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www.njtc.orgSeptember 2011Vol. 10 No. 3$3.50PHARMACOGENOMICS:The Practice of Medication PrescribingAdvances toward Personalized TherapySocial Media, Cloud Computing andMobility in the Life Sciences - 16Transforming Healthcare with thePatient in Mind - 8The Financial Landscape for NewJersey Biotech Companies - 18


Supporting InnovationAt EisnerAmper, we understand that great ideasoriginate where creativity is encouraged toflourish…where the entrepreneurial spirit issupported by business professionals who shareyour vision and pursuit of the innovative edge.EisnerAmper's Life Sciences Practice professionalshave the expertise, resources and relationships toassist both public and private life sciencescompanies bridge the gap between business andscience. Our commitment to the industry isevidenced though our active involvement in andsupport of BioNJ, New Jersey Technology Counciland Pennsylvania Bio.John Pennett CPA, Partner-in-ChargeEisnerAmper Life Sciences Groupp: 732.287.1000e: john.pennett@eisneramper.comEisnerAmper LLPAccountants & Consultantswww.eisneramper.comNew Jersey | New York | Pennsylvania | Cayman Islands


CONTENTSCOVER STORY12 Pharmacogenomics:The Practice of MedicationPrescribing Advances towardPersonalized TherapyBy By Robert L. Alesiani, PharmD, CGP,and Nicole Gogluizza, PharmDThis article discusses howpharmacogenomics is being used inmodern practice and how, with a simpletest, the use of PGx can help guidepractitioners to prescribe the correctmedication at the correct dose for apatient’s ailment.September 2011 • Vol. 10 No. 3New Jersey Technology Council& The Education Foundation1001 Briggs Road, Suite 280Mount Laurel, N.J. 08054phone (856) 787-9700fax (856) 787-9800www.njtc.orgNJTC Member News Wire:http://njtcblog.wordpress.comPUBLISHERMaxine Ballen • mballen@njtc.orgVP OF PUBLICATIONSLeo M. Mennitt • lmennitt@njtc.orgCONTRIBUTING EDITORCarly Bohach • bohachc.njtc@yahoo.comNJTC CONNECTIONS EDITORJudy Storck • Jstorck@njtc.orgGRAPHIC DESIGNERDan Trost • dtrost@breakawaycommunications.comDEPARTMENTS6 CORNER OFFICEHarold J. Wirths, Commissioner, New Jersey Department of Labor and WorkforceDevelopment explains his department’s important role in working with industry on taxconcerns, encouraging businesses to relocate into the state, troubleshooting to keepbusiness from leaving the state, offering employee training grants and linking them to oneof the best-trained workforce populations in the nation.8 BUSINESS & STRATEGYBest Practices and Trends in Developing Mobile Healthcare ApplicationsBy Yuva RajaLearn the key factors and best practices that any healthcare ISVs, SP, SIs or mobileapplication developer should consider while developing Mobile Applications for the lifesaving industry – Healthcare.10 BUSINESS & STRATEGYTransforming Healthcare with the Patient in MindBy Thomas FoleyThomas Foley explores the challenging road ahead as our healthcare system is transformed.11 BUSINESS & STRATEGYA Patch for Safer MedicinesBy Chris Mathes, Ph.D.This article explores how new and safer medicines will hit the market in this decadebecause of the automated patch clamp.16 FEATURESocial Media, Cloud Computing and Mobility in the Life SciencesBy Andrew J. HollanderThis article looks at several areas of great promise -- and peril -- for the life sciences in theinformation age: social media, cloud computing, and mobility.18 DOLLAR & SENSEThe Financial Landscape for New Jersey Biotech CompaniesBy Ryan StarkesDiscover how New Jersey life science companies will continue to work through the mostrecent wave of economic challenges.19 EDUCATION TODAYCenter for Environmental and Life Sciences - The Hub of Montclair StateUniversity’s Leadership for the FutureBy Christopher StevensonConstruction of the Center for Environment and Life Sciences (CELS) at Montclair StateUniversity (MSU) is underway. Learn about the Center’s devotion to study the environment andsustainable use of natural resources and to focus on the scientific initiatives in global health.LifeSciTrends is published by the New Jersey Technology Counciland The Education Foundation. We are located at 1001 Briggs Road,Suite 280, Mt Laurel, N.J. 08054. ©2011 NJTC All rights reserved.Reproduction or use, without permission, of editorial or graphiccontents in any manner is prohibited. To obtain permission, contact thecontributing editor Leo Mennitt at lmennitt@njtc.orgAdvertising information: Leo Mennitt at 856-787-9700 x227Subscription information: www.njtc.orgPostmaster: Send address changes to:NJTC, 1001 Briggs Road, Suite 280, Mt. Laurel, N.J. 08054.NJTC CONNECTIONS4 President’s Message20 NJTC New Members22 NJTC Calendar of ProgramsNJTC Member News Wirehttp://njtcblog.wordpress.comNJTC onhttp://twitter/njtcNJTC Group onNJTCLifeSci Trends | www.njtc.org | September 2011 3


PRESIDENT’S MESSAGEExciting things are happening thisfall at the NJTC! In a bold moveto stimulate economic recovery inNew Jersey, the NJ Department of Laborand Workforce Development awarded agrant to the NJTC to lead the Technologyand Entrepreneurism Talent Network, oneof six networks created by the grant. Thegoal of the Talent Networks is to buildcapacity and focus on creating an infrastructure and supportnetwork to provide career opportunities and training in the followingtechnology sectors: IT/Software, Communications, Life Sciences,and Electronics/Advanced Manufacturing, Energy/Environment.The NJTC is pleased to be working with Johanna Zitto, CPT,whose focus will be job growth in the areas of technology andentrepreneurism that will lead to economic recovery in the state.As with anything the NJTC does, ourmembers play a crucial role in our success.We’re reaching out to our NJTC membercompanies to identify the kinds of techrelatedjobs they currently need to fill, andthe job positions they will need to fill overthe next 3 to 5 years. In addition, we wantto learn the specific skills and knowledgethat will be needed to perform thesefuture positions, and also what positionsare difficult to fill and why members feelthese are difficult positions to fill. We arereaching out to members with e-surveysand will soon convene focus groups andpeer network meetings. Later in the year,the NJTC will host workshops and careerconferences.In addition, the NJTC has two specialupcoming events this fall that you don’twant to miss. The Executive LeadershipSummit will be held on September 22 and23, 2011. This year’s conference includesa variety of vibrant speakers including:John Crowley, President & CEO, AmicusTherapeutics, Inc.; Jerome B. Zeldis,MD, PhD, CMO, Celgene Corp. & CEO,Celgene Global Health; Steve Waldis,CEO, Synchronoss Technologies; andDonald Katz, Founder & CEO, Audible.com this is just a partial list of thetechnology executives you will hear from,learn from and interact with at the NJTCExecutive Leadership Summit. And, let’snot forget the “Academy Awards” forNew Jersey’s technology community—our annual Gala Awards which will beheld November 17, 2011. This eventrecognizes the “Best in Technology”companies as well as educational andtechnology support leaders. This yearis our fifteenth anniversary, and we’llbe honoring winning companies fromprevious years.This month’s issue of LifeSciTrendsis packed full of informative articles.Learn how pharmacogenomics is beingused in modern practice and how, witha simple test, the use of PGx can helpguide practitioners to prescribe thecorrect medication at the correct dosefor a patient’s ailment in The Practice ofMedication Prescribing Advances towardPersonalized Therapy. Also, explorethe challenging road ahead for as ourhealthcare system in TransformingHealthcare with the Patient in Mind.Now’s the time for statewide innovation!The Talent Networks are a truly uniqueapproach to stimulating economicrecovery in New Jersey. Both the NJTCand Johanna Zitto are honored to be apart of it, and you will be too. What areyou waiting for? Get in on the action.—Maxine Ballen, NJTC,President & CEOCouncil ConnectionsFOUNDER, PRESIDENT & CEOMaxine Ballen • mballen@njtc.orgCHIEF OPERATING OFFICERJoan C. Praiss • jpraiss@njtc.orgVP MEMBERSHIPPaul A. Frank III • pfrank@njtc.orgVP Publications/Business DevelopmentLeo Mennitt • lmennitt@njtc.orgCOMPTROLLERYvonne M. Riley • yvonne@njtc.orgEXECUTIVE ADMINISTRATORKaren Lisnyj • karen@njtc.orgCOORDINATOR OF SPECIAL EVENTSMeredith Meyer • mmeyer@njtc.orgMEMBERSHIP ASSOCIATEEllen Stein • ellen@njtc.orgOFFICE ADMINISTRATION/MEMBERSHIPSERVICES - CONNECTIONS EDITORJudy Storck • jstorck@njtc.orgIT COORDINATORErwin Racimo • eracimo@njtc.orgNJTC CHARTER MEMBERSDeloitteEdison Venture FundKPMG LLPMaloy Risk ServicesMorgan LewisPNCNEW JERSEY TECHNOLOGY COUNCILwww.njtc.org1001 Briggs Road, Ste 280Mount Laurel, NJ 08054856-787-97004LifeSci Trends | www.njtc.org | September 2011


