FDA, Brigham and Women’s Hospital RWE project seeks to predict Phase IV trials
Software company Aetion said Wednesday that the regulatory agency and hospital would expand the real-world evidence partnership they announced last year.
Software company Aetion said Wednesday that the regulatory agency and hospital would expand the real-world evidence partnership they announced last year.
The partnership will focus on using real-world evidence to improve understanding of responses among patients with acute myeloid leukemia whose disease carries mutations in the FLT3 gene. Astellas markets a drug for FLT3-positive AML, Xospata, approved in November.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The company plans to the use the money to extend its reach into therapeutic area-related intelligence and outcomes-based contracting for payers.
Investing in a smart, tailored real-world evidence plan from the beginning of drug development may seem expensive and premature, but it can lead to significant cost savings.
Well-designed real-world evidence studies have gained acceptance by regulators and payers, who once viewed them with skepticism. Here is what you need to consider.