www.smartlabexchange.

com

Building a SmartLab and Optimising Efficiency in 2013

Industry report compiled by SmartLab Exchange and PharmaIQ

Take me back to the Contents page

www.smartlabexchange.com

Contents
Foreword...3 Executive Summary........4 The laboratory informatics landscape 2012/2013..5 Top challenges in current projects....6 Solutions most likely to be implemented..7 Information needed when selecting a service / solution....8 Obstacles when getting sign off....9 GSK Case Study11 McLaren Applied Technologies Case Study.12 Interview: South West Water...13 Interview: Pfizer.16 Adapting Digital Signatures into your organisation..19 Additional Resources22 About the Exchange..23

Take me back to the Contents page

www.smartlabexchange.com

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 and came from all industries that included studies on full paperless workflows in hospitals, digital retail 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 our laboratory operations. Internal cross-functional collaboration among research, development, quality assurance, marketing and manufacturing is not enough anymore. The use of social networking tools has illustrated that technology can enhance collaboration once some rudimentary data standards are in place. Research is undergoing a fundamental shift from the three traditional paradigms of theory, experiment, and computation to incorporating a new fourth paradigm of data-driven discovery. Mass-market manufacturers, including makers of generics, might position themselves as high-volume, low-cost providers, taking lessons in areas of lean manufacturing, agile strategic pricing and inventory management from the consumer products industry. Big data, paperless processes, cloud strategies and secure deployments of mobile devices are no goals, just key enablers. My personal goal is to contribute and assist the industry in moving from a passive to a proactive, quality oriented mind-set. I am delighted to be chairing this years 8th Annual SmartLab Exchange, Europes premier Laboratory Informatics event. This SmartLab Exchange event will provide many opportunities including cutting-edge case studies, interactive forums and the opportunity to engage with a selection 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

Take me back to the Contents page

www.smartlabexchange.com

Executive Summary
The shift from a paper-based lab to a digital space is one which has been occurring for some time 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 data professionals are currently working with. SmartLab Exchange surveyed the network on the current state of their major laboratory informatics 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 corporate laboratory of the future will be adaptive and continuously optimised. Winners will dynamically alter operations to changing business needs based on operational analytics and leverage of institutional knowledge predicts Michael Elliot, CEO of Atrium Research & Consulting. While the Informatics vendor market is brimming with solutions. Many are constantly changing and 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. Seth Pinsky, VP Research & Development at Abbott Labs reflects, 10-12 years after the introduction and adoption of Electronic Laboratory Notebooks (ELNs), we need to ask whether it really has affected our pipelines. Not surprisingly, early concerns with ELNs and other informatics solutions lay on data security and how implementing electronic systems would impact the generation and defence of intellectual property. The development of secure, reliable digital signatures was critical in the widespread adoption of ELNs in research. The challenge for solution providers today is to provide customers with all the functions they require from their laboratory informatics system, while at the same time offering an interface which 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 of potential 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 deals with the day-to-day collating of 200-300 actual sample results, production and reporting of those results. Kim Holt, Scientific Manager of Chemistry, told SmartLab Exchange, Laboratory workers are looking for an overarching system that takes all of this information and produces a dashboard 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 a larger proportion of the community is needed to gain a wider perspective. Case studies and interviews with industry leaders are also included to support the survey findings.

Take me back to the Contents page

www.smartlabexchange.com

The Laboratory Informatics Landscape 2012/2013

We asked both the end-user and the solution provider of the informatics community what the main drivers for those who are working with lab informatics what drivers led to investments in laboratory informatics solutions; we discovered that both the end user and vendor share almost the 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 the vendor market agree with this. 55% of lab informatics users cited optimising for lab efficiency as their second reason for investment in the lab, vendors believe this to also be another reason for lab investment, with 75% 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% of respondents selecting this option while vendors believe regulatory compliance to be a reason, with 75% of them selecting this.