NJTC MilestonesHow far we’ve come!EpiGenesis <strong>Complete</strong>s $23M Private FinancingEpiGenesis Pharmaceuticals, Inc., a privately held companydeveloping inhaled respiratory medicines for the treatmentof asthma and chronic obstructive pulmonary disease(COPD), has raised $23 million in private equity financing toadvance the company’s product development efforts.“This financing represents a strong endorsement by ournew investors of the progress that our company has madein building a new management team and organization toadvance the company’s product development efforts,”said Daniel Soland, president and CEO.Researcher in Wireless Communications and formerleader of world-class industrial research organizations,Eric J. Addeo, Ph.D., brings new and distinct dimensionsto his classes in the College of Engineering andInformation Sciences at DeVry University in NorthBrunswick, NJ.As a Senior Professor at DeVry University, he teaches aspectrum of courses in the College of Engineering andInformation Sciences.Dr. Addeo is also responsible for the Capstone SeniorProject Classes in Electronics, Computer Networking,Telecommunications, and Biomedical Engineering. Dr. Addeo’sleadership in these intensive, multi-session Senior-Projectinitiatives has inspired student-centered development of realworking prototypes of new and innovative applications.Why MyCompany is aNJTC Member20042009201115Keeping Pharma and Biotech Healthy with eHealthLegal Eagle, Helen Oscislawski, Fox RothschildProbably the highest level eHealth initiative underwayis the creation of a National Health InformationNetwork (NHIN). The NHIN concept started in April of2004 when former President George W. Bush signedan Executive Order mandating that most Americanshave an electronic health record (EHR) within 10 years,or by 2014. Since then, there has been considerableeffort made to move the entire nation from paper toEHRs, and to connect health-care providers. The recentinfusion of billions of dollars into Health IT throughARRA now aims to insure that in addition to alreadyongoing projects, new efforts that promote the useof EHRs and health information exchange will drivethe NHIN forward faster. As a result, an increasingnumber of health-care providers, including physicians,pharmacies, and clinical laboratories, among others,will have access to more comprehensive and currentinformation about an individual, and will use variousHealth IT, such as e-prescribing and telemedicine, todeliver medical care.“THE NEW JERSEY TECH COUNCIL’S COMMITMENT TO GROWING AND SUPPORTING TECHNOLOGY BUSINESSES AND TOBRINGING THE ISSUES OF THE STATE’S BUSINESS OWNERS TO THE FOREFRONT CONTINUES TO PROVIDE IMMEASURABLEBENEFITS. THE COUNCIL HAS BEEN A CENTRAL FORUM FOR NETWORKING AND INFORMATION SHARING FOR FIFTEENYEARS AND WE LOOK FORWARD TO JOINING THEM IN CELEBRATING MANY MORE YEARS OF SUCCESS.”— VIRGINIA G. ALLING, MANAGING DIRECTOR, PNC BANKFifteen years later, Coriell Institute for Medical Research is proud to count itself among the first membersof the New Jersey Technology Council. While Coriell is not a “tech company” in the customary sense, weare a medical research institute that engages in cutting-edge science using the latest technology available.We joined the New Jersey Technology Council (NJTC) to connect with a core community of companiesand because Maxine Ballen asked us to! As founder, president, and CEO, much of the Council’s success isattributable to her vision, intuition, advocacy, and energy. Maxine recognizes the potential of interactionsand dialogue between companies and executives and pushes us to truly connect in conversations duringmeetings and other NJTC forums.Coriell has long embodied advanced technology in New Jersey. Founded in 1953, we are anindependent, non-profit research organization dedicated to research of the human genome. The Coriell Biobank is regarded as one of the world’s largestand most diverse collection of cell lines available to the international research community. The Coriell Personalized Medicine Collaborative ® (CPMC ® )research study is seeking to understand the utility of using your genetic information to tailor treatments and medications for you. And building on Dr.Coriell’s innovations in cell biology, the Institute recognizes the importance of induced pluripotent stem cell research as a resource that can furtherresearchers’ understanding of disease development.Modern medicine is a field guided by technology: From electronic medical records, clinical decision support systems, medical devices, and diagnostictools, to the research technologies used by Coriell. We are entering an era of healthcare when technology can efficiently and cost-effectively provide ourgenetic information to our doctor, who in turn will use that information to make clinical decisions that are tailored for us. Coriell is at the forefront ofpersonalized medicine and we join our healthcare technology partners in shaping healthcare delivery that will be safer, more timely, and cost-effective.Fifteen years later, Coriell is looking forward to continuing our partnership with the New Jersey Technology Council.LifeSci Trends | www.njtc.org | September 2011 5


CORNER OFFICEAppointed in 2010 as the Commissioner ofthe New Jersey Department of Labor andWorkforce Development, Harold J. Wirthsbrings years of valuable experience to hisposition. Wirths has served on the SussexCounty Board of Chosen Freeholdersincluding terms as Freeholder Directorand Deputy Director and has gained therespect of county employees as a tough,but fair, negotiator while successfullyconcluding contract negotiations withemployee labor unions.1How did you arrive in your currentposition?I was honored to be chosen by Governor ChrisChristie to become Commissioner of the NewJersey Department of Labor and WorkforceDevelopment right after he took office inJanuary 2010. I served as Acting Commissioneruntil my nomination was confirmed by thestate Senate in May of that year.What important life experiences do you2 feel you bring to the position?For nearly 20 years, my wife and I owned andmanaged furniture stores before selling thesuccessful businesses. I helped to establishthe Noble Community Bank, which today ispart of Highlands State Bank, and I served onthe Highlands Bank Board of Directors. Afterjoining the Sussex County Board of ChosenFreeholders in 2000, I served as deputy directorand director. I also chaired the countybudget committee and headed the capitalprojects committee.Coming from the private sector, how3 do you draw from those experiences tohelp in your current position?I know first-hand the challenges New Jersey’semployers face and how those challengesimpact the state’s talented workforce.Running a family-owned business gave meinsight into how government decisions caneither help or seriously hinder businessgrowth in New Jersey and when businessesflourish, so do jobs.During nearly a decade as a freeholder, I alsosuccessfully negotiated contracts with employeelabor unions. The results were fair agreementsthat took into consideration not onlythe needs of the county employee, but also theinterests of the general public and the impacthigh taxes can have on a community and thebusinesses on which the community relies.Life Science is important in New Jersey.4 How do we keep the concentration oflife science companies in New Jersey?New Jersey is home to the largest cluster oflife science companies in the country and thisindustry is a cornerstone of the state’s economy.We must continue our efforts to improvethe business climate in the state.More than 125,000 talented people work inthe industry, from research scientists to supplychain managers, from marketing professionalsto production workers.This talented workforce is the state’s primarycompetitive advantage in this industry.Companies stay in New Jersey and move toNew Jersey because they can find skilled workersfor nearly every need. To create jobs inthe life sciences, we must protect this asset bystrengthening our effort to build a world-classlife science workforce.What role does the Department’s new5 Talent Networks play?The Talent Networks, while seemingly complex,operate on two simple premises: First,New Jersey’s employers know best the workforcetalents and skills that will make theirindustries successful. Secondly, colleges, universities,education and training providers,workforce development organizations andemployers must work together if we aregoing to make sure our workforce is trainedand educated with the skills that the mostpromising industries need in their employeeranks to be competitive in the global market.We have identified six key industries, includinglife sciences and technology / entrepreneurship,that promise to drive our futureeconomic engine in New Jersey, and we havebuilt Talent Networks around each.What is the role of NJTC in6 this effort?The New Jersey Technology Council is anatural fit to lead the state’s Technologyand Entrepreneurship Talent Network. Aswith the other Talent Networks, NJTC willpartner with colleges and universities, tohelp connect to job seekers, who are lookingfor work, with companies that are lookingfor talent. The Talent Networks will funnelinformation from industry employers to thecolleges, training facilities, schools and thestate’s workforce development system to betterprepare students and retrain workers forthe jobs that are in demand.NJTC is partnering with NJIT, Rutgers Universityand our technology employers and entrepreneursto host networking events for individualsseeking a career in technology sectorssuch as IT and software; communications, lifesciences, electronics and advanced manufacturingand energy and environmental services.NJTC and its partners also will create an infrastructureand support network for individualsseeking to start or grow an early stage business.BioNJ, the state’s biotechnology industryassociation, is leading the state’s Life SciencesTalent Network.What other initiatives are underway at7 the Department of Labor and WorkforceDevelopment to assist the key industriesbehind the Talent Networks?Back in April we kicked off “Jobs4Jersey.com,” a website with a pure Jersey-stylemoniker that seemed like a simple idea atthe time. We wanted it to be a virtual onestopfor all the previously scattered weblinks,website services and job-search engines weoffer at the department to employers seekingskilled people and job-seekers lookingfor work. “Jobs4Jersey.com” has since beenwidely enhanced.It is now a robust, interactive on-line servicethat instantly matches job-seekers withemployers, and it gives both audiences accessto powerful search-engines and high qualityresources. At the heart of “Jobs4Jersey.com”is a new database system we like to call “TheOn-Ramp.” It goes far beyond any Internet jobsearchor talent-search. It enables employers toupload their talent needs and job-seekers toupload resumes or create new ones, allowingboth to quickly and easily find what they need.“The On-Ramp” actually has an artificial intelligence.It goes far beyond a mere matching ofstated skill sets or needs. It assesses and considerswhether the talents of job-seekers qualifythem for jobs in a vast array of fields. Thinkabout it. Previously untapped talent pools willbe identified for employers.Both job-seekers and employers receivee-mails when matches are identified.“Jobs4Jersey.com” also remains a fast andeasy link for employers to find the latestinformation on obtaining grants, jumpinginto on-the-job training programs and gettingtax credits.Think ahead. What role will the State8 play in the next five years in the growthof industry in New Jersey?The role already has been put in play byGovernor Chris Christie and it will continue tobe in play. My department, Lt. Governor KimGuadagno’s office, the New Jersey BusinessAction Center, the State EmploymentTraining Commission, Choose New Jersey andthe Economic Development Authority are allfocused on helping Garden state employersand industries succeed. We are working withindustry on tax concerns, offering financialincentives, encouraging businesses to relocateinto the state, troubleshooting to keepbusiness from leaving the state, offeringemployee training grants and linking themto one of the best-trained workforce populationsin the nation.6LifeSci Trends | www.njtc.org | September 2011


