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Corporate Overview 2013
BASi | Corporate Overview
BASi | Corporate Overview 2
Who We Are
• BASi is a drug development services firm that helps
pharmaceutical and biotech companies navigate the
complex drug development process.
• We operate along the entire drug development
continuum; however, we provide our clients with unique
technical skills and services from Discovery to Clinical
Proof-of-Concept.
• In addition, we help our clients to meet their key
milestones on time and frequently for less money than
it would cost them with internal resources.
BASi | Corporate Overview 3
What We Believe In
Technical Capability
• We have the qualifications to get the job done
Trustworthiness
• We understand the importance of the data we provide
Client Centric
• We get the job done right the first time, on time
Collaborative
• We communicate frequently to make the best decisions
Energetic
• We are eager to find solutions to our client’s complex
problems
BASi | Corporate Overview 4
Corporate Headquarters
West Lafayette, IN
Preclinical Services
Evansville, IN
Indianapolis
• 120,000ft2
• Bioanalysis
• Discovery
• Pharmaceutical analysis
• Formulation Stability
• Product R&D
• Immunochemistry
• Manufacturing
• 90,000ft2
• Preclinical Toxicology
• Pathology
BASi | Corporate Overview 5
Basic Post
Research Discovery Pre-Clinical Clinical Approval
Phase 1 | Phase 2 | Phase 3 NDAIND
In Vivo & In Vitro Discovery
• ADME-PK/PD
• BASi-developed Culex® Automated In Vivo
Sampling
• Simultaneous collection of multiple data
streams
Toxicology
• Pre- and Post-IND Studies
• General toxicology services (Acute, Chronic)
• Carcinogenicity studies
• Immunotoxicology and biomarkers
• Pharmacokinetics and drug metabolism
Bioanalysis
• 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 LIMS
Pharmaceutical 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 or
combination
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 detector
Method Development, Validation,
and Sample Analysis Utilizing:
Contract Bioanalytical Services
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) assays
Sample Analysis
BASi | Corporate Overview 8
Sample 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.
BASi | Corporate Overview 9
• Acute, Subchronic, Chronic
Toxicology
• Carcinogenicity
• Clinical Pathology
- Hematology
- clinical chemistry,
urinalysis
- coagulation assays
- specimen processing
- biomarkers
• Necropsy and
Histopathology
Preclinical Services
BASi | Corporate Overview 10
Pharmaceutical 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 combination
products
• Licensed for all schedules of
controlled substances
BASi | Corporate Overview 11
• Macromolecule PK
• Anti-drug antibody assay (immunogenicity)
• Biomarkers
• Method development, validation and sample
analysis
Immunoassay Services
BASi | Corporate Overview 12
Mass Spectrometers
• Sciex, Micromass, Finnegan TSQ
• HPLC, UHPLC, Waters Acquity®, Shimadzu
Nexera®
• 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 Immunoanalyzer
Bioanalytical Equipment
BASi | Corporate Overview 13
Key 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)
BASi | Corporate Overview 14
Sampling Pump
Empis ® Infusion Pump
Refrigerated Sample
Storage
Raturn®
Telemetry
Metabolic Waste Collection
• Freely moving,
Non-stressed subjects
• No manual handling
• 24hr operation
• Wireless notification
• Quiet operation
• IR Sample detection
• Better data
• Lower cost
• Better decisions
Automated In Vivo
Sampling System
BASi | Corporate Overview 15
Regulatory Compliance and
Quality Assurance
• Our culture is focused on
protecting our exemplary
regulatory record which
includes
– no findings
– voluntary actions for
corrections
• Your samples and data are
safe in our hands
• Our European operations are
reviewed by the FDA and the
Medicines and Healthcare
Products Agency
BASi | Corporate Overview 16
Senior Leadership
Lori Payne
VP
Analytical & Discovery
Services
Phillip Downing
Sr. Director
Preclinical Services
Candace Johnson
Director
Instruments &
Manufacturing
Jill Lynn
Director
Human Resources and
Security
Jacquelyn M. Lemke
President & CEO
BASi | Corporate Overview 17
• Contact
Ron Zimmerman, Jr.
Business Development Manager
rzimmerman@BASinc.com
(765) 497-5822 direct
(765) 414-0937 cell

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BASi corporate overview 2013

