PPD S EXPERT HEMATOLOGY AND ONCOLOGY TEAM

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1 HEMATOLOGY ONCOLOGY

2 PPD S EXPERT HEMATOLOGY AND ONCOLOGY TEAM COMMITTED TO ADVANCING DRUG DEVELOPMENT IN ONCOLOGY $ MARKETPLACE COMPLEXITIES increasingly competitive marketplace and rising cost pressures UNIQUE GLOBAL CHALLENGES ever-changing global regulatory environment

3 More than 14 million cancer diagnoses are made each year globally,* and worldwide oncology sales are expected to reach $190 billion by 2022.** The stakes have never been higher. An increasingly competitive marketplace, rising cost pressures and an ever-changing global regulatory environment make it crucial to find a partner who understands the unique complexities and opportunities of this therapeutic area. With more than 30 years of hematology and oncology clinical trial experience, PPD is the partner of choice to provide the support, guidance and scientific expertise to position our clients for optimum success. We understand the importance of getting effective therapies to market faster. Clients can count on PPD as their partner in the fight to help patients worldwide. STRONG EXPERTISE IN ONE OF PPD S LEADING THERAPEUTIC AREAS Hematology/oncology is one of our leading therapeutic areas, and we have conducted more than 460 studies with clinical components within the past five years alone. Our team of dedicated hematology and oncology professionals includes medical oncologists, clinical and project managers, and more than 1,400 clinical research associates, giving clients the benefit of a focused specialty team and the resources of a global company. A global network of more than 21,500 investigators with hematology and oncology experience expedites trial startups to help speed the development of life-saving treatments to patients. Our expert staff and breadth of experience in this therapeutic area help clients move smoothly through all phases of drug development while focusing on the patients. Worldwide Support for a Global Fight With industry-leading scientific assets and on-the-ground resources in more than 47 countries, our 2,600 hematology and oncology professionals worldwide provide the global footprint necessary for success in today s regulatory and clinical environment. Key PPD personnel possess extensive experience in hematology and oncology including: 80 percent of our data management staff 70 percent of our biostatistics and programming staff *SOURCE: World Health Organization **SOURCE: EvaluatePharma 3

4 A LEADER IN HEMATOLOGY AND ONCOLOGY RESEARCH PPD has a broad spectrum of experience managing clinical trials in complex indications such as benign hematologic disorders, hematologic malignancies and oncology diseases, including rare tumor types and supportive care indications in patients with cancer. HEMATOLOGY/ONCOLOGY TRIAL EXPERIENCE (Past Five Years) HEMATOLOGY/ONCOLOGY STUDIES BY MARKET (Past Five Years) 35% 33% Phase I 120 Phase II 175 Phase III 153 Phase IIIb/IV 12 32% 41% Latin America 79 Asia Pacific 173 Europe, Middle East, Africa 300 North America 382 3% 26% 19% 8% PPD has worked on 28 approved hematology and oncology drugs in the past three years Other 8% Hematologic Disorders 9% GU Cancer 10% GI Cancer 7% Solid Tumor 13% Lung Cancer 11% Myeloma 6% Lymphomas 9% Breast Cancer 9% Skin 7% Leukemias 11% 4

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6 PROVIDING COMPREHENSIVE SOLUTIONS IN A COMPLEX ENVIRONMENT PPD is a partner with proven capabilities to support and advance oncology research for emerging fields and methodologies, including: Industry-leading expertise and strategies to support development of targeted therapies and cancer immunotherapies Expertise in translational research approaches, including use of broad tumor profiles and biomarkers and efficient adaptive trial designs Dedicated resources to support early phase hematology/oncology development Proven capability to design and operationalize adaptive and other innovative trial designs In addition to securing study sites, finding qualified staff and investigators to support each trial, and identifying eligible patients for enrollment, PPD also provides clients: Deep experience in research involving solid tumors, hematology, hematologic malignancies, and cancer-related pain and supportive care Access to adult and pediatric hematology/ oncology cooperative study groups and specialty organizations Assistance from our government services group to provide investigator support and development and management for National Cancer Institute (NCI) proposals A patient-centric strategy leveraging science, technology, data and innovation to bring the trial closer to the patient

