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Drug Delivery Global Summit
21 September - 22 September 2005
Drug Delivery Global Summit

The demand for drug delivery systems is growing and the industry is at the forefront of innovation, with exciting new technologies threatening to break onto the market. SAE Media Group’s 2nd Annual Drug Delivery Global Summit will provide delegates with vital information and analysis of important developments driving the drug delivery industry and share key insights into oral, subcutaneous protein, pulmonary and injectable drug delivery methodologies.

This event will explore current market sizes, including drivers and shapers, an analysis of key trends and present unique case studies from top pharmaceutical companies and drug delivery specialists as they discuss best practices for development. Attendees are also kept up-to-date on new screening conditions to overcome poor oral bioavailability and product opportunities with Nanocrystal technology. Key features include: challenges and approaches to developing an oral drug delivery product, life cycle management and an analysis of novel approaches to the clinical development of modified release products.

The Drug Delivery Global Summit will provide an excellent opportunity to network with international experts, from drug delivery specialists to top pharmaceutical and biotech companies.

A unique opportunity to learn from leading industry experts including:

  • Dr Padmanabh Bhatt, Vice President, Advanced Drug Delivery, Shire Laboratories
  • Dr Jörg Breitenbach, Director & Head, Drug Delivery Business (SOLIQS), Abbott Laboratories
  • Dr Joel Richard, Director, Pharmaceutical Development, Serono
  • Dr Li Shi, Senior Research Fellow & Group Leader, Merck
  • Dr William Bosch, Director, Pharmaceutical Research, Elan NanoSystems
  • Dr Larry Brown, Chief Technology Officer, Epic Therapeutics (a subsidiary of Baxter Healthcare)
  • Dr Tomas Landh, Research Scientist, Novo Nordisk

Conference agenda

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13:30

Registration & Coffee

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14:00

Device specification

  • How to get from where you are to where you want to be
  • Importance of a "living" spec and how it drives the process
  • Device target profile (user requirements specification)
  • Detailed profile (functional requirements specification)
  • Managing risk – what are the hard issues/challenges?
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    14:40

    Technology

  • Identification: what do we want, what must it do?
  • Shortlist and selection: how could this be done, what are the choices?
  • Make or buy: can we develop this, or could we buy/license it in?
  • Licensing support: how do we select and proceed with licensing partner(s)?
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    15:20

    Afternoon Tea

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    15:35

    Device development process

  • The innovation management continuum: creativity, theory, structure from concept to post-launch
  • Risk management and mitigation, project control: navigating the route
  • Designing specifically for pharmaceutical application: managing an asynchronous development process (entity vs device)
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    16:35

    Device manufacturing issues

  • Process capability: can it be made rationally, economically and repeatable?
  • Quality plan, including verification and validation: can we make it at all? Can we make it every time?
  • Design for manufacture and assembly: can we make it commercially?
  • GMP/CGMP: can we make it in compliance with appropriate standards and regulations?
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    17:15

    Discussion & questions – review of session

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    17:30

    Close of Executive Briefing

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Linda Hakes

    Linda Hakes, Senior Vice President, Preclinical Development, Schwarz Biosciences

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    9:10

    SUPER CRITICAL FLUID TECHNOLOGY FOR PARTICLE EGINEERING AND DELIVERY OF BIOPHARMACEUTICALS

    Joel Richard

    Joel Richard, Director, Pharmaceutical Development, Serono

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    9:50

    LIFE CYCLE MANAGEMENT AND POORLY SOLUBLE

  • Factors surrounding bioavailability and solubility
  • Formulation strategies fostering life cycle management
  • Drug delivery technologies to combat poor aqueous
  • Joerg Breitenbach

    Joerg Breitenbach, Director, Head of Drug Delivery Business (SOLIQS), Abbott

    Joerg Breitenbach

    Joerg Breitenbach, Director, Head of Drug Delivery Business (SOLIQS), Abbott

    Jörg  Rosenberg

    Jörg Rosenberg, Associate Director, Pharmaceutical Development SOLIQS, Abbott

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    10:30

    Morning Coffee

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    11:00

    PRODUCT OPPORTUNITIES WITH NANOCRYSTAL™ TECHNOLOGY

    William Bosch

    William Bosch, Director, Pharmaceutical Research, Elan Nano Systems

  • Improved oral bioavailability of poorly soluble drugs
  • Biocompatible parenteral formulations
  • ‘Solutions’ to liquid product development
  • Discovery screening support
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    11:40

    BARRIERS AND OPPORTUNITIES FOR THE DEVELOPMENT

    Mark Humphries

    Mark Humphries, Management Group Consultant, PA Consulting Group

  • Nanoscience and technology developments
  • Manufacturing process development
  • Barriers and opportunities
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    12:20

    Networking Lunch

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    13:50

    CHALLENGES IN PEPTIDE AND PROTEIN DELIVERY

    Pierandrea Esposito

    Pierandrea Esposito, Senior Consultant, Drug Delivery & Devlopment, SiTec Consulting

