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April 2016 - Issue 6
Welcome to Battelle’s Life Sciences Research CRO+ Today Newsletter. The Battelle Life Sciences Research team provides fast, accurate answers for discovery, safety and efficacy with our integrated scientific and technological capabilities, world-class facilities and ability to meet technical, development and regulatory needs. Battelle Life Sciences CRO+ Today will keep you up-to-date on cutting-edge life sciences research.
Julie B. Swick the General Manager of Battelle Life Sciences Research, and is the driving force behind the expansion of Battelle’s toxicology capabilities. We sat down with her to talk about where the industry has been, where it is going and how Battelle is rising to meet the emerging toxicology challenges that our clients are facing today.
The last eight years have been a challenging time for the industry, with a lot of disruption and change in the market. Most of that comes from the fallout from the market collapse. Starting in 2009, we saw huge cuts in government and commercial funding for toxicology work, both for drug development and for environmental toxicology. Companies were pulling back from starting new, expensive drug trials and government agencies didn’t have funding to make new human health and environmental studies a priority.
Now, those markets are finally coming back, in a very healthy and exciting way. Unfortunately, the slowdown has taken a toll on the industry as a whole, and some of the smaller CROs [contract research organizations] had to cut back on operations or shut down entirely during the downturn. We’ve also seen a lot of consolidation in the industry. It’s a different landscape than it was eight years ago.
At Battelle, we’re lucky to have some real advantages that help us to weather economic downturns. We are a nonprofit organization with roots that go back to 1929, so we are not beholden to shareholders or driven by quarterly earnings reports. While of course fiscal health is as critical to us as it is to any organization, profit or nonprofit, our structure does give us more flexibility to adapt in times of change.
Ultimately, we are beholden to our mission: to conduct research that translates into societal benefits. That doesn’t stop when we’re not working on client-driven research. Per our charter, we put all of our earnings back into independent research and charitable activities. We didn’t stop conducting toxicology research when the contracts slowed down. We were able to use that time to conduct self-funded research and pursue independent projects. That means our researchers were continuing to grow professionally and expand our understanding of critical public health and environmental challenges so we would be better prepared to meet the needs of our clients when they were ready.
For our internal research, we try to look ahead to see what challenges are on the horizon six to 18 months from now and figure out what the industry will need to solve them. For example, when the Zika virus epidemic started to explode, we realized that new animal models would be needed to conduct efficacy studies for new potential treatments and vaccines. We were able to immediately deploy internal R&D assets to start working on the project, long before government funding sources were mobilized to support the research. That gives us an excellent base to start from now that agencies are ready to begin working on the problem. Rather than starting from ground zero, the organizations we collaborate with can start from the springboard provided by the internal research we have already conducted.
We’re also ramping up internal research in the areas of developmental and reproductive toxicology, or DART, and neurotoxicology. We see these areas becoming increasingly important for drug approval and environmental exposure studies. As part of our internal research, we’re conducting the studies necessary to compile a historical control database for developmental toxicity studies. This is a critical project that has tremendous value for the industry as a whole but would be difficult to conduct within a traditional CRO.
One of our biggest projects right now is the National Institute of Environmental Health Science’s National Toxicology Program (NTP). We’ve been a prime contractor for this work for more than 35 years, since the very beginning. NTP is an interagency program that evaluates the human health impacts of chemicals that are used in foods, household products, personal care products, cleaners, pesticides and other common, everyday applications. There are tens of thousands of chemicals in use that have never had full toxicology studies performed. We’re very proud to be playing key role in filling these knowledge gaps.
We also are very involved in toxicology work to support development of therapies and vaccines to protect our warfighters and the public against biological and chemical warfare agents. Our work has helped to expand the treatment options for dangerous pathogens like anthrax and plague as well as nerve agents and other chemical weapons.
