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The controlled release of a pharmaceutical in drug delivery can be a vital tool in ensuring the safety and efficacy of a treatment.

SMi’s 6th conference on Controlled Release comes at an exciting time for the industry; with novel scientific developments arriving at the time, the conference will showcase presentations from leading scientists in industry and academia. The conference will focus on the latest interesting developments in parenteral depot injections and oral controlled release formulations, as well as looking at other methods of delivery. The agenda will also include case studies setting out the latest in vivo, in vitro in silico and clinical methods of study of controlled release, and the implications that choosing the correct drug delivery strategy can have for pharmaceutical portfolio management. Our intimate meeting also provides the perfect opportunity to network with key experts and decision-makers.

  • DISCOVER the latest developments in parenteral depot delivery

  • UNDERSTAND current advances in oral delivery technologies

  • APPRAISE the benefits of hydrogel, polymer, supercritical fluid and liposome formulations

  • EXAMINE various strategies for delivering RNA, biologics and small molecule therapeutics

  • PERFECT using controlled release as part of a portfolio management strategy

  • DETERMINE the pros and cons of In vivo, in vitro and in silico techecniques for discovering and investigating controlled release technologies

Vice Presidents, Directors, Heads of Department and Managers of:

  • Pharmaceutical Research and Development

  • Drug formulation

  • Drug delivery systems

  • Sustained release

  • Business development

  • Licensing strategy

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Linda Hakes

Linda Hakes, Vice President, Development Strategy, UCB

9:10 CONTROLLED RELEASE - OVERVIEW OF THE CURRENT STATE OF AFFAIRS

Barbara Lueckel

Barbara Lueckel , Global Drug Delivery Evaluator, F. Hoffmann-La Roche

  • which areas do we talk about ?
  • which recent developments have we been seeing ?
  • where are the future needs ?
  • how to identify innovations in this field ?
  • 9:50 PARENTERAL DEPOT DELIVERY OF BIOLOGICS

    Joel Richard

    Joel Richard, Senior Director, Head of Drug Product Development, IPSEN

  • Long duration delivery increases compliance
  • Reduction in toxicity from long term delivery
  • Supercritical fluid technology for depot delivery
  • Proving efficacy
  • 10:30 Morning Coffee

    11:00 LONG ACTING DELIVERY OF SHORT ACTING PEPTIDES

    Markus Johnsson

    Markus Johnsson, Director, Pharmacuetical Development, Camurus

  • Short half lives limit the therapeutic potential of many peptides
  • Strategies to increase duration of action
  • Encapsulation protection in lipid self assembly matrices facilitates stability and long acting release
  • In vivo performance of FluidCrystal® development products
  • Manufacturing and in use features
  • 11:40 TRANSCON - TRANSIENT CONJUGATION TECHNOLOGY, PRESERVING THE ORIGINAL PHARMACOLOGY OF THE PROTEIN OR PEPTIDE

    Dirk Vetter

    Dirk Vetter, Managing Director, Ascendis Pharma

  • Transient (or "reversible") PEGylation technology has matured in recent years
  • Several advantages over conventional permanent PEGylation exist
  • Transient conjugation enables sustained release of original drug with uncompromised bioactivity
  • Based on a prodrug approach for maximal renal retention and suppression of receptor-mediated clearance
  • Key to success in transient PEGylation is the access to suitable chemical linker systems
  • Relevant parameters for linker selection are tuneability of half-life, storeability and an in vitro-in vivo correlation
  • Different linker families will be presented and case studies will be discussed
  • 12:20 Networking Lunch

    13:50 ENGINEERING BIOMATERIALS TO ENHANCE BIOAVAILABILITY

    Andreas Schatzlein

    Andreas Schatzlein, Reader, School of Pharmacy, University of London

  • Amphiphilic polymer based biomaterials - parallel synthesis and in silico strategies
  • Engineering physical chemistry to tailor biomaterial properties
  • Micellar clusters
    - Drug solubilisation  
    - Bioavailability enhancement across biological barriers
    - Oral bioavailability
    - Brain delivery of peptides and low MW drugs
  • 14:30 REGEL- A VERSATILE CONTROLLED DRUG DELIVERY SYSTEM

    Ramesh Rathi

    Ramesh Rathi, Director of Research, Protherics Salt Lake City, a BTG Company

  • Introduction to thermoreversible polymers
  • Development Regel-DDS
  • Structure property relationship
  • Examples of controlled drug release using ReGel-DDS
  • Safety of ReGel-DDS
  • Clinical experience
  • Future directions
  • 15:10 Afternoon Tea

    15:40 A THERMODYNAMIC APPROACH FOR OPTIMIZATION OF PROTEIN INTERACTIONS WITH A DELIVERY MATRIX

    Bernardo Perez-Ramirez

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

  • Strength of binding of a model protein to a collagen delivery matrix.
  • Role of formulation and solution variables
  • Monomeric vs. oligomeric mode of binding
  • 16:20 DELIVERY OF POLYMERIC DRUG CONJUGATES

