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The accelerated pace of the drug delivery industry is set to increase into 2005 and beyond with an estimated value of $70 billion dollars. Developing various methods of controlled release is important to prolong the duration of action of an active agent, to minimise adverse reactions and maximise efficacy. Innovations and developments in the application of controlled release systems are also essential for patenting new and existing drugs.

Following a series of successful drug delivery events SMi are proud to present their 4th Annual Controlled Release Conference. This event is set to uncover the latest technological advances within drug delivery, focusing on the regulatory issues in developing controlled release technologies, case studies from both pharmaceutical and drug delivery companies reporting on their current strategies and the future market for controlled release technologies. The conference will create a platform to discuss issues and challenges within controlled release systems.

Hear from leading industry experts including:

  • Dr Michael Ausborn, Group Head, Pharmaceutical Development, Parenteral & Topical Dosage Form, Novartis
  • Dr Pierandrea Esposito, Director, Serono
  • Michael Ashton, Chief Executive Officer, SkyePharma
  • Dr John Patton, Chief Scientific Officer, Nektar Therapeutic Systems
  • Dr Steven Dinh, Vice President, Research & Technology Development, Emisphere Technologies
  • Dr Marshall Whiteman, Vice President, Technology Development, Phoqus Pharmaceuticals
  • Dr Li Shi, Senior Research Fellow & Group Leader, Merck Research Laboratories
  • Dr Avinash Thombre, Research Fellow, Pharmaceutical Research & Development, Pfizer
  • Dr Tzuchi Ju, Group Leader, Abbott Laboratories

The essential event on:

  • COMPLIANCE: Understand the case of oral dispersing tablets and market dynamics
  • NEW INDICATIONS FOR EXISTING DRUGS: Hear about the controlled delivery of peptides and proteins and the delivery of complex release profiles
  • TECHNOLOGY IN USE: Gain an insight into pulmonary formulations and the current and future strategies in use as well as sustained release parenteral delivery
  • APPLICATIONS: Learn about controlled release in a discovery and exploratory development setting and achieving 'right first time' commercialisation
  • INDUSTRY EXPERTS: Network with the leaders in the field and gain an insight into their experiencesthum

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dr Paul Gellert

Dr Paul Gellert, Senior Principal Scientist, Astra Zeneca

9:10 THE ROLE OF CONTROLLED RELEASE IN THE PHARMACEUTICAL INDUSTRY

Dr Tzuchi Ju

Dr Tzuchi Ju, Group Leader, Abbott Labs

  • The value of modulating release profiles
  • Attributes of proven control release technologies
  • Selection and development of the "right" technology for your compound(s)
  • New trends of utilising controlled release technologies
  • Challenges and limitations of controlled release technologies: do we know what we do not know?
  • Emerging technologies
  • 9:50 IMPROVING COMPLIANCE OF ORAL DOSAGE FORMS

    Steve Ellul

    Steve Ellul, Director, European Business Development, Eurand

  • Market dynamics
  • Drivers for future growth
  • Tastemasking approaches
  • Next generation ODT’s
  • 10:30 Morning Coffee

    10:50 TRANSCUTANEOUS DELIVERY WITH THE MICROSTRUCTURED TRANSDERMAL SYSTEM

    Jennifer Raeder-Devens

    Jennifer Raeder-Devens, Programme Leader, Early Pharmaceutics & Technology Department, 3M Drug Delivery Systems

  • The value proposition for transcutaneous delivery of proteins
  • The features and benefits of microneedle delivery
  • Controlled delivery via the MTS platform – animal and invitro characterizations
  • Manufacturing challenges for microneedle-based delivery systems
  • Case study: model vaccine delivery: preclinicaldevelopment
  • 11:30 SINGLE-SHOT VACCINE DEVELOPMENT USING SUSTAINED RELEASE SYSTEM

    Dr Li Shi

    Dr Li Shi, Senior Research Fellow & Group Leader, Merck Research Laboratories

  • Formulation and compatibility issues
  • Pharmaceutical characterization
  • Immunological evaluation
  • 12:10 CONTROLLED DELIVERY OF PEPTIDES AND PROTEINS

