QPS Global Capabilities Presentation

Find out how to achieve your next
development milestone ahead of time
www.qps.com

Bioanalysis
That Way
Navigating Drug Development
Toxicology
This Way
Early Stage Clinical
This Way
Translational Medicine
That Way
Phase II – IV Clinical
This Way
DMPK
That Way
Neuropharmacology
This Way

Introduction
How do we introduce ourselves to you?
Corporate Mission, Vision of Success & Values
History
Brief Company Overview
Global Presence
QPS’ Linearly Integrated Core Competencies:
Neuropharmacology
DMPK
Toxicology
Bioanalytical
Early Stage Clinical Development
Phase II - IV Clinical Development
Why QPS?
29 August 2013 Confidential 3

Mission
To accelerate the development of medicines worldwide
by enabling cost effective breakthroughs in
pharmaceutical innovation

QPS is a global leader in contract research.
We are known for our quality, technical
expertise, efficiency, and customer focus.
Our passionate and productive work creates value
for patients and customers while creating
opportunities for employees to grow and thrive.
Vision of Success

Values
Integrity – We make and keep promises and build trust through honesty, proactive
communication, and reliability.
Quality – We bring the highest level of technical expertise and judgment to our
work.
Customer Focus – We tap our global resources to provide service that is
fast, flexible, and integrated.
Commitment – We work hard to solve problems and deliver results.
People – We treat people with dignity, respect, and fairness, and embrace our
differences.
Culture - We are friendly and fun. We provide opportunities to grow, we value
loyalty and teamwork, and we recognize and reward performance.

History
Confidential 729 August 2013

Core Competencies:
Neuropharmacology
DMPK (Discovery → Development)
Toxicology
Bioanalysis (Small Molecules →
Biologics & Biosimilars)
Translational Medicine (Genetic →
Protein Biomarkers)
Early Stage Clinical Development (Phase
0 → Phase IIa)
Phase II - IV Clinical Development
(Phase IIb → Phase IV)
Strategically located sites (1000+
employees) in North America, Europe &
Asia
‘QPS offers breadth and
depth, plus seamless
integrated service from
drug discovery to regulatory
submission’
‘QPS is a global service
provider to the
pharmaceutical, biotechnolo
gy and generic industries’
Brief Corporate Overview

‘Servicing customers all over the world’

QPS’ Linearly Integrated Core Competencies
Discovery/Candidate-Selection Stage
Neuropharmacology, ADME and Tolerability Studies to
support Drug Discovery
Preclinical/Non-clinical Development Stage
Animal Toxicology studies to support regulatory filing
Development DMPK studies to support regulatory filing
Regulated Bioanalysis to support animal toxicology
studies
Immunogenicity for PD and safety assessment
Biomarkers for animal pharmacology studies
PK/TK modeling
Clinical Development Stage
Phase I Healthy Volunteer studies
Phase II to IV Patient studies
Development DMPK studies to support NDA filing
Regulated Bioanalysis to support clinical studies
Immunogenicity for efficacy and safety monitoring
PGx for patient stratification and efficacy monitoring
Biomarkers for efficacy and safety monitoring
Clinical PK/PD modeling
‘Have it all done in one place.
Saves you time. Saves you
resources. Saves you money.’
Since it is a long way
(…navigating your way….) to
the bedside’

Slide Deck Navigator
Navigate me directly to….
Global Neuropharmacology Services
Global DMPK Services
Global Toxicology Services
Global Bioanalytical Services
Global Translational Medicine Services
Global Early Stage Clinical Development Services
Global Phase II - IV Clinical Development Services
Why QPS?

‘helping you navigate your way through
the screening and lead profiling
of your CNS drug candidates’
NEUROPHARMACOLOGY

Brief Global Overview
‘Neuropharmacology services on the basis of scientific excellence and international
quality standards’
In Vitro Neuropharmacology Profiling
Neuronal Tissue Culture
Mode of Action
Full Safety Package
In Vivo Neuropharmacology Profiling
Transgenic and Non-transgenic Rats and Mice
Generation / Phenotyping of new Transgenic Rat and Mouse Strains
Screening for Efficacy
Lead Profiling
Molecular Biology, Biochemistry, Histology and Bioanalytics
Full Safety Package

In Vitro Cell Culture
‘In Vitro Cell Culture facilities equipped with the latest leading edge technologies’
Key Competences (non-exhaustive list)
Isolation and Cultivation of Primary Rat/Mouse Neurons
(Cortex, Hippocampus, TH-Neurons and Microglia)
Isolation and Cultivation of Primary Chicken Cortical Neurons
Cultivation of Cell Lines (SHSY-5Y, PC12, BV-2, HMO6, human
fibroblasts and ARPE-19)
Transfection (Over-expression, Knock Down) of
Cell Lines (or Primary Cells)
Functional Screening of Test Compounds in
different Cell Culture Systems In Vitro
Immunofluorescence Analysis

In Vitro Cell Culture
‘Screening for efficacious lead drug candidates with a special focus on Neuroprotection’
Key Deliverables (non-exhaustive list)
In vitro lesion models (MPP+, BSO, L-glutamate, Aβ1-42 a.s.o.) for
AD, PD, Ischemia, AMD
Oxidative stress and mitochondrial activity
Characterization of disease models in vitro (read outs:
viability, apoptosis, necrosis and mitochondrial activity)
Neurite outgrowth assay (primary hippocampal neurons,
image based analysis)
In vitro inflammation assays (cytokines, NO release)
Screening for secretase and phosphorylation inhibitors
Screening for acetylcholine and butyrylcholine esterase
inhibitors

