QPS Global Capabilities Presentation
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QPS is your Global Link Presentation for: Sponsor MMM DD, 2011
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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 worldwide.
Transcript of QPS Global Capabilities Presentation
- 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:
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- DMPK
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- Toxicology
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- Bioanalytical
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- Translational Medicine
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- Early Stage Clinical Development
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- 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
- 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:
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- DMPK (Discovery -> Development)
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- Toxicology
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- Bioanalysis (Small Molecules -> Biologics)
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- Translational Medicine (Genetic -> Protein Biomarkers)
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- Early Stage Clinical Development (Phase 0 -> Phase IIa)
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- Late Stage Clinical Development (Phase IIb -> Phase IV)
- Strategically located sites (750+ employees) in North America, Europe & Asia:
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- QPS Delaware (Newark, DE USA)
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- QPS-Biokinetic (Springfield, MO USA)
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- QPS Netherlands (Groningen, The Netherlands)
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- QPS Taiwan; QPS-CTPS Taiwan; QPS-Qualitix Taiwan (Taipei, Taiwan)
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- QPS-Bioserve India (Hyderabad, India)
- 6. Global Presence Servicing customers all over the world
- 7. 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
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- ADME and Tolerability Studies to support Drug Discovery
- Preclinical/Non-clinical Development Stage
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- Animal Toxicology studies to support regulatory filing
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- Development DMPK studies to support regulatory filing
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- Regulated Bioanalysis to support animal toxicology studies
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- Immunogenicity for PD and safety assessment
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- Biomarkers for animal pharmacology studies
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- PK/TK modeling
- Clinical Development Stage
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- Phase 1 Healthy Volunteer studies
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- Phase 2 to 4 Patient studies
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- Development DMPK studies to support NDA filing
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- Regulated Bioanalysis to support clinical studies
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- Immunogenicity for efficacy and safety monitoring
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- PGx for patient stratification and efficacy monitoring
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- Biomarkers for efficacy and safety monitoring
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- Clinical PK/PD modeling
- 8. 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 ?
- 9.
- DMPK
- helping you navigate your way through
- the biotransformation of your drug
- 10.
- Brief Global Overview
- DMPK services include the necessary studies for regulatory filing at the appropriate time
- and mechanistic studies when required
- Pharmacokinetics
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- Single and Multiple Dose, Dose Proportionality, Absolute Bioavailability, PK/TK Modeling
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- Mass Balance/Excretion/Radiolabel Studies
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- Formulation Optimization, Intestinal Permeability, other Mechanistic studies
- Protein Binding; RBC/Plasma Distribution Partitioning
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- Protein Covalent Binding
- Tissue Distribution
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- Discovery QWBA
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- Quantitative Whole-Body Autoradiography (QWBA)
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- Micro-autoradiography (MARG)
- Metabolism
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- Metabolic Stability, Species Comparison
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- CYP450 Inhibition/Induction
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- Metabolic Reaction Pathway Profiling
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- Metabolite Profiling & Identification In Vitro, Preclinical, and Clinical
- 11. 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.
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- All were DMPK representatives on discovery and/or development teams.
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- Worked on > 50 INDs and > 10 NDAs.
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- Worked in different therapeutic areas (Antiviral, CV, Oncology, Pulmonary_
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- The same group of scientists also has on average additional 9+ years of CRO experience.
- Scientific Integrity and Quality
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- Each DMPK management team member has in-depth skill sets in different fields:
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- Pharmacokinetics & Protein Binding
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- Formulation & Absorption
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-
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- QWBA & Micro-autoradiography
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-
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- Metabolism
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-
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- Metabolite Identification
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- Program Development Consulting
- Address routine and mechanistic ADME issues
- ADME Summary for Regulatory Submission
- 12. Global DMPK Services
- Discovery ADME Studies
- QPS performs cost effective discovery ADME screens
- Metabolic stability
- CYP inhibition
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- Validated process with FDA approved specific probe substrates and chemical inhibitors
- Protein binding
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- Equilibrium dialysis using conventional device or RED or HT96
- Rodent PK linearly integrated
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- Formulation
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- In-life Discrete or N-in-1 dosing
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- Bioanalysis method development & sample analysis
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- N-in-1 bioanalysis
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- PK calculation
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- Average turnaround time < 7.5 days from compound receipt to reporting of data
- 13. Global DMPK Services
- Candidate Selection Studies
- QPS experienced staff knows how to select your best IND candidates
- Pharmacokinetics
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- Formulation, dose proportionality
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- Intestinal permeability
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- Other mechanistic studies for absorption and disposition (or clearance)
- Metabolism
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- Species comparison
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- Metabolite profiling and/or identification
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- Pilot CYP mapping
- Excretion
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- Route of elimination BDC studies
- 14. 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
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- Better technical oversight
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- Eliminate the possibility of radiolabel degrading over an extended period of time between the two studies and the requirement of re-purification
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- Increase efficiency using a single study protocol = Study Cost
- Metabolite Profiling and Identification in the same study
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- Both ion trap and quadrupoles tandem mass spectrometers for different MSn experiments
- 15.
