“No longer is demonstrating safety and efficacy enough to launch a product successfully,” Corporate Vice President and Worldwide Head of Parexel Joshua Schultz said, as pharma firms are under greater pressure to control healthcare spending.
As such, the contract research organization (CRO) has announced it is restructuring and expanding its evidence-based services with a focus on medical affairs, commercialisation and lifecycle management for pharma products, forming Parexel Access.
“The various services that make up Parexel Access have been outsourced by pharmaceutical companies for many years,” Schultz told Outsourcing-Pharma.com. “However, substantial shifts in the market access landscape and rapid growth in demand for new sorts of data are outstripping traditional approaches and internal capabilities.”
Parexel is not alone in expanding its late-stage offerings. Rival CRO Quintiles, for example, has positioned itself to service growing demand for such trials and last month penned a deal with IMS Health to access real-world data.
Furthermore, industry expert Neal McCarthy from Fairmount Partners recently told this publication the breadth and complexity of medical affairs and post-market studies typically led to pharma firms keeping such services in-house, but this is now changing.
The new division combines Parexel’s medical communications and post-approval services with the commercialisation and pharmacovigilance offering acquired when the firm bought Heron Group in 2013, which Schultz said has pushed Parexel into a greater leadership position in the market access space.
The new division will work with biopharmaceutical companies of all sizes, Schultz added, “although mid and large sized companies typically commercialise a greater percentage of the industry’s products.”
No specific investment was divulged, but Schultz said the Parexel Access “currently has several thousand individuals working within the unit and will continue to grow rapidly based upon market demand and targeted investments in key capabilities.”