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Presentation for: Sponsor MMM DD, 2011
How do we Introduce Ourselves to You? <ul><li>Our Principles </li></ul><ul><li>History </li></ul><ul><li>Brief Company Ove...
<ul><li>‘ What are our core values as a company? We believe in……’ </li></ul><ul><li>Direct Peer-to-Peer Interactions </li>...
History   1994  Bio-Kinetic Clinical Applications (BKCA) founded 1995  QPS (Delaware) founded 1999  Xendo Drug Development...
Brief Corporate Overview <ul><li>‘ QPS offers breadth and depth, plus seamless integrated service from drug discovery to r...
Global Presence ‘ Servicing customers all over the world’
QPS’ Linearly Integrated Core Competencies <ul><li>‘ Have it all done in one place. Save your time. Save your money.  </li...
Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global  DMPK   Services </li></ul><ul><li>Global ...
<ul><li>DMPK </li></ul><ul><li>‘ helping you navigate your way through  </li></ul><ul><li>the biotransformation of your dr...
<ul><li>Brief Global Overview </li></ul><ul><li>‘ DMPK services include the necessary studies for regulatory filing at the...
Global  DMPK Services <ul><li>Brief Global Overview </li></ul><ul><li>‘ QPS staff's experience is our biggest asset’ </li>...
Global  DMPK Services <ul><li>Discovery ADME Studies </li></ul><ul><li>‘ QPS performs cost effective discovery ADME screen...
Global  DMPK Services <ul><li>Candidate Selection Studies </li></ul><ul><li>‘ QPS experienced staff knows how to select yo...
Global  DMPK Services <ul><li>Radiolabeled Studies </li></ul><ul><li>‘ QPS has proven innovative study design and executio...
<ul><li>QPS Delaware DMPK Facility </li></ul><ul><li>‘ DMPK function with all necessary equipment and self-contained for s...
<ul><li>QPS Delaware DMPK Facility </li></ul><ul><li>‘ DMPK function with all necessary equipment and self-contained for s...
<ul><li>QPS Delaware DMPK Facility </li></ul><ul><li>‘ DMPK function with all necessary equipment and self-contained for s...
<ul><li>QPS Delaware DMPK Facility </li></ul><ul><li>‘ DMPK function with all necessary accreditation, certifications, per...
Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global  DMPK   Services </li></ul><ul><li>Global ...
<ul><li>Toxicology </li></ul><ul><li>‘ helping you navigate your way through the safety of your drug’ </li></ul>
<ul><li>Brief Global Overview </li></ul><ul><li>‘ QPS-CTPS Taiwan is one of the most experienced toxicology centers in Asi...
<ul><li>Safety Evaluations </li></ul><ul><li>‘ QPS-CTPS is able to provide you the complete battery of toxicological tests...
<ul><li>General & Reproductive Toxicology </li></ul><ul><li>‘ QPS-CTPS is able to provide you with a comprehensive package...
<ul><li>Genetic Toxicology </li></ul><ul><li>‘ QPS-CTPS is able to provide you a broad panel of in-house conducted genotox...
<ul><li>Biocompatibility Testing </li></ul><ul><li>‘ QPS-CTPS is able to provide you with this high-quality niche service ...
<ul><li>Topical Toxicity Testing </li></ul><ul><li>‘ QPS-CTPS is able to provide you with other high-quality niche service...
Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global  DMPK   Services </li></ul><ul><li>Global ...
<ul><li>Bioanalytical </li></ul><ul><li>‘ helping you navigate your way through the measurement of your drug’ </li></ul>
Global  Bioanalytical Services <ul><li>Brief Global Overview </li></ul><ul><li>‘ QPS is a global leader in bioanalysis for...
Global  Bioanalytical Services <ul><li>Small Molecule LC-MS/MS </li></ul><ul><li>‘ QPS is a global leader in bioanalysis f...
Global  Bioanalytical Services   in max. 10 slides (slide 3) <ul><li>Large Molecule ImmunoBioanalysis </li></ul><ul><li>‘ ...
Global  Bioanalytical Services <ul><li>Elemental Analysis in Biological Matrices </li></ul><ul><li>‘ QPS is a unique provi...
Global  Bioanalytical Services <ul><li>Large Molecule LC-MS/MS </li></ul><ul><li>‘ QPS believes strongly in this novel bio...
Global  Bioanalytical Services <ul><li>QPS Delaware GLP Facility – Newark, Delaware, USA </li></ul><ul><li>‘ QPS Delaware ...
Global  Bioanalytical Services <ul><li>QPS Netherlands GLP Facility – Groningen, the Netherlands </li></ul><ul><li>‘ QPS N...
Global  Bioanalytical Services <ul><li>QPS-Bioserve GLP Facility – Hyderabad, India </li></ul><ul><li>‘ QPS-Bioserve is a ...
Global  Bioanalytical Services <ul><li>QPS Taiwan GLP Facility – Taipei, Taiwan </li></ul><ul><li>‘ QPS-Taiwan is a high q...
Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global  DMPK   Services </li></ul><ul><li>Global ...
<ul><li>Translational Medicine </li></ul><ul><li>‘ helping you navigate your way through the efficacy of your drug’ </li><...
Global  Translational Medicine Services <ul><li>Brief Global Overview </li></ul><ul><li>‘ As an experienced provider of tr...
Global  Translational Medicine Services <ul><li>Biomarker Menu </li></ul><ul><li>‘ QPS offers laboratory biomarker service...
Global  Translational Medicine Services <ul><li>Pharmacogenomics (PGx) </li></ul><ul><li>‘ Genotyping services are offered...
Global  Translational Medicine Services <ul><li>Immunogenicity/Anti-Drug Antibody Testing </li></ul><ul><li>‘ QPS is an ex...
Global  Translational Medicine Services <ul><li>Neutralizing Antibody Assays: </li></ul><ul><li>‘ QPS is an expert in NAb ...
Global  Translational Medicine Services <ul><li>Novel Biomarker Assay Development </li></ul><ul><li>‘ QPS is a frontrunner...
Global  Translational Medicine Service <ul><li>Analytical Platforms </li></ul><ul><li>‘ QPS scientists and laboratory tech...
Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global  DMPK   Services </li></ul><ul><li>Global ...
<ul><li>Early Stage Clinical Development </li></ul><ul><li>‘ helping you navigate your way through the complex challenges ...
Global  Early Stage Clinical Development Services <ul><li>Brief Global Overview </li></ul><ul><li>‘ QPS is a global leader...
Global  Early Stage Clinical Development Services <ul><li>Full-Service Early Stage CRO  </li></ul><ul><li>‘ QPS is a full ...
Global  Early Stage Clinical Development Services <ul><li>Biomarker Support </li></ul><ul><li>‘ QPS is not only capable of...
Global  Early Stage Clinical Development Services <ul><li>QPS-Biokinetic – Springfield, Missouri, USA </li></ul><ul><li>‘ ...
Global  Early Stage Clinical Development Services <ul><li>QPS-Bioserve – Hyderabad, India </li></ul><ul><li>‘ QPS-Bioserve...
Global  Early Stage Clinical Development Services <ul><li>QPS Taiwan – Taipei, Taiwan </li></ul><ul><li>‘ QPS Taiwan is a ...
Global  Early Stage Clinical Development Services <ul><li>QPS Netherlands – Groningen, the Netherlands </li></ul><ul><li>‘...
Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global  DMPK   Services </li></ul><ul><li>Global ...
<ul><li>Late Stage Clinical Development </li></ul><ul><li>‘ helping you navigate your drug all the way across the finish l...
Global  Late Stage Clinical Development Services <ul><li>Brief Global Overview </li></ul><ul><li>‘ Widely recognized for a...
Global  Late Stage Clinical Development Services <ul><li>Program, Project & Study Management </li></ul><ul><li>‘ Apart fro...
Global  Late Stage Clinical Development Services <ul><li>Site Management & Monitoring </li></ul><ul><li>‘ QPS is able to t...
Global  Late Stage Clinical Development Services <ul><li>Data Management </li></ul><ul><li>‘ State-of-the-art clinical tri...
Global  Late Stage Clinical Development Services <ul><li>Biostatistics </li></ul><ul><li>‘ State-of-the-art clinical trial...
