Conference Presentation, Panel
Flipping the Script: Designing the System to Deliver for Patients
Milken InstituteAnnie Kennedy, Gigi Hirsch, Marcus Schabacker, Andy Schmeltz, Jeffrey Shuren, Marcus Wilson
- Parent Project Muscular Dystrophy anticipates developing more engaged regulator relationships as its pipeline of potentially curative therapies heats up and outcomes improve, necessitating new measurement standards and ensuring partners have decision-making roles.
- ECRI projects a significant demographic and workforce shift by 2025 involving a shortage of approximately 100,000 physicians and one million nurses in the United States, which will drive care delivery outside hospitals by less skilled personnel.
- ECRI expects a dramatic transition to a patient-as-caregiver environment, requiring a future medical technology design that accounts for cognitive impacts and establishing a mandated real-life evidence registry for high-risk products rather than a voluntary one.
- MIT Center for Biomedical Innovation plans to roll out platforms for its Massachusetts test bed in the first half of next year to address massive knowledge gaps, while creating embedded, scalable infrastructures to utilize real-world data.
- MIT Center for Biomedical Innovation asserts that patient-centered innovation must be sustainable and cannot be achieved through siloed efforts, describing the collaborative data marketplace model as potentially transformational for real-world evidence production.
- Pfizer intends to leverage digital technologies and expanded real-world evidence to improve drug development efficiency, reduce timelines and costs, and address unmet needs such as male breast cancer.
- Pfizer warns that without the ability to secure drug reimbursement, patients will be unable to access important medicines, emphasizing that real-world evidence will be used extensively in the future.
- FDA CDRH reports achieving nearly 97% of its two-year goal regarding employee engagement with patients and expects an increasing number of patient preference information studies to be used in device decision-making beyond the current count of 17.
- FDA CDRH plans to establish 10 additional collaborative communities where patients sit at the table, moving away from command-and-control governance to supporting community-provided solutions in the best interest of patients.
- FDA CDRH anticipates the need to assess cognitive interfaces when technology interacts with human thinking and behavior in the future.
- Health Corps intends to implement a value-based contracting platform immediately and build a value assessment framework incorporating the patient voice early in the spring, with potential details to be provided a year later.
- Health Corps acknowledges ongoing challenges in value-based contracting and expresses uncertainty regarding whether the patient voice has been sufficiently heard and understood to date.