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The need to employ innovative strategies and business ideas in order to expand and improve drug delivery technologies has never been more crucial, playing a vital part in developing drug pipelines.

‘Commercial Issues in Drug Delivery’ aims to cover key issues to carry your business forward to commercial and competitive success.

The conference will discuss and evaluate partnering and collaboration strategies, product lifecycle management, strategies for attracting investment, pricing and reimbursement issues, portfolio management etc. and will provide a platform for companies to stay abreast of the very latest developments in the drug delivery industry.

This conference is looking to cover the requirements of both big pharmaceutical companies and drug delivery companies when evaluating their business models, as well as evaluating the current and future market opportunities.

The importance of drug delivery systems is emerging as a key to product differentiation. The availability of advanced delivery technologies is essential for commercial success. Commercial Issues in Drug Delivery aims to cover key issues, such as partnering strategies and lifecycle management and provide a platform for companies to stay abreast of the latest developments in the drug delivery industry.

This conference will address the requirements of both big pharma companies and drug delivery companies when evaluating their business models. It will also look at the commercial opportunities for drug delivery companies to manufacture their own drugs as well as the current and future market opportunities. The conference will also look at practical case studies.

A unique opportunity to learn from leading industry experts including:
· Dr Gary Cupit, Vice President, Global Business Development & Licensing, Novartis
· Dr Ross MacRae, Manager, Pharmaceutical Research & Development, Pfizer
· Morten Baek Jensen, Executive Assistant, Manager, Strategic Support, Protein Delivery Systems, Novo Nordisk
· Ilkka Kivi, Technology Manager, Schering
· Dr Krishna Balakrishnan, Marketing Group Leader, National Institutes of Health
· Dr Gesine Hildebrand, Modified Drug Release, Schering
· Dr Philip Smith, Investment Manager, SR One
· Stephen Ellul, Director, European Licensing, Elan
· Ian Siragher, Commercial Development Manager, Nektar Therapeutics

Key benefits of attending:
THE CHALLENGE OF COMMERCIALISATION: from pilot plant proof to commercial scale reality
BUILDING AND MANAGING A DEAL: learn about latest strategies on how to manage strategic alliances
SUCCESSFUL COLLABORATION MANAGEMENT: discover how to avoid the icebergs
SPECIALTY PHARMA: hear from a company in transition
FUNDING A DRUG DELIVERY COMPANY: gain insight into the challenge of building a sustainable business model

“What makes this conference particularly interesting, apart from the quality of the speakers, is the coverage of widely different but all important issues of the drug delivery industry that are also of interest to the pharmaceutical industry”
Hing Kin Chan, Director, Business Development, Eurand

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Chris Hall

Chris Hall, General Manager – Respiratory Drug Delivery, Bespak

9:10 BUILDING AND MANAGING A DEAL

Stephen Ellul

Stephen Ellul, Director, European Licensing, Elan

  • Relationship building
  • Deal structure considerations
  • Valuation
  • Protecting each company’s interests
  • Intellectual property - who owns what?
  • Specific examples for recent done deals
  • 9:40 STRATEGIC PARTNERING

    Dr Gary Cupit

    Dr Gary Cupit, Vice President, Global Business Development & Licensing, Novartis

  • Extracting more value together than alone
  • Factors for successful partnership
  • Common causes for failures and their remedies
  • Establishing functional governance committees
  • 10:20 SUCCESSFUL COLLABORATION MANAGEMENT

    Dr Paul Jenkins

    Dr Paul Jenkins, Vice President, Business Development, Europe & Asia-Pacific, West Pharmaceutical Services

  • Doing the deal – planning for the relationship
  • Relationship management during the deal
  • Establishing a steering committee
  • IP and relationship management
  • 2 case studies
  • 11:00 Morning Coffee

    11:20 EXIT STRATEGIES FOR DRUG DELIVERY COLLABORATIONS

    Jim Kinnier-Wilson

    Jim Kinnier-Wilson , Partner, Manches
    View Bio

  • What happens if it all goes wrong?
  • Causes of breakdown of collaborations
  • Bringing the collaboration to an end
  • Resolving a dispute
  • 12:00 HOW TO FUND A DRUG DELIVERY COMPANY

    Dr Philip Smith

    Dr Philip Smith, Investment Manager, SR One Limited

  • Challenges of the current markets
  • Lessons from the past: drug delivery successes and failures
  • Building a sustainable business model
  • Sources of capital
  • Deciding to invest
  • Value creation
    Exit Strategies
  • 12:40 Networking Lunch

    13:40 POORLY SOLUBLE DRUGS

    Dr Gesine Hildebrand

    Dr Gesine Hildebrand, Modified Drug Release, Schering

  • Research spec
  • Industrial landscape today
  • Obstacles and pitfalls of modern drug delivery systems
  • Criteria to choose the right partner
  • The ideal solution
  • 14:20 BRINGING NEW PRODUCTS TO THE MARKET

    Rob Whewell

    Rob Whewell, Managing Consultant, PA Consulting Group

  • Assessing the potential for each product
  • Time scales, costs, risks and complexity
  • Current performance: how good are we?
  • A framework for planning
  • Managing long complex costly products
  • 15:00 MANAGING POST- LAUNCH SHORTAGES

    Geoff Tomlinson

    Geoff Tomlinson, Principal, PRTM

  • Drivers and issues of post-launch shortages - Typical areas of post-launch shortages -Key stakeholders affected
  • Securing long-term commercial responses - Manufacturing capacity, visibility of forecasts and data
  • · Potential short-medium term product availability - Commercial strategy approach to shortages - Maximising product availability in short-medium term - Working together – drug delivery manufacture and marketing/ supply management
  • Key success factors for implementation
  • 15:40 Afternoon Tea

