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The SMi Group’s 3rd Annual Optimising Drug Formulation Conference aims to explore the key role of formulation throughout pharmaceutical development.

Solubility continues to remain a fundamental challenge for the industry and will be addressed with a targeted session.
A special focus will also be placed on the unique challenges in Biopharmaceutical drug formulation, as innovations of today will prove to be the next decade’s blockbusters.

With formulation playing such a key role in the makings of a successful product, partnership sourcing and management of collaborations will be explored in dedicated case-study presentations.
The conference aims to bring two days of superb case study presentations, exploring current research and development in the formulation field.

Confirmed Speakers Include:

  • Dr Tomas Landh, Principal Scientist, Preformulation and Delivery, Novo Nordisk
  • Dr Barbara Lueckel, Global Drug Delivery Evaluator, Roche
  • Dr Thomas Backensfeld, Head, Global Pharmaceutical Development, Bayer Schering Pharma
  • Dr Ingvar Ymén, Principal Scientist, Analytical Chemistry, AstraZeneca
  • Dr David Cipolla, Director, Pharmaceutical Sciences, Aradigm
  • Kevin Maynard, Development Director, Imprint Pharmaceuticals
  • Dr Alyson Connor, Principal Scientist, Pharmaceutical Profiles
  • Annabel Boardman, Market Development Manager, Colorcon

This successful annual event attracts Executives, Directors and Scientists working in the pharmaceutical and biotech industries within:

  • Drug Formulation  - Research and Development
  • Drug Delivery
  • Business Development and Strategic Licensing
  • Technology Development

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

David Cipolla

David Cipolla, Senior Director, Pharmaceutical Sciences , Aradigm Corporation

9:10 FORMULATION OPTIMISATION FOR THE CLINICAL DEVELOPMENT OF REPRODUCTIVE HEALTH PRODUCTS

Concepcion  Rubalcava

Concepcion Rubalcava, Formulation Development Group Leader, Serono

·                Hurdles and constraints of oral route
·                Are DDS really necessary?
·                Case studies
·                Formulation optimisation in clinical development

9:50 SOLUBILITY SCREENING AND THE DEVELOPMENT OF POORLY SOLUBLE COMPOUNDS

Alyson Connor

Alyson Connor, Principal Scientist, Pharmaceutical Profiles Ltd

·                 Is MR formulation development possible for your drug?
·                 What will it take to overcome poor oral bioavailability?
·                 Challenges and solutions in developing the successful modified release formulation
·                 Clinical evaluation of prototype formulations

10:30 Morning Coffee

11:00 SOLIQ'S TECHNOLOGIES TO ENHANCE AND ENABLE API CHALLENGES

Joerg Breitenbach

Joerg Breitenbach, Director, Head of Drug Delivery Business (SOLIQS), Abbott

11:40 ISSUES AND CHALLENGES IN THE DEVELOPMENT OF HIGH CONCENTRATION ANTIBODIES AND PROTEINS

Kevin Maynard

Kevin Maynard, Director, Business Development, Imprint Pharmaceuticals Ltd

·          Issues with high concentration formulations
·          Using Microrheology as a high throughput method for analyzing aggregation
·          Unfolding in solutions with low and high concentrations of protein
·          Novel methods of formulation
·          Mixing and solubilisation methods for pastes and gels
·          Delivery methods for high concentrations

12:20 Networking Lunch

13:50 ANALYTICAL RESEARCH OF PROTEIN AGGREGATION

Hanns Christian Mahler

Hanns Christian Mahler, Head of Formulation R&D Biologics, La Roche Ltd.

