QPS is a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development. We provide quality services to pharmaceutical and biotechnology clients worldwide.
Citation preview
1. Presentation for: Sponsor MMM DD, 2011
2. How do we Introduce Ourselves to You?
Our Principles
History
Brief Company Overview
Global Presence
QPS Linearly Integrated Core Competencies
Providing services in:
DMPK
Toxicology
Bioanalytical
Translational Medicine
Early Stage Clinical Development
Late Stage Clinical Development
Why QPS?
3.
What are our core values as a company? We believe in
Direct Peer-to-Peer Interactions
Customer Focus
Timeliness / Fast Turnaround
Cost Effective Sourcing Solutions
Our Principles
4. History 1994 Bio-Kinetic Clinical Applications (BKCA)
founded 1995 QPS (Delaware) founded 1999 Xendo Drug Development
founded 2004 QPS Taiwan founded >>> 2008 QPS acquired BKCA
to establish QPS Bio-Kinetic >>> 2010 QPS acquired Xendo
Drug Development to establish QPS Netherlands >>> 2010 QPS
acquired CTPS to establish QPS-CTPS Taiwan >>> 2011 QPS
acquired Qualitix to establish QPS-Qualitix Taiwan >>>
>>> >>> >>> 1984 Center of Toxicology
and Preclinical Sciences (CTPS)/DCB founded >>> 1990 2000
2011 1997 Genovate/Qualitix founded >>> 2011 QPS acquired
Bioserve to establish QPS-Bioserve India >>> 2005 Bioserve
founded >>>
5. Brief Corporate Overview
QPS offers breadth and depth, plus seamless integrated service
from drug discovery to regulatory
submission within the context of our six core competencies
QPS is a global service provider to the pharmaceutical,
biotechnology and generic industries
Six Core Competencies:
DMPK (Discovery -> Development)
Toxicology
Bioanalysis (Small Molecules -> Biologics)
Translational Medicine (Genetic -> Protein Biomarkers)
Early Stage Clinical Development (Phase 0 -> Phase IIa)
Late Stage Clinical Development (Phase IIb -> Phase IV)
Strategically located sites (750+ employees) in North America,
Europe & Asia:
Central Lab Services: Sample Logistics / Sample Repository /
Preparation and Distribution of Sampling Kits
30. Global Bioanalytical Services
Small Molecule LC-MS/MS
QPS is a global leader in bioanalysis for small molecules and
is able to analyze samples coming from
different types of studies, containing a wide variety of
compound structures and biological matrices
Bioanalytical Method Development & Validation
Sample Analysis for different evaluation purposes:
Pharmacokinetic (PK) screening
Toxicokinetic (TK) studies
Clinical PK/Bioavailability studies
Bioequivalency studies
Therapeutic drug monitoring studies
Biomarker studies
Drug-drug interaction studies
Sample Analysis of different compound structures:
Oligonucleotides Analysis
Peptide Analysis
Sample Analysis in different biological matrices:
Dried Blood Spots
Tissues
31. Global Bioanalytical Services in max. 10 slides (slide 3)
Large Molecule ImmunoBioanalysis
QPS is a global leader in bioanalysis for large molecules and
is able to analyze samples coming from
different types of studies, containing a wide variety of
compound structures and biological matrices
Bioanalytical Method Development & Validation
Sample Analysis for different evaluation purposes:
Pharmacokinetic (PK) screening
Toxicokinetic (TK) studies
PK/Bioavailability studies
Bioequivalency studies
Therapeutic drug monitoring studies
Biomarker studies
Drug-drug interaction studies
Immunogenicity monitoring using four-tier approach:
Screening
Confirmatory (immunodepletion)
Titer assessment (quantification)
Cell-based neutralizing antibody detection
32. Global Bioanalytical Services
Elemental Analysis in Biological Matrices
QPS is a unique provider of GLP trace and ultratrace elemental
analysis by ICP-MS, a detection
technique which is increasingly being applied for studying the
pharmacokinetics, metabolism
and pharmacodynamics of metal-containing and
non-metal-containing analytes in
preclinical and clinical studies
Bioanalytical applications that have been developed using
ICP-MS at QPS include but are not
limited to:
Platinum (Pt) in plasma and urine by ICP-MS for supporting
clinical studies with platinum-based chemotherapies