The main drivers behind laboratory informatics solutions

80.00% 70.00% 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00%

Vendor

End user

Take me back to the Contents page

www.smartlabexchange.com

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 practice data flow at 42.9%. When it comes to integrating new technology, Joe Liscouski Executive Director at Institute forLaboratory Automation warns, the inability to integrate systems and components through vendor provided mechanisms results in higher development and support costs, increased regulatory burden, and reduced likelihood that projects will be successful. While the Global Business Lead at Pfizer Arnaud Sartre says one of their biggest challenges is grappling with data standards, One of our biggest challenges is understanding our data standards. What is our data quality framework? How do we use our various applications? Are we 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.

Take me back to the Contents page

www.smartlabexchange.com

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. What solutions will you be investing in and within which timeframe
4.5 4 3.5 3 2.5 Years & Months 2 1.5 1 0.5 0

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

Take me back to the Contents page

www.smartlabexchange.com

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%. What information do you need when selecting a service / solution provider?
80.00% 70.00% 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00%

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.

What factors are most important when making the decision?

17% 50% 16%

Does it solve the problem we want to address? Cost Does it fit with our longterm strategy? Is it easy to use?

17%

Take me back to the Contents page

www.smartlabexchange.com

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.

What obstacles do you face getting sign off?

28.6% 85% 14.3% Cost Flexibility Priority Support during sign-off 28.6%

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.

Take me back to the Contents page

www.smartlabexchange.com

10

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.

How often do you review your suppliers?

14% 0% 29% Annually Every 0-6 months Every 2-3 years 57% 0% Every 3-5 years Every 5+ years

Take me back to the Contents page

www.smartlabexchange.com

11

Case Study: Data Cube

GlaxoSmithKline recently implemented a piece of software that makes it easier for the user to drill down into the data and search from almost any facet, Steve Thomas, Investigator at GSK explains. Its our job at GSK to look at the fate of all our molecules in the body so that we understand what the body turns them into to ensure that we dont have a problem in the clinic with a metabolic liability. We have a lot of information coming through the department that we have to get right quickly so that we can put the best and safest drugs out onto the market and improve peoples quality of life. We want to be able to store, search and share our knowledge of the metabolites and the outcome; not just the data. We use this knowledge to add to our corporate wisdom. Up until recently, a lot of our data was on paper for regulatory submission and there was an element of having to know where the answer was before you could go and find it. Our colleagues in the US had used a certain brand of software for just storing their analytical data, but hadnt used it to map metabolic outcomes. So, we took a look at that over the last couple of years and had a pilot trial that used ACDs ChemFolder Enterprise, which allowed us to map data onto biotransformations. It wasnt really designed for it; I believe ACD had it as a chemists tool of A plus B goes to C plus D. But we took it and in a metabolic world, your parent can go up to 100 metabolites, so all through the alphabet four times over. The Result: Data is far easier to access. We now have the ability to use this data to search from almost any facet so were not limited to search by structure. I can search by mass, project, analyst or the site. I can ask for everything that was done in safety species, or say, that was done two years ago as it was seen in bile. We coined the term data cube, you can turn the face of the cube what youre interested in and drill down from whichever piece of information youve got. We have managed to shift the bottleneck to dissemination of that data; getting data to every corner of the company, thus making it available for anybody who can make use of it.

Take me back to the Contents page

www.smartlabexchange.com

12

Data Management at McLaren Racing

Stephen Rose, Solutions Architect for McLaren Applied Technologies explains the data management solution McLaren built to manage and distil 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 being able to find data when they needed it, knowing exactly where the data was and being able to compare 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. We wanted to have one version of the truth, so that if you were looking at a piece of data you would know that it was the latest piece of data and correct. These were some of the challenges we were trying to overcome when producing our system. Weve really focused on understanding the information a user wants to see on a dashboard. We try 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 on the decisions that will be made and understanding the information users need to get from any given dashboard, so that they dont have to do any processing in their heads. This way a user only has to look at one particular display in order to get enough information to be able to make a decision, or get the understanding they need. We bring everything together in the most concise way possible focusing very heavily on visualisation and how best to display that data so that it transmits the most accurate and factual representation of the data. We often also try and make the extra step from actionable information to prescriptive information, 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 also help to remove some of the ambiguities that can be created when decisions are made Business rules and anything else thats being taken into consideration when a decision is being made can also be added into the dashboard. This helps with decision consistency, and helps the business understand whats behind any decision thats been made. We always have the ability to drill down into any aggregated number or data set that you see, but we aim at the highest level to present 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 you do have. Lots of people have data, and not just in pharmaceutical but in all the industries we see, theres a lot of data. But actually extracting value from that data is a step that we dont see many 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 data you do have is a very good first step and something Id like to see a lot more people doing.

