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Controlled release remains one of the most important innovate areas in pharma, with revenues set to dramatically increase to 2020. Recent advances in drug delivery systems have created the perfect mix for opportunities in the field.

SMi is proud to present its 10th annual controlled release conference, held in central London on the 18 & 19 March 2013 the meeting will continue in a long tradition of critically acclaimed speakers who are pioneers in their field. This event offers you a unique opportunity to keep up to date with the latest in technologies and methods such as the diffusion of nanomaterials through biological and non-biological gels.

Controlled Release 2013 will aim to show you recent trends in drug delivery such as inorganic controlled release, such as silica materials in drug delivery. RNAi is an important  field - our 2013 meeting can show the latest data on RNAi delivery by nanodiamonds and avoiding capture by reticulo endothelium systems.

 

Discover the very latest developments in this innovative and booming industry

New for 2013:
- Investigating structure-activity relationships of siRNA nanoparticles
- Challenges of pre-clinical gastro-retentive dosage form development
- Numerous case studies from big pharma laboratories – such as GSKs formulation
development programme

Meet, share knowledge and do business with key industry professionals, leading
academics and healthcare representatives
 

   

You should attend this event if you are a Director, Area head, Chief Executive, CSO, or Vice President within the pharmaceutical or healthcare industry with responsibilities  in the following areas

  • Nanomedicine
  • Drug Delivery
  • Drug Development
  • Formulation
  • Business Development
  • Product Development
  • Research & Development
  • Global Alliances
  • Technical Sciences / Design

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Howard Stevens

Howard Stevens, Professor, University Of Strathclyde

9:10 Development and Scale-Up of Controlled Release Formulations: An Industrial Perspective

Mark Wilson

Mark Wilson, Director, Collaboration Management, GlaxoSmithKline

  • Choices among controlled-release approaches for product formulation
  • Issues and challenges in the development of controlled-release products
  • Scale-up and development considerations, problems and approaches
  • The origins and development of the DiffCORETM controlled release technology
  • Case study of a formulation development programme
  • 9:50 How to optimise the CMC deliverables in times of decreasing resources and increasing requirements

    Petra Wicklandt

    Petra Wicklandt, Vice President CMC-Development, Merck KGaA

  • CMC resources are limited and restructering processes and efficiency programmes lead to decreasing resources
  • At the same time challenging drug properties and drug delivery technologies together with  regulatory requirements are increasing resource demand
  • Merck concepts of clear differentiation according to priority
  • Medium priority are applied via "minimal paradigm" - Success triggered resourcing taking into account potential delays due to CMC deliverables
  • Which CMC deliverables are regarded as minial for each phase and what can be backloaded?
  • 10:30 Morning Coffee

    11:00 Patient focussed peptide delivery

    Andy Lewis

    Andy Lewis, Director Novel Formulation Technologies, Ipsen

  • Limitations of established methods of peptide delivery
  • Integrating the needs and requirements of patients into the development of peptide drug products
  • Future prospects for the peptide delivery
  • 11:40 Time delayed drug delivery - The Chronotherapeutic Challenge

    Howard Stevens

    Howard Stevens, Professor, University Of Strathclyde

  • Commercial opportunities of chronotherapeutics
  • Pharmaceutical formulation - the drug delivery challenge
  • Visualisation of drug release in humans
  • Chronotherapeutic clinical development case studies
  • 12:20 Networking Lunch

    13:20 Lubrizol gel-matrix formers for controlling drug release in oral solid dosage forms

    Elena Draganoiu

    Elena Draganoiu, Technology Manager, Lubrizol Corporation
    View Bio

  • Introduction to Lubrizol LifeScience Polymers
  • Applications of Thermoplastic Polyurethanes in Drug Delivery
  • Lubrizol Pharmaceutical Polymer Chemistry Overview
  • Carbopol® Polymers for Oral Controlled Release and Potential Benefits beyond Controlled Release
  • 13:50 Self assembled siRNA/chitosan nanoparticles: process parameters, structure and bioactivity in vitro and vivo

