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October 2015 - Issue 5
Welcome to the Battelle Health & Analytics, a quarterly publication from Battelle. We put this together as a service to our public health clients, to keep you informed of the latest public health news from our researchers and the industry.
The Battelle Health & Analytics team works with agencies and healthcare institutions to advance public health research, practice and policy with the latest science and technology. Battelle Health and Analytics will keep you up-to-date on cutting edge research and public health innovations.
Where are advances in healthcare taking us? Dr. Sudip S. Parikh, Vice President and General Manager of the Battelle Health & Analytics group, recently weighed in as a panelist at Research!America’s 2015 National Health Forum, held Thursday, September 10 at the Newseum in Washington, DC.
The annual Straight Talk! program brings together researchers, industry leaders, policy makers and healthcare providers to talk about legislative and regulatory issues that impact medical research. The panel discussion, moderated by NPR’s Richard Harris, explored the relationships between patient advocates, policy makers, industry and other stakeholders in making new treatments and technologies available. The wide-ranging discussion touched on the importance of public-private partnerships, challenges with privacy in the age of data sharing and the need for more collaboration among researchers.
Dr. Parikh, who has been with Battelle since 2009, has a long history of health research advocacy. From 2001 to 2009, he served as a Science Advisor for the United States Senate Appropriations Committee, during which time he received several Distinguished Professional Staff Awards and Public Service Recognition Awards for his work advancing biomedical research, juvenile diabetes research, HIV care, and other important health research initiatives. In his work at Battelle, he continues to share his expertise in national forums and advocate for science-based solutions for public health challenges.
We may soon have new weapons in the fight against microscopic pathogens. Researchers at Battelle are developing advanced materials with antimicrobial properties that could help prevent the spread of diseases.
The need for new antimicrobial options is especially urgent in healthcare settings, where hospital-acquired infections still affect 1.7 million people and contribute to as many as 99,000 deaths annually, according to the CDC. But interest in antimicrobials stretches far beyond the clinic. Antimicrobial agents have made their way into consumer products including soaps, mouthwashes and cleaning supplies, and are increasingly found in clothing, carpets and other household products.
Most antimicrobial products rely on chemical biocides. While these options can be effective and are generally considered to be safe, there is growing concern among consumers and healthcare providers about potential unintended consequences of long-term use. Chemicals in soaps and other products lack specificity to particular microbes of interest, can accumulate in the environment, and may accelerate the evolution of antibiotic-resistant bacteria. In addition, these products do not keep surfaces sterile for an extended period of time; surfaces have to be continually rewashed with the biocides in order to keep microbes from accumulating.
For these reasons, interest is growing in materials with inherent antimicrobial properties. Integrating antimicrobial materials into hospital surfaces and equipment could help to reduce the risk of hospital-acquired infections. Schools, commercial and government buildings, and other public gathering places could also benefit from materials that slow the spread of colds, influenza and other pathogens. Building antimicrobial properties directly into materials would offer longer-lasting protection from microbe build up and avoid many of the potential unintended consequences of chemical biocides.
Battelle researchers are working to make antimicrobial materials a reality. The Battelle initiative, called “Surfaces by Design,” focuses on engineering materials (hard surfaces, coatings, and gels) to meet specific application needs, including antimicrobial characteristics. Some of the most promising areas include:
Antimicrobial materials could be used in a wide range of products such as surgical implements, hospital scrubs, medical devices, computer keyboards, and walls and floors in sterile areas. Different applications will call for different antimicrobial approaches. Battelle researchers are working to design smart surfaces, coatings, gels and other materials that incorporate effective and application-appropriate antimicrobial properties.
Sometimes, trial and error just doesn’t cut it—like when you’re determining the effective dose for vaccines and therapies for deadly diseases. You can’t just expose people to anthrax or Ebola and see what happens.
So how do researchers know what dosages will be effective in humans? The Battelle Health & Analytics team applies advanced statistical methods to help answer some of these critical questions. Since 1987, the team has supported studies on many of the most deadly pathogens and chemical agents, including nerve agents and other chemicals used in warfare, deadly pathogens like Ebola and anthrax, and dangerous strains of flu. Their work has been instrumental in assessing the effectiveness of treatments and vaccines and determining the correct dosage for human use.
