Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Clinical Trials in CNS 2011Day One | Wednesday 23rd November 2011                                                         ...
Clinical Trials in CNS                                                                                ...
HALF DAY PRE-CONFERENCE WORKSHOP        Tuesday 22nd November 2011              12.30pm – 5.30pm Marriott Hotel Regent’s P...
2011 PHARMACEUTICALFORWARD PLANNERJune 201127/28    RNAi, miRNA, siRNA29/30    Pharmaceutical Portfolio & Product         ...
CLINICAL TRIALS IN CNSConference: Wednesday 23rd & Thursday 24th November 2011, Marriott Hotel Regent’s Park, Central Lond...
Upcoming SlideShare
Loading in …5

Clinical Trials In CNS


Published on

SMi’s 10th annual conference on Clinical Trials in CNS will bring together leading industry experts to explore the current and future opportunities within CNS drug development. With 35% of the global disease burden due to CNS disorders, this event addresses a vital area of research.

Published in: Health & Medicine, Business
  • Be the first to comment

  • Be the first to like this

Clinical Trials In CNS

  1. 1. REGISTER BY 1ST JULY AND RECEIVE A £300 DISCOUNTREGISTER BY 9TH SEPTEMBER AND RECEIVE A £100 DISCOUNT SMi present their 10th conference on… Clinical Trials in CNS Wednesday 23rd and Thursday 24th November 2011 Marriott Hotel Regent’s Park, Central London, UK OUR EXCEPTIONAL SPEAKER LINE-UP INCLUDES: Georg Terstappen Director and Department Head, Neuroscience Discovery Abbott 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 Florien von Raison Head of Global Clinical Development Unit Parkinson’s Disease Merck Serono David Dexter Reader in NeuroPharmacology Department of Medicine This year will address clinical Imperial College London drug discovery activities, new therapeutic targets, as well as BY ATTENDING YOU WILL BE ABLE TO: effective CNS drug development • Hear the latest developments in CNS clinical development strategies and problems • Focus on a variety of therapeutic areas in neurodegenerative disorders encountered in clinical trials, • Study specific trials consideration for psychiatric conditions with in-depth discussions and • Learn about cutting edge translational research and its impact case study presentations from on clinical study • Network with some of the most important industry experts the key industry players. working in the field Sponsored By HALF-DAY PRE-CONFERENCE WORKSHOP Tuesday 22th November 2011, Marriott Regent’s Park, London Innovation, superiority and best practice proof-of-concept in CNS clinical development Hosted by: Erik Buntinx CEO – Managing Director, PharmaNeuroBoost 12.30pm – 5.30pmwww.clinicaltrials-research.comRegister online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
  2. 2. Clinical Trials in CNS 2011Day One | Wednesday 23rd November 2011 www.clinicaltria8.30 Registration and Coffee 1.30 Targeting the brain Renin Angiotensin System - future prospects for Alzheimer’s disease and Vascular dementia9.00 Chairmans opening remarks • Rationale for renin angiotensin system (RAS) targeting in forms Georg Terstappen, Director and Department Head, Neuroscience dementia. Discovery, Abbott • Lessons learned from Stroke trials and outcome measures of9.10 Cognition Strategy in Research & Early Development cognition. • Cognitive Performance: Translatable across species? • Considerations for protocol development for trials of RAS targeting • Cognitive Impairment: Translatable across different drugs and common forms of dementia neuropsychiatric diseases? Patrick Kehoe, Reader in Translational Dementia Research, • The pseudospecificity puzzle: is cognition a biomarker or an independent (treatable) symptom cluster? University of Bristol Wim Riedel, Research & Early Development – Neuroscience, Hoffmann-La Roche * 2.10 Challenges and opportunities in dementia research: the Alzheimer’s Research UK perspective9.50 Indentifying cognition enhancement: Expanding opportunities in • A summary on recent progress in dementia research drug development • Current barriers to disease-modifying treatments, from the • What are the optimal cognitive tests and trial methodologies? • Traditional and emerging target populations: from dementia laboratory to the clinic through to oncology and schizophrenia • What is being done to address these challenges • Case studies in pathological ageing, sleep disorders, MS and Simon Ridley, Head of Research, Alzheimer’s Research UK oncology Keith Wesnes, Practice Leader Specialty Clinical Services, United 2. 