    David Brayden

    David Brayden, Director, Irish Drug Delivery Network (Science Foundation Ireland Strategic Research Cluster)

  • Successes and challenges for PEGylation
  • Targeted polymeric conjugate chemotherapy
  • Research in non-injected polymeric conjugates
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    David Brayden

    David Brayden, Director, Irish Drug Delivery Network (Science Foundation Ireland Strategic Research Cluster)

    9:10 NEEDS FOR CONTROLLED RELEASE TECHNOLOGIES AS DRUG DEVELOPMENT IS PROGRESSING

    Olivier Lambert

    Olivier Lambert, Technical Project Leader, Actelion Pharmaceuticals

  • What triggers the need for controlled release technologies through:
  • - First Entry into Man?
    - Phase II dose selection?
    - Phase III and final market image?

  • Influence of Life cycle management, when and how
  • Paediatric plan
  • The outsourcing concept from a research company focused on new NCEs
  • 9:50 DRUG DELIVERY – DETERMINING OPTIMAL FORMULATIONS IN CLINICAL DEVELOPMENT

    Peter Scholes

    Peter Scholes, Vice President, Pharmaceutical Sciences, Pharmaceutical Profiles

    ·               1/3 of all NCEs in development have sub-optimal bioavailability and require modified release (MR) formulation development

    ·                Around half of all drugs in development will not be amenable to straightforward MR formulation development

    ·               Using clinical diagnostic tools for investigating the causes of suboptimal bioavailability and using these data for guiding formulation development

    ·               Using an integrated formulation development, manufacturing and clinical testing platform to allow rapid screening and validation of formulation prototypes

    ·               Acceleration of timelines and reduction of cost to optimise oral dosage forms

     

    10:30 Morning Coffee

    11:00 CASE STUDIES: DEVELOPMENT OF A NOVEL POLYMERIC NANO-DELIVERY SYSTEM FOR A POORLY AVAILABLE DRUG

    Damon Smith

    Damon Smith, Vice President, Labopharm

    11:40 EMERGING DRUG DELIVERY TECHNOLOGIES

    Mark Bunger

    Mark Bunger, Research Director, Lux Research

  • What are some of the novel technologies being commercialized for targeted delivery, controlled release, and theranostic applications?
  • Which labs and startup companies are receiving (or running out of) funding, entering trials, and partnering with (or being acquired by) Big Pharma?
  • As drug discovery slows and patents expire, how will delivery technologies affect patients, payors, and the healthcare industry?
  • 12:20 Networking Lunch

    13:50 CONTROLLED RELEASE DELIVERY OF PHARMACEUTICALS

    Gerben Moolhuizen

    Gerben Moolhuizen, Chief Business Officer, OctoPlus

  • Introduction to OctoPlus' biodegradable polymer-based drug delivery technologies for biologicals and small molecules
  • Characterisation of hydrogels suitable for effective long-acting drug delivery: release profiles, process development and manufacturing
  • PolyActive(R) case study: Phase II clinical proof of concept with a controlled release formulation of interferon alfa
  • 14:30 UNCOVERING THE SECRETS OF PULMONARY CONTROLLED RELEASE SYSTEMS

    Fadi Eskandar

    Fadi Eskandar, Principal Scientist, Novartis Pharmaceuticals

  • Key aspects of inhalation therapy
  • Inhaled controlled release systems between pros and cons
  • Invitro pulmonary Models to test controlled release formulations
  • Using a particle engineering approach to develop pulmonary siRNA delivery system
  • 15:10 Afternoon Tea

    15:40 MAGNETICALLY ACTIVATED CONTROLLED RELEASE SYSTEMS

    Quentin Pankhurst

    Quentin Pankhurst, Director, Davy Faraday Research Laboratory, The Royal Institution of Great Britain

  • How magnetic nanoparticles can be used safely and conveniently in vivo
  • How composite magnetic drugs, proteins and cells may be formulated
  • Actuation, capture, heating and controlled release at a distance
  • Case studies showing efficacy in vitro and in vivo
  • 16:20 HOW TO REALISE FUNCTIONAL DELIVERY OF THERAPEUTIC NUCLEIC ACIDS IN VIVO USING SOFT, TRIGGERABLE NANOPARTICLES: WHAT ARE WE LEARNING?

    Andrew Miller

    Andrew Miller, Professor of Organic Chemistry & Chemical Biology, Imperial College London

    ·               The opportunity presented by therapeutic nucleic acids (pDNA, siRNA)

    ·               The intra- and extra-cellular barriers to functional delivery

    ·               Crafting delivery solutions from tool kits of chemical components

    ·               ABC and ABCD nanoparticles effect delivery to lung, liver and tumour in vivo

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