basi corporate overview 2013
DESCRIPTION
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.TRANSCRIPT
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 InTechnical 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 HeadquartersWest Lafayette, IN
Preclinical ServicesEvansville, 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 PostResearch 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 PayneVP
Analytical & Discovery Services
Phillip DowningSr. Director
Preclinical Services
Candace JohnsonDirector
Instruments & Manufacturing
Jill LynnDirector
Human Resources and Security
Jacquelyn M. LemkePresident & CEO
BASi | Corporate Overview 17
• ContactRon Zimmerman, Jr.Business Development [email protected](765) 497-5822 direct(765) 414-0937 cell