Pediatric Antibacterial and Antifungal Trials From 2007 to 2017.

Ph.D., North Carolina State University - 2007

I work closely with clinical and quantitative colleagues to provide statistical leadership, guidance and mentoring on the design, execution, and analysis of clinical research studies. My work includes design and analysis of observational studies (including large cardiovascular registries, and clinical care databases linked with electronic health record data) and early-phase trials in pediatric populations. My statistical interests include study design, linear and non-linear mixed effects models, survival analysis, biology- and mechanism-based models, and statistical thinking and learning. 

Dr. Danny Benjamin is the Principal Investigator and Chair of the National Institute of Child Health and Human Development’s Pediatric Trials Network. The Network is responsible for designing and leading clinical trials of off-patent medicines in children of all ages across all therapeutic areas. The team has established, or is actively studying, the correct dosing and safety of more than 70 of the most commonly used medicines in children. Each of these trials is conducted under an Investigational New Drug (IND) application with guidance from the Food and Drug Administration for labeling.

The Pediatric Trials Network has directly impacted the healthcare of over 90% of American children.

Signature programs of the Network include clinical trials in premature, term infants, breast feeding mothers, and obese children. Over the past 10 years, Danny’s group has enrolled more premature infants, at more sites, in more clinical trials of off-patent anti-infectives under an IND than all other academic medical centers, pharmaceutical companies, and government agencies in the world, combined.

Danny is recognized by the National Institutes of Health as a premiere mentor and educator. His research program serves as a platform to train students and early career investigators. Danny’s group has a clinical research summer program for high school and college students that has a focus on trainees under-represented in medicine, and he is the primary mentor for medical students, residents, subspecialty fellows, and multiple junior faculty. He has been the primary or secondary mentor for 10 faculty who have received career development awards and who have then gone on to secure their own funding.

Danny's service to the community is expressed through his passion for coaching baseball. He has coached over 500 recreation league, travel league, and scholastic baseball games and he is the head coach of Smith Middle School, the 5-year reigning southern conference champions. Danny and his wife own a charitable non-profit that provides athletic and fitness opportunities for disadvantaged school-aged boys and girls.

Dr. Smith completed his residency in pediatrics and a fellowship in neonatal medicine at Duke University Medical Center in 2004 and 2007, respectively. He completed an MHS in clinical research from Duke University in 2006 and an MPH in biostatistics from the University of North Carolina at Chapel Hill in 2009. His research is focused on pediatric drug safety, neonatal pharmacology, and the epidemiology of neonatal infections. Dr. Smith is or has been the protocol chair for more than 14 studies of drugs in infants and children. He is the Principal Investigator for the Environmental Influences on Child Health Outcomes (ECHO) Coordinating Center.

My research at Duke has focused on understanding the dynamic between host and pathogen so as to discover and develop host-response markers that can diagnose and predict health and disease.  This new and evolving approach to diagnosing illness has the potential to significantly impact individual as well as public health considering the rise of antibiotic resistance.

With any potential infectious disease diagnosis, it is difficult, if not impossible, to determine at the time of presentation what the underlying cause of illness is.  For example, acute respiratory illness is among the most frequent reasons for patients to seek care. These symptoms, such as cough, sore throat, and fever may be due to a bacterial infection, viral infection, both, or a non-infectious condition such as asthma or allergies.  Given the difficulties in making the diagnosis, most patients are inappropriately given antibacterials.  However, each of these etiologies (bacteria, virus, or something else entirely) leaves a fingerprint embedded in the host’s response. We are very interested in finding those fingerprints and exploiting them to generate new approaches to understand, diagnose, and manage disease.

These principles also apply to sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Just as with acute respiratory illness, it is often difficult to identify whether infection is responsible for a patient’s critical illness.  We have embarked on a number of research programs that aim to better identify sepsis; define sepsis subtypes that can be used to guide future clinical research; and to better predict sepsis outcomes.  These efforts have focused on many systems biology modalities including transcriptomics, miRNA, metabolomics, and proteomics.  Consequently, our Data Science team has utilized these highly complex data to develop new statistical methods, furthering both the clinical and statistical research communities.

These examples are just a small sampling of the breadth of research Dr. Tsalik and his colleagues have conducted.  

In April 2022, Dr. Tsalik has joined Danaher Diagnostics as the VP and Chief Scientific Officer for Infectious Disease, where he is applying this experience in biomarkers and diagnostics to shape the future of diagnostics in ID.