Platinum (Pt) in plasma and urine by LC-ICP-MS for the
metabolite profiling of a new investigational platinum
compound
Gadolinium (Gd) in plasma and urine by ICP-MS for supporting
clinical studies with MRI contrast agents and formulations
Magnesium (Mg), Calcium (Ca), and Phosphate (P) in food and
feces for supporting a mass balance study of a new phosphate
binder
Transferrin Vitamin B12
33. Global Bioanalytical Services
Large Molecule LC-MS/MS
QPS believes strongly in this novel bioanalytical application
of LC-MS/MS and can show you some
stunning results
Bioanalytical Method Development and Validation, and Sample
Analysis
Oligonucleotides
Peptides
Proteins
Monoclonal Antibodies
34. Global Bioanalytical Services
QPS Delaware GLP Facility Newark, Delaware, USA
QPS Delaware is a well-established high quality, cost-effective
sourcing solution for the
analysis of PK and PD samples coming from preclinical and
clinical studies conducted in
the USA
Small Molecule LC/MS/MS
27 (25 Sciex API 4000 and 2 Sciex API 5000)
Large Molecule ImmunoBioanalysis
Capability in PK, Immunogenicity, NAb assay, and
biomarkers
Hundreds of validated methods (DDI CoMeds) available Complete
list available on website http://www.qps-usa.com/
WATSON LIMS System v 6.4 (WATSON v7.4.1 Coming Soon!)
Gyrolab Automated Immunoassay Workstation
35. Global Bioanalytical Services
QPS Netherlands GLP Facility Groningen, the Netherlands
QPS Netherlands is a well established high quality,
cost-effective sourcing solution for the
analysis of PK and PD samples coming from preclinical and
clinical studies conducted in
Europe
Small Molecule LC/MS/MS
8 Triple Quadrupoles Mass Spec ( API 5500Q, 4000, 3000)
Large Molecule ImmunoBioanalysis
Capability in PK, Immunogenicity, NAb assay, and
biomarkers
Elemental Spectrometry (ICP-MS)
ICP-MS, for elemental analysis in pharmacology, toxicology and
product testing
LC-ICP-MS, for identification and quantification of unknown
metabolites from in-vitro and in-vivo drug metabolism studies
Many oncology (platinum) applications
Hundreds of validated assay methods (DDI CoMeds) available
Complete list available on website http://www.qps-usa.com/
LabVantage Sapphire LIMS System
Logistically closely linked to the phase I unit to enable fast
turnaround of plasma concentration data of laboratory biomarkers
and drug candidates during the conduct of first-in man programs
(SAD, MAD), human mass balance studies, and trials with instable
compounds
36. Global Bioanalytical Services
QPS-Bioserve GLP Facility Hyderabad, India
QPS-Bioserve is a high quality, cost-effective sourcing
solution for the analysis of
PK samples coming from bioequivalence studies conducted by
QPS-Bioserves own phase I
Unit and from clinical studies performed in India
Small Molecule LC/MS/MS
7 Triple Quadrupoles Mass Spec (2 Sciex API 3200 and 5 Sciex
API 4000)
Hundreds of generic methods available Complete list available
on website http://www.qps-usa.com/
QPS-Bioserve has a dedicated and experienced Pharmacokinetics
& Statistics team, with expertise in the application and
presentation of PK and statistical principles, critical for
successful approval of generic product submissions:
Study design, sample size and statistical power estimation
Bioequivalence analysis
PK and PK/ PD analysis
In Vitro - In Vivo Correlation (with Pharsight IVIVC toolkit
software)
WinNonlin for PK analysis and SAS for statistical analysis
Final Report submissions in E3/ CTD format
37. Global Bioanalytical Services
QPS Taiwan GLP Facility Taipei, Taiwan
QPS-Taiwan is a high quality, cost-effective sourcing solution
for the analysis of
PK samples coming from bioequivalence studies conducted by
QPS-Bioserves own Phase I
Unit and from clinical studies performed in Asia
Small Molecule LC/MS/MS
4 Triple Quadrupoles Mass Spec (4 Sciex API 4000)
Large Molecule ImmunoBioanalysis
Capability in PK, Immunogenicity, Nab assay, and
biomarkers
Hundreds of generic methods available Complete list available
on website http://www.qps-usa.com/
WATSON LIMS System v 6.4 (WATSON v7.4.1 Coming Soon!)
38. Slide Deck Navigator
Navigate me directly to.
