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Masterclass Chair;

Ann Hayes, Director, The Ann Hayes Consultancy

 

Co-hosted by;

Paul Matthews, Vice-president and Head, GSK Clinical Imaging Centre

Richard Peck, Global Head Clinical Pharmacology, Hoffmann-La Roche

 

About the Masterclass

The CNS therapeutic area covers wide range of diseases, including psychiatric and neurological diseases and also symptom classes which span a number of diseases, like pain and spasticity. The diseases share the common property that primary mechanisms leading to expression of the disease are in the brain and spinal cord. Despite the high prevalence of many of these diseases, they are still poorly treated.

Attrition rates for new drug development are higher than any other therapeutic area, and have led to several companies withdrawing resource from the area. Indeed there are issues at every stage of the discovery/development pathway including: an inadequate understanding of the aetiology and pathology, poorly predictive animal models, difficulties with drugs accessing the target organ, subjective clinical endpoints and, in some instances, uncertainty regarding outcomes that regulators will value.

However, the commercial prizes are potentially great and the medical needs high, so the industry cannot disengage from the area altogether.

 

Session objectives

The aim of the session will be to identify the key issues which are responsible for the current low success rates in CNS drug discovery and development, to highlight strategies being developed to overcome these issues and to discuss how these may change the landscape for drug development in this important area.

 

Delegates will be given practical tools and guidance for improving their CNS R&D efforts.

 

Key benefits of attending:

 

By attending this Masterclass, you will be able to;

  • Identify the problems within your R&D efforts
  • Develop your understanding of the CNS drug discovery process
  • Discover ways to improve your current approach
  • Expand your network of contacts working in the field of Neurology

 

 

Our Masterclasses are all CPD accredited, offering you measurable value as part of your continued professional development

 

About the masterclass Chair

 

 

Ann Hayes worked for 22 years for Glaxo and GlaxoWellcome, in drug discovery in the areas of CNS and pain. She was responsible for determining the strategy for the CNS therapeutic area in drug discovery and for the progression of CNS projects through to clinical proof-of-concept. She also sat on the Drug Discovery Board and hence was involved in determining long-term Discovery strategy.

Ann left GSK in 2001 and set up The Ann Hayes Consultancy Ltd in which she provides consultancy for a number of small companies and venture capitalists. She has co-founded three companies, Ionix Pharmaceuticals, a drug discovery company for pain, Therasci, a CNS drug discovery company and Theradeas.

Ann is a member of the advisory boards for Senexis and Bionomics and has held non-executive director positions at Curidium Medica plc, Plethora Solutions plc, Therasci Ltd, Ionix Ltd, Sirus Ltd and Celentyx Ltd.

 

About The Ann Hayes Consultancy Ltd

 I provide independent consulting advice to pharmaceutical and biotechnology companies and venture capitalists, in the following areas:

  • Drug discovery from early research through to clinical Proof of Concept; including general project strategy, writing product profiles, making assessments of risk/ return.
  • CNS diseases
  • Portfolio management 

 

Dr Richard Peck's biography 

Dr Richard Peck FRCP, FFPM is Global Head of Clinical Pharmacology for Roche.

He trained in pharmacology and medicine at Cambridge University and has twenty years experience in the pharmaceutical industry, working in Clinical Pharmacology, Experimental Medicine and Drug Discovery for GlaxoWellcome, SmithKline Beecham and Eli Lilly, before joining Roche.

He is a member of the MRC Population and Systems Medicine Board and several MRC grant review panels, was a member of the OSCHR Translational Medicine Board and former chair of the ABPI Experimental Medicine Group. Recently he was an industry member of the review groups for the OLS Capability Clusters Initiative and is a keen supporter of improved collaboration between the pharmaceutical industry and UK academia to enhance drug development and clinical use.

His research interests include improving the productivity of early clinical drug development, understanding and utilising variability in drug response to improve drug dosing and clinical benefit in different patient groups, applying clinical pharmacology to enable the development of personalised/stratified  medicines, and the use of model-based drug development strategies in which experimental data and quantitative models are used in an iterative learn/confirm cycle to increase the level of knowledge obtained from experimental data and thereby increase development and clinical success rates. 

 

Masterclass programme

9:30 Registration & Coffee

10:00 Welcome and Introductions

  • Background and aims of the session
  • Ann Hayes

    Ann Hayes, Director, The Ann Hayes Consultancy Ltd

    Richard Peck

    Richard Peck, Global Head of Clinical Pharmacology, Hoffmann-La Roche

    Paul Matthews

    Paul Matthews, Vice President, Imaging, Genetics and Neurology in Clinical Pharmacology and Discovery Medicine, GlaxoSmithKline

    10:30 Discussion on aetiology and pathology of CNS diseases

    Ann Hayes

    Ann Hayes, Director, The Ann Hayes Consultancy Ltd

  • How important is an understanding of the disease to providing better validated targets?
  • In which diseases have we made progress; how has this led to better drugs being developed?
  • In which diseases are we still struggling and what approaches and technologies offer new promise?
  • 11:30 Animal models of CNS diseases

    Ann Hayes

    Ann Hayes, Director, The Ann Hayes Consultancy Ltd

  • Where have animal models helped us develop new drugs for CNS disease?
  • Are the models truly models of disease or rather models of pharmacology or aspects of disease pathology
  • How do we optimise preclinical-to-clinical translation? (Are animal models helpful in validating novel CNS targets or should we use them to demonstrate in vivo activity and ‘proof of pharmacology’, and progress rapidly to man?)
  • 12:15 Lunch

    13:15 Making key early pharmacological decisions for CNS drugs

    Paul Matthews

    Paul Matthews, Vice President, Imaging, Genetics and Neurology in Clinical Pharmacology and Discovery Medicine, GlaxoSmithKline

  • How can we develop confidence in blood brain barrier penetration of new compounds?
  • How can we choose an appropriate dose range for clinical studies?
  • Linking pharmacokinetics and pharmacodynamics to provide confidence in target and molecule
  • 14:15 Issues around clinical trials in CNS diseases

    Richard Peck

    Richard Peck, Global Head of Clinical Pharmacology, Hoffmann-La Roche

  • What are the key issues in carrying out CNS clinical trials? what strategies can be used to overcome them (eg reduce the placebo response, improve compliance etc)
  • Can biomarkers and adaptive designs improve trial outcomes?
  • Will stratified medicine help to improve attrition?
  • 15:15 Issues around diagnosis of CNS diseases

  • Is diagnosis and diagnostic criteria inhibiting our ability to carry out reliable clinical studies?
  • How close are we to personalised medicine for CNS diseases?
  • Richard Peck

    Richard Peck, Global Head of Clinical Pharmacology, Hoffmann-La Roche

    Paul Matthews

    Paul Matthews, Vice President, Imaging, Genetics and Neurology in Clinical Pharmacology and Discovery Medicine, GlaxoSmithKline

    15:45 Summary and discussion

    16:30 Close of session

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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.

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    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.

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