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Controlled Release
28 April - 29 April 2010
Controlled Release

 

Click for information on Controlled Release 2011!

 

The controlled release of a pharmaceutical active can be a vital tool in ensuring the safety and efficacy of a new or existing treatment. Developing new methods of controlled release is important to prolong the duration of action, can help to minimise adverse reactions and maximise efficacy as well as being an effective way of increasing a drug's lifespan.

SAE Media Group's 7th Controlled Release conference will provide you with the latest updates in this area, including controlled release development strategies, practical issues in developing controlled release therapeutics and information on the latest advances in delivery methods.

 

 

 

Key topics to be addressed at the conference include:

  • The application of advanced science & technology to develop controlled release dosage forms
  • Controlled Release - the role of intellectual property in maintaining and growing market share
  • Controlled release in chronic diseases
  • Overcoming the blood brain barrier
  • Modified release multiparticulates 
  • Hot melt extrusion: How to enhance dissolution rate by solid dispersions
  • Developing novel inhaled controlled release therapeutics 

 

Feedback from previous delegates includes:

"Very good - Good programme, good venue. A very successful meeting." Senior Representative, IPSEN

"Good balanced panel of speakers" Senior Rep, ESTEVE

"SAE Media Group conferences are always well organised and good topics for discussion" Senior Rep, Genzyme

 

This two day conference will allow you to:

  • Identify opportunities for portfolio development
  • Discover new strategies for developing controlled release products
  • Hear from some of the leading organisations in the field
  • Network and transfer knowledge with fellow senior drug development experts
  • Establish relationships with new clients and suppliers
  • Assess your activities against those leading the way
 

This event will be chaired by:

Dr Ian Wilding, Special Professor, School of Pharmacy, Nottingham University & President, Ian Wilding Associates Limited
  Professor Howard Stevens, Emeritus Professor of Drug Delivery, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde

 

 

Conference agenda

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13:30

Registration and Coffee

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13:40

Welcome and introduction

  • The basics of European patent law
  • Importance of the claims
  • Infringement
  • Validity: novelty and inventive step
  • Enablement and added matter
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    14:10

    Case Study - the English oxycodone (OxyContin®) case

  • Infringement issues
  • Validity issues
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    15:00

    Afternoon Coffee

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    15:20

    Focus on small molecules

  • Zolpidem tartrate
  • Leuprolide acetate
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    16:10

    Focus on biosimilars and pegylation

  • Pegylated interferon alfa
  • Pegylated G-CSF
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    16:45

    Discussion and questions

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    17:00

    Close of workshop

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    8:30

    Registration and coffee

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    9:00

    Chairman's opening remarks

    Howard Stevens

    Howard Stevens, Emeritus Professor of Drug Delivery, University of Strathclyde

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    9:10

    The application of advanced science & technology to develop controlled release dosage forms

    Gurjit  Bajwa

    Gurjit Bajwa, Principal Scientist, Pfizer

  • Application of innovative technologies during product development
  • Preparing for the future - change in pharmaceutical sciences
  • Developmental, manufacturing and regulatory opportunities and challenges
     
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    9:50

    Translational Pharmaceutics™ and Formulation Design Space - innovative strategies to enhance the development of modified release formulations

    Peter Scholes

    Peter Scholes, Vice President Pharmaceutical Sciences, Quotient Clinical

  • Limitations of the conventional formulation development paradigm
  • Translational Pharmaceutics™ - what does it mean and what are the benefits?
  • Implementation of formulation design space concepts to allow galenic 'freedom to operate' within a flexible clinical protocol
  • Case studies demonstrating real-time optimisation of formulation compositions based on human clinical data
  • Formulation design space studies enable early establishment of in-vitro-in-in vivo-correlations (IVIVCs)
     
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    10:30

    Morning Coffee

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    11:00

    Increasing exposure of drugs with extensive intestinal metabolism by modifying drug release in the gastrointestinal (GI) tract

    Joseph Reo

    Joseph Reo, Research Fellow, Merck Consumer Care, Merck Consumer Care

  • Pre-systemic metabolism in the gut wall of the GI tract
  • Distribution of metabolic enzymes in gut wall of the GI tract
  • Examples of drugs with extensive gut wall metabolism
  • Examples of achieving higher bioavailability using modified release forms compared to immediate release forms
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    11:40

    Controlled Release - the role of intellectual property in maintaining and growing market share

    Alan Johnson

    Alan Johnson, Partner, Bristows

  • What can be protected by patents? - What other than small molecules?
  • Supplementary Protection Certificates
  • Benefits of "secondary" patents - keeping the generics honest
  • The European Commission's view on pharmaceutical patents
     
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    12:20

    Networking Lunch

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    13:20

    Controlled release in chronic diseases

    Hong Guo

    Hong Guo, Vice President of Research, pSivida

  • Importance of controlled release
  • Clinical trial considerations
  • Recent trials (and tribulations)
     
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    14:00

    PK/PD modelisation, example of Medusa hGH-XL formulation

    Roger Kravtzoff

    Roger Kravtzoff, Director of Clinical and Preclinical Development, Flamel Technologies

  • Medusa presentation
  • Application to hGH
  • Modelisation of PK/PD properties
  • PK/PD results
     
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    14:40

    Poorly soluble drug delivery strategy to the posterior segment of the eye

    Thomas Keller

    Thomas Keller, Director, Biophysical Sensors and Nanomaterials, GlaxoSmithKline

  • Reasons for pharma's focus on the diseases of the eye
  • Eye anatomy and the hurdles for drug delivery to the back of the eye
  • Formulation strategies for poorly soluble drugs
  • GSK's commitment to Patient in this therapeutic area
     