Global DMPK Services
Global Toxicology Services
Global Bioanalytical Services
Global Translational Medicine Services
Global Early Stage Clinical Development Services
Global Late Stage Clinical Development Services
Why QPS ?
39.
Translational Medicine
helping you navigate your way through the efficacy of your
drug
40. Global Translational Medicine Services
Brief Global Overview
As an experienced provider of translational medicine services,
QPS offers
solutions to help guide drug development teams at various
stages, including patient
stratification, toxicity prediction, evaluation of PK profiles,
dose determination, and treatment
Genotyping Assays for Other Drug Metabolizing Enzymes (NAT1,
NAT2, UGT1A1, CDA)
Genotying Assays for Transporters (ABCG2, SLCO1B1)
Genotyping Assays for Oncology (BRAF, KRAS, PIK3CA)
Genotyping Assays for Alzheimers Disease (ApoE, PPP3R1)
Genotyping Assays for Warfarin Therapy (CYP2C9*2, CYP2C9*3, and
VKORC1 (-1639 G>A))
CpG Methylation Quant
Gene Expression Profiling in various matrices (qRT-PCR)
Pyrosequencing
43. Global Translational Medicine Services
Immunogenicity/Anti-Drug Antibody Testing
QPS is an expert in immunogenicity/ADA testing and has all the
necessary knowledge and
assays technologies at its disposal
QPS has supported 15 biologic drug development programs for 10
sponsors (11 proteins and 4 therapeutic antibodies) for which over
50 studies were performed.
Anti-Drug-Antibodies (Screening, Confirmation, and
Titering)
Antibody Generation
Critical Reagent Labeling
Cell Based Neutralizing Antibody (NAb) Assays
Cell Banking and Maintenance
Technology Transfer
Custom Method Development and Optimization
Meso Scale Discovery
44. Global Translational Medicine Services
Neutralizing Antibody Assays:
QPS is an expert in NAb testing and is able to apply its
extensive knowledge and application of
new assay technologies to your benefit
Since 2002 > 40 Studies conducted for 7 Sponsors
ELISA
Cell-Based Functional Assays, e.g. cell viability assay
Other Functional Assays, e.g. activity assay
Receptor Binding Assays
45. Global Translational Medicine Services
Novel Biomarker Assay Development
QPS is a frontrunner in adopting new assay technologies for
biomarkers
Various Technology Platforms (ELISA, BioPlex, Immulite, MSD
ECL, Gyrolab)
Cell Based Assays
Multiplexing Genetic Markers (CYP450 TaqMan or Affymetrix DMET
genechips)
Pharmacodynamic (PD) Assays
On-Site Cell Stimulation and Biomarker Analysis
Fit-For-Purpose Biomarker Assay Development and Validation
(various matrices)
Protocol Design
Luminex
46. Global Translational Medicine Service
Analytical Platforms
QPS scientists and laboratory technicians are used to work and
have many validated assays on
helping you navigate your way through the complex challenges of
the early development of your drug
49. Global Early Stage Clinical Development Services
Brief Global Overview
QPS is a global leader in Phase 1 studies
QPS has one of the worlds largest Phase 1 site offerings with
400 Phase I beds on three continents:
240 in the USA
92 in India
40 in Taiwan
24 in the Netherlands
QPS offers a broad spectrum of early phase study types:
First-in-Man Programs (SAD + MAD + FE + CYP450 Interaction) -
the Netherlands
Human Mass Balance studies - the Netherlands
Microdosing studies - the Netherlands
Clinical PK/PD studies - the Netherlands, Taiwan, India and
USA
Imaging (PET, fMRI) studies - the Netherlands
Bioavailability/ANDA studies - Taiwan, India and USA
Bioequivalence/ANDA studies - Taiwan, India and USA
Vaccine studies - Taiwan, India and USA
Cardiac Safety/Thorough QT/QTc studies - USA
Drug-Drug Interaction studies - the Netherlands, Taiwan, India
and USA
50. Global Early Stage Clinical Development Services
Full-Service Early Stage CRO
QPS is a full service early stage CRO that is not only capable
of providing the clinical conduct of
your Phase 1 study but has the ability to provide the front and
back end services as well
Review of Preclinical Data
Design and Preparation of the Trial
Clinical Project Management
Preparation of the Study Protocol, Informed Consent, and Case
Report Forms
Clinical Conduct
Clinical Data Management
Biostatistics
Bioanalysis/Biomarker Assays
Conduct PK/PD and/or Pop PK/PD Data Analysis and Modeling
Prepare PK/PD Report
