smart lab e book

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Contents

Foreword...3Executive Summary........4The laboratory informatics landscape 2012/2013..5Top challenges in current projects....6Solutions most likely to be implemented..7Information needed when selecting a service / solution....8Obstacles when getting sign off....9GSK Case Study11McLaren Applied Technologies Case Study.12Interview: South West Water...13Interview: Pfizer.16

Adapting Digital Signatures into your organisation..19Additional Resources22About the Exchange..23


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Foreword

I recently visited a conference on cross industry learning and experiences in the pharmaceutical,consumer goods and electronics markets. The cases presented were from across the globe andcame from all industries that included studies on full paperless workflows in hospitals, digitalretail processes, car rental processes and a secured transportation example ending in digital

boarding passes. It appears much of the world is becoming paperless apart from in ourlaboratory operations.

Internal cross-functional collaboration among research, development, quality assurance,marketing and manufacturing is not enough anymore. The use of social networking tools hasillustrated that technology can enhance collaboration once some rudimentary data standards arein place. Research is undergoing a fundamental shift from the three traditional paradigms oftheory, experiment, and computation to incorporating a new fourth paradigm of data-drivendiscovery. Mass-market manufacturers, including makers of generics, might position themselvesas high-volume, low-cost providers, taking lessons in areas of lean manufacturing, agile strategicpricing and inventory management from the consumer products industry.

Big data, paperless processes, cloud strategies and secure deployments of mobile devices areno goals, just key enablers. My personal goal is to contribute and assist the industry in movingfrom a passive to a proactive, quality oriented mind-set.

I am delighted to be chairing this years 8th Annual SmartLab Exchange, Europes premierLaboratory Informatics event. This SmartLab Exchange event will provide many opportunitiesincluding cutting-edge case studies, interactive forums and the opportunity to engage with aselection of one-to-one meetings with industry leading solution providers and specialist.

I am looking forward to meeting you in Mnchen!

Peter Boogaard

Chairman, SmartLab Exchange 2013


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Executive Summary

The shift from a paper-based lab to a digital space is one which has been occurring for sometime and labs have discovered that unless they implement sophisticated laboratory informatics,they are likely to find themselves falling behind due to the increasing amount of dataprofessionals are currently working with.

SmartLab Exchange surveyed the network on the current state of their major laboratoryinformatics piece and their predictions of where their informatics lab will take them in 2015.

Each industry is on its own unique journey in building an informatics system; The corporatelaboratory of the future will be adaptive and continuously optimised. Winners will dynamicallyalter operations to changing business needs based on operational analytics and leverage ofinstitutional knowledge predicts Michael Elliot, CEO of Atrium Research & Consulting.

While the Informatics vendor market is brimming with solutions. Many are constantly changingand evolving to become more holistic in order to adapt to the increased workflow within the lab.No one perfect solution exists. But, perhaps this is something the Informatics community needs

to press the vendor market on in the future.

The concern today is whether technology is working hard enough for the customer. SethPinsky, VP Research & Development at Abbott Labs reflects, 10-12 years after theintroduction and adoption of Electronic Laboratory Notebooks (ELNs), we need to ask whether itreally has affected our pipelines.

Not surprisingly, early concerns with ELNs and other informatics solutions lay on data securityand how implementing electronic systems would impact the generation and defence ofintellectual property. The development of secure, reliable digital signatures was critical in thewidespread adoption of ELNs in research.

The challenge for solution providers today is to provide customers with all the functions theyrequire from their laboratory informatics system, while at the same time offering an interfacewhich is user-friendly and a significant space away from the paper designs traditionally used.There is also a desire now to have a lab informatics system which is adaptable to different silos."Balance is possible, but the highly competitive nature of the market and future demands ofpotential clients makes it a difficult challenge for any vendor Michael Elliot adds.

