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Day one – Wednesday 24 September 2008
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8.30am | Registration and coffee
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8.50am | Chairman's opening remarks
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9am | How should we be developing drugs in the 21st century?
- Changing the development process, synergy of regulation, process and technology
- Is it all about personalized medicine
- Development of targeted therapy where are we now
- The importance of predictive biomarkers, you don’t know what you don’t know
- It’s all about failing early
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9.30am | Clinical pharmacology has a critical role to play in meeting the new challenges facing drug discovery and early development
- New drug targets are more likely to be physiologic control pathways than single receptors or enzymes. Testing and optimizing combinations of actions in man will require new approaches to study design and accuracy of measurement.
- Adapting drug therapy to the individual patients needs (personalized medicine) is a very complex issue involving accurate assessment of disease severity, co-morbidity, dose-response, side-effect burden, susceptibility to adverse effects etc. All these require the skills of the clinical pharmacologist. Genetics will play a substantial part but in only a few cases will single gene polymorphisms be the dominant consideration.
- The complexity of the issues that are now being addressed is such that iterative use of sophisticated mathematical models with clinical experiment will be of great importance both in refining experimental design and in assessing a wider range of possibilities than can be tested by human experiment. This can be termed “systems clinical pharmacology”.
- More attention will have to be given to accurate, early, measurement of pharmacologic effects in man that have long term implications for drug safety. These may range from small increases in blood pressure to subtle changes in mood. For clinical pharmacologists the assessment of safety will require the same close attention as measurement of efficacy.
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10am | Clinical pharmacology and the roles of experimental medicine in exploratory development
- Transition from laboratory to phase I unit; pharmacodynamic and proof of concept studies
- Develop, validate and apply novel clinical monitoring methods to elucidate drug action
- Develop and implement global strategy to improve drug development
- Investigate and characterize the variability in disease and how that relates to the variability in response to new drugs
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| | Dr Alan Hollister, Executive Director, Clinical Pharmacology Unit, AstraZeneca Pharmaceuticals
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10.30am | Morning tea
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11am | Model-based early drug development
- Understanding “learn and confirm” paradigm in early drug development
- Characterizing variability in the exposure response relationship
- Leveraging Phase I data into the later stages of drug development:
- Rational dose selection
- Optimization of trial design
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| | Dr Seth Berry, Associate Director, Modeling and Simulation, Global Phase I, Clinical Pharmacology, Quintiles, Inc.
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11.30am | Reassessing current structures that support exploratory clinical development
- Components and deliverables of exploratory clinical development
- Functionalities required for successful exploratory development
- Consideration for ideal organizational constructs
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| | Dr Thorir Bjornsson, Vice President, Early Development and Clinical Pharmacology, Wyeth Research
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12pm | Speed networking
 This is a revolutionary, exciting, quick and non-pressurized way to meet fellow delegates and industry peers in one 45 minute session. These brief meetings are the starting point for conversation and networking throughout the congress. Be sure to bring along plenty of business cards for this session, which is where long lasting and fruitful relationships begin.
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12.45pm | Lunch
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1pm | Volunteers versus patients: scientific, operational and ethical issues
- Some Scientific consideration on conducting early clinical studies in volunteers versus patients
- Operational issues and review of study metrics – promoting rapid drug development
- Ethical issues and risk management
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1.30pm | Global challenges in conducting a phase I trial
- Overview of international regulatory and commercial pressures impacting phase I and early phase trials
- Key considerations when choosing a region for your trial
- Changes to the regulatory environment impacting on phase I trial cost
- Case study: the changes in the clinical trials environment in the UK – a unique approach
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2.30pm | Afternoon tea
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Day one - Stream 1 Safety Pharmacology
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3pm | Using preclinical QT data to impact clinical study design and decision making and clinical validation of preclinical models
- Preclinical data and internal decision making
- Integrating preclinical data into study design
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3.30pm | Regulatory, procedural, and statistical considerations in the thorough QT study: the complexity of the design of a thorough QT study
- Intrasubject variability
- Design alternatives and TQTS
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4pm | Mechanistic cardiac modeling in drug development
- Outline concept of systems biology and mechanistic modeling platforms
- Systematic data incorporation in the model
- Cardiac modeling platform validation
- Clinical utility of modeling platforms
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4.30pm | Chairmans closing remarks
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5pm | Networking drinks reception
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Day one - Stream 2 Biomarkers in Early Development
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3pm | Challenges faced in biomarker validation
- Biomarkers link human disease heterogeneity and drug development
- Types of biomarkers: Predictive, prognostic, and pharmacodynamic
- Stages of biomarker development: discovery, verification, and validation
- Challenges and strategies in integrating biomarkers into clinical development study designs and timelines
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| | Joe Arron, ITGR Biomarker Group Scientist, Genetech, Inc
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3.30pm | Translational medicine approaches in CNS drug development
- Compound biomarkers to demonstrate proof of mechanism
- Disease biomarkers to demonstrate proof of concept
- Use of preclinical biomarker data
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| | Dr Hong Wan, Associate Director, Clinical Translational Medicine, Wyeth Research
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4pm | Imaging biomarkers; what potentials can they offer in early clinical development?