The Battelle Analytics team supports both government agencies and commercial pharmaceutical companies to accelerate the development and validation of effective treatments for some of today’s most urgent public health and military threats. Using sophisticated analytical, computational and bioinformatics methods, they are able to quickly find meaningful patterns in large volumes of information from non-clinical trials. This work helps researchers target efforts to the most promising treatment options and bridge the gap between alternative models and humans.
Many of the agents and pathogens the team works with are considered too dangerous for traditional human clinical trials, or have natural outbreaks that are too rare to test the efficacy of vaccines and therapies. While it may still be possible to conduct safety testing in humans for these products, there is no direct way to know whether a certain dose of the therapy or vaccine will be effective without exposing people to the chemical or pathogen—which of course would be highly unethical.
Since 2002, the FDA has provided an alternative regulatory pathway for proving the efficacy of therapies and vaccines for deadly pathogens and chemicals. Passed in response to concerns about bio- and chemical warfare after 9/11, the FDA Animal Rule, as it has come to be known, allows alternative models to be used to determine efficacy of new products.
Extrapolating the data from these alternative models to determine potential efficacy and appropriate dosages for humans requires advanced analytical methods. The Battelle Analytics team provides support at every stage of the process:
For example, to support development of a new vaccine for a deadly pathogen, the analytics team first helps researchers to validate animal models by demonstrating that response to the pathogen is substantially similar to human response. During non-clinical trials of a candidate vaccine, data must be collected and analyzed to determine the level of immune response provoked with different doses of the vaccine. Then additional data is collected to determine how these different measurements of immune response correlate to actual protection if exposed to the pathogen. When the vaccine is tried in humans, researchers look for biomarkers that indicate a similar level of immune response. Similar immune response can be assumed to provide similar levels of protection as seen in the animal model, without exposing human subjects to the disease.
Without the alternative models and statistical methods, development of effective treatments and vaccines for deadly agents would be nearly impossible. Many of the projects that the Battelle Analytics team supports are considered critical for military force readiness and protection of troops against bio-warfare and chemical agents. Other projects have broader implications for public health, such as a flu vaccine study for a potentially deadly strain of flu supported by the National Institutes of Health (NIH) National Institute of Allergies and Infectious Diseases (NIAID). By applying advanced analytical methods, the team is doing their part to make the world a safer and healthier place.
The popularity of waterpipes for tobacco smoking is growing rapidly nationally and worldwide, especially among youth. However, with a wide variety of available waterpipe designs, materials, accessories and tobacco products, it has been difficult to determine how different components might impact puffing behavior and subsequent exposure to toxins. Researchers at the Battelle Public Health Center for Tobacco Research have developed and validated a standardized research-grade waterpipe (RWP) in order to support a better understanding of the relationship between users’ behavior and their toxin exposures.
The study, published by the Oxford Journal of Nicotine & Tobacco Research, validates the use of an RWP developed by Battelle researchers for waterpipe tobacco exposure and behavioral studies. The RWP can be configured with an in-line topography system that allows for the real-time measurement and recording of smoke volume through the RWP. In order to calibrate and validate the device, researchers collected quantitative and qualitative data from experienced waterpipe smokers in a highly controlled laboratory setting.
The device was well accepted by experienced users, who rated it similarly to commonly used waterpipes in terms of satisfaction and reward. It also delivered highly reproducible quantitative results, where puff volumes agreed strongly with true values. Because the RWP operates with known precision and accuracy and is well accepted by experienced smokers, it gives tobacco researchers a reliable tool to gather data for future studies involving waterpipes.
Further research is urgently needed to better understand the public health implications of increased waterpipe use. Over the last decade, the popularity of the devices has exploded among teens, most noticeably in the Middle East and North Africa but now spreading rapidly in the U.S. and Europe. In 2010 - 2012, the most recent data available, 18% of U.S. high school seniors reported that they had used a waterpipe in the past year. However, little is understood about the comparative risks of different waterpipe designs and products and how different accessories may impact user behavior and exposure.
