The FDA has very stringent rules and regulations surrounding chain of custody. These rules become even more strict when genetic material is involved. In gene therapy, a patient’s own DNA is their treatment, so following chain of custody by knowing the location of their genetic material at all times is imperative. This is key not only in completing successful clinical trials in a very specific timeframe (the typical door-to-door transport time is 40–50 hours or less), but in adhering to strict FDA and HIPAA guidelines around personally identifiable information and genetic materials. “Errors along any point of the process or supply chain can be potentially devastating for patients... Innovative therapies that may not only treat but potentially cure cancer and genetic diseases a

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