Global  Late Stage Clinical Development Services <ul><li>Medical Writing </li></ul><ul><li>‘ QPS can take care of all your...
Global  Late Stage Clinical Development Services <ul><li>Temporary Staffing/Flexible Sourcing Solutions </li></ul><ul><li>...
Global  Late Stage Clinical Development Services <ul><li>Therapeutic Areas </li></ul><ul><li>‘ QPS employees have dealt wi...
Why QPS? <ul><li>What sets us apart? </li></ul><ul><li>‘ QPS will help you navigate your way through the complex challenge...
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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 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.
  • Transcript of "QPS Global Capabilities Presentation"

    1. 1. Presentation for: Sponsor MMM DD, 2011
    2. 2. How do we Introduce Ourselves to You? <ul><li>Our Principles </li></ul><ul><li>History </li></ul><ul><li>Brief Company Overview </li></ul><ul><li>Global Presence </li></ul><ul><li>QPS’ Linearly Integrated Core Competencies </li></ul><ul><li>Providing services in: </li></ul><ul><ul><li>DMPK </li></ul></ul><ul><ul><li>Toxicology </li></ul></ul><ul><ul><li>Bioanalytical </li></ul></ul><ul><ul><li>Translational Medicine </li></ul></ul><ul><ul><li>Early Stage Clinical Development </li></ul></ul><ul><ul><li>Late Stage Clinical Development </li></ul></ul><ul><li>Why QPS? </li></ul>
    3. 3. <ul><li>‘ What are our core values as a company? We believe in……’ </li></ul><ul><li>Direct Peer-to-Peer Interactions </li></ul><ul><li>Customer Focus </li></ul><ul><li>Timeliness / Fast Turnaround </li></ul><ul><li>Cost Effective Sourcing Solutions </li></ul>Our Principles
    4. 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. 5. Brief Corporate Overview <ul><li>‘ QPS offers breadth and depth, plus seamless integrated service from drug discovery to regulatory </li></ul><ul><li>submission within the context of our six core competencies’ </li></ul><ul><li>QPS is a global service provider to the pharmaceutical, biotechnology and generic industries </li></ul><ul><li>Six Core Competencies: </li></ul><ul><ul><li>DMPK (Discovery -> Development) </li></ul></ul><ul><ul><li>Toxicology </li></ul></ul><ul><ul><li>Bioanalysis (Small Molecules -> Biologics) </li></ul></ul><ul><ul><li>Translational Medicine (Genetic -> Protein Biomarkers) </li></ul></ul><ul><ul><li>Early Stage Clinical Development (Phase 0 -> Phase IIa) </li></ul></ul><ul><ul><li>Late Stage Clinical Development (Phase IIb -> Phase IV) </li></ul></ul><ul><li>Strategically located sites (750+ employees) in North America, Europe & Asia: </li></ul><ul><ul><li>QPS Delaware (Newark, DE USA) </li></ul></ul><ul><ul><li>QPS-Biokinetic (Springfield, MO USA) </li></ul></ul><ul><ul><li>QPS Netherlands (Groningen, The Netherlands) </li></ul></ul><ul><ul><li>QPS Taiwan; QPS-CTPS Taiwan; QPS-Qualitix Taiwan (Taipei, Taiwan) </li></ul></ul><ul><ul><li>QPS-Bioserve India (Hyderabad, India) </li></ul></ul>
    6. 6. Global Presence ‘ Servicing customers all over the world’
    7. 7. QPS’ Linearly Integrated Core Competencies <ul><li>‘ Have it all done in one place. Save your time. Save your money. </li></ul><ul><li>Since it is a long way (…navigating your way….) to the bedside’ </li></ul><ul><li>Discovery/Candidate-Selection Stage </li></ul><ul><ul><li>ADME and Tolerability Studies to support Drug Discovery </li></ul></ul><ul><li>Preclinical/Non-clinical Development Stage </li></ul><ul><ul><li>Animal Toxicology studies to support regulatory filing </li></ul></ul><ul><ul><li>Development DMPK studies to support regulatory filing </li></ul></ul><ul><ul><li>Regulated Bioanalysis to support animal toxicology studies </li></ul></ul><ul><ul><li>Immunogenicity for PD and safety assessment </li></ul></ul><ul><ul><li>Biomarkers for animal pharmacology studies </li></ul></ul><ul><ul><li>PK/TK modeling </li></ul></ul><ul><li>Clinical Development Stage </li></ul><ul><ul><li>Phase 1 Healthy Volunteer studies </li></ul></ul><ul><ul><li>Phase 2 to 4 Patient studies </li></ul></ul><ul><ul><li>Development DMPK studies to support NDA filing </li></ul></ul><ul><ul><li>Regulated Bioanalysis to support clinical studies </li></ul></ul><ul><ul><li>Immunogenicity for efficacy and safety monitoring </li></ul></ul><ul><ul><li>PGx for patient stratification and efficacy monitoring </li></ul></ul><ul><ul><li>Biomarkers for efficacy and safety monitoring </li></ul></ul><ul><ul><li>Clinical PK/PD modeling </li></ul></ul>
    8. 8. Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global DMPK Services </li></ul><ul><li>Global Toxicology Services </li></ul><ul><li>Global Bioanalytical Services </li></ul><ul><li>Global Translational Medicine Services </li></ul><ul><li>Global Early Stage Clinical Development Services </li></ul><ul><li>Global Late Stage Clinical Development Services </li></ul><ul><li>Why QPS ? </li></ul>
    9. 9. <ul><li>DMPK </li></ul><ul><li>‘ helping you navigate your way through </li></ul><ul><li>the biotransformation of your drug’ </li></ul>
    10. 10. <ul><li>Brief Global Overview </li></ul><ul><li>‘ DMPK services include the necessary studies for regulatory filing at the appropriate time </li></ul><ul><li>and mechanistic studies when required’ </li></ul><ul><li>Pharmacokinetics </li></ul><ul><ul><li>Single and Multiple Dose, Dose Proportionality, Absolute Bioavailability, PK/TK Modeling </li></ul></ul><ul><ul><li>Mass Balance/Excretion/Radiolabel Studies </li></ul></ul><ul><ul><li>Formulation Optimization, Intestinal Permeability, other Mechanistic studies </li></ul></ul><ul><li>Protein Binding; RBC/Plasma Distribution Partitioning </li></ul><ul><ul><li>Protein Covalent Binding </li></ul></ul><ul><li>Tissue Distribution </li></ul><ul><ul><li>Discovery QWBA </li></ul></ul><ul><ul><li>Quantitative Whole-Body Autoradiography (QWBA) </li></ul></ul><ul><ul><li>Micro-autoradiography (MARG) </li></ul></ul><ul><li>Metabolism </li></ul><ul><ul><li>Metabolic Stability, Species Comparison </li></ul></ul><ul><ul><li>CYP450 Inhibition/Induction </li></ul></ul><ul><ul><li>Metabolic Reaction Pathway Profiling </li></ul></ul><ul><ul><li>Metabolite Profiling & Identification – In Vitro, Preclinical, and Clinical </li></ul></ul>Global DMPK Services
    11. 11. Global DMPK Services <ul><li>Brief Global Overview </li></ul><ul><li>‘ QPS staff's experience is our biggest asset’ </li></ul><ul><li>Team of senior DMPK scientists that all have on average 15+ years of pharmaceutical and biotech drug discovery and development experience. </li></ul><ul><ul><li>All were DMPK representatives on discovery and/or development teams. </li></ul></ul><ul><ul><li>Worked on > 50 INDs and > 10 NDAs. </li></ul></ul><ul><ul><li>Worked in different therapeutic areas (Antiviral, CV, Oncology, Pulmonary_ </li></ul></ul><ul><ul><li>The same group of scientists also has on average additional 9+ years of CRO experience. </li></ul></ul><ul><li>Scientific Integrity and Quality </li></ul><ul><ul><li>Each DMPK management team member has in-depth skill sets in different fields: </li></ul></ul><ul><ul><ul><li>Pharmacokinetics & Protein Binding </li></ul></ul></ul><ul><ul><ul><li>Formulation & Absorption </li></ul></ul></ul><ul><ul><ul><li>QWBA & Micro-autoradiography </li></ul></ul></ul><ul><ul><ul><li>Metabolism </li></ul></ul></ul><ul><ul><ul><li>Metabolite Identification </li></ul></ul></ul><ul><li>Program Development Consulting </li></ul><ul><li>Address routine and mechanistic ADME issues </li></ul><ul><li>ADME Summary for Regulatory Submission </li></ul>
    12. 12. Global DMPK Services <ul><li>Discovery ADME Studies </li></ul><ul><li>‘ QPS performs cost effective discovery ADME screens’ </li></ul><ul><li>Metabolic stability </li></ul><ul><li>CYP inhibition </li></ul><ul><ul><li>“ Validated” process with FDA approved specific probe substrates and chemical inhibitors </li></ul></ul><ul><li>Protein binding </li></ul><ul><ul><li>Equilibrium dialysis using conventional device or RED or HT96 </li></ul></ul><ul><li>Rodent PK – linearly integrated </li></ul><ul><ul><li>Formulation </li></ul></ul><ul><ul><li>In-life – Discrete or “N-in-1” dosing </li></ul></ul><ul><ul><li>Bioanalysis method development & sample analysis </li></ul></ul><ul><ul><ul><li>“ N-in-1” bioanalysis </li></ul></ul></ul><ul><ul><li>PK calculation </li></ul></ul><ul><ul><li>Average turnaround time < 7.5 days from compound receipt to reporting of data </li></ul></ul>
    13. 13. Global DMPK Services <ul><li>Candidate Selection Studies </li></ul><ul><li>‘ QPS experienced staff knows how to select your best IND candidates’ </li></ul><ul><li>Pharmacokinetics </li></ul><ul><ul><li>Formulation, dose proportionality </li></ul></ul><ul><ul><li>Intestinal permeability </li></ul></ul><ul><ul><li>Other mechanistic studies for absorption and disposition (or clearance) </li></ul></ul><ul><li>Metabolism </li></ul><ul><ul><li>Species comparison </li></ul></ul><ul><ul><li>Metabolite profiling and/or identification </li></ul></ul><ul><ul><li>Pilot CYP mapping </li></ul></ul><ul><li>Excretion </li></ul><ul><ul><li>Route of elimination – BDC studies </li></ul></ul>
    14. 14. Global DMPK Services <ul><li>Radiolabeled Studies </li></ul><ul><li>‘ QPS has proven innovative study design and executional excellence for radiolabeled studies’ </li></ul><ul><li>Combination Mass Balance /Excretion QWBA study to address MB, tissue distribution, and human radiation dosimetry questions </li></ul><ul><ul><li>Better technical oversight </li></ul></ul><ul><ul><li>Eliminate the possibility of radiolabel degrading over an extended period of time between the two studies and the requirement of re-purification </li></ul></ul><ul><ul><li>Increase efficiency using a single study protocol = ↓Study Cost </li></ul></ul><ul><li>Metabolite Profiling and Identification in the same study </li></ul><ul><ul><li>Both ion trap and quadrupoles tandem mass spectrometers for different MSn experiments </li></ul></ul>Average Recovery 93.8%
    15. 15. <ul><li>QPS Delaware DMPK Facility </li></ul><ul><li>‘ DMPK function with all necessary equipment and self-contained for speed’ </li></ul><ul><li>Vivarium – focus on mouse and rat with nine (9) rodent rooms </li></ul><ul><ul><li>1 Surgical Suite </li></ul></ul><ul><ul><li>Triple cannulated animals for special models & in situ CSF </li></ul></ul><ul><ul><li>Intracranial infusions for up to 7 days </li></ul></ul><ul><li>Eight (8) bioanalytical labs for dose formulation, sample preparation, and analysis </li></ul><ul><li>Mass Balance Studies </li></ul><ul><ul><li>Mass Balance Cages (Plastic and Glass) </li></ul></ul><ul><ul><li>Micro-Filter Cages for Mice, Nude Mice and Rats </li></ul></ul><ul><li>In Vitro cell culture Lab </li></ul><ul><ul><li>S9, microsomes, and hepatocytes </li></ul></ul><ul><ul><li>Tumor cell-lines for xenografts </li></ul></ul><ul><li>LIMS </li></ul><ul><ul><li>DEBRA and Watson </li></ul></ul>Global DMPK Services
    16. 16. <ul><li>QPS Delaware DMPK Facility </li></ul><ul><li>‘ DMPK function with all necessary equipment and self-contained for speed’ </li></ul><ul><li>Two (2) Autoradiography Labs for Macro- and Micro-autoradiography </li></ul><ul><ul><li>Leica CM 3600 Cryomacrotome (whole-body) </li></ul></ul><ul><ul><li>Leica Vibratome 9800 (whole-body) </li></ul></ul><ul><ul><li>Leica CM 3050 S Cryomicrotome (individual organ/tissue) </li></ul></ul><ul><ul><li>Molecular Dynamics Typhoon 9410 Imager </li></ul></ul><ul><ul><li>Six (6) Imaging Research MCID Elite Systems </li></ul></ul><ul><li>Support Equipment: </li></ul><ul><ul><li>Snap-freezing Equipment </li></ul></ul><ul><ul><li>Photography Equipment </li></ul></ul><ul><ul><li>Sample Oxidizers </li></ul></ul><ul><ul><li>Liquid Scintillation / Gamma Counters </li></ul></ul><ul><ul><li>Microplate Scintillation Counter </li></ul></ul><ul><ul><li>Radioactivity / LC Detectors </li></ul></ul>Global DMPK Services
    17. 17. <ul><li>QPS Delaware DMPK Facility </li></ul><ul><li>‘ DMPK function with all necessary equipment and self-contained for speed’ </li></ul><ul><li>Dedicated LC/MS/MS </li></ul><ul><ul><li>Three (3) bioanalytical labs for sample preparation and analysis </li></ul></ul><ul><ul><li>Six (6) Mass Spec (5 Sciex API 4000s, Finnigan LTQ ProteomeX) </li></ul></ul><ul><ul><ul><li>Waters UPLCs, Shimadzu VP-series LCs, Agilent 1100 LCs; LEAP HTC/PAL injectors </li></ul></ul></ul><ul><ul><li>Detectors – UV/Vis, Fluorescence, Electrochemical </li></ul></ul><ul><ul><li>Tomtec Quadra 96 for 96-well sample preparation </li></ul></ul><ul><li>Radio-Quantitation </li></ul><ul><ul><li>Two (2) Packard Model 307 Sample Oxidizers </li></ul></ul><ul><ul><li>Two (2) PE Tri-Carb 2800TR/2900TR Scintillation Counters </li></ul></ul><ul><ul><li>PE TopCount ® NXT  Microplate Scintillation Counter </li></ul></ul><ul><ul><li>Packard Cobra II Gamma Counter </li></ul></ul><ul><ul><li>Four (4) Radioactivity Detectors </li></ul></ul><ul><ul><li>ARC XFlow  System; Off-line Fraction Collectors </li></ul></ul>Global DMPK Services
    18. 18. <ul><li>QPS Delaware DMPK Facility </li></ul><ul><li>‘ DMPK function with all necessary accreditation, certifications, permits, and licenses’ </li></ul><ul><li>AAALAC Accreditation </li></ul><ul><li>ABC License </li></ul><ul><li>CDC Permit </li></ul><ul><li>CLIA Certification </li></ul><ul><li>DEA Permit for Scheduled Control Substances (I-V) </li></ul><ul><li>Federal Fish & Wildlife Permit </li></ul><ul><li>NRC License for Radiochemicals </li></ul><ul><ul><li>3 H, 14 C, 32 P, 33 P, 35 S, 45 Ca, 51 Cr, 90 Y, 99m Tc, 111 In, 125 I, 188 Re </li></ul></ul><ul><li>OLAW Assurance </li></ul><ul><li>ORCA Certification </li></ul><ul><li>USDA Permit </li></ul>Global DMPK Services
    19. 19. Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global DMPK Services </li></ul><ul><li>Global Toxicology Services </li></ul><ul><li>Global Bioanalytical Services </li></ul><ul><li>Global Translational Medicine Services </li></ul><ul><li>Global Early Stage Clinical Development Services </li></ul><ul><li>Global Late Stage Clinical Development Services </li></ul><ul><li>Why QPS ? </li></ul>
    20. 20. <ul><li>Toxicology </li></ul><ul><li>‘ helping you navigate your way through the safety of your drug’ </li></ul>
