30 years of LORENZ (part 1)
Posted on October 22, 2020
LORENZ - a pioneer in e-Regulatory solutions
For 30 years, LORENZ has been a key player in the Life Sciences market. Our company history is closely interwoven with the creation and development of the eCTD and the digitization of regulatory affairs. To mark 30 years as a founding player in this sector, we have put together some interesting facts and highlights you might not know about.
How it all started
By the late 1980s, most pharma and life sciences companies were already working with PCs internally. However, authorities still required drug approval submissions on paper. So "compiling" a submission meant exactly that: assembling hundreds or thousands of word files, spreadsheets and scanned-in documents, and then printing everything out in multiple copies, and collating it all in the right order. The final product, the actual submission, was quite literally a pallet (or two) of documents.
In 1989, Wolfgang Witzel (today President of LORENZ Life Sciences Group) was part of the Sales executive team at LORENZ Orga-Systeme GmbH, a seller of office communication systems.
While handling a project for a Darmstadt-based pharmaceutical company, their Regulatory Affairs department had a request that demanded the use of new technology. Company managers had seen a new laser storage technique demonstrated at a trade conference, and wanted to put it to use in their own area. The new storage medium was called optical disc technology.
The technology was successfully installed at the company in Darmstadt. However, it later turned out that all of these electronically stored submission documents still had to be printed out in hard copy, sorted into binders and delivered by truck to the Federal Health Office (BGA) in Berlin, which was the approval authority for Germany at the time. Upon arrival, the submission documents were stored at the authority, and the process of officially evaluating their contents began.
This duplication of effort provided the seed for a new business idea. Instead of pallet loads of paper, why not simply deliver the entire submission to the authority on a laser disc? Wolfgang Witzel posed the question to the BGA, and the authority consented to run a pilot project. This was the trigger for the official foundation of LORENZ Archiv-Systeme one year later in October 1990.
As part of this pilot project, the BGA issued a tender for creating a system and software for making submissions electronically. LORENZ won that tender. The project itself as well as the working group comprising the BGA and several pharma companies got a name: DAMOS (Drug Application Methodology with Optical Storage.)
Wolfgang Witzel with an Optical Storage Disc, 1990
After our first submission software, PharmBridge, was completed, LORENZ was required to make the actual data structure public, in the form of a “structure specification”. This enabled other players to develop software that would meet the DAMOS specification, with the overall goal of creating competition.
Based on this LORENZ-specified structure, the DAMOS group then took over the official responsibility for the further development and publishing of the so-called “specification” standard.
Since the introduction of that first DAMOS standard in 1993, team members at BfArM, the German authority, have been working with LORENZ software products continuously. At first, PharmBridge Review software was used at single workstations to scan documents and subsequently to issue the approvals, on magnetic optical discs at first, and later moving to CDs.
The first e-submission
The very first electronic submission was a “deposit document” (Hinterlegung) submitted to the German agency BGA (later BfArM) in 1990 using a LORENZ tool.
In 1995, LORENZ PharmBridge Compile was published. It contained the latest DAMOS 2.0 and 3.0 specifications, with the latter already included as part of the lifecycle management function. The same software was also used to make the first electronic submission in DAMOS format to the then European Medicines Evaluation Agency or EMEA.
The submission is ready to send to EMEA
The emergence of the first electronic submission in Europe in 1995 happened differently than the earliest electronic submissions in the US in the late 1980s. In Europe, our PharmBridge software built an inner document structure designed to help the compilation of the submission, but also to facilitate its review and approval on the authority side. Life cycle management was built into the software! From the start, it was used by both submitters and reviewers.
In contrast, electronic submissions in the US arose slightly earlier, but there, both the submission itself plus the hardware and software for reviewing it had to be delivered to the authority together so that reviewers could process it.
Since these early beginnings, LORENZ has kept its finger on the pulse of the sector, and played a critical role in the definition of the first electronic standard for the Common Technical Document – commonly known as the eCTD.
In the year 2000 LORENZ added the first eCTD publishing module into its new network-compatible flagship software docuBridge. In 2003, the first "real" eCTD in line with ICH specifications (then still draft) was submitted using it. In 2016, LORENZ piloted eCTD 4.0 during the concept phase in collaboration with representatives from industry and agencies. Currently LORENZ provides feedback to ICH via our customers and industry working groups.
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