exactly. The need for efficiency in developing effective new therapeutics has never been greater.

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2 exactly. The need for efficiency in developing effective new therapeutics has never been greater. As demands on the global healthcare system increase and treating disease becomes more complex, the research, discovery and development of new therapeutics has never been more important. Now more than ever, Charles River is committed to developing broader, more flexible relationships with our clients, providing tailored approaches to help accelerate and support research into the understanding of disease and the development and delivery of safe and effective new therapies. resources with the changing needs of a complex product development portfolio. With our global network of resources, high-quality products and services, state-of-the-art facilities and our expert staff, we are building a portfolio that provides exactly what our clients need to support their research programs. Our goal is to help accelerate research and drug development programs. Exactly. Our relationships with clients are evolving into strategic partnerships as we aim to become an extension of their internal organizations. From primary research through proof-of-concept, we deliver the capabilities and expertise needed to help balance their internal Our clients are facing a time of unprecedented change. The pressure to produce new, highly effective therapies more cost-efficiently, while meeting safety and regulatory requirements, has never been greater. By strategically supporting our clients with a unique portfolio of products, services, facilities and scientific expertise, we believe we can be part of the solution, partnering with them to accelerate drug development. Researchers are expanding their relationships with Contract Research Organizations like Charles River to help accelerate new compounds efficiently from discovery through the drug development continuum. JAMES C. FOSTER, CHAIRMAN, PRESIDENT AND CEO charles river 1 2

3 discover. With new technologies and an increasing understanding of the complexities of health and disease comes the opportunity to discover innovative therapeutics. Research and discovery requires innovation and flexibility at every stage. The appropriate use of models to identify a target, characterize compound disposition, determine a pathway or mimic a disease is essential to the discovery process. For more than half a century, Charles River has supported primary research needs, pioneering rigorous and exacting standards for animal production including strict biosecurity measures that ensure that our clients around the world receive reliable, predictive models. The key to rapid decision-making lies in high-quality assessment, rapid data availability and analytical expertise. We offer in vitro assays, in vivo screening tools, extensive xenograft and imaging capabilities and laboratory support services to help define and optimize lead candidates prior to the preclinical phase and the costly safety testing required for early-phase clinical trials. With extensive experience in research models, pharmacology and toxicology, combined with unmatched expertise in veterinary science, Charles River provides a high-quality customized approach to support research and discovery programs. Capabilities designed to help accelerate research and discovery: Research Models Discovery and Imaging Services Genetically Engineered Models and Services Surgical Services Research Animal Diagnostic Services Custom Antibody Production We are continually expanding our portfolio to provide comprehensive integrated services that align with our clients program needs and support researchers with the characterization and optimization of lead compounds. charles river 3 4

4 integrate. As newly discovered compounds move through the development process into the clinical phase and then to market, there is a critical need to balance efficacy assessment and patient safety with reduced cycle times. Whether in a single aspect of a study or through a full discoveryto-ind program, our scientists have the expertise to flexibly support and expedite all elements of preclinical work. We can assist with appropriate species selection, pre-ind consultation and toxicology and safety pharmacology study design approaches, supported by extensive laboratory services. and enhance the process, allowing maximum optimization of both internal and external resources and supporting the safe and effective acceleration of compounds through the drug development process. Our team is experienced in designing and conducting pilot and GLPcompliant general and specialty toxicology studies for a variety of compound types. Our involvement in clients preclinical programs allows us to aid in the seamless transition of a compound into Phase I clinical trials. Our consulting and regulatory experts can customize unique programs to navigate from preclinical into clinical development. Broad-based programs complement clients core competencies In addition, our early clinical development experience can aid in appropriate study design, stringent safety assessment and effective participant recruiting, ensuring that participant safety is a priority. Support to safely accelerate drug development: Safety Assessment Broad Specialty Toxicology Experience Early-Phase Clinical Trials Clinical Trial Support Services Therapeutic Area Expertise Regulatory Consulting We can help design and conduct studies to ensure the most efficient use of resources while delivering effective safety assessment programs from preclinical through first-in-human (FIH) clinical trials and beyond. charles river 5 6

5 accelerate. Rapidly obtaining the most accurate and reliable results is essential for safe and efficient quality control and manufacturing. The increasing number of novel biologics in development creates new challenges in the types of testing required to assess the manufacturing process, including the complexities of safety, potency and lot release testing. With a focus on regulatory guidelines, Charles River offers proven testing solutions and programs designed to address each step in the product manufacturing process. Rapid, reliable endotoxin test results are necessary to confirm the timely and safe manufacture of all injectable drugs and implantable devices, and the application of dialysis as well as cellular and nuclear therapeutics. As an extension of our trusted routine LAL testing products, our FDA-licensed Endosafe -PTS is an innovative handheld test system that provides quantitative results in just 15 minutes, with the convenience of portability. The new Endosafe -MCS system offers a complementary highervolume solution for laboratory settings. To meet the research and development needs of clients focused on virus and vaccine production, Charles River offers a comprehensive portfolio of avian products and testing services, including the specific pathogen-free egg. We also provide comprehensive testing, process validation and vaccine manufacturing services to help clients around the world develop and market biopharmaceutical therapies. Our services enable companies to meet regulatory guidelines and ultimately bring their products to market faster and more economically. Supporting our clients quality and manufacturing needs to ensure accurate and reliable results: Avian Products and Services Endotoxin and Microbial Detection Products and Services Biopharmaceutical Services, including: viral clearance, vaccine safety and manufacturing, cell line characterization and cell banking, in vivo biosafety and potency testing, bioassay development We support our clients quality and manufacturing needs through innovative services, products and solutions for in-process and final release testing of drugs, devices and vaccines. charles river 7 8