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BUSINESS & STRATEGYBest Practices and Trendsin Developing MobileHealthcare ApplicationsWhen Apple launched the iPhonein 2007, it transformed the waywe think about mobile devicesand their usage. Other playerslike RIM, Google (Android) and Microsoftstarted adopting the changes quickly for theirsurvival in the mobile space. Apple made theindustry look at the revolutionized innovation asmartphone can deliver and helped the businessgrowth of the industry.BY YUVA RAJACompared to other industries, the healthcare and pharma industrywas quick to respond and adopt new technologies between2000 and 2010 realizing the need for innovation when deliveringits services. Now it’s the Healthcare and Pharma Industrykeeping itself on the edge of all emerging technology. Accordingto various studies, it’s going to take a reasonable amount ofinvestment to develop efficient mobile healthcare applications incoming years.There are various healthcare sectors looking for comprehensivemobile applications for various purposes that include EMR DataIntelligence and Reporting, Monitoring, Scheduling, Payments,Accounting, Tracking and more.We will discuss key factors and best practices that any healthcareISVs, SP, SIs or mobile application developer should considerwhile developing mobile applications for the life saving industry– Healthcare.For any healthcare application, security and compliance goeshand in hand and it’s absolutely essential to adopt all healthcarecompliances and regulations including HIPAA, HITECH, ITRFRegulation or PCI/PHI compliances, governing the Healthcaresector. The designer or developer should consider how to:• transmit the data between end-points• secure the usage of the data• secure the critical information during unlikely events such asthe device being stolen, hacked or reaching the wrong hands.• apply encryption technologies, authorizationand authentications.It is smart to develop mobile healthcare applications that support avariety of Mobile Platforms, so that the users are free to choose theright device for their needs. It will help solution providers implementthe solution in hospitals, clinics or pharmacies without insistingon a device change to support the application.Other critical factors to be kept in mind while designing or developingmobile applications (these are not only for healthcare applications,but applicable for all mobile application developments).• Bandwidth – the application designer/developer shoulddesign the application assuming that the radio signal is oftenin lower bandwidth.• Memory – mobile devices now are starting to have goodmemory sizes, it is still not close to a PC or Laptop, so themobile application should not be a heavy lifter.• Energy – the designer or the developer should avoid programmingthe application in such a way that certain activitieswill not increase battery energy usage and reduce bat-8LifeSci Trends | www.njtc.org | September 2011


tery life. For example an activity thattransmits the geo-location very oftenwill drain the battery sooner.• Data Transmission – mobile networkcost is based on the volume of data wetransmit, so the application should bedesigned and developed in such a waythat it doesn’t transmit the same dataevery time it connects with back endsystems or vice versa.• Presentation and User-Friendly – themobile application screen designshould be simple, clear and clean,avoid cumbersome texts and inputs.Consider right size text, buttons andcontrols as most of the operationsare triggered by finger touch on thescreens. Keep in mind the screensizeof the device the application isdeveloped for.• Reduce Manual Errors – any automatedapplication should reducemanual error and it is not differentfor mobile healthcare applications.A study points that CPOE & theMedication Administration Applicationreduced manual errors up to 38percent and 55 percent respectively.• Increase Employee Productivity –mobile healthcare applications shouldhelp increase employee productivity,efficiency, and enable the care takeror medical practitioner to take care ofmore patients. A study indicates EHRincreased employee productivity upto 24 percent. According to a privatestudy, a good Mobile Healthcareapplication saves an average of 39minutes for Health Care employees,and allows them to provide more timeto patient care.• Increase Satisfaction – eventually theperformance of the application shouldincrease healthcare providersatisfaction and enable themto serve more patients.• Reduce Labor Costs –Mobile Healthcare Applicationsshould reducelabor cost by automatingthe manual process; and itshould not force the healthcareorganizations or providersto increase the labor to handle andmanage the application exclusively tomake it work.• An Integrated Approach –the successof these mobile healthcare solutionsrequires a holistic and integrated approach;capable to integrate with heterogeneoussystems or applications.By 2015, more than one third of the1.4 billion smartphone users will use atleast one mobile healthcare application.Developing the right mobile healthcareapplications will secure an importantrole for healthcare ISVs, SVs and SPs inthis space.• Electronic Health Record is the mostimportant application driving investmentabove 28% from HealthCare Industry.Next to it, Computerized Physician OrderEntry and Medication Administration attractsinvestment above 13% individually(Source – Motorola)• Mobile Health Care applications will playvital role taking the Health Care systemsto next level in future.• Mobile Health Care market to hit $2.1billion by end of this year – growth by17% in each of the past two years (Source– ComputerWorld)• Health Care Application set to becomehugely popular and above 500 million consumerswill be using the application in next5 years (Source – Research2guidance)• More than 1/3 of 1.4 billion smartphoneusers will use atleast one MobileHealthCare Application by 2015 (Source– Global Mobile Health Market Report2010-2015).Yuva Raja is currently heading the IDEA Lab – Global R&D division of ZSL,Inc., and is responsiblefor delivering the Value Added Research and Product Engineering Services to Enterprises, Startups,ISVs, and Systems Integrators utilizing the enterprise mobile, BI, Cloud and Social Mediatechnologies and platforms. He can be reached at yuvarajam@zslinc.com or 732.379.3934.Taryn BostjancicQAAre you prepared for thechanges in revenue recognitionfor research and developmentdeliverables?FASB Update No. 2010-17:Milestone Method of RevenueRecognitionThe FASB has issued Update No. 2010-17 whichis effective for fiscal years beginning on or afterJune 15, 2010. The Update formalized the methodof recognizing revenue based on milestones. TheUpdate defines a milestone as an event having all ofthe following characteristics: (1) there is substantiveuncertainty at the date the arrangement is enteredinto that the event will be achieved; (2) the eventcan only be achieved based in whole or in parton either the vendor’s performance or a specificoutcome resulting from the vendor’s performance;and (3) if achieved, the event would result inadditional payments being due to the vendor.The Update provides guidance on when themilestone method may be utilized to recognizerevenue that is contingent upon the achievementof a substantive milestone. Upon completion of amilestone the consideration a vendor earns must becommensurate with either the vendor’s performanceto complete the milestone or the enhancement ofvalue delivered. The consideration must relate onlyto past performance and be reasonable relative tothe other deliverables and payments in the contract,meaning there cannot be large upfront paymentswhile most of the work is done later. Additionally,if a portion of the consideration earned fromachieving a milestone may be refunded or adjustedbased on future performance, the contingentconsideration is not considered to relate solely topast performance, and, thus, the related milestonecannot be considered substantive. Finally, theestablishment of milestones must be documentedat the inception of the arrangement. It is acceptableif a vendor chooses to use some other method ofrevenue recognition that defers some portion of theconsideration arising from a milestone.The vendor must disclose in its financial statementsits policy, as well as a description of each arrangementinvolving milestone payments, a determination ofwhether each milestone is considered substantive,the factors considered in determining whether themilestone or milestones are substantive and theamount of milestone consideration recognizedduring the period.Taryn Bostjancic, CPA, is apartner in the New BrunswickOffice of WithumSmith+Brown,Certified Public Accountantsand Consultants and is amember of the firm’s LifeSciences Group. Bostjancic maybe reached at 732.828.1614or tbostjancic@withum.comLifeSci Trends | www.njtc.org | September 2011 9


