BioMarin Update on Impact of COVID-19 on Clinical Trials

Industry News
The following information is provided by BioMarin to provide general information about its ongoing clinical trials in the context of the COVID-19 pandemic. 

“As more cases of COVID-19 are confirmed, we recognize the increased challenges and concerns faced by participants in the BioMarin Gene Therapy clinical studies. The safety and well-being of patients, healthcare providers, and our communities is paramount as the ongoing COVID-19 pandemic impacts the health and livelihoods of many worldwide. 
Many regulatory bodies, health authorities, and government departments have issued directives and guidance to help sponsors safely and appropriately manage clinical trials during this pandemic. BioMarin continues to conduct our trials according to this guidance. 
BioMarin is in regular contact with and providing study-related guidance to investigators and trial site staff in all countries and to all sites. 
The current pandemic and the burden being placed on hospitals is dramatically affecting the way in which many sponsor companies can conduct clinical studies. In many cases, study participants are having difficulty attending their study site for assessments and company study support staff are also experiencing restricted access. 
For the BioMarin Gene Therapy Clinical Trial program, where possible, and without putting study participants and site staff at risk, study visits are continuing. Where this is not possible, some parts of sample collection and some assessments are being performed in a manner that is in-line with local, regional, and/or national directives and with the utmost attention paid to maintaining appropriate safety precautions for study participants who may have an alternative option to the usual study visits available to them. 
Study participants who are in self-isolation are encouraged to maintain communications remotely with their trial site staff. 
This is a rapidly evolving situation and all efforts are being made to continue the BioMarin Gene Therapy Clinical Trial program while remaining acutely aware of the safety of study participants and site staff alike. 
We acknowledge and are extremely grateful for all participants and study staff for their contribution and commitment to this program especially during this pandemic. 
For any study participant directly affected by the current pandemic, the best source of information about ongoing participation and care is their study doctor and site staff. Information about more general concerns regarding COVID-19 and hemophilia may be available through patient association websites.”

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