We bring together some of the best people and facilities in the world. We have the largest privately held BSL-3 high containment laboratory in the world, along with state-of-the-art vivarium space. We also have deep expertise in toxicology and pathology on our team. Finally, we have the ability to reach back to other teams within Battelle for scientific and engineering expertise not found in most CROs. We can bring in material scientists, medical device designers, environmental scientists, chemists, CBRNE experts and a host of other specialties to solve unique and difficult challenges. For example, we have designed new delivery mechanisms and new methods of aerosolization for some of our inhalation toxicology projects. We also have the capacity to work with highly toxic or pathogenic agents. Our clients know that they can count on us to go beyond the standard protocols for general toxicology. We can develop and validate new methods as needed, while ensuring that the final study meets all GLP and regulatory requirements.
We’re continuing to expand our DART and neurotoxicology capabilities to meet our clients’ evolving needs. We have also aggressively pursued world-renowned talent in both of these areas. Last year, we were very pleased to welcome some new experts to our team, including Dr. Eve Mylchreest, who brings exceptional developmental and reproductive expertise, and Dr. Amy Zmarowski, who is expanding our neurotoxicology and developmental neurotoxicology capabilities.
Over the next two to three years, I see us continuing to expand in these areas as well as in our core toxicology areas. Our goal is to offer a one-stop shop with a comprehensive suite of services for pre-clinical drug and vaccine development, safety and efficacy studies, and industrial and environmental exposure studies. We’re very excited to be able to continue to grow and evolve to meet the changing needs of the industry.
About Julie B. Swick
Julie has 29 years of experience at Battelle leading contract research and development for government and commercial clients. She leads Battelle’s Life Sciences Research business unit. Her team of scientists and technical experts conduct product safety and efficacy studies for development of chemical, biological and infectious disease countermeasures, and provide IND-enabling toxicology and safety pharmacology services for multiple DHHS agencies, commercial pharmaceutical and tobacco clients.
Prior to taking the helm of LSR, Julie led the Battelle Medical Devices team. She holds an M.S. in Biomedical Engineering and a B.S. in Electrical Engineering from The Ohio State University as well as a B.S. in Pre-Medicine from Pennsylvania State University. Her combination of engineering and life sciences expertise has given her a unique perspective on solving the challenges facing the industry today.
A powerful new treatment option for inhalational anthrax is now available, thanks in part to researchers at Battelle. ANTHIM (obiltoxaximab) Injection, patented and produced by Elusys Therapeutics, was licensed by the FDA in March. Battelle conducted the required efficacy research under the FDA Animal Rule to help bring it to market.
ANTHIM will be an important addition to the Strategic National Stockpile (SNS), which stores large quantities of medicines, therapies and vaccines to protect the public in the case of an epidemic, natural disaster or terrorist attack. It will be given in combination with antibiotics to victims who have been exposed to anthrax to counter the toxins produced by the bacteria.
Anthrax, caused by the Bacillus anthracis bacterium, is highly lethal but rarely seen naturally in developed countries. However, its combination of lethality and hardiness make it an attractive option as a bioweapon. Several foreign governments are known to have developed weaponized versions. This makes development of antitoxins of critical importance to protect warfighters and the public in the event of a terrorist attack.
Because the disease is rare and lethal, it is not feasible or ethical to conduct clinical trials for efficacy in humans. ANTHIM was approved under the FDA Animal Rule, which provides an alternative licensure pathway for products that cannot be tested in humans.
Elusys came to Battelle for help in conducting efficacy trials for the antitoxin using alternative animal models. Researchers at the Battelle Biomedical Research Center conducted various studies using two animal models, led by Principal Investigator and Study Director Dan Sanford and Study Director Lisa Henning. The work was awarded under a contract with Elusys that was funded by the Biomedical Advanced Research and Development Authority (BARDA), National Institutes of Health (NIH) and Department of Defense (DoD).
