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Throughout the past decade the formulation and delivery of biopharmaceuticals has played a crucial role in the development and commercialisation of pharmaceuticals products.

SMi's inaugural conference, Optimising Drug Formulation' aims to provide attendees with the latest advances in key formulation practices and methodologies. This event will consider complex macromolecule injectable and protein formulations with a view to future developments and regulatory issues pertaining to the current formulation of drugs. Consideration of the bioavailability or poorly soluble active compounds and bioequivalence will also be given as key industry personnel address this crucial market.

This is a great opportunity to meet and network with the key players within the market!

  • Dr Rao Chilamkurti, Senior Director, Pharmaceutical Technology, Baxter Healthcare
  • Prof Gert Ragnarsson, Director, Preformulation & Biopharmaceutics, AstraZeneca
  • Dr Joel Richard, Director, Pharmaceutical Development, Serono
  • Dr Andy Rignall, Associate Director, Analytical Research & Development, AstraZeneca
  • Dr Raj Patel, Senior Director, Formulations & Process Development, Titan Pharmaceuticals
  • Dr Rolf Brickl, Scientific Expert, Pharmaceutical Research & Development, Boehringer-Ingelheim
  • Dr Robert Buice, Senior Director, Pharmacokinetics & Clinical Pharmacology, DOV Pharmaceuticals
  • Dr David Cipolla, Director, Pharmaceutical Sciences, Aradigm
  • Dr Kalidas Kale, Senior Research Investigator, Bristol-Myers Squibb

Conference programme

9:00 Registration & Coffee

9:30 Chairman's Opening Remarks

Robert Buice

Robert Buice, Senior Director, Pharmacokinetics & Clinical Pharmacology, DOV Pharmaceuticals

David Cipolla

David Cipolla, Director, Pharmaceutical Sciences, Aradigm Corporation

9:40 OPTIMISING OUTSOURCING RELATIONSHIPS

Rajesh Patel

Rajesh Patel, Senior Director, Drug Formulations & Process Development, Titan Pharmaceuticals Inc

  • How to evaluate an outsourcing partner
  • Specialised skills and training an outsourcing partner can offer
  • Effective management of vendor timelines and productivity
  • 10:20 EARLY ASSESSMENT OF POTENTIAL TOXICOLOGY AND PRECLINICAL FORMULATIONS

    Uday Jain

    Uday Jain, Princiapal Research Scientist II, Wyeth Research

  • Physicochemical property challenges related to discovery and toxicology formulations
  • Formulation approaches for delivering NCE's by the oral and parenteral routes of administration in early animal studies
  • Supporting discovery research for evaluating formulations earlier to assist in decision-making and reducing development time
  • The importance of designing PK studies for future GLP toxicology and clinical studies
  • Identification of potential toxicology formulations suitable for GLP studies
  • 11:00 Morning Coffee

    11:30 HIGH THROUGHPUT METHODS IN EARLY FORMULATION DEVELOPMENT

    Rolf Brickl

    Rolf Brickl, Scientific Expert, Pharmaceutical Research & Development, Boehringer-Ingelheim

  • High throughput methods for compound selection
  • High throughput methods for salt and polymorph screening
  • High throughput methods for dissolution testing
  • High throughput methods for early formulations
  • Conclusions and possible further developments
  • 12:10 EFFECTIVE USE OF ACCELERATED AGING FOR FORMULATION DEVELOPMENT

    Andy Rignall

    Andy Rignall, Associate Director, Analytical Research & Development, AstraZeneca

  • Underlying principles behind accelerated testing
  • Relevant physical and chemical challenges
  • Influence of excipients
  • Packaging considerations
  • Storage and transportation considerations
  • 12:50 Networking Lunch

    14:30 PANEL DISCUSSION

  • Current progress being made
  • What are the problems facing pharmaceutical companies?
  • How will this affect the formulation of drugs in the future?
  • The rise of new technology
  • Andy Rignall

    Andy Rignall, Associate Director, Analytical Research & Development, AstraZeneca

    Gert Ragnarsson

    Gert Ragnarsson, Director, Preformulation & Biopharmaceutics, AstraZeneca

    Rajesh Patel

    Rajesh Patel, Senior Director, Drug Formulations & Process Development, Titan Pharmaceuticals Inc