BUSINESS & STRATEGYTransforming Healthcare with the Patient in MindBY THOMAS FOLEYARRA/HITECHOver the last few years, we’ve seen enormous growth in provider adoption ofElectronic Health Record (EHR) systems. This effort was further accelerated as aresult of the American Recovery and Reinvestment Act (ARRA) of 2009. As partof the ARRA legislation is the Health Information Technology for Economic andClinical Health (HITECH) Act, also known as HITECH. HITECH allocates $19billion to hospitals and physicians who demonstrate “meaningful use” of electronicmedical records. Meaningful Use is a three stage initiative that began generally inJanuary 2011 and extends through 2015. The fundamental intent of MeaningfulUse is to drive an incremental approach to the automation, optimization andtransformation of the healthcare system that we know today. One major incentivebehind Meaningful Use was to remove the paper and the inefficiencies thatcome with it and to transition the industry to the electronic capture of the sameinformation. This will allow healthcare providers, regardless of setting, to securelygather and process a unified view of a patient’s health records across the continuumof care; hence providing greater decision support at the point of care.To be a meaningful user, the provider must meet these basic requirements:• Stage 1: Electronically capture health information in a coded format via acertified EHR• Stage 2: Expands on Stage 1 to focus on continuous quality improvementat the point of care, greater use of CPOE likely, more robust exchange ofhealth information and provide the patients with the use of a Web portalsto access their health information• Stage 3: Expands on the two previous stages to then focus on promotingimprovements in quality, safety and efficiency with an emphasis on decisionsupport, patient access to self-management tools, access to comprehensivepatient data and improving population healthPlease note that Stage 2 and Stage 3 criteria has not been finalizedThere is no doubt that the achievement of Meaningful Use transforms how healthinformation is capture, and securely shared among healthcare providers as wellas the patient will help to collaborate on a care program. The key to this effort isto realize there are no silos in regard to a patient’s health record – the only healthrecord that proves a view of one’s entire health is a unified view that is securelyaccessible to the medical community directly involved with the care of the patient(ie. Primary Care Providers, Specialists, Hospitals, Long-Term Care facilities,Labs, Pharmacies, Insurance payers, and more.) What Meaningful Use doesn’tchange is how the care is delivered to patients within the community nor does itaddress the current episodic payment system.Accountable Care ActWith that said, now enters the Patient Protection and Affordable Care Act (ACA)- signed into law on March 23, 2010. ACA includes a number of policies to helpproviders with a medical community to improve safety and quality of patient care.One such construct created by the ACA to better coordinate care for Medicarepatients is an Accountable Care Organization (ACO). Additionally, the MedicareShared Savings Program (MSSP) is also created to reward ACOs that lowerA Patch for Safer MedicinesBY CHRIS MATHES, PH.D.Medicines should be safe. In fact, it’s in everyone’s best interest for pharmaceuticalcompanies to make safe medicines. Consumers want to be confident that sideeffects will not be worse than the condition that beckoned the medicine. Drugcompanies increase profits by making safe medicinal products. However, not everydrug that hits the market satisfies the interests of these important parties.In the late 1990’s, some drugs were taken off the market because of safety concerns.This particular action by the FDA changed the landscape of safety pharmacologyforever. Most of these problem medicines were antihistamines. Seldane, forexample (a.k.a. thapsigargin) caused potentially fatal arrhythmias in a significantnumber of users (Roden, et al., 2002; Brown, 2004). Scientists learned that thearrhythmias were caused by the blockade of an important ion channel in the heartthat conducts potassium ions (K+). This potassium channel, one of many heart ionchannels, regulates the repolarization of action potentials (or the “off signal” duringthe electrical stimulus that helps pump the heart). Blocking this potassium channel,known as human ether-a-go-related gene or hERG, delayed repolarization whichcould cause Long QT intervals – a potentially dangerous heart rhythm that couldlead to a fatal arrhythmia. (Brown, 2004).In a bold move, the FDA recommended that all drugs going to market must betested against these hERG channels to avoid the possibility of medicines reachingthat market place that caused unsafe arrhythmias. The FDA did not require thistesting, but the recommendation was so strong that it acted as a requirement. If apharmaceutical or biotech company wanted a drug to be approved by the FDA,data from these hERG tests needed to be shown.Unfortunately, the hERG tests were not cheap and easy for drug makers. The FDAguideline ICH S7B (http://www.fda.gov/cder/guidance/5533dft.htm) stipulatedthat the hERG testing must be done with direct measurement of electrical currentsflowing through these potassium channels on every potential drug going to market.The only direct method for measuring electrical current in cells comes from thepatch clamp technique. With patch clamp, the membrane potential (voltage) isclamped in a single living cell and the electrical current flowing across the cellularmembrane is measure with very specialized amplifiers (capable of measuring 10-12Amperes of current or picoamperes). This patch clamp method was developedby German scientists Sakmann & Neher, who received the Nobel Prize for thisaccomplishment in 1991 (Hamill et al., 1981).Although a remarkable advancement for ion channel research, patch clampremained a highly technical and cumbersome research method throughout the1990’s. Manual patch clamp recordings occur on one cell at a time by a highlytrained, PhD level scientist. When the FDA guideline surfaced around 1998, theidea of testing many compounds using this slow method seemed impossible andexpensive to pharma and biotech companies around the world. These companiesneeded a faster, more automated way to record potassium currents in order tosatisfy the mandate for safer medicines.In order to meet this demand, several companies around the world worked quicklyto develop automated patch clamp systems (for more information see Mathes,2006). Some of these companies were pharma or biotech companies workingto develop their own, in-house technology (i.e., Neurosearch from Denmark).Others companies, such as Axon Instruments (market leading makers of patchclamp amplifiers) set-up development teams to invent automated electrophysiology10LifeSci Trends | www.njtc.org | September 2011


growth in health care costs while meeting performance standards on quality of care and engages a patient centricdelivery of care model across the continuum of care.The policies outlined by the ACA necessitate the need for a Health IT infrastructure that adheres to theobjectives of Meaningful Use. In fact, current ACO guidelines released by the U.S. Department of Health andHuman Services (HHS) on March 31, 2011 states that 50 percent of providers participating in an ACO shouldbe Meaningful Use complaint within the first year of operation.What’s MissingToday, more than half of Medicare beneficiaries have five or more chronic conditions such as diabetes, arthritis,hypertension, and kidney disease. These patients often receive care from multiple physicians. A failure tocoordinate care can often lead to patients not getting the care they need, receiving duplicative care, and being atan increased risk of suffering medical errors. A recent study by the Agency for Healthcare Research and Quality(AHRQ) found that up to 98,000 patients die from medical errors each year. The Centers for Medicare &Medicaid Services (CMS) have indicated that nearly one in five Medicare patients discharged from the hospitalare readmitted within 30 days. Many patients could have avoided readmission if their care outside of thehospital was conducted collaboratively among the patients’ care team.There is a challenging road ahead as our healthcare system is transformed. However, it should not be abouttechnology nor solely focused on the needs of the providers within the medical community. It should becentered on the consumer, the patient, as today they are disengaged from the e-transformation. Engage themand they will drive market demand for richer and more mobile tools. Patients should be considered an equalplayer on the care delivery team – the best advice and guidance provided by a Healthcare Professional can’testablish adherence to a prescribed care plan nor establish a sustainable healthy lifestyle. Only the patient canachieve these goals – this last mile will drive 90 percent of the desired results. When they are treated as an equal,then and only then will there be a true Collaborative Accountable Care setting. On the road forward, there areweb based portals that provide access to health records but the industry needs to move past the rudimentaryfunctionally of allowing the ability to schedule an appointment, request refill, and more. Given the state oftechnology coupled with the accessibility and mobility of the web, we should consider extending a patientportal to more of a Universal Health Management Portico (UHMP). Within this portico, one can use a richset of tools such as: relevant and contextual education content, persistency and compliance programs, benefitsmanagement, HSA access, payment tools, coupled with tele-health and home-health functionality. In somecontext the UHMP is an extension of the physician office – a place one can go to receive healthcare servicesand collaborate with a Healthcare Professional is necessary; as well, the Healthcare Professional can proactivelyengage patients to encourage compliance.Thomas Foley, is the Director of Healthcare Practice at Paragon Solutions, and anindustry strategist focused on Health IT integration, Business Intelligence/Analytics, andsustainability planning. He can be reached at tfoley@consultparagon.com.systems that could quickly and inexpensively measure hERG currents for safety testing.In the early 2000’s the first automated patch clamp systems became commercially available and the pharmaworld gobbled them up. Sophion Bioscience introduced the QPatch-16 in 2004 and the first 48-channel, gigasealautomated patch clamp system (the QPatch-HT) in 2006. A “gigaseal” refers to the very tight seal between therecording electrode and the cell membrane. A gigaseal minimizes stray signals and makes the recording qualitybetter for scientists to determine the effects of potential medicines on hERG and other ion channels. Sophionnow has QPatch systems installed around the world.These days, automated patch clamp systems, like the QPatch, are routinely used by pharma and biotech companiesto test for the safety of potential medicines early on in the R&D process. If a candidate compound blocks hERGion channels, chemists often try to “tweak” the structure of the molecule in order to prevent blockage. This iterativeprocess works to make safer compounds hit the clinical trial phase of the drug discovery process.While safety testing remains an important role for automated patch clamp systems, it is not the only role. Drugdiscovery companies also use this technology to discover new medicines that target ion channels themselves.Ion channels play important roles in every cell of the body. They regulate neuronal and cardiac excitability (orelectrical signals), but they also coordinate important cellular functions, such as gene expression, in non-excitablecells (such as immune cells). Before the advent of automated patch clamp, pharma and biotech companiesbalked at pursuing ion channel targets because of the lack of high throughput technologies for testing potentialmedicines. High throughput technologies have been essential for companies to test millions of compounds ina short period of time (a few weeks) with a minimal cost. The lack of focus on ion channels was unfortunate,because they make great therapeutic targets – as proteins, ion channels reside in the plasma membrane of cellsand they regulate important cellular functions. Now that automated patch clamp systems are available, allpharmaceutical and biotech companies around the world work furiously to develop new medicines. Since it cantake 15-20 years to develop new drugs, look to see new and safer medicines hit the market in this decade becauseof automated patch clamp.Frank R. CieslaQIs Medicare Part B impactedby the current debt crisis?AA portion of Part B is fundedfrom general revenues, notfrom the Medicare TrustFund, which potentially subjects itto a resolution of the debt ceilingcrisis as well as the budget deficit.In addition, Part B payments dealwith payments to physicians, whichpayments are subject under currentlaw, to a reduction of approximately30% on January 1, 2012. Theattempt to resolve this issue underPPACA was deleted. Therefore, amechanism needs to be developedto maintain payments to physicians,who provide physician services tothe Medicare population, which willneed to be funded both out of thegeneral revenue as well as the TrustFund. For top earners, Medicare PartB already is means-tested requiringtop earners to pay more for MedicarePart B than approximately 95% ofthe population.Frank R. Ciesla is theChair of Giordano,Halleran & Ciesla’sHealthcare PracticeGroup. He can be reachedat fciesla@ghclaw.comor 732-741-3900.Chris Mathes, is a Ph.D. and vice-president & General Manager, North Americafor Sophion Bioscience, Inc. He can be reached at cma@sophion.com.ReferencesBrown A.M. Cell Calcium, 2004, 35, 543.Hamill, O.P.; Marty, A.; Neher, E.; Sakmann, B.; Sigworth, F.Pflügers Arch., 1981, 391,85.Mathes C. Expert Opinion on Therapeutic Targets, 2006,10,319.Roden, D.M.; Balser, J.R.; George, A.L.; Anderson, M.E. Annu.Rev. Physiol., 2002, 64,431.LifeSci Trends | www.njtc.org | September 2011 11


PHARMACOGENOMICS:The Practice of Medication Prescribing Advances toward Personalized TherapyBy Robert L. Alesiani, PharmD, CGP, and Nicole Gogluizza, PharmDSince the dawn of modern medicine, it has been recognizedthat what could be a potential cure for one patient maycause harm or worse for another. Pharmacogenomics (PGx)is the study of how one’s individual genetic variation affectstheir ability to metabolize different medications. This rapidlyemergent science is becoming a key phase of new drugdevelopment; examples of which can be seen in medicationsused in pain management, chemotherapeutics, hypertensionand various metabolic disorders. The purpose of this article isto discuss how pharmacogenomics is being used in modernpractice and how, with a simple test, the use of PGx can helpguide practitioners to prescribe the correct medication at thecorrect dose for a patient’s ailment.


