BATTELLE CANCER RESEARCH INITIATIVE. Bridging the Gap between Discovery and Application

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1 BATTELLE CANCER RESEARCH INITIATIVE Bridging the Gap between Discovery and Application

2 ANSWERING THE CALL TO END CANCER

3 Defeating cancer is among the most complex and ambitious goals mankind has ever attempted. No one is better equipped to rise to the challenge than Battelle. Battelle is the largest independent research and development organization in the world, with decades of experience spanning both public and private sectors. Translating cutting-edge science into practical, real-world solutions is just what we do and our award-winning team is ready to answer our nation s call to end cancer. Our Experience Battelle is a trusted collaborator for complex public health initiatives for the National Cancer Institute (NCI), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH) and many other agencies. We also have extensive experience in helping to bring new vaccines, therapies, diagnostics and drug delivery devices to market for the pharmaceutical and medical device industries. While our efforts have spanned projects ranging from childhood obesity to defense against chemical and biological warfare agents, cancer research has long been an important part of our project portfolio. Our prior and current cancer-focused projects include public health initiatives focused on cancer prevention, development of novel diagnostic devices, and safety and efficacy studies for new cancer therapies.

4 LABORATORY MANAGEMENT AND OPERATIONAL SUPPORT Laboratory Management is a core business of Battelle. Simultaneous Excellence is our approach, in which delivery of outstanding technical and mission performance and outstanding safety, security, facility operations and business function performance are equally valued. We operate extensive research facilities at multiple sites in the United States, and currently manage or co-manage seven national laboratories (Brookhaven National Laboratory [BNL], the National Biodefense Analysis and Countermeasures Center [NBACC], the Idaho National Laboratory [INL], the National Renewable Energy Laboratory [NREL], the Oak Ridge National Laboratory [ORNL], Lawrence Livermore National Laboratory [LLNL] and Pacific Northwest National Laboratory [PNNL]). Laboratory Management and Support Services Technical Onsite Professional Services (TOPS) Repository management Facilities management Scientific library services Business systems

Repository Management Through a joint project of CDC and the Agency for Toxic Substances and Disease Registry (ATSDR), Battelle provides ongoing oversight and management for the CDC and ATSDR

Technical Onsite Professional Services Our experienced personnel are providing key technical and management support to various federal agencies.

5 Repository Management Through a joint project of CDC and the Agency for Toxic Substances and Disease Registry (ATSDR), Battelle provides ongoing oversight and management for the CDC and ATSDR Specimen Packaging Inventory and Repository (CASPIR), the largest repository of biological specimens in the U.S. The biological library holds more than 6 million individual samples, including blood, urine, tissue and DNA, many of them unique in the world. Technical Onsite Professional Services Our experienced personnel are providing key technical and management support to various federal agencies. Our TOPS program puts qualified lab workers, managers and scientists to work in the agency s labs to support their goals. Technical staff placements include analytical chemists and biological lab workers, epidemiological program managers and other specialists. Management services include ongoing staff oversight, search and recruiting services; safety observations; staff education and reviews; and implementation of quality systems. Quality Management Systems Battelle has worked with NIH-NCI s Cancer Genome Atlas (TCGA) and Clinical Proteomics Tumor Analysis Consortium (CPTAC) programs to establish Quality Management Systems. These systems are designed to identify non-conforming data in the flow of information within the multi-site programs as early as possible and to help ensure that data released to the public are of the highest quality possible.

LIFE SCIENCES RESEARCH We provide a comprehensive suite of toxicology services, with extensive experience in pre-clinical research and safety pharmacology with small molecules, biologics and

Our toxicology team brings together world-class analysts, bioanalysts and statisticians with board-certified pathologists and toxicologists for an integrated approach to drug development.

6 LIFE SCIENCES RESEARCH We provide a comprehensive suite of toxicology services, with extensive experience in pre-clinical research and safety pharmacology with small molecules, biologics and vaccines, helping bring new therapeutics to the market. Our toxicology team brings together world-class analysts, bioanalysts and statisticians with board-certified pathologists and toxicologists for an integrated approach to drug development. Life Sciences Research Capabilities Assay development Biomarker identification Animal model development Vaccine, drug and biologic development; safety pharmacology; and efficacy testing Toxicology services including general toxicology, inhalation, developmental and reproductive, cardiovascular and pulmonary, and neurotoxicology Method development and validation

Biomarker Identification Battelle oversees the PNNL Clinical Proteome Characterization Center, part of the network of Protein Characterization Centers (PPCs) working to identify proteins and peptides

Our team is working on systematic discovery and verification of protein biomarkers that can be qualified in clinical studies using cancer specimens and associated data provided by the Center for

7 Biomarker Identification Battelle oversees the PNNL Clinical Proteome Characterization Center, part of the network of Protein Characterization Centers (PPCs) working to identify proteins and peptides in blood or other fluids that act as biomarkers for tumors. Our team is working on systematic discovery and verification of protein biomarkers that can be qualified in clinical studies using cancer specimens and associated data provided by the Center for Application of Advanced Clinical Proteomic Technologies for Cancer. Evaluating the Impact of an HPV Vaccine We conducted a pilot study for CDC to monitor the impact of prophylactic human papilloma virus (HPV) vaccine on HPV types in cervical and other HPVassociated cancers using tissues from the National Program of Cancer Registries (NPCR) and Surveillance, Epidemiology and End Results Program (SEER) cancer registries. The purpose of this project was to examine the feasibility of developing a surveillance system for HPVvaccine-preventable cancers and cervical precancers. This pilot study used CDC s established NPCR and SEER as the foundation for protocol development and data collection. We are currently engaged in the next round of this ongoing surveillance. Full-Service Toxicology and Safety Pharmacology Support to the NCI Program to Develop and Advance Emerging Cancer Therapeutics Life Sciences Research provides NCI with the full spectrum of general toxicology services; chemical and analytical support, including bioanalytical capabilities to perform pharmacokinetics (PK), pharmacodynamics (PD), bioavailability and bioequivalence studies; and broad safety pharmacology assessment capabilities including cardiac safety, absorption, distribution, metabolism and excretion (ADME) and genotoxicity studies.

