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Over the past few years, Swiss drug giant Roche ($RHHBY) has been moving much of its R&D effort into the cloud. The companywhich has three pharmaceutical units, five diagnostics divisions, and research partners all over the worldmanages its clinical trials in the cloud and stores patients images there, says Bryn Roberts, Roches global head of informatics for pharma research and early development. Roche is also a member of the Pistoia Alliance, a group of pharmaceutical companies, software makers, and academics working together to collect and share precompetitive information in the cloud, such as genomic sequencing data. The future of this high-dimensional biology, if you like, is collaboration, Roberts says. We need to pull data from many sources, public and private. Having the data reside in the cloud is the most efficient way to support that environment. Roche is part of a rapidly accelerating migration of pharma and biotech companies towards research collaborations that are supported almost entirely by cloud-based technologies. These tools allow researchers to share basic research and pre-clinical data, collaborate on clinical-trial designs, and collect patient information, all on servers that any member of any R&D team can access from a variety of desktop and mobile devices via the web. The life sciences industry was slow to embrace the cloudlingering concerns about protecting intellectual property and patient privacy got in the way. Now those worries are rapidly dissipating. Instead of just accessing information in a nebulous space, companies are accessing capability, applications, work products, says Henry Levy, global managing director of R&D for Accentures life sciences practice. You dont need to have a multi-layer process for employees to collaborate anymore. Now theres this cloud that each participant can access in a secure way. A collaboration can be set up in hours instead of weeks or months. To get a glimpse of the potential for a largely cloud-based pharma future, witness the growth rate of New Yorkbased Medidata Solutions ($MDSO), one of the first companies to offer a cloudbased software platform for clinical trials. In April, the company reported record firstquarter revenues of $63.3 milliona 26% increase over the same quarter a year agoand it raised its revenue guidance for the year to at least $270 million. Analysts are expecting the company to chart 20% or higher sales growth through at least 2014, according to Capital IQ. Many Medidata customers still use its software on their own servers, but French drug giant Sanofi ($SNY) and others have adopted its cloud-based products. A few key trends are driving the industrys adoption of cloud technologies. The first is the endless drive to cut costs in drug R&D by eliminating duplication of efforts, not to mention administrative hassles like having to FedEx paper records back and forth between company researchers and their clinical trial investigators. Second is the proliferation of virtual biotech startups that outsource all their R&D from day one, relying on webbased software and cloud infrastructure to support their collaborations. And as Big Pharma increasingly turns to biotech startups and academic labs for innovative ideas, the cloud becomes all that more important. The $90 billion annual spend on clinical development is just not sustainable, says Bryan Spielman, executive vice president of strategy and corporate development for Medidata. Unless youre leveraging technology and data, and thinking about things differently, this industry is not going to change. Were seeing increasing recognition of that.

Collaborations in the Cloud

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Obstacles to overcome

Perhaps, but the migration to the cloud is not without obstacles. Its a challenge to go all electronic when youre used to holding documents in your hand, says Mitchell Katz, executive director of medical research operations for Stamford, CT-based Purdue Pharma. The companywhich is most famous for pain relievers like OxyContin, but has been expanding of late into oncology and other areaswas prodded to move to the cloud by it clinical trial investigators, Katz says. Clinical sites now are motivated to do many clinical trials for multiple sponsors, and to have it be streamlined, says Katz, who adds that Purdue, which is a member of an international network of companies called Mundipharma, is increasingly employing the cloud to simplify its research collaborations. If information from a trial master file is kept in the cloud, [an overseas collaborator] can reach in and get that information if they need it, say, for their European regulatory submissions. Convincing Purdues lawyers that all this virtual storing and sharing is safe hasnt been quite so easy, though. Katz says he still has to meet regularly with an internal committee made up of lawyers and techies to discuss his plans vis-vis the cloud. Every step of the way, they want to understand what it is Im trying to do and whether it represents a real risk for the organization, Katz says. But they are becoming more accepting of it. Pharma analysts predict the industry will quickly establish standards for operating securely in the cloud, and, once that happens, even companies that have been laggards will start to
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sign on in droves. Our clients are moving towards shorter, faster trials, with more precise design, using larger and more sophisticated data sets, says Todd Skrinar, a principal in Ernst & Youngs life science advisory group in San Francisco. If that is the prevailing pattern, then we believe standardization of the tools used for managing that information becomes even more important.