- 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
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- 1 Surgical Suite
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- Triple cannulated animals for special models & in situ CSF
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- Intracranial infusions for up to 7 days
- Eight (8) bioanalytical labs for dose formulation, sample preparation, and analysis
- Mass Balance Studies
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- Mass Balance Cages (Plastic and Glass)
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- Micro-Filter Cages for Mice, Nude Mice and Rats
- In Vitro cell culture Lab
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- S9, microsomes, and hepatocytes
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- Tumor cell-lines for xenografts
- LIMS
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- DEBRA and Watson
- 16.
- QPS Delaware DMPK Facility
- DMPK function with all necessary equipment and self-contained for speed
- Two (2) Autoradiography Labs for Macro- and Micro-autoradiography
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- Leica CM 3600 Cryomacrotome (whole-body)
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- Leica Vibratome 9800 (whole-body)
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- Leica CM 3050 S Cryomicrotome (individual organ/tissue)
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- Molecular Dynamics Typhoon 9410 Imager
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- Six (6) Imaging Research MCID Elite Systems
- Support Equipment:
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- Snap-freezing Equipment
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- Photography Equipment
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- Sample Oxidizers
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- Liquid Scintillation / Gamma Counters
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- Microplate Scintillation Counter
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- Radioactivity / LC Detectors
- 17.
- QPS Delaware DMPK Facility
- DMPK function with all necessary equipment and self-contained for speed
- Dedicated LC/MS/MS
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- Three (3) bioanalytical labs for sample preparation and analysis
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- Six (6) Mass Spec (5 Sciex API 4000s, Finnigan LTQ ProteomeX)
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- Waters UPLCs, Shimadzu VP-series LCs, Agilent 1100 LCs; LEAP HTC/PAL injectors
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- Detectors UV/Vis, Fluorescence, Electrochemical
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- Tomtec Quadra 96 for 96-well sample preparation
- Radio-Quantitation
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- Two (2) Packard Model 307 Sample Oxidizers
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- Two (2) PE Tri-Carb 2800TR/2900TR Scintillation Counters
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- PE TopCount NXT Microplate Scintillation Counter
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- Packard Cobra II Gamma Counter
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- Four (4) Radioactivity Detectors
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- ARC XFlow System; Off-line Fraction Collectors
- 18.
- 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
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- 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
- 19. 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 ?
- 20.
- Toxicology
- helping you navigate your way through the safety of your drug
- 21.
- Brief Global Overview
- QPS-CTPS Taiwan is one of the most experienced toxicology centers in Asia
- Track Record
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- Over 1000 GLP Studies since 1997
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- 17 dossiers compiled for US FDA IND submission
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- 18 dossiers compiled for Taiwan IND submission
- Accreditations & Compliance:
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- AAALAC Accreditation since 2000
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- Taiwan Accreditation Foundation (TAF) ISO 17025
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- Taiwan Department of Health (DOH) GLP
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- OECD (TAF) GLP
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- US FDA GLP compliance
- 22.
- 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
- 23.
- 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
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- Up to 180 days
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- Routes of administration: oral, intravenous (injection and infusion), intramuscular, subcutaneous, intraperitoneal and others
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- Animal species: mice, rats, guinea pigs, hamsters, rabbits, dogs .and cynomolgus monkeys coming soon!
- Reproductive Toxicology
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- Fertility
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- Teratology
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- Animal species: rat and rabbit
- Clinical Pathology
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- Urine Analysis
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- Hematology
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- Serum Chemistry
- Histopathology
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- Tissue and Slide Preparation
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- Tissue Image
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- QA of Scanned Slides, Pathology Consultation and Evaluation by Board-Certified Pathologist
- 24.
