![Quality "At QPS Bio-Kinetic, you can expect the highest quality and reliable services for your Phase I studies. QPS Bio-Kinetic employs dedicated and experienced people to perform your studies.” — Sheela M. Associate Director, QA “ I have found [QPS] Bio-Kinetic to be a highly professional organization with the ability to be flexible and responsive to the needs of the clinical program.” — Nicholas P. Associate Director, Early Development “ QPS Bio-Kinetic has the most experience of any Phase I unit in the industry. They have highly-trained, long-term personnel who are not only technically expert but also understand the importance of your study. They have the equation for guaranteed success. I always recommend QPS Bio-Kinetic to my colleagues". — Rick S. CEO](https://image.slidesharecdn.com/qpspptpresentation092009v4-12554410937997-phpapp01/85/Qps-Presentation-36-320.jpg)
Qps Presentation
- 2. Quality Performance Service QPS is a GLP-compliant CRO that supports Discovery, Preclinical, and Clinical Development Services: Bioanalysis DMPK Biomarker Early Phase Clinical Research Testing Facilities: Bioanalysis/DMPK/Biomarker – Newark, DE (QPS, LLC) Bioanalysis – Taipei, Taiwan (QPS Taiwan Company Ltd) Early Phase Clinical Research – Springfield, MO (Bio-Kinetic Clinical Applications, LLC) Regional business development offices are maintained on the East Coast, the West Coast, and the Midwest
- 3. Quality Performance Service QPS QPS Taiwan Bio-Kinetic
- 4. QPS, LLC Founded Nov 1995 Senior Management from Pharma/Biotech 4 Facilities located in Newark, DE GLP 48,800 sq. ft. total 19,000 sq. ft. LC/MS/MS & ELISA 23,500 sq. ft. ADME/WBA 2,500 sq. ft. Molecular Biology 31 Mass Spec (Triples & Ion Trap) Quest Pharmaceutical Services Taiwan Company Ltd. Founded in Jan 2004 8,500 sq. ft. GLP Bioanalytical 4 Triple Quadrupoles Quality You Expect Service You Trust Turnaround You Need Quality Performance Service
- 5. Quality – Performance – Service Quest Pharmaceutical Services and Bio-Kinetic Clinical Applications merged in early 2008 to form a company based on our mutual beliefs and practices on QUALITY, PERFORMANCE, and SERVICE. Quality Performance Service
- 6. Clinical Package S upport Phase I Clinical Development for NCEs and Biologics Design the study Prepare the study protocol, informed consent, and case report forms Conduct the clinical phase of the study Bioanalysis of biological samples (LC/MS/MS, ELISA, Immunogenicity, and Hybridization-ELISA) Biostatistics and clinical data management Conduct PK/PD data analysis and modeling Prepare PK/PD report will be appended to the clinical study report Population PK or PK/PD data analysis capability is also available Prepare and publish clinical study report Service
- 7. Springfield, Missouri QPS Bio-Kinetic is located just 10 minutes from the Springfield-Branson Regional Airport Quality Performance Service
- 8. Quality Established Clinical Site Phase I – IV Founded in 1994 Over 800 studies completed State-Of-The-Art Facility Five (5) Study Units on One Campus 240 Beds
- 9. Performance State-Of-The-Art Facility Separate secure pharmacy, retention area, examination rooms, dosing, and phlebotomy stations State-of-the-art refrigerated centrifuges High speed micro centrifuges
- 10. Performance State-Of-The-Art Facility Local clinical lab provides most results within 24 hours a day, 7 days a week Laminar flow hoods -70˚C and -20˚C freezers NIST calibrated temperature recording devices in refrigerators and freezers