    21. 21. <ul><li>Brief Global Overview </li></ul><ul><li>‘ QPS-CTPS Taiwan is one of the most experienced toxicology centers in Asia’ </li></ul><ul><li>Track Record </li></ul><ul><ul><li>Over 1000 GLP Studies since 1997 </li></ul></ul><ul><ul><li>17 dossiers compiled for US FDA IND submission </li></ul></ul><ul><ul><li>18 dossiers compiled for Taiwan IND submission </li></ul></ul><ul><li>Accreditations & Compliance: </li></ul><ul><ul><li>AAALAC Accreditation since 2000 </li></ul></ul><ul><ul><li>Taiwan Accreditation Foundation (TAF) ISO 17025 </li></ul></ul><ul><ul><li>Taiwan Department of Health (DOH) GLP </li></ul></ul><ul><ul><li>OECD (TAF) GLP </li></ul></ul><ul><ul><li>US FDA GLP compliance </li></ul></ul>Global Toxicology Services
    22. 22. <ul><li>Safety Evaluations </li></ul><ul><li>‘ QPS-CTPS is able to provide you the complete battery of toxicological tests that is needed for </li></ul><ul><li>the filing of your IND submission’ </li></ul><ul><li>General & Reproductive Toxicology </li></ul><ul><li>Genetic Toxicology </li></ul><ul><li>Biocompatibility Testing </li></ul><ul><li>Topical Toxicity Testing </li></ul><ul><li>General (non-GLP) Toxicity Testing </li></ul>Global Toxicology Services
    23. 23. <ul><li>General & Reproductive Toxicology </li></ul><ul><li>‘ QPS-CTPS is able to provide you with a comprehensive package of in vivo toxicology studies’ </li></ul><ul><li>Single Dose Toxicity Studies </li></ul><ul><li>Repeated Dose Toxicity Studies </li></ul><ul><ul><li>Up to 180 days </li></ul></ul><ul><ul><li>Routes of administration: oral, intravenous (injection and infusion), intramuscular, subcutaneous, intraperitoneal and others </li></ul></ul><ul><ul><li>Animal species: mice, rats, guinea pigs, hamsters, rabbits, dogs ……….and cynomolgus monkeys coming soon! </li></ul></ul><ul><li>Reproductive Toxicology </li></ul><ul><ul><li>Fertility </li></ul></ul><ul><ul><li>Teratology </li></ul></ul><ul><ul><li>Animal species: rat and rabbit </li></ul></ul><ul><li>Clinical Pathology </li></ul><ul><ul><li>Urine Analysis </li></ul></ul><ul><ul><li>Hematology </li></ul></ul><ul><ul><li>Serum Chemistry </li></ul></ul><ul><li>Histopathology </li></ul><ul><ul><li>Tissue and Slide Preparation </li></ul></ul><ul><ul><li>Tissue Image </li></ul></ul><ul><ul><li>QA of Scanned Slides, Pathology Consultation and Evaluation by Board-Certified Pathologist </li></ul></ul>Global Toxicology Services
    24. 24. <ul><li>Genetic Toxicology </li></ul><ul><li>‘ QPS-CTPS is able to provide you a broad panel of in-house conducted genotoxicity tests </li></ul><ul><li>Gene Mutation Assays </li></ul><ul><ul><li>Ames Test </li></ul></ul><ul><ul><li>HPRT gene mutation assay </li></ul></ul><ul><ul><li>In Vitro mouse lymphoma assay </li></ul></ul><ul><li>Cytogenetic Assays </li></ul><ul><ul><li>Sister chromatid exchange assay </li></ul></ul><ul><ul><li>Chromosome aberration assay </li></ul></ul><ul><li>Micronucleus Assays </li></ul><ul><ul><li>Micronucleus assay in CHO cells </li></ul></ul><ul><ul><li>Mouse micronucleus assay </li></ul></ul><ul><li>Cell Transformation Assay </li></ul><ul><ul><li>In Vitro cell transformation assay </li></ul></ul>Global Toxicology Services
    25. 25. <ul><li>Biocompatibility Testing </li></ul><ul><li>‘ QPS-CTPS is able to provide you with this high-quality niche service which primarily involves </li></ul><ul><li>the toxicity testing of medical devices’ </li></ul><ul><li>Acute Systemic Toxicity Test </li></ul><ul><li>Pyrogen and LAL Test </li></ul><ul><ul><li>Animal species: rabbit </li></ul></ul><ul><li>Intracutaneous Irritation Test </li></ul><ul><li>Skin Sensitization Test </li></ul><ul><li>Cytotoxicity Test </li></ul><ul><li>In Vitro Hemolysis </li></ul><ul><li>Mutagenicity Test </li></ul><ul><li>Implantation Test </li></ul>Global Toxicology Services
    26. 26. <ul><li>Topical Toxicity Testing </li></ul><ul><li>‘ QPS-CTPS is able to provide you with other high-quality niche services which primarily </li></ul><ul><li>involves the toxicity testing of dermatological and cosmetic products’ </li></ul><ul><li>Irritation Studies </li></ul><ul><ul><li>Eye irritation test </li></ul></ul><ul><ul><li>Dermal irritation test </li></ul></ul><ul><ul><li>Animal species: rabbit </li></ul></ul><ul><li>Skin Sensitization Testing </li></ul><ul><ul><li>Buehler test </li></ul></ul><ul><ul><li>Maximization test </li></ul></ul><ul><ul><li>Animal species: guinea pig </li></ul></ul>Global Toxicology Services
    27. 27. Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global DMPK Services </li></ul><ul><li>Global Toxicology Services </li></ul><ul><li>Global Bioanalytical Services </li></ul><ul><li>Global Translational Medicine Services </li></ul><ul><li>Global Early Stage Clinical Development Services </li></ul><ul><li>Global Late Stage Clinical Development Services </li></ul><ul><li>Why QPS ? </li></ul>
    28. 28. <ul><li>Bioanalytical </li></ul><ul><li>‘ helping you navigate your way through the measurement of your drug’ </li></ul>
    29. 29. Global Bioanalytical Services <ul><li>Brief Global Overview </li></ul><ul><li>‘ QPS is a global leader in bioanalysis for both small and large molecules’ </li></ul><ul><li>Small molecules – using mass spectrometric techniques </li></ul><ul><li>Large Molecules - using ligand binding assay techniques </li></ul><ul><li>Global coverage of bioanalytical services with local presence in North America, Europe, and Asia </li></ul><ul><li>World leading… </li></ul><ul><ul><li>Specialists (>150 technical staff) </li></ul></ul><ul><ul><li>State-of-the-art equipment (API5500Q, API 5000, UPLC-MS/MS, ICP-MS, MSD, Gyros™) </li></ul></ul><ul><ul><li>Capacity (45 Mass Specs) </li></ul></ul><ul><ul><li>Capabilities: LC-MS/MS, ICP-MS, LC-UV, LC-Flu, LC-ECD, LC-RFD, LBA, Hybridization-ELISA </li></ul></ul><ul><li>Extensive validated assay list (> 750 assays and growing) </li></ul><ul><li>Rapid assay development, validation, sample analysis </li></ul><ul><li>Supporting a full range of development from Preclinical to Late Stage Clinical programs </li></ul><ul><li>Immunogenicity & Neutralizing Antibody Activity Assessment </li></ul><ul><li>Central Lab Services: Sample Logistics / Sample Repository / Preparation and Distribution of Sampling Kits </li></ul>
    30. 30. Global Bioanalytical Services <ul><li>Small Molecule LC-MS/MS </li></ul><ul><li>‘ QPS is a global leader in bioanalysis for small molecules and is able to analyze samples coming from </li></ul><ul><li>different types of studies, containing a wide variety of compound structures and biological matrices’ </li></ul><ul><li>Bioanalytical Method Development & Validation </li></ul><ul><li>Sample Analysis for different evaluation purposes: </li></ul><ul><ul><li>Pharmacokinetic (PK) screening </li></ul></ul><ul><ul><li>Toxicokinetic (TK) studies </li></ul></ul><ul><ul><li>Clinical PK/Bioavailability studies </li></ul></ul><ul><ul><li>Bioequivalency studies </li></ul></ul><ul><ul><li>Therapeutic drug monitoring studies </li></ul></ul><ul><ul><li>Biomarker studies </li></ul></ul><ul><ul><li>Drug-drug interaction studies </li></ul></ul><ul><li>Sample Analysis of different compound structures: </li></ul><ul><ul><li>Oligonucleotides Analysis </li></ul></ul><ul><ul><li>Peptide Analysis </li></ul></ul><ul><li>Sample Analysis in different biological matrices: </li></ul><ul><ul><li>Dried Blood Spots </li></ul></ul><ul><ul><li>Tissues </li></ul></ul>
