Integration of world-class Regulatory and Market Access teams will help companies address Clinical, Regulatory and Market Access strategies in parallel to achieve faster, smarter and patient-led development strategy
Boston and Durham, N.C. – Jan. 9, 2020 – Parexel, a leading provider of solutions to accelerate the development and delivery of innovative new therapies to improve world health, from Clinical through Commercialization, today unveiled its fully-integrated Regulatory & Access consulting organization designed to optimize clinical development from the earliest stages. Parexel’s newly formed Regulatory & Access team encompasses more than 1,000 on-staff consultants worldwide, including ~100 former regulators and HTA assessors, with extensive expertise and familiarity with the regulations, guidances and stakeholders that companies must navigate successfully to ensure new therapies reach the patients who need them.
“Today, achieving market authorization from a regulatory agency is only the first hurdle to a new therapy reaching the market,” said Paul Bridges, Senior Vice President, Regulatory & Access. “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.”
Parexel’s Regulatory & Access consulting organization includes former regulators from global agencies including the U.S. FDA, U.K.’s MHRA and NMPA in China, therapeutic experts with deep technical expertise, market access specialists with proven health technology assessment (HTA) success and medical communication experts to position evidence for greater stakeholder engagement. The alignment of these capabilities is designed to ultimately save time and resources across the drug development lifecycle.
“We understand the goal of every drug development program is to deliver results for a patient in need,” added Peyton Howell, Executive Vice President and Chief Commercial & Strategy Officer. “Our Regulatory & Access organization was designed with the patient in mind, helping companies advance through regulatory and market access hurdles without unnecessary delay in order to reduce the time that a patient must wait for an innovative new therapy.”
For more information about Parexel Regulatory & Access, please visit our website.