Using modeling and simulation to optimize your chances of clinical success

PREDICTING YOUR PATH TO APPROVAL

PAREXEL® CLINICAL RESEARCH SERVICES: QUANTITATIVE CLINICAL DEVELOPMENT

The path to smarter drug development is clear with PAREXEL’s modeling and simulation expertise.

YOUR JOURNEY. OUR MISSION™.

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PAREXEL’s global team of experienced scientists offer unsurpassed expertise in clinical PK/PD, pharmacometrics, and model-based drug development (MBDD) from translational sciences for First-in-Human (FIH) through all phases of drug development including marketed products. With pharmacometricians in the US and Europe, we offer seamless integration of PK/PD and modeling & simulation services across numerous therapeutic indications and all phases of development.

Our experts can provide scientific and regulatory input for:

• Optimizing the Phase I and II development program based on pre-clinical data and emerging clinical data (“follow the molecule” approach)

• Assimilating non-clinical data to select and justify the first-in-human dose and escalation scheme using PK/PD modeling and other techniques

• Identifying the target therapeutic concentration range together with potential Therapeutic Index (TI) relative to Cost of Goods (COG) estimates

• Continuously utilize emergent clinical data in an iterative fashion to refine the PK/PD model and inform evidence-based decision making, including Phase III trial design and dose selection

• Supporting NDA/MMA submissions, labeling and regulatory questions / interactions

PAREXEL’s Quantitative Clinical Development (QCD) team provides expertise in the strategic implementation of modeling & simulation services to help clients make smarter drug development decisions for a smoother journey to market. Through these services, our experts can help reduce the time and cost of bringing drugs to market, thereby enhancing our clients return on investment. We are committed to delivering the highest quality services to meet all aspects of regulatory compliance.

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YEARS OF OF DIRECT CLINICAL DEVELOPMENT

EXPERIENCE

PAREXEL QUANTITATIVE CLINICAL DEVELOPMENT HAS A CUMULATIVE

400+

15 MODELING & SIMULATION SCIENTISTS WHO APPLY

STATE-OF-THE-ART

METHODOLOGIES ACROSS

10+ THERAPEUTIC AREAS TO DRIVE MILESTONE

DEVELOPMENT DECISIONS

FOR FIRST-IN-HUMAN,

PROOF-OF-CONCEPT,

PHASE IIB RANGING &

SUCCESSFUL REGISTRATION

with more than

QUANTITATIVE CLINICAL PHARMACOLOGY

PAREXEL offers consulting and strategic partnering services designed to facilitate your drug development and clinical study designs at all stages of drug development, including:

• Strategic implementation of model-based drug development (MBDD)

• Development programs designed to rapidly identify promising new drug candidates

• Quantitative evaluation of probability of success for achieving target profiles using biomarkers and/or efficacy endpoints

• Early assessment of Therapeutic Index (TI) to drive future dosing options

PHARMACOMETRICS

PAREXEL’s Pharmacometrics capabilities provide the key elements for evidence-based decision making by:

• Developing fit-for-purpose models to characterize the PK/PD (exposure-response) relationship

• Providing a mechanistic understanding of the drug, disease and patient profile to inform future dose selection and justification

• Performing Clinical Trial Simulations (CTS) to enhance the probability of successful trial outcomes

COMPREHENSIVE CAPABILITIES

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SYSTEMS PHARMACOLOGY

PAREXEL offers full Systems Pharmacology support to inform critical development and investment questions with:

• Mechanistically supported systemic physiological response predictions

• Model-based translation of preclinical results to clinical outcomes

• Virtual population studies specific to your compound’s primary indication

• Integration of genetic markers to phenotype patient sub-populations

PK ANALYSIS & PROGRAMMING

PAREXEL’s Pharmacokinetic and Programming capabilities provide the essential components to address development questions and support registration / labeling by providing:

• PK analysis for enabling studies (e.g., drug-drug interaction) to inform future clinical study inclusion/exclusion criteria and labeling

• Expert interpretation of clinical PK evidence to determine whether dose adjustments are warranted for special populations (e.g., renal and hepatic impairment)

• Quality data integration and formatting services to provide Population PK/PD and meta-analysis ready datasets

PAREXEL’s Quantitative Clinical Development teams utilize various tools to deliver their services, including:

• Phoenix® WinNonlin® for non-compartmental and compartmental analysis, GastroPlus™ for physiologically based modeling, and Unix SAS® for programming purpose (e.g. NONMEM® data files)

• PDx-Pop® integrating NONMEM®, -R and MS Excel® for Population PK/PD and Modeling & Simulation analysis

• Reporting of all analysis in accordance with relevant guidelines

• Capturing, storing, managing, analyzing, and translating data into a secure, regulatory-compliant format

Our scientists can also provide planning, design, analysis and reporting for:

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We are always available for a conversation.

Yves Grenon T +1 781 434 4053 yves.grenon@PAREXEL.com

• SAD/MAD studies

• Bioequivalence/ bioavailability studies

• Food effect studies

• Drug-drug interaction studies

• Special population (e.g. hepatic and renal impairment and paediatric studies)

• Early QTc de-risking and Thorough QTc studies

• Mechanistic and Systems Pharmacology models for decision-making

WHEREVER YOUR JOURNEY TAKES YOU, WE’RE CLOSE BY.

© 2015 PAREXEL International Corporation. All rights reserved.

CORPORATE HEADQUARTERS

195 West Street Waltham, MA 02451 USA +1 781 487 9900

Offices across Europe, Asia and the Americas

www.PAREXEL.com