2009 Life Sciences Industry Document Management/Collaboration Survey. DIA Disclaimer Benchmark / Survey Objectives

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1 2009 Life Sciences Industry Document Management/Collaboration Survey Conducted and Prepared by International Life Science Solutions & Associates 10 th EU EDM Meeting Vienna, Austria, 2009 DIA Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners Benchmark / Survey Objectives Line of Inquiry: Has the industry moved from a document/content centric environment to a collaborative centric environment? Understand how EDM, collaboration practices, industry initiatives, vendor market share have changed since our 2007 survey and learn what strategies and trends are emerging. Of considerable interest is to gauge the progress in topics such as: Collaboration (especially with external organizations) Program Priorities (org., process, and systems) Solution Strategy (customized vs. off-the-shelf, vendor market share) Virtual Teaming (tools and team effectiveness) Outsourcing (trending, satisfaction, and geography) Regulatory Information Management (publishing, registration tracking, submission management) Provide comparison feedback to participating companies to their industry position (8 areas) 2 1

2 Usage of These Materials (outside of your organization) We are presenting these results for your information This is a subset of the overall results The detailed results are not in the public eye Reuse of these materials is allowed and encouraged; however we ask that you request permission to do so ( or call) to inform us of the audience and which slides you plan to use Others have utilized specific slides or graphs for industry presentations, health authority dialog, blogs, articles etc. Please retain the footer information with the content This will be very helpful to us to realize the widespread familiarity of the materials and the value it provides to the industry 3 Survey Demographics 37 companies participating (statistically representative) 17 are in the Top 20 (by revenue) Mid-tier is defined as #21 #45 by revenue Small is defined as > than 1 billion dollars 4 Contents Survey Objectives and Background Results from Selected Questions Contact t Information 5 2

3 What is your current EDM deployment for the following categories? Question 1 Submission, SOP, and Drug Safety content were more likely to be one global solution Labeling and Submission Content are seeing the highest amount of current change Appears that TMF and Intellectual Property are high types for change in the next 3 years EU and Japanese HQ participants had a higher percentage of paper based solutions compared to US HQ participants with the exception of Clinical Trials Master File and Promotional Materials Hypothesis: Emerging Market / Security Phenomenon? 6 Overall, how would you rate the effectiveness of your EDM program for the following areas? (1/2) Question 2 US participants had the most content types as part of their program 40% of small firms were ineffective implementing SOPs whereas 86% of Top 20 and Medium firms were effective There was an even distribution of amount of content types deployed by size of participants SOP, GMP, Trial Master File, and IP content types had a significant deployment increase since our 2007 study 7 How would you rate the effectiveness of your collaboration practices in the following categories? Question 3 Collaboration practices with external partners is still a significant challenge for the industry Japanese participants had the highest effective rate for R&D Authoring Teams Content exchange with FDA seems very effective possibly due to open communications (e.g. DIA forums) 8 3

4 How would your user community rate the efficiency of collaboration with Health Authorities (HA) generally? R&D Question 17 More US participants believe HA collaboration and content exchange is effective with all HAs than EU or Japanese participants EU HQ companies report generally poor collaboration effectiveness outside the 3 ICH regions Continued lack of true global Health Authority harmonization may be a contributing factor to the low level of collaboration effectiveness in these areas Does the US position reflect a comfort level with electronic submissions and a willingness to do business electronically? 9 What methods do you currently utilize and what do you plan to utilize in the future for external document collaboration? Question 5 The trend to allow open access directly into internal EDM is similar to our 2007 survey, however, significant growth in external secured collaboration site appears to be the growing trend A significant amount of content is still exchanged in unsecure methods Significant ifi movement since What is most critical for effective virtual teams in your organization? Question 6 A balance of technology (e.g. collaboration tools) and team behaviors (team leadership and trust etc.) were deemed most critical Team Leadership and Effective Communication were equally important by size of company Effective Communication was seen as more critical for EU participants compared to US and Japanese participants 11 4