Battelle has extensive experience with the FDA Animal Rule. Only four products have been awarded “in-class” approval under the rule, meaning they were undergoing approval for the first time and for their primary intended purpose. (Other products approved through the Animal Rule were already on the market and had previously completed human clinical trials for other uses.) Battelle played a leading role in the approval of all four products, including Raxibacumab, another anthrax antitoxin and the very first product to achieve in-class approval under the alternative pathway. Battelle researchers also conducted non-clinical research for AIGIV (now marketed as Anthrasil), a third anthrax antitoxin, and BAT, a botulism antitoxin.
Conducting efficacy studies as replacements for human clinical trials is highly complex. Researchers must identify an alternative animal model for the disease that demonstrates similar disease progression, and drug pharmacokinetics should be similar to those observed in healthy human subjects. Once the therapeutic dose has been established for the alternative models, sophisticated statistical and pharmacokinetic methods are used to select an appropriate effective dose for humans.
Battelle has a long history in animal model development and validation for a wide variety of pathogens. It is also home to the largest independent biocontainment facility in the world (BLS-3), with capabilities to support highly regulated GLP studies that fully meet FDA requirements. They bring together a unique range of life science research capabilities, including assay development and validation, aerosol science, microbiology, molecular immunology, clinical pathology, anatomical pathology and toxicology. Because of the depth and breadth of experience on their research teams, Battelle is often trusted with complex studies that are beyond the capabilities of standard contract research organizations.
Battelle will be able to apply the methods developed and lessons learned for this study to other research under the FDA Animal Rule. Trials are already underway for new vaccines and therapies against other deadly pathogens, including Yersinia pestis (plague), smallpox, botulism and tularemia.
What’s the best treatment for soldiers or civilians exposed to nerve agents or toxic pesticides? Researchers from Battelle and the National Institutes of Health evaluated the efficacy of several potential therapies to find out. The full study (“Assessing the Therapeutic Efficacy of Oxime Therapies Against Percutaneous Organophosphorus Pesticide and Nerve Agent Challenges”) was published in the December 2015 edition of The Journal of Toxicological Sciences.
Organophosphorus (OP) nerve agents such as sarin, soman and VX have been a potential threat to military personnel and civilians in conflict areas since World War II. At the same time, civilian populations are at risk for accidental exposure to bioactivated OP pesticides such as paraoxon, chlorpyrifos-oxon and phorate oxon (PHO). These agents can cause rapidly developing symptoms including seizures, convulsions, respiratory failure and death. Given the rapid onset of symptoms, a quick-acting, efficacious therapeutic regimen is needed.
Oxime reactivators are a common component of anti-OP therapies. Researchers tested the efficacy of eight potential oxime therapies against VR, VX, parathion and phorate oxon (PHO) using a small animal model. The study was able to determine the most effective therapies and dosages against VR, VX and parathion. None of the tested therapies was therapeutically effective against PHO, although two showed some level of protection. The results will help to inform future research that will guide treatment protocols for people who are accidentally or intentionally exposed to OP chemicals.
Read the entire paper from The Journal of Toxicological Sciences here.
Each year, Battelle recognizes young scientists for their work. We are pleased to announce that Nicole Panstingel (at far right) is the winner of the 2016 Dermal Toxicology SS Battelle Student Research Award for her paper The Effect of Silver Nanoparticles on Human Integument Post Thermal Injury. Nicole is a student in the Department of Pharmacology & Toxicology at Wright State University in Dayton, Ohio. She received a plaque and a $2,500 award from Battelle to recognize her achievement. Congratulations, Nicole.
Dr. Dinelia Rivera-Burgos applies her analytical and bioanalytical expertise to develop, optimize and quantify new methods and assays for highly toxic substances. Dinelia joined the Battelle team in February 2016 as a Principal Research Scientist. She brings extensive analytical expertise with particular specialization in chromatography, mass spectrometry, proteomics and metabolomics. Read More
Dr. Barney Sparrow has been named the new Principal Investigator for Battelle’s work on the National Institute of Environmental Health Science’s National Toxicology Program(NTP). In his new role, he will be responsible for oversight and direction of in vivo toxicology research that will provide critical insights into the toxicological profiles and potential human health impacts of dozens of chemicals that are already in widespread use. Read More