Behind Biotech: Mark Sorrentino

Dr. Mark Sorrentino cares. Actively.

One would expect a driven and empathetic person at the helm of the industry’s leading pediatric clinical development centre, but Mark’s particular brand of tenacious empathy would undoubtedly surprise you. Never one to shy away from a challenge, he has made a career out of blazing trails in the name of children’s health and spends his free time volunteering on a search and rescue team to save animals from the blazes of wildfires in his California community. This ethos of active service has been the driving force throughout many facets of his life and underpins his leadership as Vice President and Head of the Centre for Pediatric Clinical Development at ICON.

Mark’s role with ICON is a sort of inevitable culmination of a lifelong dedication to protecting the vulnerable, shaped by years in pediatric clinical care and academic research. His career hasn’t followed a straight line, per se. Instead, it has followed a deeper calling: to build systems that protect the vulnerable and create a future where science can take better care of children.

Critical care to clinical trials

Mark started his journey as a critical care nurse before going to medical school and then spent 15 years in academic medicine at Children’s National Medical Center in Washington, D.C. From the beginning, he was immersed in the fast-paced, emotionally charged world of critical care. This foundation helped him develop his clinical acumen and honed his capacity for compassion and clarity in crisis.

“Pediatrics demands a unique blend of scientific rigor and emotional intelligence,” he says. “You’re treating not just the patient, but the entire family.”

A moment of “bizarre serendipity” presented itself early on when Mark’s department got a fax from a local company recruiting physicians for what was promised to be a revolutionary new drug. RSV was the primary reason for hospitalisation in that age group at the time, and Mark saw how many lives could be saved by a drug like this, especially the lives of babies. He seized the opportunity with the enthusiasm of someone with a cause. He helped get approval and helped with global outreach for what became the first in its class monoclonal antibody ever developed for infectious disease.

It was this desire to make a broader impact that led him to consider new avenues, forging new paths to forward pediatric research to ensure safer and more efficacious treatments for everyone under the pediatric umbrella, from maternal-fetal to neonates to children and adolescents. There is a healthy dose of caution among the industry regarding pediatric clinical trials, and people like Mark understand that caution is rooted in wanting to protect children. However, most of the drugs used to treat pediatric populations have not been tested with representative groups. Forwarding pediatric trials ensures that the labeled drugs are safe and effective for the patients they’re treating, which is surely something we can all get behind.

Building pediatrics infrastructure in the industry

After a few years in the industry with biotech companies and a larger CRO, Mark’s pioneering mindset established his reputation as an expert in the uniquely complex pediatric practice area. His passion, expertise and dedication gave him clarity into both the strategies and infrastructures required to truly serve the this vulnerable patient population. He was asked to create the pediatric center of excellence at his previous CRO, which proved to be a very successful program.

When he joined ICON, Mark’s builder’s mindset only expanded. He founded both the Center for Pediatric Clinical Development and the Center for Vaccines and Emerging Infectious Diseases, which have helped define ICON’s leadership in pediatric and vaccine research. ICON is now the industry leader in pediatric development, with more than 145 ongoing peds trials.

This level of operation relies on a top team of excellent physicians and scientists that have a tremendous amount of experience and interest in furthering medicine for children. As Mark puts it, “The people are what really matters, and we have the best people.” And those people are all trained to see and seize the opportunities to do pediatric research. The team reviews incoming RFPs/RFis every day to see where sponsors and patients alike could benefit from the addition of peds populations, even just expanding into adolescent groups for adult trials could provide invaluable information.

Mark’s work has shaped global studies involving pediatric rare diseases, vaccines and infectious disease—therapeutic areas that require not only technical sophistication but also a firm ethical compass and cultural sensitivity.

Leadership with a mission, at ICON and beyond

In his role heading up ICON’s pediatric centre of excellence, Mark embraces innovation and its potential to make a real difference for patients and their families. As a cancer survivor, Mark participated in a clinical trial himself and even then could not put down his dedication to making trials more equitable, efficient and effective—he was weighing in on trial design and operations from his role as patient that helped improved his own trial. Having been on both sides of the clinical trial experience, he brings deeper insight and compassion to help advance ICON’s designs to allow for more flexible, remote data collection, better caregiver engagement and adaptive protocols tailored to pediatric populations.

Mark identifies opportunities to improve pediatric research, and importantly, he also creates them. He has also established a new maternal fetal medicine unit, which is one of only a few in the industry.

Mark’s ethos of care has been tempered through adversity. It’s a throughline that connects multiple facets of his identity, from a kid who grew up working with horses to a critical care nurse, a pediatric specialist and clinical research executive to a disaster volunteer and nonprofit board member. He leads with heart and proactively builds systems that serve the most vulnerable, from all patients under the pediatric umbrella to the horses he pulls from wildfires in his roles on multiple volunteer search and rescue teams.

Critical care to clinical trials

Building pediatrics infrastructure in the industry

Leadership with a mission, at ICON and beyond

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