    Michael Keller

    Michael Keller, Senior Fellow, siRNA Project Leader, Technical Research and Development (TRD), Novartis Pharma

  • Investigating structure-activity relationships of siRNA nanoparticles
  • Polymer based siRNA nanoparticles: a QbD approach
  • The importance to control and define excipient quality for the final DP
  • 14:30 Controlled Release and Patient Adherence: One Solution for a Complex Problem

    Sandra Erb

    Sandra Erb, Vice President, Research, Technology Catalysts

  • Patient adherence is critical to success of medical treatments
  • Controlled release formulations have been instrumental in improving patient adherence
  • Complexity of the problem requires a combining the formulation development with other solutions
  • 15:10 Afternoon Tea

    15:40 Vitamin E TPGS : an attractive candidate to boost your drug release innovation?

    Yves Robin

    Yves Robin, Innovation Director, Isochem

  • Formulation in current drug delivery is either an integrated or strategic axis of innovation
  • Overview of TPGS properties, regulatory status and uses in different areas
  • TPGS is an attractive candidate to boost your drug release innovation
  • Solubility and bioavailability enhancement of APIs with examples of drug delivery solutions
  • 16:20 The impact of changing the site of manufacture for controlled release products

    David Elder

    David Elder, Externalisation Director, GlaxoSmithKline

  • Introduction
  • Regulatory requirements
  • Technology transfer (TT)
  • Assessing obstacles with site changes
  • Key challenges
  • Summary
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Howard Stevens

    Howard Stevens, Professor, University Of Strathclyde

    9:10 Application of controlled release formulations in inhalation development

    Frank Thielmann

    Frank Thielmann, Operational Lead, Inhalation New Solids, Novartis Pharma AG

  • Why controlled release in inhalation
  • Formulation strategies and challenges
  • Case study: stability of different salbutamol sulphate formulations
  • Dissolution testing methods for inhaled products
  • Case study: milling versus micronisation - impact of process on surface properties and dissolution rate
  • 9:50 IntelliCap® – A novel tool enabling faster, risk minimized and cost efficient development of controlled release formulations

    Christoph Wanke

    Christoph Wanke, Clinical Program Leader, Medimetrics

  • Introduction to IntelliCap®
  • The story so far
  • Case study
  • Further discussion and conclusions
  • 10:30 Delivery of oligonucleotides in vivo: from basic principles to therapeutic applications

    Dmitry Samarsky

    Dmitry Samarsky, Executive Vice President, RiboBio

  • Multiple challenges of the oligonucleotide delivery in vivo
  • Diverse approaches for systemic and local delivery of olignucleotides
  • 11:10 Morning Coffee

    11:40 Controlled Release improving Patient Care

    John Fox

    John Fox, Chief Development Officer, Merrion Pharmaceuticals

  • Drugs must be delivered in a way that provides the best available risk/benefit ratio
  • The rout, regimen and profile of delivery may affect patient care and QoL
  • Creative approached in Controlled Delivery are central to improving patient care
  • Consideration of optimum delivery begins in early drug development
  • 12:20 A novel oligonucleotide that up-regulate serum albumin and down-regulate liver carcinogenesis

    Nagy Habib

    Nagy Habib, Professor Department of Surgery & Cancer, Imperial College London

  • Introductions to oligonucleotides
  • Effects of up-regulation of serum albumin
  • Pathways for down-gegulation in liver carcinsogenesis
  • 13:00 Networking Lunch

    14:10 Challenges of pre-clinical gastro-retentive dosage form development

    Richard Elkes

    Richard Elkes, Senior Research Scientist, Merck KGaA

  • Drivers for GR technology
  • Approaches to GR
  • Overview of challenges with in vitro and animal model assesments
  • 14:50 Design of Supersaturated Delivery system for improving bioavailability of poorly soluble drugs : Application of Amorphous solid dispersion

    Duk Soon Choi

    Duk Soon Choi, Senior Research Leader, Hoffmann-La Roche

  • Design of supersaturated delivery system requires thorough understanding of thermodynamics and kinetic aspects
  • Discussion of supersaturated system consisting of amorphous solid dispersion
  • Focus on how polymers and their connection as well as their physic-chemical properties as well as solid dispersion processes play a role in maintaining superstation
  • Case study
  • 15:30 A methodology to simultaneously measure size, concentration, fluorescence and zeta potential of nanoparticle drug delivery vectors

