Parexel has unveiled a fully-integrated regulatory & access consulting organization “designed to optimize clinical development from the earliest stages.” The newly formed Regulatory & Access team encompasses more than 1,000 on-staff consultants worldwide, the company reports, including ~100 former regulators and HTA assessors from global agencies such as FDA, the UK’s MHRA, and NMPA in China. Paul Bridges, Senior Vice President of the new organization, commented: “Today, achieving market authorization from a regulatory agency is only the first hurdle to a new therapy reaching the market. By more holistically considering the diverse requirements of regulators, payers and patients and aligning these insights with clinical development, companies can optimize their plans to drive smarter, more efficient and patient-focused strategies, leading to faster development and improved patient access to new medicines.”
Beyond the Birthrate: The Societal Costs of Maternal Mortality
September 6th 2024Head of Medical Affairs and Outcomes Research at Organon, Charlotte Owens, MD, FACOG, discusses the most critical changes needed to close the gaps in R&D for maternal health solutions and how feasible they are to make.