Serguei Kozlov, Ph.D., and Ligia Pinto, Ph.D., are FNL investigators using cCRADAs to partner with outside organizations. (Photo from the SPGM archive)
They say two heads are better than one. Two detectives can close a case quicker, and twice the alarms means double the chance of making it to work on time. This is the exact logic that contractor Cooperative Research and Development Agreements (cCRADAs) embody.
Although the name seems to paint the entire picture, there’s much more depth to what cCRADAs are and what they do. Consider the notion of combining these two “heads” together. A cCRADA is an agreement between a federal laboratory such as at the Frederick National Laboratory (FNL), head one, and a private sector or university laboratory, head two. It’s a legal document that specifies every aspect of the partnership, such as materials, funding, labor, and ownership rights of potentially created intellectual property.
cCRADAs fill gaps in the research and development process, such as when universities or companies find themselves in need of facilities it wouldn’t make sense for them to maintain themselves.
Serguei Kozlov, Ph.D., and his Preclinical Technology and Optimization team in FNL’s Center for Advanced Preclinical Research exemplifies how FNL meets these needs. According to Kozlov, preclinical trials within major university labs may involve multiple tissue culture models and hundreds of animals to generate valuable information about a drug candidate for subsequent clinical trials. However, many private-sector groups and smaller academic facilities can’t replicate research of this depth and magnitude, making it difficult for them to perform studies to the accuracy, breadth, or experimental power of larger groups. Through cCRADAs, these smaller companies and universities can access much-needed research capabilities in Kozlov’s lab (and others at FNL), which may help move their drugs along in the development process and position them for a potential successful clinical transition.
In short, cCRADAs allow FNL to lend out its expertise, time, and facilities to organizations with a similar research mission, and receive funding or in-kind contributions in return. There are other benefits as well; Kozlov says his group also gains key insights into the commercial world of research and development by working with collaborators. From the number of groups that apply alone, labs such as Kozlov’s can see the leanings and developments of the commercial world and develop themselves accordingly.
By opening windows of communication between FNL and the commercial world, cCRADAs allow FNL to keep its labs cutting-edge. Complementing its expertise with that of the private sector, FNL can conduct research beyond both its and collaborators’ capabilities, learning and adjusting along the way.
Ligia Pinto, Ph.D., director of the FNL Vaccine, Immunity, and Cancer Directorate, and her team are using cCRADAs to tackle an important public health problem: evaluating reduced dose schedules for HPV vaccines in different populations around the globe. HPV is a cancer-causing virus that is widely prevented by currently licensed, three-dose vaccines. However, vaccination rates remain low in low- to mid-income areas, such as parts of Africa, because the two- or even three-dose vaccine regimen requires extended storage in strict environments, an organized medical infrastructure, and several long journeys for patients to visit clinics. With an approved single-dose regimen, vaccination rates in Africa could soar, and HPV cases and HPV-driven cervical cancer could plummet.
Pinto partnered with the London School of Hygiene and Tropical Medicine to collaborate towards this goal. The university was investigating the efficacy of a single-dose HPV vaccine but needed the help of an organization such as FNL for the vaccine immunogenicity research.
“The Frederick National Laboratory has one of the very few laboratories in the world with the expertise, experience, and the technology available for performing standardized serology assessments in HPV vaccine studies,” Pinto said regarding the need for partnership.
Through their combined efforts, FNL and the university will be able to increase the evidence surrounding the immune responses and potential efficacy of a single-dose regimen. “Given the public health burden of HPV and cervical cancer in Africa, this research is critical in providing data necessary to support future recommendations for reduced vaccine schedules in Africa,” Pinto said.
Through this partnership, the London School of Hygiene and Tropical Medicine is able to access the serology labs at the FNL. Together, the institutions can advance this research and promote their public health missions.
cCRADAs make this advancement—such as the important vaccine research support to low-resource areas—possible. As Kozlov puts it, “cCRADAs clearly, clearly bring benefit.” In other words, at least in medicine, two heads are better than one.
Editor’s note: The teaser photo that appears in the online edition of this article is by Cytonn Photography on Unsplash.
Reed Fliegel is a Werner H. Kirsten intern for the Frederick National Laboratory Partnership Development Office. Here he handles assignments related to outreach about the office’s programs and contract options available to our researchers. The Partnership Development Office establishes the partnerships and collaborations among Frederick National Laboratory scientists and external researchers in government, academia, industry, and the nonprofit research sector.