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Optimising Drug Formulation
12 February - 13 February 2007
Optimising Drug Formulation
The drug formulation industry has seen a 38 per cent growth in the past five years and is expected to continue to expand as drug companies begin to seek advanced methods of delivering drugs effectively, as well as different ways of marketing both new and old compounds by devising new formulations.
SAE Media Group’s 2nd annual ‘Optimising Drug Formulation’ conference seeks to provide attendees with the latest advances key formulation practices, technologies and methodologies. Listen as influential industry experts discuss the regulatory challenges that await new products in development, concepts and rationale of novel and new drug formulations.

An opportunity to meet experts in the field to discuss how formulations can be optimised and carried forward to achieve the ultimate aim of getting effective drugs on the market faster.
This is a great opportunity to meet and network with the key players within the market!
    
Speakers Include:
  • Dr Mak Jawadekar, Director, AMP, WPM, Pfizer
  • Dr David England, Physical Chemistry, Research & Development Projects Manager, Sanofi-Aventis
  • Dr Dimitris Papoutsakis, Functional Project Leader, Novartis
  • Dr Thomas Backensfeld, Head of Analytical Development , Schering
  • Dr. Joerg Breitenbach, Director and Head, S O L I Q S, Abbott
  • Dr Tomas Landh, Principal Scientist, Preformulation & Delivery, Novo Nordisk
  • Dr Jean Haensler, Director, Formulation Research, Sanofi-Pasteur
  • Dr Mario Maio, Formulation Development Manager, Serono
  • Dr David Cipolla, Director, Pharmaceutical Sciences, ARADIGM
  • Dr Andreas Bernkop-Schnurch, CSO, Thiomatrix GmbH
  • Valery Alakhov, Vice-President R&D and CSO, Supratek Pharma
  • Dr Rao Chilamkurti, Senior Director, Pharmaceutical Technology, BioPharma Solutions, Baxter Healthcare
  • Prof. Ian Wilson, Senior Principal Scientist, AstraZeneca
  • Dr Yun Alelyunas, Principal Scientist, AstraZeneca
     
Benefits of attending Optimising Drug Formulation:
  • REGULATORY ISSUES: Listen as industry experts debate the key ethical and regulatory issues facing developers of novel drug products. Are they just a burden to the industry?
  • DRUG FORMULATION TECHNOLOGY: Discover through a case study presentation how to effectively administer drugs and the best route of delivery – pulmonary, oral or nasal?
  • INNOVATIONS IN FORMULATION: Examine the explosion of research aimed at creating methods of formulation to  fuel new research
  • ADJUVANTS: Discover how to ensure the successful design and development of adjuvants through examples of synthetic adjuvants currently used in clinical trials
  • CASE STUDIES: Hear case study examples from leading experts on the formulation development of poorly soluble drugs in discovery settings, development of spray dried powders and immunulogical stimulants for treatment of cancer
  • EXCLUSIVE INFORMAL NETWORKING: Collaborate with industry peers in an environment promoting information exchange

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Valery Alakhov

Valery Alakhov, Vice-President R&D and CSO, Supratek Pharma

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9:10

INNOVATIONS IN FORMULATION

Tomas Landh

Tomas Landh, Principal Scientist, Preformulation & Delivery, Novo Nordisk

  • Examining the explosion of research aimed at creating methods of formulation – fuelling new research
  • Applications of new drug discovery technologies – yielding more new drug targets
  • Enabling new therapeutics
  • New formulations for biological targets – said to be worth $25 billion dollars
  • New drug targets increase formulation complexity – excipients are becoming multi-functional
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    9:50

    DRUG FORMULATION TECHNOLOGY

    Dr David Cipolla

    Dr David Cipolla, Senior Director, Pharmaceutical Sciences , ARADIGM

  • Platforms of drug technology
  • Improving solubility
  • Capability to experiment with many formulations
  • Effectively administering drugs
  • Routes of delivery - pulmonary, oral or nasal?
  • Scientific assessment of the maturity and novelty of the technology
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    10:30

    Morning Coffee

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    11:00

    EXPLORING SOLUBILITY LIMIT OF CNS DISCOVERY CANDIDATE

    Dr Yun Alelyunas

    Dr Yun Alelyunas, Principal Scientist, AstraZeneca

  • A description of a high throughput and thermodynamic solubility measurement using the “dried-DMSO” method
  • A summary of experimental solubility profiling results of marketed CNS drugs
  • Application of local solubility predictive model for synthetic design
  • A discussion of the need of good solubility to minimise potential tox side effects in vivo
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    11:40

    MODERN FORMULATION STRATEGIES

    Dr Thomas Backensfeld

    Dr Thomas Backensfeld, Global Pharmaceutical Development, Schering

  • Oral Bioavailability
  • Solubility and Dissolution Enhancement
  • Biopharmaceutical Classification System and Developability
  • Booster compounds
  • Interaction potential of excipients with biological barriers
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    12:20

