1. CurriculumVitae – Nanna Keeling (MSc Dip MPharm)
Personal Details
Name: NannaKeeling
Address:Brannemysten1B,436 55, Hovas, Sweden
Mobile:+46 (0) 727370641
LinkedIn:http://se.linkedin.com/pub/nanna-keeling/1/917/746
Career summary
Overthe past 20 yearsI have beenworkinginvariousdisciplinesandtherapeuticareas of the
Pharmaceutical industry. The keyfeature of mycareerhas beenprojectmanagementof cross-
functional complexglobal clinical &drugdevelopment programs,ensuringtheirstrategicalignment
withcompany’score objectivesandtheirdeliverytotime,budgetandquality. Myexperience
stretchesfromdesign,set-upandleadingof earlyphase and largerglobal late phase clinical studies
to workingcloselywithFunctional Headsonimplementationof results. Ihave extensiveknowledge
of GCP/ICHguidelinesandFDA/EMEA regulationsandbeeninvolvedinregulatorysubmissions.
Leadershipof global &cross-functionalteamsandprojects,withreal passionfor myteamsand
customers hasbeenalwaysbeen keyfeature of mycareer.I alsohave experience fromworking
withexternal partnersandCROs,KOLs,andscientificAd-boardsandbeenresponsibleforbudget,
resources (incl.linemanagementof staff) andrisk andopportunitymanagementof multimillion
dollarprojects. Iam passionate abouthighqualityandethical deliveryof soundscientific/clinical
data to supportthe strategiesfordevelopinglifesavingdrugsandproducts.
Education & Qualifications
Master of Science inPharmacy, UppsalaUniversity,Sweden
Jan.1990 - June 1995
Postgraduate studies,Diplomain Pharmacy, UppsalaUniversity
Sept1995 - Aug.1996
EU-PharmacyPractice
Career Details
Pharmaceutical Advisorand Head of Pharmacy
May 2016- Ongoing
Lloyds Apotek
Vastra GotalandsRegion
Sweden
2. Global Clinical Lead
November2015 – April 2016
Thrombosis ResearchInstitute,London
Manresa Road, London SW3 6LR, UK
Key areasof responsibility:
Oversightandmanagementof the clinical operationsdepartmentatTRI London. Internationally
renownedforpioneering,multi-disciplinaryresearch,the ThrombosisResearchInstitute is
dedicatedtothe studyof thrombosisandrelateddisorders.The TRIisa charityand a purely
scientificresearchinstitute whichworksindependentlyasanacademicinstitution. The Institutes’
research programs aim to understandthe diseaseprocessanddevelopnovel andaffordable
therapiesinordertointervene topreventlongtermdisablementandearlydeath. Asglobal clinical
leadI workalongside the COOandmanage the Global & Regional ProjectManagers at the institute
and provide global strategicleadershipandoversightforthe on-goingandplannedclinical work.
For furtherinformationaboutthe currentandpastachievementsof the TRI,please goto www.TRI-
london.ac.uk
Freelance Medical Writer& Editor
January 2015 – November2015
FPEC UK,BN1 5BF, Brighton,UK
Keyareasof responsibility:
As a medical writerIcommunicate scientificresearchtoa professional orlayaudience,eitherfor
journals,promotionalbrochuresandwebsites.Myworkhas an elementof editingorbroader
communicationsresponsibilitiesinadditiontoresearchingandwriting. Thisrole isaproject
managementrole withinthe scientificpublicationsarena.
