Identifying Potential Pathways to Overcome Regulatory/
Legal Barriers in Patient Involvement
Moderator:
MarcBou-n,JD
ChiefExecu+veOfficer,Na-onalHealthCouncil
Panelists:
MarilynMetcalf,PhD
SeniorDirector,BenefitRiskEvalua+on,GlaxoSmithKline
SaraPalmer
AssistantGeneralCounsel,GlaxoSmithKline
Dialogue/AdvancingMeaningfulPa-entEngagement
inDrugResearch,Development&Approval
•  Promoteacultureshi0
•  Facilitateopencommunica4on
•  Createregulatoryguardrails
PromoteaCultureShiI
PRIMARYACTIONS
•  Generatebuy-in
•  Createaccountabilityforcollec4ng/integra4ngpa4entperspec4ves
•  Createpublic-privatepartnership
SUPPORTIVEACTIONS
•  Develop/implementtoolsandmetrics
•  Train/educateresearchers
•  Helppa4entgroupssolicit/fundpa4ent-centeredstudies
FacilitateOpenCommunica-on
PRIMARYACTIONS
•  Makeinforma4oncomprehensible
•  Documentimpactofpa4entperspec4vestudies
•  Makepubliclyavailableexperiences,advice,bestprac4ces,lessons
learned,andotherresources
SUPPORTIVEACTIONS
•  Createafeedbacksystem
•  U4lizeopen-sourceproduc4onmodelwheneverpossible
•  Createpartnershipstoencourageinforma4onsharing
CreateRegulatoryGuardrails
PRIMARYACTIONS
•  Formalizeregulatoryasksfornego4a4oninPDUFA
•  Priori4zedevelopmentofguidances
•  EnhanceFDAdivisionalignmentontheuseoftoolsforevalua4ng
pa4entinforma4on
SUPPORTIVEACTIONS
•  Alignstakeholderadvocacystrategies
•  Increasetransparency
•  Createmoreopportuni4estocollectfeedback
KeyTakeaways
•  Thisambiguityaroundlegalissuesisalready
beginningtoclearupandwillsubstan4allyclearup
intheUSratherquickly.Therewillbelegal
guardrailswithinthenext18monthsthatwillhelp
guideonhowtoimplementitwithineach
company.