50 Revival of EEG as a translational biomarker for the development of BioSource Corporation Neuroscience drugs10.30 Morning Coffee • Can EEG be used as a biomarker of central activity? • The value of EEG as a target engagement biomarker for specific10.50 Current challenges in translational CNS research receptors • Identification and validation of disease-relevant target molecules • Diagnostic and prognostic biomarker properties of EEG in • Design of disease-relevant screening cascades depression and neurocognitive disorders • Crossing the blood-brain barrier • Identification of translatable biomarkers • Revaluation of EEG as a response biomarker • Improving the success rate of clinical Phase 2 (POC) studies Ge Ruigt, Director Experimental Medicine Neuroscience, MSD Georg Terstappen, Director and Department Head, Neuroscience Discovery, Abbott 3.30 Afternoon Tea11.30 Development of OncologyMAP®: A Public-Private Partnership Dedicated to Providing a Powerful New Tool for Discovery of 3.50 CNS repair in MS: Role of biomarkers Biomarker Patterns in Cancer • Treatment goals beyond immunomodulation • OncologyMAP is the newest service offering in Rules-Based • Imaging approaches for demonstrating repair Medicine’s portfolio of Multi-Analyte Profiles (MAPs). • Biofluid markers to support repair • Developed in partnership with the National Cancer Institute’s Paul Thompson, Associate, Director Discovery Medicine Unit, GSK Proteomics Initiative, OncologyMAP contains 101 quantitative, multiplexed immunoassays for measuring cancer-related proteins in serum, plasma or tissue extracts. 4.30 Recent Clinical Trials in MS -Achievements and Challenges • This novel tool offers an unparalleled platform to aid in the • Overview of research at the MS4 institute discovery and development of novel therapies and diagnostics in • Current trials and results oncology. • Common challenges in this therapeutic area • The OncologyMAP is powered by RBM’s data-driven approach to • Lessons to learn efficiently and cost-effectively discover useful biomarker patterns. Mike Spain, VP and Chief Medical Officer, Myriad RBM Peter Joseph, Jongen Founding Director, MS4 Research Institute12.10 Networking lunch 5.10 Chairmans Closing Remarks and Close of Day One *Subject to final confirmation Register online at • Alternatively Sponsored by Rules-Based Medicine® (RBM) is a CLIA-certified biomarker testing laboratory that uses multiplexed immunoassays to provide innovative products and services. Enabled by microsphere technology and decades of experience, our proprietary Multi-Analyte Profiling (MAP) platform makes drug discovery and development more efficient and effective. Using extremely small sample volumes, we provide discovery, pre-clinical and clinical researchers with reproducible, quantitative, multiplexed immunoassay data for hundreds of biomarkers. The RBM Approach utilizes DiscoveryMAP®, our largest MAP providing quantitative data for 266 biomarkers, as a hypothesis-generating tool in the primary study. Once identified, the biomarker pattern of interest is evaluated in subsequent studies to validate its utility. Data acquired helps support subsequent trial designs and critical go/no go decisions. At each step, assay precision and reproducibility are the keys to success. RBM’s fully automated platform is analytically validated to clinical laboratory standards that we provide as a service to pharmaceutical, biotech and central laboratories. The RBM approach to biomarker testing delivers advantages that are changing the way therapeutics are developed, people are diagnosed and patients are treated. United BioSource Corporation (UBC), is a global scientific and medical affairs organization that partners with life science companies to develop and commercialize biopharmaceuticals, medical devices, and other health care products. We help deliver authoritative, real-world evidence to characterize product effectiveness, address safety risk, and demonstrate value. Supported by
  3. 3. Clinical Trials in CNS Day Two | Thursday 24th November 2011 8.30 Re-registration and Coffee 1.30 Prediction of efficacy in depression • Antidepressant drugs may affect the behavioral and neural processing 9.00 Chairmans opening remarks of emotional information prior to clinical changes in mood, emotional Chas Bountra, Chief Scientist, Structural Genomics Consortium, biomarker tests for use in drug development may therefore be possible. University of Oxford • Patients with depression and those with subclinical dysphoria show negative biases in emotional processing both in a behavioural test battery 9.10 Trialling neuroprotection in Parkinson’s: Translating basic science into (the emotional test barry, ETB) and in neuroimaging paradigms with fMRI clinical trials • Negative affective biases in the ETB and fMRI paradgims are resolved • Drawbacks of currents symptomatic therapies and goals of with antidepressant drug treatment before changes in mood are seen. neuroprotective strategies Similar effects are seen in healthy (non-depressed) controls. • The importance to the therapeutic action of antidepressant treatments • Current concepts in understanding neurodegenerative mechanisms in in depression: a new translational approach to screening and Parkinson’s and developing suitable drug targets developing novel candidate treatments • Are animal models good predictors of effective therapies Catherine Harmer, Head of Group, Psychopharmacology and Emotion • Translating effective neuroprotective approaches in in vivo animal Research Laboratory, Oxford University models of Parkinson’s to clinical trials David Dexter, Reader in NeuroPharmacology Department of Medicine, 2.10 The allosteric binding site for antidepressants in the serotonin Imperial College London transporter is located to the conserved extracellular vestibule • Using experimentally verified induced fit docking models we have 9.50 Parkinson’s disease and non-motor symptoms. Challenges in the mapped an allosteric binding site for antidepressants on the serotonin evaluation of non-motor symptoms in clinical trials and development transporter. programs • The most pronounced effect was observed for escitalopram inhibiting • New concept of Parkinson’s disease escitalopram dissociation with a potency of 4.3 μM. • Non-motor symptoms overlooked in the past development of PD drugs • This dual action of escitalopram could be responsible for the higher • What makes non-motor symptoms so interesting to look at efficacy and faster onset observed in clinical trials for escitalopram as • Translating of motor as non-motor symptoms into clinical studies and compared to racemic citalopram. labels • On the basis of these results, it is now possible to develop drugs Florien von Raison , Head of Global Clinical Development Unit selective for the allosteric binding site posing a different clinical profile Parkinson’s Disease, Merck Serono Claus Juul Loland, Associate Professor, Department of Neuroscience and Pharmacology, University of Copenhagen 10.30 Morning Coffee 2.50 Afternoon Tea 10.50 Potential novel targets for neuropsychiatric disorders 3. 10 Sleeping with the enemy: Facilitating and establishing industry and • Role of proteins modifying chromatin and hence gene expression academic partnering • Why is targeting these proteins likely to deliver better therapeutics? • Overcoming the high attrition of new CNS drugs through industry- • Are they chemically tractable? academic collaborations • Will they be safe on chronic dosing in patients? • Experiences from collaborations: IMI and CCN Chas Bountra, Chief Scientist, Structural Genomics Consortium, • The Pharma perspective University of Oxford Sophie Dix, Senior Research Scientist, Neurodegenerative Diseases Drug Hunting Team, Lilly 11.30 Disease biomarkers for schizophrenia - from laboratory to patient beside 3.50 Patient recruitment and retention issues in CNS clinical trials • The identification of significant peptides and proteins that distinguish • Features of CNS trials that affect patient recruitment and retention. first-onset paranoid schizophrenia patients from healthy controls, • Getting the patient into the trial in the first place. leading to a candidate biomarker panel in patient serum. • Retaining the enrolled patient in the trial. • A panel of 51 markers was found to yield an average sensitivity and • Recruitment and retention issues in Alzheimer’s Disease and dementia specificity of >85% across five clinical centres comprising 572 first- clinical trials. onset drug-naive and recent onset schizophrenia patients versus 235 Hitendra Parmar, European Medical Director for Alzheimer’s Disease, Pfizer matched healthy control samples. 4.30 CNS tissue banking for neuroscience research • As part of the EU Innovative Medicine Initiative NewMeds we have also • Introduction to brain banking in the UK: achieving high standards in evaluated the serum protein signatures of 17 animal models of tissue collection, diagnosis, quality and access schizophrenia (as used by the pharmaceutical industry in preclinical • Clinical assessment and cohort recruitment: increasing the scientific studies) and compared the changes with schizophrenia patients. We value of donated tissue found that only few animal models show significantly similar serum • Importance of tissue banking in clinical trials and biomarker validation signatures to the human disease. • Aspirations for the future: centralised coordination, multi-sample biobanks Sabine Bahn, Director, Cambridge Centre for Neuropsychiatric Research, Claire Troakes, Brain Bank Coordinator London Neurodegenerative University of Cambridge Diseases Brain Bank, Kings College London 12.10 Networking lunch 5.10 Chairman’s closing remarks and close of conferencefax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding Who should attend: packages, uniquely tailored to complement your company’s You should attend this event if you are a Director, Area Head, CSO, or VP from within the marketing strategy. Prime networking opportunities exist to Pharmaceutical or Healthcare industry with responsibilities in the following areas: entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you • CNS Clinical Discovery/Nervous System Research • Pre-Clinical/Clinical R&D wish to join the increasing number of companies benefiting from • Clinical Trial Management and Operation • Clinical Pharmacology sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: • CNS Therapeutics and Molecular Profiling • Patient Recruitment • Neurology/Neuroscience • Translational Medicine Want to know how you can get involved? • Medical Directors • Biostatistics and Modelling Interested in promoting your pharmaceutical services to this market? • Pain Research/Management • Emerging Targets/Lead Optimisation Contact Margaret Mugema, • Biomarkers and Imaging • Genomics/Bioinformatics/Neuroinformatics SMi Marketing on +44 (0) 20 7827 6072, or email