Global Medical Marketing& Evidence Director
March 2013 – October 2014
Mölnlycke HealthCare AB, Gothenburg,Sweden
Keyareasof responsibility;
● Headof Medical Marketing (Medical Affairs) &Evidence divisiongloballyforMölnlycke
HealthCare,includingline management of the staff (6directreports) andown budget
● Providingleadershiptothe managementteamforthe Medical MarketingInformation
supportfor all products& technologiesglobally
● Responsible forthe creationanddevelopmentof abrand new operatingmodel andrelated
processes (SOPs) forthe managementof scientificevidence atMolnlycke HealthCare
● Accountable forthe implementationof the new operatingmodel globally
● Responsible forsupportingstrategiesandtacticswhichdrive the developmentof evidence;
including,butnotlimitedtolaband benchtesting,animal studiesandclinical andfinancial
studiesinalignmentwithMölnlyckeHealthCare'sWoundCare Division’sbusinessneeds
● Directlyinvolvedinclinical studyprotocol development
● Monitor/collate performance indicatorsforthe Medical Marketing&Evidence Team
● Chairand headof the Clinical andEconomicEvidence Committee(CEEC)
● Coordinate anddirectworkloadforthe Medical Marketing& Evidence Team
● Accountable fortimely,accurate review andapproval of promotionalmaterialsin
accordance withthe relevantCodesof Practice bythe Medical Marketing & Evidence Team
3. ● Accountable forthe developmentandmaintenanceof Medical Marketing andmedical
information’s SOPsandguidelines
● Provisionof scientificandtechnical supportandadvice toidentifyandsupportbusiness
developmentopportunities/productlaunchesandcontribute tothe developmentof
marketingcampaigns
● Representationof medical &scientificinformationinmultiplestrategicteamsand Core
TherapeuticTeams
● Responsible forkeepingup-to-datewithemergingtechnology/businessrequirementsand
the potential impactonthe business andreportingbacktothe board
● Responsible forteam’sactivitiestosupportmarketingandsalesactivities byproviding
scientific/medical information,enquiryhandling,clinical paperprovisionandtraining
● Responsible andaccountable forthe supportmarketingteamswithuptodate information
on products,disease areasandcompetitoractivity
● Representthe Medical Marketing&Evidence divisionbothinternallyandexternally
● Responsible forthe coordinationandprovisionof traininginthe fieldof medical &
scientificinformationandevidence management
SeniorManagementConsultant
October 2011 – Feb2013
Wenell MangamentAB,GothenburgSweden
Keyareasof responsibility;
Providingmanagementconsultancytopharma/ biotech clientsonbehalf of the firm
Reviewandassessmentof keystrategicprojectsonbehalf of the clientandidentifyareasof
riskand slippage (includingproposalsforimprovementandcontingencyplanning)and
generatingreportstothateffectforseniormanagementanddecisionmakingbodies
Providinginput andadvice asa consultantintoprogramplanningeffortstogetherwiththe
supportingfunctions,client’sprojectmanagers andvendorstocreate operational plans
Supportingandhelpdrive the coordinationof governance approvalsforthe keyproject
deliverables
Clinical InformationScience Director, Cardiovascular & Respiratory & InflammationTherapy Area
Aug 2008-Sept 2011
AstraZeneca R&D Molndal,Sweden
Keyareasof responsibility;
● SeniorR&D memberwithinthe ClinicalDevelopmentdivisionatAstraZeneca
● Core memberof the Clinical ProjectTeam,responsible forthe projectmanagementand
deliveryof the clinicalinformationscience componentsof one ormultipledrugproject
withinaspecificTherapeuticArea(TA)
● Leaderof a cross-functionalteamof multiple seniorleadersincl. biostatistics
(Global productStatistician),datamanagement(DataManagementProjectLeader),
Programming(Global ProgrammingLeader),medical authoring(Global Medical Writer),
scientificpublications(Global PublicationManager),clinical publication(GlobalClinical
4. PublicationLeader),regulatoryaffairs(RegulatoryAffairsManager),healtheconomics
(Global HEOR lead)
● Accountable fordeliveryof all clinical information components fromstarttofinishindrug
developmentprojects, includingprotocol development &signoff, the scientific
interpretation,reportingandpublishingof the data/informationforregulatorysubmissions
and scientificpublications
● Workingcross-functionallyandglobally withkeystakeholderssuchasRegulatoryAffairs,
Pharmacovigilance,Marketingandheadof TA to ensure projectswere continuouslyaligned
to core strategicobjectivesandsubmissionsandapproval deadlineswere kept
● Accountable forcommunicationof keystrategicmaterialtobothinternal seniorR&D
stakeholdersanddecisionmakers,suchasthe PortfolioReview Boardandexternallyat
scientificmeetings
● As the projectmanagerforInformationSciencesinthe TA;responsibleforestablishing,
communicatingandexecutingplansinordertoachieve projectgoals including
● Accountable forthe on-time,accurate andqualityassureddeliveryof all the clinical
componentsof ourassigneddrugprojects includingidentifyinganddrivingprojectand
resource prioritiesthatalignwiththe businessobjectives
Global ProjectManager, Symbicort® Global Product Team
May 2006-July 2008
AstraZeneca R&D Lund, Sweden
Keyareasof responsibility:
● SeniorR&D role withinthe DevelopmentProjectsorganisationwith cross-functional project
managementaccountability,reportingdirectlytothe VPGlobal ProductDirector(VPGPD).