For example, how do popular flavor additives for waterpipes—available in flavors such as chocolate, apple or mango—impact consumer appeal, puffing behavior and overall toxin exposure? How do nicotine levels impact user behaviors such as puff volume, duration and number? This standardized RWP will allow for more accurate, precise and reproducible data collection in order to answer these and other critical questions related to waterpipe use.
Researchers from Battelle, along with partners from the University of South Carolina, the University of Kansas and the University of California-Berkeley, have published detailed protocol papers for Healthy Communities Study (HCS), a large-scale study examining the impact of school and community health programs on childhood obesity rates.
The seven protocol papers were published as part of a special feature section in the October edition of the American Journal of Preventative Medicine. Each of the seven papers describes a specific aspect of the study. Taken together, they outline the full study protocol. Four of the seven papers were led or co-led by Battelle researchers. Papers include:
The National Institutes of Health (NIH) study, led by Battelle, is the first systematic study to attempt to correlate the characteristics of community programs and policies targeting childhood obesity and children’s obesity-related outcomes. Researchers gathered extensive data from community leaders and households in 130 communities across the country. The results will provide critical insights into what appears to be working to prevent childhood obesity in different types of communities, and help to inform public policy and design effective youth programs.
Making the study protocol papers fully available to the research community will provide a fuller understanding of the results and implications of this landmark study. Data analysis is still underway. Full results will be published in 2016.
Battelle has recently been awarded a new Indefinite Delivery/Indefinite Quantity (IDIQ) contract from the Centers for Disease Control and Prevention (CDC), along with several new task orders for existing contracts. Battelle was selected for these projects because of our experience and proven past performance in a broad range of public health arenas, including program and policy assessment and analysis, program management, evaluation design, data collection and analysis, information technology, and more.
This ten-year IDIQ, with a ceiling value of $170M, is for information technology and data analytics work to support the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD). The IDIQ put Battelle on a list of federally approved vendors who can bid on task orders put out as part of the project.
NCIRD is working to coordinate and integrate state and regional Immunization Information Systems (IIS) to allow for better coordination of disease control efforts between states. An ISS is a confidential, population-based database that tracks immunizations administered by participating providers. The systems allow for population-level monitoring of immunization rates and effectiveness and support ongoing efforts by the NCIRD to improve immunization rates and reduce the spread of preventable diseases.
Currently, there are a number of state and regional ISSs in use across the country. The goal of ICRA is to help integrate these systems so that data can be more easily shared between states and analyzed on a national level. Battelle has extensive experience working on data analytics projects for the CDC, including data visualization work for the National Environmental Health Tracking Network.
Battelle has won a contract with the CDC’s National Institute for Occupational Safety and Health (NIOSH) to develop an online introductory toxicology primer. Battelle will bring expertise in toxicology and computer programming to develop an online education module. The course will teach participants foundational toxicology concepts in connection with nine “health endpoints” that are used in NIOSH’s Occupational Exposure Banding process.
Battelle recently won several task orders under the CDC Achieving Public Health Impact through Research (APHIR) contract vehicle.
APHIR 51: Case Investigation of Cervical Cancers
Battelle will conduct a case investigation of invasive cervical cancers to identify potential missed opportunities for proven public health interventions, identify programmatic weaknesses, and determine the barriers and facilitators to screening. The three-year project involves working with state cancer registries to identify and recruit subjects, collecting survey data, performing medical records abstraction, conducting data analysis, and delivering data and reports.
APHIR 56: Evaluation of Activities and Outcomes of the National Cancer Survivorship Resource Center
Battelle will conduct an evaluation to examine the unmet needs of the National Comprehensive Cancer Control Program (NCCCP) grantees, and provide a description of future activities that would fill those gaps. The two-year project involves assessing the extent to which the activities undertaken and materials produced by the National Cancer Survivorship Resource Center provide appropriate, evidence- and guidelines-based cancer survivorship messages, and have met the current needs of NCCCP grantees in increasing the implementation of survivorship activities.
APHIR 69: Chemical Emergency Preparedness and Response Support
Battelle will continue to provide research services to support CDC’s Emergency Response Branch’s (ERB) mission to develop biomonitoring methods for toxic chemicals. Battelle will provide a variety of tasks including: