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Sample & Assay Technologies
QIAGEN Research & Development
Pipeline 2009/2010
QIAGEN Analyst and Investor Day 2010
Dr. Joachim Schorr Senior Vice President Global Research & Development
New York, February 11th, 2010
Sample & Assay Technologies- 2 -QIAGEN Analyst and Investor Day, February 11, 2010
Agenda
R&D @ QIAGEN
- R&D Centers of Excellence
- Development Cycles
- R&D Budget Allocation
New Product Launches & Regulatory Pipelines
Prevention
Profiling
Personalized Healthcare
Point of Need
Regulatory Pipelines
Sample & Assay Technologies- 3 -QIAGEN Analyst and Investor Day, February 11, 2010
Global R&D Organization
690 Scientists in Research & Development Enabling Technologies for Sample and Assay Technologies
Switzerland
USA
Asia
MDx Prevention
siRNA
Application Lab
Pathway Analysis
Automated System Development
Basic R&D
ApplicationDevelopment
MDx AssayDevelopment
SystemsIntegration
MDx AssayDevelopment
SystemsValidation
SampleTechnologies
GermanyUK
Personalized Healthcare
CDx Program Management
Sample & Assay Technologies- 4 -QIAGEN Analyst and Investor Day, February 11, 2010
PRC PRC
Phase 2 Phase 3 Phase 4 Launch
PRC
Phase 0 Phase 1
PRC PRC/GRMPT
QIAGEN’s Global R&D:
Running Projects: 150+
Status: 60 in phase 3 or later
Development time: Approx. 12 months(LifeSciences ~ 9 months, MDx incl. approval 9 - 24 months)
Employees: 690+ researchers allocated according priorities within portfolios
Investment: Approx. 12% of revenues per year
Return on investment: Approx. 5% of revenue growth from products younger 12 months
IP: Expansion of IP position>2,100 patents (757 issued, 799 pending, 550+ licensed)
QIAGEN Product Development Focus & Execution
Sample & Assay Technologies- 5 -QIAGEN Analyst and Investor Day, February 11, 2010
R&D Budget Allocation Expenses per Technology Center
Note:MDx Assay & Samples including clinical trials (US$ 18.1 M)Life Science including QIAGEN Manchester
Sample & Assay Technology Instruments & SWFor all customer classes
Life Sciences, Pharma, Applied TestingSample & Assay Technology Consumables
MDxSample & Assay Technology Consumables
~61%
~20%
~11%
~8%
~61%
~20%
~19%
Sample & Assay Technologies- 6 -QIAGEN Analyst and Investor Day, February 11, 2010
Agenda
R&D @ QIAGEN
- R&D Centers of Excellence
- Development Cycles
- R&D Budget Allocation
New Product Launches & Regulatory Pipelines
Prevention
Profiling
Personalized Healthcare
Point of Need
Regulatory Pipelines
Sample & Assay Technologies- 7 -QIAGEN Analyst and Investor Day, February 11, 2010
Technology Roadmap 2010: Sample and Assay Technologies Structure Based on Identical Workflows in All Segments
Detection
Collection
Stabilization & Storage
Enrichment
Purification
Content
Disruption
Amplification / Modification
Bio-Informatics
Sample Technologies
Ass
ay T
echn
olog
ies
Aut
omat
ed S
yste
ms
Integrated Microsystem
s
Point of Need
Personalized Healthcare
Prevention
RSV
CMVEBV
HBV
GBS
HCV
QIA
symphony
Influenza
Profiling
Sample & Assay Technologies- 8 -QIAGEN Analyst and Investor Day, February 11, 2010
From Components to Content Strategy for R&D
Rotor-Gene Q
Biology/Chemistry excellence
Automation excellence
Integrated solutions
QIAsymphony QIAensemble PON Devices
EZ1BioRobot MDxBioRobot 8000 QIAcube QIAxcel PyroMarkQIAgility Rotor Gene Q
• Broad portfolio assays, incl. regulated
• Content engine
• Several novel markers in pipeline
1996 2000 Today
Content engine
2008
Sample & Assay Technologies- 9 -QIAGEN Analyst and Investor Day, February 11, 2010
The QIAGEN Content Engine MDx Roadmap
ExamplesNear-term
ExamplesMid-term
ExamplesLong-term
Prevention QIAensemble Evolutioncare HPV (3rd world)
HPV, CT/GC, Trich, GBS, Vaginosis, etc.Screening and Progression markers
Screening for: cancers incl. colon, ovarian, thyroid etc.
Profiling ResPlex II artus assays for QIAsymphony RGQ
GastroPlex, HHV-6, Adenovirus, JC, HSV,Candida, Aspergillus
Autoimmune diseases, CNS, cardiovascular diseases, women’s health, etc.
