The eCTD summit

Recently, I caught up with my old friend Steve Gens (of Gens and Associates Inc.) to talk with him about a very interesting global survey he just completed on “Benchmarks of Emerging Technologies and Approaches for Collaboration and Document Management” in the Pharma industry.  The 2009 survey was completed in partnership with Steve Scribner of International Life Sciences Solutions, as a follow-up to their well-received 2007 survey.  Steve and Steve worked with 37 Pharma companies (including 17 of the top 20, but no very small companies) to understand their collaboration and document management practices, program priorities and challenges, technology landscapes, outsourcing, and total cost of ownership.  Some of their findings may surprise you.   

Here are a few key points from the Gens & Scribner survey (including both the expected and the surprising):

• Over 90% of respondents feel that their Electronic Document Management (EDM) solution for submission documents is effective, with less than 10% considering their solution ineffective; however 44% will be changing their systems within the next three years.  All of the respondents had implemented an EDM solution.
  • Top priorities for companies in the EDM area are integration with collaboration systems, enhancing system performance, improving searching, and reducing TCO
• Speaking of collaboration, just over 50% feel that they have an effective solution.  The survey also provided insight on specific aspects of collaboration, such as collaboration with partners and regulators, with details available in the figure below.

• Adoption of XML authoring remains rare outside of the obvious areas of labeling, with less than 10% of companies reporting other applications such as clinical and nonclinical reports and protocols.  Even in the labeling area, only 25% of companies are doing XML authoring themselves. Many companies are projecting to conduct pilots in 2010 & 2011.
• eCTD adoption was nearly universal, with only a couple of the participants (both Japanese) still researching or unsure about adoption.
• PIM, on the other hand, has been adopted by only about 15% of companies, with another 10% in the process.  (and lots researching, probably due to the news that PIM will be mandated in the relatively near future).
  • Out of the 37 companies, only 8 are submitting PIM right now – four top 20 and (surprisingly to me) four mid-tier
• Dossier publishing was outsourced to low cost regions at least in part by 15 out of the 37 companies, with India (4) and China (4), with 10 companies planning to expand outsourcing.  Although companies are increasingly driven to overseas outsourcing due to economic reasons, they are also very concerned with Intellectual Property issues in many outsourcing regions.
• Twenty-four percent of EU participants outsource NeeS production.  Out of that group, 31% were satisfied with their outsourcing arrangements and about 31% actively dissatisfied.   Interestingly, satisfaction rates with eCTD outsourcing were significantly higher.

One conclusion that was surprising to Steve was that a great many companies do not yet collect metrics on cycle times and the efficiency and value of their EDM-related programs. Companies are also much slower to implement regulatory tracking than projected, most likely due to issues regarding data cleansing and harmonization/adoption of a global system by stakeholders used to many specialized if less capable local systems.

What’s Next?

Steve and Steve will be conducting individual debriefing sessions with the survey participants in the coming weeks.   These sessions help the participating companies understand where they stand with respect to their peers in the industry.  In previous years, the extremely detailed information provided to the participants has proven invaluable in confirming their direction and priorities or helping them re-plan.    Having seen the detailed information and analysis that will be presented in the debriefing sessions (a subset was presented at the DIA Annual Meeting in June), I can well believe that the participants in the 2009 survey will conclude that the time they spent participating in the survey was a good investment.

If you didn’t participate in the survey, you may still be able to get more detailed information since Steve and Steve will most like make some of it available in a series of articles or presentations in upcoming months. Contact information is as follows: Steve Gens (sgens@comcast.net) and Steve Scribner (SteveScribner@nc.rr.com). They have over 40 years experience in the Life Science industry and both their companies provide consultancy services (Strategy, Implementation Planning, and Program Management).