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1 US Investigator Meeting DIAS-4, Chicago, July 2011 DIAS 4 USA Investigators meeting Introduction: Lundbeck July 15-16, 2011 Chicago, IL Bob Anders US.

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Presentation on theme: "1 US Investigator Meeting DIAS-4, Chicago, July 2011 DIAS 4 USA Investigators meeting Introduction: Lundbeck July 15-16, 2011 Chicago, IL Bob Anders US."— Presentation transcript:

1 1 US Investigator Meeting DIAS-4, Chicago, July 2011 DIAS 4 USA Investigators meeting Introduction: Lundbeck July 15-16, 2011 Chicago, IL Bob Anders US Clinical Lead Lundbeck Inc. Deerfield, IL

2 US Investigator Meeting DIAS-4, Chicago, July Lundbeck in Brief - Worldwide We are a global pharmaceutical company specializing in central nervous system disorders Founded by Hans Lundbeck in 1915 An integrated company with core competencies in research, development, production, marketing and sales Marketed pharmaceuticals to treat Alzheimers disease, depression, anxiety, Parkinsons disease and schizophrenia Headquarters in Copenhagen, Denmark Approximately 5,300 employees in 54 countries

3 US Investigator Meeting DIAS-4, Chicago, July Lundbeck: Dedicated to Innovation Our strengths Research has been the foundation of Lundbeck activities for more than 50 years Known worldwide for our pioneering work Multidisciplinary, empowered project teams In-house expertise in CNS State-of-the-art technologies Extensive international collaboration Our focus Stroke, depression, anxiety, psychosis, neurodegenerative disorders and epilepsy Our investments Lundbeck invested 23% of total revenue in R&D in 2009

4 US Investigator Meeting DIAS-4, Chicago, July MAKING A DIFFERENCE Marketed Products Depression Alzheimers Schizophrenia Parkinsons InsomniaEpilepsy Huntingtons Ebixa® Cipralex® Sabril® Xenazine® Circadin® Azilect® Serdolect®

5 US Investigator Meeting DIAS-4, Chicago, July CompoundIndicationActivityPhase IPhase IIPhase III Regulatory filing Clobazam Lennox-Gastaut syndrome GABA enhancer2011 I.V. CarbEpilepsySodium channel blocker2012 DesmoteplaseStrokePlasminogen activator2012 Lu AA24493 Stroke/neuronal damage Tissue protective cytokine Lu Parkinsons diseaseDopaminergic agent2012+ Lu AE04621Parkinsons diseaseDopaminergic agent2012+ PIPELINE: NEUROLOGY

6 US Investigator Meeting DIAS-4, Chicago, July DEDICATED TO INNOVATION CompoundIndicationActivityPhase IPhase IIPhase III Regulatory filing Serdolect ® USSchizophreniaDopamine/serotonin NalmefeneAlcohol dependence Specific opioid receptor antagonist 2011 Lu AA21004Depression + GAD 5HT 3, 5HT 7 antagonist, 5HT 1a agonist and 5HT enhancer 2012 Lu AA24530DepressionMultiple targets 1) ZicronapinePsychosisMonoaminergic Lu AE58054Psychosis Selective 5-HT 6 antagonist Lu AA ) Psychosis/bipolarIon channel modulator )In pre-clinical studies, Lu AA24530 has demonstrated activities as a monoamine enhancer with reuptake inhibition at monoamine transporters, and antagonist activity at 5-HT 3 and 5-HT 2c receptors 2)Clinical trials currently on hold PIPELINE: PSYCHIATRY

7 US Investigator Meeting DIAS-4, Chicago, July Research and development facilities Production facilities Sales Headquarters Global Presence

8 US Investigator Meeting DIAS-4, Chicago, July Who we are: Lundbeck Inc Chicago area-> Deerfield, IL

9 US Investigator Meeting DIAS-4, Chicago, July Who we are: Copenhagen, Denmark (Valby) -> Lu HQ

10 US Investigator Meeting DIAS-4, Chicago, July DIAS 4 US General Responsibilities for Study Management and Collaboration CRAsClinical Coordinating Center (CCC) and Regional Hubs Lu Inc/ H Luc Operational- first level of contactSite Recruitment/ facilitating enrollment/ peer support Operational and coordination overview Pre-trial Visits (PTVs), site initiation visits (SIVs), close out visits (COVs) Ongoing monitoring visits Handle queries from sites as initial contact Manage shipment of lab supplies initially, re-order done by sites. Send IMP notifications upon RGL approval Review RAVE data entry, answer questions Review source documents Perform RAVE training Recruit potential sites Initial site screening Stimulate recruitment Address study issues from sites with Sponsor including issues related to inclusion/ exclusion criteria, study design, visit structure, etc. Track enrollment activity (weekly) Review site issues to minimize turnover and encourage commitment Discuss screening efforts and strategy within centers Hold monthly teleconferences, web conferences with site staff Contract finalizations Grant Payment – set up and finalization Manage other supplies Track enrollment activity (real time) Handle queries on inclusion/exclusion criteria Safety (manage SAE reporting) Conduct periodic visits, discuss study challenges with site staff

11 US Investigator Meeting DIAS-4, Chicago, July DIAS 4 US Study Team Yasir Al-Rawi Sr Specialist, Desmoteplase expert physician Bob Anders US coordination Thomas Breuer International Study Manager Lidiya Flaksman Clinical Program Manager Ebru Karakoc Specialist, Clinical Research Physician Rich McVey Clinical Program Manager Krishna Talluri Director, Medical Affairs Thomas Truelsen Senior Specialist Dipali Patel Clinical Trial Associate Christina Giannoulis-Kolodziej Clinical Trial Associate

12 US Investigator Meeting DIAS-4, Chicago, July DIAS 4 US Regional CRAs CRA manager- Denise Redding Michael Burke: Mid-Atlantic/ Midwest Karen Dumka: Northeast

13 US Investigator Meeting DIAS-4, Chicago, July DIAS 4 US Regional CRAs, cont. Elisa Dauphinee: Southeast Susan Pickell: Northeast/Mid-Atlantic Audrey Sumner: Southeast Gloria Gambit- West

14 US Investigator Meeting DIAS-4, Chicago, July UIC Dept of Neurology US DIAS CCC Members 1. Philip B. Gorelick, MD MPH FACP (director) 2. Dilip Pandey, M.D. (co-director) 3. Rebecca Grysiewicz, DO (local site PI) 4. Maureen Hilllmann, RN (nurse manager) 5. Yvonne Harris, MPA (administrator) 6. Vidas Simkus (internet support manager) CCC= Clinical Coordinating Center

15 US Investigator Meeting DIAS-4, Chicago, July Region Hub Directors- CCC Midwest- Phil Gorelick, Dilip Pandey, UIC Southwest- David Hess, Med College GA Mid-Atlantic- Max Hammer, UPMC, PA Northeast- Lee Schwamm, MGH, Boston Southwest – Timothy Ingall, Mayo, AZ West- Greg Albers, Stanford, CA

16 US Investigator Meeting DIAS-4, Chicago, July DIAS-4 VERY IMPORTANT TRIAL Our goals are common: Enhance patient recruitment Right patient selection Timely evaluations and imaging Timely randomization Timely TMP and observations Timely follow up We will work together to reach our goals

17 US Investigator Meeting DIAS-4, Chicago, July DIAS-4 We will work together to reach our goals

18 US Investigator Meeting DIAS-4, Chicago, July OUR JOURNEY We want to improve the quality of life for those suffering from psychiatric and neurological disorders


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