Take me back to the Contents page

www.smartlabexchange.com

13

Interview: South West Water

South West Water laboratories take in water samples; portable water samples and waste water samples from the whole Southwest region. They analyse that water to make sure that its safe for people to drink and also ensure that the waste theyre putting out into the rivers is not going to cause any massive contamination. Kim Holt, Scientific Manager Chemistry at South West Water explains the informatics system they use. SmartLab Exchange: Firstly, can you give me an overview of the work that youre currently doing at South West Water and the informatic system thats currently established there? K Holt: We receive hundreds of samples, up to 200/300 samples per day and weve got to turn these samples around; do a great deal of analysis on it and produce results so that people can take actions out in the field. We have a LIMS system; Thermos Sample Manager, which is dealing with the day-to-day collating of actual sample results, production and reporting of those results. But we also have other systems that are involved to make sure that the results that were producing are accurate. One system that weve recently introduced, checks our quality standards and the results from those through producing charts. We report on those charts, so that we can take actions if an instrument is performing badly, we can reject the results and retest them. Weve put a lot of work into this AqcTools package which is what weve recently introduced and its quite new to the water industry. SmartLab Exchange: Do you face any integration problems by using various systems? K Holt: We have in some ways but because our LIMS system was very established and was a known quantity we werent trying to introduce both of these systems at the same time. We had a lot 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 able to take a lot of our experience with LIMS and integrate quite easily with that system. The integration 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 the integration and speed of the link, but it functions absolutely fine. SmartLab Exchange: What challenges are you facing when it comes to managing your data? K Holt: We do have a lot of data to store. Our servers up to this point have been satisfactory. Its only now that we are trying to take a lot of paper-based or previously paper-based systems for auditing 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; were running out of space to actually handle this information and to pull it back quickly enough.

Take me back to the Contents page

www.smartlabexchange.com

14

Were making inroads with the new package that weve put in. But we are very interested in looking for an overarching, overall system that takes all of this information and produces a dashboard of sorts, which holds all of it. But again, how that information is going to be managed is 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? K Holt: Its becoming increasingly so. There are products that are coming out onto the market which do a lot of this work. And its actually thinking bigger, we could have, not just a laboratory but we could have a South West Water corporate system which handles and makes this consistent across the whole company. Yes, it is one of our priorities coming up. SmartLab Exchange: Having attended the Smart Labs Exchange and having spoken to your peers, where do you think the industry is going? K Holt: I think, having looked at whats available, having spoken to other people and seeing 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 userfriendly 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 pull back 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 lack of standards in the industry. Can you give any example or any of your own experience on how standards have been set for best practice state? K Holt: Well, again, thats a difficult question for me in that we have a lot of standards here and were highly regulated. Every single thing that we actually do on a daily basis, theres a standard out 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 a problem because almost the regulations and the standards are lagging behind the technology thats becoming available. SmartLab Exchange: Where is your focus going to be in the next three years. Will you also 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 really put 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 the business as a whole. I think once weve got the backing of the people higher up and the decision-makers within the company then that goes a long way to us being able to get further

Take me back to the Contents page

www.smartlabexchange.com

15

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

Take me back to the Contents page

www.smartlabexchange.com

16

Interview: Pfizer
The SmartLab Exchange caught up with Arnaud Sartre, Global Business Lead: LIMs, Pfizer ahead of the 8th Annual SmartLab Exchange event. He gave an overview of ways to improve work-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 working with 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 we manage to integrate our various lab informatics solutions that we have from a local level, a laboratory level all the way up to enterprise level applications. There are obviously other areas of challenge around maintenance and around global footprints of various applications. But one of the key hot topics at the moment is assimilating integration and finding ways to reuse as much existing data as possible, as opposed to making a lot of manual input in a variety of systems that could lead to discrepancies. SmartLab Exchange: How do you manage secure data, because 55% of our community said they were struggling with this? A Sartre: One of our biggest challenges is understanding our data standards. What is our data quality framework? How do we use our various applications? Are we actually using the same terminology across our various platforms? That sounds very simple, but, if you look at the various 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 are talking 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 external parties 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 basis and 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 actually serves 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 business value as possible for our customers.

