What do Test System Shortages and Vendor Closures mean to your IND Studies?
Attentive can offer solutions and IND experience to meet your study needs.
Obviously supply chain delays and unexpected closures have affected every industry over the last year or so, and ours is no exception. One particular devastating closure of a major industry vendor has recently affected sponsor’s access to test systems. These test systems are involved in a number of studies needed for our clients, but the most significantly impacted is likely to be Investigational New Drug studies (IND) studies. INDs involve different study types and specific test systems, but the recent closure of one of the primary vendors has caused a bit of a delay for everybody. This means waiting until the last minute to plan your studies may mean that your study starts could potentially be a year out or more. Based on normal biological cycles required, there will now be quite a waiting period while the industry catches back up. No one can just flip a switch. A lot of infrastructure and training has to be put in place to allow the industry vendors to meet existing and future demand in a responsible way.

INDs (an FDA requirement prior to clinical trials) involve a vast range of studies.  Attentive offers a portion of the vast range of these studies that need to be completed by our clients. Depending on the results of each study, the test article could take several different paths to complete the series of studies. Contrary to common characterization of a drug development “pipeline” being a unidirectional flow from discovery to utilization, a diverse route of potentially failure-prone learning maps must be navigated by scientists with multiple backgrounds. It is vital to find a CRO with the experience and expertise to help steer the drug through the complex maze of tests.  This is where Attentive Science comes in.

But more than just our experience and expertise with INDs, Attentive’s versatility and history working with multiple tests systems allow us to handle these recent test system shortages for our clients, while working to determine the best way to address the testing they require. Associates at Attentive have decades of expertise in putting together study designs for our clients that lead to high quality data and clear answers to their project needs. We can suggest alternatives and offer simple solutions, as long sponsors are open to the idea of previously unconventional solutions in regards to (for instance) the age of individual test systems. Previously some of our clients might have insisted on having a specific age associated with their test systems. With all the changes and limitations, we’re all facing within the industry, the specialists at Attentive took it upon ourselves to ask Pathologists, what they think about the slightly older test systems for certain studies. We found that the age was not as significant a consideration as previously accepted. We had a client come to us, wanting historical data about the age range available test systems. After a conversation about some of the industry’s recent considerations, they acknowledged that they could have a slightly more mature test system enrolled. This allowed us to plan their research and we subsequently proceeded with the slightly more mature systems. Because of this flexibility in the age of their test systems, the study sponsor is now going to be able to meet their IND timelines. This means that if the industry can be flexible moving forward, we can still all be sure we meet the endpoints of the various tests needed, without a detrimental effect to a study being done.

Attentive’s versatility to recent changes within the market, coupled with our Client-Calibrated Approach allows us to quickly communicate unexpected challenges to our clients, discuss creative solutions with them about alternatives and provide solutions to deliver trustworthy data quickly and ensure the success of their IND program.

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We look forward to assisting you by providing reliable defendable data for your program