missions. In all of these instances, each country all sizes have been struggling with this issue; looked mostly to the U.S. and Europe for best they are stuck using systems that cost a lot with practices to follow when establishing their huge annual maintenance and initial imple- F and maintained a series of ever-ex- compliance requirements. So while countries mentation costs. Content management technol- like Brazil, Australia, India, Mexico, and oth- ogy needs to evolve to be more cost-effective. In agement tools to help them efficiently manage ers strive to be self-sufficient, there is still a addition, the pharmaceutical industry needs a content. The creation of industry-specific appli- convergence of regulatory requirements across cations added to these technologies’ ability to the globe while some maverick countries — more flexible and that more easily enables col- support more specific life sciences needs, such as especially China — seem to be willing to take laboration with external partners and resources.
regulatory submissions and document manage- an altogether different approach and create With existing technologies, the most challeng- ment. And while content management technol- their own standards. This creates problems ing question is: how to provide third-party ac- ogy vendors have continued to tack on new when managing regulatory content in any con- cess to the content management system across functions and increase capacity, the platforms sistent way around the globe so we need our the firewall without making the company vul- themselves have not fundamentally changed. In systems to be able to adapt rapidly to this ever- nerable, without incurring a huge expense, and stark contrast, the life sciences industry has un- shifting global compliance landscape.
dergone dramatic change in the last 20 years, in-cluding a greater focus on emerging markets, RUEDI BLATTMANN: Traditional content man-
IAN TALMAGE: It is incredibly important for
global operations, and strategic and tactical agement systems only manage the authoring of new content management systems to be built partnerships. These changes are calling into content without any efficient mechanism to upon new technology that allows for comput- question traditional methods and tools for reg- manage the distribution and use of that con- ing elasticity; this is the real value of cloud tent, which is one of the most important aspects of content management. After all, what good is need a flexible user interface that allows peo- content management technology to where it a document if you don’t know who also has ac- ple to add user-generated content so that it needs to be for today’s life sciences organiza- cess to it, or whether it has been sent to the can be easily uploaded and shared (but not ed- tions? To enable companies to collaborate health authority? This problem multiplies as ited) for regulatory purposes and clinical trials closely, connect globally, comply swiftly, and companies go outside their country to submit manage costs effectively? Veeva Systems — content to global health authorities in areas makers of Veeva CRM and recently launched such as Latin America, China, Russia, etc. CM Q: What are the benefits and challenges of
systems have always included document meta- the cloud platform for content management
Veeva Vault — invited industry leaders to dis- data, and this is associated at the document applications?
level. In order to relate documents together, thesame property needs to be populated in the STEVE HASLER: One of the greatest benefits of
Q: Given the dramatic changes that the life
same way on each document and across applica- the cloud is cost savings. Costs are lower than sciences industry is undergoing, what are
tions, which can be difficult. A property that as- traditional technologies because it’s a pay-as- some of the ways in which content manage-
sociated with one kind of document may have a you-go model. In addition, the cloud has the ment technology will need to change?
different label when associated with a different potential to better enable functional outsourc- type of document. The point is that content ing by making it easier to collaborate with PIERRE MORGON: The No. 1 issue that con-
management systems need to address metadata partners. The cost-savings potential is not in- tent management vendors need to address sur- as much as they do content. Both the content cremental, but rather, transformational.
rounds global compliance. Today, compliance and the information about each content compo- challenges — and more broadly, regulations nent must be considered in any content man- JOHN COGAN: One of the cloud’s greatest ad-
and policies — extend well beyond the domes- vantages to life sciences companies is the tic borders. As an example, take a look at the tremendous potential cost savings. In addition ICH, aimed at aligning various international STEVE HASLER: The most important way con-
to maintenance, hardware, and software usage regulatory guidelines. The Chinese are working tent management systems need to change is savings from the massive economies of scale af- with French authorities. Brazil, too, has re- cost; the cost of content management must de- forded, cloud computing offers a dramatically formed the way it evaluates the regulatory sub- crease considerably. Life sciences companies of June 2011 ● PharmaVOICE
Five prominent life sciences executives from around the globe
debate the past and future of regulated content management systems.