South West Water in the UK implemented a Laboratory Information System (LIMS), which dealswith the day-to-day collating of 200-300 actual sample results, production and reporting of thoseresults. , told SmartLab Exchange, LaboratoryKim Holt, Scientific Manager of Chemistryworkers are looking for an overarching system that takes all of this information and produces adashboard which holds all of it. But managing information is a challenge.

The results are the opinions of a small percentage of the community and further analysis with alarger proportion of the community is needed to gain a wider perspective. Case studies andinterviews with industry leaders are also included to support the survey findings.


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The Laboratory Informatics Landscape 2012/2013

We asked both the end-user and the solution provider of the informatics community what themain drivers for those who are working with lab informatics what drivers led to investments inlaboratory informatics solutions; we discovered that both the end user and vendor share almostthe same opinions in their top 3 priorities.

Improved data management appears to be the top priority for the end user, with over 60%selecting it as the reason for laboratory informatics solutions investment. Three quarters of thevendor market agree with this.

55% of lab informatics users cited optimising for lab efficiency as their second reason forinvestment in the lab, vendors believe this to also be another reason for lab investment, with75% of the vendor market selecting this same option.

The third reason end users are looking at lab upscaling is to improve LIMS systems, with 50% ofrespondents selecting this option while vendors believe regulatory compliance to be a reason,with 75% of them selecting this.

0.00%10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

The main drivers behind laboratory informatics solutions

Vendor End user


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The Top Challenges in Current Projects

When looking to the main challenges that end users are currently experiencing in laboratory

informatics: we can draw on the following conclusions from the results of the survey: The three

main challenges affecting the end user are integrating new technologies at 57.1%, managing

data flow between laboratories securely at 55% and putting standards in place for best practicedata flow at 42.9%.

When it comes to integrating new technology, Joe Liscouski Executive Director at Institutewarns, the inability to integrate systems and components throughforLaboratory Automation

vendor provided mechanisms results in higher development and support costs, increasedregulatory burden, and reduced likelihood that projects will be successful.

While the Global Business Lead at Pfizer Arnaud Sartre says one of their biggest challengesis grappling with data standards, One of our biggest challenges is understanding our datastandards. What is our data quality framework? How do we use our various applications? Arewe actually using the same terminology across our various platforms?

The vendor market appears to be in the picture of what the end-users challenges are apart from

they recognise the number one challenge to be streamlining technology used within laboratories

at 75%. Across the board they appear to have an evenly-spread opinion of the challenges that

end users are experiencing, with half agreeing that managing data flow between laboratories

securely and setting standards for best practice data flow are impacting informatics projects.


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Looking ahead to informatics solutions that are most likely to be invested in, we can share the

results of two timelines: medium term investment (6mths to 12mths) and long term (12mths to

18mths). Our results show that the most popular investment is likely to be in search systems and

data mining over a 12-18 month period. The most likely medium term investment, looking to our

survey results will be in the area of change management and data quality and in accuracies.

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1

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Years & Months

Solution Type

What solutions will you be investing in and within which timeframe

Medium term investment (6-12 months) Long term investment (12-18 months)


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So what information do end users require when looking to invest a new solution? The most

popular requirement at just over 70% is references; this is followed by history and functionality,

both at 57%.

Looking to factors which are most important when making a decision on buying an informatics

solution; does it fit in with a long-term strategy at 50%, with an average of 16-17% across cost,

ease of use and whether it will actually solve the problem the end user wants to address.

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

What information do you need when selecting a service /

solution provider?

16%

17%

50%

17%

What factors are most important when making the

decision?

Does it solve the problem

we want to address?

Cost

Does it fit with our long-

term strategy?

Is it easy to use?


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When looking at the obstacles that affect the signing off of solutions, cost is the main obstacle at

85%, while flexibility and receiving support during sign off, both account for over 28% of the

reasons of why solutions are not acquired and implemented.

