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.
What are the biggest changes going on in the toxicology and contract research industry 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.
What has Battelle done to adapt to these industry changes?
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.
What kinds of internal toxicology research has Battelle been engaged in?
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.
What other toxicology projects is Battelle engaged in?
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.
Why is Battelle involved in so many high-level national toxicology programs?
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.
Where do you see the Battelle toxicology team going next?
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.