If one theme emerged out of this year’s Drug Information Association conference, it’s that the life sciences industry expects more: better quality documents, faster submissions, and an ability to scale in a smart and productive fashion. Throughout the five-day event in Chicago in June, the Microsystems team met hundreds of medical writers, regulatory managers, submission specialists, compliance managers, and other industry leaders, discussing the trends they see, the challenges the industry faces, and how to solve those challenges. Here are our top three takeaways.
Your chances at approval are only as good as your eCTDs
You can know everything there is to know about a new drugs’ benefits and side effects, but if the four people who review a document use conflicting style guides, the end result will be a complicated document that looks bad and has a high probability of rendering incorrectly. Authoring and template creation tools are a starting point; they don’t validate document formatting or help with table consistency. As one attendee said to us, “I know everything about the science. But formatting a document and creating hundreds of tables to show how the science works isn’t why I got a Ph.D.”
But formatting a document and creating those tables is what needs to be done. Electronic Common Technical Documents (eCTDs) are not the future—they are the present. In 2016, the industry saw more eCTDs than ever. In fact, the FDA now requires NDAs, ANDAs, and BLAs to be submitted in eCTD format. Materials being submitted electronically make it easier for FDA to review data, approve new drugs, and monitor drugs after they go on the market. Using eCTD also simplifies the process for submitters, because it is the same format used by drug regulatory agencies in other countries.
With an increased focus on electronic submission, an automated solution that can validate document formatting in minutes allows pharmaceutical and biotech professionals to concentrate on what they know—which leads to faster submission turnarounds and faster approvals.
Being first to market is an advantage you can’t afford to lose—and that means faster submission timelines
The first-mover advantage is quite real; practically speaking, that means more companies now look to shorten the timeline for document submissions to get their products to market before anyone else. We talked with quite a few DIA attendees about how those shortened timelines can result in 17-hour days or booking a hotel room near the office close to submission deadlines to make the most of their time.
There’s a problem with this approach: humans are, well, human. People get tired and need rest to do their best work. You can throw multiple resources into a document, but you’ll end up with something muddied because no two people approach their work in the same way, not to mention that no two people set up their document drafting systems the same way. And be honest: after 17 hours staring at a 200-page document, cross-references will almost certainly make you cross-eyed.
There’s also a solution: technology doesn’t get tired. It doesn’t miss its family, Netflix, or its pets. It can maintain consistency across multiple touchpoints in a way that one person just can’t. Integrating technology into a standard submission workflow can save time before submission and during the increasingly short period after a regulatory body requires changes after submission. The right piece of tech can mean making corrections in hours instead of days.
More isn’t always merrier—mergers and rapid growth mean challenges in scaling
Companies are growing at a breathtaking clip in this industry. Whether it’s a merger or a promising clinical trial that drives a major hiring boom over six months, more staff in pharma and life sciences face the reality that rapid growth is not always a harmonious process.
When two companies merge, they don’t just bring their staff together—they bring together multiple approaches to document drafting, including multiple style guides and workflows. Getting a new team merged and working well together adds yet another wrinkle to the demands that electronic filing and shrinking submission times put onto your team.
As your company scales, it’s critical to identify tools and processes that increase efficiency and consistency. Instead of focusing on content and what your products can achieve, your focus is instead on technicalities, repetitive tasks, and merging style guides. The right technological tool can automate those processes and free your time to concentrate on those areas where you’re an expert.
Finding the right strategy to solve these problems
Like many industries, life sciences is experiencing a technological boom. A robust Quality Management System (QMS) or a template builder may address some parts of these issues, but it won’t take you through the entire document lifecycle, from creation to submission and approval. Developing the right strategy, and taking a holistic approach with the right technological tool, will lead to higher quality documents and more efficiency—and, as a result, cutting the submission time down significantly, allowing for faster reviews and approvals. First-to-market, or best-in-market, patients are waiting!