Can’t See the Forest for the Trees in Life Sciences?

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

People usually use this phrase when trying to describe the tendency to become too involved in the details of a problem versus looking at the situation as a whole. Could thissunrise in a forest same concept apply to an industry such as life sciences?

During our webcast, “Improve Compliance by Gaining a Complete View of Regulatory Activity” held earlier this week with IDC, we polled the audience.

  • The first polling question asked, “Which of the following is a primary concern at your organization today?” 37.5% of the respondents answered, “Eliminating data silos and creating a unified information architecture.”
  • The second polling question asked, “What would you consider to be your highest RIM priority in the next 2 years?” 57.9% of the respondents answered, “Centralizing/integrating systems to unify RIM functions (single authoritative source.)”

In an industry where most life science organizations have historically taken a siloed approach to product development—that is, they create, manage, and store information by function (clinical, regulatory, manufacturing etc.); could these survey results indicate a potential opportunity for transformative change?

Well, let’s start with how information flows across the lifecycle of a drug in a pharmaceutical company today. As a new compound is discovered and goes through non-clinical and clinical testing, information must be shared internally with Regulatory Affairs (and ultimately with health authorities) in order to gain approval. Information from across the drug development process must be shared and overviews, study reports and summaries authored, reviewed and approved. Once an application is submitted to the regulators, there are on-going interactions with them through approval, and then continuing on for the life of the drug. Upon approval, specifications and formulas which originated in R&D, now have to transfer to production manufacturing. And the process continues on through sales and marketing, pharmacovigilence etc.

So, what would the process look like if it was redefined? How transformative could it be? What if information residing in each functional area could flow seamlessly throughout a drug’s lifecycle? For starters, workers wouldn’t have to export and import information from Diagrammsystem to system along the drug development lifecycle. By leveraging a consistent data model, information could be linked across solutions. This could reduce the risk and inefficiencies of manually exporting and importing information, stem the proliferation of multiple copies and eliminate the difficulty associated with determining final versions of documents. In addition, this would provide an authoritative source for drug development information and provide detailed audit trails across the process. Most importantly, it could help streamline the process helping to get needed drugs to market faster. This makes sense, doesn’t it? Organize information according to the business process and lifecycle of products rather than by business function.

What do you think? Do you think your organization is beginning to see the forest that includes the trees and embark on this type of transformation?

Embracing Change in Regulatory Information Management

Steve Scribner

Steve Scribner

More than 20 years experience in business strategy and implementation of Content Management in Life Sciences

“Companies that are still relying on paper or Excel spreadsheets to track their regulatory submissions are missing out on much of the value that their documents contain and the benefit of having a comprehensive view of regulatory activity. Working transparently in many ways, life science-specific content management solutions like EMC Documentum SSV have best practice intelligence built in, delivering value to projects both today and for projects yet to come,” says Dr. Alan Louie, Research Director, IDC Health Insights

alan louieWe welcome Alan S. Louie, Ph.D. Research Director, of IDC Health Insights as our guest blogger today on embracing change in regulatory information management. Read on as he shares his thoughts with us:

The persistence of elegantly crafted and refined paper templates and Excel spreadsheets to manage regulated documents and processes in the life sciences can in large part be attributed to a strong resistance to change, the lack of time, money, and a measurable ROI needed to assess and validate new solution approaches. At the same time, the increasing use of external partners is further complicating document and process management for regulatory and IT staff, with many key project and process managers increasingly residing outside of the organization and often thousands of miles away geographically. While it may have been possible in the past to walk across the hall in the past to collect a signature or determine the status of a submission, today’s efforts routinely rely on less personal phone or email to track project status and hear about issues that may arise. As an additional concern, documents supporting regulatory compliance often resides across multiple systems, including email, separate document repositories, individual laptop/desktops, and manual filing systems.

lifescissv blog imageBeyond conversion to electronic versions of their historically paper documents and processes, electronic content management systems (CMS) are designed to capture supporting metadata that can add significant immediate value to regulated documents and processes. Effective content management systems can also contain significant embedded intelligence by translating industry best practices into automated workflows that can be used to automatically identify omissions and discrepancies, highlight important deadlines, assess whether a submission is complete (and identify missing documents, if any), and enable extended use of data, information, and knowledge beyond the project at hand. From a regulatory compliance perspective, use of enterprise regulatory information management (RIM) solutions brings required documents into a single repository, facilitates more effective information access, sharing and review on a global basis, and simplifies responses to regulatory inquiries and audits.