    31. 31. Global Bioanalytical Services in max. 10 slides (slide 3) <ul><li>Large Molecule ImmunoBioanalysis </li></ul><ul><li>‘ QPS is a global leader in bioanalysis for large molecules and is able to analyze samples coming from </li></ul><ul><li>different types of studies, containing a wide variety of compound structures and biological matrices’ </li></ul><ul><li>Bioanalytical Method Development & Validation </li></ul><ul><li>Sample Analysis for different evaluation purposes: </li></ul><ul><ul><li>Pharmacokinetic (PK) screening </li></ul></ul><ul><ul><li>Toxicokinetic (TK) studies </li></ul></ul><ul><ul><li>PK/Bioavailability studies </li></ul></ul><ul><ul><li>Bioequivalency studies </li></ul></ul><ul><ul><li>Therapeutic drug monitoring studies </li></ul></ul><ul><ul><li>Biomarker studies </li></ul></ul><ul><ul><li>Drug-drug interaction studies </li></ul></ul><ul><li>Immunogenicity monitoring using four-tier approach: </li></ul><ul><ul><li>Screening </li></ul></ul><ul><ul><li>Confirmatory (immunodepletion) </li></ul></ul><ul><ul><li>Titer assessment (quantification) </li></ul></ul><ul><ul><li>Cell-based neutralizing antibody detection </li></ul></ul>
    32. 32. Global Bioanalytical Services <ul><li>Elemental Analysis in Biological Matrices </li></ul><ul><li>‘ QPS is a unique provider of GLP trace and ultratrace elemental analysis by ICP-MS, a detection </li></ul><ul><li>technique which is increasingly being applied for studying the pharmacokinetics, metabolism </li></ul><ul><li>and pharmacodynamics of metal-containing and non-metal-containing analytes in </li></ul><ul><li>preclinical and clinical studies’ </li></ul><ul><li>Bioanalytical applications that have been developed using ICP-MS at QPS include but are not </li></ul><ul><li>limited to: </li></ul><ul><li>Platinum (Pt) in plasma and urine by ICP-MS for supporting clinical studies with platinum-based chemotherapies </li></ul><ul><li>Platinum (Pt) in plasma and urine by LC-ICP-MS for the metabolite profiling of a new investigational platinum compound </li></ul><ul><li>Gadolinium (Gd) in plasma and urine by ICP-MS for supporting clinical studies with MRI contrast agents and formulations </li></ul><ul><li>Magnesium (Mg), Calcium (Ca), and Phosphate (P) in food and feces for supporting a mass balance study of a new phosphate binder </li></ul>Transferrin Vitamin B12
    33. 33. Global Bioanalytical Services <ul><li>Large Molecule LC-MS/MS </li></ul><ul><li>‘ QPS believes strongly in this novel bioanalytical application of LC-MS/MS and can show you some </li></ul><ul><li>stunning results’ </li></ul><ul><li>Bioanalytical Method Development and Validation, and Sample Analysis </li></ul><ul><ul><li>Oligonucleotides </li></ul></ul><ul><ul><li>Peptides </li></ul></ul><ul><ul><li>Proteins </li></ul></ul><ul><ul><li>Monoclonal Antibodies </li></ul></ul>
    34. 34. Global Bioanalytical Services <ul><li>QPS Delaware GLP Facility – Newark, Delaware, USA </li></ul><ul><li>‘ QPS Delaware is a well-established high quality, cost-effective sourcing solution for the </li></ul><ul><li>analysis of PK and PD samples coming from preclinical and clinical studies conducted in </li></ul><ul><li>the USA’ </li></ul><ul><li>Small Molecule LC/MS/MS </li></ul><ul><ul><li>27 (25 Sciex API 4000 and 2 Sciex API 5000) </li></ul></ul><ul><li>Large Molecule ImmunoBioanalysis </li></ul><ul><ul><li>Capability in PK, Immunogenicity, NAb assay, and biomarkers </li></ul></ul><ul><li>Hundreds of validated methods (DDI CoMeds) available Complete list available on website http://www.qps-usa.com/ </li></ul><ul><li>WATSON LIMS System v 6.4 (WATSON v7.4.1 Coming Soon!) </li></ul>Gyrolab ™ Automated Immunoassay Workstation
    35. 35. Global Bioanalytical Services <ul><li>QPS Netherlands GLP Facility – Groningen, the Netherlands </li></ul><ul><li>‘ QPS Netherlands is a well established high quality, cost-effective sourcing solution for the </li></ul><ul><li>analysis of PK and PD samples coming from preclinical and clinical studies conducted in </li></ul><ul><li>Europe’ </li></ul><ul><li>Small Molecule LC/MS/MS </li></ul><ul><ul><li>8 Triple Quadrupoles Mass Spec ( API 5500Q, 4000, 3000) </li></ul></ul><ul><li>Large Molecule ImmunoBioanalysis </li></ul><ul><ul><li>Capability in PK, Immunogenicity, NAb assay, and biomarkers </li></ul></ul><ul><li>Elemental Spectrometry (ICP-MS) </li></ul><ul><ul><li>ICP-MS, for elemental analysis in pharmacology, toxicology and product testing </li></ul></ul><ul><ul><li>LC-ICP-MS, for identification and quantification of unknown metabolites from in-vitro and in-vivo drug metabolism studies </li></ul></ul><ul><ul><li>Many oncology (platinum) applications </li></ul></ul><ul><li>Hundreds of validated assay methods (DDI CoMeds) available Complete list available on website http://www.qps-usa.com/ </li></ul><ul><li>LabVantage™ Sapphire LIMS System </li></ul><ul><li>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 </li></ul>
    36. 36. Global Bioanalytical Services <ul><li>QPS-Bioserve GLP Facility – Hyderabad, India </li></ul><ul><li>‘ QPS-Bioserve is a high quality, cost-effective sourcing solution for the analysis of </li></ul><ul><li>PK samples coming from bioequivalence studies conducted by QPS-Bioserve’s own phase I </li></ul><ul><li>Unit and from clinical studies performed in India’ </li></ul><ul><li>Small Molecule LC/MS/MS </li></ul><ul><ul><li>7 Triple Quadrupoles Mass Spec (2 Sciex API 3200 and 5 Sciex API 4000) </li></ul></ul><ul><li>Hundreds of generic methods available Complete list available on website http://www.qps-usa.com/ </li></ul><ul><li>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: </li></ul><ul><ul><li>Study design, sample size and statistical power estimation </li></ul></ul><ul><ul><li>Bioequivalence analysis </li></ul></ul><ul><ul><li>PK and PK/ PD analysis </li></ul></ul><ul><ul><li>In Vitro - In Vivo Correlation (with Pharsight™ IVIVC toolkit software) </li></ul></ul><ul><ul><li>WinNonlin™ for PK analysis and SAS for statistical analysis </li></ul></ul><ul><ul><li>Final Report submissions in E3/ CTD format </li></ul></ul>
    37. 37. Global Bioanalytical Services <ul><li>QPS Taiwan GLP Facility – Taipei, Taiwan </li></ul><ul><li>‘ QPS-Taiwan is a high quality, cost-effective sourcing solution for the analysis of </li></ul><ul><li>PK samples coming from bioequivalence studies conducted by QPS-Bioserve’s own Phase I </li></ul><ul><li>Unit and from clinical studies performed in Asia’ </li></ul><ul><li>Small Molecule LC/MS/MS </li></ul><ul><ul><li>4 Triple Quadrupoles Mass Spec (4 Sciex API 4000) </li></ul></ul><ul><li>Large Molecule ImmunoBioanalysis </li></ul><ul><ul><li>Capability in PK, Immunogenicity, Nab assay, and biomarkers </li></ul></ul><ul><li>Hundreds of generic methods available Complete list available on website http://www.qps-usa.com/ </li></ul><ul><li>WATSON LIMS System v 6.4 (WATSON v7.4.1 Coming Soon!) </li></ul>
    38. 38. Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global DMPK Services </li></ul><ul><li>Global Toxicology Services </li></ul><ul><li>Global Bioanalytical Services </li></ul><ul><li>Global Translational Medicine Services </li></ul><ul><li>Global Early Stage Clinical Development Services </li></ul><ul><li>Global Late Stage Clinical Development Services </li></ul><ul><li>Why QPS ? </li></ul>