Speeding up Discovery

Cloud-based collaborations are catching on most rapidly in the realm of pre-competitive research, where IP concerns arent so pressing, and there are no worries about protecting patient privacy, because all the work is happening in cell cultures or animal models. Companies are realizing there are parts of the R&D process that are generally shareable, says Sanjeev Wadhwa, a principal in Ernst & Youngs life science advisory group in Iselin, NJ, Why not extract those things and put them in a common infrastructure? That allows you to take out costs of unnecessary duplication. For example, a group called the Coalition Against Major Diseases is using the cloud to share data related to Alzheimers and Parkinsons diseases. The groupwhich includes Big Pharma companies such as Eli Lilly & Co ($LLY) and Pfizer ($PFE)is working to identify biomarkers they can use in the future to predict the potential efficacy of new compounds. Rather than spending $600 million on research pathways that they shouldnt go down, they can use these biomarkers to design new ways to measure [neurological disorders], Wadhwa says.

In Europe, a group called the Innovative Medicines Initiative (IMI) is supporting several cloudbased collaborations designed to speed up R&D. Roche is involved in one such project, called eTRIKS, which uses an open-sourced technology developed by New Brunswick, NJ-based Johnson & Johnson ($JNJ) to facilitate data sharing on translational research efforts. Software and informatics companies can also use eTRIKS to develop tools for running translational trials. Robert McBurney, CEO of the

non-profit Accelerated Cure Project for Multiple Sclerosis in Waltham, MA, is using cloud technology to allow scientists working on new therapies for MS to access tissue samples from patients. Every scientist who uses a sample agrees to post the data from

their studies in the organizations cloud-based server, so other MS researchers can pull insights from it. The database has supported 75 studies since it was launched in 2006, McBurney says. The organizations repository is designed to act both as a bio-bank

The future of this high-dimensional biology, if you like, is collaboration.

Bryn Roberts, Global head of informatics for pharma research and early development, Roche

and an open-source data-sharing platform, McBurney says. Say there was an academic organization or company that wanted 100 plasma samples from MS patients, defined in a certain way, McBurney says. Rather than choose 100 randomly, you can access the samples where your measurement data would be amplified by all the other data that had been obtained. Furthermore, all the data points are linked to anonymous patient cases, allowing scientists to weigh their research plans against what other members of the MS research community are doing. If they see another lab is planning the same experiment and theyll be delivering the data in nine months, they can either choose not to be duplicative or to do exactly the same experiment to try to validate the other labs results, McBurney says. In 2012, Cleveland-based consulting firm NineSigma saw such a swell in demand for opensourced research collaborations that it launched NineSights, a website where companies can cast a wide net to find ideas for solving specific research problems, and then collaborate with outside partners to complete those tasks. NineSigma describes NineSights as the first worldwide open-innovation social media destination, a reference to its mission for bringing disparate members of the research community together in the cloud. Before open innovation, companies really did everything in-house. Everything was secret, says Al Malouf, NineSigmas senior program manager. By casting a broad net out to the cloud, companies can find solutions they may not have ever found before. For example, NineSights is now
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Unless youre leveraging technology and data, and thinking about things differently, this industry is not going to change.
Bryan Spielman, Executive vice president of strategy and corporate development, Medidata

hosting a competition, sponsored by General Electric ($GE) and the National Football League (NFL), to award grants to researchers developing biomarkers and other technologies for diagnosing mild traumatic brain injuries.

Bolstering Clinical Trials

Much of the innovation in cloud computing is emanating from contract research organizations and other service providers, which are
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focusing on improving collaborations beyond the basic-research phase. Global CRO Quintiles ($Q), based in Durham, NC, introduced a cloud platform called Infosario in 2011. Infosario pulls together a range of informationfrom lab data, to clinical-trials management information, to safety reportsin real time, and makes it available to anyone who is part of a research team, regardless of where theyre based geographically. Where

the significant spend occurs is when you get into phase 2 and 3 trials, says Richard Thomas, chief information officer of Quintiles. By bringing back-end data together, you can create an awful lot of value, because you can get a single view into how well a trial is progressing, in terms of patient recruitment, efficacy, safety. Britains BT Group ($BT), which offers a cloud service for the life sciences industry, built an extensive compliance system designed to alleviate its customers concerns about what might happen if the FDA or other regulatory agency decided to audit their cloudbased collaborations. In addition to collecting and archiving all of the documentation associated with a research project, BT maintains compliance centers in New Jersey and Switzerland that are staffed by people who used to work for regulatory agencies, says Yury Rozenman, head of business development for the life sciences solutions unit of BT Global Services in Glenview, IL. Rozenman describes BTs service as something akin to an app store, where life sciences companies can subscribe to a variety of cloudbased services and then run them within BTs secure servers. But unlike using more established players like Amazon, where it may not be quite clear where, exactly, the cloud is physically located, BT manages its cloud services to meet all of the IP-protection and regulatory-compliance requirements the pharma industry faces. Our big differentiator has been our ability to deliver this compliance wrap to the pharma industry, Rozenman says. We provide the implementation qualification, operation qualification,