Personalized Healthcare
KRAS, BRAF A/C-Raf, MEK-1/2, p53, EGFR, BCR-ABL, NRAS, I3-Kinase, N/H-RasAKT, BCR, PTEN et. al. CDx for cancer therapeutics
Autoimmune diseases, CNS, cardiovascular diseases, others
Point of Need MRSA, cDiff, VREPseudomonas, Acinetobacter, other bacteria
Meningitis
Other Blood screening (China)
Blood screening emerging countries
Sample & Assay Technologies- 10 -QIAGEN Analyst and Investor Day, February 11, 2010
The 4 Ps in MDx
Point of NeedPHC
Profiling
RSV
CMVEBV
HBV
GBSInfluenza
HCV
QIA
symphony
Prevention
Sample & Assay Technologies- 11 -QIAGEN Analyst and Investor Day, February 11, 2010
Platform Technology Assays Samples
Ultra High/High (up to 2000/shift)
Throughput Instrument Floor model
Configuration
screening: digene HPV eHC Testgenotyping: digene HPV
eHC 16 18/45 Test
Low/Medium (up to 600/shift)
Throughput Instrument Benchtop
Configuration
screening: digene HPV eHC Testgenotyping: digene HPV
eHC 16 18/45 Test
QIAensembleUltra High to Mid Throughput Screening Platform
LBC Vials
Co-collected“DCM”
LBC Vials
Co-collected“DCM”
Sample & Assay Technologies- 12 -QIAGEN Analyst and Investor Day, February 11, 2010
Platform Technology Assays Samples
Ultra High/High (up to 5000 CT/GC/shift)Throughput Instrument
Floor model Configuration
Ultra High/High (up to 3000 CT/GC/shift)Throughput Instrument
Floor model Configuration
QIAensemble plusAdds Module for Amplified Assays
HPV, HPV GT
CT/GC AssayGBS
TrichomonasVaginosis
and many more
Amplified:
Non-amplified:
LBC Vials
Urine Vials
Co-collected“DCM”
Sample & Assay Technologies- 13 -QIAGEN Analyst and Investor Day, February 11, 2010
CT/GC Assay Workflow (Closed Tube Format)HC tHDA Fluorescent Endpoint Detection
Clinical sample
Lysis & denaturation
~ 20 short RNA probes
Probe hybridization &
capture
DNA-RNA hybrid
Magnetic separation of beads
&wash
Magnet
Beads with
Hybrid Capture antibody
CT and/or NG
DNA
Lysis & denaturation
~ 20 short RNA probes
Probe hybridization &
capture
DNA-RNA hybrid
Magnetic separation of beads
&wash
Magnet
Beads with
hybrid capture
antibody
CT and/or NG
DNA
Hybrid Capture Sample Preparation Amplification & Fluorescent Endpoint Detection
Amplification in the presence ofhybrid capture sample prep beads
QIAensemble SP+ QIAensemble 3000+
Sample & Assay Technologies- 14 -QIAGEN Analyst and Investor Day, February 11, 2010
Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Assay
Reaction: Isothermal Helicase-Dependent Amplification (tHDA)Detection: End-Point Fluorescent
. Assay performance specificationsAnalytical sensitivity ~1 IFU of CT/GC per assay
10 copies of target per amplificationAnalytical specificity: No cross-reactivity with non-pathogensInput material: Urine, LBC and swabs (more to come)Assay time should allow various throughputs (design goal: 1500/shift, actual 3000/shift)
. Assay automationSame platform as for HPV screeningComplete automation for all throughput labsDe-capping capability of all sample vials
QIAGEN CT/GC Assay Project Goals
Sample & Assay Technologies- 15 -QIAGEN Analyst and Investor Day, February 11, 2010
CT/GC Assay Performance Sensitivity of 10 Copies in a Multiplex Assay Format
CT1/CT2/NG/IC tHDA multiplex assay performance
0
1
2
3
4
5
6
7
8
NTC 10 copiesCT/NG
100 copiesCT/NG
1000 copiesCT/NG
S/N
IC, 250 copiesNGCT
End-Point Fluorescent Detection Real-Time Detection
*Research Gaithersburg
Detection of Mixture of CT and NG Targets and IC in One Well
IC, 250 copiesNGCT
CT/GC assay
Sample & Assay Technologies- 16 -QIAGEN Analyst and Investor Day, February 11, 2010
Prevention
The 4 Ps in MDx
Point of NeedPHC
Profiling
RSV
CMVEBV
HBV
GBSInfluenza
HCV
QIA
symphony
Sample & Assay Technologies- 17 -QIAGEN Analyst and Investor Day, February 11, 2010
Launches and Developments 2009/ 2010 QIAsymphony System Family
QIAsymphony RG-Q family
QIAsymphony SP