Kim Holt, Scientific Manager of Chemistry at South West Water describes how cost may

slow their progression despite the companys ambition and talent, when budget is a concern,

the way that I would look to do it, is try to get a supplier on board to work closely with. We

havent got the cash to spend but weve got time; weve got people who are very passionate and

keen to get the products out there.Steven Thomas, Investigator at GlaxoSmithKline adds

that expensive software can prohibit how and when equipment is distributed though the

company, there needs to be a smart way of looking at either low-cost browsers or other web

smart interfaces that can allow people access that data for next-to no cost.

85%

28.6%

14.3%

28.6%

What obstacles do you face getting sign off?

Cost

Flexibility

Priority

Support during sign-off


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The SmartLab Exchange also asked the informatics community how often they review suppliers.

Over half said they did so every 2-3 years, while 29% said they did so annually.

29%

0%

57%

0%

14%

How often do you review your suppliers?

Annually

Every 0-6 months

Every 2-3 years

Every 3-5 years

Every 5+ years


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Data Management at McLaren Racing

Stephen Rose, Solutions Architect for McLaren Appliedexplains the data management solution McLaren built to manage and distilTechnologies

a huge volume of data around racing down into a set of configurable dashboards.

We were facing a number of challenges at McLaren. One of them was having engineers beingable to find data when they needed it, knowing exactly where the data was and being able tocompare that to any other data sets that they were interested in.

We have data at a number of different sites, including our headquarters and at the track side.We needed to be able to compare and contrast data sets from all of these different locations. Wewanted to have one version of the truth, so that if you were looking at a piece of data you wouldknow that it was the latest piece of data and correct. These were some of the challenges wewere trying to overcome when producing our system.

Weve really focused on understanding the information a user wants to see on a dashboard. Wetry very hard to find ways to translate data into information which can then be used to make a

decision. When were designing dashboards and creating systems were always very focused onthe decisions that will be made and understanding the information users need to get from anygiven dashboard, so that they dont have to do any processing in theirheads. This way a useronly has to look at one particular display in order to get enough information to be able to make adecision, or get the understanding they need.

We bring everything together in the most concise way possible focusing very heavily onvisualisation and how best to display that data so that it transmits the most accurate and factualrepresentation of the data.

We often also try and make the extra step from actionable information to prescriptiveinformation, so where possible we can actually suggest the action that should be taken based on

the data. This particularly helps in times when you need to make a quick decision, but does alsohelp to remove some of the ambiguities that can be created when decisions are made Businessrules and anything else thats being taken into consideration when a decision is being made canalso be added into the dashboard. This helps with decision consistency, and helps the businessunderstand whats behind any decision thats been made. We always have the ability to drilldown into any aggregated number or data set that you see, but we aim at the highest level topresent the minimum amount of information thats needed for somebody to make a decision.

My advice around data management is to make sure youre getting the most out of the data youdo have. Lots of people have data, and not just in pharmaceutical but in all the industries wesee, theres a lot of data. But actually extracting value from that data is a step that we dont seemany people taking. Instead of focusing necessarily on collecting more data and getting more

data integrated into one system, making sure youre extracting the maximum value from the datayou do have is a very good first step and something Id like to see a lot more people doing.


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Interview: South West Water

South West Water laboratories take in water samples; portable water samples and waste watersamples from the whole Southwest region. Theyanalyse that water to make sure that its safefor people to drink and also ensure that the waste theyre putting out into the rivers is not goingto cause any massive contamination. Kim Holt, Scientific Manager Chemistry at South West

explains the informatics system they use.Water

SmartLab Exchange: Firstly, can you give me an overview of the work that yourecurrently doing at South West Water and the informatic system thats currentlyestablished there?

We receive hundreds of samples, up to 200/300 samples per day and weve got to turnK Holt:these samples around; do a great deal of analysis on it and produce results so that people cantake actions out in the field. We have a LIMS system; Thermos Sample Manager, which isdealing with the day-to-day collating of actual sample results, production and reporting of thoseresults.