    39. 39. <ul><li>Translational Medicine </li></ul><ul><li>‘ helping you navigate your way through the efficacy of your drug’ </li></ul>
    40. 40. Global Translational Medicine Services <ul><li>Brief Global Overview </li></ul><ul><li>‘ As an experienced provider of translational medicine services, QPS offers </li></ul><ul><li>solutions to help guide drug development teams at various stages, including patient </li></ul><ul><li>stratification, toxicity prediction, evaluation of PK profiles, dose determination, and treatment </li></ul><ul><li>decisions’ </li></ul><ul><li>Biomarkers </li></ul><ul><ul><li>PD protein or biochemical markers </li></ul></ul><ul><ul><li>Various biomarker assay platforms (ELISA, Immulite ® , Bioplex ® , MSD ® Imager 6000 ECL, LC-MS/MS, LC-ECD) </li></ul></ul><ul><ul><li>Cell-based & functional assays </li></ul></ul><ul><ul><li>Western Blot analysis & quantification </li></ul></ul><ul><ul><li>Radioligand binding assay </li></ul></ul><ul><ul><li>On-site cell stimulation and cytokine biomarker panel evaluation </li></ul></ul><ul><li>Pharmacogenomics (PGx) </li></ul><ul><ul><li>DNA isolation and banking </li></ul></ul><ul><ul><li>Genotyping (SNPs, insertions, deletions, copy numbers, etc.) </li></ul></ul><ul><ul><li>CpG methylation quantification </li></ul></ul><ul><ul><li>RNA isolation & expression profiling (qRT-PCR) </li></ul></ul>
    41. 41. Global Translational Medicine Services <ul><li>Biomarker Menu </li></ul><ul><li>‘ QPS offers laboratory biomarker services for many different therapeutic areas’ </li></ul>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
    42. 42. Global Translational Medicine Services <ul><li>Pharmacogenomics (PGx) </li></ul><ul><li>‘ Genotyping services are offered by QPS offers to help ‘individualize’ disease therapies’ </li></ul><ul><li>Nucleic Acids Isolation (DNA & RNA) and Banking </li></ul><ul><li>Genotyping (SNPs, Insertions, Deletions, Copy numbers, etc.) </li></ul><ul><li>CYP450 Genotyping Assays (CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C19, CYP2D6 genotyping panels) </li></ul><ul><li>Genotyping Assays for Other Drug Metabolizing Enzymes (NAT1, NAT2, UGT1A1, CDA) </li></ul><ul><li>Genotying Assays for Transporters (ABCG2, SLCO1B1) </li></ul><ul><li>Genotyping Assays for Oncology (BRAF, KRAS, PIK3CA) </li></ul><ul><li>Genotyping Assays for Alzheimer’s Disease (ApoE, PPP3R1) </li></ul><ul><li>Genotyping Assays for Warfarin Therapy (CYP2C9*2, CYP2C9*3, and VKORC1 (-1639 G>A)) </li></ul><ul><li>CpG Methylation Quant </li></ul><ul><li>Gene Expression Profiling in various matrices (qRT-PCR) </li></ul>Pyrosequencing
    43. 43. Global Translational Medicine Services <ul><li>Immunogenicity/Anti-Drug Antibody Testing </li></ul><ul><li>‘ QPS is an expert in immunogenicity/ADA testing and has all the necessary knowledge and </li></ul><ul><li>assays technologies at its disposal’ </li></ul><ul><li>QPS has supported 15 biologic drug development programs for 10 sponsors (11 proteins and 4 therapeutic antibodies) for which over 50 studies were performed. </li></ul><ul><li>Anti-Drug-Antibodies (Screening, Confirmation, and Titering) </li></ul><ul><li>Antibody Generation </li></ul><ul><li>Critical Reagent Labeling </li></ul><ul><li>Cell Based Neutralizing Antibody (NAb) Assays </li></ul><ul><li>Cell Banking and Maintenance </li></ul><ul><li>Technology Transfer </li></ul><ul><li>Custom Method Development and Optimization </li></ul>Meso Scale Discovery
    44. 44. Global Translational Medicine Services <ul><li>Neutralizing Antibody Assays: </li></ul><ul><li>‘ QPS is an expert in NAb testing and is able to apply its extensive knowledge and application of </li></ul><ul><li>new assay technologies to your benefit’ </li></ul><ul><li>Since 2002 > 40 Studies conducted for 7 Sponsors </li></ul><ul><li>ELISA </li></ul><ul><li>Cell-Based Functional Assays, e.g. cell viability assay </li></ul><ul><li>Other Functional Assays, e.g. activity assay </li></ul><ul><li>Receptor Binding Assays </li></ul>
    45. 45. Global Translational Medicine Services <ul><li>Novel Biomarker Assay Development </li></ul><ul><li>‘ QPS is a frontrunner in adopting new assay technologies for biomarkers’ </li></ul><ul><li>Various Technology Platforms (ELISA, BioPlex™, Immulite™, MSD ECL, Gyrolab™) </li></ul><ul><li>Cell Based Assays </li></ul><ul><li>Multiplexing Genetic Markers (CYP450 TaqMan or Affymetrix DMET genechips) </li></ul><ul><li>Pharmacodynamic (PD) Assays </li></ul><ul><li>On-Site Cell Stimulation and Biomarker Analysis </li></ul><ul><li>Fit-For-Purpose Biomarker Assay Development and Validation (various matrices) </li></ul><ul><li>Protocol Design </li></ul>Luminex™
    46. 46. Global Translational Medicine Service <ul><li>Analytical Platforms </li></ul><ul><li>‘ QPS scientists and laboratory technicians are used to work and have many validated assays on </li></ul><ul><li>many different assay technology platforms’ </li></ul><ul><li>ELISA </li></ul><ul><li>Pyrosequencing Technology Platform </li></ul><ul><li>Roche Modular P® </li></ul><ul><li>Affymetrix GeneChip Microarray System </li></ul><ul><li>Siemens Immulite® </li></ul><ul><li>TaqMan Real-Time PCR System </li></ul><ul><li>Bioplex® </li></ul><ul><li>Gradient Gel Electrophoresis (GGE) </li></ul><ul><li>Luminex™ </li></ul><ul><li>HPLC/UHPLC/UV/Fluorescence/ECD </li></ul><ul><li>Meso Scale Discovery (MSD®) ECL Platform (SECTOR™ PR100 and Imager 6000) </li></ul><ul><li>LC – MS/MS </li></ul><ul><li>Gyrolab™ </li></ul><ul><li>Ultracentrifugation </li></ul><ul><li>RIA </li></ul><ul><li>Western Blot Analysis </li></ul><ul><li>Radioligand Binding Assay (SPA) </li></ul>
    47. 47. Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global DMPK Services </li></ul><ul><li>Global Toxicology Services </li></ul><ul><li>Global Bioanalytical Services </li></ul><ul><li>Global Translational Medicine Services </li></ul><ul><li>Global Early Stage Clinical Development Services </li></ul><ul><li>Global Late Stage Clinical Development Services </li></ul><ul><li>Why QPS ? </li></ul>
    48. 48. <ul><li>Early Stage Clinical Development </li></ul><ul><li>‘ helping you navigate your way through the complex challenges of the early development of your drug’ </li></ul>
    49. 49. Global Early Stage Clinical Development Services <ul><li>Brief Global Overview </li></ul><ul><li>‘ QPS is a global leader in Phase 1 studies’ </li></ul><ul><li>QPS has one of the world’s largest Phase 1 site offerings with 400 Phase I beds on three continents: </li></ul><ul><ul><li>240 in the USA </li></ul></ul><ul><ul><li>92 in India </li></ul></ul><ul><ul><li>40 in Taiwan </li></ul></ul><ul><ul><li>24 in the Netherlands </li></ul></ul><ul><li>QPS offers a broad spectrum of early phase study types: </li></ul><ul><ul><li>First-in-Man Programs (SAD + MAD + FE + CYP450 Interaction) - the Netherlands </li></ul></ul><ul><ul><li>Human Mass Balance studies - the Netherlands </li></ul></ul><ul><ul><li>Microdosing studies - the Netherlands </li></ul></ul><ul><ul><li>Clinical PK/PD studies - the Netherlands, Taiwan, India and USA </li></ul></ul><ul><ul><li>Imaging (PET, fMRI) studies - the Netherlands </li></ul></ul><ul><ul><li>Bioavailability/ANDA studies - Taiwan, India and USA </li></ul></ul><ul><ul><li>Bioequivalence/ANDA studies - Taiwan, India and USA </li></ul></ul><ul><ul><li>Vaccine studies - Taiwan, India and USA </li></ul></ul><ul><ul><li>Cardiac Safety/Thorough QT/QTc studies - USA </li></ul></ul><ul><ul><li>Drug-Drug Interaction studies - the Netherlands, Taiwan, India and USA </li></ul></ul>
