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Lecture 8
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HC8 van Clinical Trials and Clinical development
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Lecture 8 Challenges and strategies in clinical developmentHow to identify challenges and strategies?
-Brain storm
-Conceptual model -> valorisation model
-Stakeholder perspective
What constitutes a challenge depends on your perspective
-Society; to develop products that meet the unmet medical need
-Government; to develop products that ensure access to medication for all
-Pharmaceutical industry; to develop products that help sustain and grow business
Big challenges
Pharma
-low hanging fruit has been picked
-1,8 bln dollar to develop new drug (Dimasi, 2016)
-Regulation (munos, 2009)
- Productivity crisis, Scannell et al., 2012
-Need for finding new drugs, all the time
-R&D is risky, lengthy and costly (all papers)
-Revenues and output are decreasing (Munos, 2009)
-Stricter regulations (Smits & Boon, 2009)
-Pressure on pricing (PWC, 2015/2016)
-Bad reputation
-Lack of knowledge on society on clinical research
Government
-Making/keeping the best healthcare available, accessible and affordable
-Preserve free market principle
-Balancing industry’s and society’s interest
Society;
Productivity crisis, Scannell et al., 2012
-Lack of knowledge leading to delay in clinical research
-Drugs that are developed do not have much clinical benefit
-Lack of knowledge leading to no demand articulation
-Market failure: economic rationale….
-Affordable and reasonable prices/price transparency (light & Lexchin, 2012)
Strategies
Pharma
-publish knowledge in lay language
-Try and find more effective and less expensive ways to execute clinical trials
-Implement an innovation model
-Focus, portfolio management
-New business model, involving other stakeholders
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