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Controlled-release products remain amongst the largest sectors for innovation, with worldwide revenues of US$29.5bn by 2017, as products mature and face patent expiration.  Advances in nanobiotechnology, drug delivery vehicles, and formulation science have created unique opportunities for the development of a new generation of controlled

SMi proudly presents its 9th annual Controlled-Release conference to be held in London on Wednesday 28th & Thursday 29th of March 2012. This conference continues SMi’s previous highly successful Controlled-Release events and offers the opportunity to keep up-to-date with the latest regulations, challenges and solutions that you need to know about for successful and cost-effective drug delivery. 

New for 2012, the conference focuses more on developments in hard-to-formulate areas.  Case studies by leading pharmaceutcal scientists include presentations on how chemistry and materials science are improving in-vivo stability, cellular and subcellular biorecognition and dissolution rate kinetics

Prolonging the functionality of active pharmaceutical ingredients to extend product life-cycles will feature clinical case studies from companies including GlaxoSmithKline, Lundbeck and Bristol-Myers Squibb. 

   

 

  • Increase patent revenue for oral and non oral drug delivery products
  • Extend product lifecycles through reformulation to keep market share
  • Accelerate to phase III faster with lipid-based compounds
  • Improve manufacturing efficiency and scale-ability for miniaturisation and bead milling
  • Reduce costs with in silico applications to maximise commercial development
  • Apply lessons for ADMET testing when using nanoparticles

Chief Executives, Chief Scientific Officers, Vice Presidents, Heads,
Directors, Principal Scientists and Managers in the following areas:

• Nanomedicine
• Drug Delivery
• Drug Development
• Nanotechnology
• Formulation
• Business Development
• Regulatory and Technical Affairs
• Product Development

• Research & Development
• Dissolution Testing
• Operations
• Global Alliances
• Product Development
• Technology Development
• Technical Sciences
• Particle Design



 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Simon Holland

Simon Holland, Director, Process Understanding & Control, GSK

9:10 Drug nanoparticles: formulating poorly water-soluble compounds

Elaine Merisko-Liversidge

Elaine Merisko-Liversidge, Senior Director, Alkermes

  • Challenges in convention formulation strategies
  • Nanoparticles: a newer drug delivery strategy
  • Improved bioavailability and enhanced drug exposure for oral delivery
  • Implications for toxicology testing and commercial viability
  • 9:45 Formulation approaches for optimization of protein interactions with a delivery matrix

    Bernardo Perez-Ramirez

    Bernardo Perez-Ramirez, Senior Scientific Director, BioFormulations Development, Genzyme Corporation

    10:20 Morning Coffee

    10:40 Bridging API manufacturing and formulation through particle design…. a solution for every challenge

    Marcio Temtem

    Marcio Temtem, Process Development Engineer, Hovione Sociedade Quimica SA

  • Solid dispersions - a formulation strategy for poorly soluble compounds
  • Inhalation grade APIs
  • Extended release formulations
  • 11:20 Utilising SIMCYP simulation when deciding the best formulation strategy

    Karin Liltorp

    Karin Liltorp, Director, Lundbeck Denmark

  • Utilizing SIMCYP computer simulation in deciding on the correct formulation strategy for poorly soluble drugs: Identifying critical issues for the compound in question.
  • Generating sufficient physico-chemical data to obtain predictive simulations for controlled release formulations
  • Gaining advanced knowledge from API through to clinical development and thereby improving inter-departmental communication
  • Learning from the past - using clinical results to obtain a better understanding of the compound
  • Next generation software - Applying SIMCYP software to biological development
  • 11:55 Inorganic carriers for dissolution rate enhancement

    Mario Maio

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

  • How to select the most appropriate formulation tool for poorly soluble drugs
  • When nano is inside
  • The untapped potential of mesoporous inorganic carriers
  • Case studies of dissolution rate enhancement
  • 12:30 Networking lunch

    13:30 New inorganic glass-ceramic controlled release technology for pharmaceutical applications

    Xiang  Zhang

    Xiang Zhang , Principal Consultant, Medical & Pharmaceutical Materials, CERAM

  • Advantages of Inorganic CRT compared to organic polymeric systems
  • Materials characterisation and drug loading capacity
  • Effect of the compositional and non compositional parameters during synthesis on drug release and matrix degradation.
  • Conclusions and future investigation on the new technology
  • 13:45 The drug delivery marketplace – a perspective

    Mark Wilson

    Mark Wilson, Director, Collaboration Management, GlaxoSmithKline

  • What are the current needs of large companies with respect to drug delivery technologies and technology partners?
  • How has the drug delivery landscape changed over the last 5 years, and how have drug delivery deals and alliances evolved?
  • Why did GSK initiate in-house technology development, a decade ago?
  • What led GSK to make its proprietary technologies available to others?
  • What is the future for this sector, for drug delivery providers and for pharmaceutical company users?
  • 14:20 Trends in oral lipid-based formulation technology

    David J. Hauss

    David J. Hauss, Principal, Hauss Associates

  • Gastrointestinal absorption of dietary lipids and hydrophobic xenobiotics
  • Biopharmaceutical aspects of oral lipid-based formulation design
  • Expanded role of liquid-filled gelatin capsules for oral delivery of lipid-based formulations
  • Recent growth, market trends and future prospects for oral lipid-based dosage forms
  • 14:55 Afternoon Tea

    15:25 Challenges and solutions in the delivery of a prodrug in an oral, extended-release delivery system

    Jonathan Brown

    Jonathan Brown, Senior Research Investigator, Bristol-Myers Squibb

  • Obstacles to small-molecule, oral pro-drug delivery
  • In silico approaches to speeding the development of oral, extended-release delivery systems
  • Proof of principle and milestone objectives
  • 16:00 Effects of rotigotine on sleep and quality of life in patients with Parkinson's disease (PD)

    Lars Bauer

    Lars Bauer, Senior Medical Director , UCB GmbH

  • Rotigotine: a non-ergolinic dopamine agonist for PD and restless legs syndrome
  • Pharmacology and transdermal drug delivery
  • Findings from the RECOVER study
  • 16:35 Enhanced oral delivery of a poorly bioavailable ultra low molecular weight heparin (glycosaminoglycan C3) for Alzheimer’s disease utilizing GIPET technology neuroprotective

    John Fox

    John Fox, Chief Development Officer, Merrion Pharmaceuticals

  • Product development process
  • GIPET mechanism of action for glycosaminoglycan C3 delivery
  • Reduction of brain inflammation
  • Results from phase I clinical studies
  • 17:10 Challenges in drug formulation for oral delivery- where are we and what are the prospects for the future?

    Despite oral administration remaining the delivery route of choice for clinical applications, drugs in classes II - IV of the Biopharmaceutical Classification System suffer from low solubility, low permeability or both.  Panelists will discuss developments to overcome these challenges using non-invasive HDA studies, bioadhesive, and drug-porous materials.

    John Fox

    John Fox, Chief Development Officer, Merrion Pharmaceuticals

    Alex Seifalian

    Alex Seifalian, Professor of Nanotechnology and Regenerative Medicine, University College London Medical School

    Elaine Merisko-Liversidge

    Elaine Merisko-Liversidge, Senior Director, Alkermes

    17:50 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Bernd Riebesehl

    Bernd Riebesehl, Principal Fellow, Parenteral Dosage Forms, Pharmaceutical and Analytical Development, Novartis Pharmaceuticals

    9:10 Development of a novel intra-nasal steroid product for treatment of seasonal rhinitis

    David Elder

    David Elder, Externalisation Director, GlaxoSmithKline Research & Development

  • Intra-nasal drug delivery overview
  • Design attributes of steroid nasal spray
  • Development of side-actuated intra-nasal device
  • Development of steroid nasal spray formulation
  • Steroid nasal spray specification
  • Conclusions
  • 9:45 Overview of challenges and solutions for dissolution testing of non-oral formulations

    Samir Haddouchi

    Samir Haddouchi, Managing Director, SPS Pharma Services

  • Semi-solid forms for topical use
  • Dispersed forms: liposomes, nanoparticles
  • Injectable suspensions
  • 10:25 Morning Coffee

    10:50 Demonstrating bioequivalence for controlled release formulations

    Arne Ring

    Arne Ring, Head of the Statistics and Modelling Group, University Of Oxford

  • Differences to demonstration of immediate release bioequivalence
  • Regulatory concerns
  • Example studies
  • 11:25 Simultaneous: multi-parameter analysis of nanoparticles by Nano-Particle Tracking Analysis

    Andrew Malloy

    Andrew Malloy, Head of Applications, NanoSight Ltd

    12:05 Networking Lunch

    13:05 Development of modified human serum albumin molecules for peptide and protein half-life extension

    Mark Perkins

    Mark Perkins, Customer Specialist , Novozymes Biopharma UK Ltd

  • Overview of peptide and protein drug delivery using human serum albumin
  • Fusion Proteins
  • Chemical conjugation
  • FcRn mediated recycling and it’s significance to the plasma half-life of human serum albumin
  • Design and development of albumin molecules with increased and decreased plasma half-life
  • Therapeutic opportunities with modified albumin molecules
  • 13:35 Current status of oligonucleotide technology with respect to delivery

    Dmitry Samarsky

    Dmitry Samarsky, Executive Vice President, RiboBio

  • The need to address the challenge of in vivo delivery to realise the therapeutic potential of oligonucleotides
  • Different oligonucleotides may require different approaches to achieve safe and efficacious delivery for different indications
  • Principles of oligonucleotide in vivo delivery with and without delivery vehicles
  • 14:10 Afternoon Tea

    14:40 Case study: challenges and opportunities for delivering biologics to the central nervous system

    Jan Powell

    Jan Powell, Director, Physiology, Shire

    15:15 Antibodies for the brain: Looking past the blood-brain barrier

    Lois Lampson

    Lois Lampson, Associate Professor, Harvard Medical School

  • Antibodies are being used in many contexts that involve the brain.  Tumors, autoimmunity, neurodegenerative disorders, infection, and drug addiction are all examples.
  • Results are typically interpreted in terms of the blood-brain barrier, and much effort has gone into increasing delivery across it.  Yet, in many cases, the blood-brain barrier is not the main impediment.
  • The barrier itself is plastic, while other factors can also impede antibody access or function.  When antibody is beneficial, its site of action is not necessarily in the brain.
  • Antibody and barrier functions are not necessarily antagonistic.  Indeed, they can be complementary.
  • When antibody must act within the brain, antibody production or sustained release from within the brain is an attractive alternative to delivery across the blood-brain barrier.
  • 15:50 From bench to bedside: overcoming translational challenges for nanotherapeutics

    Rogerio Gaspar

    Rogerio Gaspar, Professor of Pharmaceutics, University Of Lisbon Faculty Of Pharmacy

  • Major recommendations for scientists
  • Recommendations to industry, regulatory agencies, and government committees
  • Meeting regulatory approval
  • 16:25 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
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

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    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.

     

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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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