A small US-based biotech company faced illegal supply issues of their innovative and highly demanded treatment for paediatric glioma in Europe. Clinigen established a compassionate use program in Germany and France, ensuring regulatory compliance and preventing entry of unauthorised product. Their expertise in regulatory strategy and operational control facilitated safe and compliant patient access while protecting the company’s intellectual property.


The proactive approach of Clinigen not only resolved legal disputes but also helped the company meet patient need for the treatment. Read more in this case study.