In Vivo Animal Models
‘High quality and cost effective lead profiling’
Key Competences (non-exhaustive list)
Breeding
Non-transgenic Mice and Rat Models
MPTP (acute and chronic) induced Parkinson's
disease
MK-801-induced psychosis
Forced swim test (depression)
Scopolamine induced learning or memory recall impairments
6-OHDA induced injury of dopaminergic neurons
Transgenic Mice and Rat Models
All relevant transgenic models for Alzheimer’s Disease (AD) and Parkinson’s
Disease (PD) research available
Various genetically modified animal models: FTD, Amyotrophic Lateral
Sclerosis, Niemann Pick Disease and Huntington’s Disease
Cross-breds of the different strains form complete models of human disease

In Vivo Animal Models
‘Unique combination of in house characterized transgenic disease models with the
most advanced pharmacological readouts’
Key Deliverables (non-exhaustive list)
Acute and Chronic treatment via all common routes but also
intrathecal injection and infusions, Alzet™ osmotic mini pumps with
and without brain kit a.s.o.
Behavioral Test Data (over 20 paradigms):
General Health and Motor Ability;
Learning and Memory;
Anxiety, Depression;
Social Behavior, Attention and other Tests
Molecular Biology Data
Biochemistry Data
Histology Data

Molecular Biology
‘Our validated protocols for molecular biological assays allow for quantitative
evaluations which fulfill the strictest guidelines’
Genetic Testing
Generation of Expression Vectors for Transgenic Animals
Generation of Stably Transfected Cell-lines
Generation of Transgenic Mice
Genotyping of Transgenic Animals by Quantitative PCR
Analysis of Gene Expression by RT-PCR
Quantification of Virus Particles by PCR
Safety Monitoring for Gene Therapy

Biochemistry
‘Our GLP certified laboratory is ready to analyze all types of neurological biomarkers’
Bioanalysis in human blood or CSF samples
Amyloid beta, tau and phospho-tau, alpha Synuclein
Inflammation marker
Enzyme activity: Cholinesterase, Monoaminooxidase and Myeloperoxidase
Oxidative stress
Cholesterol
Analysis of disease related markers in brain, CSF, blood of Tg animal models;
Assay Techniques:
ELISA
Western Blot
Mesoscale Discovery Multiplex Assays
Enzymatic assays
Amorfix Aggregated Aβ Assay A4
(exclusively at QPS)

Histology
‘World-class quantitative histopathology services backed by a highly dedicated team
of histology, pathology, neurobiology and image analysis experts’
Histotechniques
According to principles of uniform, systematic random sampling
Vibratome, cryotome or slide microtomes
Immunohistochemistry
Standard stainings (e.g. H&E, Nissl, Congo Red, ThioS, Silver Stains)
Antibody testing (specificity, sensitivity)
Development of customer based multiple labelings (mainly fluorescent)
> 400 primary and secondary antibodies on stock
Imaging on fully automatized microscopes
High throughput multichannel mosaic imaging
Z-stacking for high magnification
Large data storage
Quantifications
Automated and semi-automated measurements
Total comprehensibility of obtained data to images
Customized quantification procedures and feasibility analyses

Why QPS?

‘helping you navigate your way through
the biotransformation of your drug’
DMPK

‘DMPK services include the necessary studies for regulatory filing at the appropriate
time and mechanistic studies when required’
Pharmacokinetics
Single and Multiple Dose, Dose Proportionality, Absolute Bioavailability, PK/TK Modeling
Mass Balance/Excretion/Radiolabel Studies
Formulation Optimization, Intestinal Permeability, other Mechanistic Studies
Protein Binding; RBC/Plasma Distribution Partitioning
Protein Covalent Binding
Tissue Distribution
Discovery QWBA
Quantitative Whole-Body Autoradiography (QWBA)
Micro-autoradiography (MARG)
Metabolism
Metabolic Stability, Species Comparison
CYP450 Inhibition/Induction
Metabolic Reaction Pathway Profiling
Metabolite Profiling & Identification – In Vitro, Preclinical, and Clinical
Rat PK 3-in-1 IV/PO
1
10
100
1000
10000
0 4 8 12 16 20 24
Comp'd #1(IV)
Comp'd #1 (PO)
Comp'd #2 (IV)
Comp'd #2 (PO)
Comp'd #3 (IV)
Comp'd #3 (PO)

‘QPS staff's experience is our biggest asset’
Team of senior DMPK scientists that all have on average 15+ years of pharmaceutical and
biotech drug discovery and development experience.
All were DMPK representatives on discovery and/or development teams.
Worked on > 50 INDs and > 10 NDAs.
Worked in different therapeutic areas (Antiviral, CV, Oncology, etc.)
The same group of scientists also has on average additional 10+ yrs of CRO experience.
Scientific Integrity and Quality
Each DMPK management team member has in-depth skill sets in different fields:
Formulation & Absorption
Pharmacokinetics & Protein Binding
QWBA & Micro-autoradiography
Metabolism
Metabolite Identification
Program Development Consulting
Address routine and mechanistic ADME issues
ADME Summary for Regulatory Submission

