Research breakthroughs often emerge in the laboratory, but bringing these discoveries to the clinic, especially in high-risk populations like premature infants, requires a significant investment of time, resources, and expertise. The Wake Forest Clinical and Translational Science Institute (CTSI) Pilot Program provides critical support for researchers making this leap from preclinical findings to clinical application.
Jared Weis, PhD, who recently received one of the Wake Forest School of Medicine’s Research Award for Early Career Investigator in Basic/Translational Science, was also named one of the 2024-2025 Translational Research Pilot Recipients as co-PI. As a result of this award, a research team was assembled that utilized the resources of Wake Forest CTSI to develop a new diagnostic technology for necrotizing enterocolitis (NEC), a severe intestinal disease affecting premature infants. This project led the study team to be awarded the 2024 WFUSM New Team Science Research Award.
In this article, we explore the motivation behind their application for the CTSI Pilot Program, the ways in which the program has supported their research, and the broader implications for future pediatric diagnostics.
The team recognized that even after completing their preclinical studies, a large gap would remain in translating their findings to clinical use. The Wake Forest CTSI Pilot Program presented an opportunity to bridge this gap, allowing the team to begin the critical process of adapting their findings for real-world clinical settings. Their motivation was clear: by applying for the program, they could accelerate the translation of this imaging technology into something that could directly benefit critically ill infants.
Additionally, the program offered access to several essential resources, including a CTSI study coordinator, a recruitment team, and others that helped translate their preclinical understanding of infant intestinal PAI to clinical use.
The unmet clinical needs identified in the clinician’s case initiated a new research collaboration between Drs. Victoria Weis (Wake Forest Institute for Regenerative Medicine), Jared Weis (Biomedical Engineering), Cherrie Welch (Neonatology), and Kristen Zeller (Pediatric Surgery) to develop diagnostic imaging technologies for NEC.
The CTSI Pilot Program has been instrumental in facilitating this transition. While they found exceptional preclinical data, having a promising approach is only one part of the translational process. The CTSI Pilot Program allowed the team to start taking takings steps to use their developed approach in a clinic setting by supporting and connecting them to invaluable resources to help with the ins-and-outs of performing clinical research.
In addition to the financial budget that supports research efforts, instrument costs, and participant expenses, the pilot program includes assistance from the team’s CTSI study coordinator to navigate the IRB process and protect study participants using the new imaging technology. It also includes support from the CTSI recruitment team to reach pediatric study participants. The pilot program includes regular consultations with their CTSI Research Navigator and CTSI Pilot Program Faculty Advisor. This support will be instrumental for facilitating future research.
Drs. Weis and their team plan to continue applying for CTSI Pilot Program funding as they move forward with their research. They emphasize the importance of such programs in advancing medical science, particularly in areas like pediatric healthcare, where new diagnostic technologies are urgently needed.
The CTSI Pilot Program has proven to be a critical resource for researchers working to bridge the gap between preclinical discoveries and clinical application. For Drs. Victoria Weis, Jared Weis, Cherrie Welch, and Kristen Zeller, it has provided the financial, logistical, and expert support necessary to begin translating their promising work on photoacoustic imaging into a real-world tool for diagnosing necrotizing enterocolitis in premature infants.
If you are interested in collaborating with the Wake Forest CTSI, please review and request our services here. If you are considering our pilot program and wish to apply for funding, please find the details here.
Jared Weis, PhD, who recently received one of the Wake Forest School of Medicine’s Research Award for Early Career Investigator in Basic/Translational Science, was also named one of the 2024-2025 Translational Research Pilot Recipients as co-PI. As a result of this award, a research team was assembled that utilized the resources of Wake Forest CTSI to develop a new diagnostic technology for necrotizing enterocolitis (NEC), a severe intestinal disease affecting premature infants. This project led the study team to be awarded the 2024 WFUSM New Team Science Research Award.
In this article, we explore the motivation behind their application for the CTSI Pilot Program, the ways in which the program has supported their research, and the broader implications for future pediatric diagnostics.
