Risk Mitigation in Clinical Trials

Tue, Mar 19, 2019 | By Ryan Carpentier, Sr. Director, Business Development, Cryoport

In 2016, Congress passed the 21st Century Cures Act.  One of the more important aspects of the Act was to expedite the approval process for new drugs and medical devices.  This Act has been a tremendous help in getting new Regenerative Therapies to market by reducing the regulatory barrier to entry.  Even with the passage of the Act, Congress only reduced the need for clinical trials while also relying on patient input, anecdotal data, and observational data to help inform decisions. 

Clinical trials are complex and that along with that complexity comes risk.  For the sponsor, resources are limited both in terms of dollars; and, time (need to reduce the time it takes to get to market).  It is important to focus those limited resources on the highest areas of risk.  It also means that sponsors should look to partner with those companies that have expertise and bench strength in those critical areas that are not core to their areas of expertise.  One of those areas is Supply Chain and Temperature-Controlled Logistics. 

It is beyond critical to ensure that the material being shipped arrives in the condition needed to administer the therapy. There are almost an infinite number of external factors (light, heat, humidity, g-forces, shock, vibration, etc) that can affect the condition of the therapy.  Having a technology platform that gives you visibility into the condition of the cells is helpful so that you can use that data to make informed decisions.  The last thing you want to ask yourself is:  Where are my cells?  Using technology like Cryoport’s SmartPak II™ Condition Monitor and Live View are tools available to help give you a view into the condition and location of the cells thereby giving you the ability to interject, as needed, to ensure, the cells arrive on time and in the right condition.  These tools are helpful in reducing and mitigating risk in your Supply Chain.  As biology continues to advance, the ability to see, in near real time, the status, location, and condition of a shipper is only going to be more critical.

Written by: Ryan Carpentier, Sr. Director, Business Development, Cryoport  

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