Discovery ADME Studies
‘QPS performs cost effective discovery ADME screens’
Metabolic stability
CYP inhibition
“Validated” process with FDA approved specific probe
substrates and chemical inhibitors
Protein binding
Equilibrium dialysis using conventional device or RED
or HT96
Rodent PK – linearly integrated
Formulation
In-life – Discrete or “N-in-1” dosing
Bioanalysis method development & sample analysis
“N-in-1” bioanalysis
PK calculation
Average turnaround time < 7.5 days from compound
receipt to reporting of data

Candidate Selection Studies
‘QPS experienced staff knows how to select your best IND candidates’
Pharmacokinetics
Formulation, dose proportionality
Intestinal permeability
Other mechanistic studies for
absorption and disposition
(or clearance)
Metabolism
Species comparison
Metabolite profiling and/or
identification
Pilot CYP mapping
Excretion
Route of elimination – BDC studies
Bile Duct-Cannulated Studies using 3H-labeled Compounds
0
10
20
30
40
50
60
70
80
90
100
110
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 59
# of Study
%DoseRecovered
Cage Wash
Feces
Urine
Bile
Average Recovery
87.4%
Bile Duct-Cannulated Studies using 3H-labeled Compounds
0
10
20
30
40
50
60
70
80
90
100
110
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 59
# of Study
%DoseRecovered
Cage Wash
Feces
Urine
Bile
Average Recovery
87.4%

Radiolabeled Studies
‘QPS has proven innovative study design and executional excellence for
radiolabeled studies’
Combination Mass Balance /Excretion QWBA study to address MB, tissue distribution, and
human radiation dosimetry questions
Better technical oversight
Eliminate the possibility of radiolabel degrading over an extended period of time
between the two studies and the requirement of re-purification
Increase efficiency using a single study protocol = ↓Study Cost
Metabolite Profiling and Identification in the same study
Both ion trap and quadrupoles tandem mass spectrometers for different MSn
experiments
Mass Balance Excretion Studies in Rats using 14C-labeled Cpds
0
10
20
30
40
50
60
70
80
90
100
110
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45
# of Studies
%DoseRecovered
Carcass
Air
Cage Wash
Feces
Urine
Bile
Average Recovery
93.8%

QPS Delaware DMPK Facility
‘DMPK function with all necessary equipment and self-contained for speed’
Vivarium – focus on mouse and rat with nine (9) rodent rooms
1 Surgical Suite
Triple cannulated animals for special models & in situ CSF
Intracranial infusions for up to 7 days
Eight (8) bioanalytical labs for dose formulation,
sample preparation, and analysis
Mass Balance Studies
Mass Balance Cages (Plastic and Glass)
Micro-Filter Cages for Mice, Nude Mice and Rats
In Vitro cell culture Lab
S9, microsomes, and hepatocytes
Tumor cell-lines for xenografts
LIMS
DEBRA and Watson
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
100.0
IV PO PO/BDC
PercentDoseRecovered
Rinse
Urine
Bile
Feces

Two (2) Autoradiography Labs for Macro- and Micro-autoradiography
Leica CM 3600 Cryomacrotome (whole-body)
Leica Vibratome 9800 (whole-body)
Leica CM 3050 S Cryomicrotome (individual organ/tissue)
Molecular Dynamics Typhoon 9410 Imager
Six (6) Imaging Research MCID Elite Systems
Support Equipment:
• Snap-freezing Equipment
• Photography Equipment
• Sample Oxidizers
• Liquid Scintillation / Gamma Counters
• Microplate Scintillation Counter
• Radioactivity / LC Detectors

Dedicated LC/MS/MS
Three (3) bioanalytical labs for sample preparation and analysis
Six (6) Mass Spec (5 Sciex API 4000s, Finnigan LTQ ProteomeX)
Waters UPLCs, Shimadzu VP-series LCs, Agilent 1100 LCs;
LEAP HTC/PAL injectors
Detectors – UV/Vis, Fluorescence, Electrochemical
Tomtec Quadra 96 for 96-well sample preparation
Radio-Quantitation
Two (2) Packard Model 307 Sample Oxidizers
Two (2) PE Tri-Carb 2800TR/2900TR Scintillation Counters
PE TopCount® NXT Microplate Scintillation Counter
Packard Cobra II Gamma Counter
Four (4) Radioactivity Detectors
ARC XFlow System; Off-line Fraction Collectors

‘DMPK function with all necessary accreditation, certifications, permits, and licenses’
AAALAC Accreditation
ABC License
CDC Permit
DEA Permit for Scheduled Control Substances (I-V)
Federal Fish & Wildlife Permit
NRC License for Radiochemicals
3H, 14C, 32P, 33P, 35S, 45Ca, 51Cr, 90Y, 99mTc, 111In, 125I, 188Re
OLAW Assurance
ORCA Certification
USDA Permit

Why QPS?

