Navigating Complexity for Accelerated Growth

IN-MARKET EXPERTISE ACROSS THE PRODUCT LIFECYCLE

ASIA PACIFIC

An Integrated Approach for Optimized ResultsBiopharmaceutical companies, regardless of location, face high costs, long timelines and the need for enhanced data visibility. And in Asia Pacific, additional challenges await. Companies must adapt to government-imposed cost-containment methods and manage the push toward generics over novel therapeutics. To establish product safety and value, they must now conduct real-world risk-benefit assessments.

Implementing an Asia Pacific strategy can address these specific challenges and lead to transformative success. With our integrated capabilities, Quintiles can help you build a strategy that will support clinical programs

and commercial launch throughout Asia Pacific. Strengthened by local, in-depth therapeutic knowledge and a deep understanding of key regional issues, we can help you:

• Conduct local trials to navigate dynamic regulatory frameworks

• Demonstrate value to a broad range of local payers through tactics such as medical science liaisons, publication planning and late phase research

• Implement local market access and commercial strategies

From protecting patient safety to enforcing the highest quality measures, Quintiles maintains a strong ethical code of conduct to protect our customers’ global reputations and our own.

Capture the Promise of New Markets For an industry looking for new paths to growth, the Asia Pacific region holds vast potential. Fueled by rising and aging populations, a surge in chronic diseases and increased healthcare spending, the markets for new drugs are expected to explode over the coming decades. These trends aren’t confined to the traditional powerhouses of China and India. Markets from South Korea and Vietnam to the Philippines and Indonesia are bolstered by powerful economic forces.

However, significant complexity also defines the region. To gain approval, companies must often conduct local clinical trials and navigate unique regulatory frameworks. To drive product uptake, they must negotiate a diverse array of payers and providers and evolving pricing and reimbursement schemes.

Seizing new opportunities requires a partner with a track record of delivering results. Quintiles offers proven approaches to optimize any step of the product lifecycle. And our scientific, therapeutic, operational and regulatory experts are located in the markets you need to access. Together, an integrated strategy and the experience to implement it will give you the

confidence to accelerate a path to potential approval and market adoption. Quintiles provides:

• Unmatched reach: 28 offices in 15 markets in Asia Pacific, with more than 6,700 employees ready to deploy where you need them most

• Local expertise building on global resources: In-market experts, including more than 220 MDs and PhDs, and our own in-region central labs, backed by our global therapeutic centers of excellence to help increase your productivity and efficiency

• Strategic relationships: Alliances with local thought leaders, local partner sites, regulators and government agencies for enhanced clinical and commercial decision-making

Growing at a rate of 9.1% between 2008 and 2012, local trials accounted for about 60% of studies in Asia.BioPharm Clinical 15 January 2013

DESIGN AND EXECUTE TRIALS FOR BETTER OUTCOMES

Regulators in Asia Pacific increasingly require drug developers to run trials in the markets where they plan to launch. With Quintiles, you get a trusted partner who knows how to execute at the local level. Since 2008, we’ve conducted more than 700 projects throughout Asia Pacific, successfully recruiting more than 162,000 patients. Leveraging our on-the-ground therapeutic and scientific expertise, operational excellence and powerful data analytics, we help you optimize trial planning and execution across all phases of development through:

• Strategic Planning & Design: Our highly collaborative, data-driven approach to drug development strategy gives you the visibility into relevant data insights, the objective expertise to validate critical decisions – and the agility to move quickly.

• Study Start Up: We help you target the right patients and sites to streamline your clinical trials. Our local feasibility teams, and almost 70 site alliances in key therapeutic areas across the region, help reduce the likelihood of delays, resulting in more accurate timelines and more productive sites.

• Data-driven Trial Execution: Integrating data from diverse sources, we tailor a dynamic monitoring strategy based on our upfront risk assessment. We continually monitor key clinical and operational data to reassess risks to help ensure regulatory compliance and protect patient safety.

• Reporting & Oversight: Our breakthrough technology platform, Quintiles Infosario, gives you full transparency to your trials across the region – identifying risks before they threaten your timelines or quality. Between 2008 and April 2013, we have passed 24 regulatory inspections and/or accrediting body audits in Asia Pacific without a warning letter or sanctions.