While often presented as a more effective approach to managing and responding to regulatory audits, IDC has seen few cases where this was the primary driver for conversion from paper or an Excel spreadsheet to a CMS or in this case, a RIM system. In most cases, additional benefits must be realized for investments to be made. Reduction and/or elimination of low value, repetitive activities at the operational level, improved process reuse for related efforts, improved compliance across partner organizations, and more real time monitoring and analyses of ongoing project efforts are regularly mentioned as key drivers of CMS implementations, with measurable ROI helping to justify investments to the C-suite. For RIM systems in particular, capturing and tracking of correspondence with regulatory authorities can come in multiple forms, including paper, email, and phone. While heavily time consuming to track retrospectively, systematic access to this information can better inform ongoing project efforts on a global basis, simplify compliance, and help to reduce the insanity of regulatory audit fire drills.

Regulatory information management (RIM) systems are helping regulatory organizations to work more efficiently and effectively. At an industry level, RIM solutions that reflect key industry (and company-specific) best practices are helping companies to maintain global compliance in an increasingly complex global ecosystem while freeing up remaining key staff to concentrate on more important concerns such as handling agency interactions rather than providing updates, status etc. The ongoing and well advanced transition away from legacy solutions in the life sciences reflects the increasing maturity of commercial solution offerings and their ability to advance efforts that build on well-established industry best practices and bring enhanced levels of compliance and efficiency to key business processes.

To learn more join EMC Life Sciences experts and me (where I’ll be a guest speaker) for an upcoming webcast October 21, 2014 at 11am ET.

Boston Is Not Beijing for Life Sciences Marketing

Tom Broering

Tom Broering

Head of Americas Alliances and Channel Sales, Information Intelligence Group at EMC

Next week, EMC and some of our partners will be exhibiting at, and participating in, the DIA EDM and ERS 2014 event in Washington, DC, to explore evolving global trends in e-records, systems and e-context in the Clinical and Regulatory space. I thought it was fitting to share some insights about the global differences that Ameen Datoo, Principal Consultant at EMC Certified Solution partner, Paragon Solutions, sees as he  works with life sciences clients on streamlining globally regulated content.

Boston is Not Beijing for Life Sciences Marketing
by Ameen Datoo, Principal Consultant, Paragon Solutions


Social scientists like to talk about the world getting smaller, and borders disappearing. They point to how global connectivity is enabling us to reach out and touch anyone, anywhere at any time, and how multinational corporations are spreading their ubiquitous brands across continents.

But a smaller world is not necessarily a simpler one. And no one understands that better than those who navigate regulatory differences in the life sciences industry.

Life sciences companies must manage vast amounts of information to effectively and legally market their products around the world. Few things are more complicated. Selling the latest wonder drug in Boston is not at all the same as selling it in Beijing. Designing a promotional campaign that works in both locales, and many more in between, is far from simple or straightforward.

At home or abroad, compliance is the biggest driver of that complexity. In the U.S.A., it’s difficult enough to track, support, document and verify every claim in every piece of domestic promotional material through creation, revision, approval and submission to the FDA. It’s a major challenge to connect all the relevant players: medical, legal, quality control, ad agencies; at every stage of approval.

Now imagine multiplying that effort, country by country. Every government writes its own regulations. France drafts requirements similar to those of its Euro-neighbors, but China goes largely its own way. Moscow demands proprietary considerations that are unknown elsewhere (not to mention the cultural differences that can turn a brilliant promotional piece in Location A, into a coarse or vulgar insult in Location B).