Previously, medications were chosen based on prescriberpreference; it was known what drugs had been shown to workfor that prescriber’s patients in the past for a disease. However,not much existed in the way of comparison of therapies; i.e.each prescriber developed his/her own list of “favorite” drugsto prescribe.Today, the idea of evidence- based medicine guides the decisionmaking of most enlightened prescribers. Using knowledgegleaned through scientificstudies and randomizedcontrol trials, prescribers assignmedications that have provento work best within the generalpopulation into which theirpatient belongs. Even with thisapproach, however, prescribingstill contains an element of “trialand error” due to the variedindividual response withina population. The final stepin the evolution of medicationprescribing is to base suchdecisions not only on populationdata, but also on the individualpatient’s drug metabolizing characteristics. Pharmacogenomicsis the method which can move us towards this goal of“personalized prescribing.”Pharmacogenomics identifies how individual variations inthe human genome affect disposition, transport (through thebloodstream) and response to medications. While humans eachhave about three billion DNA base pairs (which are segmentedinto approximately 30,000 genes), pharmacogenomics onlyfocuses on the 225 genes responsible for the approximately1,900 drug metabolizing enzymes, and receptors. Drugmetabolizing enzymes may either activate a “pro-drug” byconverting an inactive drug into an active molecule thatproduces an effect or, conversely, deactivate a drug so that itmay be more easily excreted from the body.There are four possible variants of each gene which leadto differing rates of metabolism based on a person’sgenetics: “normal” (or “extensive”) metabolizer, “partial” (or“intermediate”) metabolizer, “non” (or “poor”) metabolizer,and “ultra rapid” (or “accelerated”) metabolizer. Based ona person’s rate of metabolism, it is easy to see how there canbe differences in response to medications. Among patientsconsidered to be in the same treatment population, differencesmay be observed, regardless of whether the enzyme isresponsible for deactivation or activation of the drug.Determination of an individual’s genetic variation is accomplishedby analysis of metabolizing DNA gathered via a non-invasivecollection of saliva or cells via cheek swab. Most commercialinsurers and Medicare are reimbursing for pharmacogenomictesting in relevant diagnostic situations. Because one’s geneticprofile does not change over one’s lifetime, once typed for aspecific gene, a patient need not be tested for that gene again.Adverse Reactions to Common Drug TherapiesThe Cytochrome P450 (CYP450) family of enzymes, locatedpredominately in the liver, is the most well studied andunderstood group of drugmetabolizing enzymes. TheCYP2D6 enzyme constitutes only1 percent of all CYP450 enzymes,however is responsible for themetabolism of approximately25 percent of medications. 1 Theinfluence of genetic variation inCYP2D6 on medication responsecan be seen in the case of thecommonly used pain medication,codeine. Codeine is a prodrugthat requires CYP2D6 forconversion into its active form,morphine. A patient who is a“partial” or “non” metabolizer will get little or no analgesiceffect from the medication, yet may experience side-effectsattributed to the inactive “parent” formulation. Conversely, if aperson is an “ultra rapid” metabolizer, it can lead to increasedand possibly toxic levels of morphine in the patient.While incidents of these extreme responses to codeine therapyare rare, they are real as seen in an example from the NewEngland Journal of Medicine in 2009. A two year-old boyunderwent elective adenotonsillectomy (surgical removal oftonsils and adenoids) and was prescribed acetaminophenwith codeine liquid for post-operative pain. While the dosageprescribed was within the recommended pediatric dosagerange for post-operative pain, the prescriber did not knowthe child was an “ultra rapid” (“accelerated”) metabolizer odCYP2D6. As a result, the boy incurred a higher conversionof codeine to morphine which resulted in respiratory failureand death after a single dose of the medication. 2 Had thechild’s CYP2D6 status been known prior to prescribing, a saferalternative may have been prescribed.The effect of genetic variation on patient response to medicationscan also be demonstrated with metabolism of clopidogrel(Plavix ® ) 3 by CYP2C19. Clopidogrel is an antiplatelet drugused to ensure blood flow in patients with vascular disease.CYP2C19 is responsible for converting clopidogrel into its activeform responsible for making the blood’s platelets less “sticky”(decreases platelet aggregation). Poor CYP2C19 metabolizerstatus is linked to a decreased antiplatelet response toLifeSci Trends | www.njtc.org | September 2011 13


clopidogrel; if the drug is not activated or activation is decreased,the patient may not receive full protection from myocardialinfarction, thrombotic stroke (caused by clot or blockage in thebrain), and cardiovascular death. Accelerated metabolism of2C19 may result in a patient having problems with spontaneousbleeding episodes and increased risk of hemmoragic stroke(caused by bleeding in the brain). If the prescriber were awarethat a patient’s genetics prevented the drug from attaining adesired response, another medication could be prescribed toavoid complications due to unexpected therapeutic response ofclopidogrel.With approximately 1,900 enzymes being involved in drugmetabolism, these are just two of numerous examples of howgenetic variation of these enzymes can not only lead to suboptimaltreatment, but also serious adverse drug reactions oreven death. Medication-related problems, if thought of as adisease, would be the fifth leading cause of death in the U.S. 4Drug related problems are not only dangerous, but also costly. In one study of UtahMedicaid participants, the average pharmacy cost per month for patients with atleast one drug related problem was $1,081 versus the average pharmacy cost of$91 per month for all other patients receiving at least one prescription. 5 Althoughindividual diversity in drug metabolizing enzymes is not the only cause of adverse drugreactions, utilization of pharmacogenomics and “personalized medicine” can helpdecrease these numbers. According to Dr. Edward Abrahams, executive director of thePersonalized Medicine Coalition, “The point of personalized medicine is to developbetter efficacy, better outcomes, fewer adverse events and lower systemic costs.” Thescience of pharmacogenomics provides the foundation for personalized medicine.Throughout history, medicine and prescribing have evolved with advances in scienceand technology. With the application of personalized prescribing, there can be ashift from “trial and error” prescribing to precision prescribing. When the individualcharacteristics of the patient are considered, adverse medication outcomes can bedecreased and the therapeutic outcomes can be optimized for the patient. A keytool in personalized medicine is the use of pharmacogenetic testing to understandthe extent to which the patient will metabolize, and in turn respond to a medication.Although genetics are not the only cause of drug-related problems, it is one that can bepredicted and avoided with the use of pharmacogenomics. Thus, with a simple test apatient’s medication regimen can be tailored specifically for that patient.Robert L Alesiani, PharmD, GCP, Senior Vice President of Pharmacotherapy andPharmacogenomic Translation, Carekinesis, Inc, Moorestown, NJ 08057Nicole Gogluizza, PharmDc, Doctor of Pharmacy Candidate, Temple University,Philadelphia, PA and Pharmacy Intern, Carekinesis, Inc, Moorestown, NJ 08057References1 Foley K., Quigley D. “Pharmacogenomic potential of psychiatric medications and CYP2D6”.http://www.mlo-online.com/. January 2010; 32-34.2 Ciszkowski C. et al. “Codeine, Ultrarapid-metabolism genotype, and postoperative death”.New England Journal of Medicine 2009; 361;8:827-8.3 Plavix is a registered trademark of Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership4 Lazarou j et al. “Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies”.JAMA 1998; 279:1200-05.5 Lafleur et al. “Prevalence of drug-related problems and cost-savings opportunities in Medicaid high utilizers identified by apharmacist-run drug regimen review center”. JMCP 2006; 12:8: 677-685One new company utilizingpharmacogenomicsis CareKinesis, located inMoorestown, New Jersey.CareKinesis provides personalizedmedication therapy management toindividuals with complex medicationneeds though personalizedmedication management andcustomized medication distributionfor at-risk, elderly populations.CareKinesis partners with healthcareproviders to coordinate routinegenetic testing and translate resultsfor individuals in need. Some of themore common genes probed includeCYP2D6, CYP2C9, CYP2C19,and CYP3A4. Based on the resultsof the genetic tests, CareKinesisPharmDs provide pharmacotherapysuggestions and pharmacogenomicseducation to the prescribers. Thisis all done with the purpose ofmeasurably enhancing the qualityof life of the patient by assuringappropriate medication selection,which leads to improved medicationoutcomes and reduced costs.14LifeSci Trends | www.njtc.org | September 2011


November 17, 2011The Addison Park, Aberdeen, NJCelebrating 15 Years2011 NJTC AWARDS GALA SPONSORSThe Council will recognize andcelebrate New Jersey technologycompanies and their leaders forbusiness accomplishments intechnological innovation. Winnersare posted at www.njtc.orgAs part of the 15th anniversarycelebration, the NJTC will hold itssecond Hall of Fame induction atthe Gala.Contact Meredith Meyer at mmeyer@njtc.org to reserve your space.