    Andrew Malloy

    Andrew Malloy, Head of Application Sciences, Nanosight

  • How is particle size measured, why is this important in drug delivery vectors
  • Particle concentrations and dosage
  • Fluorescence and how this can be used to track delivery vectors in biological fluids and measure the state of aggregation
  • Discussion of the measurement of zeta potential and stability of nanoparticle vectors
  • 16:00 Afternoon Tea

    16:30 Single multiple pill - SmPil - Innovative solution for oral delivery

    Monica Rosa

    Monica Rosa, Head of Production, Sigmoid Pharma Limited

  • Insight on the SmPill technology
  • Case studies highlighting SmPill - enabled formulations for different drug classes (poorly soluble drugs, peptides and oral vaccines)
  • Examples of translating formulation concepts into preclinical and clinical products
  • 17:00 Intellectual property issues in controlled release

    Gerry Kamstra

    Gerry Kamstra, Partner, Bird & Bird

  • Novelty and inventive step issues to tackle in securing patent protection for controlled release formulations
  • Regulatory data protection / market exclusivity protection for controlled release formulations
  • Long term legal perspectives on product life cycle management using controlled release formulations 
  • 17:40 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Andy Lewis

    Andy Lewis

    Director Novel Formulation Technologies, Ipsen
    David Elder

    David Elder

    Externalisation Director, GlaxoSmithKline
    Frank Thielmann

    Frank Thielmann

    Operational Lead, Inhalation New Solids, Novartis Pharma AG
    Petra Wicklandt

    Petra Wicklandt

    Vice President CMC-Development, Merck KGaA

    Andrew Malloy

    Head of Application Sciences, Nanosight
    Andrew Malloy

    Andy Lewis

    Director Novel Formulation Technologies, Ipsen
    Andy Lewis

    Christoph Wanke

    Clinical Program Leader, Medimetrics
    Christoph Wanke

    David Elder

    Externalisation Director, GlaxoSmithKline
    David Elder

    Dmitry Samarsky

    Executive Vice President, RiboBio
    Dmitry Samarsky

    Duk Soon Choi

    Senior Research Leader, Hoffmann-La Roche
    Duk Soon Choi

    Elena Draganoiu

    Technology Manager, Lubrizol Corporation
    Elena Draganoiu

    Elena is a technology manager with LifeScience Polymers business at The Lubrizol Corporation.

    She is a graduate of the University of Cincinnati (Ph.D., Pharmaceutics). She has ten years of experience working in the excipients industry and has also worked as a resident pharmacist and in academia.

    Currently, Elena is responsible for leading Lubrizol’s technical programs in the area of pharmaceutical ingredients.
     

    Frank Thielmann

    Operational Lead, Inhalation New Solids, Novartis Pharma AG
    Frank Thielmann

    Gerry Kamstra

    Partner, Bird & Bird
    Gerry Kamstra

    Howard Stevens

    Professor, University Of Strathclyde
    Howard Stevens

    John Fox

    Chief Development Officer, Merrion Pharmaceuticals
    John Fox

    Mark Wilson

    Director, Collaboration Management, GlaxoSmithKline
    Mark Wilson

    Michael Keller

    Senior Fellow, siRNA Project Leader, Technical Research and Development (TRD), Novartis Pharma
    Michael Keller

    Monica Rosa

    Head of Production, Sigmoid Pharma Limited
    Monica Rosa

    Nagy Habib

    Professor Department of Surgery & Cancer, Imperial College London
    Nagy Habib

    Petra Wicklandt

    Vice President CMC-Development, Merck KGaA
    Petra Wicklandt

    Richard Elkes

    Senior Research Scientist, Merck KGaA
    Richard Elkes

    Sandra Erb

    Vice President, Research, Technology Catalysts
    Sandra Erb

    Yves Robin

    Innovation Director, Isochem
    Yves Robin

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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, 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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