  4. 4. HALF DAY PRE-CONFERENCE WORKSHOP Tuesday 22nd November 2011 12.30pm – 5.30pm Marriott Hotel Regent’s Park, Central London Innovation, superiority and best practiceproof-of-concept in CNS clinical development In association with Overview of Workshop This session shall provide unique insight into establishing best practise in POC trials, innovation in CNS discovery and PNB boosting, by utilising a data driven case study in to antidepressant therapy and our host’s vast expertise in mid to late phase CNS development. Workshop agenda 12.30 Registration & Coffee 1.00 Welcome & Introductions 1.10 Innovative CNS Drugs: To Be Superior of Not to Be! • Unmet Medical Needs and New Clinical Paradigms • Regulatory Requests • Designing ‘superior’ clinical trials • New End Points 1.45 The PNB Boosting Concept: Demonstrating Superiority • Pharmacological Considerations • Clinical Goals • IP Matters • Pipeline 2.45 Coffee 3.00 The PNB01 Clinical Development Program – A Novel Boosting Antidepressant Therapy • Objectives • Phase II Proof of Concept Data showing beneficial effects • The New Pivotal End Point: Early and Sustained Response Rate (ESR) • The Phase III Study: Outline 4.10 Discussion Session 5.30 Close of Workshop About the workshop host Erik Buntinx, MD, CEO, founded the Belgian CNS specialty company PharmaNeuroBoost (PNB) in December 2006 and has raised up till date EUR 25 M. PNB’s platform technology is based on Buntinx’s discovery of the boosting capabilities of highly-selective serotonin 2A and dopamine 4 receptor antagonists. Buntinx is a qualified psychiatrist, and previously founded the Anima Center, an outpatient psychiatric clinic and integrated clinical research unit. He obtained his MD degree from the Catholic University of Leuven (KUL), Belgium and completed his psychiatric residency at the KUL and the University of Maastricht, The Netherlands. About the organisation PharmaNeuroBoost (PNB) creates NCE’s out of existing therapeutics combined with the company’s proprietary boosting technology. PNB has granted CoM and use patent coverage in different countries around the world for the individual compounds in its pipeline. Over its first five years of life, PharmaNeuroBoost has proved its innovative fixed- dose combination concepts in preclinical and clinical proof of concept trials, and has shown support from the FDA for a pivotal trial that uses a new endpoint demonstrating superior efficacy over standard of care. During 2011, the company will initiate phase III trials for PNB01 and phase IIa trials for PNB02, respectively in the treatment of major depression and schizophrenia.
  5. 5. 2011 PHARMACEUTICALFORWARD PLANNERJune 201127/28 RNAi, miRNA, siRNA29/30 Pharmaceutical Portfolio & Product Life Cycle Management29/30 Pharmaceutical Nanotechnology29/30 KOL Management and MSL Best Practice in Europe (Munich, Germany)July 201106/07 ADMET06/07 Social Media in the Pharmaceutical Industry11/12 BioBanking18/19 Pharmaceutical and Clinical Trial Logistics Asia Pacific (Singapore)20/21 Pre Filled Syringes Asia (Singapore)September 201119/20 Biomarkers in Clinical Trials26/27 Biosimilars and Biobetters28/29 KOL Liaison and MSL Best PracticeOctober 201103/04 Partnerships with CROs10/11 Pharmaceutical m-Health12/13 GP Commissioning19/20 COPD: Novel Therapeutics and Management Strategies24/25 Point of Care Diagnostics - Market Opportunities and Technology TrendsNovember 201131 Oct/1 Nov European Pharmaceutical Pricing & Reimbursement (Switzerland)16/17 Clinical Trials in CNS21/22 Cell Based AssayDecember 20115/6 Cold Chain DistributionAll conferences take place in central London, UK - Unlessindicated otherwise in brackets. ABOUT THE SMi PHARMACEUTICAL TEAM SMi have been involved in the pharmaceutical industry since 1993 and have developed a series of informative and niche events, covering the latest issues and developments surrounding the industry. Events bring together senior industry professionals and serving companies who have a focus on being at the forefront of developments in this area. SMi aim to generate informed and topical discussion through the medium of both conferences and executive briefings. Our pharmaceutical events are research-based and content driven with regular contact with major industry personnel and cover a wide range of industry sectors. For more information, please visit www.smi-