But we also have other systems that are involved to make sure that the results that wereproducing are accurate. One system that weve recently introduced, checks ourqualitystandards and the results from those through producing charts. We report on those charts, sothat we can take actions if an instrument is performing badly, we can reject the results and retestthem. Weve put a lot of work into this AqcTools package which is what weve recentlyintroduced and its quite new to the water industry.

SmartLab Exchange: Do you face any integration problems by using various systems?

We have in some ways but because our LIMS system was very established and was aK Holt:known quantity we werent trying to introduce both of these systems at the same time. We had alot of awareness of the limitations and the abilities of the LIMS system as it currently stands.When we went to create the brand new system to handle these products, the supplier was ableto take a lot of our experience with LIMS and integrate quite easily with that system. Theintegration works pretty well; our only limitation really is in service base and service speed,which were looking to improve. We could buy new servers to improve the speed of theintegration and speed of the link, but it functions absolutely fine.

SmartLab Exchange: What challenges are you facing when it comes to managing yourdata?

We do have a lot of data to store. Our servers up to this point have been satisfactory. ItsK Holt:only now that we are trying to take a lot of paper-based or previously paper-based systems forauditing and for managing training and even for our consumables ordering; its only now that

were facing those challenges because we were storing this all in hard copy in filing boxes.Were now hitting those problems where not all the systems are talking to each other; wererunning out of space to actually handle this information and to pull it back quickly enough.


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Were making inroads with the new package that weve put in. But we are very interested inlooking for an overarching, overall system that takes all of this information and produces adashboard of sorts, which holds all of it. But again, how that information is going to be managedis going to be actually one of our challenges over the next two to three years.

Smartlab Exchange: Would you say that this is a primary objective for you between now

and 2015?

Its becoming increasingly so. There are products that are coming out onto the marketK Holt:which do a lot of this work.And its actually thinking bigger, we could have, not just a laboratorybut we could have a South West Water corporate system which handles and makes thisconsistent across the whole company. Yes, it is one of our priorities coming up.

SmartLab Exchange: Having attended the Smart Labs Exchange and having spoken toyour peers, where do you think the industry is going?

I think, having looked at whats available, having spoken to other people and seeingK Holt:some of the innovative solutions that are out there; its possible in the next five years that this

laboratory could be completely paperless. To have everything going in electronically in a user-friendly single system, that, for me, and I think for quite a few of the other people that I speak to,would be the ultimate goal. The people who are managing those systems would be able to pullback information at the touch of a PC; that would be my driver, my aim.

SmartLab Exchange: Kim, another issue we hear a lot of is people talking about the lackof standards in the industry. Can you give any example or any of your own experience onhow standards have been set for best practice state?

Well, again, thats a difficult question for me in that we have a lot of standards here andK Holt:were highly regulated. Every single thing that we actually do on a daily basis, theres a standardout there for it, except when it comes to managing data and managing electronic data,

particularly. We have to manage it but not how were supposed to do that. And I think thats aproblem because almost the regulations and the standards are lagging behind the technologythats becoming available.

SmartLab Exchange: Where is your focus going to be in the next three years. Will youalso consider increasing peoples skills or employing new people to work in the lab?Where will your main focus be?

K Holt If weve got these huge ambitions budget is a huge issue to us. The way we got round it:with developing the AqcTools package was we got on board with a particular supplier and reallyput a lot of hours into helping to create the solution that they could then take to other companies,possibly water companies, but its not just water companies that could take on this particular

package.

I also have to put a lot of time and effort into selling this ambition, selling these ideas to thebusiness as a whole. I think once weve got the backing of the people higher up and thedecision-makers within the company then that goes a long way to us being able to get further


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down the road, really. I think weve got the people; weve got the knowledge; weve got theskills; we just need the backing, really, to make things happen.


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Interview: Pfizer

The SmartLab Exchange caught up withArnaud Sartre, Global Business Lead: LIMs, Pfizerahead of the 8thAnnual SmartLab Exchange event. He gave an overview of ways to improvework-flow automation levels in laboratories and advice on how to choose the right vendors.