STEVE HASLER: In terms of potential chal-
In the regulation space, a lot of content that is that enables consistency in use of product data.
lenges, security comes to mind. However, secu- submitted to U.S. and European health au- Sure, there would still be different countries that rity concerns are no different than the ones the thorities is used more than once and then want to tweak the storyline a little to mirror the industry confronts today when outsourcing reused for China and other countries, but users local culture or customer expectations but we business processes to other organizations or struggle to find it again. Lastly, systems need need a CM system that ensures the approved countries. Life sciences companies have already to be easier to use and there needs to be more product/clinical data remains consistent and faced security issues with information sharing, that any deviation is spotted immediately to and have found ways to manage and mitigate help reduce risk. And, closely tied to this, is the these risks. Five years ago, the industry would RUEDI BLATTMANN: Technically speaking,
critical requirement for CM systems that enable not have allowed mission-critical content to be one the top three things that should happen is global consistency with the ability to share as- accessible to anyone outside of the mother ship.
the use of Structured Component Authoring sets across all different stakeholders.
But the industry realizes that it is possible to se- (SCA) so that content can be easily found, cure the information, so companies are prepared used, and reused across functional areas and IAN TALMAGE: There are probably dozens of
to be convinced. I would want to see proof, but across the world. Clinical is not the only group ways that traditional content management sys- I am much less skeptical today than I was. to create and use content, so content compo- tems can be improved upon. They need to be- nents need to be available consistently across come simpler to use and safer and more reliable.
JOHN COGAN: Security may be a hindrance to
the entire organization. Next, users want a sys- But, accessibility to a single system by all de- cloud technology adoption, at least initially.
tem that is as close to off-the-shelf as possible partments is paramount. Life sciences compa- or that requires the least possible customiza- nies must move away from the days of working wholesale, primary data to the cloud. Old data tion, because increased customization increases in isolated narrow silos towards working closely and back-ups are no-brainers, but current data cost and complexity. A system in the cloud together and leveraging all of the knowledge are often a concern. For some, it will take a leap would not require any of this customization, and data collected by different teams. Cloud of faith. But if the content was stored internally just some simple configuration. Third, users technology may be a viable solution because it on a company’s own servers, how much safer want a single source for content to avoid ex- allows equal access to one system via the web.
would that data be? Public clouds offer a great cessive re-work and to maximize content reuse alternative and low-cost opportunity, especially Q: Smart phones, tablet PCs, iPads, and other
mobile devices are changing the way that
PIERRE MORGON: It is very important for life
people consume and contribute informa-
Q: Content management applications are
sciences companies to be able to track what tion. How could these devices enhance or
often described as cumbersome and diffi-
claims have been used where, basically a content change existing content management
cult to use. What are the top three things that
audit trail. CM systems today need to enable an processes and functions for life-sciences or-
most users would change about content
unbroken chain of custody for all content, es- ganizations?
management if given the opportunity?
sentially linking the different pieces of theprocess from authoring to work flow, publish- JOHN COGAN: These devices are already en-
STEVE HASLER: The first thing I would
ing, and withdraw/archiving. In promotional hancing, and changing the game. We need to change would be to have access to the content materials, especially, these are all separate sys- urgently embrace mobile collaboration. The tems so there is no one system with end-to-end sooner life-sciences companies invest in mobile time. With a lot of users creating and review- audit trail tracking of content. This is also par- device applications for corporate functions, the ing content, in-house systems can be slow and ticularly important as companies are being put better. Security and infrastructure teams often cumbersome when accessed remotely; so users in the line of fire more and more when it comes list all of the reasons not to invest in mobile definitely want a quick, easy way to access the to regulatory oversight. An unbroken chain of technologies, but it’s time to get these concerns system when on the go. Secondly, users need a evidence sets users up for success with fewer into the right context. It doesn’t matter anyway faster, easer way to search and find old content.
chances of mistakes. Secondly, we need a system because business is and will continue to march PharmaVOICE ● June 2011
forward on this front without IT if we don’t em- was reviewed and submitted to the health au- raised additional questions around regula-
brace and enable mobile technologies. Do you thority. This last item has proven particularly tory requirements. How do organizations
think a business team can’t find a third-party to difficult to control. It’s hard to believe, but we and the technologies they use need to
develop an iPhone or iPad application for them? used to have to complete a word-by-word check evolve to support the changing regulatory
Of course they can. As a matter of fact, I really on every single piece to ensure we were work- landscape?
