Your strategic guide to faster, smarter drug development

PAREXEL®

CONSULTING

Addressing your needs throughout the drug development lifecycle

YOUR JOURNEY.OUR MISSION.™

In a constantly evolving landscape, biopharmaceutical

and medical device manufacturers are looking ever

more critically at a drug development process largely

conceived in an era of blockbusters. Innovation can be

applied to solve the challenges of science and technology,

but achieving regulatory and reimbursement approval

demands more. We can help ensure commercial success by:

• Incorporating the needs and requirements of key

stakeholders early in the development process

• Demonstrating and communicating efficacy, safety

and value throughout the product lifecycle

• Developing and implementing innovative operating

models and processes to drive efficiency and

maximize portfolio value

On the journey to cure disease, the challenges can be daunting. As pressure builds on available healthcare resources, regulators are applying higher levels of scrutiny. Access to drugs is more consistently dependent on demonstration of value and effectiveness.

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OUR APPROACH

GLOBAL HARMONIZATION

Our global footprint is significant, but it is global harmoni-zation that allows us to provide high-level consulting, with the benefit of local expertise, to inform the best possible solutions to our clients’ most complex challenges across the world.

PERVASIVE OPTIMIZATION

Pervasive optimization and innovation refers to our constant pursuit to simplify the journey and focus on “what’s next?” throughout the product development lifecycle. It’s not just what we do; it’s how we do it that distinguishes our consultancy services.

THE BIGGER JOURNEY

Whether it’s strategic consulting on matters involving regulatory approval and compliance, development of a cost-effectiveness model, or a strategic partnership that allows for deeper collaboration throughout the development process, our consultative mindset makes us problem solvers and true partners from start to finish.

PAREXEL® Consulting is your strategic guide across the product lifecycle, overcoming the challenges, and accelerating imperatives to gain and maintain optimal product market positioning. Our scientific, regulatory, and commercial expertise put best practice standards to work for biopharmaceutical and medical device companies large and small, designing solutions for the complexities of an ever- changing global marketplace.

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OUR SERVICES

PAREXEL Consulting’s integrated services translate client vision to bold solutions throughout the development lifecycle. As your strategic partner and guide, we draw upon our unique fusion of expertise to effec-tively chart the best course for the future. We understand the need to differentiate your product today and anticipate how to sustain that competitive edge tomorrow—through to the next decade—and beyond.

Our focus is on maximizing the value of your portfolio, leveraging our unique fusion of scientific, regulatory, and commercial expertise.

IND/CTA

NDA/MAA(CTD)PRE-IND

PHASEI

PHASEII

PHASEIIB

PHASEIII

PERI-APPROVAL/PHASE IV

INTEGRATED PRODUCT DEVELOPMENT CONSULTING

REGULATORY SCIENTIFIC BUSINESS

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INTEGRATED PRODUCT DEVELOPMENT

ACCELERATING TIME TO MARKET WITH INTELLIGENCE, DATA AND STRATEGIC INSIGHTS

Sound global product and portfolio strategies require both specialized expertise and local resources. PAREXEL Consulting supports clients in the prioritization of assets and portfolios including determination of the most optimal regulatory and clinical paths available. Enhanced speed of patient recruitment and the potential for lower clinical trial costs are just two of the benefits your company may realize.

PAREXEL Consulting’s expert teams provide the intelli-gence, data and strategic insight necessary to prioritize portfolio development, shape global strategies, and map optimal clinical and regulatory pathways that speed time to market.

Led by an extensive team of former healthcare profes- sionals and regulators from around the world, we are an industry leader in strategic product development services, able to provide you with the data and insights you need to accelerate your products through regulatory and development hurdles, achieve regulatory approval, and support post-approval lifecycle management to enhance and extend commercial success.

Key Offerings

• Global product development strategy, planning and execution

• Regulatory strategy and intelligence services

• Health authority/agency consulting, advisory and liaison services

• Clinical trial applications (INDs, CTAs, CTNs)

• Regulatory submissions

• Comprehensive labeling services

• Clinical and nonclinical development consulting

• Global regulatory planning

• Specialized expertise to speed approval

•New product acquisition support

In today’s marketplace, biopharmaceutical and medical device companies must leverage the global environment to develop products efficiently, gain market advantage, and realize a return on investment. While opportunities abound, navigation can be complex, most notably given the changing topography at local, regional, and global levels.

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OPTIMIZING PERFORMANCE AND PIPELINE VALUE

Outsourcing has become a key competitive strategy in the life sciences industry, enabling clients to focus their expertise on core competencies and innovation while moving to variable cost models via a more agile workforce. By applying multidisciplinary expertise both internally and externally where it is needed most, regulatory outsourcing can reduce costs, improve processes, and accelerate approvals.

