In the midst of a global pandemic, Pfizer, under the leadership of its chief digital and technology officer Lidia Fonseca, achieved what was once thought impossible. The company, with the partnership of BioNTech, developed a COVID-19 vaccine in only 269 days, a process that traditionally would have taken 8 to 10 years. While prior research…
Incorporating real-world evidence into the life cycle of drug development
Utilizing real-world data (RWD) to generate real-world evidence (RWE) is not new and pharmacoepidemiologists have long-standing experience designing and implementing studies utilizing RWE to satisfy regulatory post-marketing safety commitments and to evaluate the effectiveness of drugs. However, RWD and RWE can be used more largely to support the full life cycle of drug development, during…