1 US Investigator Meeting DIAS-4, Chicago, July 2011 DIAS 4 USA Investigators meeting Introduction:...
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Transcript of 1 US Investigator Meeting DIAS-4, Chicago, July 2011 DIAS 4 USA Investigators meeting Introduction:...
1 US Investigator Meeting DIAS-4, Chicago, July 2011
DIAS 4 USA Investigators’ meeting
Introduction: Lundbeck
July 15-16, 2011Chicago, IL
Bob AndersUS Clinical Lead
Lundbeck Inc. Deerfield, IL
2US Investigator Meeting DIAS-4, Chicago, July 2011
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 Alzheimer’s disease, depression, anxiety, Parkinson’s disease and schizophrenia
Headquarters in Copenhagen, Denmark
Approximately 5,300 employees in 54 countries
3US Investigator Meeting DIAS-4, Chicago, July 2011
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
5US Investigator Meeting DIAS-4, Chicago, July 2011
Compound Indication Activity Phase I Phase II Phase IIIRegulatory
filing
ClobazamLennox-Gastaut syndrome
GABA enhancer 2011
I.V. Carb Epilepsy Sodium channel blocker 2012
Desmoteplase Stroke Plasminogen activator 2012
Lu AA24493Stroke/neuronal damage
Tissue protective cytokine 2012+
Lu 02-750 Parkinson’s disease Dopaminergic agent 2012+
Lu AE04621 Parkinson’s disease Dopaminergic agent 2012+
PIPELINE: NEUROLOGY
6US Investigator Meeting DIAS-4, Chicago, July 2011
DEDICATED TO INNOVATION
Compound Indication Activity Phase I Phase II Phase IIIRegulatory
filing
Serdolect® US Schizophrenia Dopamine/serotonin
Nalmefene Alcohol dependenceSpecific opioid receptor antagonist
2011
Lu AA21004 Depression + GAD5HT3, 5HT7 antagonist, 5HT1a agonist and 5HT enhancer
2012
Lu AA24530 Depression Multiple targets 1) 2012+
Zicronapine Psychosis Monoaminergic 2012+
Lu AE58054 PsychosisSelective 5-HT6 antagonist
2012+
Lu AA39959 2) Psychosis/bipolar Ion channel modulator 2012+
1) In pre-clinical studies, Lu AA24530 has demonstrated activities as a monoamine enhancer with reuptake inhibition at monoamine transporters, and antagonist activity at 5-HT3 and 5-HT2c receptors
2) Clinical trials currently on hold
PIPELINE: PSYCHIATRY
7US Investigator Meeting DIAS-4, Chicago, July 2011
Research and development facilities Production facilities Sales
Headquarters
Global Presence
8US Investigator Meeting DIAS-4, Chicago, July 2011
Who we are: Lundbeck IncChicago area-> Deerfield, IL
9US Investigator Meeting DIAS-4, Chicago, July 2011
Who we are: Copenhagen, Denmark (Valby) -> Lu HQ
10US Investigator Meeting DIAS-4, Chicago, July 2011
DIAS 4 US General Responsibilitiesfor Study Management and Collaboration
CRAs Clinical Coordinating Center (CCC) and
Regional Hubs
Lu Inc/ H Luc
Operational- first level of contact Site 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 questionsReview source documentsPerform 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 centersHold 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
11US Investigator Meeting DIAS-4, Chicago, July 2011
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
12US Investigator Meeting DIAS-4, Chicago, July 2011
DIAS 4 USRegional CRAs
CRA manager- Denise Redding
Michael Burke: Mid-Atlantic/ Midwest
Karen Dumka: Northeast
13US Investigator Meeting DIAS-4, Chicago, July 2011
DIAS 4 USRegional CRAs, cont.
Elisa Dauphinee: Southeast
Susan Pickell: Northeast/Mid-Atlantic
Audrey Sumner: Southeast
Gloria Gambit- West
14US Investigator Meeting DIAS-4, Chicago, July 2011
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
15US Investigator Meeting DIAS-4, Chicago, July 2011
Region Hub Directors- CCC
Midwest- Phil Gorelick, Dilip Pandey, UICSouthwest- David Hess, Med College GAMid-Atlantic- Max Hammer, UPMC, PANortheast- Lee Schwamm, MGH, BostonSouthwest – Timothy Ingall, Mayo, AZWest- Greg Albers, Stanford, CA
16US Investigator Meeting DIAS-4, Chicago, July 2011
DIAS-4
VERY IMPORTANT TRIALOur goals are common: Enhance patient recruitmentRight patient selectionTimely evaluations and imagingTimely randomizationTimely TMP and observationsTimely follow upWe will work together to reach our goals
17US Investigator Meeting DIAS-4, Chicago, July 2011
DIAS-4
We will work together to reach our goals
18US Investigator Meeting DIAS-4, Chicago, July 2011
OUR JOURNEY
We want to improve the quality of life for those suffering
from psychiatric and neurological disorders