● Memberof the Global ProductTeam(GPT)
● Responsible forthe coordinationof the GPT activities,suchasmeetings,minutesand
disseminationof actionsanddecisionstofunctional deliveryteams
● Responsible forprovidinglinemanagement teamwithinputincross-functional delivery
team’sperformance andactive memberof the appraisal team
● Responsible forprovidingsubjectmatterexpertinputand part of final draftapproval
processof clinical studyprotocols
● As GPMresponsibleforall PMactivitieswithinthe GPTincluding;
- Riskmanagementthroughproactivelyidentifyingpotentialissuesorobstaclesand
developingsolutionsorcontingencypwithappropriate follow upprocessestill
resolution
- Managementof projectstatusreportsboth forplannedorad-hocitems
- Responsible forensuringthe involvementof all appropriate regional teams,functions
and divisions(includingexternal partnersorservice providers) inrelevant
communications,decisionsandworkinggroups –statusupdateson a weeklybasisto
the GPT
- Responsible foridentifyinganddrivingprojectandresource prioritiesthatalignwith
the businessobjectives
5. - Responsible forgeneratingglobal communicationplansonbehalf of the GPTandthe
disseminationof the plantoregional,functional anddivisional teams(incl.external
partners) – Ensuringclearcommunicationandplanningacrossthe project(Symbicort)
● Involvedandcontributed toall decisionspertainingtothe successful developmentandLife
Cycle Managementactivitiesforthe productandthe leadershipof multiple DeliveryTeams
(DT) – I.e. US NDA Submissionof Symbicort,JapanRegulatorysubmissionTeam, EU& RoW
DT for the developmentof newstrategiesforfurthermarketaccess (incl the Rapihaler
Project)
Global Clinical Study Leader,Nexium® & Crestor®
Sept 2000-May 2006
AstraZeneca R&D Mölndal
Keyareasof responsibility;
● Global clinical programleadandresponsible projectmanagerforthe clinical operations
aspectsof the studies
● Accountable andresponsible forthe deliveryof clinical studiesfromearlytolate phase of
developmentandmultipletherapyareasaccordingtoGCP and internal companystandards
and SOPs
● Responsible andaccountable fordevelopingclinical studyprotocolsandfinal approval
● Projectmanagementof the operationalplansensuringstudy delivery totime,budgetand
quality
● Identifyingandmanagingriskswithinthe projectsandworkingcollaborativelytodeliver
solidsolutionsorcontingencyplans
● Responsible forcommunicationplansforthe project,globally
● Responsible forprojectplanninganddeliveryof monitorsmeetings,investigatormeetings,
endof studymeetings
● Representingthe clinical studyteamandprojectinternallyandexternallyona global scale
● Workingcross-functionallyandcross-regionallytoensure projecttimelinesanddeliverables
were kept
● Commissioningauditsof internal projectteamandinvestigatorssitesandworkingclosely
withthe internal QA teamto enable suchaudits,includingreportingbacktoHead of Clinical
TA
SeniorDrug/Device SafetyScientist,Diabetes& Neurology
March 1998 – Aug. 2000
Eli Lilly& CompanyErl WoodManor, Windlesham,SurreyGU20 6PH, UK
Keyareasof responsibility;
Pharmacovigilancescientistresponsible foranalysingandreportingof safetyreports
Responsible forprocessimprovementandSOPdevelopmentwithinthe PV-departmenton
a global scale
6. SeniorMedical Information Executive
Dec. 1996 – Feb.1998
Warner Lambert Parke Davis, Eastleigh,Hants, SO53 3ZQ, UK
Keyareasof responsibility;
● Medical Informationexecutive providingscientificandmedical supportfor all productsin
the UK.
