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Monday,September28,20153:56:47PMHKT

Thursday,20August2015,20:30HKT/SGT

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marcusevansSummits
Sept23,201512:29HKT/SGT

Source:marcusevansSummits(http://www.marcusevans.com)

OvercomingDrugDevelopmentChallengesthroughCollaborativePartnerships
Kenneth I. Kaitin a keynote speaker at the marcus evans Evolution Summit 2015, on the challenge of clinical
developmentandhowcompaniesareaddressingit.
NEWYORK,NY,Aug20,2015(ACNNewswire)"There is often misunderstanding and lack of appreciation by the public
aboutthevalueofclinicaltrialparticipation.Theindustryshouldcontinueitseffortstoeducatepeopleontheimportanceof
clinicalstudiesinsupportingmedicalresearchandinthedevelopmentofcriticalnewmedicines,"advisesKennethI.Kaitin,
ProfessorandDirector,TuftsCenterfortheStudyofDrugDevelopment,TuftsUniversitySchoolofMedicine.
KaitinisakeynotespeakeratthemarcusevansEvolutionSummit2015takingplaceinLasVegas,Nevada,September20
22.
Whatarethecomplexitiesofbringingnewdrugstomarketinthepharmaceuticalindustrytoday?
Our studies have shown that the current cost of bringing a single new drug to market, including the cost of failures, has
skyrocketed to USD 2.6 billion, which represents a 145 percent increase from our previous study in 2003. High drug
development costs are a significant obstacle for developers, with important public health consequences in terms of finding
newtreatmentsforunmetmedicalneeds.
Themostsignificantfactorcontributingtothesehighcostsisnottheconsiderabletimeittakestodevelopanewdrug,but
rather the exceedingly low success rates of compounds entering clinical development. Our recent analysis indicates that
overall clinical success rates have fallen from 22 percent in the early 2000s to less than 12 percent today. In some
therapeutic areas, success rates are alarming low for example, for neuropsychiatric drugs, less than five percent of drugs
enteringclinicaltrialsarelikelytoreachthemarket.
Thedecreaseinclinicalsuccessratesisdueinparttoincreasingcomplexitybuiltintoclinicaltrials.Therehasbeenasteady
riseinproceduresdoneandprotocolamendmentsfiledduringclinicaldevelopment,whichultimatelyhavemadeitharderto
recruitandretainpatientsforclinicalstudies,prolongingstudytimesandraisingtrialcosts.
Whatarecompaniesdoingtoaddressthesecomplexities?
Pharmaceutical companies, academic institutions, teaching hospitals, patient groups and government agencies are
collaborating through consortia and integrated alliances to find better biomarkers and tools for determining what drugs are
likelytosucceedinclinicaldevelopment.
Notlongago,manyofthelargelegacypharmaceuticalcompaniestookgreatprideinthefactthattheyalonecouldtakea
compoundfromthelaboratorybenchallthewaytothemarketplace.Nowthosesamecompaniespromotethefactthatthey
actively partner with other organizations in the discovery and research phase, and that they have preferredprovider
relationshipswithcontractresearchorganizations.Throughtheserelationships,companiesareabletocontainresearchand
development(R&D)costs,"derisk"thedevelopmentprocess,andincreasethelikelihoodofsuccess.Thebottomlineisthat
theeraoftheselfsufficient,fullyintegratedpharmaceuticalcompanyisover.Companiesarenowengaginginpartnerships
andintegratedalliancestoreduceoverallR&Dspendandboostproductivity.
Whatwouldimprovethequalityofdecisionmakinginclinicaltrials?
Theclinicaltrialprocesshasremainedvirtuallyunchangedforthepast50plusyears.Manycompanieshavelegacysystems
inplacethatarenoteasilychanged,mademoredifficultbythefactthatproductdevelopmenttimescanlasttento15years.
Inresponse,somecompaniesaredevelopingnewgovernancemechanismsforreviewingclinicalprotocolsandthedesignof
clinicalstudiestoweedoutinefficienciesindrugdevelopmentprograms.Insomecases,companieshavechosentomovethe
decisionmaking process outside the company, to get an objective efficiency assessment, rather than relying on individuals
withinthecompany,whomayhaveavestedinterestinkeepingproductsalive.
Theeraoftheselfsufficient,fullyintegratedpharmaceuticalcompanyisover.
AbouttheEvolutionSummit2015
The9thEvolutionSummitisthepremiumforumbringingclinicaltrialexpertsfromleadingdrugdevelopmentcompaniesand
solutionproviderstogether.TheSummitoffersanintimateenvironmentforafocuseddiscussionofkeynewdriversshaping
drug development. Taking place at Red Rock Resort & Spa, Las Vegas, Nevada, September 2022, the Summit includes
presentationsonshapingtheindustry'sfuture,viewingCROsasstrategicbusinesspartners,analyzingthebenefitsofpatient
centereddrugdevelopmentandpatientrecruitmentandretention.

