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QPS Global Capabilities Presentation
 

QPS Global Capabilities Presentation

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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 ...

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.

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  • The foundation of QPS was established in 1995 as Quest.
  • QPS Europe has a state of the art 25,000 ft 2 GLP compliant bioanalytical facilities. The laboratory is in operations since 1999 and has a real international customer base serving the majority of the top 10 Pharma companies and the top 5 Biotech companies. The services consists of Chromatography and Mass Spectrometry; Biochemistry and Immunology and in the competence centre Elemental Spectrometry QPS Europe offers ICP-MS and LC-ICP-MS.

QPS Global Capabilities Presentation QPS Global Capabilities Presentation Presentation Transcript

  • Presentation for: Sponsor MMM DD, 2011
  • 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?
    • ‘ 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
  • 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 >>>
  • 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:
      • QPS Delaware (Newark, DE USA)
      • QPS-Biokinetic (Springfield, MO USA)
      • QPS Netherlands (Groningen, The Netherlands)
      • QPS Taiwan; QPS-CTPS Taiwan; QPS-Qualitix Taiwan (Taipei, Taiwan)
      • QPS-Bioserve India (Hyderabad, India)
  • Global Presence ‘ Servicing customers all over the world’
  • QPS’ Linearly Integrated Core Competencies
    • ‘ Have it all done in one place. Save your time. Save your money.
    • Since it is a long way (…navigating your way….) to the bedside’
    • Discovery/Candidate-Selection Stage
      • ADME and Tolerability Studies to support Drug Discovery
    • Preclinical/Non-clinical Development Stage
      • Animal Toxicology studies to support regulatory filing
      • Development DMPK studies to support regulatory filing
      • Regulated Bioanalysis to support animal toxicology studies
      • Immunogenicity for PD and safety assessment
      • Biomarkers for animal pharmacology studies
      • PK/TK modeling
    • Clinical Development Stage
      • Phase 1 Healthy Volunteer studies
      • Phase 2 to 4 Patient studies
      • Development DMPK studies to support NDA filing
      • Regulated Bioanalysis to support clinical studies
      • Immunogenicity for efficacy and safety monitoring
      • PGx for patient stratification and efficacy monitoring
      • Biomarkers for efficacy and safety monitoring
      • Clinical PK/PD modeling
  • 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 ?
    • DMPK
    • ‘ helping you navigate your way through
    • the biotransformation of your drug’
    • Brief Global Overview
    • ‘ DMPK services include the necessary studies for regulatory filing at the appropriate time
    • and mechanistic studies when required’
    • Pharmacokinetics
      • Single and Multiple Dose, Dose Proportionality, Absolute Bioavailability, PK/TK Modeling
      • Mass Balance/Excretion/Radiolabel Studies
      • Formulation Optimization, Intestinal Permeability, other Mechanistic studies
    • Protein Binding; RBC/Plasma Distribution Partitioning
      • Protein Covalent Binding
    • Tissue Distribution
      • Discovery QWBA
      • Quantitative Whole-Body Autoradiography (QWBA)
      • Micro-autoradiography (MARG)
    • Metabolism
      • Metabolic Stability, Species Comparison
      • CYP450 Inhibition/Induction
      • Metabolic Reaction Pathway Profiling
      • Metabolite Profiling & Identification – In Vitro, Preclinical, and Clinical
    Global DMPK Services
  • Global DMPK Services
    • Brief Global Overview
    • ‘ QPS staff's experience is our biggest asset’
    • Team of senior DMPK scientists that all have on average 15+ years of pharmaceutical and biotech drug discovery and development experience.
      • All were DMPK representatives on discovery and/or development teams.
      • Worked on > 50 INDs and > 10 NDAs.
      • Worked in different therapeutic areas (Antiviral, CV, Oncology, Pulmonary_
      • The same group of scientists also has on average additional 9+ years of CRO experience.