● Deputyto the Headof Medical Informationdepartmentasrequired
● Monitoringandcollationof performance indicatorsforthe Medical InformationTeam –
auditthe Medical EnquiryDatabase and setstandardsas and whenrequired.
● Responsible forensuringthatmedical enquirieswere handledinaccordance withthe PIPA
guidelines
● Maintainand developMedical InformationITandlibraryresources
● Timely,accurate reviewandapproval of promotionalmaterialsinaccordance withthe
relevantCodesof Practice bythe Medical InformationTeam
● KeyContributortothe developmentandmaintenance of Medical InformationBOPsand
guidelines
● Part of team which operatedandprovidedsupportforthe 24 hour medical on-call service
● Preparingstandardletters,productsummaries/reviews,formularypacks.
● Responsible forthe supporttomarketingandsalesactivitiesbyprovidingscientific/medical
information,enquiryhandling,clinical paperprovisionandtraining
● Supportmarketingteamswithupto date informationonproducts,disease areasand
competitoractivity
● Responsible forproductinformationtraining
Scientific Publications
Labenz J, Armstrong D, Lauritsen K, Katelaris P,SchmidtS, Schütze K, Wallner G, PreiksaitisH, Keeling N,
Nauclér E, Eklund S, Juergens H. A randomized comparativestudy of esomeprazole 40 mg versus
pantoprazole40 mg for healingerosiveoesophagitis:the EXPO study. Alimentary Pharmacology &
Therapeutics 2005;21(6):739-46
Bayerdörffer E, Sipponen P, Bigard M, Weiss W,Mearin F, Rodrigo L, Dominguez Muñoz J, GrundlingH,
Nauclér E, Svedberg L, Keeling N, Eklund S. Esomeprazole 20 mg continuous versus on demand treatment of
patients with endoscopy-negative reflux disease(ENRD). Gut 2004;53(Suppl VI):A106, Abs MON-G-168
Bayerdörffer E, Sipponen P, Nauclér E, Svedberg LE, KeelingN, Eklund S. Esomeprazole 20 mg on-demand
compared to long-term therapy in patients with non-erosive esophageal reflux disease(NERD). Zeitschriftfür
Gastroenterologie 2004;42(8):Abs P055.
Labenz J, KeelingN, Eklund S, Nauclér E. A comparison of esomeprazole 40 mg once-daily and pantoprazole
40 mg once-daily for the healingof erosiveesophagitis. Can J
Gastroenterol 2004;vol 18 Suppl A: abstract147
7. Labenz J, KeelingN, Eklund S, Nauclér E. Treatment of erosivereflux esophagitis with esomeprazole and
pantoprazole: results froma randomized, double-blind multicenter study (EXPO). Zeitschriftfür
Gastroenterologie 2004;42(8):Abs V007
Labenz J, KeelingN, Eklund S. A comparison of esomeprazole 40 mg once-daily and pantoprazole40 mg once-
daily for the healingof reflux oesophagitis.Gut 2003; 52
(Suppl VI) A241
Labenz J, Naucler E, Keeling N, Eklund S. Esomeprazole 40 mg heals significantly more Helicobacter pylori -
negative erosiveesophagitis patients than pantoprazole40 mg. Gastroenterology 2004;126(4 Suppl 2):A-338,
Abs M1458.
Schmidt S, Keeling N, Eklund S, Naucler E, Labenz J. A comparison of esomeprazole 40 mg once-daily and
pantoprazole40 mg once-daily for the healingof erosiveesophagitis. SAMJ South African Medical Journal
2004;94(8):688.
Labenz J, Armstrong D, Lauritsen K, Katelaris P,SchmidtS, Schütze K, Wallner G, Juergens H, Preiksaitis H,
Keeling N, Nauclér E, Adler J, Eklund S. Esomeprazole 20 mg versus pantoprazole20 mg for maintenance
therapy of healed erosiveesophagitis:results fromthe EXPO study. in press 2005 Alimentary Pharmacology
and Therapeutics
Membershipof Professional Bodies
Memberof: The Royal Pharmaceutical Societyof GreatBritain,andmemberof AIOPI&Institute of
Clinical Research.The SwedishPharmaceutical Associationandthe SwedishPharmacistAssociation,
Registered&licensedpharmacistwiththe SwedishNational Boardof Health.