Cloud ComputingIf you use Google for email (“gmail”) you docloud computing. In other words, you useyour Internet browser to connect with remotecomputing resources managed by a third partyout there in “the cloud.” The servers, storageand IT personnel could be next door, in Oregon,or abroad, or all of these places and more.Cloud computing has many benefits.Computing power is virtually unlimited. Thecloud provider just adds servers if you needmore power. It can be cheaper -- you don’town the servers, hire the IT personnel, or payfor data storage -- you just use your browseras the “joystick” to control them all. It allowsmassive collaborative efforts. It lets end usersbe more mobile. Quick, scalable, and flexible,it can reduce the barrier to entry for a newproject and speed time to market. Some of thebiggest cloud providers are household names:Google, Amazon, IBM, Microsoft, Oracle.Cloud computing has its challenges, however.Security and privacy are always questions.You don’t own the servers or employ theadministrators. You may have limitedknowledge of exactly what safeguards are inplace regarding your sensitive data. Also, youlose control over the software and hardwareand must depend on the provider.With the above risk/reward profile, cloudcomputing has made gradual inroads intothe life sciences. Pfizer uses a “virtual privatecloud” for R&D that requires enormouscomputing power. Pfizer established rules fora private micro-Internet of its own designwalled off from the public Internet, andAmazon provides the cloud platform. Pfizersays that this cuts computing time from weeksto hours for discovering molecule properties.Another cloud user is Varian. The medicalequipment maker needed to run Monte Carlocalculations to help develop new products.Varian used Amazon’s EC2 (Amazon ElasticCompute Cloud) -- which harnessed numerousservers -- and cut calculations from a projectedsix weeks to one day.Cloud computing can facilitate research andclinical trials. Researchers from The NationalCancer Institute’s Cancer Therapy EvaluationProgram and Bristol-Myers Squibb use cloudcomputing -- joined with digital signaturesand digital identity credentials -- to reduce theneed for paper forms and signatures. Sanofiaventisresearchers joined these efforts. It’sdriven by the digital authentication protocolset by a non-profit group, Safe-BioPharmaAssociation, developed by a group of lifesciences companies with participation fromthe FDA and the European Medicines Agencyto verify and manage digital identities for thelife sciences.The cloud can strengthen customerrelationships and revenues. Oracle and IBMtout it for closed-loop marketing, in whichhuge amounts of data can flow from customerinteractions, undergo analytics, and withconstant feedback, help refine marketing,sales, and the ultimate value proposition forthe client.Despite its benefits, cloud computing canpresent thorny legal issues for life scienceclients. One is HIPAA. HIPAA (see the HealthInsurance Portability and Accountability Act of1996, 42 U.S.C. § 201 et seq. and 29 U.S.C. §1181 et seq.) is always a consideration for lifesciences data. The U.S. Department of Healthand Human Services (HHS) issued the PrivacyRule to implement HIPAA. The Privacy Rulemandates that “covered entities” safeguard“protected health information” (PHI). (45 C.F.R.§ 160.103, § 164.501.) And there is the SecurityRule, which requires that only permitted entitiesbe given access to electronic PHI (ePHI), andthere be adequate safeguards -- administrative,physical and technical ones -- to protect theePHI. (E.g., 45 C.F.R. § 160 et seq.).In 2009, HIPAA was supplemented by HITECH(the Health Information Technology for Economicand Clinical Health Act, see 42 U.S.C. § 17931et seq.). HITECH expands security provisionsto “business associates” of the coveredentity, which could include service providers,subcontractors or downstream entities thatcome into contact with ePHI -- including,conceivably, cloud computing providers.While it is not certain if a given cloud computingprovider would be considered a “businessassociate,” it may be prudent to consider thepossibility. It may be desirable to proposea “business associate agreement” with theprovider such that it expressly agrees to adhereto HIPAA and HITECH. Microsoft proclaims thatit’s one of the first in the industry to offer a“business associate agreement” to customers,through its Office 365 Cloud Service.Of course, beyond typical negotiating pointsrelevant to software contracts, the underlyingcloud computing Service Agreement may havecloud-unique issues. For example, HIPAA haslogging and auditing requirements, whichmight apply even to cloud administrators andmay be raised in negotiations.Also, there are several types of cloud services,and one of them may “subcontract” to another– one more point to consider in the negotiationprocess. For example, Netflix is layered onAmazon EC2. Netflix provides the softwarepiece of the cloud but Amazon providesstorage, servers, and connectivity. You mayknow the first level provider (Netflix), but notthe second (Amazon). So before signing onthe dotted line, you may wish to ask whetheryour cloud service provider (whom you know)is “subcontracting” to a hosting service (whichyou may not), and find out whom.Noncompliance with HIPAA/HITECH could “earn”one a mention on the HHS “wall of shame,”which publicly discloses security violationsaffecting more than 500 people. Because cloudcomputing is relatively young, violations uniqueto cloud computing are not prominent. Butchances are that the shadow of a cloud violationmay fall on the wall before long.MobilityMobility is one benefit to cloud computing. Youjust need a browser, which could be in a “thin”laptop with minimal hardware or software.Naturally, mobility creates added complications,such as security. Google offers two-factorverification for paid applications, where to obtaincloud access you must enter your mobile phonenumber and a one-time code.Steps that life sciences companies can take tomanage risks of cloud computing and mobilityinclude:• Undertake good due diligence into a cloudcomputing provider. If you’re not gettingsensible answers consult another providerwho will address your unique concerns.• Negotiate a cloud computing serviceagreement that, besides the usual softwareagreement negotiating points, takesinto account regulatory and compliancerequirements, and consider “businessassociate agreements.”• Set forth a policy that employee accessto cloud computing resources be properlymanaged, and comply with not only companyguidelines but regulatory requirements.Andrew J. Hollander, Of Council, can be reached at andrew.hollander@klgates.com.LifeSci Trends | www.njtc.org | September 2011 17


LIFESCI DOLLARS & SENSEThe Financial Landscapefor New Jersey Biotech CompaniesBy Ryan StarkesAs lifescience companies continue to work through themost recent wave of economic challenges, a study ofbio-technology companies’ 2010 performance providesan indication of management’s evolving perspectiveon R&D spending. The 2011 BDO Biotech Briefingexamined the most recent 10-K SEC filings of the publicly tradedcompanies listed on the NASDAQ Biotechnology Index (NBI), and– for the purpose of the analysis - were classified as “large” (between$50 million and $300 million in revenue) and “small” (less than $50million in revenue).According to the study, research and development (R&D) expendituresin the biotechnology industry have declined for the second straight yearas companies narrow their focus to only the most promising products andinitiatives. On average, biotech companies in the NASDAQ BiotechnologyIndex (NBI) spent $54 million on R&D in 2010, reflecting a 7 percentdecline from 2009. This follows the 9 percent decline in spending seenin 2009. Further, the drug industry -- a prominent source of revenue forlocal firms -- also cut research spending for the first time ever in 2010,according to Thomson Reuters.Cash Reserves:The costs and challenges in obtaining FDAapproval have made it more important than everfor biotech companies to focus their R&D efforts.Decreasing R&D spend in favor of preservingcash is a strategic move for many biotechsand will provide a competitive advantage asopportunities for investment arise. On average,biotech companies had $142 million in cashand short-term investments in 2010, a 3 percentdecrease from 2009. Still, larger companiestook the brunt of the decline, reporting a 10percent decrease. Smaller companies also sawa more favorable, 6 percent, increase in cash,following a much more drastic decrease in R&Dexpenditures to preserve cash as a strategic asset.Overall, biotech companies maintained financialliquidity fairly consistently and companies of allsizes are relatively flush following the 26 percentincrease in cash reported in 2009. Overall, cashreserves are equivalent to approximately 2.64years of R&D spending in 2010, up slightly from2.54 years in 2009.Accessing Capital:Biotech companies have historically relied oncapital markets to raise funds to invest in product development. In 2010,51 percent of smaller companies were able to raise an average of $64million equity financing. This shows a promising rebound as companiesare approaching pre-recessionary levels -- 61 percent of smaller companiesraised financing in 2007 and the average value was also $64 million.Despite the turbulent economy, small biotechs have shown a remarkableability to access capital markets and raise funds. This shows that investorscontinue to have an appetite for investments in this sector, but havebecome more selective. Just 13 percent of companies with more than $50million in revenues raised equity financing which indicates that largercompanies rely significantly more on cash generated from operations tofund their activities.Revenues:Despite R&D cutbacks, the biotech sector enjoyed a robust 2010. Averagerevenues for all companies rose 11 percent to $77 million, up from $69million in 2009. Small biotechs with less than $50 million in revenues tookthe lead in this jump, reporting a healthy 42 percent increase. The demandfor more innovative products has helped smaller, more flexible biotechsincrease average revenue to $41 million, anotable jump from $24 million in 2009. Largerbiotech companies, however, reported averagerevenue of $124 million, a 3 percent declinefrom 2009. The overall increase in revenuehas been spurred by strategic partnershipswith large pharmaceutical companies whoincreasingly rely on biotechs to fill potentialgaps in the pipeline of drugs. These partnershipshave afforded biotech companies, includingthose located in New Jersey, additional productand licensing revenue opportunities.New Jersey-based biotechs have demonstrateda resilient ability to manage resources duringtough economic times, and the average increasein revenue is indicative of this sector’s overallstrength. With over 300 firms comprising thelocal biotech industry, the positive financialfundamentals are encouraging for health of thelocal economy, too. With more scrutiny fromcollaborative partners and equity investors,local companies will need to be increasinglystrategic in funding projects that have a higherchance of obtaining regulatory approval andfocus resources on strong drug candidates thatwill likely be commercially successful.Ryan Starkes is a partner and leader of the Life Sciences Practice at BDO USA, LLP. Based in the firm’s Woodbridge office, he can be reached at rstarkes@bdo.com.18LifeSci Trends | www.njtc.org | September 2011