5 What is your policy to allow third parties (CRO, CMO, Regulatory Agents, Co-Development Partners, Distributors, Non-Employee Affiliates, Investigators, etc.) access to your EDM environment? IT / Mgt Question 30 Third party access to the DM environment is more common among US participants; 92% of US participants responded yes now or within 24 months Japanese participants are least likely to allow third party access Qualified Yes 12 Collaboration Security and Levels of Trust Author Perspective Premise Not all partners are considered equal! Privileges for partners should be constrained by parameters appropriate to your relationship. Some examples: Internal Specific Product(s) Organization Specific Studies Integrated Document Type(s) Operations Level of information detail available that is appropriate to your extent of trust Any combination of the above Each participant in the exchange has a view towards the others based on their roll in the partnership. Preferred Partners Integrated Affiliates Business Partners Contracted Services Independent Affiliates Undisciplined Partners 3 rd World Affiliates Must preserve the anonymity of other partners Levels of Trust 13 What would you consider the top priorities of your EDM program over the next 24 months? R&D Question 12 Collaboration Tools and Systems Performance continue to be critical needs for industry Slow performance was the top critical issue in the 2007 study Collaboration tool integration was as important as Registration & Submission tracking integration in 2007 US participants were more likely to cite the need to reduce TCO Japanese and US participants were more likely to cite move to enterprise model 14 5

6 What business metrics are tracked as part of your document management program? Question 4 Not much change since the 2007 survey; surprisingly low interest in metric tracking The US is placing a higher priority on tracking EDM cost 15 What is the status of applying structured content (XML Authoring) in your environment? Question 7 Adoption of XML authoring for content is driven by current or expected mandatory requirements for SPL and PIM Only one company expects a non-labeling XML authoring solution to be in production in % of the non-labeling pilots are planned for 2011 Debrief Learning: Key Themes a) Significant process / change management effort b) Fast follower: Have others figure it out (reduced cost) SPL R4(2) No XML Planned(2) GMP Product Spec through Use the following scale to express your adoption level for the following initiatives? R&D Question 13 Mandatory use and international acceptance has driven ectd adoption PIM adoption rates are higher in the US (30%) than in EU (23%) while more EU companies are researching PIM SAFE adoption is only in Top 20 companies All other initiatives appear to be low priorities 17 6

7 Given the spring 2008 EMEA guidance, what is your PIM readiness status? R&D Question 14 Sept 2009 EMEA Guideline: Q End formal pilots Q to Q Migrate CP to PIM End 2011 PIM strongly recommended for all new MAA and post-authorization submissions More companies are exploring PIM adoption (Question 13) than have committed to a readiness date Only 4 EU and 4 US companies are currently submitting PIM or have set a PIM readiness date 5 are Top 20 and 3 are Mid-size Expect the majority to have a capability by late 2010, early 2011 based on Sept EMEA guidance EU HQ 18 What is your satisfaction level (generally) and trends (specifically) toward outsourcing the following items to an external vendor? R&D Question 18 The nature of dossier outsourcing is changing from spill over projects to capability outsourcing Those participants that were unsatisfied with ectd outsourcing were also unsatisfied with NeeS outsourcing Surprisingly, NeeS Publishing had the lowest satisfaction ratings 24% of EU participants outsource NEES and 0% are satisfied 19 Submission Outsourcing: Macro Trends Near-term (2010/2011) Significant increase in large projects; especially Top 20 segment Growing competition from Contract Research Organization and other large outsourcers is expected to traditional niche vendors (ISI, Liquent, Octagon etc.) Emphasis on ectd and NeeS submission i outsourcing and not paper submissions Longer-term (2012 +) Potential vendor consolidation Larger companies opening publishing centers in Asia Pacific as a natural extension to their global Regulatory Operations or Clinical Trial capability 20 7

