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Published by: SMI Publishing, Ltd
Published: Apr. 26, 2006
Table of Contents
- Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Dr Steven Kesten, Therapeutic Area Director, Respiratory, Boehringer Ingelheim .
- 9.10 REGULATORY GUIDELINES
- European regulatory guidelines for asthma dn COPD
- Current status
- Guidelines for asthma
- Guidelines for COPD
- Dr John Warren, Medical Assessor, Medicines & Healthcare products Regulatory Agency (MHRA).
- 9.50 IMPROVING EFFICIENCY IN THE DEVELOPMENT OF INHALED DRUGS
- Smart selection of formulation, device and inhalation route
- Streamlining drug development timelines through integrated study design
- Approaches in the evaluation of inhaled drug delivery: right place, right time, right level?
- Better delivery, better patient compliance - case studies
- Mr Mark Egerton, Chief Executive Officer, Pharmaceutical Profiles Ltd..
- 10.30 Morning Coffee
- 10.50 DEVELOPMENT OF A NOVEL SMALL MOLCULE ANTAGONIST FOR INFLAMMATION AND ATOPY
- The role of chemoattractants in allergic and inflammatory disorders of lung and skin
- Novel target validation and the discovery of suitable small molecule antagonists
- Actimis Pharmaceutical’s novel anti-inflammatory compound
- Pharmacological efficacy and preclinical development overview
- Dr Kevin Bacon, Founder, Chief Scientific Officer, & Head, Research & Development, Actimis.
- 11.30 LONG-ACTING ANTICHOLINERGIC AGENTS
- Novel advances in COPD management
- Bronchodilators and anticholinergics are the mainstays of COPD treatment
- Abnormal inflammatory response in the lung
- Cholinergic bronchoconstriction plays a significant role in the severity of COPD symptoms
- Anticholinergic agents antagonise the airway bronchoconstrictive action of acetylcholine
- Inhaled bronchodilators alleviate symptoms, improve airflow and decrease hyperinflation
- Mr Craig Conoscenti, Associate Director , Boehringer Ingelheim
- 12.10 THE LABA ASTHMA DEBATE
- A case study in ICS/LABA combination therapy
- Review of risk/benefit and positioning of LABA in asthma management
- The salmeterol SMART study and response by regulatory authorities
- The potential impact on positioning of LABA in asthma management
- Dr Dzelal Serdarevic, Director, A&R Therapeutic Area, Clinical R&D, , Pfizer Ltd.
- 12.50 Networking Lunch
- 2.20 ADAPTATION OF ASTHMA MODELS TO MEET PRECLINICAL NEEDS
- Current preclinical asthma models
- Development of more rapid/sensitive readouts
- Visualisation of the immune response as it occurs in asthma
- Identification of mode of action in situ and in real time
- Dr Alison Kerr, Director, Respiratory Inflammations, MD Biosciences.
- 3.00 PROTEASE INHIBITORS IN THE TREATMENT OF COPD AND CF
- Potential disease-modifying agents in COPD
- Human clinical studies with protease inhibitors
- Dr Malinda Longphre, Medical Science Liaison & Head, Medical Affairs, Aerovance Inc.
- 3.40 Afternoon Tea
- 4.00 PHASE IV: REACHING THE PATIENT
- Clinical endpoints through to market
- Meeting international regulations
- Getting the right patients into the right studies
- Efficacy and safety
- Other strategies for late phase studies
- Reducing long-term side-effects and introducing prompt counter-measures
- Dr Alan Davies, European Medical Director, Kendle.
- 4.40 LUNG FUNCTION PARAMETERS
- Respiratory clinical trials - blow by blow
- Measuring lung functions and the relevant parameters differentiating asthma and COPD
- Variables influencing LFTs
- Identifying abnormalities and deducing their causes
- The value of centralised spirometry over-reading
- Case studies
- Dr Aleck Harrison, Consultant Clinical Scientist, AJH Partners.
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Dr Noel Snell, Global Medical Science Director, AstraZeneca R&D.
- 9.10 COMPARATIVE PATHOPHYSIOLOGY OF ASTHMA AND COPD
- Novel therapeutic approaches
- Asthma and COPD - similarities and differences
- Asthma - pathophysiology and potential therapeutic targets
- COPD - pathophysiology and potential therapeutic targets
- ‘Excluded’ trial subjects in obstructive lung disease - are we missing something important?