PAREXEL’s Regulatory Outsourcing Services leverage an operating model specifically designed to deliver a high- quality, cost-effective solution for lifecycle maintenance of established products. PAREXEL uniquely combines enabling technology, operational expertise, and both global and local market regulatory intelligence to deliver these services. The result is a scalable and flexible outsourcing model that results in predictable year-over-year savings and addresses the regulatory complexities, increased workloads, and limited budgets that are facing the industry.

Our Regulatory Outsourcing Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports, and other product lifecycle maintenance tasks.

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REGULATORY OUTSOURCING

Life sciences companies can expend up to two-thirds of their regulatory resources on maintaining products that have already been approved and are on the market. These maintenance activities provide little competitive advantage but are critically important to maintain sales.

As your trusted partner, delivering a net positive effect on your bottom line, PAREXEL’s Regulatory Outsourcing Services can help you stay focused on core competencies while improving processes to expedite your product’s time to market. Operational and cost efficiencies, process improvement, and the ability to align available human capital to more strategic regulatory activities are just some of the key benefits.

Key Offerings

• Submissionmanagement

• Regulatorydossiercompilation,publishing and dispatch

• Investigationalfilingsandlifecycle maintenance

•Marketauthorizationfilingsandlifecycle maintenance

• Post-approvallifecyclemaintenance

• Reportcompilationandpublishing

• Contentcreationanddocumentservices

STRATEGIC GCP/GMP COMPLIANCE AND RISK MANAGEMENT

There’s nothing more harmful to a company than having a product pulled off the market or having a high-profile approval delayed. Regulatory bodies around the world have become more aggressive in their enforcement efforts. Setbacks associated with routine FDA inspections, as well as more serious Warning Letters and Consent Decrees, are costly and often result in approval delays, product recalls, harm to reputation and adverse impact on shareholder value. Non-compliance is an expense that no biopharmaceutical company can afford.

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DRIVING VALUE BY MANAGING RISK

PAREXEL’s experienced team of former FDA investiga-tors and quality professionals proactively minimize risk as well as effectively respond to urgent compliance challenges. Our approach is grounded in the belief that compliance and quality should be managed as any other critical business issue. Proper quality management and a state of regulatory compliance will result in a decrease in direct costs such as rejects, and indirect costs such as adverse events and recalls.

PAREXEL Consulting offers compliance solutions for small and large companies, from loaned executives to global audits, ad-hoc advice or inspection readiness training. We help our partners manage risk effectively in global markets to protect and grow product and company reputation and value by developing practical, tailored plans that align global quality capabilities with business strategy.

Our team of experts includes renowned former regula-tors who know how to institute proactive compliance programs and have a strong track record helping companies out of regulatory crises. They are well versed in biopharmaceutical, medical device, and diagnostic regulations, and are focused on helping you create and maintain a culture of compliance and continuous improvement.

Key Offerings

•GxPcompliancestrategies

•GxPaudits

•Pre-approvalinspection(PAI)readiness

•Operationalreadinessandsustainabilityprograms(mentoring)

•Assistanceduringinspections/post-inspection correspondence and meetings

•AssistancetolegalcounselinFDAenforcementmatters

•Duediligenceofproductandfacilityacquisitions

• TraininginGxPcomplianceandtopicalissues

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HERON™ COMMERCIALIZATION

ELIMINATING BARRIERS TO ACCESS AND REIMBURSEMENT

PAREXEL Consulting offers a bold solution in the form of HERON™ Commercialization. Our expertise aligns evidence development and economic evaluation with pricing, reimbursement and market access strategy. We help you discover value and opportunity early and throughout your development process.

PAREXEL’s Commercial Decision Pathways lay the foundation for what will ultimately quantify the differentiation of product value and effectiveness globally:

Due diligence review for asset evaluation Systematic review of competitive and comparator treatments, economic analysis of market potential, epide- miologic analysis of patient populations, indication review (including sub-populations) and reimbursement/payer review in influential markets support go/no-go decision in the prioritization of drug and biologic acquisition.

Evidence-based compound/indication prioritization Early health economic modeling, review of competitive and comparator products, clarification of unmet needs and epidemiologic analysis of patient sub-populations inform compound development and indication sequencing, which contribute directly to commercial success.

Optimal reimbursement, target market access, and pricing are critical challenges for manufac-turers as they seek to achieve acceptable levels of return on investment after lengthy and costly development programs. Commercialization, particularly the evidence requirements of payers, however, has yet to be routinely integrated into clinical and regulatory planning. The consequence is noteworthy as many new health treatments fail to achieve their commercial potential.

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Clinical trial protocol, Target Product Profile and label claim development As critical milestones in the development process, each of these decision points requires trusted insights based on a review of comparators, payer coverage and data requirements, and health economic analysis of market requirements that support reimbursement and access through value demonstration and communication.

