qps tlm services

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With specialized pharmacogenomic and pharmacoproteomic biomarker assay capabilities in various therapeutic niches QPS supports development of targeted therapies and personalized medicines Translational Medicine Overview TRANSLATIONAL MEDICINE OVERVIEW PHARMACOPROTEOMICS PHARMACOGENOMICS ELISA BIOMARKERS MULTIPLEXING GENOTYPING FLOW CYTOMETRY

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Page 1: QPS TLM Services

Time is of the essence

in drug development,

so contact a member

of the QPS Business

Development Team today

and � nd out what QPS

can do for you.

HQ BD Offi ce Lily Rosa (USA)

+1 512 350 2827 [email protected]

Company 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 judgement to our work - Customer Focus - We tap our global resources to provide service that is fast, fl exible 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.

DARLING_130103_QPSBROCHURE1.indd 2 18-02-13 12:04

With specialized pharmacogenomic and pharmacoproteomic biomarker assay capabilities

in various therapeutic niches QPS supports development of targeted therapies and

personalized medicines

TranslationalMedicine Overview

T R A N S L A T I O N A L M E D I C I N E O V E R V I E W

P H A R M A C O P R O T E O M I C S

P H A R M A C O G E N O M I C S

E L I S A

B I O M A R K E R S

M U LT I P L E X I N G

G E N O T Y P I N G

F L O W C Y T O M E T R Y

DARLING_130103_QPSBROCHURE1.indd 3 18-02-13 12:04

Page 2: QPS TLM Services

Why should QPS be your fi rst and only choice to conduct all of your translational

medicine studies?

Direct Peer-to-Peer InteractionsAt QPS we realize that the quality of the biomarker data you receive from us is directly related to the scienti� c expertise that is available within our laboratories. Each of your biomarker programs will have a dedicated Study Director assigned who has the overall responsibility for the conduct of your study and is your single point of study control to get your science done. The Study Director is available to answer all your questions and provide analysis and interpretation of biomarker data.

Fast TurnaroundThe direction taken by your drug discovery and development programs can be substantially in� uenced by the timely availability of biomarker data. QPS’ state-of-the-art specialized biomarker laboratory services and fast turn around times will help you make your “go/no-go” decisions faster while reducing your total preclinical and clinical study costs. To meet your timeline requirements, we offer for instance custom genotyping services with 48-72 hour data turnaround for patient strati� cation and inclusion/exclusion decisions to support your global clinical Phase I, II, III, and IV trials.

Global FlexibilityBene� t from QPS’ global resources with the � exibility to transfer methods among any of our four specialized laboratory sites in the USA, Netherlands, Austria and Taiwan. QPS can provide you with a truly “� t-for-purpose” option to support your global clinical studies. QPS is in an excellent position to cater to the growing global biomarker needs by providing access to a large biomarker menu for many types of therapeutic indications.

Customer FocusQPS focuses on the needs of each client and works to ensure that those needs are met. We strive to ensure optimal communications so you have always complete visibility into your project’s status and can rest assured that your deadlines will be met and your budgets will not be exceeded. At QPS, we measure our success by your success.

Discovery Lab - InnovationOur experienced molecular biology and immuno-biomarker scientists can con� dently perform the biochemistry of your design, such as a proof-of-concept study originating from your lab or a collaborative effort between you and QPS. We will work to ensure your study is completed to global standards and procedures. Proper optimization and validation of assays are critical steps to your biomarker program. Proper validation includes an assessment of assay sensitivity, speci� city and precision. Additional criteria such as accuracy, LLOQ determination, linearity, interferences, normal range evaluation, robustness and other parameters apply for quantitative tests or as appropriate.

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

Call to schedule your tour at one of QPS’ worldwide locations today!

DARLING_130103_QPSBROCHURE1.indd 5 18-02-13 12:04

Introduction to QPS’ Translational Medicine Services:

With four highly specialized laboratory sites established in the USA,

Netherlands, Austria and Taiwan, where QPS’ translational medicine

laboratory scientists routinely develop and validate hundreds of new bio-

marker methods annually, QPS has positioned itself as a true global player

in translational medicine laboratory services. As an experienced provider of

pharmacogenomics and pharmacoproteomics services for clinical trials, QPS

offers you valuable translational solutions to help guide your drug develop-

ment teams at various levels,including patient stratifi cation, toxicity predic-

tion, evaluation of PK profi les, dose determination, and treatment decisions.

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

Call to schedule your tour at one of QPS’ worldwide locations today!