    16:00 THE CHALLENGE OF COMMERCIALISATION

    Ian Siragher

    Ian Siragher, Commercial Development Manager, Nektar Therapeutics

  • Technology challenges are only half the story
  • Living with the multiple uncertainties
  • Development flexibility vs manufacturing efficiency: looking two ways at the same time
  • When to commit resources and which resources to commit
  • Lies, damm lies and cost and production capacity
  • A strategy – the route adopted by Nektar Therapeutics
  • 16:40 GUIDING THE DEVELOPMENT OF COMPLEX ORAL DRUG DELIVERY FORMULATIONS

    Dr Paul J Clewlow

    Dr Paul J Clewlow, Business Development Director, Pharmaceutical Profiles

  • What is pharmacoscintigraphy?
  • When should it be used in early product development?
  • What complex oral drug delivery technologies can be evaluated and what are the potential commercial benefits?
  • Advances in guiding oral formulation development – ‘clever capsule’ technologies
  • Adding commercial value to a focused oral drug delivery strategy
  • 17:20 GENE AND ANTISENSE DELIVERY

    Dr Gerold Endert

    Dr Gerold Endert, Head of Research, Novosom

  • Delivery is the bottleneck in nucleic acid based therapies
  • Liposomes are well approved in vitro, but lack function in vivo
  • Charge reversible liposomes (Smarticles) were developed at novosom
  • Smarticles are functional in gene transfer or oligonucleotide transport in vivo
  • Targeting is achieved with different chemistries
  • Smarticles are safe and well tolerated upon repeated dosage
  • 18:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Stephen Ellul

    Stephen Ellul, Director, European Licensing, Elan

    9:10 COLLABORATING WITH ACADEMIA

    Dr Krishna Balakrishnan

    Dr Krishna Balakrishnan, Marketing Group Leader, National Institutes of Health

  • The origins and growth of academic technology transfer
  • Competitive advantage through licensing from academia
  • Academia industry relationships: different motivations but converging public health goals
  • The US National Institutes of Health’s technology transfer program
  • Success stories
  • Technology licensing opportunities from NIH
  • 9:40 SPECIALTY PHARMA

    Dr Hing Kin Chan

    Dr Hing Kin Chan, Business Development Director, Eurand

  • What is specialty pharma?
  • Identifying market opportunities
  • What specialty pharmaceutical companies identify as significant commercial opportunities in comparison to big pharma
  • Key considerations for specialty pharma
  • Why the excitement about specialty pharma?
  • Case study: a company in transition
  • 10:20 USING DRUG DELIVERY TECHNOLOGY TO CREATE OR ENHANCE PRODUCTS

    Dr Ross MacRae

    Dr Ross MacRae, Manager, Pharmaceutical Research & Development, Pfizer

  • Line extensions vs product enhancements
  • Where has drug delivery technology been successful in the past?
  • What are the needs of big pharma, present and future?
  • How to get pharmaceutical companies interested in proprietary drug delivery technologies – do’s and don’ts
  • 11:00 Morning Coffee

    11:20 DRUG DELIVERY IN PROTEIN LIFE CYCLE MANAGEMENT

    Morten Baek Jensen

    Morten Baek Jensen, Executive Assistant, Manager, Strategic Support, Protein Delivery Systems, Novo Nordisk

  • Scope of opportunity
  • What are the major value drivers?
  • Added value to customers: pateints, HCPs, payers
  • Past performance of drug delivery as a value driver
  • Promising future concepts and their potential
  • What do we expect to achieve and what not
  • 12:00 COMMERCIALIZATION OF A NOVEL DRUG DELIVERY TECHNOLOGY

    Robert Baughman

    Robert Baughman, Managing Director, Corporate Strategy, Emisphere Technologies

  • COMMERCIALIZATION OF A NOVEL DRUG DELIVERY TECHNOLOGY
  • 12:40 Networking Lunch

    14:00 COMPLIANCE AND UNMET NEEDS IN LONG-TERM MEDICATION

    Ikka Kivi

    Ikka Kivi, Technology Manager, Schering

  • Compliance – an issue in long-term medication
  • Life cycle management
  • Polymer modification
  • Release rate adjustments
  • 14:40 UTILIZING TECHNOLOGY ADVANCES AND BUSINESS STRATEGY TO ADVANCE THE TREATMENT OF CNS DISEASE

  • Introduction of timely data on development of LipoBridge™ - Blood brain barrier (BBB) model - Animal data on the delivery of small molecules, antibodies and proteins
  • Disease fields where the technology is needed to deliver therapeutic quantities of a desired pharmaceutical active
  • Summary of business development and collaboration strategies
  • Dr Peter Hoffmann

    Dr Peter Hoffmann, Vice President, New Technology Assessment & Development , Genzyme

    Matthew Roe

    Matthew Roe, Senior Director, Business Development & Licensing, Genzyme

    15:20 Afternoon Tea

    15:40 NEEDLE-FREE INJECTION SYSTEMS

    Dr Roger Harrison

    Dr Roger Harrison, Chief Executive Officer & President, Antares Pharma

  • History of needle-free delivery technology
  • Perceived limitations
  • Current state of the art
  • Other needle-free approaches to delivery of complex molecules
  • Future predictions
  • 16:20 TRANSFORMING THE PATIENT-THERAPY INTERFACE

    Kevin Maynard

    Kevin Maynard, Business Development Manager, Imprint Pharmaceuticals

  • Drug delivery systems at the patient interface
  • Unique drug delivery systems transform product revenues
  • Methods of identifying useful unique differentiation for DDS
  • Case study DepotOne – a ‘small’ neddle to replace large needles
  • 17:00 Chairman's Closing Remarks and Close of Conference

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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:

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