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The incidence of asthma and COPD is increasing throughout the world, and acts as a major incentive for the development of new drug therapy, and there is the urgent need to validate non-invasive biomarkers as an adjunct to clinical studies. In respiratory disease it is possible to directly study clinical effects of new therapies on patients through electronic monitoring of lung function (FEV1) as well as advanced lung function and exercise and challenge test. Increasingly pharmaceutical companies are employing human whole blood flow cytometry and non-invasive sampling to assess pharmacodynamic effects of new therapies in phase I/II clinicial studies. For both asthma and COPD, surrogate biomarkers may be assessed in blood, exhaled breath, induced sputum, bronchial mucosal biopsy, bronchoalveolar lavage (BAL), and through advanced radiographic imaging. Development of biomarkers will rely on collaboration between academics in clinical research, the pharmaceutical industry and regulatory authorities, and this will facilitate the clinical development of new therapies for patients with respiratory diseases.

About the workshop leader:

Dr. Trevor Hansel is Medical Director of the National Heart and Lung Institute (NHLI) Clinical Studies Unit of Imperial College, and an Honorary Consultant at the Royal Brompton Hospital in London. He obtained his medical degree at the Welsh National School of Medicine, Cardiff and then completed higher specialist medical training in clinical immunology in Birmingham.

Trevor Hansel has a specialist interest in phase II clinical testing of new anti-inflammatory therapies for asthma and COPD, involving nasal and bronchial challenge, and use of non-invasive biomarkers. His team have developed a novel method to measure cytokines and chemokines in induced sputum samples.  In addition, nasal challenges have been performed with allergen and used to assess effects of anti-inflammatory agents on tissue reactions. Synmtehtic absorptive matrices (SAM) are used to sample nasal and bronchial lining fluid, and cytokines and chemokines can be measured in neat secretions. These clinical pharmacology studies enable the accurate definition of pharmacodynamic effects, especially dose magnitude and interval, and enable reliable decision making before entering phase III studies.

With Peter Barnes he has edited “New Drugs for Asthma, Allergy and COPD” (Karger, 2001), and is currently working on “New Drugs and Targets for Respiratory Diseases” with Prous Science, that are now part OF Thomson Reuters. Trevor Hansel is on the editorial board of  Clinical and Experimental Allergy, and  has authored with Peter Barnes the comprehensive “Atlas of COPD” (Parthenon Publications). Trevor Hansel has over a hundred publications on eosinophils, cytokines and chemokines, biomarkers, inhaled and nasal challenge models, whole blood flow cytometry methods, and evaluation of new drugs for asthma and COPD.

Workshop programme

8:30 Registration & Coffee

9:00 Respiratory Biomarkers in Phase I and II studies

Trevor Hansel

Trevor Hansel, Medical Director, NHLI Clinical Studies Unit

  • Blood
  • Exhaled breath
  • Sputum
  • Nasal

9:30 New Biotechnology Agents and Biomarkers for Asthma

Ian Anderson

Ian Anderson, Vice President of Research, Respiratory, Inflammation and Autoimmunity, Medimmune

10:00 Role of Systems Biology & the Capacity to Dissect Complex Diseases

10:30 Morning Coffee

11:00 Case study: the role of biomarkers in PDE inhibitor development

Richard Marshall

Richard Marshall, Head of External Discovery, GSK

11:30 Challenge of Developing Biomarkers for RNA directed Therapy

Mark  Parry-Billings

Mark Parry-Billings, Chief Executive Officer, Topigen Pharmaceuticals

12:00 Challenge of Biomarker Validation for Academia, Industry & Regulators

12:30 End of Workshop

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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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