AT THE CUTTING EDGE OF SCIENCE

With harmonized molecular biology, anatomic pathology and flow cytometry capabilities, our labs in China, India, Japan and Singapore follow the same SOPs as the rest of the Quintiles network, so you can count on consistent, quality results from patient samples obtained from any market. Quintiles is the first central lab with CAP ISO 15189 accreditation in two locations in Asia (Mumbai and Singapore). And, because our labs are located near your trial sites, we can help you navigate your regulatory or logistical challenges, minimizing shipping costs and expediting export/import approvals.

DEVELOP REAL-WORLD EVIDENCE TO WIN MARKET ADOPTION

Stakeholders are increasingly looking for demonstration of a product’s value. Quintiles will work with you to determine the right approach for developing the evidence payers, providers and patients demand. We can help you monitor safety, evaluate benefit-risk, and demonstrate efficacy and effectiveness with a full range of observational and late phase research, so you can gain market adoption and explore expanded labeling and indications. As a leader in real-world and observational research, we were contracted by the Agency for Healthcare Research and Quality (AHRQ) to develop the leading practices handbook, “Registries for Evaluating Patient Outcomes: A User’s Guide,” which has been used globally throughout the industry and is now available in Mandarin.

Quintiles Infosario® gives you a holistic view of your trial data so you can maximize efficiency while minimizing risk. That’s The Data Driven Difference™.

FLEXIBLE COMMERCIAL MODELS FOR GREATER REWARDS

Accessing each Asia Pacific market means understanding unique healthcare systems. With our in-region regulatory, market access and commercial experts, we leverage our local presence and practical experience to deliver insights you can act on. From analyzing stakeholder needs to performing benefit-risk and competitive analyses, we can help you create the right value proposition to apply for preferred formulary status and help achieve favorable pricing and reimbursement. We can also help implement a tailored plan for a seamless multichannel launch to help you maximize your commercial opportunities.

Accelerate your development in Asia Pacific. Quintiles’ median Phase III enrollment duration in the region is 120 days. That’s 35% faster than the global CMR International benchmark.

Local Resources, Right Where You Need Them In 1995, we established our regional headquarters in Singapore. Since then, we’ve won multiple industrywide accolades and built a significant local presence. Today, our in-market resources can deliver end-to-end services, helping you to optimize development and commercialization in your targeted markets and across the region.

CHOOSE A PARTNER THAT GETS YOU RESULTS

Across the region and at any point in the product lifecycle, Quintiles is positioned to help you succeed in Asia Pacific. From strategy to execution, count on us to bring efficiency and quality so you can quickly deliver your products to these promising markets. Contact Quintiles today to learn how.

JOIN US FOR SUCCESS IN THE NEW HEALTH. WE’RE HERE FOR YOU.Copyright © 2013 Quintiles. 01.28.02-052013

US Toll Free: +1 866 267 4479 Direct: +1 973 850 7571 Non US: +44 203 564 4649

Website: www.quintiles.com/asia-pacificEmail: asia@quintiles.com

QUINTILES IN ASIA PACIFIC

CLINICAL & REGULATORY

SERVICESCENTRAL LABS DATA & SAFETY

MANAGEMENT REAL-WORLD & LATE PHASE

MARKET ACCESS/COMMERCIAL

In-market consulting on regulatory, development and commercial strategy across lifecycle

AUSTRALIAEst. 1993

CHINAEst. 1997

Multilingual data management hub in Dalian

INDIA Est. 1997

Global hub

INDONESIA Est. 2006

Exclusive alliance with Jakarta-based Prodia Clinical Laboratory

JAPANEst. 1993

MALAYSIA Est. 2001

NEW ZEALAND Est. 1996

PHILIPPINESEst. 1998

SINGAPORE Est. 1995

SOUTH KOREAEst. 2000

Exclusive alliance with South Korea’s

premier bioanalytical provider, BioCore

TAIWANEst. 1998

THAILAND Est. 1998

VIETNAM Est. 2005

First CRO to establish a legal entity in Vietnam

In-country capability In-region capability