·                What are the issues?
·                How to detect and characterize protein aggregation
·                How to optimize formulations to reduce the aggregation risk

14:30 FORMULATION STRATEGIES FOR USE IN INJECTABLE OR INHALATION DEVICES

David Cipolla

David Cipolla, Senior Director, Pharmaceutical Sciences , Aradigm Corporation

·                 Analysis of attempts at delivery via the oral route – the prospects for biopharmaceuticals in upcoming years
·                 The surge in formulations for antibodies: promising routes of delivery
·                 Fresh approaches to protein formulation and delivery

15:10 Afternoon Tea

15:40 FORMULATION STRATEGIES FOR ORAL DELIVERY IN THE 21ST CENTURY

Karrar Khan

Karrar Khan, , Consultant

  • Key strategic issues of formulation development
  • Formulation development challenges for oral delivery for FIM and phase 2
  • Drug product characterization and manufacturing of clinical trails supplies
  • Design of controlled release and realistic expectations for clinical outcome
  • 16:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Tomas Landh

    Tomas Landh, Senior Principal Scientist, Preformulation and Delivery, Novo Nordisk

    9:10 SOURCING PARTNERSHIPS IN DRUG FORMULATION

    Tomas Landh

    Tomas Landh, Senior Principal Scientist, Preformulation and Delivery, Novo Nordisk

    ·                 Understanding the incentives for large companies to seek small specialized external resources
    ·                 Enhancing the visibility in the pharmaceutical arena – information of interest and showcasing platforms

    9:50 DEVELOPMENT TIME OPTIMISATION: BRIDGE BETWEEN EARLY CLINICAL PHASE AND FINAL DOSAGE

    Annabel Bordman

    Annabel Bordman, Market Development Manager, Colorcon

    ·                 Starcap 1500, a new excipient for capsule and tablet
    ·                 From capsule to tablet, a new concept to shorten new drug development time
    ·                 Case study with Cyclobenzaprine as model drug

    10:30 Morning Coffee

    11:00 ROBUST SOLUBILITY ASSESSMENT FOR CRYSTALLISATION AND SOLID STATE FORMULATIONS

    Ingvar  Ymén

    Ingvar Ymén, Principal Scientist, Analytical Chemistry, AstraZeneca

    Obtaining background information on solid state materials for further use in formulations
    ·                Examining solubility across an array of solvent
    ·                Crystal design modifications and process design for obtaining the correct polymorphic form

    11:40 PRECIPITATION RATES AND SUPERSATURATION RATIOS OF DRUGS IN AQUEOUS SOLUTION

    John Comer

    John Comer, Technichal Director, Sirius Analytical Instruments Ltd. (UK)

    12:20 Networking Lunch

    13:50 IMPROVING FORMULATION DEVELOPMENT USING NOVEL INSTRUMENTATION TECHNOLOGIES

    Carl Levoguer

    Carl Levoguer, , Malvern Instruments

    ·              A better understanding of formulation from ingredients to products
    ·              Is size information enough for your particulates?
    ·              Optimising blending and dissolution with NIR imaging
    ·              Better characterisation of novel drug delivery systems

    14:30 THE USE OF EFFLUX PUMP INHIBITORS IN ORAL DRUG DELIVERY

    Andreas Bernkop-Schnurch

    Andreas Bernkop-Schnurch, Chief Scientific Officer, University Of Innsbruck

    ·          Types of efflux pumps and impact on orally administered drugs
    ·                Low molecular mass efflux pump inhibitors vs. polymeric efflux pump inhibitors
    ·                Reversible vs. non-reversible inhibitors
    ·                New generations of efflux pump inhibitors
    ·                Favourable dosage forms for oral administration

    15:10 Afternoon Tea

    15:40 INCREASING THE TECHNOLOGY INNOVATION BASE THROUGH ACCESS TO EXTERNAL DRUG DELIVERY TECHNOLOGIES

    Barbara Lueckel

    Barbara Lueckel, Drug Delivery Evaluator, F. Hoffman-La Roche

    ·                Reasons for looking at external drug delivery technologies
    ·                What should be achieved through a feasibility study?
    ·                How to approach the implementation of a technology

    16:20 FORMULATION INNOVATION - THE CHALLENGE OF THE FUTURE FOR DRUG DEVELOPMENT

    Michael Hildebrand

    Michael Hildebrand, Professor for Industrial Pharmacy, University Of Jena

    ·                 Global pharma markets: NDAs vs NCEs/NBEs
    ·                 Dimensions and Drivers of formulation and innovation
    ·                 Success stories
    ·                 New markets and cannibalization
    ·                 Perspectives

    17:00 Chairman’s Closing Remarks and Close of Day One

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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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