References
Provided upon request.
Interests andHobbies
I love spendingqualitytime withmyfamily.Iamalsoa fitness&travel enthusiast.
List of Clinical Study Work – 2000 - 2011
Role on Study (e.g.
CRA, CPM etc.)
Indication Phase No. of
patients
No. of
sites
Countries involved Services involved
(e.g. full service or
just clinical)
Stages of study involved (e.g. set u
etc.)
Clinical Study/
programme Leader
Erosive
oesophagiti
s
IV 3000 <250 Australia, Brazil,
Argentina,
Poland, Slovakia,
Romania, Hungary, UK,
Germany, Russia,
Bulgaria, Switzerland,
Sweden,
Denmark, Greece, France,
Spain, Canada
R&D funded trial, as
study / program lead
all services
were managed
All stages from start (CSP w
8. Clinical Study/
programme Leader
endoscopy-
negative
reflux
disease
(ENRD)
IIIb 450 56 Germany, Poland, UK,
Switzerland, Denmark,
Hungary
R&D funded trial, as
study / programme
lead all services
were managed
All stages from start (CSP w
Clinical Study/
programme Leader
endoscopy-
negative
reflux
disease
(ENRD)
IIIa 250 30 Germany, Poland,
Switzerland, Denmark,
Hungary
R&D funded trial, as
study / programme
lead all services
were managed
All stages from start (CSP w
Clinical Study/
programme Leader
Heart
failure
IIIb/IV 5011 371 19 European countries,
Russia, and South Africa
R&D funded trial, as
study / programme
lead all services
were managed
All stages from start (CSP w
Clinical Information
Science Director
member of the
Clinical project Team
COPD (S&T) IIa 87 10 Bulgaria, Germany,
Hungary,
Ukraine
R&D funded,
outsourced to CRO
for conduct.
Involved in study design concept, d
handover to CRO, collaboration wi
progression and taking over from i
Clinical Information
Science Director
member of the
Clinical project Team
COPD
(Bronchiect
asis)
IIb 52 8 UK, Czech Republic,
Poland.
R&D funded,
outsourced to CRO
for conduct.
Involved in study design concept, d
handover to CRO, collaboration wi
progression and taking over from i
Clinical Information
Science Director
member of the
Clinical project Team
COPD I
(JS
AD/
JMAD
)
63 1 UK
(Japanese subjects
recruited in UK)
R&D funded,
outsourced
to CRO for
conduct
Involved in study design concept, drawing up agre
and handover to CRO, collaboration with CRO thro
study progression and taking over from interpreta
stage
Clinical Information
Science Director
member of the
Clinical project Team
COPD I
(ADM
E)
6 1 UK R&D funded,
in-house
study
Overseeing all aspects from start to finish – from
CSP to CSR & Publication
Clinical Information
Science Director
member of the
Clinical project Team
COPD
(S&T)
IIa 63 4 Bulgaria, Slovakia. R&D funded,
outsourced
to CRO for
conduct
Involved in study design concept, drawing up agre
CRO, collaboration with CRO throughout study pro
from interpretation stage
Clinical Information
Science Director
member of the
Clinical project Team
COPD IIb 43 3 Germany R&D funded,
outsourced
to CRO for
conduct
Involved in study design concept, drawing up agre
CRO, collaboration with CRO throughout study pro
from interpretation stage
Clinical Information
Science Director
member of the
Clinical project Team
Oral Anti-
Arrhythmia
IIa 125 12 CEE, Germany, UK R&D funded
trial, In-
house study
management
Involved in all aspects from start to finish, CSP to
CSR & Publication
Clinical Information
Science Director
member of the
Clinical project Team
Oral Anti-
Arrhythmia
I 75 1 Japan R&D funded
trial, In-
house study
management
Involved in all aspects from start to finish, , CSP to
CSR & Publication
9. Clinical Information
Science Director
member of the
Clinical project Team
Oral Anti-
Arrhythmia
IIb 112 7 CEE, Germany, UK,
Switzerland
R&D funded
trial, In-
house study
management
Involved all aspects from start to finish, , CSP to CS
& Publication