Prepare and publish Fully Integrated Clinical Study
Reports
Monitoring
Pharmacovigilance
51. Global Early Stage Clinical Development Services
Biomarker Support
QPS is not only capable of conducting phase 1 studies for you
in specialty and patient
populations but QPS is capable of doing the additional
measurement and interpretation of
therapeutic-specific biomarker data as well
Adrenal / Pituitary Disorders Diabetes / Lipid Metabolism /
Carbohydrate Metabolism Reproductive Endocrinology Allergy / Asthma
/ COPD Gastrointestinal Thyroid Function Alzheimers Disease
Hemostasis / Angiogenesis Anemia Infectious Disease Autoimmune
Disease Inflammation / Immune Status / Cell Response Bone Disease /
Metabolism Oncology (Tumor / Neoplasia Markers) Cardiac Markers
Phenotypic Markers of Drug Metabolism Cell Response Renal Toxicity
and Function
52. Global Early Stage Clinical Development Services
QPS-Biokinetic Springfield, Missouri, USA
QPS-Biokinetic is ideally suited to conduct a wide variety of
phase I studies, especially when
substantial numbers of volunteers need to be recruited in
record breaking time
5 Clinical Units on one Campus
Over 900 studies completed since 1994
15 FDA audits
Clinical Staff Experience
8+ years average length of employment
Less than 3% staff turnover rate
Over 20,000 active subjects database
Specialty Studies
Vaccine
Cardiac Safety/TQTc
Postmenopausal
Elderly
Birth Control and Birth Control Nave
53. Global Early Stage Clinical Development Services
QPS-Bioserve Hyderabad, India
QPS-Bioserve is a full service Phase I CRO with a long list of
regulatory approvals for generic
products that have been tested at this site
Full-service CRO, all aspects of study (from study design to
final report generation) are conducted in-house
ISO 9001:2008 certified organization
Approved by the Drugs Controller General of India (DCGI)
Audited by the US-FDA in March 2008 & July 2009 (no
483s)
Inspected by UK MHRA and WHO in 2010
Over 550 conventional BA/BE studies conducted for various
regulatory agencies (130 are pivotal studies)
20 products successfully approved by US-FDA
Clinical End Point Studies: QPS-Bioserve has experience in
using PD end points or other acceptable surrogate parameters to
establish bioequivalence for products (e.g. locally acting/topical
preparations) for which it is impossible to use PK endpoints to
establish bioequivalence. Examples: Sucralfate (suspension),
Pentosan Polysulfate (capsules), Adapalene (gel)
Pharmacoscintigraphic Imaging
NCE PK studies like Food Effect, Dose Proportionality and
Drug-Drug Interaction
54. Global Early Stage Clinical Development Services
QPS Taiwan Taipei, Taiwan
QPS Taiwan is a full service Phase I unit with a long list of
regulatory approvals for locally
manufactured generic products
Full-service CRO, all aspects of study (from study design to
final report generation) are conducted in-house
Bioavailability / Bioequivalence Studies
Healthy Normal Populations
PK in Cancer Patient Population
Scaled Average Bioequivalence
Conventional BA/BE studies conducted for various regulatory
agencies
More than 40 products successfully approved by Taiwan FDA
55. Global Early Stage Clinical Development Services
QPS Netherlands Groningen, the Netherlands
QPS Netherlands is ideally suited to conduct your FIM and more
complex phase I programs
Hospital based
Over 100 studies completed: 20 first-in-man programs (of which
12 with biologics); 7 PET studies; 6 Oral Contraceptive (OC)
interaction studies
2 FDA audits (1 in 2009 and 1 in 2010)
Fast and easy access to top-notch medical, clinical
pharmacological , medical and scientific expertise
Parallel submission to Competent Authority (CCMO) and local
Ethics Committee (EC) resulting in Clinical Trial Approval within
14 days! Substantial amendments: 48 h turnaround time; Dose
escalations: 24 h turnaround time
Logistically closely linked to the bioanalytical laboratory to
enable fast turnaround of plasma concentration data of laboratory
biomarkers and drug candidates
Female Health Care (OC interaction studies, Lactation studies
and Fertility studies)
Validated neuropathic (capsaicin) and acute (M3 extraction)
pain models
Imaging (PET, fMRI) studies
(Continuous) CSF sampling in HV
Radiolabel (14C) Mass Balance studies
56. Slide Deck Navigator
Navigate me directly to.
