Advion Bioanalytical Labs

A Quintiles Company

CPSA 2012October 3, 2012

is now

Your global one-source solution for early clinical studies and laboratory testing across the development spectrum

Then

•High Quality Regulated Bioanalytical Laboratories for PK/ Immunogenicity/ Biomarkers

•Automated ADME In Vitro Laboratory

•Well Respected Senior Scientific staff that includes:

Jack Henion, Steve Lowes, Gary Schultz, John Perkins, Dan Mulvana, et al.

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Now with Quintiles

• High Quality Regulated Bioanalytical Laboratories for PK/ Immunogenicity/ Biomarkers

• Automated ADME In Vitro Laboratory

• Well Respected Senior Scientific staff that includes:

Jack Henion, Steve Lowes, Gary Schultz, John Perkins, Dan Mulvana, et al.

Advion? Quintiles?What is different?

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Advion Bioanalytical Labs, A Quintiles CompanyIntegrated Services

Laboratory and Clinical Development services across the lifecycle – and the globe• LC/MS Bioanalytical & Immunoassay • In Vitro ADME & Metabolism ID• PK/PD Data Analysis, Modeling and Simulation• Biomarkers – LC/MS/MS, Immunoassays, and More • Global Phase I Units & Central Laboratories Network

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Bioanalytical Services Three Centers of Excellence and Global Capabilities

– LC/MS Bioanalytical (PK and Biomarkers): Ithaca, New York• GLP-compliant & discovery LC/MS bioanalytical – small molecules• GLP-compliant LC/MS bioanalytical – biotherapeutics and fit-for-purpose-biomarkers• Discovery bioanalytical – determine PK profiles of drug candidates

– Immunoassay Bioanalytical (PK and Biomarkers): Manassas, VA• GLP-compliant & discovery bioanalytical/ligand binding assays – macro molecules• Immunogenicity – immunoassay and cell-based assays• Immunoassay fit-for-purpose biomarkers

– In Vitro ADME and Metabolite Identification: Indianapolis, IN• In vitro assays to determine metabolism, solubility, permeability of drug candidates• Metabolite profiling and metabolite identification – definitive and discovery

– High Quality Bioanalytical with Quintiles Global Sample Shipping Logistics, Phase I Clinics Throughout the World, and PK Data Analysis Capabilities

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Jack Henion & Tom Kurz establish Advion , remain engaged and passionate about Advion Bioanalytical Labs (1993)

Name changed to Advion BioSciences (2001)

Creation of BioServices & BioSystems subsidiaries (2001)

Large Investments initiated to pursue the latest technologies (2002-Present)

Opened 33,000 sq ft headquarters and bioanalytical lab in Ithaca, NY (2007)

Opened 10,000 sq ft Immunoassay lab in Manassas, VA (2007)

LC/MS Biomarker services business is launched, Ithaca, NY (2008)

Opened major 22,000 sq ft Discovery/Metabolism Lab in Indianapolis, IN (2011)

One of the largest bioanalytical groups in North America

Advion Bioservices acquired by Quintiles (October 2011)

Part of a Quintiles global network that consists of > 25,000 employees worldwide in 84

countries

Our scientific heritage and progression

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What we are known for

– Established bioanalytical lab with many years of experience• 19 years of GLP-compliant bioanalytical experience• Clients include 14 of 15 largest pharmaceutical companies in the world

– Well respected reputation for scientific excellence• Renowned scientific leadership – Dr. Jack Henion & Dr. Steve Lowes• Reputation for solving challenging bioanalytical problems others could not• Pioneered many key industry developments, (e.g., 96-well, Watson LIMS,

biotherapeutic bioanalysis by LC/MS, nanoelectrospray)• Stringent scientific review of all assays assures the use of rugged, reliable and

reproducible methods

– Leader in bioanalytical GLP compliance• Dr. Steve Lowes serves on many significant committees, authored guiding papers,

and speaks at major bioanalytical scientific conferences• Excellent inspection record and reputation for GLP compliance

Services OverviewBioanalytical and ADME Services

Small MoleculeBioanalysis

(PK & TK Support)

GLP-Compliant LC/MS• Assay method

development• Method validation• Sample analysis• Validated assay list

Discovery LC/MS• Plasma and tissue• Tier 0 through tier 3

Sample Management• Global capabilities• Custom kits

PK Data Analysis

BiotherapeuticsBioanalysis

(PK & TK Support)

GLP-Compliant• LC/MS assays• Immunoassays

Discovery• LC/MS assays• Immunoassays

Immunogenicity• Screen & confirm• NAB Assays

Sample Management• Global capabilities• Custom kits

PK Data Analysis

BiomarkersBioanalysis

LC/MS Biomarkers• Protein & peptides• Lipids• Small molecule• SISCAPA

Immunoassays• ELISA• MSD Platform• Validated assay list

Sample Management• Global capabilities• Custom kits

ADMEAssays

In vitro Screening• Solubility screening• Permeability screening• Microsomal clearance• Hepatocyte clearance• Metabolite stability• Plasma-protein binding

Definitive Assays• Reaction phenotyping• CYP450 inhibition• Plasma- protein binding

Metabolite ID• Discovery met ID• Radio-profiling• Development met ID

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Drug Development CycleAdvion Bioanalytical Labs Services

Discovery Preclinical Phase I Phase II-IIIPost

Marketing

Discovery Advion Services• High-throughput LC/MS bioanalytical• High-throughput immunoassay• ADME Screening

Preclinical Advion Services• GLP-compliant LC/MS & immunoassay• Immunogenicity• LC/MS & immunoassay biomarkers• Definitive ADME assays• Development metabolite ID• Met ID radioprofiling

Clinical Phase I Advion Services• GLP-compliant LC/MS & immunoassay• Immunogenicity• LC/MS & immunoassay biomarkers• Definitive ADME assays• Development metabolite ID• Met ID radio-profiling• Sample management

Clinical Phase II-III Advion Services• GLP-compliant LC/MS & immunoassay• Immunogenicity• LC/MS & immunoassay biomarkers• Sample management

Phase IV Advion Services• GLP LC/MS & immunoassay• Immunogenicity• LC/MS & immunoassay

biomarkers• Sample management

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Advion Bioanalytical Labs

– In our 20th year of operation as a GLP bioanalytical lab

– Quality bioanalytical services with a global reach through Quintiles

– A scientific leader in bioanalytical services

• Renowned scientific leadership

• Reputation for scientific excellence & method development

• Outstanding regulatory compliance

• Broad expertise– LC/MS of small molecules and biologics– Ligand binding assays– ADME assays– Metabolite identification

• Proactive communication from skilled project managers

• Flexibility in scheduling and record of meeting deadlines

• One of the largest bioanalytical lab groups

• Strong synergies with Quintiles Phase I and global sample logistics