SmartLab Exchange: What are the main challenges that you are currently facing workingwith lab informatics at Pfizer?

A Sartre The number one challenge is really around the data management piece and how to:ensure that we generate data once and reuse it multiple times. In other words, how do wemanage to integrate our various lab informatics solutions that we have from a local level, alaboratory level all the way up to enterprise level applications.

There are obviously other areas of challenge around maintenance and around global footprintsof various applications. But one of the key hot topics at the moment is assimilating integrationand finding ways to reuse as much existing data as possible, as opposed to making a lot ofmanual input in a variety of systems that could lead to discrepancies.

SmartLab Exchange: How do you manage secure data, because 55% of our communitysaid they were struggling with this?

A Sartre: One of our biggest challenges is understanding our data standards. What is our dataquality framework? How do we use our various applications? Are we actually using the sameterminology across our various platforms? That sounds very simple, but, if you look at thevarious business processes when you work in a global environment, multiple departments,multiple divisions, various different work streams; you realise very quickly that a lot of people aretalking about the same thing in completely different ways.

So for us it really is the number one challenge, around the business analysis of things and how

this actually gets applied to our global application.

SmartLab Exchange: How do you ensure a secure data flow between internal and externalparties and, indeed, just internally at Pfizer as well?

A Sartre In terms of the data flow between internal and external parties, we do have some:systems that may be open to some of our partners. This is done on a project by project basisand is very much controlled through some good levels of training and system access with,obviously, a high level of internal oversight.

Internally, when looking at how data flows, we try to have a core set of applications that actuallyserves a variety of business lines and purposes. This is where we try and minimise the footprint

to get the best of our existing footprint and, at the end of the day, deliver as much businessvalue as possible for our customers.


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SmartLab Exchange: From your own experience, could you share some ways ofimproving workflow automation levels in labs?

A Sartre: Workflow automation at a lab level starts from the ground up so we really need tohave our key stakeholder and laboratory colleagues understand what we are trying to achieve.

From my own experience I have often seen very good systems and new processes beingimplemented to a variety of laboratories, without necessarily seeing an overarching definitionand answer to the question of what's in it for me at the lab level.

Beyond, it is very much around defining what the end business goal is. We can have a lot ofsystems; we can have a LIMS, ELN, SDMS, a CDS, at the end of the day all of these varioussystems actually allow us to do a lot of things. Various vendors provide a tremendous range ofcapabilities. The real question is around what are we actually achieving or trying to achieve?

I sometimes like to start from the end; what is the end business goal? Is the business goal tojust generate data? Is the business goal to generate knowledge? Is it intermediate? Is it aboutgenerating information? Or maybe it's a bit of all three. It may be about generating data that

leads you to information and, at the end of day, about knowledge and this is really where youhave to start thinking around the overall lab informatics platform and how the various systemsactually interface with each other in a very meaningful fashion.

SmartLab Exchange: I know that you have an ELN and a LIMs system in place, how doyou select the right vendors to work with and what factors are most important whenmaking the decision of investing in technology?

A Sartre: Obviously cost is a big element; there are a variety of cost structures, differentsystems to all sorts of different things, but really at the end of the day it's finding the rightbalance between meeting a business need as well as working within a constrained budget.

SmartLab Exchange: Are you saying budgets really affect the overall decision-making orare there any other factors which become obstacles when moving forward with newtechnology?

A Sartre I've not been directly involved in this decision in the recent past. I would say that cost:is one element; it is certainly not the only element. The other element is around how the systemis really performing. What sort of business solutions has been provided to other customers andare we likely to benefit. Mainly, it's about understanding the best system that we can get to meetthe business need and meet the internal constraints of cost, but also technical abilities andmerits.

SmartLab Exchange: What changes do you expect to see within the next five years that

will have an impact on lab informatics?