  6. 6. CLINICAL TRIALS IN CNSConference: Wednesday 23rd & Thursday 24th November 2011, Marriott Hotel Regent’s Park, Central London Workshop: Tuesday 22nd November 2011, London 4 WAYS TO REGISTER www.clinicaltrials-research.comFAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, Great GuildfordPHONE on +44 (0) 870 9090 711 Business Square, 30 Great Guildford Street London, SE1 0HS, UK EARLY BIRD □ Book by 1st July to receive £300 off the conference price DISCOUNT □ Book by 9th September to receive £100 off the conference price CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee Total □ Conference & Half-Day Workshop £1998.00 + VAT £2397.60 □ Conference only £1399.00 + VAT £1678.80Unique Reference Number □ Half-Day Workshop £599.00 + VAT £718.80 PROMOTIONAL LITERATURE DISTRIBUTIONOur Reference LVP-009 □ Distribution of your company’s promotionalDELEGATE DETAILS literature to all conference attendees £999.00 + VAT £1198.80Please complete fully and clearly in capital letters. Please photocopy for additional delegates. GROUP DISCOUNTS AVAILABLETitle: Forename: The conference fee includes refreshments, lunch, conference papers and accessSurname: to the Document Portal containing all of the presentations.Job Title:Department/Division: VENUE Marriott Hotel Regent’s Park, 128 King Henrys Road, London, NW3 3ST, UKCompany/Organisation:Email: □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711,Address: email: or fax +44 (0) 870 9090 712Town/City: DOCUMENTATIONPost/Zip Code: Country: I cannot attend but would like to purchase access to the following DocumentDirect Tel: Direct Fax: Portal/paper copy documentation Price TotalMobile: □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80Switchboard: □ The Conference Presentations – paper copy £499.00 - £499.00Signature: Date: (or only £300 if ordered with the Document Portal)I agree to be bound by SMis Terms and Conditions of Booking.ACCOUNTS DEPT PAYMENTTitle: Forename: Payment must be made to SMi Group Ltd, and received before the event, by one of theSurname: following methods quoting reference P-009 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. PleaseEmail: indicate method of payment:Address (if different from above): □ UK BACS Sort Code 300009, Account 00936418 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18Town/City: □ Cheque We can only accept Sterling cheques drawn on a UK bank.Post/Zip Code: Country: □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges.Direct Tel: Direct Fax: Card No: □□□□ □□□□ □□□□ □□□□Terms and Conditions of Booking Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX cardPayment: If payment is not made at the time of booking, then an invoice will be issued and must bepaid immediately and prior to the start of the event. If payment has not been received then credit carddetails will be requested and payment taken before entry to the event. Bookings within 7 days ofevent require payment on booking. Access to the Document Portal will not be given until paymenthas been received. Cardholder’s Name:Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, anotherdelegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘share’ a place at an event. Please make separate bookings for each delegate. Signature: Date:Cancellation: If you wish to cancel your attendance at an event and you are unable to send a I agree to be bound by SMis Terms and Conditions of Booking.substitute, then we will refund/credit 50% of the due fee less a £50 administration charge,providing that cancellation is made in writing and received at least 28 days prior to the start of the Card Billing Address (If different from above):event. Regretfully cancellation after this time cannot be accepted. We will however provide theconferences documentation via the Document Portal to any delegate who has paid but is unable toattend for any reason. Due to the interactive nature of the Briefings we are not normally able toprovide documentation in these circumstances. We cannot accept cancellations of orders placedfor Documentation or the Document Portal as these are reproduced specifically to order. If we haveto cancel the event for any reason, then we will make a full refund immediately, but disclaim anyfurther liability.Alterations: It may become necessary for us to make alterations to the content, speakers, timing,venue or date of the event compared to the advertised programme.Data Protection: The SMi Group gathers personal data in accordance with the UK Data ProtectionAct 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other VATproducts and services. Unless you tick here □ we may also share your data with third partiesoffering complementary products or services. If you have any queries or want to update any of the VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on Documentdata that we hold then please contact our Database Manager Portal and Literature Distribution for all UK customers and for those EU customers not supplyingor visit our website quoting the URN as detailed above youraddress on the attached letter. a registration number for their own country here: ______________________________________ If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at