Empowered Patient Podcast AI Revolutionizing Drug Development Regulatory Documentation and FDA Submission with Lindsay Mateo Weave
Lindsay Mateo is the Chief Commercial Officer at Weave. This company has developed a platform to automate and streamline the regulatory documentation process for FDA submission for pharmaceutical and biotech companies. The regulatory lifecycle for drug development currently involves data from various sources in digital and paper formats. Weave Bio's tools are designed to automate and streamline administrative aspects of the regulatory process and create a living digital record of the development of the drug, which supports collaboration and saves time.
Lindsay explains, "I look at the regulatory life cycle for any given drug program, and experts are at the core of that. Those experts, who are scientists, strategists, and project managers, essentially put all the work into the documentation that goes to regulators like the FDA here in the US. And that information goes on to allow this drug to continue through various stages of development to ultimately get to market and obviously help patients."
"That is everything from early studies looking at how drugs are being handled in animals, in mice and rats, all the way through to clinical development. We start to get into humans and then again out through what gets drugs to market and even post-market expansion of various labels. So this is critical to getting any therapy to any patient with any condition. The process itself, the challenge with the process is that it's manual."
#Weave #WeaveBio #Pharma #Biopharma #WeavePlatform #AINative #AutoCT #AutoND #FDASubmission #RegulatoryDocumentation