A Sartre I have this vision of a fully integrated lab and I really think that we are on the brink of:actually seeing this becoming a reality. Obviously the technology aspect is one element, but I'malso starting to see a lot of vendors moving into platforms that allow customers to perform a lot


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of things in a very similar fashion. I'm not going to get into the detail of which vendors, whatsolutions, but there is definitely some very good headway into that direction.

There are obviously a lot of questions pending these changes, but really it's about achieving afully integrated lab. Do we need to re-evaluate our technology solution; the answer might be yes,the answer might be no, time will tell. But I think ultimately the key point for me is how to

actually benefit from these new technologies, new platforms and systems.

And the platform is really the key. I think we are moving away from the system-specific to a moreplatform-like where the various lab informatics solutiona actually become more modularised andthe labs, in some ways, pick and mix different types of solutions that may have been presentedbefore in various software suites.

SmartLab Exchange: What industries are you looking forward to hearing from at theSmartLab Exchange this year?

A Sartre Primarily, from our peer group: the pharmaceutical industry. I'd personally welcome:any other industry just to broaden the horizon and try and understand what other industries are

actually doing because I'm sure there is a lot of very good work happening in different industriesaround very similar topics that the pharma world is interested in.


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Interview: Adapting Digital Signatures into your Organisation

The world is becoming an electronic landscape and businesses are no longer paper-based. Thedigital signature is replacing the wet signature in all organisations, reducing time and costs andcan be used globally. Mollie Shields-Uehling, President & CEO, Safe Bio-Pharma Associationexplains.

SmartLab Exchange: Digital versus electronic signatures at SAFE Bio-Pharma, aretransitioning the bio-pharmaceutical and healthcare community to fully electroniccommunities, what are the benefits of digital signatures?

: Using digital signatures is transformative. Businesses become fullyM Shields-Uehlingelectronic and, consequently, more efficient and more productive. This transformation is madepossible because digital signatures, unlike common electronic signatures, are uniquely linkedalgorithmically to the individuals proven identity. This assures that the identity of the personbehind the signature can be trusted. The signature is legally enforceable in the worlds major

jurisdictions, and the signature meets regulatory requirements in all leading regulatoryjurisdictions.

Business processes are struggling to keep up with electronic communications. Paper-relatedprocesses like scanning, faxing, email attachments, and courier use no longer cut it. We need tofocus on full electronic immersion -- creating the document electronically, modifying itelectronically, signing it electronically, and exchanging it electronically.

SmartLab Exchange: So what is the difference between an electronic signature and adigital signature?

: Common electronic signatures are vulnerable because there is no identityM Shields-Uehlinglinkage. The laboratory, regulatory body or court of law doesnt know whether or not thesignatory actually applied the signature. It might be as simple as a faxed version of a wet

signature.

Digital signatures remove the vulnerability by linking the signers proven identity to the signature.

There are additional advantages to digital signatures. If a digitally signed document is changed,the viewer knows it immediately because the signature is invalidated. You may never know thatan electronically signed document had been changed. Digital signatures are also persistent; theycan be validated at any time now or in the future. This is extremely important in protectingintellectual property. Common electronic signatures simply dont provide sustainable levels ofprotection.

SmartLab Exchange: The development of secure digital signatures obviously has been

critical to the adoption of informatics systems. Could you give us some clear reasons asto why this is?

M Shields Uehling Identity trust is the fundamental issue in electronic systems -- the assurance:that you can trust the identities of those accessing your sensitive information. Unfortunately,


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business is applying industrial era policies to the information age. Most organizations require aseparate identity for anyone entering their enterprise. Instead, we should strive for universalidentities that are interoperable with multiple information systems.

The SAFE-BioPharma digital identity standard supports a single, universal, portable identityand digital signature that can be used with all partners across multiple systems. Users need only

one digital identity to deal with multiple sponsors, multiple regulatory agencies and to conduct allof their work in the cloud.