No regulation in any country can be taken lightly. Penalties for even minor lapses can be steep. Failure to provide fair balance or worse, engaging in misleading claims, can cost billions.

Prescription Medication Medicine Pill TabletsNor can the industry shrug off international sales. The studies are clear: Drug companies that hope to keep growing are going to have to do it overseas, in the so-called “pharmerging” markets: China, Russia, Brazil, India, etc.

Old information management systems that relied on emails, file-sharing, a few spreadsheets and the like, are no match for these global challenges. But newer “generic” solutions not built specifically for life sciences often lack the industry savvy to do the job, potentially leading to critical, even dangerous gaps.

To those of us working in Life Sciences ECM, the message is clear: pharmas and other life sciences organizations must seek out and adopt industry-specialized solutions for promotional materials management. These solutions need to be capable of connecting multiple players, handling multiple drafts, on multiple platforms, and in multiple cultures. That’s a level of subtlety, flexibility, and adaptability not easily achieved, yet with our current technology it is a reachable goal. Visionary information management companies are getting it done right now, indeed making the world smaller. And simpler too!

Do you have a specialized technical solution for managing promotional materials? Should you?

A Complete View of Regulatory Activity is Greater Than the Sum of its Parts

Steve Scribner

Steve Scribner

More than 20 years experience in business strategy and implementation of Content Management in Life Sciences

Regulatory Submission Management is an extensive process that requires many integrated capabilities. In my initial blog, I likened the process for submitting a drug LifeSci SSV-2application to regulatory authorities as being similar to completing a mortgage application. Bio-pharmaceutical companies have to keep a current, complete and concise record of all their drug applications with the government agencies in each market of the world. That requires a record of exactly what was submitted, plus a thorough collection of correspondence from the first contact to the last update.

I then validated the industry need by referencing the survey and the analytic work performed by Gens and Associates. Their survey results indicated that 78% of respondents plan to change their Heath Authority Communication solution in the next 2 years. It would seem that what is needed to solve this challenge as an integrated solution is missing or at least not meeting all the industry requirements.

With the challenge outlined and the need validated, I then looked at how this process could be redefined. To meet these business needs, a solution would need to have a solid answer for importing submissions, published by a variety of tools (both current and legacy.) It would also need the ability to easily import correspondence from multiple systems (local storage, collaborative spaces, file shares and email systems.) Ideally, this information would be integrated into a common repository so that a comprehensive view could be achieved and easily searched with minimal effort. The end result would be a tool that could be easily used by Global Regulatory organizations anywhere and also fit the needs of participants in the development lifecycle and external organizations (affiliates) so that a consistent message could be conveyed with all agencies.

Today, EMC is announcing a new solution that aims to deliver on these needed capabilities. Documentum Submission Store and View, part of the EMC Documentum for Life Sciences solution suite, links regulatory correspondence and communications to submission files, enabling a 360-degree view of regulatory activity. It also automatically stores eCTD, NeeS and paper submissions into a scalable Documentum repository that delivers advanced security, audit trail, metadata and indexing capabilities. More specifically, Documentum Submission Store and View enables:

Regulatory submission and associated communications storage in a compliant and secure repository that includes audit trails and indexing for more efficient tracking of submissions and queries and a complete view for better clarity and understanding with regulatory authorities.

  • Easy access and view of regulatory correspondence that’s linked with submissions, which includes an out-of-the-box integration with Microsoft Outlook and follows a best practice document taxonomy for submissions and agency correspondence.
  • Quick search and retrieval of archived submissions and associated documents using a faceted navigation on metadata properties such as product, country, manufacturer, submission type and date.
  • Streamlined viewing of Electronic Common Technical Document (eCTD), including the full regulatory submission lifecycle, even the navigation of inter-document hyperlinks.

