Biopharma Dealmakers – What's an ECTD, and Why Should You Care?13 July, 2016
Experienced biopharma dealmakers know that pharma companies seeking to partner with a biotech will require full disclosure of the regulatory submission documents. During due diligence, they will need to share the entirety of the IND or NDA with a potential partner. While many business development professionals may regard the internals of the IND or NDA as a huge black box of documents, regulatory professionals know this structure of documents inside the electronic submission is called an eCTD (electronic Common Technical Document).
The eCTD format is a complex nested hierarchy, which is not easy to read. For this reason, several software companies have developed eCTD viewers, which make reviewing regulatory documents faster and more convenient, and which enable more efficient identification of the critical information contained in the submission.
Why Should Dealmakers Care?
We all want due diligence to go as quickly as possible, since less time generally translates into better deal terms. Experienced dealmakers know that if due diligence doesn't go swiftly, it can result in unfavorable changes in business conditions or the loss of deal momentum. They also know that most of the documents in a biopharma partnering due diligence data room are regulatory documents, and that most of the time spent in due diligence document review is related to reviewing those documents.
Regulatory experts on the due diligence team would love to request the full eCTD submission, which they could then load into an eCTD viewer in order to accelerate due diligence. But they know that you would never want to give them the full submission because once you've shared it in eCTD format, you can't "unshare" it if the deal goes south. So without an eCTD viewer, the due diligence teams instead slog through the eCTD submission in the dataroom's built-in viewer.
ShareVault is very excited to announce the release in a few weeks of a new integrated eCTD viewer, developed in collaboration with one of the leading providers of eCTD viewing software for pharmaceutical companies and biotech companies alike.
First Data Room With an Integrated eCTD Viewer
ShareVault has always been the innovation leader in data rooms. One example is our support of document-to-document hyperlinking, which is another vital way to accelerate the review of regulatory submission documents. ShareVault has been–and still is–the only data room to support this essential feature.
One important capability offered by ShareVault's integration with the eCTD viewer is that the ShareVault administrator can decide which sections of the eCTD (pre-clinical, clinical, quality, manufacturing, etc.) should be permissioned to the different parties involved. This gives our customers fully granular control of the permissions within the submission itself.
The new secure eCTD viewer will significantly accelerate the speed of regulatory due diligence. The announcement will reinforce our commitment to the life sciences industry as the only data room that has features specifically developed for life sciences.
Stay tuned for the official announcement of the collaboration. We have already started beta testing and will be going live this summer with this exciting new feature.