- 11. Performance State-Of-The-Art Facility 24-hour security and monitoring systems Secure archive/ document storage FM 200 Gas fire suppression Automatic natural gas powered generators for power backup AEDs
- 12. Performance State-Of-The-Art Facility Fully equipped ECG and vital sign monitoring State-of-the-art self-interpreting electrocardiographs
- 13. Service Population Specialties Healthy normal males Healthy normal females Healthy normal birth control free females Healthy postmenopausal women Healthy geriatric males and females Other select populations
- 14. Service Administration Expertise: Oral Intravenous Intramuscular Intradermal Subcutaneous Buccal Transdermal — cream, gel, patch Vaginal — cream, gel, suppository Suppository Intranasal Intrauterine
- 15. Service
- 16. Performance Examples of Study Experience (between 2004 – 2009) 24 Vaccine Trials 1 Hepatitis B 1 Japanese Encephalitis 1 Yellow Fever 2 West Nile 4 Dengue Fever 5 Small Pox 10 Flu 43 Postmenopausal Studies 36 Geriatric Studies 19 Birth Control Studies 12 Cardiac Safety Studies
- 17. Service Collaboration with Quintiles for TQTc Full service TQTc offering Ability to conduct large cohorts High throughput paperless system 24/7 monitoring by cardiologists ECG data management from initiation through submission to the FDA ECG Warehouse
- 18. Quality Clinical Staff Experience Four (4) Principle Investigators Two (2) started in 1994 One (1) started in 2000 One (1) started 2005 Clinical Staff Experience 6+ years average length of employment Less than 5% staff turnover rate Leadership team averages over 15 years of experience managing clinical trials
- 19. Quality Audit Experience Twelve (12) FDA Audits Ten (10) Clinical Sites Two (2) IRBs One 483 (Sept. 2003) 16 Studies (Most recent- Aug. 2009)
- 20. Performance Rapid Recruitment 500,000 Metropolitan Area Population 40,000 College Student Population Over 3 hours from nearest Phase I units Large Database of High Quality Subjects Less than 5% drop out rate Over 20,000 registered subjects in database Fill 80% of studies exclusively from database
- 21. Performance Rapid Recruitment Multi-tiered Outreach Effort Direct Email & Mail Phone Calls Internet New Interactive Website QPSBioKinetic.com Community websites Interviews
- 22. Performance Rapid Recruitment Multi-tiered Outreach Effort Community Events Job Fair University Social Events Promotional Events Sponsorship Mass Marketing Billboards & Buses TV & Radio Newspaper Ads Referral Programs Participants Local Business
- 23. Service Rapid Recruitment Patient Stratification Identification of Poor or Extensive metabolizers Genotyping (CYP2C9, CYP2C19, CYP2D6, NAT1, NAT2, ApoE, etc.) 48-72 hours turnaround
- 24. Quality Individualized Study Preparation Protocol Training Initiation Visit Protocol Review Walk Through Meetings “ Dry Runs” Protocol Training AE Preparation and Review Study Events Review Weekly Staff Review Meeting Protocol Training GCP Training Review Study Preparation AE Preparation and Review Custom Communication Plan
- 25. Performance Study Integrity Concise SOPs Protocol Adaptable Processes Continual Staff Training On-Time Study Events Accurate Sample Collection Thorough Sample Reconciliation
- 26. GLP Compliant Follow FDA Crystal City Guidelines, OECD, MHLW “ Incurred Sample Reproducibility” White Paper Discovery, Preclinical, and Clinical programs Biological matrices, Target organs, Dosing solutions, CMC Rapid Assay Development, Validation, Sample Analysis “ N -in-1” or Discrete Analysis Automated Sample Preparation Chiral Separations Extensive Validated Assays HIV, Pain, Oncology Anti-infectious LC/MS/MS Service M1 M2 M3 M4 M5 M6 IS1 IS2 IS3
