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.
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.
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
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
Notas do Editor
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