    Networking Lunch

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    13:50

    INFLUENCE OF MANUFACTURING PROCESS AND ENHANCED PACKAGING ON PARENTAL FORMULATIONS

    Dr Rao Chilamkurti

    Dr Rao Chilamkurti, Senior Director, Pharmaceutical Technology, BioPharma Solutions , Baxter Healthcare

  • Impact of formulation on solution mixing processes – solubility and stability effects
  • Filtration and sterilization effects on formulation
  • Effect of formulation components on lyophilization process
  • Enhanced packaging to stabilize drug formulations
  • Enhanced packaging for ‘Ready to Use’ formulations
  • Balancing formulation, process and packaging
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    14:30

    UNDERSTANDING DRUG PRODUCTS TO NEARLY THE SAME DETAIL AS THE DRUG SUBSTANCE

    Dr David England

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

  • Polymorphism and amorphous content
  • Polymer based formulations
  • Mechanism of delivery
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    15:10

    Afternoon Tea

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    15:40

    TARGETED BLOCK COPOLYMER DRUG FORMULATIONS FOR ONCOLOGY

    Valery Alakhov

    Valery Alakhov, Vice-President R&D and CSO, Supratek Pharma

  • Block copolymer based Biotransport nano-technology provides formulations for a broad range of oncology drugs 
  • Biotransport carries have been shown to considerably increase efficiency of cytotoxic drugs against drug resistant settings
  • Biotransport carriers enable oral administration of taxanes and camptothecins 
  • Biotransport technology provides a set of robust tools for formulation optimization
  • The leasd Biotransport based product SP1049C is entering a pivotal phase III clinical trial in upper GI cancer indication
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    16:20

    MELTREX BRINGS BENEFITS TO HIV THERAPY

    Dr Joerg Breitenbach

    Dr Joerg Breitenbach, Director and Head, SOLIQS, Abbott

  • BCS class IV compounds and poor solubility
  • Solid solutions
  • Nanodispersions
  • Life Cycle Management
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    17:00

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Re-Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Professor Ian  Wilson

    Professor Ian Wilson, Senior Principal Scientist, AstraZeneca

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    9:10

    REGULATORY VIEWS

    Gert Ragnarsson

    Gert Ragnarsson, Scientific Director, Medical Products Agency

  • Background
  • Quality by Design
  • Design Space
  • Real Time Release
  • Industrial and Regulatory Impact and Potential
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    9:50

    IMMUNOLOGICAL ADJUVANTS

    Dr Jean Haensler

    Dr Jean Haensler, Director, Formulation Research, Sanofi-Pasteur

  • The design and development of adjuvants
  • Classification and mechanism of action
  • Key regulatory considerations
  • Industrial aspects
  • Examples of synthetic adjuvants currently in clinical trials
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    10:30

    Morning Coffee

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    11:00

    FORMULATION DEVELOPMENT

  • Strategies for preformulation and formulation assessment of poorly water soluble drugs at the early stages of drug discovery
  • Design of in vivo experiments to assess development issues
  • Correlation of physicochemical properties to exposure
  • Developability concept and compound selection
  • Dr Dimitris Papoutsakis

    Dr Dimitris Papoutsakis, Functional Project Leader, Novartis Institutes for BioMedical Research

    Janet Maas

    Janet Maas, , Novartis

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    11:40

    RECONSTITUTION AND DELIVERY OF HIGH DOSE FORMULATIONS

  • Optimising mixing regimens
  • Managing pastes
  • Managing quick setting formulations
  • Bernd Riebesehl

    Bernd Riebesehl, Reasearch Advisor, Eli Lilly

    Kevin Maynard

    Kevin Maynard, Director, Imprint Pharmaceuticals Ltd

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    12:20

    Networking Lunch

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    13:50

    DRUG METABOLISM AND DISPOSITION

    Professor Ian  Wilson

    Professor Ian Wilson, Senior Principal Scientist, AstraZeneca

  • Identifying drug metabolites
  • New technologies for drug metabolism studies
  • Metabolites in safety testing – MIST
  • Reactive metabolites
  • Predicting and controlling metabolism
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    14:30

    THIOMERS

    Professor Dr Andreas Bernkop-Schnurch

    Professor Dr Andreas Bernkop-Schnurch, CSO, ThioMatrix

  • Mucoadhesive properties
  • Permeation enhancing properties
  • In situ gelling properties
  • Efflux pump inhibition
  • Thiomer micro- and nanoparticulate drug delivery systems
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    15:10

    Afternoon Tea

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    15:40

    ORAL BIOAVAILABILITY ENHANCEMENT FOR FIM AND EARLY CLINICAL DEVELOPMENT

    Dr Mario Maio

    Dr Mario Maio, Formulation Development Manager, Serono

  • Hurdles and constraints of oral route
  • Are DDS really necessary?
  • All the arches in your bow
  • Case studies
  • Life cycle management in clinical development
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    16:20

    Chairman’s Closing Remarks and Close of Day One

    Crowne Plaza Hotel - The City

    19 New Bridge Street
    London EC4V 6DB
    United Kingdom

    Crowne Plaza Hotel - The City

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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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