Panel, Conference Presentation
Creating a Culture of Biomedical Innovation
Milken InstituteMike Rea, Christopher Austin, Amitabh Chandra, Margaret Hamburg, Jennifer Miller, Jason Spangler
- NCATS aims to serve as NIH's primary venture space, targeting the ultimate endpoint of accelerating the delivery of treatments to more patients faster by navigating a translational process defined as a 20-to-25-step pipeline.
- A shift in strategy is required to move beyond traditional methods fraught with failure, utilizing acceleration and advancement metrics rather than pure velocity to prevent quality degradation while fostering a culture that normalizes risk-taking and failure.
- Innovation is defined as increasing value through improved outcomes without price hikes, or reduced prices without outcome changes, with a specific focus on patient-centered, ethical results and a broader societal value that extends beyond individual patient benefits.
- The ecosystem requires breaking down silos between research, development, regulation, reimbursement, and investment to align incentives, with a particular emphasis on addressing the misalignment between the R&D pipeline and the social burden of disease.
- Geographic concentration remains a significant factor, with the top three cities accounting for one-third of global biotech patents; future market products are expected to be influenced by these clusters 15 years from now, necessitating strategic placement near universities to attract talent.
- Specific therapeutic areas, such as Alzheimer's disease, face high failure rates and a lack of commercial pull despite increased funding, requiring public sector and foundation intervention in spaces where commercial imperatives are low and biology is difficult.
- Regulatory frameworks, exemplified by the FDA, are shifting toward a lifespan approach for products and accepting that post-market safety issues can be identified and acted upon through existing systems without constituting total system failure.
- Patient involvement is projected to act as a disruptive force in setting research priorities, designing trials, and maintaining public trust to mitigate issues like vaccine hesitancy, while manufacturing innovation seeks to reduce environmental footprints.
- Long-term organizational strategies are prioritized over short-term thinking, with companies expected to engage in areas lacking immediate profit, such as treating Ebola or drug-resistant TB, to bridge gaps in unmet medical needs.
- Future improvements in the biomedical innovation ecosystem rely on implementing accreditation, certification, and rating systems to measure quality, alongside creating environments where leadership models ignorance to encourage questioning and laughter to prime the brain for new information.