‘helping you navigate your way through the
safety of your drug’
Toxicology

‘QPS CTPS Taiwan is one of the most experienced toxicology centers in Asia’
Track Record
Over 1000 GLP Studies conducted since 1997
17 dossiers compiled for US FDA IND submission
18 dossiers compiled for Taiwan IND submission
Accreditations & Compliance:
AAALAC Accreditation since 2000
Taiwan Accreditation Foundation (TAF)
ISO 17025
Taiwan Department of Health (DOH) GLP
OECD (TAF) GLP
US FDA GLP compliance

Safety Evaluations
‘QPS CTPS is able to provide you the complete battery of toxicological tests
that is needed for the filing of your IND submission’
General & Reproductive Toxicology
Genetic Toxicology
General (non-GLP) Toxicity Testing
Pharmacokinetics with Bioanalysis
Biocompatibility Testing
Topical Toxicity Testing

General & Reproductive Toxicology
‘QPS CTPS is able to provide you with a comprehensive package of in vivo toxicology studies’
Single Dose Toxicity Studies
Repeat Dose Toxicity Studies
Up to 6 months in duration
Routes of administration: oral, intravenous (injection and
infusion), intramuscular, subcutaneous, intraperitoneal and others
Animal species: mice, rats, guinea pigs, hamsters, rabbits, dogs ……….and cynomolgus monkeys
coming soon!
Reproductive Toxicology
Fertility
Teratology
Animal species: rat and rabbit
Clinical Pathology
Urine Analysis
Hematology
Serum Chemistry
Histopathology
Tissue and Slide Preparation
Tissue Image
QA of Scanned Slides, Pathology Consultation and Evaluation by US Board-Certified Pathologist

Genetic Toxicology
‘QPS CTPS is able to provide you a broad panel of in-house conducted
genotoxicity tests’
Gene Mutation Assays
Ames Test/Mini-Ames Test
HPRT gene mutation assay
In Vitro mouse lymphoma assay
Cytogenetic Assays
Sister chromatid exchange assay
Chromosome aberration assay
Micronucleus Assays
Micronucleus assay in CHO cells and
human peripheral lymphocytes
Mouse micronucleus assay
Cell Transformation Assay
In Vitro cell transformation assay

Biocompatibility Testing
‘QPS CTPS is able to provide you with this high-quality niche service which primarily
involves the toxicity testing of medical devices’
Acute Systemic Toxicity Test
Pyrogen and LAL Test
Animal species: rabbit
Intracutaneous Irritation Test
Skin Sensitization Test
Cytotoxicity Test
In Vitro Hemolysis
Mutagenicity Test
Implantation Test

Topical Toxicity Testing
‘QPS CTPS is able to provide you with other high-quality niche services which
primarily involves the toxicity testing of dermatological and cosmetic products’
Irritation Studies
Eye irritation test
Dermal irritation test
Animal species: rabbit
Skin Sensitization Testing
Buehler test
Maximization test
Animal species: guinea pig

Why QPS for Toxicology
‘QPS CTPS Taiwan supports you with a quality operation for the highest value ’
US owned, 15-year US GLP study history (1997 - present)
Highly experienced toxicologists, US, EU and Japan trained
(DABT, DJST)
Highly experienced QA, registered with SQA
Large/small molecule, device development expertise
On-site clinical pathology, histopathology by DACVP, dose
analysis, bioanalytical
Established global procedures for sample shipping and data analysis
Remote video study monitoring
Gold standard animal sourcing (Charles River; Marshall Beijing)
State of the art automatic data collection system (Xybion Pristima®)
Considerable price savings versus US site labs

Why QPS?

measurement of your drug’
Bioanalytical

‘QPS is a global leader in bioanalysis for both small and large molecules’
Small molecules – using mass spectrometric techniques
Large Molecules - using ligand binding assay techniques
Global coverage of bioanalytical services with local presence in North America, Europe, India
and Asia
World leading…
Specialists (> 150 technical staff)
State-of-the-art equipment (API5500Q, API 5000, UPLC-MS/MS, ICP-MS, MSD6000 and Gyros™)
Capacity (> 45 Mass Specs)
Capabilities: LC-MS/MS, ICP-MS, LC-UV, LC-Flu, LC-ECD, LC-RFD, LBA, Hybridization-ELISA and RIA
Extensive validated assay list (> 800 assays and growing)
Rapid assay development, validation, sample analysis
Supporting a full range of development from Preclinical to Late Stage Clinical programs
Immunogenicity & Neutralizing Antibody Activity Assessment
Central Lab Services: Sample Logistics / Sample Repository / Preparation and Distribution of
Sampling Kits

Small Molecule LC-MS/MS
‘QPS is a global leader in bioanalysis
for small molecules and is able to
analyze samples coming from
different types of studies, containing
a wide variety of compound
structures and biological matrices’
Bioanalytical Method Development &
Validation
Sample Analysis for different evaluation
purposes:
Pharmacokinetic (PK) screening
Toxicokinetic (TK) studies
Clinical PK/Bioavailability studies
Bioequivalency studies
Therapeutic drug monitoring studies
Biomarker studies
Drug-drug interaction studies
Sample Analysis of different compound
structures:
Oligonucleotides Analysis
Peptide Analysis
Sample Analysis in different biological
matrices:
Dried Blood Spots
Tissues

Large Molecule
ImmunoBioanalysis
‘QPS is a global leader in bioanalysis for
large molecules and is able to analyze
samples coming from different types of
studies, containing a wide variety of
compound structures and biological
matrices’
Bioanalytical Method Development &
Validation for Biologics and Biosimilars
Sample Analysis for different evaluation
purposes:
Pharmacokinetic (PK) screening
Toxicokinetic (TK) studies
PK/Bioavailability studies
Bioequivalency studies
Therapeutic drug monitoring studies
Biomarker studies
Drug-drug interaction studies
Immunogenicity monitoring using
four-tier approach:
Screening
Confirmatory (immunodepletion)
Titer assessment (quantification)
Cell-based neutralizing antibody detection

