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Technology Transfer is an important stage for any Pharmaceutical or Biotech company, SMi recognises this is and is proud to announce its inaugural conference Technology Transfer in the Pharmaceutical & Biotech Industries. This conference aims to bring together leading industry experts to discuss the current market, best practices and strategies for success.

SMi’s Technology Transfer in the Pharmaceutical & Biotech Industries conference will promote further discovery of technology trends, define principles of technology transfer and update you on the latest legislation governing the process; who is responsible? What information is required? How do you comply? Key speakers will also identify successful management strategies and relevant case studies to demonstrate effective technology transfer projects.

A must attend event giving you access to practical advice from leading industry experts.

Speakers at the 2005 event include:

  • Dr Bill Vennart, Senior Director, Global Clinical Technology, Pfizer
  • Dr Brendan Hughes, Director, Development, Wyeth
  • Richard Fazackerley, QA Validation Team Leader, Eli Lilly
  • Andrew Eibling, Alliance Manager, Eli Lilly
  • Dr Suketu Desai, Principal Scientist, Process Sciences, Global Biologics Supply Chain, LLC (a wholly owned subsidiary of Johnson & Johnson)
  • Dr Feroz Jameel, Principal Scientist, Drug Product Process Development, Amgen
  • Dr John Kilama, President, Global Bioscience Development Institute
  • Dr Christian Wichard, Deputy Director, WIPO Arbitration & Mediation Centre

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

John Kilama

John Kilama, President, Global Bioscience Development Institute

9:10 DEFINING A TECHNOLOGY TRANSFER

John Kilama

John Kilama, President, Global Bioscience Development Institute

  • Principles of the technology transfer process
  • Definition of technology transfer
  • The framework for technology transfer
  • Benefits of using technology transfer
  • 9:50 RECENT TRENDS IN THE PHARMACEUTICAL MARKET

    Richard Fazackerley

    Richard Fazackerley, QA Validation Team Leader, Eli Lilly & Company

  • Trends and changes in the external environment
  • Changes - temporary or structural?
  • Looking around the corner – new market scenario’s
  • Technology transfer – implications and impacts
  • 10:30 Morning Coffee

    11:00 TRANSFER OF IMAGING TECHNOLOGIES FOR EARLY DECISION-MAKING IN CLINICAL TRIALS FOR DRUG DEVELOPMENT

    Bill Vennart

    Bill Vennart, Senior Director, Global Clinical Technology, Pfizer UK

  • How do imaging technologies aid drug development?
  • What are the issues around validating these technologies?
  • How is transfer of knowledge achieved?
  • What are the key issues for a collaboration between Universities and the Pharmaceutical Industry?
  • What and how much data needs to be transferred?
  • What publication policy should be followed?
  • 11:40 WHAT IS REQUIRED FOR PRE-APPROVAL?

  • Who is responsible for what?
  • What information is required?
  • Compiling the information
  • Overview of the Technology Transfer Block Exemptions (TTBE)
  • The impact of new TTBE guidelines on the pharma and biotech industries
  • Ben Prickril

    Ben Prickril, Chief Scientific Officer, Biovision

    Justin Watts

    Justin Watts, Partner, Freshfields Bruckhaus Deringer

    12:20 Networking Lunch

    13:50 KNOWLEDGE TRANSFER

    Jolyon White

    Jolyon White, Technology Consultant, London Technology Network

  • Where the deal begins
  • Drivers for the relationship
  • Barriers to completion of the deal
  • The value of the relationship in the valorisation of the deal
  • Is there a role for a third party as broker, deal-maker or facilitator? If so, what is the optimum structure and process?

