partnering with industry for clinical research luke lin, md, and ralf schnall
DESCRIPTION
HOW CAN YOU PARTNER WITH INDUSTRY?TRANSCRIPT
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Partnering With Industry for Clinical ResearchLuke Lin, MD, and Ralf Schnall
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Two trends in the research and development of new therapies
have been observed over the past several decades, resulting
in the expansion of academic-industry partnerships
• Academia: Commercialization of discoveries from basic
research into medical products for the marketplace
• Industry: Externalization of the search for innovative R&D
approaches and scientific knowledge in order to expand the
capacity
Trends in Academic-Industry Partnerships
Collaboration is central to this partnership
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HOW CAN YOU PARTNER WITH INDUSTRY?
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Investigator-Initiated Study
• Idea and proposal for a study from an external physician
• Sponsor is one or several physicians
• Pharma industry supports
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Goals of doing IIS, BI perspective
• Generating scientific data, development programme not sufficient
• Detecting new signals of safety and/or efficacy in the same or new indications
• Benefitting of your scientific knowledge
• Achieving a potential label extension
• Getting publications
• Often cheaper than own trials
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MAC Interactions
Med Affairs Coordinator
(MAC)
Sponsor-Investigator
Clinical Safety Officer (CSO)
Med Director/delegate
TM MA
IIS-RC(IIS Release Committee)
IIS-RG(IIS Review
Group)
Local affiliate
Global BI
Investigator
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MAC – Key Responsibilities
• Ensure that the Sponsor-Investigator is qualified
• Negotiate the IIS contract between the responsible OPU and the Sponsor-Investigator
• Ensure that Safety Reporting Responsibilities are described in the agreement
• Ensure transparency of study conduct and data dissemination
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IIS Process
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Investigator BI
Investigator hands in a proposal
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InvestigatorLocal
MedicalAffairs
Assessment of the study proposal
• Scientific rationale• Statistical design• Company strategy (Trial Guidance Document)• Local regulations• Local resources• Budget
• Prepare for Corporate Review
IIS Process
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Corporate Medical AffairsIIS Manager
Thorough assessment of the study proposal
• Completeness• Prepare for Corporate Review• Proposal number
InvestigatorLocal
MedicalAffairs
IIS Process
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Corporate Medical AffairsIIS Manager
IIS Review Group
Thorough assessment of the study proposal• Monthly meeting• MAC presents study to global team• Scientific rationale• Statistical design• Company strategy• Budget
Monthly meeting
InvestigatorLocal
MedicalAffairs
IIS Process
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Corporate Medical AffairsIIS Manager
IIS Review Group
Possibility 1:• Rejection
InvestigatorLocal
MedicalAffairs
Monthly meeting
IIS Process
Rejection
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Monthly meeting
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IIS Review Group Possibility 2:• After some major
issues have been resolved, ready for re-review
• After some minor issues have been resolved, ready for release
IIS Release Committee
Monthly meeting12 days after RG
Corporate Medical AffairsIIS Manager
InvestigatorLocal
MedicalAffairs Next month RG
Next m
onth RC
IIS Process
Comm
ents
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Possibility 3:• Ready for release
IIS Review Group
IIS Release Committee
Monthly meeting12 days after RG
InvestigatorLocal
MedicalAffairs
IIS Process
Monthly meeting
Corporate Medical AffairsIIS Manager
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Assessment of the study proposal
• Monthly meeting• Company strategy• Budget• Final Decision
IIS Review Group
IIS Release Committee
Monthly meeting12 days after RG
InvestigatorLocal
MedicalAffairs
IIS Process
Monthly meeting
Corporate Medical AffairsIIS Manager
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Possibility 1:• Rejection
Corporate Medical AffairsIIS Manager
IIS Review Group
IIS Release Committee
Monthly meeting
Monthly meeting12 days after RG
InvestigatorLocal
MedicalAffairs
IIS Process
Rejection
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Possibility 2:• Work on it again
Corporate Medical AffairsIIS Manager
IIS Review Group
IIS Release Committee
Monthly meeting
Monthly meeting12 days after RG
InvestigatorLocal
MedicalAffairs Next month RG
Next m
onth RC
IIS Process
Com
ments
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Corporate Medical Affairs
Study in database
• Info to local Medical Affairs• Info to CTSU• Info to PK
Possibility 3:• Released
Corporate Medical AffairsIIS Manager
IIS Review Group
IIS Release Committee
Monthly meeting
Monthly meeting12 days after RG
InvestigatorLocal
MedicalAffairs
Activation of internal
operation system
Activation of internal operation system
IIS Process
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Study preparation• Info to investigator• Protocol by investigator• Plausibility check of protocol by company• Contract• Implementation of study• Tracking• Report and publication
InvestigatorLocal
MedicalAffairs
IIS Process
Local process
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BI's challenges of doing IIS
• Loss of control about your trials and data
• Difficult planning of timelines and budgets
• Potential negative publications about your products
• Budget limitation versus too many ideas
• Patent expiry
• Loss of motivation of investigator