GlobalBrandManagement:RisksandStrategies
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Sept23,201511:27HKT/SGT

WhyPowerPlantExecutivesShouldBeInvolvedinRegulatoryClim
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Sept8,201502:23HKT/SGT

ImageAnalysis:AVitalToolinDrugDiscovery
(http://en.acnnewswire.com/pressrelease/english/24555/image
vitaltoolindrugdiscovery)
Sept8,201501:57HKT/SGT

TheTransformationoftheRussianEconomy
(http://en.acnnewswire.com/pressrelease/english/24555/the
transformationoftherussianeconomy)
Sept4,201505:00HKT/SGT

InvestmentInsightsintotheMENARegion
(http://en.acnnewswire.com/pressrelease/english/24555/investm
insightsintothemenaregion)
Sept4,201504:30HKT/SGT

HowtoManageAlternativeBillingandHighProfileCases
(http://en.acnnewswire.com/pressrelease/english/24555/howto
alternativebillingandhighprofilecases)
Sept4,201504:00HKT/SGT

ClosingtheGapBetweenOperationalandFinancialDatabasesinH
(http://en.acnnewswire.com/pressrelease/english/24555/closing
betweenoperationalandfinancialdatabasesinhospitals)
Aug20,201520:15HKT/SGT

HowBrandingCanChangetheFaceofPackaging
(http://en.acnnewswire.com/pressrelease/english/24555/howbr
changethefaceofpackaging)
Aug20,201520:00HKT/SGT

PreparingfortheRoboticsRevolution(http://en.acnnewswire.com
release/english/24555/preparingfortheroboticsrevolution)
July31,201503:00HKT/SGT

AmplifyingtheCustomerExperienceOnline
(http://en.acnnewswire.com/pressrelease/english/24555/amplify
customerexperienceonline)
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For more information please send an email to press@marcusevanscy.com (mailto:press@marcusevanscy.com) or visit the
eventwebsiteatwww.evolutionsummit.com/Kaitin_Interview(http://www.evolutionsummit.com/Kaitin_Interview)
marcus evans group life sciences /
(http://www.marcusevans.com/reviews/sciences)

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The Pharma Network marcus evans Summits group delivers peertopeer information on strategic matters, professional
trendsandbreakthroughinnovations.

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PleasenotethattheSummitisaclosedbusinesseventandthenumberofparticipantsstrictlylimited.

AboutmarcusevansSummits
marcus evans Summits are high level business forums for the world's leading decisionmakers to meet, learn and discuss
strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique
opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and oneonone business
meetings.Formoreinformation,pleasevisitwww.marcusevans.com(http://www.marcusevans.com).
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All rights reserved. The above content may be republished or reproduced. Kindly inform us by sending an email to
press@marcusevanscy.com.
Contact:
LuzdaryHammad
PressManager,marcusevans,SummitsDivision
Tel:+35722849385
Email:press@marcusevanscy.com(mailto:press@marcusevanscy.com)

Aug20,201520:30HKT/SGT
Source:marcusevansSummits(http://www.marcusevans.com)
Topic:TradeShoworConference
Sectors:FinancialGeneral,BusinessGeneral
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