Michael W. Ryan advises clinical laboratories, device manufacturers (including IVD manufacturers), and investors on the legal, regulatory and reimbursement issues that arise during the development and commercialization of diagnostic testing services and devices. He guides clients by evaluating and implementing strategies to optimize coverage (including evidence generation), coding, and payment for novel technologies. Michael also helps innovative companies identify and navigate applicable FDA regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. In particular, he regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and digital health products.
- Courtney McFall, UCSF
- Ben Rubin, UCSF
Patient-centric data – Real-World Evidence (RWE) and Real-World Data (RWD) - is becoming instrumental in the drug development process and for health care decisions in general. This data is not only informative for the process from discovery to new indications, clinical trial design, and drug development, it also can be of value to monitor post-marketing drug safety and for decision support in clinical practice. As the data becomes a decision driver, science companies and medical organizations are increasingly focused on leveraging RWD and RWE to not only better understand the patient populations using their drugs and the respective outcomes, but also to accelerate clinical decision support. This session will focus on the various aspects of integrating RWE and RWD to support drug development and clinical decision support.