DIA EDM and EDS – Day One Recap

I just got done with day one of the DIA EDM and EDS conference in DC. It was a great day, with lots of strong sessions, compelling speakers, and a rich cross-section of vendors and service providers in the expo. Based on the sessions I saw and conversations I had on the networking breaks, I wanted to share some initial observations about the state of life sciences document management.

Silos

It’s safe to say that at most large life sciences organizations, information and documents are almost completely siloed by function. Even if there’s a common platform enterprise wide, documents across the product lifecycle are stored in isolated buckets that are difficult (if not impossible) to access across those functions. R&D, clinical ops, reg ops, reg affairs, med affairs, manufacturing, quality, PV–they all have a shared interest in a given product going to market successfully, yet their documents (and the underlying business processes) live in isolation from each other, with all the negative effects one would expect, e.g., findability, rework, orphaned information, process inefficiencies (esp. longer time to market), compliance risk, etc.

Affiliates are the Future

For most large life sciences organizations, global affiliates are an important growth area…if not THE most important growth area for the bottom line. Emerging economies in BRIC as well as other developing nations represent huge growth opportunities for global life sciences organizations over the next decade. However, their ability to realize these potential opportunities relies heavily on the effectiveness and efficiency of their affiliate regulatory operations. Yet from everything I’ve seen so far at the show (and that I’ve been hearing from folks in the industry over the last few years), most organizations struggle to empower their global affiliates to develop effective submission capabilities. In fact, one document management vendor I spoke with at the show thought that most organizations could shave four to five weeks off the time to approval in their global affiliates–four to five weeks, people…at how many hundreds of thousands to millions of dollars per day? Yet very few organizations are addressing their affiliate challenges head on. Not sure why.

Product Lifecycle Management

Without a doubt, almost universally, I heard folks complain that life sciences organizations are approaching their documents and information from a functional, rather than a product lifecycle, perspective. That is, they slice and dice their org into R&D, clinical ops, regulatory ops, manufacturing, quality, PV, etc. rather than by product or product line. The result is that organizations struggle to respond to regulatory requests for information within mandated timeframes, to leverage existing IP for new product development and product extension, to drive the predicted value out of mergers and acquisitions, and to improve process efficiency to speed time to market.

The Final Word

So much for day one. Not sure if these issues will be solved days two and three, but I look forward to encountering more data points on each, having impassioned conversations about how to address them, and meeting like minded practitioners who are committed to solving them at their organizations. And if you’re at DIA EDM and EDS, let me know, and we can get together to talk about all this in person…