Research and Development Your Head Should Be In the Clouds

by John Murphy, Director, Enterprise Industry Marke ting, Ak amai Technologies

Sponsored Content

July, 2013 Cloud computing is taking the corporate world by storm. This is particularly true for biotech, pharmaceutical, and clinical trials companies many of which are finding efficiencies in areas like global collaboration. These companies are turning to the cloud to accelerate R&D projects at a time when the R&D network, comprised of many internal and external participants, couldnt get more dynamic and complex. So, why should your head be in the clouds? Cloud computing delivers agility and speed. It allows you to stand up IT resources and supporting business tools (e.g., collaboration) quickly and cost-effectively to support your
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dynamic, unplanned, and fast-paced initiatives. When you consider that a pharmaceutical R&D project delay can cost an astounding 150 dollars a second1, speed and time-tomarket can be a critical component to your competitive advantage. But not so fast, right? The cloud, in large part, relies on the Internet, and the Internet is plagued with many issues - from poor performance and availability, to major compliance and security concerns such as data breaches, to lack of visibility and control. And if a SaaS or cloud application does not deliver a good, safe, reliable user experience if researchers and doctors are left waiting, if data is compromised, if IT staff is unable

to manage the process the cost savings and efficiencies gained in the cloud can evaporate quickly (sorryI couldnt resist one cloud-ism). This is where Akamai comes in. Today, Akamai is enabling global brands to operate in the cloud as if they own the cloud. Akamai does not provide cloud infrastructure the way companies such as Rackspace do but instead provides a cloudbased solution designed to give you the power to safeguard, accelerate, and control your cloud. Eleven of the worlds largest pharmaceutical companies have trusted Akamai to accelerate delivery of cloud-based content and data. Akamai also helps organizations protect cloud-based data, web sites, and business processes (e.g., collaboration tools) from cyber-attacks attacks that can lead to costly outages, lost intellectual property, data breach, and compliance issues. Without question, cloud computing is a force in pharmaceuticals and biotech. Its paying big dividends, helping to drive down costs while enabling companies to deliver new drugs to market faster. Dont let its potential for outages, data breaches, poor performance, and lack of control stand in the way of your competitive advantage and R&D innovation. Akamai and Cloud finally, you can have your cake and eat it too. l

Cost of research for a blockbuster drug is $150 a second; SC Magazine Interview with Adriann Seccombe, CISO, Eli Lilly

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validation. You can do a physical audit of our facilities. You can audit all of the paper records. Despite all that, pickup has been slow since BT introduced its cloud service for the life sciences industry in 2012, Rozenman admits. Thats because pharma companies are still reluctant to hand over security responsibilities to an outside partner, he says. The market has been conditioned by Amazon, he says. A lot of customers think the services that are available are all in the same vein, where you have to really develop your own security model, or you can only work [in the cloud] on projects that are early in development, where you dont have to worry about intellectual property protection or compliance is not an issue. We have to change the mindset of a lot of these pharmaceutical organizations and convince them that you can

work on bigger, more downstream problems in the cloud. The sense of optimism that pharma will make that shift is so strong that a plethora of software startups are racing in to service the industry. They include companies such as Silicon Valleys Teambox, which offers a cloudbased collaboration platform, and Wellspring Worldwide, a Carnegie Mellon spinoff that has developed several software products to support open innovation in companies, hospitals, and universities, including one tool for

scouting new technologies and another for managing IP assets. Wellspring CEO Rob Lowe predicts a shakeout in the cloudservices space. We see a massive trend towards more applications to manage R&D at a broader level, Lowe says. Five to ten years ago, a pharmaceutical firm used a different piece of software to run their clinical trials, to operate their lab equipment, and to manage a relationship with a university. I think youre going to see a lot of consolidation. Lowe likens the cloud-computing

You need to manage the cloud like you own the cloud.

Our clients are moving towards shorter, faster trials, with more precise design, using larger and more sophisticated data sets.
Todd Skrinar, Principal, Ernst & Young

Today, Akamai is enabling global brands to operate in the cloud as if they own the cloud. Akamai provides cloud-based solutions that give you the power to safeguard, accelerate, and control your cloud applications, data, and business processes. Learn how you can manage the cloud like you own it - anywhere in the world, on any device, at any time at Akamai.com/Cloud

2013 Akamai Technologies, Inc. The Akamai logo is a registered trademark of Akamai Technologies, Inc. All Rights Reserved.