SmartLab Exchange: Can these signatories be used or adapted to other industries?

M Shields Uehling Digital signatures are about productivity improvement and cycle time:reduction. They are being utilized in multiple industries and by the US federal government.

Among others, theyre used in financial services, telecommunications, aerospace and defence,and atomic energy. There are initiatives to make all of these identities interoperable meaningbroader bilateral trust of digital identities between multiple enterprises. This exists betweenSAFE-BioPharma and US Government agencies. And there are similar efforts underway that willresult in being able to trust different digital identities across Europe.

SmartLab Exchange: Have you any case studies that you could share with us of anorganisation that has adopted digital signatures and perhaps discuss the challenges theyovercame?

M Shields Uehling: Digital signatures are used extensively to sign electronic lab notebooks,chemical lab notebooks, and bio books. Scientists no longer have to hold signing parties, theycan sign anywhere in the world if they have internet access. It makes the process fullyelectronic and provides much more rigour in terms of defending patents and other challenges.There have been hundreds of thousands, if not millions of regulatory submissions to the FDAusing digital signatures.

The European Medicines Agency and the FDA have publicly stated that theyre on path to fullyelectronic receipt, review and respond systems. In the future, we'll see all clinical data signedand submitted electronically. We're seeing the initial cases of that today. Regulatory documentmanagement systems have adapted to support the SAFE-BioPharma standard.

The greatest growth of SAFE-BioPharma digital identities and signatures is in the area ofcollaboration. External partners, particularly clinical investigators authenticate into websites togain access to clinical trial documents, sign their contracts, and submit their backgroundinformation.

In the United States we see huge use of SAFE-BioPharma digital signatures associated withelectronic prescribing of controlled substances. The Drug Enforcement Administration requires a

strong level of trust in a digital signature related to electronic prescribing of controlledsubstances. Some 400,000 prescribers now in the process of receiving digital identitycredentials that are compliant with the SAFE-BioPharma standard..


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SmartLab Exchange: I understand that you will be speaking about the National CancerInstitute and research partners at the SmartLab Exchange and their use of identities,signatures and, indeed, cloud computing to accelerate their drug development. Can youelaborate a little bit more on the work that they're doing?

M Shields Uehling: The National Cancer Institute is the largest conductor of clinical trials in the

world. At any given time they have 800 to 900 trials underway. They have some 33,000patients enrolled and they have multiple, multiple partners, sponsors, major pharmaceuticalcompanies and small companies as well as many clinical researchers, both in academia and inprivate practice.

NCI has an elaborate study initiation process whereby many documents have to be signed,submitted and exchanged before a study starts.

SAFE-BioPharma and the National Cancer Institute have been using a signing application thatallows NCI researchers and their private sector counterparts (in this case from Sanofi andBristol-Myers Squibb) to put trial start-up documents, in the cloud where, using the signingapplication, theyre signed. Once signed, the signing app notifies the originator and the

document is taken off the signing app and executed. This process is possible because theSAFE-BioPharma digital identity credentials used by the company researchers are interoperablewith the government identity credentials used by the NCI researchers. There is bilateral identitytrust.

The process allows the National Cancer Institute to reduce the amount of time and cost to start astudy.

Among the hard costs NCI eliminated are couriers, scanning, photocopying, etc. Although theyhave not yet calculated personnel costs for those and other functions, NCI saved 2.2 hours forevery transaction and for every wet signature that was replaced by digital signature. NCI is nowmoving into production with this application and will expand it to a variety of business processes.

SmartLab Exchange: What are you looking forward to most at this year's SmartLab Exchangeevent?

M Shields Uehling: Im looking forward to discussing the success of SAFE-BioPharma membercompanies using interoperable digital identities to move business and research collaboration tothe cloud.