    50. 50. Global Early Stage Clinical Development Services <ul><li>Full-Service Early Stage CRO </li></ul><ul><li>‘ QPS is a full service early stage CRO that is not only capable of providing the clinical conduct of </li></ul><ul><li>your Phase 1 study but has the ability to provide the front and back end services as well’ </li></ul><ul><li>Review of Preclinical Data </li></ul><ul><li>Design and Preparation of the Trial </li></ul><ul><li>Clinical Project Management </li></ul><ul><li>Preparation of the Study Protocol, Informed Consent, and Case Report Forms </li></ul><ul><li>Clinical Conduct </li></ul><ul><li>Clinical Data Management </li></ul><ul><li>Biostatistics </li></ul><ul><li>Bioanalysis/Biomarker Assays </li></ul><ul><li>Conduct PK/PD and/or Pop PK/PD Data Analysis and Modeling </li></ul><ul><li>Prepare PK/PD Report </li></ul><ul><li>Prepare and publish Fully Integrated Clinical Study Reports </li></ul><ul><li>Monitoring </li></ul><ul><li>Pharmacovigilance </li></ul>
    51. 51. Global Early Stage Clinical Development Services <ul><li>Biomarker Support </li></ul><ul><li>‘ QPS is not only capable of conducting phase 1 studies for you in specialty and patient </li></ul><ul><li>populations but QPS is capable of doing the additional measurement and interpretation of </li></ul><ul><li>therapeutic-specific biomarker data as well’ </li></ul>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
    52. 52. Global Early Stage Clinical Development Services <ul><li>QPS-Biokinetic – Springfield, Missouri, USA </li></ul><ul><li>‘ QPS-Biokinetic is ideally suited to conduct a wide variety of phase I studies, especially when </li></ul><ul><li>substantial numbers of volunteers need to be recruited in record breaking time’ </li></ul><ul><li>5 Clinical Units on one Campus </li></ul><ul><li>Over 900 studies completed since 1994 </li></ul><ul><li>15 FDA audits </li></ul><ul><li>Clinical Staff Experience </li></ul><ul><ul><li>8+ years average length of employment </li></ul></ul><ul><ul><li>Less than 3% staff turnover rate </li></ul></ul><ul><li>Over 20,000 active subjects database </li></ul><ul><li>Specialty Studies </li></ul><ul><ul><li>Vaccine </li></ul></ul><ul><ul><li>Cardiac Safety/TQTc </li></ul></ul><ul><ul><li>Postmenopausal </li></ul></ul><ul><ul><li>Elderly </li></ul></ul><ul><ul><li>Birth Control and Birth Control Naïve </li></ul></ul>
    53. 53. Global Early Stage Clinical Development Services <ul><li>QPS-Bioserve – Hyderabad, India </li></ul><ul><li>‘ QPS-Bioserve is a full service Phase I CRO with a long list of regulatory approvals for generic </li></ul><ul><li>products that have been tested at this site’ </li></ul><ul><li>Full-service CRO, all aspects of study (from study design to final report generation) are conducted in-house </li></ul><ul><li>ISO 9001:2008 certified organization </li></ul><ul><li>Approved by the Drugs Controller General of India (DCGI) </li></ul><ul><li>Audited by the US-FDA in March 2008 & July 2009 (no 483s) </li></ul><ul><li>Inspected by UK MHRA and WHO in 2010 </li></ul><ul><li>Over 550 conventional BA/BE studies conducted for various regulatory agencies (130 are pivotal studies) </li></ul><ul><li>20 products successfully approved by US-FDA </li></ul><ul><li>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) </li></ul><ul><li>Pharmacoscintigraphic Imaging </li></ul><ul><li>NCE PK studies like Food Effect, Dose Proportionality and Drug-Drug Interaction </li></ul>
    54. 54. Global Early Stage Clinical Development Services <ul><li>QPS Taiwan – Taipei, Taiwan </li></ul><ul><li>‘ QPS Taiwan is a full service Phase I unit with a long list of regulatory approvals for locally </li></ul><ul><li>manufactured generic products’ </li></ul><ul><li>Full-service CRO, all aspects of study (from study design to final report generation) are conducted in-house </li></ul><ul><li>Bioavailability / Bioequivalence Studies </li></ul><ul><ul><li>Healthy Normal Populations </li></ul></ul><ul><ul><li>PK in Cancer Patient Population </li></ul></ul><ul><ul><li>Scaled Average Bioequivalence </li></ul></ul><ul><li>Conventional BA/BE studies conducted for various regulatory agencies </li></ul><ul><li>More than 40 products successfully approved by Taiwan FDA </li></ul>
    55. 55. Global Early Stage Clinical Development Services <ul><li>QPS Netherlands – Groningen, the Netherlands </li></ul><ul><li>‘ QPS Netherlands is ideally suited to conduct your FIM and more complex phase I programs’ </li></ul><ul><li>Hospital based </li></ul><ul><li>Over 100 studies completed: 20 first-in-man programs (of which 12 with biologics); 7 PET studies; 6 Oral Contraceptive (OC) interaction studies </li></ul><ul><li>2 FDA audits (1 in 2009 and 1 in 2010) </li></ul><ul><li>Fast and easy access to top-notch medical, clinical pharmacological , medical and scientific expertise </li></ul><ul><li>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 </li></ul><ul><li>Logistically closely linked to the bioanalytical laboratory to enable fast turnaround of plasma concentration data of laboratory biomarkers and drug candidates </li></ul><ul><li>Specialty Studies </li></ul><ul><ul><li>Multi-purpose Umbrella Protocols (SAD + MAD + food effect + CYP450 fenotyping) – adaptive designs with flexible dosing escalation schemes </li></ul></ul><ul><ul><li>Female Health Care (OC interaction studies, Lactation studies and Fertility studies) </li></ul></ul><ul><ul><li>Validated neuropathic (capsaicin) and acute (M3 extraction) pain models </li></ul></ul><ul><ul><li>Imaging (PET, fMRI) studies </li></ul></ul><ul><ul><li>(Continuous) CSF sampling in HV </li></ul></ul><ul><ul><li>Radiolabel (14C) Mass Balance studies </li></ul></ul>
    56. 56. Slide Deck Navigator <ul><li>Navigate me directly to…. </li></ul><ul><li>Global DMPK Services </li></ul><ul><li>Global Toxicology Services </li></ul><ul><li>Global Bioanalytical Services </li></ul><ul><li>Global Translational Medicine Services </li></ul><ul><li>Global Early Stage Clinical Development Services </li></ul><ul><li>Global Late Stage Clinical Development Services </li></ul><ul><li>Why QPS ? </li></ul>
    57. 57. <ul><li>Late Stage Clinical Development </li></ul><ul><li>‘ helping you navigate your drug all the way across the finish line’ </li></ul>
    58. 58. Global Late Stage Clinical Development Services <ul><li>Brief Global Overview </li></ul><ul><li>‘ Widely recognized for achieving high-quality study data and high patient enrollment rates, QPS’ </li></ul><ul><li>site management & monitoring teams bring you years of experience’ </li></ul><ul><li>Phase I-IV Project Management </li></ul><ul><li>Phase II-IV Study Management </li></ul><ul><li>Clinical Trial Monitoring (incl. Phase I) </li></ul><ul><li>Clinical Trial Logistics and Supplies </li></ul><ul><li>Data Management </li></ul><ul><li>Biometrics </li></ul><ul><li>PK/PD Modeling </li></ul><ul><li>Medical Writing </li></ul><ul><li>In- and outsourcing of clinical professionals </li></ul>