Motivation for Applying to the CTSI Pilot Program
The team, led by Drs. Victoria Weis, Jared Weis, Cherrie Welch, and Kristen Zeller, had already made significant strides in utilizing photoacoustic imaging (PAI)—an emerging imaging technology—in a small animal model of NEC. Their promising preclinical studies, supported by a recent NIDDK R01 award, showed that PAI could potentially serve as an innovative imaging biomarker for NEC, a disease notoriously difficult to diagnose early in premature infants. However, the technology had not yet been tested in pediatric intestines, with only a few studies exploring its application in children.The team recognized that even after completing their preclinical studies, a large gap would remain in translating their findings to clinical use. The Wake Forest CTSI Pilot Program presented an opportunity to bridge this gap, allowing the team to begin the critical process of adapting their findings for real-world clinical settings. Their motivation was clear: by applying for the program, they could accelerate the translation of this imaging technology into something that could directly benefit critically ill infants.
Support from the CTSI Pilot Program
The CTSI Pilot Program provided invaluable support in several key areas, enabling the research team to move forward with their clinical investigation. One of the major benefits was the financial backing to cover research effort, study and core costs, and to collect pilot data on the safety and feasibility of using PAI for imaging pediatric intestines. This initial support was crucial in generating data that would be used to justify further clinical trials and regulatory approvals.Additionally, the program offered access to several essential resources, including a CTSI study coordinator, a recruitment team, and others that helped translate their preclinical understanding of infant intestinal PAI to clinical use.
From Preclinical to Clinical: The Transition
Historically, much of the research conducted by this team has been preclinical, developing technologies in the laboratory setting. However, their work on PAI was inspired by clinical needs identified directly within the neonatal intensive care unit (NICU) at Atrium Health Wake Forest Baptist. Dr. Victoria Weis, during a “research rounds” mentoring session, recognized the lack of advanced diagnostic tools for detecting intestinal diseases in premature infants. A particular case, where a clinician expressed the desire to see deeper into an infant’s abdomen, became a driving force behind this new line of research.The unmet clinical needs identified in the clinician’s case initiated a new research collaboration between Drs. Victoria Weis (Wake Forest Institute for Regenerative Medicine), Jared Weis (Biomedical Engineering), Cherrie Welch (Neonatology), and Kristen Zeller (Pediatric Surgery) to develop diagnostic imaging technologies for NEC.
The CTSI Pilot Program has been instrumental in facilitating this transition. While they found exceptional preclinical data, having a promising approach is only one part of the translational process. The CTSI Pilot Program allowed the team to start taking takings steps to use their developed approach in a clinic setting by supporting and connecting them to invaluable resources to help with the ins-and-outs of performing clinical research.
Impact on Future Research
The pilot study is laying the groundwork for future clinical trials that will test the safety and feasibility of using PAI to diagnose NEC in premature infants. A key advantage of this work is that PAI was developed with the pediatric population in mind, rather than adapting adult technologies for children. This approach addresses the unique challenges of imaging in smaller, more delicate bodies and avoids the pitfalls of “scaling down” technologies designed for adults. The team hopes that their success will serve as a model for the development of other pediatric-specific tools.In addition to the financial budget that supports research efforts, instrument costs, and participant expenses, the pilot program includes assistance from the team’s CTSI study coordinator to navigate the IRB process and protect study participants using the new imaging technology. It also includes support from the CTSI recruitment team to reach pediatric study participants. The pilot program includes regular consultations with their CTSI Research Navigator and CTSI Pilot Program Faculty Advisor. This support will be instrumental for facilitating future research.
Recommendation for Other Researchers
Having benefited greatly from the CTSI Pilot Program, the team strongly recommends it to other researchers working to translate preclinical technologies into clinical practice. The program offers far more than just financial support; it provides resources, including access to expert guidance, recruitment assistance, and the administrative infrastructure necessary for clinical research. These resources are essential for navigating the complexities of clinical trials and ensuring that new technologies can make the transition from the lab to the patient’s bedside.Drs. Weis and their team plan to continue applying for CTSI Pilot Program funding as they move forward with their research. They emphasize the importance of such programs in advancing medical science, particularly in areas like pediatric healthcare, where new diagnostic technologies are urgently needed.
The CTSI Pilot Program has proven to be a critical resource for researchers working to bridge the gap between preclinical discoveries and clinical application. For Drs. Victoria Weis, Jared Weis, Cherrie Welch, and Kristen Zeller, it has provided the financial, logistical, and expert support necessary to begin translating their promising work on photoacoustic imaging into a real-world tool for diagnosing necrotizing enterocolitis in premature infants.
If you are interested in collaborating with the Wake Forest CTSI, please review and request our services here. If you are considering our pilot program and wish to apply for funding, please find the details here.