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BASi corporate overview 2013


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BASi is a drug discovery and development services company with the energy and expertise to help you with your drug development project. We provide world-class research to the global pharmaceutical industry. Our services include preclinical toxicology, bioanalysis and a full range of pharmaceutical analysis services. BASi also manufactures innovative scientific instruments including the Culex® Automated In Vivo Sampling System which can collect blood, bile, and more from awake, freely-moving subjects. We are known for our scientific expertise, responsiveness to clients, exemplary regulatory record, and helping our clients meet key milestones on time.

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BASi corporate overview 2013

  1. 1. Corporate Overview 2013BASi | Corporate Overview
  2. 2. BASi | Corporate Overview 2Who We Are• BASi is a drug development services firm that helpspharmaceutical and biotech companies navigate thecomplex drug development process.• We operate along the entire drug developmentcontinuum; however, we provide our clients with uniquetechnical skills and services from Discovery to ClinicalProof-of-Concept.• In addition, we help our clients to meet their keymilestones on time and frequently for less money thanit would cost them with internal resources.
  3. 3. BASi | Corporate Overview 3What We Believe InTechnical Capability• We have the qualifications to get the job doneTrustworthiness• We understand the importance of the data we provideClient Centric• We get the job done right the first time, on timeCollaborative• We communicate frequently to make the best decisionsEnergetic• We are eager to find solutions to our client’s complexproblems
  4. 4. BASi | Corporate Overview 4Corporate HeadquartersWest Lafayette, INPreclinical ServicesEvansville, INIndianapolis• 120,000ft2• Bioanalysis• Discovery• Pharmaceutical analysis• Formulation Stability• Product R&D• Immunochemistry• Manufacturing• 90,000ft2• Preclinical Toxicology• Pathology
  5. 5. BASi | Corporate Overview 5Basic PostResearch Discovery Pre-Clinical Clinical ApprovalPhase 1 | Phase 2 | Phase 3 NDAINDIn Vivo & In Vitro Discovery• ADME-PK/PD• BASi-developed Culex® Automated In VivoSampling• Simultaneous collection of multiple datastreamsToxicology• Pre- and Post-IND Studies• General toxicology services (Acute, Chronic)• Carcinogenicity studies• Immunotoxicology and biomarkers• Pharmacokinetics and drug metabolismBioanalysis• LC-MS/MS analytical platforms• Immunoassay• High throughput and fast turnaround analysis• GLP/GCP compliant• History of successful regulatory audit (FDA, MHRA)• 21-CFR-Part11 compliant systems including Watson LIMSPharmaceutical Analysis• NDA, IND and Q stability• Experts in method development and validation• Final product release and testing• Dosing solutions analysis• Compendial testing• In Vitro bioequivalence• GLP- and cGMP-compliant• Any dosage form, medical devices orcombination
  6. 6. BASi | Corporate Overview 6• MS Platforms: Sciex, Micromass, Finnegan TSQ• TomTec Quadra 96 platforms• UPLC systems – Waters Acquity® and Shimadzu Nexera®• CTC and Shimadzu multi-plate autosamplers• UV-Vis, fluorescence, EC, CAD• SpectraMax® M5 Microplate Readers• MesoScale Discovery ECL detectorMethod Development, Validation,and Sample Analysis Utilizing:Contract Bioanalytical Services
  7. 7. BASi | Corporate Overview 7• Bioanalytical support for domestic and international studies• Clinical and non-clinical studies• Proprietary and non-proprietary drugs• Exogenous and endogenous (biomarkers) assaysSample Analysis
  8. 8. BASi | Corporate Overview 8Sample Types• Plasma, serum, whole blood, urine, bile, milk• Dried Blood Spots• Tissues: kidney, lung, brain, muscle, spleen,coronary band, artery and others• Microdialysate• In vitro test system: hepatocyte, media• Different species: human, mouse, rat, dog, pig,monkey, rabbit, etc.
  9. 9. BASi | Corporate Overview 9• Acute, Subchronic, ChronicToxicology• Carcinogenicity• Clinical Pathology- Hematology- clinical chemistry,urinalysis- coagulation assays- specimen processing- biomarkers• Necropsy andHistopathologyPreclinical Services
  10. 10. BASi | Corporate Overview 10Pharmaceutical Analysis Capabilities• GLP and cGMP Compliant• Method development and validation• NDA, IND, and QC Stability• Final product release• In-Vitro Bioequivalence• Compendial testing• Dosing solution analysis• Formulation stability• Analysis of various dosage forms,including devices and combinationproducts• Licensed for all schedules ofcontrolled substances
  11. 11. BASi | Corporate Overview 11• Macromolecule PK• Anti-drug antibody assay (immunogenicity)• Biomarkers• Method development, validation and sampleanalysisImmunoassay Services
  12. 12. BASi | Corporate Overview 12Mass Spectrometers• Sciex, Micromass, Finnegan TSQ• HPLC, UHPLC, Waters Acquity®, ShimadzuNexera®• UV, Fluorescence, photodiode array,electrochemical and CAD detectors• TomTec Quadra 96 platforms• CTC and Shimadzu multi-plate autosamplers• SpectraMax® M5 Microplate Readers,MesoScale Discovery ECL detector• Triturus® Automated ImmunoanalyzerBioanalytical Equipment
  13. 13. BASi | Corporate Overview 13Key Bioanalytical Staff• 45 total staff members (11 PhD)• R&D Group (MD) – 5 staff (2 PhD, 1 MS)• Bioanalytical Production – 20 staff (7 PhD)• Mass Spec Group – 2 staff (2 PhD)• Sample Management - 5 staff• Metrology - 3 staff• Quality Control & Assurance - 7 staff• Report writing and document management (3 staff)
  14. 14. BASi | Corporate Overview 14Sampling PumpEmpis ® Infusion PumpRefrigerated SampleStorageRaturn®TelemetryMetabolic Waste Collection• Freely moving,Non-stressed subjects• No manual handling• 24hr operation• Wireless notification• Quiet operation• IR Sample detection• Better data• Lower cost• Better decisionsAutomated In VivoSampling System
  15. 15. BASi | Corporate Overview 15Regulatory Compliance andQuality Assurance• Our culture is focused onprotecting our exemplaryregulatory record whichincludes– no findings– voluntary actions forcorrections• Your samples and data aresafe in our hands• Our European operations arereviewed by the FDA and theMedicines and HealthcareProducts Agency
  16. 16. BASi | Corporate Overview 16Senior LeadershipLori PayneVPAnalytical & DiscoveryServicesPhillip DowningSr. DirectorPreclinical ServicesCandace JohnsonDirectorInstruments &ManufacturingJill LynnDirectorHuman Resources andSecurityJacquelyn M. LemkePresident & CEO
  17. 17. BASi | Corporate Overview 17• ContactRon Zimmerman, Jr.Business Development 497-5822 direct(765) 414-0937 cell