hope there is a content management vendor out there right now developing an iPad or iPhone STEVE HASLER: Regulatory requirements, and
app. This is the new frontier and we better be PIERRE MORGON: Collaborations are on the
the pace of regulatory change, have grown rise throughout the entire life sciences organiza- tremendously. In the submissions space, this can tion — R&D, industrial operations, commer- impact both the content and format of the sub- STEVE HASLER: I couldn’t agree more. Work-
cial, IT. Anything that is critical to the business mission. Today, every time we need to update ing with document authors and reviewers in is still performed internally, but anything else is our CM systems to meet a new compliance re- R&D over many years, I’ve found that one of the most important items of functionality missing vendors need to provide systems that can pro- process that includes development, installation, from current CM systems is support for mobile tect the all-important confidentiality of docu- and testing in multiple environments, valida- ments and enable efficient information sharing tion, implementation, and training. In many cases, it takes four to six months just to com- IAN TALMAGE: We need to be able to use mo-
plete a software upgrade required to meet a new bile tools and technologies efficiently, but in a STEVE HASLER: In the last couple of years, I’ve
regulatory requirement. During that time, we way that enables change. One of the struggles noticed that GSK, for example, has signifi- might have four to five people working for now with content is that when a change is cantly increased its number of external collabo- weeks just on the revalidation of the system and made, it doesn’t cascade throughout the content ration partnerships. In fact, many large phar- this is a conservative estimate. The bottom line maceutical companies are adopting a similar is that the process is complex, time-consuming, processes and find a way to incorporate mobile strategy. But one of the collaboration challenges and costly. We need a simpler, more streamlined technology so that it allows users to change, with content management is that many part- mechanism for addressing regulatory change.
ners know little or nothing about how to use a content management system. Given this, CM this might be possible. Within the cloud, a soft- Q: How has the nature of both internal and
systems must be simplified so that trusted ware vendor can make a change once for all external collaboration changed in the last
third-parties — from academia to marketing clients and the costs are spread across a number five years? What are some of the most im-
agencies — will find them easy to learn and use.
of companies rather than each company tackling portant types of collaborations today? And
it on their own. Additionally, validation time how must content management change to
RUEDI BLATTMANN: Additionally, too often,
and costs are mitigated because installation as support this in the future?
employees only look at content in relation to well as some of the validation are handled by the their specific job function rather than across vendor. We focus on testing our specific config- IAN TALMAGE: The short answer? A lot. Today,
functional areas, creating silos of information.
urations. In the end, this makes particular sense there are more internal cross-functional partners For example, drug safety content might include for life sciences companies because we are all and more external collaboration than ever.
a note that says “this medication should not be used by a pregnant woman,” which is some- specifically, there are dozens of different people thing that appears in many different locations PIERRE MORGON: While we work in a global
touching documents, from internal brand teams like promotional materials, package inserts, la- economy today, the U.S. law has no geographi- and operations to writers, designers, and pro- bels, medical information to the provider com- cal limitations to its reach. Any employee of a grammers at marketing agencies. We need a munity, and more across functional areas.
company that's trading securities in the United clear audit trail so we know exactly where these Therefore, that single piece of content needs to States, any contract signed by such an employee, content assets go, when, and who they were be available to everyone. If the wording needs to and any trading partner with a tie to the United transferred to internally and externally. Today’s be changed to meet a new regulation, employ- States must comply with U.S. regulations. Es- systems have failed to keep up, especially con- ees need to be able to apply changes quickly sentially, this means that companies either play sidering the fact that there is a greater expecta- across all instances in all published documents by the U.S. rules or they don’t play in the tion of control over the distribution and track- one time. Content management systems must United States. The way information is being not only allow traditional collaboration, but managed internally is directed by this reality, so management applications need to allow compa- also allow the re-use and re-purposing of con- while organizations need to comply with local nies to control the supply chain of promotional tent across functional areas so that not just the regulations, oftentimes the tougher regulations assets and detail what has happened to those as- document, but the information it contains, can are set by the U.S. government and often over- sets via a comprehensive audit trail. Second, also be controlled, re-used, and tracked. rule local regulations. The net result is that they need to allow companies to quickly search companies tend to go by a simple rule: between for and find assets so that when an asset needs to Q: Regulatory requirements continue to
the company regulations (aligned with the U.S.
