINAL PRODUCTS

    Dr Anne-Marie Georges

    Dr Anne-Marie Georges, Director, Regulatory Affairs, Legal and Information, GlaxoSmithkline Biologicals

  • General issues with the Directive
  • Ethics Committee approval
  • Regulatory dossier requirements
  • Approval procedure by regulatory authorities
  • Delays to clinical research with biologicals
  • Generics to biologicals: new rule in the EU
  • 12:40 Networking Lunch

    13:40 THE CURRENT REGULATORY ISSUES AFFECTING THE BIOTECH INDUSTRY

    Scott Gottlieb

    Scott Gottlieb, Director of Medical Policy Development, Food & Drug Administration (FDA)

  • FDA's measures to facilitate production of biological products by reforming the current Good Manufacturing Practices for the industry
  • The background and impact of the agency's consolidation of the processing of all therapeutic products in FDA's Center for Drug Evaluation and Research
  • The meaning and implementation of the US Project Bioshield
  • FDA's program to enhance and encourage the development of vaccines and drugs for the prevention and treatment of potential agents of terrorism, such as anthrax, smallpox, bubonic plague and tularemia
  • 14:20 BIOASSAY DEVELOPMENT: CHALLENGES AND CHANCES

    Dr Hans-Joachim Wallny

    Dr Hans-Joachim Wallny, Group Head Bioassay, Biotechnology Development, Novartis

  • Regulator’s perspective on potency assays vs a manufacturer’s position
  • Update on ongoing revisions of USP Chapter <111> and EP chapter 5.3
  • Bioassay methodology
  • Problems and trouble shooting
  • 15:00 CASE STUDY

    Miriam Monge

    Miriam Monge, European Marketing Manager, STEDIM

  • Presentation of facility design
  • Disposable ‘work-stations’
  • Kleenpak disposable Aseptic Connector and IDC sterile fluid transfer technology – impact on layout
  • Economic analysis – COG, capital, time to market
  • 15:40 Afternoon Tea

    16:00 PROJECT MANAGEMENT IN BIOPHARMACEUTICAL DEVELOPMENT

    Dr Elise Brownell

    Dr Elise Brownell, Project Director, Bayer

  • Why is biopharmaceutical development so complex?
  • What elements of process development and manufacturing are strategic choices?
  • What is the value of connecting operational/logistical and R&D elements early in development?
  • What are some useful tools for maximizing strategic and tactical alignment?
  • 16:40 Electronic Batch Recording in Biotech Manufacturing

    Lars Hornung

    Lars Hornung, Manager, Sales & Business Consulting, Werum Software & Systems AG

    17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Dr Elise Brownell

    Dr Elise Brownell, Project Director, Bayer

    9:10 SETTING THE STAGE FOR SUCCESSFUL TECHNOLOGY TRANSFER

    Dr Don Bergmann

    Dr Don Bergmann, General Manager, GlaxoSmithKline Biopharmaceuticals

  • Factors affecting technology transfer costs, schedules and subsequent manufacture
  • Structuring and managing the client/supplier relationship
  • GSK model for technology transfer
  • 9:40 CHALLENGES IN THE DEVELOPMENT AND MANUFACTURE OF HIGH-CONCENTRATION PROTEIN FORMULATIONS FOR OUTPATIENT ADMINISTRATION

    Dt Steven Shire

    Dt Steven Shire, Staff Scientist, Genentech

  • Manufacturing challenges
  • Stability challenges
  • Analytical challenges
  • All the above to be considered using a case study development of a Mab
  • 10:20 DELIVERY SYSTEMS FOR MACROMOLECULE DRUGS

    Dr Linda Hakes

    Dr Linda Hakes, Senior Vice President, Preclinical Development, Schwarz BioSciences

  • Formulation challenges of macromolecules
  • Balancing scientific and market needs
  • Consideration of the patient’s view
  • Delivery systems today and tomorrow
  • 11:00 Morning Coffee

    11:20 PROCESS DEVELOPMENT FOR MONOCLONAL ANTIBODIES

    Dr Andrew Racher

    Dr Andrew Racher, Principal Scientist, Lonza

  • Industry drivers
  • Expression and fermentation improvements
  • Downstream improvements
  • Hopes for the future
  • 12:00 MICROBIAL MANUFACTURING PROCESSES FOR ANTIBODY FRAGMENTS

    Dr Leigh Bowering

    Dr Leigh Bowering, Fermentation Group Leader, Celltech

  • Expression of antibody fragments in E coli
  • Development of manufacturing processes
  • Technology transfer to contract manufacturing
  • Experiences of scaling-up manufacturing processes
  • 12:40 Networking Lunch

    14:00 SMALL MOLECULES OR BIOLOGICS

    Dr Steven Projan

    Dr Steven Projan, Assistant Vice President, Protein Technologies, Wyeth

  • Why are orally bioavailable small molecule drugs the Holy Grail of the pharmaceutical industry?
  • Are small molecule drugs more profitable than biologics?
  • How does one choose small molecule vs protein-based approaches to novel therapeutics?
  • Why does it take longer to develop biologics than small molecules? Or is this just a myth?
  • 14:40 THE MANUFACTURE OF VACCINES

    Dr Joseph Santangelo

    Dr Joseph Santangelo, Associate Director, Microscience

  • The position of the FDA
  • Contract manufacturing for vaccines
  • Value added activities in process and assay development
  • Securing long-term manufacturing
  • Case studies
  • 15:20 MANUFACTURING GENERIC BIOLOGICS

    Dr Günter Jagschies

    Dr Günter Jagschies, Vice President, Bioprocess Separations, Amersham Biosciences

  • Why the turn to generics?
  • Update on generic drugs in the pipeline - Insulin - Human growth hormone - Urokinase
  • The current position of the FDA
  • Patent wars
  • Projections for the future
  • 16:00 Chairman's Closing Remarks and Close of Conference

    +

    Workshops

    Scale-Up for Biologicals
    Workshop

    Scale-Up for Biologicals

    The Hatton, at etc. venues
    10th March 2004
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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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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