- 27. Bioanalysis Services Drug Concentration and Dosing Solution Concentration Small Organics, Polypeptides LC/MS/MS, LC-UV, LC-Flu Proteins and Vaccines ELISA and Immunogenicity Oligonucleotides Hybridization-ELISA, LC/MS/MS, LC-UV Radiolabeled Mass Balance Studies LC/RFD (Radio-Flow Detector) Service
- 28. QPS(US) GLP LC/MS/MS Facility 24 Triple Quadrupoles (31 US total) 19 Sciex API 4000s Shimadzu VP-series LCs; Agilent 1100 LCs Waters UPLCs Leap HTS/PAL and HTC/PAL injectors 2 Cohesive Technologies ARIA Systems 2 UV (VWD) and 3 Fluorescence Detectors Sample Prep Sample Receipt/Inventory Lab 4 General Sample Prep Labs P2 Lab for HIV, HBV, HCV samples 3 Tomtec Quadra 96 for 96-well sample prep Service
- 29. Typically get a Study Underway within 2 – 4 weeks with receipt test material(s) signed protocol Validate assay within 2 – 4 weeks PK/TK study with 1500 samples preliminary data within 2 weeks of sample receipt audited data within 2 weeks of prelim data 48 hr. turnaround, if needed for dose range/escalation study QPS(US) GLP Bioanalysis Timelines Performance
- 30. QPS Clinical PK/PD Capabilities Contribute to the design of a clinical PK/PD study & the preparation of the study protocol PK/PD data analysis and report preparation (including population PK & PK/PD analysis, PK & PK/PD compartmental modeling, & non-compartmental PK & PK/PD data analysis) Contribute to the preparation of the CSR Service
- 31. PK/PD Data Analysis Software PK/PD Analysis: WinNonlin & NONMEM Statistical Analysis: PCSAS, S-Plus, & nQuery Graphing: SigmaPlot & S-Plus Simulation: WinNonlin, NONMEM, & S-Plus Service
- 32. Why QPS? Good Critical Mass – Reasonably Sized and User Friendly Responsive and On Time Direct Access to Key Personnel Focused Science and Extensive Experience in Drug Development Specialized CRO: Preclinical DMPK & Clinical Drug Metabolism, Clinical Pharmacology/Pharmacokinetics/Pharmacodynamics Drug Analysis LC/MS/MS, ELISA, Immunogenicity, Hybridization-ELISA, LC/RFD Comprehensive Discovery and Preclinical ADME Studies Drug Metabolism: Metabolite Profiling & Identification in Animals & Humans Biomarkers and Cell-based Assays Protein, Biochemical, and Pharmacogenomics/Pharmacogenetics Phase I Clinical Pharmacology/PK/PD Health Volunteers Quality Performance Service
- 33. Performance 91% of the time QPS has been the low cost provider In cases where the sponsor has shared competitor’s cost information or from participation on online auctions. Large subject database Lower recruiting costs Lower Cost of Living Lower direct business costs Lower subject stipends Established Business Process efficiencies Single location efficiencies (staffing, operations, logistics) Experienced, flexible staff
- 34. Performance Recent Examples of Performance Study 11708 1242 Subjects enrolled in 4 weeks Aged 40 to 90 80% over the age of 60 per protocol 16,160 Samples processed and shipped on time Study 11508 90 postmenopausal subjects recruited in 4 weeks Conducted over holiday weekend on time 7 Studies in same compound 116 to 140 subjects each All subjects naïve to compound Returns out to 3 months 50/50 male/female Single IM injection
- 35. Service Commitment to Customer! Highly experienced staff works to obtain results quickly, on time and on budget Work with you to meet your objectives Minimize your costs Recruit and start your study fast and full We keep you updated every step of the way Your Success is Our Success!