PUBLIC HEALTH SERVICES Our research has long been trusted to guide program development and public policy for organizations such as CDC, NIH, NCI and many more.

Program Evaluation From gynecological cancer awareness to tobacco cessation, Battelle has been chosen to evaluate a wide range of large and complex public health programs.

8 PUBLIC HEALTH SERVICES Our research has long been trusted to guide program development and public policy for organizations such as CDC, NIH, NCI and many more. We support critical public health research and program development with expert evaluation, on-the-ground support and subject matter expertise for a number of cancer-related public health programs. Program Evaluation From gynecological cancer awareness to tobacco cessation, Battelle has been chosen to evaluate a wide range of large and complex public health programs. Our team combines deep experience in public health policy and program development with advanced data collection and analysis methods to provide insight into program effectiveness. Health Communications Our health communications experts can help you reach your target population with accurate, effective and easy-to-understand health information. We develop effective communication campaigns and educational programs to help people understand complex issues and make better health decisions for themselves and their families.

Cervical Cancer Prevention We are working with CDC and state-based cancer registries to understand the screening and care histories of women diagnosed with invasive cervical cancer in order to

Another study with CDC examined knowledge, attitudes and beliefs related to Pap and HPV testing among underserved patients and their providers.

9 Cervical Cancer Prevention We are working with CDC and state-based cancer registries to understand the screening and care histories of women diagnosed with invasive cervical cancer in order to identify facilitators and barriers to the receipt of routine screening and treatment of cervical neoplasia prior to invasion. Another study with CDC examined knowledge, attitudes and beliefs related to Pap and HPV testing among underserved patients and their providers. Colorectal and Prostate Cancer Screening We developed a systems-level intervention to improve colorectal cancer screening in primary care settings, which four medical practices in New Jersey implemented. The practices used clinical decision support tools and electronic health records (EHR) to build registries of patients who were due for screening and conducted outreach to patients due for screening. We have also developed, implemented and evaluated patient- and clinicfocused interventions to increase CRC screening in a study across 21 clinics. We have also conducted national surveys of medical providers to understand practices related to prostate cancer screening and HPV detection and management. Program Evaluation for a Gynecological Cancer Awareness Program Battelle completed an evaluation of the CDC s Inside Knowledge campaign, which is aimed at increasing awareness of gynecological cancers. Evaluating the Implementation and Outcomes of Policy and Environmental Cancer Control Interventions This project evaluates the 13 comprehensive cancer control (CCC) programs awarded additional funds by CDC (1017 Program) to increase their focus on Policy, System and Environmental (PSE) change strategies. The premise of the 1017 Program is that providing additional funding and convening a targeted taskforce will increase the ability of CCC programs to implement PSE change. Through rigorous evaluation of the program, this study will contribute to a limited but growing body of evidence for the effectiveness of health coalitions in achieving policy goals. The mixedmethod evaluation includes longitudinal case studies, surveys of CCC programs, a network analysis of 1017-funded programs and focus groups with technical assistance providers.

MEDICAL DEVICE DEVELOPMENT Battelle s proven, integrated approach to medical device design, development and validation is helping to condense development timelines and improve the

Our medical device team brings together unmatched experience in life sciences, device engineering, optics, analytics, human centric design and more to translate today s discoveries

10 MEDICAL DEVICE DEVELOPMENT Battelle s proven, integrated approach to medical device design, development and validation is helping to condense development timelines and improve the safety and efficacy of new medical devices. Our medical device team brings together unmatched experience in life sciences, device engineering, optics, analytics, human centric design and more to translate today s discoveries into lifesaving diagnostic and drug delivery devices. Drug Delivery Novel injection devices Contrast-media injectors Patch pumps Infusion pumps Skin permeation delivery systems Diagnostics Assay development Bioinformatics Optics development and engineering Human Factors Testing/ Human Centric Design Medical Device Cybersecurity

Expanding Drug Delivery Options We develop devices

enabling patients to self-administer more of them.

quickly identify and study tumor cells, including

Cervical Cancer Detection Battelle developed the

11 Expanding Drug Delivery Options We develop devices that deliver lifesaving drugs more effectively, enabling patients to self-administer more of them. Detecting Cancer Cells in Body Fluids We developed the technology behind RareCyte, a novel cellisolation device that enables scientists to quickly identify and study tumor cells, including cancer cells, circulating in the blood. Cervical Cancer Detection Battelle developed the ThinPrep Pap Test, an automated diagnostic tool that screens slides for cervical cancer cells.

12 About Battelle Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio, since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. What can we solve for you today? ú Ready to join the Battelle team? We are actively looking for top talent to join the Battelle Cancer Research Initiative. Visit to see open opportunities or contact us at Battelle and its logos are registered trademarks of Battelle Memorial Institute. Battelle Memorial Institute All Rights Reserved. ID /17

Regulatory Support for Tobacco Products. Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help.

Regulatory Support for Tobacco Products Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help. PREMARKET TOBACCO (PMTA) HUMAN FACTORS STUDIES SUBSTANTIAL EQUIVALENCE