Partnering With Industry for Clinical ResearchLuke Lin, MD, and Ralf Schnall

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

HOW CAN YOU PARTNER WITH INDUSTRY?

Investigator-Initiated Study

• Idea and proposal for a study from an external physician

• Sponsor is one or several physicians

• Pharma industry supports

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

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

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

IIS Process

8

Investigator BI

Investigator hands in a proposal

9

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

10

Corporate Medical AffairsIIS Manager

Thorough assessment of the study proposal

• Completeness• Prepare for Corporate Review• Proposal number

InvestigatorLocal

MedicalAffairs

IIS Process

11

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

12

Corporate Medical AffairsIIS Manager

IIS Review Group

Possibility 1:• Rejection

InvestigatorLocal

MedicalAffairs

Monthly meeting

IIS Process

Rejection

Monthly meeting

13

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

14

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

15

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

16

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

17

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

18

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

19

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

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