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By casting a broad net out to the cloud, companies can find solutions they may not have ever found before.
Al Malouf, Senior program manager, NineSigma

trend to what happened in manufacturing. In the 1980s, supply-chain management really took off when a lot of manufacturing firms recognized that to be competitive, they needed to become more efficient. Thats how we see R&D moving in the healthcare sector. Historically its been distributed across systems and processes. Were now in a world where it has to be a knowledge supply chain, just like a supply chain in manufacturing.

In Search of Standards

On June 5, a group of more than 70 research organizations and advocacy groups, including the National Institutes of Health, announced that they would work together to establish an organized method for sharing genetic information collected from patients, using a variety of technologies including cloud computing. Their mission is to make it easier for scientists across academia and industry to use the rapidly growing trove of genomic sequencing data

while at the same time shielding patient privacy and protecting their own commercial interests. But many industry leaders believe that there must be standards in place before all that information can be safely stored and shared in the cloud. Interoperability is really the key here, says Tom Plasterer, principal informatics scientist and semantic framework lead for AstraZenecas ($AZN) R&D operation near Boston. Plasterer is a supporter of linked data, a type of semantic technology that would allow for the integration of data from many sources. Once its available as linked data, then you can start to add all of the analytics on top of it that are necessary to find the types of patients you need for clinical trial recruitment, for example, or find the molecules that are available for a particular target and a particular disorder. Alexandria, VA-based 3 Round Stones provides a linked-data platform, and has been building applications specifically for the life sciences industry. Scientists have primarily been passing data around in Power Point and Excel, says David Wood, chief technology officer at 3 Round Stones. The problem is you get 20 Excel spreadsheets, all with the same file name. Which one should you be using? You have to figure out how to describe your data so others can replicate a study. We started 3 Round Stones specifically to create a product where anything can link to anything. Regardless of whether or not linked data and other such semantics technologies catch on, theres no doubt the life sciences industry is planning to use the cloud for a host of new collaborations.

We are seeing a different behavior in the clinical development space on sharing and actually helping each other, says Accentures Levy. He cites as an example TransCelerate BioPharma, a nonprofit founded by 10 pharma and biotech companies in late 2012 with the mission of improving the quality and efficiency of clinical trials. The participants in TransCelerate, which is based in King of Prussia, PA, include Roche, Bristol-Myers Squibb ($BMY), and Biogen Idec ($BIIB). This industry recognizes its troubles and is working together to create technologies and processes that they share, and that helps them all be better. Levy detects a growing interest in using the cloud to run joint placebo-controlled trials, for example. Instead of one company comparing their drug to a placebo, and another company doing a different study where they have 100 patients on a placebo, and then another thats comparing 100 patients on placebo against their drug, why not just run one trial across several companies? he says. Theyre willing to do that, because theyll still own their data, but theyll share the placebo data, which doesnt need to be repeated. Theres no reason to give a placebo to so many different groups of patients. Even the FDA is starting to embrace the cloud. Taha KassHout, the agencys chief health informatics officer, says the FDA is experimenting with a number of cloud-based platforms, including a virtual conference room to enable industry players to share and communicate their data. The reality is that much of the FDAs data should be accessible to our

partners and stakeholders through a data-sharing platform that simplifies and centralizes our ability to manage this information, says Kass-Hout in an email. He adds that the initiative, called open.fda.gov, is modeled after data-sharing platforms tried at other federal agencies, including NASA and the Centers for Disease Control and Prevention. Meanwhile, both pharma companies and software developers are planning their next round of escapades in the cloud. Medidatas Spielman says the company has done a lot of work on what he calls the patient cloud, including providing software that allows patients to report how theyre feeling during clinical trials using a smartphone app. We think of the patient cloud as a conduit to connecting much more closely to patients, Spielman says.

At Janssen Research & Development, a unit of J&J, every cloud-based possibility is up for discussion, says Gunaretnam (Guna) Rajagopal, the divisions vice president and chief information officer. Definitely we have been expanding our footprint in the cloud for supporting the research environment, Rajagopal says. The company is using the cloud to store data on genomic sequencing and pharmacokinetics, he says, but its examining all of the other ways that cloud infrastructure might make R&D more efficient. Like many companies, J&J is proceeding with caution. The technical capabilities [of the cloud] are relatively well understood, he says. But the legal, administrative, and policy implications of using the cloud are still being worked on, so we have to be very careful. l
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