‘QPS is an experienced provider of GLP trace
and ultra-trace elemental analysis in preclinical
and clinical studies by (LC)-ICP-MS. Applications
range from quantitative, high throughput
analysis (700 samples/day) to
qualitative, stability or metabolite profiling
studies .
Sample matrices are
blood, plasma, urine, feces, tissue or
formulation.
Examples of routine applications at QPS using
ICP-MS in drug development studies are:
Total and free Platinum (Pt) in oncology
studies
Platinum (Pt) in plasma and urine by LC-
ICP-MS for the metabolite profiling of a
new platinum compounds
Gadolinium (Gd) in plasma and urine by
ICP-MS supporting clinical studies with
MRI contrast agents and formulations
Magnesium (Mg), Calcium (Ca), and
Phosphate (P) in food and feces for
supporting a mass balance study of a
new phosphate binder
Ag, Zn, Al, Pd, Gd, Tc, I, P, S, Mn, Co.
Ni, Se, Cu, As, Si and Eu in different
biological or pharmaceutical matrices
Fe in Transferrin Co in Vitamin B12
8/29/2013 Confidential 46
Elemental Analysis in
Drug Development

Large Molecule LC-MS/MS
‘QPS believes strongly in this novel
bioanalytical application of
LC-MS/MS and can show you some
stunning results’
Bioanalytical Method Development and
Validation, and Sample Analysis
Oligonucleotides
Peptides
Proteins
Monoclonal Antibodies

QPS Delaware GLP Facility – Newark, Delaware, USA
‘QPS Delaware is a well-established high quality, cost-effective sourcing solution for
the analysis of PK and PD samples coming from preclinical and clinical studies
conducted in the USA’
Small Molecule LC/MS/MS
29 (25 Sciex API 4000 and 4 Sciex API 5000)
Large Molecule ImmunoBioanalysis
Capability in PK, Immunogenicity, NAb assay, and
biomarkers
Various technology platforms: ELISA, MSD ECL, GYROS
and RIA
Hundreds of validated methods (DDI CoMeds) available
Complete list available on website (www.qps.com)
WATSON LIMS System v7.4.1 with Immune Response Module
(IRM)
29 August 2013
Gyrolab™ Automated Immunoassay Workstation
Confidential 48

QPS Netherlands GLP Facility – Groningen, the Netherlands
‘QPS Netherlands is a well established high quality, cost-effective sourcing solution
for the analysis of PK and PD samples coming from preclinical and clinical studies
conducted in Europe’
8 Triple Quadrupoles Mass Spec (API 5500Q, 4000, 3000)
Capability in PK, Immunogenicity, NAb assay, and Biomarkers
Elemental Spectrometry (ICP-MS)
ICP-MS; total analysis, product testing, free and protein bound, e.g., Pt for oncology
LC-ICP-MS; speciation, metabolite identification, stability/degradation studies
UV-Vis Spectrometry, determination of radioactive labeled compounds
Hundreds of validated assay methods (DDI CoMeds) available
Logistically closely linked to the phase I unit to enable fast turnaround of plasma
concentration data of laboratory biomarkers and drug candidates during the conduct of first-
in man programs (SAD, MAD), human mass balance and microdosing studies, and trials with
instable compounds
24 July 2012 Confidential 49

QPS Bioserve GLP Facility – Hyderabad, India
‘QPS-Bioserve is a high quality, cost-effective sourcing solution for the analysis of
PK samples coming from bioequivalence studies conducted by QPS-Bioserve’s own
phase I Unit and from clinical studies performed in India’
7 Triple Quadrupoles Mass Spec (2 Sciex API 3200 and 5 Sciex API 4000)
Hundreds of generic methods available
Complete list available on website www.qps.com
QPS-Bioserve has a dedicated and experienced Pharmacokinetics & Statistics team, with
expertise in the application and presentation of PK and statistical principles, critical for
successful approval of generic product submissions:
Study design, sample size and statistical power estimation
Bioequivalence analysis
PK and PK/ PD analysis
In Vitro - In Vivo Correlation (with Pharsight™ IVIVC toolkit software)
WinNonlin™ for PK analysis and SAS for statistical analysis
Final Report submissions in E3/ CTD format

QPS Taiwan GLP Facility – Taipei, Taiwan
‘QPS-Taiwan is a high quality, cost-effective sourcing solution for the analysis of PK
samples coming from bioequivalence studies conducted by QPS-Bioserve’s own
Phase I Unit and from clinical studies performed in Asia’
4 Triple Quadrupoles Mass Spec (4 Sciex API 4000)
Capability in PK, Immunogenicity, Nab Assay, and Biomarkers
Hundreds of generic methods available
WATSON LIMS System v 6.4 (WATSON
v7.4.1 Coming Soon!)

