Working for a company that supports cell and gene therapy industry, it’s always exciting to see new treatments finally go to market. Drug companies spend years trying to clear their new medicines through clinical trials and government approvals, and sometimes they don’t make it. But we know that success and failure are both important parts of the innovation process.
That’s why many were surprised to read recent statements from Janet Woodcock, the research director of the FDA Center for Drug Evaluation and Research. She called for the drug development process to be re-engineered to be faster and more reliable, using the examples of the airline and construction industries. “Usually they can build an airplane and it can fly the first time,” she said, noting that it’s the same for bridges and skyscrapers working when they are first built. She also said academics and the National Institute of Health haven’t provided this consistency, despite their history of leading drug discovery. “We have to engineer this so it’s not trial and error every time," she concluded.
To many in the industry, Woodcock’s statements seemed a bit out of touch. Cryoport is currently supporting more than 400 clinical research trials for new cell and gene therapies across the world. (Every quarter Cryoport reports a net number of trials supported, as each quarter some trials are halted or fail.) Whether it’s the development of a molecular drug or a cellular-level therapy, these pharmaceuticals will be used on real, live people. Human biology and diseases are complex and dynamic, and a failed medical treatment can be disastrous – even fatal. New treatments need to be tested for safety and efficacy in a careful process that strives not to harm human test subjects. “Trial and error every time” is critical.
It’s also important to point out that advancements in medicine are relatively new. A simple drug like aspirin has been around for a little more than 100 years. When it comes to cell and gene therapies, we are still just starting to understand their potential, and we are going to continue learning – via trial and error.
While outcomes of experiments and trials are beyond our control, the scientific process is there to ensure those outcomes are sound – that results weren’t influenced by faulty processes or logistics. And for the newest medical therapies out there, Cryoport helps ensure logistics and transportation are foolproof parts of the process.
We can make certain that cell and gene therapies travel safely and securely between labs, manufacturers, hospitals and back again. We provide customized shippers for our clients, and we track shipments 24 hours a day, every single day of the year. Our smart tracking system alerts us if a shipment is experiencing any problems, and we’re able to intervene when necessary. We ensure a variety of critical variables – temperature, orientation, location, shock, vibration – are maintained and recorded so that the treatment arrives in perfect condition. And we do this thousands of times a day, all around the world.
When it comes to a clinical trial, you can’t always guarantee a successful outcome. But you can control every step of the scientific process so that you can ensure that your outcomes are sound. This is what we help do, and it’s in our logo: Science. Logistics. Certainty.
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