THE EVOLVING MEDICAL AFFAIRS FUNCTION · the evolving medical affairs function medical affairs “a...
17
Driving Medical Affairs & MSL Excellence Presented at a MedComms Networking event, 4 th April 2018 THE EVOLVING MEDICAL AFFAIRS FUNCTION Helen Kane, MD, PIVOT MSL
Transcript of THE EVOLVING MEDICAL AFFAIRS FUNCTION · the evolving medical affairs function medical affairs “a...
DrivingMedicalAffairs &MSLExcellencePresentedataMedCommsNetworkingevent,4th April2018
THEEVOLVINGMEDICALAFFAIRSFUNCTION
HelenKane,MD,PIVOTMSL
WeareaspecialistconsultancywhichwasborneoutofapassionfortheMSLandthewiderMedicalAffairsfunction:
COPYRIGHT© 2018PIVOTMSL
OURSTORY
Weengagewithin theglobalbiopharmaceuticalindustry asatrustedandrespectedpartner
Wedefineanddrivestandardsoffieldmedicalexcellenceandvalue
Webuild in–rolecapabilities,optimizevalueandeffectiveness
Wesupport theMSLandtheMSLManagerthroughouttheirprofessionaldevelopmentjourney
‘Tobringlifesaving&lifeenhancingmedicinestopatients’
Achievedthrough:
THEBIOPHARMAINDUSTRY
DISCOVERY DEVELOPMENTREGULATORY
APPROVALCOMMERCIALISATIO
N
DRUG LIFECYCLE
COPYRIGHT© 2018PIVOTMSL
Improvedoutcomesforpatients‘Patientsallovertheworldarelivinglonger,healthier
andmoreproductivelives,thankstoinnovativemedicinesdevelopedbybiopharmaceuticalcompanies1’
INDUSTRYVALUE
1. Jackman,D.TheValueofPharmaceuticalProductsandtheHealthcareSystemversustheCost.http://blog.cslbehring.com/2016/01/value-versus-cost
0.5- 2YEARS6 - 7 YEARS
10,000 - 15,000 Compounds
1 EMA approved
drug
250 Compounds 5 Compounds
DISCOVERY PRE-CLINICAL
IND
SU
BM
ITTE
D
EMA
SU
BM
ITTE
D
PRE-
DIS
CO
VER
Y
CLINICAL TRIALS
PHASE I
20 – 100volunteers
1 FDA approved Drug
3 - 6 YEARS
FDA Review Manufacturing
PHASE II
100 – 500volunteers
PHASE III
1,000 – 5,000volunteers
DURATION 10 - 15 years
COST $2.5bn
PHASE IV
POST-APPROVAL
DRUGDEVELOPMENTPROCESS
COPYRIGHT© 2018PIVOTMSL
AbridgebetweenDevelopmentandCommercial
THEOLDWORLD
PRESCRIBERINVESTIGATOR
PATIENT
MEDICALAFFAIRS
RESEARCH&DEVELOPMENT COMMERCIAL
COPYRIGHT© 2018PIVOTMSL
THEEVOLVINGMEDICALAFFAIRSFUNCTION
MEDICALAFFAIRS
“Asupportfunction”
COMMERCIALORGANISATION
COPYRIGHT© 2018PIVOTMSL
OLDWORLD:Medicalmarketing&information
THESHIFTINGLANDSCAPE
Trustinpharma
Patientvoice
Safetyconcerns
Costpressures
Physicianaccess
Complexscience
Digitalhealthcare
Competitiveenvironment Transparency Payer
demands
THEEVOLVINGMEDICALAFFAIRSFUNCTION
MEDICALAFFAIRS
“Asupport function”
MEDICALAFFAIRS
“Acrucialpartner”
COMMERCIALORGANISATION
COMMERCIALORGANISATION
COPYRIGHT© 2018PIVOTMSL
NEWWORLD
AbridgebetweenDevelopmentandCommercial
THENEWWORLD
PRESCRIBERETAL
INVESTIGATORETAL
PATIENT
MEDICALAFFAIRS
RESEARCH&DEVELOPMENT COMMERCIAL
COPYRIGHT© 2018PIVOTMSL
ASPIRATION
Atrustedscientificpartner
PEERTOPEERRELATIONSHIPS
REALITY• ‘Imeetatleast4-5differentpeoplefromone
companybuttheydon’tseemtotalktoeachother’
• ‘Ihaveinformationoverloadandamtimepoor’
• Sometimesittakesweekstogetananswertomyquestions,Idon’tknowwhy.BythenIamwrestlingwithanotherproblem’
MEDICALAFFAIRSINACTION
ENGAGE EXCHANGE GENERATE INFORMEDUCATE
COPYRIGHT© 2018PIVOTMSL
ACTIVITIES&INDIVIDUALROLES
ENGAGE EXCHANGE GENERATE INFORMEDUCATE
Connector Facilitator Educator Collaborator Communicator
COPYRIGHT© 2018PIVOTMSL
CORECOMPETENCIES
BUSINESS
INTERPERSONAL
SCIENTIFIC
• Therapeuticexpertise• Scientificacumen• Clinicalresearch• Healthcaresystems• Criticalappraisal• Biostatistics• InvestigatorInitiatedTrials
• Communication(verbalandwritten)• Teamworking&collaboration• Presentation• Networking&influence• Relationshipmanagement• Emotionalintelligence
• Industryawareness• Corporateunderstanding• Strategicplanning• Governance&compliance• Technology&IT• Projectmanagement
MANYFACESOFMEDICALAFFAIRS
COPYRIGHT© 2018PIVOTMSL
1. MedicalAffairsisuniquelyplacedtoengageasastrategicandtrustedscientificpartnerinultimatesupportofthepatient
2. Trustneedstobeearnedthroughcredibility,objectivityandanunderstandingofstakeholderneeds
3. Essentialcompetencieshaveexpandedtoincludescientificknowledgeandexpertise,businessacumen,leadershipandcommunicationskills
4. MedicalAffairsisinaphaseofrapidevolution,organisationsneedtosupportanddeveloptheirteamssothattheycandeliverin-roleexcellence
INSUMMARY
COPYRIGHT© 2018PIVOTMSL
