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Sophie Dix, Senior Research Scientist, Neurodegenerative Diseases Drug Hunting Team, Lilly
Ge Ruigt, Director Experimental Medicine Neuroscience, MSD
Paul Thompson, Associate, Director Discovery Medicine Unit, GSK
Georg C. Terstappen, Director and Department Head, Neuroscience Discovery, Abbott
Florian von Raison, Head of ,Global Clinical Development Unit Parkinson’s Disease, Merck Serono
Hitendra Parmar, European Medical Director for Alzheimer’s Disease, Pfizer
Keith Wesnes, Practice Leader Specialty Clinical Services, Bracket Global
Peter Joseph Jongen, Founding Director, MS4 Research Institute
Catherine Harmer, Head of Group, Psychopharmacology and Emotion Research Laboratory, Oxford University
Sabine Bahn, University Lecturer, University of Cambridge
Patrick Kehoe, Reader in Translational Dementia Research, University of Bristol
Simon Ridley, Head of Research, Alzheimer’s Research
Conference agenda
Chairman's Opening Remarks Georg C. Terstappen, Director and Department Head, Neuroscience Discovery, Abbott Laboratories Cognition strategy in research & early development Willem Riedel, Professor of Experimental Psychopahrmacology, Faculty of Psychology & Neuroscience, Maastricht University
Cognitive Performance: Translatable across species?
Cognitive Impairment: Translatable across different neuropsychiatric diseases?
The pseudospecificity puzzle: is cognition a biomarker or an independent (treatable) symptom cluster?
Indentifying cognition enhancement: Expanding opportunities in drug development
What are the optimal cognitive tests and trial methodologies?
Traditional and emerging target populations: from dementia through to oncology and schizophrenia
Case studies in pathological ageing, sleep disorders, MS and oncology
Keith Wesnes, Practice Leader, Bracket Global Current challenges in translational CNS research Georg C. Terstappen, Director and Department Head, Neuroscience Discovery, Abbott Laboratories
Identification and validation of disease-relevant target molecules
Design of disease-relevant 'screening cascades'
Crossing the blood-brain barrier
Identification of 'translatable' biomarkers
Improving the success rate of clinical Phase 2 (POC) studies
Disease biomarkers for schizophrenia – from laboratory to patient beside Sabine Bahn, Senior Medical Director, Neuropsychiatry, Myriad RBM Inc • Results from biomarker discovery studies
• What these findings suggest
• Identification of candidate biomarker panel Targeting the brain Renin Angiotensin System - future prospects for Alzheimer’s disease and Vascular dementia Patrick Kehoe, Reader in Translational Dementia Research, University Of Bristol Challenges and opportunities in dementia research: the Alzheimer’s Research UK perspective Simon Ridley, Head of Research, Alzheimer’s Research UK
A summary on recent progress in dementia research
Current barriers to disease-modifying treatments, from the laboratory to the clinic
What is being done to address these challenges
Sleeping with the enemy: Facilitating and establishing industry and academic partnering Sophie Dix, Senior Research Scientist, Eli Lilly
Overcoming the high attrition of new CNS drugs through industry-acdemic collaborations
Experiences from collaborations: IMI and CCN
The Pharma perspective
Recent Clinical Trials in MS -Achievements and Challenges Peter Joseph Jongen, Founding Director , MS4 Research Institute
Overview of research at the MS4 institute
Current trials and results
Common challenges in this therapeutic area
Lessons to learn
Designing better trials in secondary progressive multiple sclerosis (SPMS) Jeremy Chataway, Honorary Clinical Senior Lecturer, Imperial College London
SPMS is major cause of disability in young people affected by neurological illness
Whilst the early stages of MS are increasingly well treated, the pivotal problem of altering an established gradient of progression remains
I will review briefly the underlying clinico-pathological substrate; examine trials carried out over the last 2 decades; and discuss methods (particularly of an adaptive type) which might accelerate the trial process
Chairman’s Closing Remarks and Close of Day One Chairman's Opening Remarks Hitendra Parmar, Medical Director, Alzheimers Disease, Pfizer Trialling neuroprotection in Parkinson’s: Translating basic science into clinical trials David Dexter, Reader in NeuroPharmacology, Department of Medicine, Imperial College London Parkinson’s disease and non-motor symptoms. Challenges in the evaluation of non-motor symptoms in clinical trials and development programs Florian von Raison, Head of Global Clinical Development Unit, Parkinson's Disease, Merck Serono Molecular biomarkers in translational animal models for neuropsychiatric disorders Sabine Bahn, Director, Cambridge Centre for Neuropsychiatric Research, Cambridge University
Significant challenges of modelling neuropsychiatric disorders in animals
Characterising animal models that more closely reflect human molecular abnormalities
Employing a multi-analyte ELISA platform to define the serum proteome of preclinical models
Identifying suitable candidate models for schizophrenia pre-clinical studies
Evidence that serum biomarkers in animal models and patients correlate with certain behavioural abnormalities
Prediction of efficacy in depression Catherine Harmer, Department of Psychiatry, Oxford University
Antidepressant drugs may affect the behavioral and neural processing of emotional information prior to clinical changes in mood, emotional biomarker tests for use in drug development may therefore be possible.
Patients with depression and those with subclinical dysphoria show negative biases in emotional processing both in a behavioural test battery (the emotional test barry, ETB) and in neuroimaging paradigms with fMRI
Negative affective biases in the ETB and fMRI paradgims are resolved with antidepressant drug treatment before changes in mood are seen. Similar effects are seen in healthy (non-depressed) controls.
The importance to the therapeutic action of antidepressant treatments in depression: a new translational approach to screening and developing novel candidate treatments
The allosteric binding site for antidepressants in the serotonin transporter is located to the conserved extracellular vestibule Claus Juul Loland, Associate Professor, Department of Neuroscience and Pharmacology, University of Copenhagen
Using experimentally verified induced fit docking models we have mapped an allosteric binding site for antidepressants on the serotonin transporter.
The most pronounced effect was observed for escitalopram inhibiting escitalopram dissociation with a potency of 4.3 μM.
This dual action of escitalopram could be responsible for the higher efficacy and faster onset observed in clinical trials for escitalopram as compared to racemic citalopram.
On the basis of these results, it is now possible to develop drugs selective for the allosteric binding site posing a different clinical profile
Patient recruitment and retention issues in CNS clinical trials Hitendra Parmar, Medical Director, Alzheimers Disease, Pfizer
Features of CNS trials that affect patient recruitment and retention.
Getting the patient into the trial in the first place.
Retaining the enrolled patient in the trial.
Recruitment and retention issues in Alzheimer’s Disease and dementia clinical trials.
CNS tissue banking for neuroscience research Claire Troakes, Brain Bank Coordinator, London Neurodegenerative Diseases Brain Bank , Kings College London Integrating Market Access upfront clinical development is a must Mondher Toumi, Chair Market Access, University Claude Bernard of Lyon 1 • Clinical development strategy and trial design has become critical for achieving Market Access
• Inappropriate comparators, outcomes, study duration are the first reasons for non-recommendation
• Health economics output is mainly driven by efficacy and effectiveness Chairman’s Closing Remarks and Close of Day Two
Workshops
Workshop Marriott Regents Park
22 November 2011
London, United Kingdom
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