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Parexel Unveils Combined Regulatory & Access Consulting Organization
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.”
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