Why QPS?

efficacy of your drug’

Global TLM Services
‘As an experienced provider of translational medicine services, QPS offers solutions to help
guide drug development teams at various stages, including patient stratification, toxicity
prediction, evaluation of PK profiles, dose determination, and treatment decisions’
Biomarkers
PD protein or biochemical markers
Various biomarker assay platforms (ELISA, Immulite®, Bioplex®, MSD® Imager 6000
ECL, GYROS, Flow Cytometry, LC-MS/MS and LC-ECD)
Cell-based & functional assays
Western Blot analysis & quantification
Radioligand binding assay
On-site cell stimulation and cytokine biomarker panel
evaluation
Pharmacogenomics (PGx)
DNA & RNA isolation and banking
Genotyping (SNPs, insertions, deletions, copy numbers, etc.)
CpG methylation quantification
RNA isolation & expression profiling (qRT-PCR)

Global TLM Services
Biomarker Panels
‘QPS offers laboratory biomarker panels for many different therapeutic areas’
Adrenal/Pituitary Disorders Diabetes/Lipid Metabolism/
Carbohydrate Metabolism
Reproductive Endocrinology
Allergy Gastrointestinal Thyroid Function
Alzheimer’s Disease Hemostasis/Angiogenesis
Anemia Infectious Disease
Autoimmune Disease Inflammation/Immune
Status/Cell Response
Bone Disease / Metabolism Oncology (Tumor/Neoplasia
Markers)
Cardiac Markers Phenotypic Markers of Drug
Metabolism
Cell Response Renal Toxicity and Function

Global TLM Services
Pharmacogenomics (PGx)
‘Genotyping and gene expression analysis services are offered by QPS to help
‘individualize’ disease therapies’
Nucleic Acids Isolation (DNA & RNA) and Banking
Genotyping (SNPs, Insertions, Deletions, Copy numbers, etc.)
CYP450 Genotyping Assays (CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C19, CYP2D6 genotyping
panels)
Genotyping Assays for Other Drug Metabolizing Enzymes (NAT1, NAT2, UGT1A1, CDA)
Genotying Assays for Transporters (ABCG2, SLCO1B1)
Genotyping Assays for Oncology (BRAF, KRAS, PIK3CA)
Genotyping Assays for Alzheimer’s Disease (ApoE, PPP3R1)
Genotyping Assays for Warfarin Therapy (CYP2C9*2, CYP2C9*3, and VKORC1 (-1639 G>A))
CpG Methylation Quant
Gene Expression Profiling in various matrices (qRT-PCR)
Pyrosequencing

Global TLM Services
Immunogenicity/Anti-Drug Antibody Testing
‘QPS is an expert in immunogenicity/ADA & Nab testing and has all the necessary
knowledge and assays technologies at its disposal’
QPS has supported 50+ biologic drug development programs for 23 sponsors (24 proteins
and 26 therapeutic antibodies) for which over 120 studies were performed.
Anti-Drug-Antibodies (Screening, Confirmation, and Titering) by ELISA or MSD ECL
Antibody Generation
Critical Reagent Labeling
Cell Based Neutralizing Antibody (NAb) Assays
Cell Banking and Maintenance
Technology Transfer
Custom Method Development and Optimization
Meso Scale Discovery

Global TLM Services
Neutralizing Antibody Assays
‘QPS is an expert in NAb testing and is able to apply its extensive knowledge and
application of new assay technologies to your benefit’
Since 2002 > 50 Studies conducted for 7 Sponsors
ELISA
Cell-Based Functional Assays, e.g. cell viability assay
Other Functional Assays, e.g. activity assay
Receptor Binding Assays

Global TLM Services
Novel Biomarker Assay Development
‘QPS is a frontrunner in adopting new assay technologies for biomarkers’
Various Technology Platforms (ELISA, BioPlex™, Immulite™, MSD ECL, Gyrolab™ and BD FACS Canto II)
Cell-Based Assays
Pharmacodynamic (PD) & Safety Markers
Multiplexing Genetic Markers (CYP450 TaqMan or Affymetrix DMET genechips)
Pharmacodynamic (PD) Assays
On-Site Cell Stimulation and Biomarker Analysis
Fit-For-Purpose Biomarker Assay Development and Validation (various matrices)
Protocol Design
Standard Curves from Custom 6-Plex Cytokine Assay
Concentration, pg/mL
1 10 100 1000 10000
signal
0
5000
10000
15000
20000
25000
IL-1ß
IL-2
IL-4
TNF-a
IL-6
INF-g
Luminex™

Global TLM Services
Analytical Platforms
‘QPS scientists and laboratory technicians are used to work and have many validated assays on
many different assay technology platforms’
ELISA Pyrosequencing Technology Platform
Roche Modular P® Affymetrix GeneChip Microarray System
Siemens Immulite® TaqMan Real-Time PCR System
Bioplex® (Luminex™) Gradient Gel Electrophoresis (GGE)
Meso Scale Discovery (MSD®) ECL Platform
(SECTOR™ PR100 and Imager 6000)
HPLC/UHPLC/UV/Fluorescence/ECD
Gyrolab™ LC – MS/MS
BD FACS Canto II® Ultracentrifugation
RIA Western Blot Analysis
Radioligand Binding Assay (SPA)

Why QPS?

