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.
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Decoding AI in software as a medical device (SaMD)
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Software as a medical device (SaMD)
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Representation and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Prioritising patient-centred research for regulatory approval
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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Exploring FDA guidance for modern Data Monitoring Committees
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Streamlining dossier preparation
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An innovative approach to rare disease clinical development
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Therapeutics insights
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Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
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Central Nervous System
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A mind for digital therapeutics
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Challenges and opportunities in traumatic brain injury clinical trials
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Challenges and opportunities in Parkinson’s Disease clinical trials
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Early, precise and efficient; the methods and technologies advancing Alzheimer’s and Parkinson’s R&D
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Key Considerations in Chronic Pain Clinical Trials
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ICON survey report: CNS therapeutic development
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A mind for digital therapeutics
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Glycomics
- Infectious Diseases
- NASH
- Obesity
- Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Endocrine and Metabolic Disorders
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
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Blended solutions insights
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Clinical trials in Japan: An enterprise growth and management strategy
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How investments in supply of CRAs is better than competing with the demand for CRAs
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The evolution of FSP: not just for large pharma
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Embracing a blended operating model
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Observations in outsourcing: Survey results show a blended future
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Clinical trials in Japan: An enterprise growth and management strategy
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Behind Biotech: Stories of science and resilience
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Integrating openness and precision for competitive advantage
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Strategies for commercialising oncology treatments for young adults
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