PointCross offers SENDBox and Send-as-a-Service to biopharmas
The FDA will soon require biopharma companies to submit their nonclinical study data in standardized electronic formats such as CDISC SEND, the Standard for the Exchange of Nonclinical Data. This will enable reviewers to analyze all the studies across species in a submission, and to detect important toxicity signals in the data. PointCross Life Sciences announces the immediate availability of its SENDBox and SEND-as-a-Service offerings to assist companies and their CROs prepare for such regulatory analytics. Associate Web Editor Mia Burns spoke to Dr. Shree Nath, VP, PointCross Life Sciences.
Q: If weak or toxicity signals are found within the study data, what would be the next step for the biopharma company to take?
A: There are two aspects to this question. If it is a research activity, in other words, if they are using this kind of technology within their organization as they conduct research, by identifying the signals sooner across all of their disparate data, it allows them to decide the next step for the drug candidate which might include extending an ongoing study or adding a new study or possibly modifying the protocol moving forward. In other words, when they see that there is a safety signal, there are a number of decisions that companies are already doing today, but our technology allows them to do it better, sooner, and faster.
The other part of it is if the company is within a regulatory context and have actually provided a submission to the FDA for an IND, or an NDA, then in that case, the FDA may use the same technology that they have procured from us to identify certain signals within the dataset or from running research from other datasets across the environment from other submissions. This allows the agency to conduct a more efficient review process and may provide better feedback to the company regarding next steps. Reviewers may also pose more detailed questions about the submission.
The whole reason that the FDA is moving quickly toward this initiative of submitting electronic datasets instead of PDFs reports is to improve the quality of the review process and to ensure that they continue to be very diligent about product safety because their first goal is to ensure that they have that they have taken the best measures that they could to determine the safety profile of that drug candidate before any human is subjected to these drug candidates in the clinic. The technologies like ours allows them to do that better than they have in the past and more efficiently.
Q: Does the SENDBox have the ability to accept multiple biopharma and CRO submissions all at once?
A: The SENDBox is a technology offering that PointCross supplies to help companies prepare data sets for submission to the FDA in the required formats. It is available either as a deployment within a company’s firewall, or it is hosted by PointCross on the Cloud M. Companies can access the solution securely with access only to their own data. So in other words, even though they are accessing a common SENDBox in the environment from a solution standpoint, their data is kept completely separate from each other. It is a very secure way of providing the technology in what is called a Cloud hosted environment. They can access it, they can load their own data and they get secure access and visibility only to their own datasets. There is no sharing of datasets or access to other companies.
Q: What is NIMS and how does it help improve reviewer efficiency?
A: NIMS or Nonclinical Information Management System is the name the FDA uses for the environment that we have deployed for them. NIMS allows the identification of safety signals within and across studies and species using advanced visualization and analytics in order to improve the review process. It also creates more efficiency by automating manual steps in preparing summary tables, graphs, and observations to complete FDA reviewer report reports.
Q: What is the cost to use SENDBox and SEND-as-a-Service?
A: PointCross uses a volume based pricing starting with a lower price for smaller companies that may use the SENDBox less frequently. As companies use it more and the volume increases, the fee increases in line with that increase in volume. SEND-as-a-Service is priced on a per study basis based on complexity and size of the studies. CROs and biopharma companies simply outsource the preparation of submission ready SEND datasets to PointCross’ experts. This is a hassle-free way for companies to become SEND Ready quickly.
Q: Would you consider SENDBox and SEND-as-a-Service as unique when compared to other solutions on the market?
A: Yes, absolutely. The SEND-as-a-service offering is extremely unique. No one else is combining technology, services and expertise to provide a turnkey solution of this nature. PointCross is also able to prepare datasets besides those currently supported by SEND into a submission-ready package.
The SENDBox is also unique because it is built on a proven technology that has been deployed at major pharma companies as well as at the FDA. It’s part of the FDA’s NIMS infrastructure and provides an entirely new way of harmonizing disparate data and terminologies, and generating SEND datasets. Since it is offered both behind the firewall or on the Cloud, companies now have a range of choices to become readily compliant with FDA requirements.
Posted: October 2013