Take me back to the Contents page

www.smartlabexchange.com SmartLab Exchange: From your own experience, could you share some ways of improving workflow automation levels in labs?

17

A Sartre: Workflow automation at a lab level starts from the ground up so we really need to have 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 being implemented to a variety of laboratories, without necessarily seeing an overarching definition and 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 of systems; we can have a LIMS, ELN, SDMS, a CDS, at the end of the day all of these various systems actually allow us to do a lot of things. Various vendors provide a tremendous range of capabilities. 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 to just generate data? Is the business goal to generate knowledge? Is it intermediate? Is it about generating 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 you have to start thinking around the overall lab informatics platform and how the various systems actually 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 do you select the right vendors to work with and what factors are most important when making the decision of investing in technology? A Sartre: Obviously cost is a big element; there are a variety of cost structures, different systems to all sorts of different things, but really at the end of the day it's finding the right balance 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 or are there any other factors which become obstacles when moving forward with new technology? 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 system is really performing. What sort of business solutions has been provided to other customers and are we likely to benefit. Mainly, it's about understanding the best system that we can get to meet the business need and meet the internal constraints of cost, but also technical abilities and merits. 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'm also starting to see a lot of vendors moving into platforms that allow customers to perform a lot

Take me back to the Contents page

www.smartlabexchange.com

18

of things in a very similar fashion. I'm not going to get into the detail of which vendors, what solutions, 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 a fully 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 more platform-like where the various lab informatics solutiona actually become more modularised and the labs, in some ways, pick and mix different types of solutions that may have been presented before in various software suites. SmartLab Exchange: What industries are you looking forward to hearing from at the SmartLab 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 industries around very similar topics that the pharma world is interested in.

Take me back to the Contents page

www.smartlabexchange.com

19

Interview: Adapting Digital Signatures into your Organisation

The world is becoming an electronic landscape and businesses are no longer paper-based. The digital signature is replacing the wet signature in all organisations, reducing time and costs and can be used globally. Mollie Shields-Uehling, President & CEO, Safe Bio-Pharma Association explains. SmartLab Exchange: Digital versus electronic signatures at SAFE Bio-Pharma, are transitioning the bio-pharmaceutical and healthcare community to fully electronic communities, what are the benefits of digital signatures? M Shields-Uehling: Using digital signatures is transformative. Businesses become fully electronic and, consequently, more efficient and more productive. This transformation is made possible because digital signatures, unlike common electronic signatures, are uniquely linked algorithmically to the individuals proven identity. This assures that the identity of the person behind the signature can be trusted. The signature is legally enforceable in the worlds major jurisdictions, and the signature meets regulatory requirements in all leading regulatory jurisdictions. Business processes are struggling to keep up with electronic communications. Paper-related processes like scanning, faxing, email attachments, and courier use no longer cut it. We need to focus on full electronic immersion -- creating the document electronically, modifying it electronically, signing it electronically, and exchanging it electronically. SmartLab Exchange: So what is the difference between an electronic signature and a digital signature? M Shields-Uehling: Common electronic signatures are vulnerable because there is no identity linkage. The laboratory, regulatory body or court of law doesnt know whether or not the signatory 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 that an electronically signed document had been changed. Digital signatures are also persistent; they can be validated at any time now or in the future. This is extremely important in protecting intellectual property. Common electronic signatures simply dont provide sustainable levels of protection. 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 as to 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,