  • 14:30 TECHNOLOGY TRANSFER TO A START-UP SITE

    Brendan Hughes

    Brendan Hughes, Director of Development, Wyeth

  • Integration of site start-up and technology transfer
  • Key enabling factors
  • Unique challenges
  • Key business processes
  • Outcomes
  • 15:10 Afternoon Tea

    15:40 CONDUCTING TECHNOLOGY TRANSFER FOR MANUFACTURING TO A NEW SITE

    Suketu Desai

    Suketu Desai, Principal Scientist, Process Sciences, Global Biologics Supply Chain (a Johnson & Johnson Company)

  • Description, types, needs and phases of the technology transfer process
  • Phase III/commercial scale manufacturing of lyophilised biopharmaceuticals at a new site
  • Site selection – in-house vs contract manufacturing
  • Formulation composition, materials and components
  • Equipment – shakedown and validation
  • Manufacturing process – development, optimisation and validation
  • Analytical methods and validation – IPC, release and stability
  • Regulatory submission and commercialisation support
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Brendan Hughes

    Brendan Hughes, Director of Development, Wyeth

    9:10 AN INTEGRATED TECHNOLOGY TRANSFER PLAN

    Feroz Jameel

    Feroz Jameel, Principal Scientist, Amgen

  • Specifications
  • Scale-up and research
  • Maintaining consistency and quality
  • Technology transfer from R&D to development
  • Validation and production
  • Feedback and documentation
  • 9:50 INVESTMENT AND VENTURE CAPITAL

    Nessan Bermingham

    Nessan Bermingham, Principal in the Life Sciences Sector, Atlas Venture

  • Benefits of venture capital
  • What are the risks for investors?
  • What are the risks for the pharma and biotech industries?
  • What is expected in return?
  • What do venture capitalists consider for an investment?
  • 10:30 Morning Coffee

    11:00 COMMUNICATION IN TECHNOLOGY TRANSFER ALLIANCES

    Andrew Eibling

    Andrew Eibling, Alliance Manager, Eli Lilly

  • Communication challenges – what can go wrong?
  • Managing expectations
  • Investing in up-front foundational planning
  • Tools for success
  • 11:40 MEDIATION AND ARBITRATION OF TECHNOLOGY TRANSFER DISPUTES

    Christian Wichard

    Christian Wichard, Deputy Director, WIPO Arbitration and Mediation Center

  • Role and experience of the WIPO Arbitration and Mediation Centre
  • Main steps in WIPO mediation, WIPO arbitration and WIPO expedited arbitration
  • WIPO arbitration case study; a pharma-biotech dispute
  • 12:20 Networking Lunch

    14:00 PANEL DISCUSSION

  • What types of technologies are available – innovative vs commodity?
  • Globalisation and the acquisition of technologies
  • What are the right environmental conditions for sustaining technology transfer?
  • Examining policy, legal systems, regulations, IP systems and funding
  • John Kilama

    John Kilama, President, Global Bioscience Development Institute

    Jolyon White

    Jolyon White, Technology Consultant, London Technology Network

    Christian Wichard

    Christian Wichard, Deputy Director, WIPO Arbitration and Mediation Center

    14:40 TECHNOLOGY TRANSFER REQUIREMENTS FOR PAT

    Ingrid Maes

    Ingrid Maes, Senior Consultant, Innovative Technology, Siemens, Europe

  • Aims of PAT
  • Data acquisition and analysis tools
  • Advanced sensor use
  • Process monitoring and control
  • Continuous improvement and knowledge management
  • 15:20 RESPONDING TO EVOLVING REGULATORY PAT DEMANDS DURING TECHNOLOGY TRANSFER

  • Case studies on the application of PAT techniques in late-stage product development
  • Incorporating the most up-to-date concepts of risk management
  • Development of the process design space
  • Potential regulatory flexibility and concessions
  • Process robustness and continuous improvement
  • Paul Stott

    Paul Stott, Associate Director, Research & Technology, Product Development, AstraZeneca

    Lesley Mackin

    Lesley Mackin, Associate Principal Scientist, AstraZeneca

    16:00 Chairman’s Closing Remarks and Close of Day One

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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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