    Rao Chilamkurti

    Rao Chilamkurti, Senior Director, Pharmaceutical Technology , Baxter Healthcare

    15:10 PHYSIO-CHEMICAL AND BIOPHARMACEUTICAL ASPECTS ON DRUG CANDIDATE SELECTION AND EVALUATION

    Gert Ragnarsson

    Gert Ragnarsson, Director, Preformulation & Biopharmaceutics, AstraZeneca

  • Current trends – CD properties and attrition
  • Physio-chemical aspects
  • Biopharmaceutical considerations and evaluation
  • Decision making and risk management   
  • 15:50 Chairman’s Closing Remarks Followed by Afternoon Tea

    Robert Buice

    Robert Buice, Senior Director, Pharmacokinetics & Clinical Pharmacology, DOV Pharmaceuticals

    9:00 Registration & Coffee

    9:30 Chairman's Opening Remarks

    David Cipolla

    David Cipolla, Director, Pharmaceutical Sciences, Aradigm Corporation

    9:40 UNDERSTANDING PHYSIO-CHEMICAL FORMULATION PROPERTIES TO AVOID LATE STAGE PROBLEMS

    Andrew Parker

    Andrew Parker, Business Development Officer , Molecular Profiles

  • Utilising advanced, solid state, interfacial analytical techniques in formulation development
  • Preformulation screening of materials to aid selection
  • Evaluating possible physical and structural transitions
  • The benefits of in-situ analysis through generations of spatially resolved information
  • 10:20 THE EVOLUTION OF INJECTABLE FORMULATIONS

    David Cipolla

    David Cipolla, Director, Pharmaceutical Sciences, Aradigm Corporation

  • Review of the injectable marketplace
  • The role of competition driving formulation innovation
  • Overview of the development of solution formulations and longer-acting formulations
  • Formulation requirements of new injection technologies
  • Formulation challenges for use with next generation needle-free delivery systems
  • 11:00 Morning Coffee

    11:30 OPTIMISING FORMULATIONS FOR READY-TO-USE INJECTABLES

    Rao Chilamkurti

    Rao Chilamkurti, Senior Director, Pharmaceutical Technology , Baxter Healthcare

  • Influence of formulation in the selection of injectable dosage forms for new drug substances
  • Role of container compatibility and enhanced packaging in formulation optimisation
  • Optimisation of formulation along with manufacturing process parameters     
  • Optimisation of formulation in frozen and liquid states for frozen drug products
  • 12:10 REGULATORY ISSUES SURROUNDING COMPLEX INJECTABLES

  • Unique issues with complex injectables
  • Finding solutions
  • Developing a regulatory programme for these products
  • Impact of unique issues on the development timetable
  • Michael Gamlen

    Michael Gamlen, Managing Director, Pharmaceutical Development Services Ltd

    Kevin Maynard

    Kevin Maynard, Senior Consultant, Imprint Pharmaceuticals Ltd

    12:50 Networking Lunch

    14:30 SCIENTIFIC FOUNDATIONS OF PROTEIN FORMULATION

    Susan Martin

    Susan Martin, Principal Scientist, Pfizer

  • Considerations for proteins vs small molecules
  • Developing a robust and successful protein formulation
  • Designing the formulation to gain market share
  • Formulations to enable non-invasive delivery routes
  • Utilisation of delivery device technology
  • 15:10 ENHANCING AND PROTECTING PHARMACEUTICAL BRANDS AS A KEY STAGE OF FORMULATION DEVELOPMENT

    Deborah Taylor

    Deborah Taylor, Market Development Manager, Brand Enhancement Services , Colorcon

  • More than colour, shape and logo
  • Using on-tablet technologies to protect against counterfeiting and product diversion
  • Optimising branding and creating visual appeal
  • Protecting patients and reduction of medical errors
  • Role of film-coating technologies
  • 15:50 Chairman’s Closing Remarks Followed by Afternoon Tea

    David Cipolla

    David Cipolla, Director, Pharmaceutical Sciences, Aradigm Corporation

    +

    Workshops

    Improving Injectable Formulations Through Good Device Design
    Workshop

    Improving Injectable Formulations Through Good Device Design

    Jurys Great Russell Street Hotel
    23rd November 2005
    London, United Kingdom

    Jurys Great Russell Street Hotel

    16-22 Great Russell Street
    London WC1B 3NN
    United Kingdom

    Jurys Great Russell Street Hotel

    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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