    59. 59. Global Late Stage Clinical Development Services <ul><li>Program, Project & Study Management </li></ul><ul><li>‘ Apart from stand-alone clinical research activities, QPS is also able to manage your </li></ul><ul><li>entire clinical drug development program’ </li></ul><ul><li>Clinical Consultancy </li></ul><ul><ul><li>Design of clinical program </li></ul></ul><ul><ul><li>Design of clinical study </li></ul></ul><ul><li>Phase 1 to Phase 4 </li></ul><ul><li>Budget, Resource and Timeline Control </li></ul><ul><li>Experience with the following therapeutic indication areas: Allergy, Cardiology, Metabolic diseases, CNS, Vascular Surgery, Oncology, Multiple Sclerosis, Gastroenterology, Hematology, Genetic Diseases, Radiology </li></ul>
    60. 60. Global Late Stage Clinical Development Services <ul><li>Site Management & Monitoring </li></ul><ul><li>‘ QPS is able to take a lot of clinical research activities away from you’ </li></ul><ul><li>Site Selection </li></ul><ul><li>Site Training </li></ul><ul><ul><li>study reference manual </li></ul></ul><ul><ul><li>study materials </li></ul></ul><ul><ul><li>one-on-one sessions </li></ul></ul><ul><ul><li>train-the-trainer sessions </li></ul></ul><ul><ul><li>online presentations </li></ul></ul><ul><ul><li>online tutorials for EDC </li></ul></ul><ul><li>Site Recruitment </li></ul><ul><li>On-Site Monitoring </li></ul><ul><li>(Remote) Data Quality Review </li></ul><ul><li>Site Audit and/or Qualification </li></ul><ul><ul><li>at study initiation </li></ul></ul><ul><ul><li>at interim visits </li></ul></ul><ul><ul><li>at study close out </li></ul></ul><ul><ul><li>for cause </li></ul></ul><ul><li>Essential Document Collection </li></ul><ul><li>Regulatory Submissions </li></ul><ul><li>Site Logistics </li></ul>
    61. 61. Global Late Stage Clinical Development Services <ul><li>Data Management </li></ul><ul><li>‘ State-of-the-art clinical trial management and electronic data capture systems enable QPS to </li></ul><ul><li>deliver first rate data management services’ </li></ul><ul><li>Streamlined clinical information capabilities between QPS Sites/Branches </li></ul><ul><li>Clinical Database (Oracle Clinical™ and OpenClinica) </li></ul><ul><ul><li>CRF Design </li></ul></ul><ul><ul><li>Paper based CRF </li></ul></ul><ul><ul><li>eCRF </li></ul></ul><ul><li>Fast Data Base Lock </li></ul><ul><li>Experience with the following therapeutic indication areas: Vascular Surgery, Metabolic diseases, Cardiology, Vaccins, CNS, Observational Studies (Phase 4) </li></ul>
    62. 62. Global Late Stage Clinical Development Services <ul><li>Biostatistics </li></ul><ul><li>‘ State-of-the-art clinical trial management and electronic data capture systems enable QPS to </li></ul><ul><li>deliver first rate biostatistics services’ </li></ul><ul><li>Data Analysis for Late Stage Clinical Studies </li></ul><ul><li>SAS Programming </li></ul><ul><li>Exports of Tables, Figures and Listings (TFLs) </li></ul><ul><li>PK / PD Analysis (including Pop PK) </li></ul><ul><ul><li>Pharmacokinetic and statistical consultancy </li></ul></ul><ul><ul><li>Study design including optimization of PK sampling and power evaluation of subject size </li></ul></ul><ul><ul><li>Non-compartmental and compartmental PK modeling </li></ul></ul><ul><ul><li>Population pharmacokinetics </li></ul></ul><ul><ul><li>Stand-alone PK/PD report </li></ul></ul><ul><li>Experience with the following therapeutic indication areas: Vascular Surgery, Metabolic Diseases, Cardiology, CNS, Various Phase I </li></ul>
    63. 63. Global Late Stage Clinical Development Services <ul><li>Medical Writing </li></ul><ul><li>‘ QPS can take care of all your medical writing needs’ </li></ul><ul><li>Clinical Study Protocol </li></ul><ul><li>Investigator’s Brochure </li></ul><ul><li>IMPD (Investigational Medicinal Product Dossier) </li></ul><ul><li>ICF </li></ul><ul><li>Scientific Manuscripts </li></ul><ul><li>Final Clinical Report (CTD or eCTD) </li></ul><ul><li>Experience with the following therapeutic indication areas: Vascular Surgery, Metabolic diseases, Cardiology, Immunology, CNS, MS, Allergy and Pulmonary Diseases </li></ul>
    64. 64. Global Late Stage Clinical Development Services <ul><li>Temporary Staffing/Flexible Sourcing Solutions </li></ul><ul><li>‘ QPS employees can be outsourced and be brought temporarily on to your own drug </li></ul><ul><li>development team’ </li></ul><ul><li>Clinical Research Associates </li></ul><ul><li>Clinical Research Coordinators </li></ul><ul><li>Clinical Project Managers </li></ul><ul><li>Regulatory Affairs Staff </li></ul><ul><li>Data Managers </li></ul><ul><li>Biostatisticians </li></ul><ul><li>Clinical Pharmacokineticists </li></ul><ul><li>Medical Writers </li></ul><ul><li>Quality Control Staff </li></ul><ul><li>Safety Reporters </li></ul><ul><li>Clinical Research Trainers </li></ul>
    65. 65. Global Late Stage Clinical Development Services <ul><li>Therapeutic Areas </li></ul><ul><li>‘ QPS employees have dealt with a lot of therapeutic areas for significant periods of time’ </li></ul><ul><li>Adrenal / Pituitary Disorders </li></ul><ul><li>Hemostasis/Angiogenesis </li></ul><ul><li>Allergy </li></ul><ul><li>Immunology / Autoimmune Disease / Rheumatoid Arthritis </li></ul><ul><li>Alzheimer’s Disease / CNS Disorders </li></ul><ul><li>Infectious Disease </li></ul><ul><li>Anemia </li></ul><ul><li>Inflammatory Diseases / Immune Status / Cell Response </li></ul><ul><li>Asthma/COPD </li></ul><ul><li>Renal Disease </li></ul><ul><li>Bone Disease / Metabolism </li></ul><ul><li>Thyroid Disorders </li></ul><ul><li>Cardiovascular Disease </li></ul><ul><li>Oncology / Tumors / Neoplasia </li></ul><ul><li>Diabetes / Obesity / Lipid Metabolism / Carbohydrate Metabolism </li></ul><ul><li>Female Health Care / Gynecological Endocrinology / Reproductive Endocrinology </li></ul><ul><li>Gastrointestinal Disorders </li></ul>
    66. 66. Why QPS? <ul><li>What sets us apart? </li></ul><ul><li>‘ QPS will help you navigate your way through the complex challenges of the </li></ul><ul><li>development of your drug….and while navigating your way, you will enjoy having….’ </li></ul><ul><li>Direct access to QPS’ people's minds! </li></ul><ul><ul><li>Direct access to key personnel </li></ul></ul><ul><ul><li>Direct access to a vast amount of drug discovery & development experience </li></ul></ul><ul><ul><li>Scientific approach </li></ul></ul><ul><li>Direct access to QPS’ people's hearts! </li></ul><ul><ul><li>Enthusiasm </li></ul></ul><ul><ul><li>Professional attitude </li></ul></ul><ul><ul><li>Flexibility </li></ul></ul><ul><ul><li>Focus on long-term professional customer relationships </li></ul></ul><ul><li>Direct access to QPS’ people's hands! </li></ul><ul><ul><li>Responsive and on-time </li></ul></ul><ul><ul><li>Cost effective </li></ul></ul>
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