Signed into law in August 2022, the IRA authorizes Medicare to negotiate directly with drug companies on prices. This process is viewed by many in the industry as “nothing more than price setting.” The CMS sent initial offers for the first 10 prescription drugs selected for negotiation on February 1, 2024.
The rapid evolution of artificial intelligence (AI) in healthcare promises transformative impacts across various medical domains, "precision medicine" being one of them. However, the surge in AI technologies comes with notable challenges, including concerns over patient data privacy, the unpredictability of AI in clinical scenarios, and potential breaches linked with extensive data sharing.
As applied to the clinical research enterprise, “cultural humility” is a continuous process of self-orientation toward caring for others based on self-reflection and assessment, appreciation of others’ experiences, and expertise on the social and cultural context of their lives, with an openness to establishing strong relationships within the research team and with study subjects.
Adoption of technology by clinical trial sites has increased significantly over the past decade, especially amongst organizations that perform more than five research studies annually. Sponsors and CROs looking for process automation, higher quality study delivery, and transparency into study status are also investing in technology related to such activities and features as essential document collection, learning management systems, eConsent, patient recruitment tracking, and many more.
It is widely accepted that biosimilars hold the potential to improve patient access to life-changing therapies. However, questions remain about what will be needed to deliver on the promise of greater biosimilar access and affordability. In a recent panel discussion, industry experts weighed in on the state of the biosimilar market, today’s regulatory climate, and what will be required to realize their potential.