- Imaging’s impact on decision making in exploratory medicine
- The use of medical imaging techniques
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4.30pm | Chairmans closing remarks
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5pm | Networking drinks reception
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Day two – Thursday 25 September 2008
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9am | Adaptive trial design in early phase development, realizing the potential
- Why and where adaptive trial designs should be used
- Greatest benefit when applied to clinical development program, not trial by trial
- Maximum information can be acquired in minimum time in the exploratory setting
- Case studies from trials which used flexible designs
- Solutions to address issues raised by regulatory groups
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9.30am | Novel paradigms in assessing proof-of-concept for new molecular entities
- Early assessment of target engagement and inferences on proof-of-concept
- New technologies for early assessment of POC
- Value of strategic modeling and simulation to reduce the uncertainty in response
- Enabling early assessment of clinical utility for unprecedented targets
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10am | Clinical study simulation: an integration tool for pharmacokinetic, pharmacodynamic and disease models in early development
- The role and use of model based drug development
- A quantitative basis to improve the design of clinical trials
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| | Dr Hui Kimko, Associate Director, dvanced PK/PD Modelling Simulation, Johnson & Johnson
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10.30am | Morning tea
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11am | Translational pharmacokinetic and pharmacodynamic for the design of dosing strategies with monoclonal antibodies
- The successful transition of preclinical data into the clinic
- Highlights crucial considerations for effective translation of information gained from preclinical research, and safety studies into the clinical development
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| | Dr Mohammad Tabrizi, Director, Translational Science, Global PK-PD & Bioanalysis, Medimmune Inc.
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| SMARTER EARLY DEVELOPMENT |
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11.30am | Human Phase 0/microdosing and accelerated phase I strategies
- Background to low dose studies
- Update/current position of human Phase 0/microdosing
- How accelerated Phase I Studies can speed up drug development decision making
- META-ID studies in response to FDA ‘safety testing of human metabolites’ guidance
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12pm | Drug development by early generation of human metabolism data
- The role of in vitro, first-in-man and human ADME studies in meeting new regulatory challenges
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12.30pm | Lunch
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1.30pm | Achieving optimal formulations in early clinical development
- Optimizing oral drug delivery
- Effective diagnosis and remedy of bioavailability issues
- Designing the first prototype formulations
- Rapid manufacture and testing in the clinic
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| EARLY CLINICAL CASE STUDIES |
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2pm | Application of a biomarker strategy from phase I to patient selection in a marketed product
- The application of biomarkers from first-in-human through to post-marketing
- Better decision making through analysis of direct effects of candidates on biochemical pathways
- Different tools required to execute patient stratification approaches
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2.30pm | Afternoon tea
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3pm | Enabling personalized medicine with preclinical and phase I clinical studies: a case study of the VEGFR/FGFR inhibitor brivanib
- Discovery of pharmacodynamic markers using preclinical studies and their use for dose selection in a phase I clinical study
- Discovery and development of a candidate predictive marker in a phase I clinical study
- Use of a validated predictive marker in a Phase II clinical study to optimize the development of a novel therapeutic
- Companion diagnostic development and personalized medicine
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| | Dr Edwin Clark, Director Oncology Biomarker Group, Bristol Myer Squibb
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3.30pm | Case study: Pharmacogenomics and disease genetics application in exploratory development
- Landscape of biomarkers in clinical development
- Target variability initiative
- Large-scale biomarker discovery approach using clinical samples
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4pm | Closing remarks from the chair
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