CONTEXT: Industry sponsored piece on RWE and RWD – nothing new.
IMPACT: Low
READ TIME: 1 min
Quality Level Mean [1 – 10]: 4
1. “No matter the exit strategy, the use of Real-World Evidence (RWE) can provide a framework for Biotech companies to develop insights needed for the various stakeholders.”
2. “Real-world evidence (RWE) is the translation of that data into actual evidence that can be used to support different objectives, including supporting regulatory submissions, go/no-go decisions, trial design, marketing and sales decisions, safety analysis and more.”
3. “With the growing acceptance of RWE by a more diverse group of stakeholders, there is now a greater range of use for Biotech organizations that can be tailored to the strategic goals of the organization, development stage of the product, and ultimate exit strategies.”
4. “In addition to informing clinical trial decisions and potential use in regulatory submissions, RWE has significant uses in commercialization plans—which are of interest to potential investors, partners or acquirers.”
5. “Many Biotechs are focused (appropriately) on the regulatory approval pathway and understand the importance of RWE, even as early as the initiation of Phase II clinical trials, but due to resource constraints or other factors, do not incorporate RWE into the clinical planning.”
Source URL: https://www.biopharmadive.com/spons/how-rwe-can-help-biotechs-optimize-the-value-of-their-asset/597001/