    • Scientific Integrity and Quality
      • Each DMPK management team member has in-depth skill sets in different fields:
        • Pharmacokinetics & Protein Binding
        • Formulation & Absorption
        • QWBA & Micro-autoradiography
        • Metabolism
        • Metabolite Identification
    • Program Development Consulting
    • Address routine and mechanistic ADME issues
    • ADME Summary for Regulatory Submission
  • Global DMPK Services
    • Discovery ADME Studies
    • ‘ QPS performs cost effective discovery ADME screens’
    • Metabolic stability
    • CYP inhibition
      • “ Validated” process with FDA approved specific probe substrates and chemical inhibitors
    • Protein binding
      • Equilibrium dialysis using conventional device or RED or HT96
    • Rodent PK – linearly integrated
      • Formulation
      • In-life – Discrete or “N-in-1” dosing
      • Bioanalysis method development & sample analysis
        • “ N-in-1” bioanalysis
      • PK calculation
      • Average turnaround time < 7.5 days from compound receipt to reporting of data
  • Global DMPK Services
    • Candidate Selection Studies
    • ‘ QPS experienced staff knows how to select your best IND candidates’
    • Pharmacokinetics
      • Formulation, dose proportionality
      • Intestinal permeability
      • Other mechanistic studies for absorption and disposition (or clearance)
    • Metabolism
      • Species comparison
      • Metabolite profiling and/or identification
      • Pilot CYP mapping
    • Excretion
      • Route of elimination – BDC studies
  • Global DMPK Services
    • Radiolabeled Studies
    • ‘ QPS has proven innovative study design and executional excellence for radiolabeled studies’
    • Combination Mass Balance /Excretion QWBA study to address MB, tissue distribution, and human radiation dosimetry questions
      • Better technical oversight
      • Eliminate the possibility of radiolabel degrading over an extended period of time between the two studies and the requirement of re-purification
      • Increase efficiency using a single study protocol = ↓Study Cost
    • Metabolite Profiling and Identification in the same study
      • Both ion trap and quadrupoles tandem mass spectrometers for different MSn experiments
    Average Recovery 93.8%
    • QPS Delaware DMPK Facility
    • ‘ DMPK function with all necessary equipment and self-contained for speed’
    • Vivarium – focus on mouse and rat with nine (9) rodent rooms
      • 1 Surgical Suite
      • Triple cannulated animals for special models & in situ CSF
      • Intracranial infusions for up to 7 days
    • Eight (8) bioanalytical labs for dose formulation, sample preparation, and analysis
    • Mass Balance Studies
      • Mass Balance Cages (Plastic and Glass)
      • Micro-Filter Cages for Mice, Nude Mice and Rats
    • In Vitro cell culture Lab
      • S9, microsomes, and hepatocytes
      • Tumor cell-lines for xenografts
    • LIMS
      • DEBRA and Watson
    Global DMPK Services
    • QPS Delaware DMPK Facility
    • ‘ DMPK function with all necessary equipment and self-contained for speed’
    • Two (2) Autoradiography Labs for Macro- and Micro-autoradiography
      • Leica CM 3600 Cryomacrotome (whole-body)
      • Leica Vibratome 9800 (whole-body)
      • Leica CM 3050 S Cryomicrotome (individual organ/tissue)
      • Molecular Dynamics Typhoon 9410 Imager
      • Six (6) Imaging Research MCID Elite Systems
    • Support Equipment:
      • Snap-freezing Equipment
      • Photography Equipment
      • Sample Oxidizers
      • Liquid Scintillation / Gamma Counters
      • Microplate Scintillation Counter
      • Radioactivity / LC Detectors
    Global DMPK Services
    • QPS Delaware DMPK Facility
    • ‘ DMPK function with all necessary equipment and self-contained for speed’
    • Dedicated LC/MS/MS
      • Three (3) bioanalytical labs for sample preparation and analysis
      • Six (6) Mass Spec (5 Sciex API 4000s, Finnigan LTQ ProteomeX)
        • Waters UPLCs, Shimadzu VP-series LCs, Agilent 1100 LCs; LEAP HTC/PAL injectors
      • Detectors – UV/Vis, Fluorescence, Electrochemical
      • Tomtec Quadra 96 for 96-well sample preparation
    • Radio-Quantitation
      • Two (2) Packard Model 307 Sample Oxidizers
      • Two (2) PE Tri-Carb 2800TR/2900TR Scintillation Counters
      • PE TopCount ® NXT  Microplate Scintillation Counter
      • Packard Cobra II Gamma Counter
      • Four (4) Radioactivity Detectors
      • ARC XFlow  System; Off-line Fraction Collectors
    Global DMPK Services
    • QPS Delaware DMPK Facility
    • ‘ DMPK function with all necessary accreditation, certifications, permits, and licenses’
    • AAALAC Accreditation
    • ABC License
    • CDC Permit
    • CLIA Certification
    • DEA Permit for Scheduled Control Substances (I-V)
    • Federal Fish & Wildlife Permit
    • NRC License for Radiochemicals
      • 3 H, 14 C, 32 P, 33 P, 35 S, 45 Ca, 51 Cr, 90 Y, 99m Tc, 111 In, 125 I, 188 Re
    • OLAW Assurance
    • ORCA Certification
    • USDA Permit
    Global DMPK Services
  • 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 ?