6 optimize. Expertise, experience, insight, flexible availability of resources exactly what is needed to support efficient research and drug development. Optimizing programs and maximizing resources are essential for today s research and development climate. Precise planning helps clients anticipate and navigate through the many challenges that can adversely affect research, delay development and cause unnecessary expenditure, and even ultimately prevent products from reaching their full market potential. These challenges may be related to animal care activities, drug safety, dose regimen, clinical planning or fundamental strategic approaches to program design. To help anticipate and overcome these hurdles, Charles River offers a range of consulting options and resources, including strategic assistance, regulatory and scientific advice, individualized program management, contract staffing within clients facilities and also veterinary care training. the experience, insight and knowledge necessary to help clients reach strategic milestones. This wealth of experience encompasses multiple disciplines, compound classes and therapeutic areas, enabling clients to leverage this expertise to manage a facility, design and direct focused research and development programs and prepare regulatory documents in a timely and efficient manner. Our goal is to provide exactly what our clients need to fully leverage their core competencies and extend their internal resources by flexibly utilizing ours. Optimizing programs and maximizing resources are essential for today s research and development climate. Our global network of scientific, regulatory and veterinary professionals and highly trained animal caretakers all possess Resources, experience and expertise to enhance our clients capabilities: Consulting and Staffing Services IND/Global Regulatory Consulting Program Management and Strategic Consulting Educational Programs charles river 9 10

7 commitment. The quality of our lives can be impacted by the quality of theirs. Humane care is not only a moral imperative, but a scientific necessity. Research animal models are an important resource that enables us to further our knowledge of living systems and contribute to the discovery and delivery of life-saving drugs and procedures for both humans and animals. In addition to the role we play in helping improve human health, we offer a full range of services to support development of products for animal health. We also continue to seek innovative ways to provide effective testing without relying on traditional research models. Charles River also implemented a global Humane Care Initiative nearly ten years ago. Going beyond the requirements set forth in global, federal and international regulations, this initiative raises awareness of the importance of humane care. Through effective orientation and training, we continually reinforce this culture of caring that has been a passion of Charles River employees for more than 60 years. Treating animals with care and respect can also directly influence the success of a research protocol. For decades we have fostered this culture across our company and around the globe to establish ourselves as a worldwide leader in the compassionate care of research animals. This concern for animal welfare is expressed in one of our core values: We are committed to the humane care of the research animals produced and used in all Charles River activities. As animal caregivers and researchers, we are all responsible for the health and well-being of the animals in our care. charles river 11 12

8 Market Approval NDA/BLA/MAA Submission IND/CTA Filing From the global standardization of our research models to the high standards that we set for our professional team and our state-of-the-art facilities and technologies, we can customize programs to meet the specific research needs of our clients. The Charles River portfolio of capabilities supports primary research and spans each phase of the drug discovery and development process. The breadth and depth of our portfolio allows for the customization of solutions, enabling clients to reduce costs, enhance productivity and increase speed to market, all with the convenience of working with one reliable partner. As pressure for efficiency increases, outsourcing non-core activities can alleviate internal bottlenecks and align internal resources with immediate needs, allowing clients to focus on proprietary drug discovery and go-to-market efforts. In the academic sector, Charles River remains strongly committed to supporting high-quality research through our globally exactly. standardized models and health surveillance programs, as well as our continuing technical support, and veterinary science and animal husbandry training. With approximately 70 facilities in 17 countries, Charles River aims to be the ideal partner for progressing new therapies from research models to humans in a rational, cost-effective and timely manner. Understanding our clients needs for global standards and compliance, flexible resources and a competent partner, we continue to invest in and expand our portfolio of technologies and resources to add the scientific expertise and capacity needed to support the efficient acceleration of drug development. Global Support for Research and Integrated Drug Development RESEARCH MODELS SERVICES FOR RESEARCH MODELS DISCOVERY, IMAGING AND PRECLINICAL SERVICES CLINICAL SERVICES EARLY RESEARCH Research Models Laboratory Animal Equipment PRECLINICAL DEVELOPMENT Research Animal Diagnostic Services Consulting and Staffing Services Genetically Engineered Models and Services Preconditioning Services Functional and Anatomical Imaging In Vitro and In Vivo Screening Lead Optimization Pharmacology Pharmacokinetics / ADME Pharmacodynamics / Biomarkers Safety Pharmacology IND Enabling Toxicology Genetic Toxicology Pathology Services Bioanalytical Services Strategic / Regulatory Consulting PHASE 0/I Early-Phase Clinical Trials Central Laboratory Clinical Bioanalysis Data Management and Biostatistics CLINICAL TRIALS Subchronic / Chronic Toxicology MARKET PHASE II PHASE III PHASE IV Developmental and Reproductive Toxicology Carcinogenicity Studies BIOPHARMACEUTICAL AND VACCINE SUPPORT SERVICES IN VITRO DETECTION SYSTEMS Viral Safety Vaccine Safety and Manufacturing Cell Line Banking and Characterization Potency, Stability, Bioassay Development In Vivo Biosafety Avian Products and Services Endotoxin and Microbial Detection Products and Services charles river 13 14

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