LIFESCI EDUCATION TODAYCenter for Environmental and Life SciencesThe Hub of Montclair State University’s Leadership for the FutureBy Christopher StevensonDemolition has begun on a 1940s era building to makeway for the Center for Environment and Life Sciences(CELS) at Montclair State University (MSU). CELSis an important commitment to MSU’s nearly 2,500science and other majors in the College of Science andMathematics (CSAM) - and to the students who will follow.In the planning stages for over five years, CELS, at 100,000 square feet,will be one of the largest buildings on MSU’s campus. Its twin missionswill be a devotion to the study of environment and sustainable use ofnatural resources and to focus on the scientific initiatives in globalhealth. CELS will build on New Jersey’s pre-eminence in research andcommercial development for the global life sciences industry and onMSU’s long tradition of providing employees for it.The cost of CELS will be $55 million and Montclair State University’sgoal is to raise $20 million in corporate, foundation and philanthropicsupport for the project. “For more than a century, Montclair StateUniversity has been responding to the educational and workforce needsof an ever-evolving New Jersey,” said Dr. Susan Cole, the President ofMSU. “The Center for Environmental and Life Sciences reflects ourcontinued commitment to that core mission. The development of theCELS building will help ensure our future ability to meet the rapidlychanging research, workforce and partnership paradigm of our state’slife sciences industry.”CELS’ role as a “hub” for scientific partnerships will build on MSU’shistory of effective collaborations. In the past few years, MSU has shownits strong ability to cut across its four colleges and two schools to fostereffective, bottom-line partnerships with New Jersey’s private researchcommunity led by its life sciences and “green technology” industries.But “collaboration” today means something very different than it dideven a decade ago. Internally, MSU realized long ago that traditionalacademic silos could no longer stand in isolation. For example,business and science leaders at MSU have long worked together as isdone in industry. Externally, MSU’s Sokol Institute for PharmaceuticalLife Sciences has attracted a number of critical evaluative projectswith New Jersey’s life sciences industry. The Sokol Institute – hard atwork developing other evaluative relationships with the pharmaceuticalindustry - will be a key resident of CELS.One of those emerging relationships is with Celgene Corporation, nowlisted as the fifth largest biopharma company in the world. Celgene hadhumble beginnings as a spin-off from the former Hoechst CelaneseCorporation in the late 1980s. Since 2009, MSU and the SokolInstitute have entered into an evaluative research partnership with theCelgene Corporation.Those forces - and others - will come together within CELS as itfosters the unique interplay between New Jersey technology and healthindustries and academia. Critical to this mission, and inherent withinthe new building and the rapidly changing landscape of the sciences inNew Jersey, will be:• MSU’s ability to expand capacity and generate new long-termdiscoveries, new processes, and new technologies. This is criticalto support the long-term growth of New Jersey’s life sciences andrelated cluster industries.• Efforts to enhance life sciences research partnerships. MSU hasattracted a number of key industry leaders to its campus andCELS will help attract many others.• CELS physical structure is designed to promote interdisciplinaryresearch and collaboration by providing flexible research space.• A large suite for CELS state-of-the-art research laboratoriesspecifically designed to serve as incubator sites for emergingindustries.• CELS modern and collaboratively designed facilities for someof MSU’s well-established programs within environmentalmanagement and sustainability, such as the Passaic River Instituteand the PSEG Institute for Sustainability Studies.• CELS research capacity to provide the expanded capabilitiesnecessary to examine the unique environmental challenges ofNew Jersey’s coastal infrastructure within an environment verysusceptible to the ramifications of global climate change.The layout flexibility of CELS will help MSU maintain and enhanceits reputation for leadership in environmental management andsustainability studies. CELS will help MSU greatly extend its uniquePh.D. program in Environmental Management, one of only a handfulof such programs in the United States, and a first in the state of NewJersey. CELS will also deeply expand the research capacity of theSokol Institute for Pharmaceutical Life Sciences during a time of“reinvention” in that industry.Great programs need an appropriate home such as CELS. CELSrepresents years of careful and focused planning for MSU’s continuedleadership for training in the sciences. It will help produce studentswho are strategic thinkers and who possess the science savvy andleadership capabilities that are essential to New Jersey’s industries.New Jersey’s economic future depends upon CELS!Christopher Stevenson is a member of the Bridgewater law firm of Norris, McLaughlin & Marcus, where he practices environmental, land use, and redevelopment law and isthe convener of the firm’s Green Energy and Buildings Practice Group. He holds Master’s Degrees in Environmental Management and Business Administration from MSU.LifeSci Trends | www.njtc.org | September 2011 19


NJTC NEW MEMBERSNew Members of the New Jersey Technology Council (July 1 – July 31)Electronics, Advanced Materials & Manufacturing• East Coast Electronics – Hillsboroughwww.eastcoastelectronics.com - Is a multifaceted industrialdistributor specializing in expert service, competitive pricingand fast, overnight deliveries of Military and Commercialgrade connectors, relays and wire. We also specialize in Solarinterconnects, wire, and racking systems.Information Technologies• Dynamic Clinical Systems, Inc – Hanover, NHwww.dynamicclinical.com - DCS specializes in knowledge andtechnology driven patient-reported outcomes services and solutionsthat improve the process of care, create better research and takeadvantage of the patient perspective in care value measurement.• Sparta Systems, Inc. – Holmdel - www.sparta-systems.comSparta Systems, Inc. is the industry leader for global quality andcompliance management systems. Its TrackWise product is a webbasedsoftware application used by quality, manufacturing, andregulatory affairs professionals to manage quality and complianceissues across the enterprise.• Sterling Rose LLC – Cedar Knolls - www.sterlingrosellc.comSterling Rose offers answers from the basic to the most complexquestions and implements swift and strategic resolutions for yourtechnology issues. Whether your needs are just fine-tuning anexisting system or building an entire network from the groundup, Sterling Rose is all about working with its clients to providereliable, trustworthy service to keep your office or home systemrunning smoothly.• The Positive Internet Company – Middletownwww.positive-internet.com - Linux and Unix managed hosting andmanaged cloud services. We specialize in designing, building andmaintainability highly-available and resilient servers, clusters andclouds for serious websites, services and applications.• World Currency USA – Marlton – www.worldcurrencyusa.comWorld Currency USA, Inc. wholesales electronic foreign exchangesolutions to community Banks with a turn-key approach that offerscommunity banks the ability to easlily provide FX services withoutexposing their customer to a competitor correspondent bank.Life Sciences• Dell Healthcare – Doylestown, PA – www.dell.comDell believes better healthcare starts with better information,Renewals• Ace Electronics, Inc.www.aceelectronics.com• Alphion Corp.www.alphion.com• AMBLER Growth StrategyConsultants, Inc.www.thegrowthstrategist.com• American Clean Energy LLCwww.amcleanenergy.com• Applechem, Inc.www.applechem.biz• Aptron Corporationwww.aptron.com• ASIFT Software, LLCwww.asift.com• Bluenogwww.bluenog.com• County College of Morriswww.ccm.edu• Gehrlicher Solar America Corp.www.gehrlicher.com• Grant Thornton LLPand the Dell Healthcare approach connects people to the righttechnology and processes to create information-driven healthcareand accelerate innovation. More healthcare providers, payers,researchers and doctors turn to Dell for healthcare technologyservices than any other company in the world. With over onethousand dedicated healthcare specialists and numerouscustomized healthcare solutions, Dell is leading the way toinformation driven healthcare.Service Providers – Business Consultants• Copy To Go – Hillsborough - www.technicalcopytogo.comTechnical and scientific marketing communications includingnewsletters, press releases, trade magazine articles, white papers,brochures, website content, etc.• Morris-Meyer, LLC – Bound Brook - www.morris-meyer.comStrategic technology, ventures and consulting.Service Providers – Insurance• The Commercial Agency – Park Ridgewww.thecommercialagency.com - The Agency offers excellentinsurance programs tailored specifically towards technologybased companies. Insurance products offered include professionalliability/errors & omissions coverage, general liability, employmentpractices, directors & officers, property, crime, workerscompensation, health, and life as well as personal lines.Service Providers – Marketing• Plastic Mobile – Toronto, Ontario - www.plasticmobile.comWe are a full service mobile agency, providing mobile services andproducts that empower global businesses, and brands to thrive inthe mobile space. We have offices in Canada and the United States.Telecom/Media• Achieveopedia.com – Mt. Royal - www.achieveopedia.comUniversal Success System tied into Goal Setting, Training and aSocial Network of Communities as well as libraries of Idea Bankswhich serve as blueprints for business and personal success.• Burgess Communications Solutions, Inc. – Vinelandwww.burgesscommunications.com - Burgess CommunicationsSolutions is an independent communications technologyconsulting firm, providing project management, technicalleadership, and configuration guidance on large scaleimplementation projects for clients in the healthcare, financial,educational, and manufacturing industries.www.grantthornton.com• Health Informatics Consulting (HIC) LLCwww.myhic.net• Karlinda Associates, LLCwww.i-warehouse.com• Mack-Cali Realty Corporationwww.mack-cali.com• Microsoft Corporationwww.microsoft.com• Middlesex County Collegewww.middlesexcc.edu20LifeSci Trends | www.njtc.org | September 2011