- Genetic Toxicology
- QPS-CTPS is able to provide you a broad panel of in-house conducted genotoxicity tests
- Gene Mutation Assays
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- Ames Test
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- HPRT gene mutation assay
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- In Vitro mouse lymphoma assay
- Cytogenetic Assays
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- Sister chromatid exchange assay
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- Chromosome aberration assay
- Micronucleus Assays
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- Micronucleus assay in CHO cells
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- Mouse micronucleus assay
- Cell Transformation Assay
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- In Vitro cell transformation assay
- 25.
- 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
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- Animal species: rabbit
- Intracutaneous Irritation Test
- Skin Sensitization Test
- Cytotoxicity Test
- In Vitro Hemolysis
- Mutagenicity Test
- Implantation Test
- 26.
- 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
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- Eye irritation test
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- Dermal irritation test
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- Animal species: rabbit
- Skin Sensitization Testing
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- Buehler test
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- Maximization test
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- Animal species: guinea pig
- 27. 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 ?
- 28.
- Bioanalytical
- helping you navigate your way through the measurement of your drug
- 29. 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
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- Specialists (>150 technical staff)
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- State-of-the-art equipment (API5500Q, API 5000, UPLC-MS/MS, ICP-MS, MSD, Gyros)
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- Capacity (45 Mass Specs)
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- 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
- 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:
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- Pharmacokinetic (PK) screening
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- Toxicokinetic (TK) studies
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- Clinical PK/Bioavailability studies
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- Bioequivalency studies
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- Therapeutic drug monitoring studies
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- Biomarker studies
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- Drug-drug interaction studies
- Sample Analysis of different compound structures:
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- Oligonucleotides Analysis
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- Peptide Analysis
- Sample Analysis in different biological matrices:
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- Dried Blood Spots
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- 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:
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- Pharmacokinetic (PK) screening
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- Toxicokinetic (TK) studies
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- PK/Bioavailability studies
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- Bioequivalency studies
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- Therapeutic drug monitoring studies
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- Biomarker studies
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- Drug-drug interaction studies
- Immunogenicity monitoring using four-tier approach:
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- Screening
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- Confirmatory (immunodepletion)
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- Titer assessment (quantification)
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- 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
- 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
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- Peptides
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- Proteins
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- 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
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- 27 (25 Sciex API 4000 and 2 Sciex API 5000)
- Large Molecule ImmunoBioanalysis
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- 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!)
- 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
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- 8 Triple Quadrupoles Mass Spec ( API 5500Q, 4000, 3000)
- Large Molecule ImmunoBioanalysis
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- Capability in PK, Immunogenicity, NAb assay, and biomarkers
- Elemental Spectrometry (ICP-MS)
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- ICP-MS, for elemental analysis in pharmacology, toxicology and product testing
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- LC-ICP-MS, for identification and quantification of unknown metabolites from in-vitro and in-vivo drug metabolism studies
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- 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
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- 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:
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- Study design, sample size and statistical power estimation
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- Bioequivalence analysis
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- PK and PK/ PD analysis
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- In Vitro - In Vivo Correlation (with Pharsight IVIVC toolkit software)
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- WinNonlin for PK analysis and SAS for statistical analysis
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- 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
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- 4 Triple Quadrupoles Mass Spec (4 Sciex API 4000)
- Large Molecule ImmunoBioanalysis
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- 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
- decisions
- Biomarkers
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- PD protein or biochemical markers
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- Various biomarker assay platforms (ELISA, Immulite , Bioplex , MSD Imager 6000 ECL, LC-MS/MS, LC-ECD)
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- Cell-based & functional assays
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- Western Blot analysis & quantification
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- Radioligand binding assay
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- On-site cell stimulation and cytokine biomarker panel evaluation
- Pharmacogenomics (PGx)
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- DNA isolation and banking
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- Genotyping (SNPs, insertions, deletions, copy numbers, etc.)
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- CpG methylation quantification
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- RNA isolation & expression profiling (qRT-PCR)
- 41. Global Translational Medicine Services
- Biomarker Menu
- QPS offers laboratory biomarker services for many different therapeutic areas
- 42. 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 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)
- 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
- 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
- 46. 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)
- 47. 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 ?
- 48.
- Early Stage Clinical Development
- 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:
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- First-in-Man Programs (SAD + MAD + FE + CYP450 Interaction) - the Netherlands
-
- Human Mass Balance studies - the Netherlands
-
- Microdosing studies - the Netherlands
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- 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
- 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
- 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
- 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
- Adrenal / Pituitary Disorders
- Hemostasis/Angiogenesis
- Allergy
- Immunology / Autoimmune Disease / Rheumatoid Arthritis
- Alzheimers 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
- 66. 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