  • Established and novel technologies for protein and peptides delivery
  • Extension of biological activities: controlled release of chemical modification
  • Early drug development and life cycle management: challenge and risk
  • Chemical manufacturing and marketing role in supporting the choice of drug delivery approaches
  • Dr Pierandrea Esposito

    Dr Pierandrea Esposito, , Sitec Consulting

    12:50 Networking Lunch

    13:50 MEETING THE DELIVERY CHALLENGES OF BIOPHARMACEUTICS

    Dr Vered Bisker-Leib

    Dr Vered Bisker-Leib, Scientist, Baxter Healthcare

  • An overview of the PROMAXX protein drug delivery technology
  • Examples: sustained release LHRH-agonist and pulmonary insulin
  • Traditional approaches for particle fabrication of low molecular weight drugs
  • A new process to form small spherical particles with uniform size
  • Applications and future prospects
  • Challenges ahead: nucleotides, monoclonal antibodies, etc
  • 14:30 CONTROLLED RELEASE OF BIOPHARMACEUTICALS

    Patrick Bols

    Patrick Bols, President, PR Pharmaceuticals

  • The encapsulation of PEGylated therapeutic proteins and nucleic acids in biodegradable polymers: a simple idea with great applications.
  • Example: InsuLAR™- the once a week basal insulin product
  • Outstanding burst control
  • High drug content
  • Integrity preservation
  • Favourable release kinetics
  • Peptides in PLGA: a new technology for certain peptides- Example SomaLAR™, long acting octreotide
  • Excellent preservation of peptide integrity
  • High drug loading
  • 15:10 Afternoon Tea

    15:30 DELIVERING COMPLEX RELEASE PROFILES

    Dr Marshall Whiteman

    Dr Marshall Whiteman, Vice President, Technology Development, Phoqus Pharmaceuticals

  • Delaying: time and place
  • Extending: declining, maintaining, accelerating
  • Varying: phasing and switching
  • Combination approaches: multiple effects
  • Technology and process choice considerations
  • 16:10 BARRIER MEMBRANE SLOW RELEASE FORMULATIONS

    Dr Ali Rajabi-Siahboomi

    Dr Ali Rajabi-Siahboomi, Global Technical Director, Modified Release Technologies, Colorcon

  • Overview of formulation criteria
  • Current polymeric systems: definitions, highlights and limitations
  • Designing novel approaches to achieve desired release profiles
  • In vivo performance
  • 16:50 NOVEL APPROACHES TO THE EARLY CLINICAL DEVELOPMENT OF CONTROLLED RELEASE PRODUCTS

    Dr Paul Clewlow

    Dr Paul Clewlow, Business Devlopment Director, Pharmaceutical Profiles

  • Never has it been more important to develop controlled release dosage forms – both for new molecules and during the life-cycle management of marketed products
  • Novel approaches are being used in early clinical development to guide the development strategy and evaluate in vivo performance in man
  • Drug absorption studies, using intubation and sophisticated engineering-based capsules, are used to guide the product development strategy – examples will be presented
  • Pharmacoscintigraphy studies (pharmacokinetic evaluation and gamma scintigraphy) are undertaken on prototype oral CR technologies to provide human in vivo data – examples will be presented
  • Clinical studies involving radionuclide labelling are used to evaluate complex controlled release technologies – examples will be presented
  • 17:30 DEVELOPMENT OF DELIVERY METHODS FOR MICROPARTICULATE THERAPIES

    Kevin Maynard

    Kevin Maynard, Business Development Director, Imprint Pharmaceuticals Ltd

  • Value of high dose medication
  • Routes to delivering high dose medication
  • The advantages and disadvantages of microparticulates
  • Physics of delivery of microparticulates
  • Challenges in delivering higher dose microparticulates
  • Solutions to the delivery of microparticulates
  • 18:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr David Brayden

    Dr David Brayden, Chairman , United Kingdon-Ireland Controlled Release Society (UKICRS)

    9:10 PEPTIDE AND PROTEIN DELIVERY USING POLYMERIC DEPOT SYSTEMS

    Dr Michael Ausborn

    Dr Michael Ausborn, Group Head, Pharmaceutical Development, Parenteral & Topical Dosage Forms, Novartis