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Additional ResourcesINTERVIEW

Arrays ELN: Maturing into the Teenage YearsWith Cat Andersen , Scientific Data Analyst, Array BioPharma

Array Biopharma was one of the first pharmaceutical organisations to implement an

ELN 11 years ago. Cat Andersen and the team at Array have been instrumental to

ensuring its success. She spoke to the Exchange team, about the secret behind a

successful integration with an existing informatics systems, followed by a lightweight

LIMS, the advantages and disadvantages of customisation and looks ahead to the

next 5 years.

Ralph Haffner, Head of Biologics Research Informatics at Roche, spoke to Andrea

Charles, about the challenges of achieving seamless integration between ELNs, LIMS

and other IM systems and how the industry is addressing these challenges to achieve

better integration, interoperability and collaboration.

Ever wondered how CIOs, Global/Regional Heads of R&D, QA, QC and Principal

Scientists choose which solution providers they will be investing in over the next 12

months? We surveyed our international network of data management and lab

informatics professionals to find out which solutions they will be investing in, to help

them achieve an efficient lab in the most cost-effective manner

INTERVIEW

Accelerating Discovery by Enhancing Data and Information IntegrationWith Ralph Haffner, Head of Biologics Research Informatics , Roche

INFOGRAPHIC

Building a SmartLab & Optimising Efficiency in 2013

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About The Exchange

The SmartLab Exchange Network is an invitation only forum designed to help senior strategy

makers overcome their most pressing challenges. Exchange only invites CIOs and LaboratoryInformatics executives with the highest credentials, and solution providers with the most cutting

edge capabilities, to deliver a unique business development opportunity and true peer-to-peer

learning and networking forum.

If you would like more information about the Exchange, please contact us:

Telephone: +44 (0)207 368 9484

Email:[email protected]

Website:www.smartlabexchange.com

About the Author

Niamh Madigan is Editor of Pharma IQ . Niamh has used her combined experience asjournalist and events manager to produce and host online learning forums such aswebinars and Online conferences for IQPC.

Niamhs journalistic career began in Ireland where she worked for the NationalBroadcaster, RTE, as a Television Producer on current affairs and health programmes

for 5 years. She holds a BA (Hons) in Media Studies and a First PostGraduateDiploma in Journalism.
http://localhost/var/www/apps/conversion/tmp/scratch_5/[email protected]://localhost/var/www/apps/conversion/tmp/scratch_5/[email protected]://localhost/var/www/apps/conversion/tmp/scratch_5/[email protected]://www.smartlabexchange.com/http://www.smartlabexchange.com/http://www.pharma-iq.com/informatics/&mac=PMIQ_Content_Nmadigan&utm_source=PharmaIQ&utm_medium=ExactTarget&utm_campaign=laboratoryinformaticscurrenttrends&predictionsfor2015&utm_content=cdn&utm_term=cdnhttp://www.smartlabexchange.com/http://localhost/var/www/apps/conversion/tmp/scratch_5/[email protected]


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8

26 - 27 February 2013, Hilton Munich

Want to fnd outmore?Are you interested in exploring the themes o this report in greater depth with

Director-level representatives rom ood & beverage, FMCG, cosmetics, healthcare,

oil & gas, petrochemical, pharmaceutical and biotech industries?

The 8th Annual SmartLab Exchange will take place 26 - 27 February 2013 in

Munich, Germany.

You will have the unique opportunity to learn, network and fnd solutions to some o

your biggest challenges by joining innovative solution providers and the most senior

decision makers at the Exchange, to discuss how the largest o smart laboratory

and inormatics projects can be ully realised.

For more inormation about requesting an

invitation to attend SmartLab Exchange

2013, please call +44 (0)207 368 9484

or email [email protected]

Alternatively, i you are a solution

provider and want to fnd out how

you can join the event, please call

+44 (0)207 368 9500 or email

[email protected]
http://www.smartlabexchange.com/Event.aspx%3Fid%3D807628http://www.smartlabexchange.com/Event.aspx%3Fid%3D807628http://www.smartlabexchange.com/Event.aspx%3Fid%3D807628

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