‘helping you navigate your way
through the complex challenges of the early
development of your drug’
Global Early Stage Clinical Research

‘QPS is a global leader in Phase I/IIa studies’
QPS has one of the world’s largest Phase 1 site offerings with almost 500 Phase I beds on
three continents:
QPS offers a complete spectrum of early phase study types:
240 in Springfield, Missouri, USA 75 in South Miami, Florida, USA
20 in Hollywood, Florida, USA 92 in Hyderabad, India
40 in Taipei, Taiwan 58 in Groningen, The Netherlands
First-in-Man Programs (SAD + MAD + FE + CYP450) Human Mass Balance studies
Microdosing studies Imaging (PET, fMRI) studies
Clinical PK/PD studies Drug-Drug Interaction studies
Cardiac Safety/Thorough QT/QTc studies Bioavailability/Bioequivalence/ANDA studies
Vaccine studies Specialty Populations
Proof-of-Concept (PoC) in multiple therapeutic
areas

Biomarker Support
‘QPS is not only capable of conducting phase 1 studies for you in specialty and
patient populations but QPS is also capable of doing the additional measurement
and interpretation of therapeutic-specific biomarker data as well’
Adrenal / Pituitary Disorders Diabetes / Lipid Metabolism
/ Carbohydrate Metabolism
Reproductive Endocrinology
Allergy / Asthma / COPD Gastrointestinal Thyroid Function
Alzheimer’s Disease Hemostasis / Angiogenesis
Anemia Infectious Disease
Autoimmune Disease Inflammation / Immune
Status / Cell Response
Bone Disease / Metabolism Oncology (Tumor / Neoplasia
Markers)
Cardiac Markers Phenotypic Markers of Drug
Metabolism
Cell Response Renal Toxicity and Function

Full-Service Early Stage CRO
‘QPS is a full service early stage CRO that is not only capable of providing the clinical conduct of
your Phase 1 study but has the ability to provide the front and back end services as well’
Review of Preclinical Data
Design and Preparation of the Trial
Clinical Project Management
Preparation of the Study Protocol, Informed
Consent, and Case Report Forms
Clinical Conduct
Clinical Data Management
Biostatistics
Bioanalysis/Biomarker Assays
Conduct PK/PD and/or Pop PK/PD Data
Analysis and Modeling
Prepare PK/PD Report
Prepare and Publish Fully Integrated
Clinical Study Reports
Monitoring
Pharmacovigilance

QPS Bio-Kinetic – Springfield, Missouri, USA
‘QPS Bio-Kinetic is ideally suited to conduct a wide variety of phase I studies,
especially when substantial numbers of volunteers need to be recruited in record
breaking time’
5 Clinical Units with 240 beds on one Campus
Over 1000 studies completed since 1994
17 FDA Inspections
Clinical Staff Experience
8+ years average length of employment
Less than 3% staff turnover rate
37,000 subjects in database
Specialty Studies
Vaccine
Postmenopausal
Geriatric
Birth Control and Birth Control Naïve
Cardiac Safety/TQTc

QPS MRA – South Miami, Florida, USA
‘QPS MRA conducts complex phase I studies that other sites are unable to execute’
16,000 Square Feet facility
50 actively monitored beds
Unique high-level medical oversight
Healthy volunteers (FIM, SAD, MAD), specialty populations, and Proof-of-Concept (PoC) in
multiple therapeutic areas
Consistent high enroller, often exceeding contracted subject allocation
Excellent subject retention (over 90%)
Specialty & PoC Populations
Elderly Obesity
Hepatic Insufficiency Parkinson’s
Renal Insufficiency Depression
Psoriasis Pediatric ADHD
Type II Diabetes Arthritis
Rheumatoid
Osteoarthritis
Post-Menopausal Lupus
Hypertension On Demand

QPS Broward – Hollywood, Florida, USA
‘QPS Broward is an experienced Phase I site with a great track record in reliable and
efficient study conduct’
BRG established in 2000 – 10,000 sq. ft. facility
David Seiden, MD – Board-Certified in Sleep, Neurology, and Psychiatry
Healthy Volunteers/Special Populations – Sleep, Vaccines, Depression, Anxiety,
ADHD, Birth Control, T2DM, Obesity, Parkinson's, Alzheimer's, OA etc…
Over 150 Clinical Trials completed – Phase I-IV
BRG Facility
20 beds
15 ACRP-Certified Coordinators, Nurse Practitioner, Neuropsychologist, RN’s,
LPN’s, Sleep Technicians
QA / Regulatory depts
Laboratory, EEG, ECG, pulse oximetry recording equipment, polysomnography,
refrigerators, centrifuge, freezers (-20 C and -70 C)

QPS Bioserve – Hyderabad, India
‘QPS Bioserve is a full service Phase I site with a long list of regulatory approvals for
generic products that have been tested at this site’
Full-service CRO, all aspects of study (from study design to final report generation) are
conducted in-house
ISO 9001:2008 certified organization
Approved by the Drugs Controller General of India (DCGI)
Audited by the US-FDA in March 2008 & July 2009 (no 483s)
Inspected by UK MHRA and WHO in 2010
Over 630 conventional BA/BE studies conducted for various
regulatory agencies (130 are pivotal studies)
Twenty (20) products successfully approved by US FDA
Clinical End Point Studies: QPS Bioserve has experience in using PD end points or other
acceptable surrogate parameters to establish bioequivalence for products (e.g. locally
acting/topical preparations) for which it is impossible to use PK endpoints.
Examples: Sucralfate (suspension), Pentosan Polysulfate (capsules), Adapalene (gel)
Pharmacoscintigraphic Imaging
NCE PK studies like Food Effect, Dose Proportionality and Drug-Drug Interaction