    • Toxicology
    • ‘ helping you navigate your way through the safety of your drug’
    • Brief Global Overview
    • ‘ QPS-CTPS Taiwan is one of the most experienced toxicology centers in Asia’
    • Track Record
      • Over 1000 GLP Studies since 1997
      • 17 dossiers compiled for US FDA IND submission
      • 18 dossiers compiled for Taiwan IND submission
    • Accreditations & Compliance:
      • AAALAC Accreditation since 2000
      • Taiwan Accreditation Foundation (TAF) ISO 17025
      • Taiwan Department of Health (DOH) GLP
      • OECD (TAF) GLP
      • US FDA GLP compliance
    Global Toxicology Services
    • Safety Evaluations
    • ‘ QPS-CTPS is able to provide you the complete battery of toxicological tests that is needed for
    • the filing of your IND submission’
    • General & Reproductive Toxicology
    • Genetic Toxicology
    • Biocompatibility Testing
    • Topical Toxicity Testing
    • General (non-GLP) Toxicity Testing
    Global Toxicology Services
    • General & Reproductive Toxicology
    • ‘ QPS-CTPS is able to provide you with a comprehensive package of in vivo toxicology studies’
    • Single Dose Toxicity Studies
    • Repeated Dose Toxicity Studies
      • Up to 180 days
      • Routes of administration: oral, intravenous (injection and infusion), intramuscular, subcutaneous, intraperitoneal and others
      • Animal species: mice, rats, guinea pigs, hamsters, rabbits, dogs ……….and cynomolgus monkeys coming soon!
    • Reproductive Toxicology
      • Fertility
      • Teratology
      • Animal species: rat and rabbit
    • Clinical Pathology
      • Urine Analysis
      • Hematology
      • Serum Chemistry
    • Histopathology
      • Tissue and Slide Preparation
      • Tissue Image
      • QA of Scanned Slides, Pathology Consultation and Evaluation by Board-Certified Pathologist
    Global Toxicology Services
    • Genetic Toxicology
    • ‘ QPS-CTPS is able to provide you a broad panel of in-house conducted genotoxicity tests
    • Gene Mutation Assays
      • Ames Test
      • HPRT gene mutation assay
      • In Vitro mouse lymphoma assay
    • Cytogenetic Assays
      • Sister chromatid exchange assay
      • Chromosome aberration assay
    • Micronucleus Assays
      • Micronucleus assay in CHO cells
      • Mouse micronucleus assay
    • Cell Transformation Assay
      • In Vitro cell transformation assay
    Global Toxicology Services
    • Biocompatibility Testing
    • ‘ QPS-CTPS is able to provide you with this high-quality niche service which primarily involves
    • the toxicity testing of medical devices’
    • Acute Systemic Toxicity Test
    • Pyrogen and LAL Test
      • Animal species: rabbit
    • Intracutaneous Irritation Test
    • Skin Sensitization Test
    • Cytotoxicity Test
    • In Vitro Hemolysis
    • Mutagenicity Test
    • Implantation Test
    Global Toxicology Services
    • Topical Toxicity Testing
    • ‘ QPS-CTPS is able to provide you with other high-quality niche services which primarily
    • involves the toxicity testing of dermatological and cosmetic products’
    • Irritation Studies
      • Eye irritation test
      • Dermal irritation test
      • Animal species: rabbit
    • Skin Sensitization Testing
      • Buehler test
      • Maximization test
      • Animal species: guinea pig
    Global Toxicology Services
  • 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 ?
    • Bioanalytical
    • ‘ helping you navigate your way through the measurement of your drug’
  • Global Bioanalytical Services
    • Brief Global Overview
    • ‘ QPS is a global leader in bioanalysis for both small and large molecules’
    • Small molecules – using mass spectrometric techniques
    • Large Molecules - using ligand binding assay techniques
    • Global coverage of bioanalytical services with local presence in North America, Europe, and Asia
    • World leading…
      • Specialists (>150 technical staff)
      • State-of-the-art equipment (API5500Q, API 5000, UPLC-MS/MS, ICP-MS, MSD, Gyros™)
      • Capacity (45 Mass Specs)
      • Capabilities: LC-MS/MS, ICP-MS, LC-UV, LC-Flu, LC-ECD, LC-RFD, LBA, Hybridization-ELISA
    • Extensive validated assay list (> 750 assays and growing)
    • Rapid assay development, validation, sample analysis
    • Supporting a full range of development from Preclinical to Late Stage Clinical programs
    • Immunogenicity & Neutralizing Antibody Activity Assessment
    • Central Lab Services: Sample Logistics / Sample Repository / Preparation and Distribution of Sampling Kits
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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-Bioserve’s 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
  • 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-Bioserve’s 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!)
  • 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 ?
