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.”
Planning for Unique Challenges Faced by Cell & Gene Therapy Developers
May 8th 2024In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora, discusses the unique challenges that developers of cell and gene therapies need to plan for when building their channel strategy.
The State of Mining Data Insights in the Life Sciences Industry – 2024
April 30th 2024A Frost & Sullivan industry-wide survey reveals which insights most pharmaceutical companies have mastered and which are still painful or impossible to extract and details the complexity of the process, the confidence companies have in their findings, and more. Hear Web Sun, President and Co-founder of Komodo Health, share what's driving these challenges and how you can overcome them.