LIFESCI PHOTO GALLERYJuly 21, 2011Best Practices RoundtableNJTC Venture Capital and Finance Peer NetworkFacilitated by Zev Scherl, General Partner and colleaguesat NewSpring Capital this round table event featured anopen discussion of best practices and trends in the ventureindustry including due diligence, structuring/syndication,operating trends with portfolio companies and fund/portfolio management.July 21, 20112011 New Jersey Health Information Exchange Summit – Filling in the White SpacePresented by: New Jersey Technology CouncilNew Jersey Health Information Technology CoordinatorNew Jersey Health Information Technology CommissionThe summit was a full day open forum that collectively provided solutions to meet the goals of the HITECH Act so providers areappropriately positioned to get the incentive dollars. Opportunities are available for companies offering Health IT products,services and how these will impact hospitals, healthcare systems, physicians and other health care providers as well as healthinsurance, pharmaceutical, biotech, and medical device companies.Where Are We Now and Where are We GoingPresented by: Colleen Woods, NJ Health IT CoordinatorAl Campanella, Chair of NJ Health ITCommission & CIO, VirtuaSpeaker: Colleen Woods,NJ Health IT CoordinatorSpeaker: Al Campanella,Chair of NJ Health ITCommission & CIO, VirtuaLuncheon Keynote Speaker:Carlos Dominguez, SeniorVP, Cisco’s Office of theChairman of the Board, CEO& Technology EvangelistCollaboration Panel: L-R: Moderator: Dean Boyer, Director,McGladrey, Inc.; Bill Lynch, Sr. Regional Director, NE, Optum;Joe Torrace, VP of Sales, Optimum Lightpath; Alan Gold, VPEnterprise Partnerships, Siemens Medical Solutions, USA andNam Vo, Sr. Director of Healthcare Growth Strategy, OracleFinancing for Early Stage Healthcare IT Companies BreakoutPanel:: L-R: Tom Olenzak, Venture Partner, SafeguardScientifics; Joe Riley, Managing Member, Psilos GroupManagers, LLP, Donna Usiskin, VP Business Development,Edison Ventures and Moderator: Ryan Starkes, Partner, BDOMaxine Ballen, President &CEO, NJTC; Carlos Dominguez,Senior VP, Cisco’s Office of theChairman of the Board, CEO& Technology Evangelist andColleen Woods, NJ Health ITCoordinator• Millennium Communications Group Incwww.millenniuminc.com• Mobility Partners, LLCwww.mobilitypartners.com• MVP Capital Partnerswww.mvpcap.com• Nanobiz LLCwww.nanobizllc.com• New Market Translations, LLCwww.NMTRANS.com• NorthStar Business Consultantswww.northstarusa.com• NPS Pharmaceuticalswww.npspharmaceuticals.com• Pfizer Inc.www.pfizer.com• Pipeline Biomedical Holdingswww.pipemed.net• Raritan Valley Community Collegewww.raritanval.edu• RCM Technologieswww.rcmt.com• Robert Half International, Inc.www.rhi.com• TAKE Solutions, Inc.www.takesolutions.com• Telcordia Technologies, Inc.www.telcordia.com• The Judge Group, Inc.www.JUDGE.com• United Silicon Carbide, Inc.www.unitedsic.com• Wells Fargo Bank N.A.www.wachovia.com• Zweena LLCwww.zweenahealth.comLifeSci Trends | www.njtc.org | September 2011 21


NJTC CALENDAR OF PROGRAMSLICENSING TECHNOLOGY AND THEBENEFITS OF SOFTWARE ESCROWAND VERIFICATIONIT/SOFTWARE INDUSTRY NETWORKSeptember 14 @ 3:00 PM - 5:00 PMNew Jersey EconomicDevelopment AuthorityCommercialization Center forInnovative Technologies675 US Hwy 1 North BrunswickMembers $25.00 • Non-Members $50.00Refreshment Sponsor: Iron MountainDuring today’s challenging economic times,vendors want to shorten their sales cycle anddifferentiate themselves from their competition.Likewise, licensees are looking to mitigate risks andset up business continuity plans. In this session,learn how software companies have proactivelyeased concerns of their prospective licenseesby offering software escrow as a solution, andhow prospective licensees, as part of the vendorselection process, leverage escrow and verificationservices to solidify their vendor relationships andprotect their investment.RECYCLING & BIOFUELS- OPPORTUNITIES ANDCHALLENGESSeptember 20 @ 9:00 AM - 11:00 AMBayshore Recycling75 Crows Mill Road, KeasbeyMembers $25.00 _ Non-Members $50.00Join us for an interactive discussion on opportunities,trends and challenges in the field of recycling.Speakers will present an overview of the recyclingindustry, bio-fuels and efforts toward sustainability.Following the discussion there will be tours of theRecycling Technology Development facility, part of a52 acre EcoComplex/Energy Campus.11:00AM – 12:00PM - BioFuels and SustainabilityWorkgroupsNJTC EXECUTIVE LEADERSHIPSUMMITSeptember 22-23The Hyatt on the Hudson2 Exchange Place, Jersey City, NJMembers $600.00 • Non-Members $850.00Members-Friday Only $525.00Non-Members Friday Only $600.00The NJTC Executive Leadership Summit willassemble New Jersey’s best and brightesthigh-tech and life science executives for insightfuldiscussions, engaging and successful speakers andpractical advice for managing a more profitablecompany. With topics ranging from preparing foracquisitions to managing costs to creating valuethrough marketing and human capital, this eventpromises to position you and your company forgreater success.UNCONFERENCE ONMANUFACTURING INELECTRONICS & LIFE SCIENCESSeptember 26 @ 1:00 PM - 6:00 PMLocation: Northern New JerseyMembers $25.00 • Non-Members $50.00NJTC is developing a unConference which willcenter on the issues that are top of mind forElectronic and Life Science Manufacturers.Whole group and breakout sessions will includeknowledge exchange, networking and opendialogue surrounding the biggest challengesfacing executives and others in the manufacturingindustry today. Attendees will share methods, bestpractices, challenges and successes.NJTC CLEAN ENERGY SUMMITOctober 4 @ 9:00 AM - 3:00 PMPrinceton Plasma Physics Lab100 Stellarator Road, Princeton, NJMembers $60.00 • Non-Members $120.00Professional Service Providers $240.00Students $25.00The NJTC Clean Energy Summit, to be heldon October 4, 2011 will bring togetherleaders in the emerging industries of energyconservation, climate control and renewableenergy sources from the entire mid-Atlanticregion. Attendees will include representativesfrom major utilities, as well as companiesengaged in alternative energy solutions (wind,solar, nuclear power), and regulators from BPUand other governmental agencies.New Products and Services GreenCompetition Call for Presentationscontact Paul Frank at pfrank@njtc.orgDELAWARE VALLEY TECHNOLOGYRESEARCH SYMPOSIUMOctober 6 @ 2:00 PM - 6:30 PMRowan University201 Mullica Hill Road, GlassboroMembers $25.00 • Non-Members $50.00Students $5.00The Delaware Valley Technology ResearchSymposium will present an array of companies,post graduate and post doctoral efforts fromthroughout the region showcasing technologyresearch, development and commercialization. TheSymposium will provide participants a glimpse oftechnology entrepreneurs, inventors and investorswho are reinventing technology in South Jersey,Delaware and Pennsylvania.NJTC INNOVATION CONFERENCEOctober 19 @ 8:30 AM - 2:00 PMATT 900 Route 202-206 NBedminsterMembers $50.00 • Non-Members $100.00The NJTC Innovation Conference will highlightand promote innovations in technologies such assolar, smart grids, telehealth, mobile applications,telepresence, and wireless spectrum. The programwill feature a keynote speaker, a panel discussingthe innovative technologies listed above anda panel of public policy experts discussing thegovernment perspective on these technologies.The Conference will conclude with exhibits frominnovative entrepreneurs, followed by a tour of GNOC.22LifeSci Trends | www.njtc.org | September 2011


The New Jersey Technology Council & Education Foundation1001 Briggs Road, Suite 280Mt. Laurel, N.J. 08054Non-profit Org.U.S. PostagePAIDNew JerseyTechnology CouncilON THE NJTC MEMBER NEWS WIREDaily Updates about New Jersey’s MostTech Savvy Companies• AT&T enlists support of N.J. business groups in proposedT-Mobile merge• Senesco Finalizes Agreement with Mayo Clinic to StudySNS01-T in Multiple Myeloma• NJBIN Welcomes New Director and Associate Director forBusiness Development at Rutgers EcoComplex• UK Financial Services Authority Selects Cognizant as KeySupplier under Strategic Outsourcing Framework Agreement• Cognizant Will Support and Develop Operational andRegulatory Systems to Help the FSA Boost Efficiencies andResponsiveness, Improve Market Surveillance.• Oracle Unveils Oracle VM 3.0• Ocean Power deploys wave energy device for US Navy’sLEAP program

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