QPS Taiwan – Taipei, Taiwan
‘QPS Taiwan is a full service Phase I site with a long list of regulatory approvals for
locally manufactured generic products’.
Full-service CRO, all aspects of study (from study design to final report generation) are
conducted in-house
Bioavailability / Bioequivalence Studies
Healthy Normal Populations
PK in Cancer Patient Populations
Scaled Average Bioequivalence
Conventional BA/BE studies conducted for various
regulatory agencies
More than 40 products successfully approved by Taiwan
FDA

QPS Netherlands – Groningen, the Netherlands
‘QPS Netherlands is ideally suited to conduct your FIM and more complex phase I
programs’
Hospital-based Phase I unit
Over 100 studies completed: 20 first-in-man programs (of which 12 with biologics); 7 PET studies; 6 Oral
Contraceptive (OC) interaction studies
Fast and easy access to top-notch medical, clinical-pharmacological, medical and scientific expertise
Parallel submission to Competent Authority (CCMO) and local Ethics Committee (EC) resulting in Clinical
Trial Approval within 14 days. Substantial amendments: 48h turnaround time; Dose escalations: 24h
turnaround time
Logistically closely linked to the bioanalytical laboratory to enable fast turnaround of plasma
concentration data of laboratory biomarkers and drug candidates
Specialty Studies:
Multi-Purpose Umbrella Protocols (SAD + MAD + food effect + CYP450
phenotyping) - adaptive designs with flexible dosing escalation schemes
Female Health Care (OC Interaction, Lactation and Fertility studies)
Validated neuropathic (capsaicin) and acute (M3 extraction)
pain models
Pulmonary/Respiratory Medicine
Imaging (PET, fMRI) studies
Continuous) CSF sampling in Healthy Volunteers and (Alzheimer) Patients
(Radiolabel (14C) Human Microdosing and Mass Balance studies

Why QPS?

‘helping you navigate your drug all the way
across the finish line’
Global Phase II-IV Clinical Research

‘Widely recognized for achieving high-quality study data
and high patient enrollment rates, QPS’ site management
& monitoring teams bring you years of experience’
Phase I - IV Project and Study Management
Clinical Trial Monitoring
Clinical Trial Logistics and Supplies
Data Management
Biostatistics
Medical Writing

Phase II – IV Clinical Study Experience
Phase II
67 Studies
Phase III
59 Studies
Phase IV
63 Studies
N = 189 Studies

Top 10 Therapeutic Indications

‘Apart from stand-alone clinical research activities, QPS is also able to manage your
entire clinical drug development program’
Clinical Consultancy and support through
Project Life Cycle
Design of Clinical Program and Individual
Studies
QPS will conduct your project according to
the protocol with high quality data within
timelines and within budget
Project Management

Site Management & Monitoring
‘Let QPS manage your Clinical Research Activities’
Site Selection, Patient Recruitment and Site
Logistics
Site Training
Study Reference Manual
Protocol/Study Materials
One-on-One Sessions
Train-the-Trainer Sessions
Online Presentations
Online Tutorials for EDC
EDC On-Site Monitoring
Study Initiation
Interim Visits
Study Close Out
Regulatory Document Collection, Review
and Submission
Site Audit and/or Qualification
Per Request
For Cause

‘State-of-the-art clinical trial management and electronic data capture systems
enable QPS to deliver first rate data management services’
Streamlined clinical information capabilities between QPS and Investigational Sites/Branches
Clinical Database
Paper based CRF
eCRF
Fast Data Base Lock
Data Management

Data Analysis for Late Stage Clinical Studies
SAS Programming
Exports of Tables, Figures and Listings
(TFLs)
PK / PD Analysis (including Pop PK)
Pharmacokinetic and statistical
consultancy
Study design including optimization of
PK sampling and power evaluation of
population size enrolled
Non-compartmental and
compartmental PK modeling
Population pharmacokinetics
Stand-alone PK/PD report
‘State-of-the-art clinical trial
management and electronic data capture
systems enable QPS to deliver first rate
biostatistics services’
Biostatistics

‘QPS can take care of all your medical writing needs’
Clinical Study Protocol
Investigator’s Brochure
IMPD (Investigational Medicinal Product
Dossier)
ICF
Scientific Publications
Final Clinical Report (CTD or eCTD)
Medical Writing

Clinical Advantages
Global capabilities yielding significant cost savings
Low turn-over of QPS staff, specifically CRAs
Access to a large network of investigators
Experienced central management and local expertise
Personal touch of a boutique CRO but with global
capabilities

Why QPS?
What sets us apart?
‘QPS will help you navigate your way through the complex challenges of the
development of your drug….and while navigating your way, you will enjoy having….’
Direct access to QPS’ people's minds!
Direct access to key personnel
Direct access to vast amounts of drug
discovery & development experience
Scientific expertise spanning preclinical
work to drug approval
Direct access to QPS’ people's hearts!
Enthusiasm
Professional attitude
Flexibility in meeting client needs
Focus on long-term professional
customer relationships
Direct access to QPS’ people's hands!
Responsive and committed to your timelines
Cost effective approach for program development

QPS Global Capabilities Presentation

QPS Global Capabilities Presentation

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QPS Global Capabilities Presentation

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