  • 1. Corporate Overview 2013 BASi | Corporate Overview
  • 2. BASi | Corporate Overview 2 Who We Are • BASi is a drug development services firm that helps pharmaceutical and biotech companies navigate the complex drug development process. • We operate along the entire drug development continuum; however, we provide our clients with unique technical skills and services from Discovery to Clinical Proof-of-Concept. • In addition, we help our clients to meet their key milestones on time and frequently for less money than it would cost them with internal resources.
  • 3. BASi | Corporate Overview 3 What We Believe In Technical Capability • We have the qualifications to get the job done Trustworthiness • We understand the importance of the data we provide Client Centric • We get the job done right the first time, on time Collaborative • We communicate frequently to make the best decisions Energetic • We are eager to find solutions to our client’s complex problems
  • 4. BASi | Corporate Overview 4 Corporate Headquarters West Lafayette, IN Preclinical Services Evansville, IN Indianapolis • 120,000ft2 • Bioanalysis • Discovery • Pharmaceutical analysis • Formulation Stability • Product R&D • Immunochemistry • Manufacturing • 90,000ft2 • Preclinical Toxicology • Pathology
  • 5. BASi | Corporate Overview 5 Basic Post Research Discovery Pre-Clinical Clinical Approval Phase 1 | Phase 2 | Phase 3 NDAIND In Vivo & In Vitro Discovery • ADME-PK/PD • BASi-developed Culex® Automated In Vivo Sampling • Simultaneous collection of multiple data streams Toxicology • Pre- and Post-IND Studies • General toxicology services (Acute, Chronic) • Carcinogenicity studies • Immunotoxicology and biomarkers • Pharmacokinetics and drug metabolism Bioanalysis • 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 LIMS Pharmaceutical 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 or combination
  • 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 detector Method Development, Validation, and Sample Analysis Utilizing: Contract Bioanalytical Services
  • 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) assays Sample Analysis
  • 8. BASi | Corporate Overview 8 Sample 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. BASi | Corporate Overview 9 • Acute, Subchronic, Chronic Toxicology • Carcinogenicity • Clinical Pathology - Hematology - clinical chemistry, urinalysis - coagulation assays - specimen processing - biomarkers • Necropsy and Histopathology Preclinical Services
  • 10. BASi | Corporate Overview 10 Pharmaceutical 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 combination products • Licensed for all schedules of controlled substances
  • 11. BASi | Corporate Overview 11 • Macromolecule PK • Anti-drug antibody assay (immunogenicity) • Biomarkers • Method development, validation and sample analysis Immunoassay Services
  • 12. BASi | Corporate Overview 12 Mass Spectrometers • Sciex, Micromass, Finnegan TSQ • HPLC, UHPLC, Waters Acquity®, Shimadzu Nexera® • 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 Immunoanalyzer Bioanalytical Equipment
  • 13. BASi | Corporate Overview 13 Key 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. BASi | Corporate Overview 14 Sampling Pump Empis ® Infusion Pump Refrigerated Sample Storage Raturn® Telemetry Metabolic Waste Collection • Freely moving, Non-stressed subjects • No manual handling • 24hr operation • Wireless notification • Quiet operation • IR Sample detection • Better data • Lower cost • Better decisions Automated In Vivo Sampling System
  • 15. BASi | Corporate Overview 15 Regulatory Compliance and Quality Assurance • Our culture is focused on protecting our exemplary regulatory record which includes – no findings – voluntary actions for corrections • Your samples and data are safe in our hands • Our European operations are reviewed by the FDA and the Medicines and Healthcare Products Agency
  • 16. BASi | Corporate Overview 16 Senior Leadership Lori Payne VP Analytical & Discovery Services Phillip Downing Sr. Director Preclinical Services Candace Johnson Director Instruments & Manufacturing Jill Lynn Director Human Resources and Security Jacquelyn M. Lemke President & CEO
  • 17. BASi | Corporate Overview 17 • Contact Ron Zimmerman, Jr. Business Development Manager rzimmerman@BASinc.com (765) 497-5822 direct (765) 414-0937 cell

Hinweis der Redaktion

  1. SPEAKING NOTES (LANGUAGE SUGGESTIONS)Corporate HeadquartersWest Lafayette, IN, 2 hours Southeast of ChicagoBioanalytical, Pharm Analysis, Method Development, Discovery Services, Large Molecule, Biomarker Assays and Instrument ManufacturingPreclinical ServicesEvansville, IN, Southwest corner of the stateDiscovery Services, ToxicologyWest Coast OperationsBioanalytical and Sample Analysis