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Published by: SMI Publishing, Ltd
Published: Jan. 24, 2007
Table of Contents
- Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Keith Wesnes, Chief Executive, Cognitive Drug Research.
- 9.00 THE CHALLENGES OF FORMULATING PAEDIATRIC SPECIFIC MEDICINES
- Developing paediatric products
- Designing studies to test existing adult drugs in children
- How can you identify the problem areas in drug formulation?
- Issues with dose testing, efficacy and specificity
- Strategies to deal with taste, swallowing, dosing regimes and compliance
- Dr John Bolodeoku, Senior Director, Medical Affairs & Health Economics, Europe, Astellas Pharma EU Ltd.
- 9.50 THE SUCCESSFUL ENROLMENT OF CHILDREN INTO CLINICAL TRIALS
- The rate limiting step
- Designing and implementing viable recruitment plans
- What are the challenges facing the recruitment process?
- Methods of finding and recruiting patients
- Enrolment incentives and informed consent on entering a trial
- What are the common oversights and how can recruitment be improved?
- Elizabeth Moench, President & Chief Executive Officer, MediciGroup Inc.
- 10.30 Morning Coffee
- 10.50 PATIENT RETENTION IN PAEDIATRIC CLINICAL TRIALS
- A fundamental element of ensuring your trial success
- Evaluation of why patients leave before the end of a trial
- What are the effects on
- The study
- The patient
- How can you prevent a patient from leaving a study before completion and what incentives can they legally be offered
- Stephen Lockhart, Assistant Vice President & Head, Bacterial Clinical Research, Wyeth Vaccines Research.
- Susan Tansey, Associate Director, Wyeth Research.
- 11.30 BEST PRACTICES IN PAEDIATRIC PATIENT RECRUITMENT & CLINICAL TRIAL MANAGEMENT
- Overcoming the challenges
- Patient recruitment strategies and tactics
- The relevance of qualitative research (focus groups) for study strategy
- Increased study efficiency through measurement - a case study
- The future of paediatric participation in clinical trials
- Kathleen Drennan, Senior Vice President & Managing Director, Iris Global Clinical Trial Solutions.
- 12.10 CONDUCTING PAEDIATRIC CLINICAL TRIALS FOR RARE DISEASES
- Congenital protein deficiencies
- How do you recruit and retain paediatric patients with a rare disease?
- Overcoming the challenges of finding enough participants
- Designing and conducting clinical trials for rare disease
- Decision making - outsouring and site management
- Study outcomes and lessons learned
- Hartwig Gajek, Medical Director, Europe, Baxter BioPharmaceuticals.
- 12.50 Networking Lunch
- 2.20 CONSENT AND ASSENT IN PAEDIATRIC CLINICAL TRIALS
- Practical considerations and enhancing parental consent
- The guideline and regulations for consent
- Informed consent and ensuring effective, consistent conveyance of accurate and complete information
- Consent documentation design
- Implications of the consent process on enrolment of children into a study
- Evaluating the level of patient and parent understanding
- Renate Gilbert, GPRD Clinical Training Manager, Abbott GmbH & Co KG.
- 3.00 ETHICAL CHALLENGES AND CONCERNS
- Facing the ethical issues head on
- An overview of the principles of medical ethics
- What are the ethical issues that are unique to children?
- Balancing the risk and the benefits of conducting a paediatric clinical trial
- Human subject protection
- What are the common and not so common ethical issues that impact on paediatric clinical trial design and implementation?
- Francis Crawley, Director General, Good Clinical Practice Alliance.
- 3.40 Afternoon Tea
- 4.00 THE PUBLIC PERCEPTION OF PAEDIATRIC TRIALS
- Consent vs assent challenges
- Effective and appropriate visual and written information for recruitment and retention - the teen/child divide
- Case studies
- Linda Capsey, , Fast4wd Ogilvy.
- 4.40 THE ASSESSMENT OF COGNITIVE FUNCTION IN PAEDIATRIC CLINICAL TRIALS
- How, why and when?
- What cognitive domains should be measured?
- The validation of tests in children
- Large trials of cognitive function in school children
- Year by year changes in performance from 4 to 18 years - the need for closely controlling for age
- The sensitivity, reliability and utility of automated tests of cognitive function in children
- Epilepsy and cognitive function in children
- Keith Wesnes, Chief Executive, Cognitive Drug Research.
- 5.20 Chairman’s Closing Remarks and Close of Day One
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Francis Crawley, Director General, Good Clinical Practice Alliance.
- 9.10 ASSESSING THE BENEFITS AND DISADVANTAGES OF PAEDIATRIC DRUG DEVELOPMENT
- Is it worthwhile?
- The most important considerations in deciding which drugs to develop
- Developing adult drugs into paediatric drugs vs new paediatric drugs
- Financial considerations and time constraints
- Epidemiological factors
- Tim Higenbottam, Principal Research Physician & Senior Principal Scientist, AstraZeneca R&D.
- 9.50 SOME SPECIAL CHALLENGES IN PAEDIATRIC DRUG DEVELOPMENT
- The moving target(s) - there isn't just one paediatric age group
- Child friendly formulations and studies with them
- Research infrastructure
- Albert Allen, Medical Director, Eli Lilly.