R N A I T H E R A P E U T I C S

M O N O C L O N A L A N T I B O D I E S

C L I A

T H E R A P E U T I C P R O T E I N S

G L P

P E R S O N A L I Z E D M E D I C I N E

DARLING_130103_QPSBROCHURE1.indd 4 18-02-13 12:04

Page 3: QPS TLM Services

Why should QPS be your fi rst and only choice to conduct all of your translational

medicine studies?

Direct Peer-to-Peer InteractionsAt QPS we realize that the quality of the biomarker data you receive from us is directly related to the scienti� c expertise that is available within our laboratories. Each of your biomarker programs will have a dedicated Study Director assigned who has the overall responsibility for the conduct of your study and is your single point of study control to get your science done. The Study Director is available to answer all your questions and provide analysis and interpretation of biomarker data.

Fast TurnaroundThe direction taken by your drug discovery and development programs can be substantially in� uenced by the timely availability of biomarker data. QPS’ state-of-the-art specialized biomarker laboratory services and fast turn around times will help you make your “go/no-go” decisions faster while reducing your total preclinical and clinical study costs. To meet your timeline requirements, we offer for instance custom genotyping services with 48-72 hour data turnaround for patient strati� cation and inclusion/exclusion decisions to support your global clinical Phase I, II, III, and IV trials.

Global FlexibilityBene� t from QPS’ global resources with the � exibility to transfer methods among any of our four specialized laboratory sites in the USA, Netherlands, Austria and Taiwan. QPS can provide you with a truly “� t-for-purpose” option to support your global clinical studies. QPS is in an excellent position to cater to the growing global biomarker needs by providing access to a large biomarker menu for many types of therapeutic indications.

Customer FocusQPS focuses on the needs of each client and works to ensure that those needs are met. We strive to ensure optimal communications so you have always complete visibility into your project’s status and can rest assured that your deadlines will be met and your budgets will not be exceeded. At QPS, we measure our success by your success.

Discovery Lab - InnovationOur experienced molecular biology and immuno-biomarker scientists can con� dently perform the biochemistry of your design, such as a proof-of-concept study originating from your lab or a collaborative effort between you and QPS. We will work to ensure your study is completed to global standards and procedures. Proper optimization and validation of assays are critical steps to your biomarker program. Proper validation includes an assessment of assay sensitivity, speci� city and precision. Additional criteria such as accuracy, LLOQ determination, linearity, interferences, normal range evaluation, robustness and other parameters apply for quantitative tests or as appropriate.

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

Call to schedule your tour at one of QPS’ worldwide locations today!

DARLING_130103_QPSBROCHURE1.indd 5 18-02-13 12:04

Introduction to QPS’ Translational Medicine Services:

With four highly specialized laboratory sites established in the USA,

Netherlands, Austria and Taiwan, where QPS’ translational medicine

laboratory scientists routinely develop and validate hundreds of new bio-

marker methods annually, QPS has positioned itself as a true global player

in translational medicine laboratory services. As an experienced provider of

pharmacogenomics and pharmacoproteomics services for clinical trials, QPS

offers you valuable translational solutions to help guide your drug develop-

ment teams at various levels,including patient stratifi cation, toxicity predic-

tion, evaluation of PK profi les, dose determination, and treatment decisions.

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

Call to schedule your tour at one of QPS’ worldwide locations today!

R N A I T H E R A P E U T I C S

M O N O C L O N A L A N T I B O D I E S

C L I A

T H E R A P E U T I C P R O T E I N S

G L P

P E R S O N A L I Z E D M E D I C I N E

DARLING_130103_QPSBROCHURE1.indd 4 18-02-13 12:04

Page 4: QPS TLM Services

Why should QPS be your fi rst and only choice to conduct all of your translational

medicine studies?

Direct Peer-to-Peer InteractionsAt QPS we realize that the quality of the biomarker data you receive from us is directly related to the scienti� c expertise that is available within our laboratories. Each of your biomarker programs will have a dedicated Study Director assigned who has the overall responsibility for the conduct of your study and is your single point of study control to get your science done. The Study Director is available to answer all your questions and provide analysis and interpretation of biomarker data.

Fast TurnaroundThe direction taken by your drug discovery and development programs can be substantially in� uenced by the timely availability of biomarker data. QPS’ state-of-the-art specialized biomarker laboratory services and fast turn around times will help you make your “go/no-go” decisions faster while reducing your total preclinical and clinical study costs. To meet your timeline requirements, we offer for instance custom genotyping services with 48-72 hour data turnaround for patient strati� cation and inclusion/exclusion decisions to support your global clinical Phase I, II, III, and IV trials.

Global FlexibilityBene� t from QPS’ global resources with the � exibility to transfer methods among any of our four specialized laboratory sites in the USA, Netherlands, Austria and Taiwan. QPS can provide you with a truly “� t-for-purpose” option to support your global clinical studies. QPS is in an excellent position to cater to the growing global biomarker needs by providing access to a large biomarker menu for many types of therapeutic indications.