Documentum Submission Store and View extends EMC’s commitment in the life sciences regulatory arena by addressing a critical aspect of the regulatory submission process. This new addition to the Documentum for Life Sciences solution suite means Life Sciences organizations can now gain a complete view of regulatory submissions and related correspondence in a single, compliant solution. By integrating correspondence and submissions in one view, regulatory workers can be freed from constant requests for status updates etc. and focus their time on more important tasks at hand – having timely and quality interactions with health authorities.

Learn more about the latest SSV announcement on the EMC Pulse Blog, Video, and upcoming Webcast.

Enabling Population Health Management Programs in EMEA

Dmitry Etin

Dmitry Etin

Member of EMEA Strategic Pursuits Team, responsible for strategic healthcare opportunities in the region such as national EMR projects, health information exchange hubs and regional vendor neutral archives.

I read a lot about clinical analytics these days. The US government has recently launched initiatives like ACA, generating the basis for use cases in this area. Recently, Andy Crowne, IIG Healthcare GM shared his thoughts around this topic too.

In EMEA, population health management (PHM) models as theoretical studies have existed for a while, and are getting adopted by some European countries and in the Middle East. Today, emerging technologies particularly in big data analytics are providing new promising opportunities for governments on implementing and executing these programs.

All those programs, ramping up in adoption even without having similar maturity levels, tackle a common public health challenge: disease prevention and promotion of aDoctor and touch screen 158245439 healthier lifestyle. Chronic disease management, epidemic control, personalized treatment and clinical pathways improvement are part of the agenda. However, prevention is most likely the highest in the priority list, directly impacting the cost of the whole Healthcare system. Take a look at a new IDC study about chronic disease and prevention management programs.

The figures speak for themselves: major causes for type 2 diabetes are directly associated with lifestyle and wellness. The Middle East is suffering strongly from by this disease, for example, 25% of Saudi Arabia population is diagnosed with type 2 diabetes and a lot of studies and programs are trying to improve the situation.

Similarly the “eat better move more” wellness promotion example shows the health management program focusing on cardiovascular diseases.

Sources of information and data models are the foundation for any type of analytical endeavor. It’s as simple as this; analytical tools aren’t very valuable if the data is limited and not meaningful enough. In order to address the prevention programs properly, we have to accept that it is no longer just data from medical records sourced by clinicians’ observations and diagnostics to be taken in consideration. We need to go far beyond hospital facilities and the set of data they provide. Citizens have to be engaged into complementing medical records with the necessary information, using different types of wearable devices and mobile apps. Moreover, genome sequencing, which is becoming more and more affordable, such as Illumina, 23andMe woman walking outdoors with earphones graphs 461992871and other emerging companies in this area which add up critical information and allow for a focus on risky groups of population and drive highly personalized prevention data mining.

We’ve identified several key sources of information to aggregate: electronic medical records, clinical and wellness data from wearable devices and perspective data results of the sequenced genome. The challenge is obvious: not only are those sources limited when it comes to sharing data, but the data collected is also quite different in meaningfulness and trustworthiness. For example, how could we associate fitbit© activity reports with blood test results?

That’s why some of the programs in the PHM domain took several years to take speed. Analytical tools have been around for over 15 years, but experience in managing heterogeneous content and big data is just maturing now.

There is also an alternative approach to connecting the sources: on-demand, transformation and analysis made on the fly. We at EMC believe that Healthcare authorities require control of the data, as they are sensitive to vulnerability and availability to move responsibility to external parties. In the different projects that we run across EMEA, we first advise and build the robust Healthcare data layer, and then enable proper analytical tools making use of data.

Of course, we know well that data confidentiality and security aspects cannot be missed. Prevention models also strongly depend on the patient consent in the secure and appropriate use of data. This is obviously a must to have access to the needed wide range of information that is required for Big Data Analytics to be effective. Patient privacy and consent management (PPCM) system needs to control all the sources, as well as the consumers of the information in the modern healthcare system.

What do you think? What are the best ways to engage patients in being active participants of the new Healthcare ecosystem?