Medpace is excited to welcome Kristi Clark, PhD, to Medpace Core Laboratories. Dr. Clark is trained in neuroscience and joins Medpace as a Project Manager in the Medpace Imaging Core Laboratory. We asked Dr. Clark about her experience and what drew her to Medpace.
Before joining Medpace Imaging Core Laboratory you had an academic research career as a faculty member at UCLA and USC. Can you tell us a little bit about your educational background and academic experiences during that period of your career?
My educational background combines quantitative methods with neuroscientific principles; as part of my PhD training in neuroscience, I developed a software package to analyze brain MRI data. As faculty at UCLA and USC, I developed and led an NIH-funded research program that combined neuroimaging analytics and data science to bridge the gap between basic neuroscience research and clinical interventions in neurodevelopmental disorders. My research expertise is in developing analytic models that map brain networks related to several disorders, including: autism, dyslexia, schizophrenia, depression, epilepsy, hemispherectomies, brain tumors, childhood obesity and diabetes.
The transition from academia to clinical trials research in an industrial setting is a significant one. What led you to decide to make this transition and how do you feel your background prepared you for this field?
I am most excited about using technology to improve the quantity and quality of the lives of patients, specifically using computer algorithms to drive precision medicine applications. In academia, most of my research involved developing and testing potential neuroimaging-based biomarkers that theoretically could be used in future clinical trials. The move from academia to industry was a natural progression as my research goals moved from the theoretical to the applied. Clinical trials research moves faster from idea to application in an industrial setting, and the potential for direct, tangible impact on patients is much greater. In medicine, there is often a gap between the data that scientists can acquire and the knowledge that clinicians would like to have to treat patients. My academic research career focused on methods for turning research data into clinical knowledge, and I plan to apply those methods to clinical trials.
Your academic experience focused on pediatric brain imaging and advanced analysis methods for brain mapping. Are there some unique considerations involved in doing imaging for clinical trials in pediatrics compared with working with adults?
In some ways, the adult brain can be thought of as a complex system that is being built during childhood. This way of thinking helps explain why diseases or injuries that occur during childhood can cause far more widespread changes than the same disease or injury that occurs during adulthood, after the brain has fully developed. At the same time, somewhat paradoxically, childhood is a time when interventions may have the biggest impact. This is because there are such large-scale changes occurring in the organization of brain that there is an opportunity to introduce relatively small changes in behavior or chemical changes in the brain and make relatively large gains in the treatment of diseases. Clinical trials in pediatrics require a developmental design so that changes due to intervention can be separated from developmental changes. This is an added layer of complexity compared to working with adults that I have experience taking into consideration.
How does your prior experience working with children translate into the work you do with the imaging core laboratory at Medpace?
Studying pediatric populations often requires adapting analytic models that are used in adult populations to account for the differences between the brains of adults and children. These differences can be something as obvious as changes in overall brain size or something as subtle as refining neural circuitry in parts of the brain that process complex information. Much of my prior experience focused on developing analytic approaches to not only model the changes that occur during childhood in health and disease but also to simplify those results to intuitive measures that could be used clinically. For example, one of my projects was to develop an MRI-based growth chart, where the size and shape of brain structures in a single subject were compared to a typically developing population to estimate the percentile for how that subject compared to the population. This type of approach translates well to the work I am doing with the Medpace Imaging Core Laboratory because it transforms less intuitive measures, such as the thickness of motor cortex in millimeters, into more intuitive measures, such as the motor cortex thickness for this individual is at the 8th percentile for 9-year-old girls. Growth charts are frequently used in clinical trials because they provide a context for how an individual compares to a population.
The Pharmaceutical industry in general tends to carry out trials in adults and then seek FDA off label approval to use these drugs in children, but in some cases of rare diseases and diseases of childhood that model doesn’t work. Are there some unique capabilities that you and your colleagues in the Medpace Imaging Core Lab can offer to sponsors who are seeking to carry out clinical trials in children?
One of the unique strengths of the Medpace Imaging Core Lab is that it is an organization that is clinician-led; this is evident in these trials of rare diseases and diseases of childhood because the strategies for conducting these clinical trials are defined by clinicians who are familiar with those disorders. In addition, it can be more challenging for children to tolerate research protocols, leading to a lower enrollment and higher dropout rate. In many diseases, the most severely affected children are the ones who may benefit the most from the treatment; yet, these are also the children who are the least likely to tolerate the research protocols. My colleagues at Medpace Imaging Core Lab include well-known scientific experts in pediatric neuroimaging who have developed strategies to improve the success rates of acquiring imaging data in children. We can share this expertise with sponsors to improve compliance, which increases the chance that a clinical trial will be successful.
Learn more about the imaging core lab here.