- 36. Quality "At QPS Bio-Kinetic, you can expect the highest quality and reliable services for your Phase I studies. QPS Bio-Kinetic employs dedicated and experienced people to perform your studies.” — Sheela M. Associate Director, QA “ I have found [QPS] Bio-Kinetic to be a highly professional organization with the ability to be flexible and responsive to the needs of the clinical program.” — Nicholas P. Associate Director, Early Development “ QPS Bio-Kinetic has the most experience of any Phase I unit in the industry. They have highly-trained, long-term personnel who are not only technically expert but also understand the importance of your study. They have the equation for guaranteed success. I always recommend QPS Bio-Kinetic to my colleagues". — Rick S. CEO
- 37. Quality “ Our company has placed studies at QPS Bio-Kinetic for over 10 years, including the key pharmacokinetic study assessing Drug X components, as well as many of our postmenopausal women, Drug Y pilot bioavailability studies, and all of our pivotal bioequivalence studies. One wouldn't normally think of Springfield, Missouri, as a major CRO site, but the types of subjects they continually enroll are just solid, middle-class citizens with excellent retention for a clinical study. For our pivotal Drug Y BE studies, we routinely enroll over 70 postmenopausal women subjects and no other site in this country or EU can enroll and dose them in one day, as can be done at QPS Bio-Kinetic. QPS Bio-Kinetic is planned as a site for all future Drug Y BE studies. Having served on the Drug Y team and been involved in many management presentations, there is simply no way we can make our timelines and meet our project objectives without using this site.” — Phil M. Assistant VP of Clinical Pharmacology
- 38. Quality “ When we look for clinical research sites, we prefer smaller organizations that understand the unique pressures of optimizing speed, quality and price we face as a small company. We demand they be trustworthy, can perform the protocol as directed, are able to communicate study progress and are focused on client service. I have worked with QPS Bio-Kinetic for many years, in particular for BE/BA, DDI and cardiac safety studies. Because of their experienced staff, training and detailed processes, I am confident I can count on qualified study participants, quality data and PK samples to be drawn on time. I trust QPS Bio-Kinetic to tell me when they don’t have the capacity to perform my study according to my specifications or timeline. Based on their history of meeting my expectations and my trust in the QPS Bio‑Kinetic staff, QPS Bio-Kinetic has become my first choice as a clinical site.” — Jim M. Senior Director, Clinical Development
- 39. Ligand Binding Assay GLP Compliant – FDA Crystal City Guidelines, Pharma Research 2006 White Paper “ Incurred Sample Reproducibility” White Paper Discovery, Preclinical, and Clinical programs Biological matrices, Target organs, Dosing solutions PK Drug Concentration / PD Biomarker Assessment Assay Development/Validation Sample Analysis Immunogenicity Assay Development/Validation for different classes of Antibodies (IgG, IgM, etc.) Screening samples for positive response Confirmation for samples displayed positive response Titer ‘confirmed’ samples for the relative intensity of the immunogenicity Design bioassay for measuring neutralizing antibodies Service
- 40. QPS(US) ELISA/LBA Facility Plate Readers 4 Spectramax PLUS 384 Versamax 96-well reader Lmax Chemluminescence reader Gemni Fluorescence reader MSD ® ECL Platform (SECTOR PR100, Imager 6000) Perkin Elmer Top Count ® NTX WATSON LIMS System v 6.4 Sample Prep 2 Immunochemistry Labs Cell Culture Lab Meso Scale Diagnostics, LLC Service
- 41. QPS(US) Additional Biomarker Facility Bead-based MultiPlex 2 BioRad Bioplex ® Automated ELISA 2 IMMULITE ® Molecular Biology Equipment Qiagen BioRobot Automated Sample Processing System (MDx) Qiagen TissueLyzer NanoDrop ND-1000 Spectrophotometer Agilent 2100 BioAnalyzer Biotage Pyrosequencing PSQ HS 96 SNP System ABI 7900HT TaqMan RT- PCR System (TLDA, 96-well plate) Affymetrix GeneChip Microarray System with 7G Upgrade Ultra Lum Discovery 12iC Molecular Imaging & Analysis System Sample Prep 4 Molecular Biology Labs Tissue Culture Lab Service
