Partnering With Industry for Clinical Research Luke 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 Investigator Local Medical Affairs 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 Affairs IIS Manager Thorough assessment of the study proposal Completeness Prepare for Corporate Review Proposal number Investigator Local Medical Affairs IIS Process

11 Corporate Medical Affairs IIS 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 Investigator Local Medical Affairs IIS Process

12 Corporate Medical Affairs IIS Manager IIS Review Group Possibility 1: Rejection Investigator Local Medical Affairs 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 meeting  12 days after RG Corporate Medical Affairs IIS Manager Investigator Local Medical Affairs Next month RG Next month RC IIS Process Comments

14 Possibility 3: Ready for release IIS Review Group IIS Release Committee Monthly meeting  12 days after RG Investigator Local Medical Affairs IIS Process Monthly meeting Corporate Medical Affairs IIS Manager

15 Assessment of the study proposal Monthly meeting Company strategy Budget Final Decision IIS Review Group IIS Release Committee Monthly meeting  12 days after RG Investigator Local Medical Affairs IIS Process Monthly meeting Corporate Medical Affairs IIS Manager

16 Possibility 1: Rejection Corporate Medical Affairs IIS Manager IIS Review Group IIS Release Committee Monthly meeting  12 days after RG Investigator Local Medical Affairs IIS Process Rejection

17 Possibility 2: Work on it again Corporate Medical Affairs IIS Manager IIS Review Group IIS Release Committee Monthly meeting  12 days after RG Investigator Local Medical Affairs Next month RG Next month RC IIS Process Comments

18 Corporate Medical Affairs Study in database Info to local Medical Affairs Info to CTSU Info to PK Possibility 3: Released Corporate Medical Affairs IIS Manager IIS Review Group IIS Release Committee Monthly meeting  12 days after RG Investigator Local Medical Affairs 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 Investigator Local Medical Affairs 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