be pulled back or retired, we can respond evolve across the life sciences business. Pro-
compliance standards) and the local rules, the quickly and accurately. Third, we need to know motional materials, for example, have come
with certainty that the promotional asset we under increased scrutiny and the growing
sent into the market is the very same asset that use of social media for communications has
IAN TALMAGE: In addition to thinking about
June 2011 ● PharmaVOICE
regulatory requirements from a geographic per- sharing information with local affiliates is not ences companies need to get smarter about how spective, we really need to consider the how the easy. We usually have to find a different way to they spend money and specifically, IT depart- geographically neutral World Wide Web affects transfer even using non-audit trail approaches, ments need to carefully consider what is “appro- things. Social media is changing the way in such as e-mail. One of the top priorities for con- priate” because the answer may be different which patients and other stakeholders consume tent management providers must be to find an whether you are on the IT side or the business information. For example, the site www.pa- easy, cost-effective way to connect other coun- side of an organization. At Shire, data are one of tientslikeme.com allows the sharing of drug in- tries to a common document management sys- the biggest growth areas in terms of cost. Our formation, such as side effects, efficacy, and data grew by 50% in just 12 months, this is as- more. The pharmaceutical industry in general tronomical. And this trend is only going to con- — and regulators specifically — must develop RUEDI BLATTMANN: Globally speaking, con-
tinue if we do not move away from the store a better awareness and understanding of these everything forever world that we work in now.
kinds of social media channels with regard to language translation issues as well. Obviously, Even though the price for data storage contin- the regulations that govern them. If we want to the more you go global, the more important it ues to go down, the sheer volume of data being leverage the benefits of such new media, then is to establish terms that are consistent in all stored is increasing faster than the cost is de- content management technology needs to en- languages and approved by all authorities. The creasing. Cloud computing offers a low-cost op- able parallel conversation, controlled manage- semantic model can help here as can the Darwin tion to store data, and a good content manage- Information Typing Architecture (DITA). Both ment system could really help to bring the total DITA and semantic approaches can be applied, cost of storing data way down. As an example, such intelligent XML technologies allow meta- consider Amazon’s Platform-as-a-Service. Mas- Q: Emerging markets and globalization of
data to be linked to content components in sive amounts of data can be stored here, but be- key capabilities have been persistent
published documents. Set up this way, compa- cause it is a cloud service, the cost associated themes at many organizations recently. How
with that storage is tiny in comparison to on- can content management tools and
need to make a change to a regulatory docu- premise systems. This presents an opportunity.
processes evolve to better support this shift,
ment or when required thereby increasing the I want to put the massive amount of data that and what technologies will most influence
level of granularity to accommodate country- are being backed up every night somewhere this area?
by-country variations rather than reconstruct- where there is no manpower and no mainte- ing every content component in published doc- nance fees because those services are not neces- STEVE HASLER: Current content management
uments to meet the needs of different regions or sary for this type of data storage and the cost sav- technologies simply do not allow us to quickly and easily share information around the globe.
As emerging markets continue to grow, this Q: While much has already been done to cut
will have to change. Today, in most cases, we are costs, how can new technologies lead to
Veeva Systems is a provider of cloud-based
able to share documents across the U.S., Europe, even greater cost savings when it comes to
content management?
management systems are not easily accessible in other markets and extending these systems to JOHN COGAN: Cost-appropriateness, not cost-
smaller countries is often too costly. As such, reduction, is the ultimate goal, meaning life sci- PharmaVOICE ● June 2011

Source: http://veeva.jp/wp-content/uploads/2011/12/thefutureofregulatedcontentmanagement.pdf


rearrangement is initiated by the presence of a heteroatomJ ˆ 0.8, 2.2 Hz, 1H), 6.50 (d, J ˆ 12.4 Hz, 1 H), 6.17 (dd, J ˆ 1.3,and there must be other reactions similar to this one. 12.4 Hz, 1H), 4.97 ± 4.93 (m, 2 H), 1.18 (s, 9H); 13C NMR (50 MHz,CDCl3): d ˆ 153.9, 153.7, 145.0, 132.3, 129.9, 129.8, 127.2, 125.5, 121.4,111.3, 110.7, 106.6, 35.9, 29.3. 17: 1H NMR (300 MHz, CDCl3): d ˆ 7.


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