Take me back to the Contents page

www.smartlabexchange.com

20

business is applying industrial era policies to the information age. Most organizations require a separate identity for anyone entering their enterprise. Instead, we should strive for universal identities that are interoperable with multiple information systems. The SAFE-BioPharma digital identity standard supports a single, universal, portable identity and 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 all of 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 meaning broader bilateral trust of digital identities between multiple enterprises. This exists between SAFE-BioPharma and US Government agencies. And there are similar efforts underway that will result in being able to trust different digital identities across Europe. SmartLab Exchange: Have you any case studies that you could share with us of an organisation that has adopted digital signatures and perhaps discuss the challenges they overcame? 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, they can sign anywhere in the world if they have internet access. It makes the process fully electronic 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 FDA using digital signatures. The European Medicines Agency and the FDA have publicly stated that theyre on path to fully electronic receipt, review and respond systems. In the future, we'll see all clinical data signed and submitted electronically. We're seeing the initial cases of that today. Regulatory document management systems have adapted to support the SAFE-BioPharma standard. The greatest growth of SAFE-BioPharma digital identities and signatures is in the area of collaboration. External partners, particularly clinical investigators authenticate into websites to gain access to clinical trial documents, sign their contracts, and submit their background information. In the United States we see huge use of SAFE-BioPharma digital signatures associated with electronic prescribing of controlled substances. The Drug Enforcement Administration requires a strong level of trust in a digital signature related to electronic prescribing of controlled substances. Some 400,000 prescribers now in the process of receiving digital identity credentials that are compliant with the SAFE-BioPharma standard..

Take me back to the Contents page

www.smartlabexchange.com

21

SmartLab Exchange: I understand that you will be speaking about the National Cancer Institute and research partners at the SmartLab Exchange and their use of identities, signatures and, indeed, cloud computing to accelerate their drug development. Can you elaborate 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 33,000 patients enrolled and they have multiple, multiple partners, sponsors, major pharmaceutical companies and small companies as well as many clinical researchers, both in academia and in private 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 that allows NCI researchers and their private sector counterparts (in this case from Sanofi and Bristol-Myers Squibb) to put trial start-up documents, in the cloud where, using the signing application, 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 the SAFE-BioPharma digital identity credentials used by the company researchers are interoperable with the government identity credentials used by the NCI researchers. There is bilateral identity trust. The process allows the National Cancer Institute to reduce the amount of time and cost to start a study. Among the hard costs NCI eliminated are couriers, scanning, photocopying, etc. Although they have not yet calculated personnel costs for those and other functions, NCI saved 2.2 hours for every transaction and for every wet signature that was replaced by digital signature. NCI is now moving 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 Exchange event? M Shields Uehling: Im looking forward to discussing the success of SAFE-BioPharma member companies using interoperable digital identities to move business and research collaboration to the cloud.

Take me back to the Contents page

www.smartlabexchange.com

22

Additional Resources
INTERVIEW Arrays ELN: Maturing into the Teenage Years
With 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.

Listen Now

Get help solving this challenge

INTERVIEW Accelerating Discovery by Enhancing Data and Information Integration

With Ralph Haffner, Head of Biologics Research Informatics , Roche
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. Listen Now

Get help solving this challenge

INFOGRAPHIC
Building a SmartLab & Optimising Efficiency in 2013
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 View Now

Get help solving this challenge

Take me back to the Contents page

www.smartlabexchange.com

23

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 Laboratory Informatics 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 as journalist and events manager to produce and host online learning forums such as webinars and Online conferences for IQPC. Niamhs journalistic career began in Ireland where she worked for the National Broadcaster, 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 PostGraduate Diploma in Journalism.

Take me back to the Contents page

26 - 27 February 2013, Hilton Munich

Want to find out more?

Are you interested in exploring the themes of this report in greater depth with Director-level representatives from food & 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 find solutions to some of your biggest challenges by joining innovative solution providers and the most senior decision makers at the Exchange, to discuss how the largest of smart laboratory and informatics projects can be fully realised. For more information about requesting an invitation to attend SmartLab Exchange 2013, please call +44 (0)207 368 9484 or email [email protected] Alternatively, if you are a solution provider and want to find out how you can join the event, please call +44 (0)207 368 9500 or email [email protected]

www.smartlabexchange.com