Customer FocusQPS focuses on the needs of each client and works to ensure that those needs are met. We strive to ensure optimal communications so you have always complete visibility into your project’s status and can rest assured that your deadlines will be met and your budgets will not be exceeded. At QPS, we measure our success by your success.

Discovery Lab - InnovationOur experienced molecular biology and immuno-biomarker scientists can con� dently perform the biochemistry of your design, such as a proof-of-concept study originating from your lab or a collaborative effort between you and QPS. We will work to ensure your study is completed to global standards and procedures. Proper optimization and validation of assays are critical steps to your biomarker program. Proper validation includes an assessment of assay sensitivity, speci� city and precision. Additional criteria such as accuracy, LLOQ determination, linearity, interferences, normal range evaluation, robustness and other parameters apply for quantitative tests or as appropriate.

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

Call to schedule your tour at one of QPS’ worldwide locations today!

DARLING_130103_QPSBROCHURE1.indd 5 18-02-13 12:04

Biomarker Panels: Neurodegeneration Biomarker Panels Oncology Biomarker Panels In� ammatory Biomarker Panels Type 2 Diabetes Biomarker Panels Respiratory Biomarker Panels For a complete list of our Biomarker Panels please go to: www.qps.com

Genomic Biomarkers: Nucleic Acids Isolation (DNA & RNA) and Banking Genotyping Assays for Drug Metabolizing Enzymes (CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C19, CYP2D6, NAT1, NAT2, UGT1A1, CDA)

Genotyping Assays for Drug Transporters (ABCG2, SLCO1B1) Genotyping Assays for Oncology (BRAF, KRAS, PIK3CA) Genotyping Assays for Alzheimer’s Disease (ApoE, PPP3R1) CpG Methylation Quant Multiplexing Genetic Markers (CYP450 TaqMan or Affymetrix DMET genechips)

Gene Expression Pro� ling in various matrices (qRT-PCR)

Proteomic Biomarkers: Immunoassays Cell Based Assays On-Site Cell Stimulation and Analysis Custom Assay Development and Fit-For-Purpose Validation (various matrices)

Regulatory Status: CLIA certi� ed GLP Compliant

Analytical Platform USA Netherlands Taiwan Austria

ELISA/EIA x x x x

ECL (MSD) x x x x

Immulite Clinical Analyzer x x

Luminex (BioPlex) x x

Gyrolab x

Cell-Based Assays x x x x

Flow Cytometry x x

HPLC x x x

LC-MS/MS x x x

Nephelometry x

ICP-MS x

Western Blot x x

Enzyme Assays x x x

RIA/SPA x x

PyroSequencing(genotyping/epigenetics)

x

TaqMan (genotypingand qRT-PCR)

x

RNA/DNA Sample Prep & Analysis

x x

PCR x x x

In-Situ Hybridization x

Immunohistochemistry x

Colorimetric Assays x x x x

P R O D U C T I V E

P H A R M A C E U T I C A L I N N O V A T I O N

P A S S I O N A T E

B E N E F I T P A T I E N T S

DARLING_130103_QPSBROCHURE1.indd 6 18-02-13 12:04

Page 5: QPS TLM Services

Call to arrange for a tour at one of QPS’ four worldwide Translational Medicine Laboratories today

6 Hyderabad, INDIA 92 Phase I beds

7 Madrid, SPAIN 233 Phase I bed s

8 New York, FL, USA 22 Phase I beds

12 3

4

1 QPS|Delaware 2 QPS|Netherlands 3 QPS|Austria 4 QPS|Taiwan

DARLING_130103_QPSBROCHURE1.indd 1 18-02-13 12:04

Page 6: QPS TLM Services

Call to arrange for a tour at one of QPS’ four worldwide Translational Medicine Laboratories today

6 Hyderabad, INDIA 92 Phase I beds

7 Madrid, SPAIN 233 Phase I bed s

8 New York, FL, USA 22 Phase I beds

12 3

4

1 QPS|Delaware 2 QPS|Netherlands 3 QPS|Austria 4 QPS|Taiwan

DARLING_130103_QPSBROCHURE1.indd 1 18-02-13 12:04

Time is of the essence

in drug development,

so contact a member

of the QPS Business

Development Team today

and � nd out what QPS

can do for you.

HQ BD Offi ce Lily Rosa (USA)

+1 512 350 2827 [email protected]

Company 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 judgement to our work - Customer Focus - We tap our global resources to provide service that is fast, fl exible 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.

DARLING_130103_QPSBROCHURE1.indd 2 18-02-13 12:04