7 THE SERVICES AND EXPERTISE YOU NEED. THE SUPPORT AND DEDICATION YOUR STUDIES DEMAND A specialized team of experts, the resources of a leading global CRO More than 50 percent of our total staff has direct experience in hematology/ oncology, which allows us to efficiently guide our clients through all phases of drug development to keep studies on track, on time and on budget. With a project management staff that is therapeutically aligned worldwide, PPD has employees whose sole focus is hematology and oncology. Our experienced project managers ensure that, from beginning to end, our hematology/oncology clients have a single point of contact committed to the safety and accuracy of their research. KNOWLEDGE AND EXPERIENCE TO ADVANCE IMMUNOTHERAPIES Immunotherapy, one of the most important advances in oncology in decades, is coming of age with the development and introduction of therapies based on immune-modulatory mechanisms, including vectorbased and dendritic cell vaccines, checkpoint inhibitors and adoptive cell transfer (ACT) therapies. PPD offers both the research and regulatory expertise to meet special development challenges posed by this emerging class of cancer drugs. For example, PPD can guide clients in the use of non-traditional endpoints in clinical trials. For vector-based vaccines that use genetically modified viruses, we lead the industry in operational approaches to address GMO-driven regulatory complexities and potential site issues. Our deep oncology experience and global resources make PPD an ideal partner to deliver such therapeutic advances. IMMUNO-ONCOLOGY CENTER OF EXCELLENCE PPD is a leader in immuno-oncology innovation having conducted more than 120 immuno-oncology programs that include checkpoint inhibitors, immune modulators, monoclonal antibodies, cancer vaccines, adoptive cell therapy and cytokines. Our Immuno-oncology Center of Excellence is the foundation of our program, providing regular updates to our project teams and clients about the competitive environment, efficient adaptive designs and the dynamic regulatory landscape that has evolved with these new and exciting immunotherapies. 7

8 Successfully addressing the complexities of hematology and oncology research requires a partner who not only understands their significance, but also has the resources and talent to deliver innovative and comprehensive solutions. THE UNIQUE ADVANTAGE OF PPD S GLOBAL PRODUCT DEVELOPMENT GROUP When clients choose PPD, they gain the benefits of our global product development group, which includes an experienced staff of hematologists and oncologists. As an integral part of our medical organization, this group is comprised of experienced drug development professionals who work with clients and our internal clinical operations and business development teams to provide global medical, scientific, regulatory and product development expertise. Our experts monitor study performance, adjusting strategies to maintain the required balance between protocol integrity and milestone achievement. Over the life of the study, they continually assess the global competitive landscape to make recommendations regarding necessary contingency plans and optimal locations for protocol conduct. PROVIDING SEAMLESS RESCUE STUDY ASSISTANCE When a study with another partner gets off track, PPD is often called upon to step in, take over and keep the study moving. Our extensive rescue study experience can save the client money, time and clinical resources, while simultaneously ensuring that much-needed therapies get to patients faster. Additionally, PPD has developed and evolved a suite of study transition tools and plans that are customized to a variety of rescue study scenarios, such as transition during the planning and site activation period, enrollment rescue, data quality rescue, data management and biostatistics transitions. THE UNIQUE ADVANTAGE OF PPD S GLOBAL PRODUCT DEVELOPMENT GROUP PPD s cross-functional Rare Disease and Pediatric Center of Excellence provides patient-centric solutions and disruptive approaches to recruitment. The center of excellence team works to address the strategic, operational, medical and scientific challenges presented by the small, widely dispersed patient populations that characterize rare diseases and drive trial participation and retention in this fast-growing area of drug development. EARLY DEVELOPMENT ONCOLOGY GROUP PPD understands that Phase I oncology trials are not the same as Phase I trials in other therapeutic areas. To address the differences and support the intensive nature of these studies, we have established a dedicated team within the hematology/oncology therapeutic area. This team of experts is charged with managing and educating the resources associated with early phase oncology trials and nurturing those trials through completion. EARLY PHASE ONCOLOGY SITES PPD has established relationships with a global group of sites for early oncology development. These sites achieve excellence in delivery across solid and hematologic malignancies and varying dose escalation study designs.. These sites are a combination of academic and non-academic sites with investigators who contribute expertise in complex study execution and enrollment in a competitive environment. 8