    • Translational Medicine
    • ‘ helping you navigate your way through the efficacy of your drug’
  • 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
    • decisions’
    • Biomarkers
      • PD protein or biochemical markers
      • Various biomarker assay platforms (ELISA, Immulite ® , Bioplex ® , MSD ® Imager 6000 ECL, LC-MS/MS, LC-ECD)
      • Cell-based & functional assays
      • Western Blot analysis & quantification
      • Radioligand binding assay
      • On-site cell stimulation and cytokine biomarker panel evaluation
    • Pharmacogenomics (PGx)
      • DNA isolation and banking
      • Genotyping (SNPs, insertions, deletions, copy numbers, etc.)
      • CpG methylation quantification
      • RNA isolation & expression profiling (qRT-PCR)
  • Global Translational Medicine Services
    • Biomarker Menu
    • ‘ QPS offers laboratory biomarker services for many different therapeutic areas’
    Adrenal/Pituitary Disorders Diabetes / Lipid Metabolism / Carbohydrate Metabolism Reproductive Endocrinology Allergy Gastrointestinal Thyroid Function Alzheimer’s 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
  • Global Translational Medicine Services
    • Pharmacogenomics (PGx)
    • ‘ Genotyping services are offered by QPS offers to help ‘individualize’ disease therapies’
    • Nucleic Acids Isolation (DNA & RNA) and Banking
    • Genotyping (SNPs, Insertions, Deletions, Copy numbers, etc.)
    • CYP450 Genotyping Assays (CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C19, CYP2D6 genotyping panels)
    • 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 Alzheimer’s 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
  • 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
  • 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
  • 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™
  • Global Translational Medicine Service
    • Analytical Platforms
    • ‘ QPS scientists and laboratory technicians are used to work and have many validated assays on
    • many different assay technology platforms’
    • ELISA
    • Pyrosequencing Technology Platform
    • Roche Modular P®
    • Affymetrix GeneChip Microarray System
    • Siemens Immulite®
    • TaqMan Real-Time PCR System
    • Bioplex®
    • Gradient Gel Electrophoresis (GGE)
    • Luminex™
    • HPLC/UHPLC/UV/Fluorescence/ECD
    • Meso Scale Discovery (MSD®) ECL Platform (SECTOR™ PR100 and Imager 6000)
    • LC – MS/MS
    • Gyrolab™
    • Ultracentrifugation
    • RIA
    • Western Blot Analysis
    • Radioligand Binding Assay (SPA)
  • 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 ?
    • Early Stage Clinical Development
    • ‘ helping you navigate your way through the complex challenges of the early development of your drug’
  • Global Early Stage Clinical Development Services
    • Brief Global Overview
    • ‘ QPS is a global leader in Phase 1 studies’
    • QPS has one of the world’s 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
  • 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
  • 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 Alzheimer’s 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
  • 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 Naïve
  • 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
  • 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
  • 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
    • Specialty Studies
      • Multi-purpose Umbrella Protocols (SAD + MAD + food effect + CYP450 fenotyping) – adaptive designs with flexible dosing escalation schemes
      • 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
  • 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 ?
    • Late Stage Clinical Development
    • ‘ helping you navigate your drug all the way across the finish line’
  • 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
  • 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
  • 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
  • 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)
  • 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
  • Global Late Stage Clinical Development Services
    • Medical Writing
    • ‘ QPS can take care of all your medical writing needs’
    • Clinical Study Protocol
    • Investigator’s 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
  • 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
  • Global Late Stage Clinical Development Services
    • Therapeutic Areas
    • ‘ QPS employees have dealt with a lot of therapeutic areas for significant periods of time’
    • Adrenal / Pituitary Disorders
    • Hemostasis/Angiogenesis
    • Allergy
    • Immunology / Autoimmune Disease / Rheumatoid Arthritis
    • Alzheimer’s Disease / CNS Disorders
    • Infectious Disease
    • Anemia
    • Inflammatory Diseases / Immune Status / Cell Response
    • Asthma/COPD
    • Renal Disease
    • Bone Disease / Metabolism
    • Thyroid Disorders
    • Cardiovascular Disease
    • Oncology / Tumors / Neoplasia
    • Diabetes / Obesity / Lipid Metabolism / Carbohydrate Metabolism
    • Female Health Care / Gynecological Endocrinology / Reproductive Endocrinology
    • Gastrointestinal Disorders
  • Why QPS?
    • What sets us apart?
    • ‘ QPS will help you navigate your way through the complex challenges of the
    • development of your drug….and while navigating your way, you will enjoy having….’
    • Direct access to QPS’ people's minds!
      • Direct access to key personnel
      • Direct access to a vast amount of drug discovery & development experience
      • Scientific approach
    • Direct access to QPS’ people's hearts!
      • Enthusiasm
      • Professional attitude
      • Flexibility
      • Focus on long-term professional customer relationships
    • Direct access to QPS’ people's hands!
      • Responsive and on-time
      • Cost effective