Global DMPK Services
Global Toxicology Services
Global Bioanalytical Services
Global Translational Medicine Services
Global Early Stage Clinical Development Services
Global Late Stage Clinical Development Services
Why QPS ?
57.
Late Stage Clinical Development
helping you navigate your drug all the way across the finish
line
58. Global Late Stage Clinical Development Services
Brief Global Overview
Widely recognized for achieving high-quality study data and
high patient enrollment rates, QPS
site management & monitoring teams bring you years of
experience
Phase I-IV Project Management
Phase II-IV Study Management
Clinical Trial Monitoring (incl. Phase I)
Clinical Trial Logistics and Supplies
Data Management
Biometrics
PK/PD Modeling
Medical Writing
In- and outsourcing of clinical professionals
59. Global Late Stage Clinical Development Services
Program, Project & Study Management
Apart from stand-alone clinical research activities, QPS is
also able to manage your
entire clinical drug development program
Clinical Consultancy
Design of clinical program
Design of clinical study
Phase 1 to Phase 4
Budget, Resource and Timeline Control
Experience with the following therapeutic indication areas:
Allergy, Cardiology, Metabolic diseases, CNS, Vascular Surgery,
Oncology, Multiple Sclerosis, Gastroenterology, Hematology, Genetic
Diseases, Radiology
60. Global Late Stage Clinical Development Services
Site Management & Monitoring
QPS is able to take a lot of clinical research activities away
from you
Site Selection
Site Training
study reference manual
study materials
one-on-one sessions
train-the-trainer sessions
online presentations
online tutorials for EDC
Site Recruitment
On-Site Monitoring
(Remote) Data Quality Review
Site Audit and/or Qualification
at study initiation
at interim visits
at study close out
for cause
Essential Document Collection
Regulatory Submissions
Site Logistics
61. Global Late Stage Clinical Development Services
Data Management
State-of-the-art clinical trial management and electronic data
capture systems enable QPS to
deliver first rate data management services
Streamlined clinical information capabilities between QPS
Sites/Branches
Clinical Database (Oracle Clinical and OpenClinica)
CRF Design
Paper based CRF
eCRF
Fast Data Base Lock
Experience with the following therapeutic indication areas:
Vascular Surgery, Metabolic diseases, Cardiology, Vaccins, CNS,
Observational Studies (Phase 4)
62. Global Late Stage Clinical Development Services
Biostatistics
State-of-the-art clinical trial management and electronic data
capture systems enable QPS to
deliver first rate biostatistics services
Data Analysis for Late Stage Clinical Studies
SAS Programming
Exports of Tables, Figures and Listings (TFLs)
PK / PD Analysis (including Pop PK)
Pharmacokinetic and statistical consultancy
Study design including optimization of PK sampling and power
evaluation of subject size
Non-compartmental and compartmental PK modeling
Population pharmacokinetics
Stand-alone PK/PD report
Experience with the following therapeutic indication areas:
Vascular Surgery, Metabolic Diseases, Cardiology, CNS, Various
Phase I
63. Global Late Stage Clinical Development Services
Medical Writing
QPS can take care of all your medical writing needs
Clinical Study Protocol
Investigators Brochure
IMPD (Investigational Medicinal Product Dossier)
ICF
Scientific Manuscripts
Final Clinical Report (CTD or eCTD)
Experience with the following therapeutic indication areas:
Vascular Surgery, Metabolic diseases, Cardiology, Immunology, CNS,
MS, Allergy and Pulmonary Diseases
64. Global Late Stage Clinical Development Services
Temporary Staffing/Flexible Sourcing Solutions
QPS employees can be outsourced and be brought temporarily on
to your own drug
development team
Clinical Research Associates
Clinical Research Coordinators
Clinical Project Managers
Regulatory Affairs Staff
Data Managers
Biostatisticians
Clinical Pharmacokineticists
Medical Writers
Quality Control Staff
Safety Reporters
Clinical Research Trainers
65. Global Late Stage Clinical Development Services
Therapeutic Areas
QPS employees have dealt with a lot of therapeutic areas for
significant periods of time
