Gene Therapy – Monitoring

Transcript

Depending on how long lasting these gene therapies are or how durable they are, they may need other supplemental treatments, follow-up treatments. They certainly will need clinical monitoring over time. So the clinical system will have to continue to interact with these patients. Just because they don’t have the symptoms and the manifestations of the disease being treated immediately after or immediately in the next few years after the gene therapy is administered, doesn’t mean we can allow them to be lost to follow-up. There needs to be monitoring for adverse events. There needs to be monitoring for effectiveness. There needs to be monitoring, both laboratory and clinical, to make sure that there aren’t new signs and symptoms that are resulting, that may be much more minor manifestations of the disease than what they would have had if they didn’t get the treatment in the first place. All of these are important questions to wrestle with as gene therapy becomes much more part of the mainstream and starts to proliferate over the next several years.