Therapeutics case studies
How we maximise the value of our clients' development approach while reducing costs and timelines
Learn more on how we bring life changing therapies to market.
Providing empirically based guidance and built-to-spec models and solutions across every phase of clinical research and lifecycle management for therapeutic development.
Saving a lean biotech more than $4 million with strategic regulatory support
A US-based clinical stage biotech company had several 505(b)(2) NDA assets in development for rare diseases. This very small biotech operated with a lean team which did not have the necessary regulatory expertise to manage regulatory strategy and submissions.
Regulatory problem-solving secures crucial extensions in pediatrics and rare disease
As a result of the comprehensiveness of the documentation and the efficient management of the process, the European Commission granted both indication extension and the additional year of market exclusivity.
Regulatory solutions for uncharted scientific waters
Some therapeutic areas, especially rare pediatric diseases, lack clear development guidelines. ICON’s Regulatory Consulting Solutions helped a pharma client gain global regulatory and payer alignment on novel endpoints for a rare neurodevelopmental disorder, boosting confidence ahead of pivotal trials.
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Regulatory Strategy in Clinical Development (EU)
"A large pharma customer sought expert regulatory support from ICON for a paediatric rare disease development
program."
program."
Agile operations drive enrollment in COVID-19 treatment studies
A mid-sized biopharmaceutical sponsor was conducting a phase 3 study on CDKL5 deficiency disorder, a rare
genetic seizure disorder in children.
genetic seizure disorder in children.
In-Home Services: Patient centric practices
Accellacare was contracted by a large pharma organisation to recruit and provide In-Home Services to paediatric patients with autism.
Examining approved adult drugs for kidney disease in children
A pharmaceutical company faced significant delays in its pediatric program, particularly in recruiting younger age groups, putting the study at risk. After missing multiple deadlines, the sponsor turned to ICON’s Centre for Paediatric Clinical Development for a strategic review, which resolved recruitment challenges and aligned the program with U.S. and European regulatory guidance.