Brilliant Leap

Liquent's New Daddy Has Bucks

Why is no one writing about Liquent being acquired by Marlin Equity Partners? Sure, there’s a press release (the same press release) all over the web, but no one seems to be speculating as to why Thomson-Reuters sold Liquent (to make money? to cease losing money on its investment? it longer fit its product portfolio? they got an offer they couldn't refuse?....) or exactly why Marlin purchased it.

For those who aren't familiar with the document/information management/regulatory Life Sciences space, Liquent (its products include(d) Insight Manager, Publisher, Viewer, CoreDossier, and EZsubs) provides the software that most of the major pharmaceutical and biotechnology firms use to prepare and publish their drug submissions to the FDA and its international counterparts. Founded as ESPS (Electronic Submissions Publishing Systems) in 1993, with funding from Adobe Ventures, it initially revolutionized the assembling and publishing of documents required for new drug applications (NDAs). Though I’m not able to find precise data on Liquent’s market share, I think it’s safe to say that more than half of the large pharmas use its products for FDA submissions (industry analysts have said that as many as 33/50 of the top Life Sciences firms used CoreDossier at one time). I believe that Liquent has since lost market share to companies like Image Solutions  , Extedo, and most recently Datafarm .

For those of us who are unfamiliar with Marlin Equity Partners, the company says that it:

The eCTD/ Document Management Connection- What say the vendors

I asked a question on Linkedin a few weeks back, namely "What questions would you ask an eCTD publisher to determine a high level of expertise?"  I got some interesting answers.

Before I go on, it may be worthwhile to explain what an eCTD (Electronic Common Technical Document) is; it's the vehicle that Pharmaceutical,  Biotechnology, and other Life Sciences firms use to transfer regulatory information to the FDA and its international counterparts. It's made up of five modules:

1. Administrative Information and Prescribing Information
2. Common Technical Document Summaries
3. Safety
4. Nonclinical Study Reports
5. Clinical Study Reports

Each of these modules contains a host of documents and making sure that the right information is put in the right place in the right format is an ordeal. Consider that one eCTD can be made up of nearly 6000 files and that an eCTD supplement can be made up of as many as 15,000. Put the wrong stuff in the wrong place and the FDA rejects it; the approval of the new drug application is delayed, stock holders get angry, and those who might benefit from the therapy have to suffer and wait.

What Keeps Regulatory Professionals Up at Night?

Three things: Concerns about Compliance, Staffing, and Knowledge. But what are these potential problems and why is it so important to understand them? Ultimately, the problems impact the business in 1 of 2 ways: increased costs brought on by fines or inefficiencies OR decreased revenues because new products are not approvable as quickly as possible or existing approved products are not maximized for distribution in the marketplace. Overarching all of this is the general frustration that the "rule book" that these companies have to "play by" is one that has been imposed upon the regulatory affairs professional by many outside/external organizations - specifically, the world's many and diverse regulatory authorities responsible for approving new drugs for sale in their geographies.