8 Dossier Outsourcing by Company Size R&D Question 19 Publishing outsourcing has more of a distribution within low cost regions and is exclusive to mid-tier and top-20 participants ISI has a leadership position in offshore publishing outsourcing; especially the Top 20 segment India is the leader for current and planned technology outsourcing (e.g. Help Desk) Exclusively ISI 21 What is your strategy (approach) to manage aging customized EDM systems? IT / Mgt Question 28 Strong strategy to convert to packaged solutions Consistent intent across size 22 Off the Shelf EDM systems have a higher total ease of use score than internally customized solutions R&D Question Ease of Use for "Custom" vs "Off The Shelf" EDMS Ease of Use Sco ore Average Particpants Custom OTS 23 8

9 What is the status of various integrations into your R&D Document Management environment? R&D Question 20 Registration Tracking and Submission Management integration projects are taking longer than planned from the 2007 study Collaboration Tools and Clinical edc have accelerated integration plans as compared to the 2007 study 2007 Study Left: In Production % Right: Planned by 2009 % 9/28 0/19 22/81 22/63 22/50 24 Will you or have you adopted the Microsoft SharePoint (MOSS) platform for the following? IT / Mgt Question 31 More participants are using and planning to use SharePoint for both collaboration and document management The US has the highest current SharePoint adoption among regions European adoption could equal US adoption if participants who are considering SharePoint decide to adopt 25 Authors and the Extended Team Survey Authors Steve Gens (G&A) Steve Scribner (ILSS) Greg Brolund Business Phone sgens@comcast.net SteveScribner@nc.rr.com gregbrolund@cfalls-llc.com ll ll Survey Design Review and Feedback Support Five of the top 25 companies Thanks again for your participation Enrollment and Debrief Support for: Europe = Ruedi Blattmann of LSCP Japan = Hitoshi Matsui of CAC 26 9

10 Other Recent Industry Survey s Name Auth Year N Target EDM/eCTD Industry Survey (Quantitative) Label Pulse (Quantitative) ectd Pulse Organizational Implications (Quantitative) ILSS and Gens and Associates Feb Top 50 Dec Top 40 April il08 15 Top 40 Label Deep Dive (Qualitative) July (2 experts) Top 20 Common Dossier (Quantitative) Document Management/Collaboration (Quantitative) Industry Engagement (Quantitative) ILSS and Gens and Associates Oct Top 50 April Top 60 June Top 30 Submission Management Pulse In-Process est. + Vendors Top Background Survey Authors Steve Steve Scribner have worked together over the past 9 years and have a combined 31 years of EDM experience (strategy and transformation) in the Pharmaceutical Industry. Greg Brolund has recently participated in the global network and worked with Steve Gens at Booz Allen Hamilton Steve Gens has over 23 years experience with the majority in the Bio-Pharmaceutical Industry. He has both industry (Johnson & Johnson) and consulting (Booz Allen Hamilton & FCG) experience. He assists and advises clients with program and organizational strategy, transformation frameworks, deployment readiness/strategy, vendor analysis and decision-making, information management strategy and is a change management. expert Steve is a frequent speaker and has a Masters of Science Organization Development from American University. Steve Scribner is a seasoned consultant with 40 years of experience in business solutions development. For the past 17 years, he has focused on enterprise document/content management consulting with 22 different engagements to build corporate vision and strategy in the Pharmaceutical or Life Sciences industries. He specializes in mergers and acquisitions, business value, strategy, user requirements, globalization, harmonization and business process redesign. Greg Brolund is a management and technology consultant with experience with global Pharmaceutical companies in product labeling, submission publishing, Health Authority interactions, pharmaceutical safety and pharmacovigilance programs and ICH ectd, E2B and HL7 ICSR electronic submissions. He has over 25 years of experience in all aspects of information technology including the Food and Drug Administration s drug review process and supporting systems and as Chief Technology Officer for the US Department of Health and Human Services