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    15:20

    Afternoon Tea

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    15:50

    Design and clinical manufacture of controlled release biopharmaceuticals

    Gerben Moolhuizen

    Gerben Moolhuizen, Chief Business Officer, OctoPlus

  • Types of controlled release formulations and release profiles
  • Critical parameters in the process development of controlled release biopharmaceuticals
  • Clinical results to date: Phase II clinical data of a controlled release formulation of interferon alfa
     
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    16:30

    In-vivo performance of oral controlled release formulations: the role of gamma scintigraphy

    Howard Stevens

    Howard Stevens, Emeritus Professor of Drug Delivery, University of Strathclyde

  • Performance of oral controlled release formulations
  • Non-invasive visualisation of drug formulations
  • Clinical studies
  • Scintigraphic data analysis
     
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    17:10

    Chairman's closing remarks and close of day one

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    8:30

    Re-registration and coffee

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    9:00

    Chairman's opening remarks

    Howard Stevens

    Howard Stevens, Emeritus Professor of Drug Delivery, University of Strathclyde

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    9:10

    Modified release multiparticulates

  • Modified release concept and application
  • Multiparticulates as modified release
  • Extrusion spheronization technology
  • Melt extrusion technology
     

     

  • Hassan Mohammad

    Hassan Mohammad, Principal Scientist, Mundipharma International

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    9:50

    Engineering amphiphilic polymers increase bioavailability across biological barriers

    Andreas Schatzlein

    Andreas Schatzlein, Reader in Cancer Pharmacology, School of Pharmacy, University of London

  • Biomaterials derived from amphiphilic polymers
  • Engineering chitosan based nanoparticles as solubilises
  • Enhancing oral and brain bioavailability of hydrophobic drugs
  • Oral delivery of peptides to the brain
     
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    10:30

    Morning Coffee

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    11:00

    Engineering controlled-release formulations for peptides and proteins

    Celal Albayrak

    Celal Albayrak, CEO and Founder, Alrise Biosystems GMBH

  • ImSus® Technology
  • Fields of application
  • Increasing efficiency without affecting toxicity

     

  • clock

    11:40

    Hot melt extrusion: How to enhance dissolution rate by solid dispersions

    Mario Maio

    Mario Maio, Head of Formulation & Process Development , Merck Serono

  • What is new
  • Merck's progress
  • Next steps 
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    12:20

    Nanoparticles for enhanced bio-efficacy and controlled release

    Jens Uhlemann

    Jens Uhlemann, Head of Product Design & Nanotechnology, Bayer Technology Services

  • Pharmaceutically relevant nanoparticles within the nanotechnology landscape
  • Nanoparticles for bio-efficacy enhancement
  • Nanoparticles for controlled release
  • Progress to date, future, benefits and disadvantages
  • clock

    13:00

    Networking Lunch

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    14:00

    Long-acting TMC278, a parenteral depot formulation delivering sustained NNRTI plasma concentrations in preclinical and clinical settings

    Katie Amssoms

    Katie Amssoms, Senior Scientist, Tibotec BVBA

  • Tibotec, HIV long acting program
  • TMC278, a non-nucleoside reverse transcriptase inhibitor
  • Once monthly injectable
  • Nanoparticles as a depot formulation
     
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    14:40

    Advanced biologic delivery systems

    Andy Lewis

    Andy Lewis, Director, Critical Pharmaceuticals

  • Nasal spray formulations
  • Absorption of Somatropin  through the nasal mucosa
  • Progress
  • Routes to market
     
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    15:20

    Afternoon Tea

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    15:50

    Recent advances in mucoadhesives

    Vitaliy Khutoryanskiy

    Vitaliy Khutoryanskiy, Lecturer in Pharmaceutics, University of Reading

  • Mucoadhesive interactions in solutions
  • Developing mucoadhesive formulations
  • Designing polymeric materials to mimic mucosal tissues
     
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    16:30

    Dermal delivery of pharmaceutical actives with nanoparticles

    Gregor Cevc

    Gregor Cevc, Chief Executive Officer, Pamet

  • Targeting
  • Micro-needles
  • Transformosomes
  • Products in development
     
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    17:10

    Chairman's closing remarks and close of conference

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James


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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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    • Dr Paul Ashton, President & Ceo, pSivida 
    • Professor Gregor Cevc, Chief Executive Officer, IDEA AG
    • Alan Johnson, Partner, Bristows
    • Dr Thomas Keller, Director - Biophysical Sensors & Nanomaterials PCD, GlaxoSAE Media GroupthKline
    • Dr Vitaliy Khutoryanskiy, Lecturer in Pharmaceutics, University of Reading
    • Dr Roger Kravtzoff, Director of Clinical and Preclinical Development, Flamel Technologies
    • Dr Andrew Lewis, Operations Director, Critical Pharmaceuticals
    • Dr Mario Maio, Head of Formulation and Process Development, Merck
    • Dr Hassan Mohammad, Principal Scientist, Mundipharma International 
    • Gerben Moolhuizen, Chief Business Officer, OctoPlus
    • Dr Joseph P. Reo, Research Fellow, Schering Plough Consumer Healthcare
    • Dr Andreas Schatzlein, Reader in Cancer Pharmacology, The School of Pharmacy, University of London
    • Dr Peter Scholes, VP Pharmaceutical Sciences, Quotient Clinical Ltd
    • Professor Howard Stevens, Emeritus Professor of Drug Delivery, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde
    • Dr Jens Uhlemann, Head of Product Design & Nanotechnology, Bayer Technology Services
    • Professor Ian Wilding, Professor, Institute of Pharmaceutical Sciences, Nottingham University & President, Ian Wilding Associates Limited
    • Dr Katie Amssoms, Senior Scientist, Tibotec
    • Dr Gurjit Bajwa, Principal Scientist, Pfizer