- Dr Noel Snell, Global Medical Science Director, AstraZeneca R&D.
- 9.50 PHOSPHODIESTERASE-4 INHIBITORS
- A new class of drugs in asthma and COPD
- PDE4 as an important target for the development of anti-inflammatory therapy for airway disease
- Mechanism of action in preclinical models
- Efficacy and safety of PDE4 inhibitors under development - how might they change future treatment algorithms for asthma and COPD?
- Profile of Roflumilast as a PDE4 inhibitor in late phase III development
- Dr Dirk Bredenbroeker, Head, Clinical Research Pulmonology, ALTANA AG.
- 10.30 Morning Coffee
- 11.00 BIOLOGICALS IN THE TREATMENT OF ASTHMA AND COPD
- Novel concepts in the treatment of moderate to severe asthma
- Targeting IgE and TNFa
- Review of the clinical data available to date
- Strong scientific rationale, no clinical efficacy
- Anti-TNFa in COPD
- Dr Rozsa Schlenker Herceg, General Medicine, Centocor Incorporated Corporate Headquarters.
- 11.40 IMMUNE SYSTEM TARGETS IN THE TREATMENT OF ASTHMA
- Targeting IgE and T-cells for asthma therapies
- Update on clinical experiences with Xolair®
- Update on the immunomodulatory effects of long term Xolair® therapy
- Review advances in the understanding of the role of T- cells in asthma pathophysiology
- Describe the potential benefits and risks of targeting T- cells as a new therapeutic approach for asthma
- Case study: Daclizumab (Zenapax®)
- Dr David Valacer, Senior Medical Director, Genentech Inc.
- 12.20 Networking Lunch
- 1.50 ANTI-INFLAMMATORY CORTICOSTEROIDS IN ASTHMA AND COPD
- Inhaled corticosteroid therapy
- Characteristics of an ideal inhaled corticosteroid
- Pharmacological attributes predicting topical efficacy and systemic safety
- Corticosteroid sensitivity and sub-sensitivity
- Current research and development
- Dr Malcolm Johnson, Global Director, Respiratory Science, GlaxoSmithKline.
- 2.30 INHALER DEVICES FOR PULMONARY DELIVERY
- Understanding and delivering future requirements
- Inhalation market trends and impact on device selection
- Understanding patient, clinical, industry and regulatory requirements
- How can current/future device technology meet these needs?
- What is required for success in the future marketplace?
- Dr Peter Scholes, Manager, Early Pharmaceutics & Technology, Drug Delivery Systems Division, 3M Healthcare.
- 3.10 Afternoon Tea
- 3.40 PATIENTS' ATTITUDES TO INHALATION THERAPY
- A review of patients needs and expectations
- Practical aspects of inhaled therapy
- Factors that contribute to poor compliance in inhaled therapy
- Lessons learned in delivering value to patients
- Mr Keith Allan, Director, Respiratory Products, Novartis.
- Mrs Monica Fletcher, Chief Executive Officer, Education for Health.
- 4.20 DEVELOPMENTS IN DRY POWDER INHALERS
- Why are there so many DPIs in development?
- What are the drivers for DPI development
- What is coming next?
- Emerging device overview
- What might the future hold?
- Will electronic devices ever be commercially viable?
- Can Asthma and COPD benefit from more advanced platforms?
- Mr David Whitaker, Consultant, PA Consulting Group.
- 5.00 Chairman’s Closing Remarks and Close of Day One
AbstractWith the proliferation of chronic lung conditions, pharmaceutical companies and research institutions need to continuously find new innovative therapeutic solutions. Inseparable from the issues concerning Asthma, the problems associated with Chronic Obstructive Pulmonary Disease (COPD) are striking. These diseases combined, form one of the biggest potential killers in the coming decades.
SMi’s Asthma & COPD II Conference will uncover the latest developments in clinical research and uncover new advances delivery technologies. Special emphasis will be given to problems being faced in a global market, the acceleration of new drug concepts, the similarities and differences in the two diseases, as well as the various drug classes assigned to combat progressive symptoms.
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