Evidence and economic needs assessment and evaluation Claims analysis and budget impact combined with comparative effectiveness models, value dossiers and comparative effectiveness research translate into a powerful and rigorous evidence strategy for successful reimbursement and sustainable market access.

Market access, pricing and reimbursement strategy Health Technology Assessment submission, payer value proposition development, geographically relevant market access strategies and qualitative and quantitative pricing research optimize market access by creatively addressing payer needs.

Aligning your commercial strategy with clinical and regula-tory planning early in the development process creates the opportunity to address contemporary and forward-looking needs of key healthcare stakeholders globally, realizing maximum return on investment and the greatest potential to positively impact the patient population.

Key Offerings

•EvidenceGeneration

• SystematicReviewandMetaAnalyses

• HealthEconomicModeling

• Data Analytics

• Global Value Dossiers and Country Reimbursement and HTA Submissions

• Strategic Payer Communications

•AccessRealization

• Health Technology Assessment Strategy and Submission

• Payer Value Proposition Development and Articulation

• MarketAccessStrategy

• Qualitative and Quantitative Pricing

• Evidence Assessment and Communication

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DRIVING BRAND PERFORMANCE THROUGH INTEGRATED, EVIDENCE-BASED COMMUNICATIONS

One of the most tangible return on investments in the drug development process comes from the translation of complex scientific data and healthcare discoveries into effective communications that motivate both healthcare professionals and payers, drive launch excellence, and accelerate product adoption.

OurMedicalCommunicationsteamprovidesthevitalsupport necessary to drive brand performance at each step of your journey.

We translate your scientific data and healthcare discover-ies into communications that motivate multiple audiences. We can help you achieve pre-launch and launch excellence

MEDICAL COMMUNICATIONS

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and accelerate product adoption and recommendation by healthcare professionals.

TheMedicalCommunicationsteamiscomprisedofworld-class experts including scientific strategists and medical writers, clinicians, and creative production teams. Our experts ensure that your medical and/or marketing message is disseminated accurately to support product positioning and appropriately for expert engagement. Strong technical and creative expertise also ensures that data are conveyed to all target audiences in a professional and compliant manner.

Our multi-stakeholder approach provides your product with the most effective medical communications support to succeed in the all-important launch window and help you achieve launch excellence and long-term brand success.

Key Offerings

• Communicationsplanningandimplementation

• Publicationsplanningandimplementation

• Scientific,clinicalandhealth-economicwriting

• Expertidentificationandengagement

• Exhibitsupport

• Brandinganddesign

• Digitalinteractivemedia

• Globalmeetingsandeventsmanagement

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FROM PROJECTS TO PARTNERSHIPS ON THE PATH TO CURING DISEASEWith a global presence and expertise in all aspects of the drug development journey, PAREXEL Consulting aligns clinical, regulatory, and commercial work streams while addressing specific client needs at any point in the drug development continuum. Your journey is to cure disease with efficacious, safe, and cost-effective health treatments. Our mission is to support you with talent and experience that result in faster, smarter drug development. We look forward to the opportunities.

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CLIENT PROFILES

Emerging to Mid-sized BioPharma

Specialty BioPharma

Large BioPharma

Medical Device/Diagnostics

Drug and Biologic Generics

Investment Banks and VCs

Law Firms

BioPharma Distributors

FROM PROJECTS TO PARTNERSHIPS ON THE PATH TO CURING DISEASE

Our regional leads are always available for a conversation.

THE AMERICAS

Jim Park +1 781 434 4086 jim.park@PAREXEL.com

EUROPE & ASIA PACIFIC

Heather Alford +44 1 895 61 4632 heather.alford@PAREXEL.com

1,200+NUMBER OF PROJECTS PER YEAR PAREXEL CONSULTING DELIVERS TO A VARIETY OF CLIENTS IN A BROAD RANGE OF THERAPEUTIC AND PRODUCT AREAS

THERAPEUTIC AREAS

Oncology

Cardiovascular

CNS

Endocrinology/Metabolism

Infectious Diseases

Allergy/Immunology

Pulmonology

Gastroenterology

Obstetrics/Gynecology

PRODUCT AREAS

Drugs

Biologics

Medical Devices/Diagnostics

Vaccines (Prophylactic, Therapeutic, Defense)

Biosimilars

Generics

Combination products

Other

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

©2014PAREXELInternationalCorporation.Allrightsreserved.Perceptive,PerceptiveMyTrials,LIQUENT,ClinPhone,DataLabsandIMPACTaretrademarksorregisteredtrademarksofPAREXELInternationalCorporationoritssubsidiaries. All other trademarks are the property of their respective owners and hereby acknowledged.

CORPORATE HEADQUARTERS

195 West Street Waltham,MA02451 USA +1 781 487 9900

Offices across Europe, Asia and the Americas

www.PAREXEL.com