  • Trends and changes in protein and peptide drug development
  • Applying drug delivery at early stage of drug development
  • Strategic choices, risks and benefits: new delivery technologies or molecular design?
  • Emerging delivery technologies for new types of biomolecules
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    14:20

    DRUG DELIVERY OF PROTEIN ANTI-DIABETICS

    Tomas Landh

    Tomas Landh, Research Scientist, Novo Nordisk

  • Current drug delivery systems applied to insulin therapies
  • Emerging insulin therapies using advanced drug delivery systems
  • Other anti-diabetic therapies using drug delivery
  • Emerging non-insulin diabetes therapies using advanced drug delivery systems
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    15:10

    Afternoon Tea

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    15:40

    NEEDLE-FREE DELIVERY OF PROTEINS

    Mike Redmond

    Mike Redmond, Senior Vice President, Business Development, Bioject Inc

  • Delivery of proteins via jet injection technology
  • Pre-filled needle-free technology development
  • Advantages of needle-free delivery
  • Case study: injecting HGH with needle-free technology
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    16:20

    PROTEIN MICROSPHERES FOR PULMONARY AND INJECTABLE APPLICATIONS

    Larry Brown

    Larry Brown, Chief Technology Officer, Epic Therapeutics

  • Essentially pure drug microsphere compositions
  • Delivery of nucleic acids
  • Novel monoclonal antibody formulations
  • Pulmonary PROMAXX insulin formulations
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    17:00

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Linda Hakes

    Linda Hakes, Senior Vice President, Preclinical Development, Schwarz Biosciences

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    9:10

    IMPROVING ANTIGEN DELIVERY

    Li Shi

    Li Shi, Associate Director, Biologics and Vaccines, Pharmaceutical R&D, Merck Research Laboratories

  • Challenges of vaccine dosage from development
  • Compatibility of microsphere formulation for vaccines
  • Sustained-release vaccine preparation
  • Pharmaceutical characterisation
  • Immunological evaluation
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    9:50

    DELIVERY DEVICES FOR SUBCUTANEOUS PROTEIN

    Morten Baek Jensen

    Morten Baek Jensen, Senior Principal Scientist, Novo Nordisk

  • Problems and unmet needs of patients and healthcare providers
  • Emerging technologies in protein delivery by injection
  • Emerging technologies in protein delivery by infusion
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    10:30

    Morning Coffee

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    11:40

    DELIVERY OF BIOTHERAPEUTICS BY INHALATION

    Sujata Mudumba

    Sujata Mudumba, Senior Scientist, Aradigm Corporation

  • Conventional inhalation therapies
  • Novel inhalation therapies and challenges
  • Formulation strategies for inhalation
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    12:20

    Networking Lunch

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    13:50

    CHALLENGES AND APPROACHES FOR DEVELOPING AN

    Padmanabh Bhatt

    Padmanabh Bhatt, Vice President, Advanced Drug Delivery , Shire Labs

  • Screening for solutions to overcome the identified challenge/s
  • Evaluating the region of absorption issue for extended release
  • Identifying the controlled release technology to design the product
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    14:30

    NOVEL APPROACHES TO THE CLINICAL DEVELOPMENT OF MODIFIED-RELEASE (MR) PRODUCTS

    Paul Clewlow

    Paul Clewlow, Business Development Director, Pharmaceutical Profiles

  • Human drug absorption studies, using engineering-based capsules, are widely used to focus the development of oral MR products - examples will be presented
  • Pharmacoscintigraphy studies (PK & gamma scintigraphy) provide critical evidence of human in vivo performance of oral MR products - examples will be presented
  • These novel clinical studies help focus the MR product development strategy and enhance the chance of success
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    15:20

    PAEDIATRIC AND GERIATRIC DRUG DELIVERY

  • Issues with the use of conventional dosage forms
  • Alternative formulation approaches
  • Taste and compliance
  • Approaches used to overcome unpleasant drug taste
  • Steve Ellul

    Steve Ellul, Director, Business Development, Eurand

    Alen Guy

    Alen Guy, Associate Director, Business Development, Eurand

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    16:20

    DEVELOPMENT OF NEW PARTICLE TECHNOLOGIES FOR DRUG DELIVERY

    Carl Lentz

    Carl Lentz, Worldwide Director, Technology, Ferro International

  • Demonstrate potential advantages and unmet needs
  • Define links between the drug delivery applications and appropriate particle production techniques
  • Select formulation methods suitable for different drug delivery routes
  • Achieve GMP and scale-up transition
  • Appreciate the value of new manufacturing technologies in the drug product development
  • Address collaborative business issues and commercial strategies
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    17:00

    Chairman’s Closing Remarks and Close of Conference

    Linda Hakes

    Linda Hakes, Senior Vice President, Preclinical Development, Schwarz Biosciences

    Workshops

    Drug Delivery Devices: Making the right decisions

    Drug Delivery Devices: Making the right decisions

    Venue To Be Confirmed
    20 September 2005
    London, United Kingdom

    Hilton London Metropole

    225 Edgware Road
    London W2 1JU
    United Kingdom

    Hilton London Metropole

    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, SAE Media 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@saemediagroup.com

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