QIAsymphony RG-Q
QIAsymphony plus
Launch in Q1/2010artus HIVartus HBVartus HCVartus CMVartus EBV
Launch in Q3/2010artus VZVartus BKVartus HSV
Currently in assay development artus HSVartus CT/GCKras; EGFR; PIK3; MEK; BRAF; JAK2; EGFRvIIIartus Influenza
Planned near term (RUO, CE, 510K)artus HHV-6artus JC (human polyomavirus) artus Adenovirusartus Aspergillusartus GBS
Sample & Assay Technologies- 18 -QIAGEN Analyst and Investor Day, February 11, 2010
Prevention
The 4 Ps in MDx
Point of Need
Profiling
RSV
CMVEBV
HBV
GBSInfluenza
HCV
QIA
symphony
PHC
Sample & Assay Technologies- 19 -QIAGEN Analyst and Investor Day, February 11, 2010
KRAS Status Major Impact on Anti-EGFR Drug Efficacy
Cell growth via EGF-Ras-Raf signal transductionControlled normal cell growthUncontrolled oncogenic cell growth = uncontrolled signal amplification
EGFR-Inhibitors against EGF receptor block cell growthAntibodies Erbitux (Imclone), Vectibix (Amgen)About 140 EGF inhibitors in clinical trialsStrategies against colon, lung, head & neck etc.
Oncogenic Ras Mutations in 4 critical positionsFound in up to 30% of all human tumors Send permanent cell growth signal „Down-stream of EGF-Receptor“Lead to drug resistance of EGFR-Inhibitors
Patient stratification increase efficacy of Anti-EGF drugsErbitux and Vectibix only for KRAS Wildtype30-40% of patients with Oncogenic KRASEfficacy significantly increased with KRAS tests
(1) Epidermal Growth Factor Receptor
EGFR
P KRAS KRAS
raf
MEK
ERK
Cell growth
active
Ras-signal transductions pathway
EGF Epidermal growth factor
Sample & Assay Technologies- 20 -QIAGEN Analyst and Investor Day, February 11, 2010
Personalized Medicine Becomes Reality
Source: Personalized Medicine Coalition, 2008
Molecular Biomarker test Therapy Indication
BCR-ABL Gleevec® Chronic myeloid leukemia
c-KIT Gleevec® Gastrointestinal stromal tumor (GIST)
HER-2/neu receptor Herceptin® Breast cancer
BRCA 1, Breast/ ovarian cancer Pharmaceutical and surgical prevention options
AlloMap® gene profile Immunosuppressiva Monitors immune response to heart transplant
Familion® 5-gene profile Pharmaceutical prevention Inherited cardiac channelopathies:Prevention & drug selection
p16/CDKN2A Melanoma: Preventive treatment Pharmaceutical and surgical prevention options
TruGene®-HIV 1 Genotyping Kit Anti-retroviral drugs Therapy selection based on resistant HIV mutations
Oncotype DX™ 21-gene assay Cancer treatment regimens Quantifies the likelihood of breast cancer
UGT1A1 Camptosar® Drug side effects in colon cancer treatment
Amplichip® CYP2D6/CYP2C19 Drugs metabolized by P450 Treatment dose for drugs that are metabolized by P450
Estrogen receptor Tamoxifen Relevance of tamoxifen citrate in breast cancer therapy
TPMT Purinethol® Dose adjustment in acute lymphoblastic leukemia treatment
KRAS (BRAF) Vectibix Exclusion of KRAS mutants increase efficacy
Sample & Assay Technologies- 21 -QIAGEN Analyst and Investor Day, February 11, 2010
Discovery Pre- clinical Clinical Trials FDA Launch
5 Years 1.5 Years 6 Years 2 Years 2 Years 10 Years +
ApprovalMarker
Marker
Marker
MarkerMarker
MarkerMarker
Marker
MarkerMarker
Marker Marker Diagnostic
Biomarkers -Possible Companion Dx? Routine UseExplore pathways
and molecules ValidateFile for
IVDClearance
Use IVD for
More data
Approval
Marker
Covering the Entire Pharma Development Process From Discovery through Development to Companion Diagnostics
Sample & Assay Technologies- 22 -QIAGEN Analyst and Investor Day, February 11, 2010
Technology Toolbox and Assays Roadmap Personalized Healthcare
PCR
Biomarker
First Indication(Cancer) Partnered CE FDA
KRAS Colon Lung Yes 2008 2011
BRAF Colon Melanoma No 2010/2011 2012
EGFR Lung Yes H1 2009 2012
EGFR vIII Glioblastoma Yes H2 2009 2012
PI3K Breast At proposal 2011 2014
NRAS Melanoma In discussion 2012 2014
ABL