9 ACTIVATE SITES FASTER TO OPTIMIZE ENROLLMENT PPD is able to deliver studies on time with our proven trial optimization methodology. This four-part approach results in high-level site activation and performance and includes: Development consulting/early engagement Experts with deep therapeutic knowledge engage with clients before the study s protocol is developed or advise on an existing protocol to limit amendments and reduce costs. Data-driven analysis Analytics and expert recommendations are used to to improve forecasting in order to optimize both the protocol and the trial and to mitigate risk before a study begins. Investigator feasibility and site selection Sites and investigators with experience conducting similar studies and who are proven to recruit patients according to set timelines are recommended. Continuous feasibility and optimization A feedback loop is used to determine what parts of the trial optimization strategy are successful and what changes are needed to create time and cost savings. APPLYING ADAPTIVE TRIAL DESIGN TO HEMATOLOGY AND ONCOLOGY TRIALS Through the use of adaptive trial design, potential issues are revealed earlier, enabling faster go, no-go decision-making and more confidence in outcomes. Adaptive trial design has also seen an increase in Administration (FDA) issued its draft guidance in PPD s experience in planning and executing adaptive trial designs provides clients significant advantages that lead to safer, faster and more cost-effective outcomes. regulatory acceptability since the U.S. Food and Drug Berry Consultants Partnership PPD partners with Berry Consultants, a statistical consulting group specializing in the Bayesian approach and adaptive clinical trial design for pharmaceutical and medical device research, and development. Through this partnership, we are able to help clients plan for and effectively realize the benefits of adaptive trial design.

10 PPD LABORATORIES: A COMPLETE RANGE OF SOLUTIONS FOR HEMATOLOGY AND ONCOLOGY Across every phase of pharmaceutical development, clients count on PPD Laboratories industry-leading service offering and world-class scientific expertise to deliver the data needed for fast, accurate decision-making. Our hematology/oncology portfolio covers a wide range of disease mechanisms and targets. Our scientific leaders have extensive hematology/oncology research experience with small molecules, biologics, antibody-drug conjugates (ADCs), biomarkers and companion diagnostics. 95% PPD Laboratories helped develop 20 of the top 20 best-selling oncology drugs of 2016

11 PPD LABORATORIES OFFERS AN EXPANSIVE ARRAY OF LAB SERVICES INCLUDING: Bioanalytical Lab + + Assay development and validation in a good laboratory practice (GLP)-compliant setting years of industry experience and an extensive list of validated assays + + More than 11,500 studies in the past five years, 33% in oncology + + Substantial capacity and experience in ligand-binding assays, mass spectrometry (LC/MS), cell-based assays and immunochemistry Biomarker Lab + + Integration with both bioanalytical lab and central lab + + Assay development, transfer and validation capabilities across the regulatory spectrum from fit-for-purpose to full regulatory compliance + + Broad technical capabilities including flow cytometry/ cell-based assays, immunoassays, LC/MS, molecular genomics, immunohistochemistry and anatomic pathology Central Lab GMP Lab + + A leading provider of chemistry, manufacturing and controls (CMC) pharmaceutical development services + + More than 20 years of analytical experience working with both small molecules and biologics + + Technical expertise in method development and validation, stability, release and QC testing + + Extensive experience with extractables/leachables analysis and inhaled drug development + + Unparalleled regulatory history Vaccine Sciences: + + Over 20 years of experience developing vaccines + + More experience with FDA submissions than any other CRO + + Therapeutic experience in oncology, neuroscience and infectious diseases + + Unique collection of commercial vaccine assays including immunochemistry, opsonophagocytic, serum bactericidal and cell-based/functional assays + + Locations is Belgium, China, Singapore and the United States + + Access to more than 50,000 sites in 77 countries + + Hematology/oncology represents more than 25% of central lab studies + + A single, web-based global database that eliminates the need for integration and/or harmonization of data from different sources + + Globally standardized testing platforms + + Advanced technologies to provide clients and project teams secure and real-time access to lab data 11

12 For more information, please contact us at , or at Pharmaceutical Product Development, LLC. All rights reserved.