The Programme

Programme Day One Tuesday 2 June 2009

08:30

Registration

09:00

Florian von Raison
Senior Medical Director, Neurology
MERCK SERONO INTERNATIONAL

Opening remarks from the Chair

Improving and accelerating patient recruitment and retention

09:10

Florian von Raison
Senior Medical Director, Neurology
MERCK SERONO INTERNATIONAL

Discussing the issues in patient recruitment and retention

Gaining informed consent from older patients in clinical trials: hurdle or booster for recruitment and retention?
Decision making and cognitive performance
Assessing decision making capacity in a clinical trial setting

9:45

Gail Adinamis
President, CEO
Clinical Resource Network

Improving and accelerating patient recruitment and retention by utilizing a mobile clinician network in clinical trials

Centrally managed in-home clinical service model overview
Initiation and integration of home healthcare services into
clinical trials
Performance Metrics - Case studies
- Accelerated patient recruitment
- Increased patient retention
- Increased patient satisfaction
Return on Investment
Summary

10:20

Morning refreshments

10:50

A panel made up of speakers from throughout the two days will discuss hurdles, challenges and strategies for recruiting patients in CNS clinical trials.

Panel discussion
Optimising patient recruitment and retention in CNS clinical trials.

Highlighting ethical challenges and achieving Good Clinical Practice (GCP) Compliance

11:25

Lena Höglund
Compliance Advice &
Assurance Lead Advisor
Astrazeneca

Reviewing GCP guidelines for CNS clinical trials

Recruiting psychologically impaired and unconscious study subjects
Reviewing GCP at each stage of the process
Complying with GCP guidelines

Bridging the gap between pre-clinical and clinical CNS trials

12:00

Simone Braggio
Director of Neuroscience CEDD DMPK
GSK

Adding value to the discovery of CNS active drugs through the application of mechanistic PK/PD principles

Overcoming the blood brain barrier
Understanding the key drivers of in-vivo pharmacological effects and ensuring they are prominent in the lead optimisation paradigm
Establishing the link between blood concentration, receptor occupancy and drug efficacy

12:35

Lunch

13:40

Roundtable afternoon

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of CNS clinical trials.



1	Discussing adaptive trials in CNS Graeme Archer Director of Neurosciences Discovery Biometrics GSK	2	Exploring the potential of translational medicine Johannes Streffer Director of Experimental Medicine Europe, Neurologist Johnson & Johnson	3	Explaining the use of biomarkers in CNS clinical trials Gabriel Vargas Biomarker Expert & Head of the CNS Clinical Biomarker Group Hoffmann-La Roche


4	Discussing the role of fundamental neurosciences in CNS clinical trials Professor Serge Schiffman Director of Neurophysiology Laboratory Universite Libre de Bruxelles (ULB) Secretary of Belgian Society of Neuroscience	5	Developing effective recruitment methods for CNS clinical trials Florian von Raison Senior Medical Director Neurology Merck Serono International	6	Optimising chances of success in psychiatric trials Jean-Michel Germain Global Trial Director, Europe Wyeth


7	Clinical trials beyond registration Samuel Agus Global Medical Affairs Director, Neurology Solvay Pharmaceuticals	8

17:05

Closing remarks from the Chair and close of day one

Programme Day Two Wednesday 3 June 2009
08:30		Registration
09:00	Yves Auberson Head of Chemistry, Neuroscience and PET Imaging Novartis	Opening remarks from the Chair
Designing effective trials in CNS clinical trials
09:10	Gabriel Vargas Biomarker Expert & Head of the CNS Clinical Biomarker Group Hoffmann-La Roche	Using event-related potentials to determine the efficacious dose of a nicotinic alpha 7 agonist Translating preclinical assays to the clinic Analysing genetic polymorphisms Overcoming issues with inverted-U dose response curves Studying proof of mechanism
09:45	Graeme Archer Director of Neurosciences Discovery Biometrics GSK	Implementing adaptive Proof of Concept (PoC) trials in CNS: statistical and practical considerations Making the best use of limited resource in early phass of drug discovery/development Useful statistical thinking for designing adaptive trials and making instream adaptive decisions Protecting the blind in (any, but especially adaptive) PoC trials: what can go wrong if you don't?
10:20		Morning refreshments
Tools and technologies to enhance clinical development
10:50	Ge Ruigt Senior Director Translational Medicine, Neuroscience Schering-Plough	Utilising biomarkers for PoC and prognostics Identifying and validating clinically relevant biomarkers for psychiatry and neurology Establishing a PoC: challenges and limitations Analysing the role of Cerebrospinal fluid (CSF) biomarkers
11:25	Johannes Streffer Director of Experimental Medicine Europe, Neurologist Johnson & Johnson	Adopting biomarkers for diagnostics and disease modification for Alzheimer disease and neurodegeneration Using biomarkers to enhance the accuracy of diagnosis Defining disease modification regarding each disease or disorder Supporting evidence of disease modification with biomarkers
12:00	Richard Hadden Chief Executive Officer Cytox	Blood tests for patient selection and stratification in AD/MCI trials Overview of role of cell cycle dysregulation in neurodegeneration Relationship of cell cycle phenotypes, genotypes and pathology Applications: disease and stratification biomarkers Results of recent Cytox clinical study Blood test to predict which MCI patients suffer rapid, overt cognitive decline Blood test to stratify MCI/AD patients
12:35		Lunch
13:35	Yves Auberson Head of Chemistry, Neuroscience and PET Imaging Novartis	Improving CNS clinical trials with PET imaging Analysing the main uses of PET imaging in drug development (early human PK, receptor occupancy studies, patient population studies) Improving clinical development strategies and supporting efficacy studies with PET imaging Developing a new PET ligand: optimising the process and taking advantage of medicinal chemistry for PET ligand discovery methods
14:10	Mark Schmidt Senior Director and CNS Clinical Expert Johnson & Johnson	Functionning imaging in early clinical development Performance characteristics of various imaging methods for functional assessment Functional imaging in the evaluation of cognition Potential for multi modal approaches in functional imaging
14:45	A panel made up of speakers from throughout the two days will explain the role of imaging in CNS clinical trials.	Panel discussion – Imaging technologies and methodologies in CNS clinical trials
15:20		Afternoon refreshments
Optimising CNS trial strategies & management
15:50	Mark Latymer Associate Director Phase 3b/4 Unit; Europe & Clinical Project Manager Pfizer	Improving the communication with patients, investigators and sites Creatin a partnership and a team Maintaining the relationship The challenges of informed consent
16:25	Babak Boroojerdi Senior Director, Neurologist, Head of Movement Disorders UCB Pharma	I Implementing disease modification strategies for Parkinson's disease Reviewing recent European regulatory guidelines Analysing historical data and new developments Identifying and overcoming trial design issues
17:00	Marc Debelle Global Medical Affairs Director NBD/R&D Psychiatry euroscience Solvay Pharmaceuticals marketing & Licensing ag	Clinical trials beyond registration Facilitating pricing and reimbursement: health economics in phase II/III Planning early for post approval commitments: the Risk Management Plan (RMP) and Post Authorisation Safety Studies (PASS) Establishing a late phase programme: observational and/or non-interventional studies registries
17:45		Closing remarks from the Chair and end of the conference.