Chronic myelogenous leukemia (CML)
In discussion 2010 2013
Sample & Assay Technologies- 23 -QIAGEN Analyst and Investor Day, February 11, 2010
Prevention
The 4 Ps in MDx
PHC
Profiling
RSV
CMVEBV
HBV
GBSInfluenza
HCV
QIA
symphony
Point of Need
Sample & Assay Technologies- 24 -QIAGEN Analyst and Investor Day, February 11, 2010
Sigma 42 Project Core Technologies: Helicase Dependent Amplification (HDA)
tHDA mimics nature’s method of replicating DNA by using helicase (± ssBP) to denature the DNA at a constant temperature of 65°C
Like in PCR two sequence specific primers are flanking the DNA fragment enabling the amplification by using an enzymatic mixture
QIAGEN is adding proprietary hot start function to HDA reaction to improve enzyme function
Sample & Assay Technologies- 25 -QIAGEN Analyst and Investor Day, February 11, 2010
Sigma 42 Project Portable Device for CT/GC Detection
. BMBF funded Project
. 09/08 applied
. 02/09 approved
. 06/09 launched
CT/GC
Process
50µl
Load chip intothe processingdevice
Sample & Assay Technologies- 26 -QIAGEN Analyst and Investor Day, February 11, 2010
Fluorescence Detection Technology by ESE Today’s Standard in Point of Need
Target: Amplification specific for Chlamydia trachomatis detecting a portion of the major outer membrane protein (omp)
Method: Genomic DNA from Chlamydia trachomatis was used as template in a tHDA reaction and fluorescence was measured in real-time mode on the ESE Tube Scanner from samples containing the equivalent of 100 copies of the omp gene and negative control samples (NTC).
tHDA Reaction on a ESE Tube Scanner
Sample & Assay Technologies- 27 -QIAGEN Analyst and Investor Day, February 11, 2010
Agenda
R&D @ QIAGEN
- R&D Centers of Excellence
- Development Cycles
- R&D Budget Allocation
New Product Launches & Regulatory Pipelines
Prevention
Profiling
Personalized Healthcare
Point of Need
Regulatory Pipelines
Sample & Assay Technologies- 28 -QIAGEN Analyst and Investor Day, February 11, 2010
Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1
2013201220112010YEARPROJECT QUARTER
Regulatory Approval Projects USA
artus EBV RG 6000
NextGen HPV Screening
TheraScreen KRAS
AXpH QIAsymphony for HC 2.0
Resplex II
artus CMV RG 6000
artus Influenza
cador BVDV (USDA)
TheraScreen EGFR
Estimated Approval/Launch (typically 15 months after submission for PMA, 6 months for 510K) PMA Submission510K SubmissionStart clinical trialRunning / planned project
Sample & Assay Technologies- 29 -QIAGEN Analyst and Investor Day, February 11, 2010
Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1
2013201220112010YEARPROJECT QUARTER
Selected Regulatory Approval Projects Europe
artus HHV-6
NextGen HPV Screening
TheraScreen KRAS RGQ
TheraScreen EGFR RGQ
AXpH QIAsymphony for HC 2
artus HSV 1,2
Estimated CE Mark
Resplex II Plus
PyroMark Cancer Panel (12 markers)
Running / planned project
artus VZV and artus BKV
Sample & Assay Technologies- 30 -QIAGEN Analyst and Investor Day, February 11, 2010
Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1
2013201220112010YEARPROJECT QUARTER
Regulatory Approval Projects China / Asia
care HPV
NextGen HPV Screening
TheraScreen KRAS RGQ
HBV v2
Blood Screening
Digene HC2 HPV
SubmissionStart clinical trialRunning / planned project
UU Test
CT and NG
Flag indicates Estimated Approval/Launch
TheraScreen EGFR RGQ
Sample & Assay Technologies- 31 -QIAGEN Analyst and Investor Day, February 11, 2010
Regulatory Project Pipeline ( CE, FDA, SFDA) In Preparation
Prevention Profiling Personalized Healthcare Point of Need
CT/GC artus HHV-6 EGFR vIII Tuberculosis
Tricomonas artus JC (human polyomavirus)
PI3K Influenza
Vaginosis artus adenovirus NRAS MRSA
GBS artus aspergillus ABL
Clostridium difficile (CD MEK
BRAF
BCR-ABL
Sample & Assay Technologies- 32 -QIAGEN Analyst and Investor Day, February 11, 2010
. Thank you !