  • Rational design and scale-up of microspheres
  • Peptide delivery using PLGA
  • Protein delivery issues
  • Surface eroding systems
  • 9:50 ORAL CONTROLLED RELEASE

    Dr Puchun Liu

    Dr Puchun Liu, Senior Director, Drug Delivery, Emisphere Technologies

  • Overview of protein and peptide based delivery
  • Mechanism of oral delivery technology
  • Challenges and opportunities in product development
  • Case study: from basic research to clinical development
  • 10:30 Morning Coffee

    10:50 SUSTAINED RELEASE PREPARATIONS OF PROTEINS AND POLYPEPTIDES

    Dr Tomas Landh

    Dr Tomas Landh, Research Scientist, Novo Nordisk

  • Current trends in SR protein formulations
  • Novo Nordisk protein portfolio and unmet clinical need for SR formulations
  • Towards the needs: Balancing in house efforts and external collaborations
  • 11:30 MESOSCALE MODELLING

    David England

    David England, Physical Chemistry Research & Development Projects Manager, Sanofi-Aventis

    12:10 CONTROLLED RELEASE DELIVERY VIA THE LUNGS

    Dr John Patton

    Dr John Patton, Chief Scientific Officer, Nektar Therapeutic Systems

  • Absorption rate is determined by molecular weight and water solubility. The higher the molecular weight the slower the absorption
  • Small hydrophobic molecules are absorbed extremely fast (within seconds) if partially water soluble. Polar and charged small molecules are absorbed slower with peaks in serum occurring at about 60 minutes
  • Water insoluble small molecules may be retained as particles in the lungs for long periods (days)
  • Controlled release with peptides and proteins is best achieved with molecular engineering such as PEGylation
  • Controlled release of small molecules may be achieved with particle engineering as well as molecular engineering
  • 12:50 Networking Lunch

    14:20 PULMONARY FORMULATIONS

    Dr Brooks Boyd

    Dr Brooks Boyd, Manager, Pharmaceutical Development, Aradigm

  • Existing controlled release pulmonary systems
  • Effective pulmonary delivery – main contributors
  • Controlled release in the lung – influential factors
  • Challenges and limitations of pulmonary controlled release
  • Drivers and shapers of new technologies
  • 15:00 SUSTAINED RELEASE PARENTERAL DELIVERY

    Michael Ashton

    Michael Ashton, Chief Executive Officer, SkyePharma

  • The delivery platform – what does it encompass?
  • Tailored delivery of proteins and peptides
  • Fundamental requirements of the dosage form
  • Undesirable stresses – meeting the challenging criteria
  • Case study: preclinical and clinical developments
  • Reasons for success
  • 15:40 Afternoon Tea

    16:00 CONTROLLED RELEASE IN A DISCOVERY AND EXPLORATORY DEVELOPMENT SETTING

    Dr Avinash Thombre

    Dr Avinash Thombre, Research Fellow, Pharmaceutical Research & Development, Pfizer

  • CR feasibility assessment
  • Selection of CR technology
  • Case studies
  • 16:40 ACHIEVING ‘RIGHT FIRST TIME’ COMMERCIALISATION

    Dr Arvind Jayan

    Dr Arvind Jayan, Senior Scientist, Pfizer

  • Formulation and process design – quality by design and science of scale
  • The importance of process and product understanding in ensuring reproducible drug release kinetics
  • The role of Process Analytical Technology (PAT)
  • 17:20 NOVEL POLYMERIC SYSTEMS FOR CONTROLLED RELEASE PARENTERAL PROTEIN DELIVERY

  • Alternative polymers for PLGA
  • Release without burst effect
  • Release profiles adjusted by compositional parameters
  • Production via solvent evaporation or an all-aqueous process
  • In vitro versus in vivo correlation in animals and in man
  • Dr Delphine Ramos

    Dr Delphine Ramos, Scientist & Project Manager, OctoPlus Technologies

    Dr Ruud Verrijk

    Dr Ruud Verrijk, Senior Scientist, OctoPlus

    18:00 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:

    ‘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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