- 42. DMPK Services Discovery ADME Screen Drug Candidate Selection Studies IND/NDA-filing Studies Animal Pharmacokinetics In vitro/In vivo Metabolism In vitro/In vivo Protein Binding Tissue Distribution (QWBA) Clinical PK/PD Modeling Preclinical ADME Summary for IND submission Service
- 43. Comprehensive ADME Studies Animal Pharmacokinetics Single and Multiple Dose Pharmacokinetics, Dose Proportionality, and Absolute Bioavailability Mass Balance/Excretion Formulation Optimization and Mechanistic Studies with different dose administration routes In vitro/In vivo Metabolism In vitro Metabolic Stability in Animal and Human Hepatic Preparations In vitro Inhibition in Human Liver Microsomes In vitro Reaction Pathway Profiling Ex vivo Induction in Animal Hepatic Preparations and In vitro in Human Hepatic Preparations Metabolite Profiling & Identification In vitro/Ex vivo Protein Binding; RBC/Plasma Distribution Tissue Distribution Quantitative Whole-Body Autoradiography (QWBA) Microautoradiography and Discovery QWBA Service
- 44. QPS(US) ADME Facility Vivarium – focused on mouse and rat with 9 rodent rooms Triple cannulated animals for special models and in situ CSF > 200 Metabolism cages In vitro Cell Culture Lab Dedicated Bioanalysis/Metabolism Equipments 5 Analytical Labs for dose formulation and sample prep 7 Mass Spec (6 API 4000s, LTQ ProteomeX) Shimadzu VP-series LCs, Agilent 1100 LCs; LEAP HTC/PAL injectors Tomtec Quadra 96 for 96-well sample prep 4 Radioactivity Detectors 2 Autoradiography Labs Leica CM 3600 Cryomacrotome Leica CM 3050 S Cryomicrotome Leica Vibratome 9800 Molecular Dynamics Typhoon 9410 Imaging Research MCID Elite System Service
- 45. QPS(US) Licenses & Permits AAALAC Accreditation OLAW Assurance ABC License NRC License for Radiochemicals ( 3 H, 14 C, 32 P, 33 P, 35 S, 45 Ca, 51 Cr, 90 Y, 99m Tc, 111 In, 125 I, 188 Re) DEA Registration for Scheduled Controlled Substances (Schedule I – V) CLIA Certification CDC Permit – Export/Import Primate samples Federal Fish & Wildlife Permit Quality You Expect Service You Trust Turnaround You Need Service
- 46. Approved by Taiwan’s Department of Health as a qualified CRO QPS Taiwan / QPS(US) Same Set of SOPs Same Set of Laboratory Procedures Same High Quality Standard GLP LC/MS/MS NCEs and non-proprietary compounds for US, European, and Local Pharmaceuticals and Biotechnology Companies Generic compounds for local Generic Companies Pilot BA/BE Studies in collaboration with the Taipei Clinical Research Center (part of Taipei Medical University Hospital) Discovery Dog PK Studies with our in-life Affiliate – DCB Taiwan QPS Taiwan Services Service
- 47. Study Management Bioanalytical/Immunoanalytical/Biomarker Design and Perform Studies Schedule Studies as per Protocol Review Sample Inventory Follow-up with sponsor & study site if discrepancy occur Plot data to reveal possible trend Flag discrepancy for Sponsor review Discovery ADME Screen Drug Candidate Selection Studies IND/NDA-filing ADME Studies Design, Manage, and Perform Studies Review, Prepare Study Reports, and Preclinical ADME Summary for IND submission Service
- 48. Process Map: Clinical with Bioanalysis/Biomarker RFP Clinic plus Bioanalysis Biomarkers needed? Receiver Review RFP Generate Proposal, Internal Review/Approval, f/b Issuance to Sponsor Yes Receiver Distribute RFP to relevant Proposal Distribution List No Individual P&L Center Generate Proposal(s) f/b Internal Review QPS Bio-Kinetic – Combine Proposals into a Single QPS Proposal Proposal Accepted? End. Ask for Feedback No Yes Project Manager Needed? Decide on Project Manager, Study Monitor, Principle Investigator(s) Yes QPS Bio-Kinetic and QPS Bioanalysis parallel Internal Process QPS Bio-Kinetic – Conduct the clinical phase QPS Bio-Kinetic – Ship Clinical Samples QPS Bioanalysis/Biomarker – Receive Clinical Samples QPS Bio-Kinetic – Internal Process & Clinical Summary Generation QPS Bioanalysis/Biomarker – Conduct Sample Analysis QPS Bioanalysis/Biomarker – Internal Process & Report Generation QPS WHO – Combine Both Reports into a Single QPS Report Report Issuance for Sponsor Review Sponsor send RFP to QPS (any organization) Internal Review/Approval, f/b Issuance to Sponsor Decide on Study Monitor, and Principle Investigator(s) No