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

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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

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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

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• ContactRon Zimmerman, Jr.Business Development Managerrzimmerman@BASinc.com(765) 497-5822 direct(765) 414-0937 cell