Parexel announced a partnership with Weave Bio aimed at accelerating regulatory submission processes and the time to market for new therapies.
Under the agreement, Parexel will serve as Weave’s CRO design partner and will leverage its regulatory consulting expertise across clinical, non-clinical, clinical pharmacology and chemistry, manufacturing, and controls (CMC) to enhance Weave’s AI platform and product pipeline. Parexel will also maintain a period of exclusivity as the only CRO licensed to use Weave’s solutions after new products launch.
“This partnership represents a significant advancement in Parexel’s vision to leverage AI to speed clinical research processes, enhance first-time quality and accelerate the delivery of life-changing therapies to patients,” said Paul Bridges, President, Consulting, Parexel. “We’re beginning this partnership by addressing an area where sponsors feel extreme urgency – early regulatory authoring and submission preparation. By combining Weave’s cutting-edge AI technology with the human-in-the-lead expertise of Parexel Consulting, we’re helping teams move faster and with greater confidence while maintaining the highest levels of quality and compliance.”
Parexel has already used Weave’s flagship offering, AutoIND, to support Investigational New Drug (IND) applications and has been able to complete them 50 per cent faster than traditional IND authoring timelines. According to Parexel, these efficiency gains enable INDs to be developed at a faster pace, supporting sponsors with the step of initiating new clinical trials sooner than current industry timelines. Weave’s AutoIND functionality is now included in Weave’s regulatory workflow solution, The Weave Platform, which spans the entire regulatory lifecycle.
“AI tools are only as strong as the people behind them. Human experts provide the context that guides our platform and help translate its findings into action,” said Lindsay Mateo, Chief Commercial Officer at Weave. “Through this partnership, Weave will tap into Parexel’s deep regulatory expertise to refine and expand our solutions across the drug development industry.”
Parexel and Weave will present at the Regulatory Affairs Professionals Society (RAPS) Convergence from 7 to 9 October in Pittsburgh, Pennsylvania, where they will discuss the partnership during presentations and at their booths.