- 10.30 Morning Coffee
- 11.00 KEYNOTE ADDRESS - IMPLICATIONS OF THE NEW EU LEGISLATION
- Necessary changes to the design and implementation of paediatric clinical trials
- How have these new laws affected the pharmaceutical industry?
- Will they benefit the industry in the long run?
- The financial impact of putting these laws into action
- Will these laws protect the patient further?
- EU vs US legislation
- Charles Bouchard, Director, European Government Affairs, Merck.
- 11.40 THE ROLE OF PHARMACOGENOMICS AND DEVELOPMENTAL BIOLOGY IN THE PRODUCTION OF PAEDIATRIC DRUGS
- Incorporating these differences into the design of clinical trials in oncology
- How children differ in rates of absorption, distribution, metabolism and excretion, compared to adults
- Age-associated differences in drug clearance
- Incorporating this knowledge into the design of the clinical trial
- Methods of observation to track these differences with the study
- Iman El-Hariry, Senior Director, Oncology Medicines Centre, GlaxoSmithKline.
- 12.20 Networking Lunch
- 1.50 PAEDIATRIC ASSESSMENT AND SPECIALISED TRAINING
- Improving paediatric competencies
- - Challenges in the assessment of paediatric patient - Age-dependence of paediatric measures - Choosing appropriate outcomes for paediatric clinical trials - Multidisciplinary approach to paediatric assessment - Training opportunities
- Christoph Male, Associate Professor of Pediatrics, Medical University Of Vienna.
- 2.30 DESIGNING CLINICAL TRIALS IN THE EARLY INFANCY
- Ethical demands and standards
- Placebo paediatric trials - the bronchiolitis case study
- Drug safety and efficacy in formulations that are not prepared for children
- Drug research in children - new drugs, old drugs, dosages and method of administration
- Overcoming practical problems in drug therapy - case studies in respiratory diseases; how early, what dose, how long?
- Clinical trials in neonates and during pregnancy
- Zorica Zivkovic, Liason Officer, CESP.
- 3.10 Afternoon Tea
- 3.40 CLINICAL TRIAL DESIGN
- Assessing the evidence
- Phase III trials. Deciding what the important questions are - what do we know at present?
- Systematic reviews - finding them, what do they tell us and how reliable are they?
- Doing a systematic review
- Including other types of evidence
- Paediatric issues
- Sue Richards, Senior Research Fellow, Oxford University.
- 4.20 MEASURING OUTCOME IN CNS PAEDIATRIC CLINICAL TRIALS
- Issues and challenges
- Age-associated differences in brain function
- When to use child-specific vs altered adult measurement tools?
- Issues with repeated assessment of children
- How to analyse paediatric outcomes data
- Paul Maruff, Chief Scientific Officer, Cogstate Ltd.
- 5.00 Chairman’s Closing Remarks and Close of Day Two
AbstractThe EU Commission is soon to implement a new legislative system to drive the development and market release of drugs specifically designed for children. Due to pharmacogemonic and biological development differences, paediatric therapeutics must differ significantly from those given to adults.
To address this, The SMi Group proudly presents our Paediatric Clinical Trials Conference. Falling two months after the new legislation is due to be realized, you will hear from key players in the industry about how they will contend with these changes.
Hear contributions from leading industry experts, including:
- Dr Charles Bouchard, Director, European Government Affairs, Merck
- Dr Iman El-Hariry, Group Director, Oncology MDC Europe, GlaxoSmithKline
- Dr Albert Allen, Medical Director, Neuroscience Global Brand Development, Eli Lilly
- Dr Hartwig Gajek, Medical Director, Europe, Baxter BioPharmaceuticals
- Dr Francis P Crawley, Executive Director, Good Clinical Practice Alliance - Europe & Member, Ethics Working Group, Confederation of European Specialists in Paediatrics (CESP)
- Dr Susan Tansey, Associate Director, Wyeth Vaccines Research Professor
- Tim Higenbottam, Principal Research Physician & Senior Principal Scientist, Respiratory & Inflammation Therapy Area, AstraZeneca
- Dr Renate Gilbert, GPRD Clinical Training Manager, Abbott
- Kathleen Drennan, Senior Vice President & Managing Director, Iris Global Clinical Trial Solutions
Hear international case studies and expert perspectives on:
- REGULATORY AFFAIRS: Learn how to comply to the new legislation and overcome the pitfalls
- PAEDIATRIC RECRUITMENT & RETENTION: Discover strategies and best practices in the recruitment of children into clinical trials and how to reduce drop out rates
- PAEDIATRIC DRUG DEVELOPMENT: Learn about the challenges in developing drugs designed for children and how to overcome them
- CLINICAL TRIAL DESIGN AND METRICS: Gain an insight into the key drivers and problems facing trial design and analysis and hear practical solutions to overcome them
- ETHICS & CONSENT: Listen to the ethical considerations behind paediatric studies and how to gain parental consent, ensuring their full understanding
- INDUSTRY EXPERTS: Network with influential experts from leading pharmaceutical companies and learn from their experiences and expertise.
Get Full Details About This Report >>
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