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Wheeler Bio, Pharmefex Consulting Enter Partnership

Together, the companies will integrate IND Drafting and CMC Support into Wheeler's ModularCMC Platform.

By: Rachel Klemovitch

Assistant Editor

Wheeler Bio, Inc., a U.S.-based contract development and biomanufacturing organization (CDMO), has established a strategic partnership with Pharmefex Consulting, a CMC consultancy, focused on accelerating client success in Investigational New Drug (IND) filings and regulatory submissions.

This collaboration enhances Wheeler’s ModularCMC platform by integrating the preparation of high-quality Common Technical Document (CTD) Module 3 documentation, supporting IND submissions for programs advancing from discovery to IND-enabled first-in-human clinical trials. 

Adding Pharmefex’s biologics regulatory expertise to Wheeler’s streamlined and agile manufacturing platform supports biopharmaceutical innovators by providing a comprehensive CMC offering, including a sound and defensible regulatory strategy.

Pharmefex Consulting brings combined experience across CMC strategy, regulatory submissions, and technical operations for biologics, biosimilars, and advanced therapies. The Pharmefex team will collaborate closely with Wheeler Bio’s scientific, manufacturing, and quality teams to streamline the preparation and review of IND-enabling documentation, including risk assessments, analytical methods, and process development reports.

Wheeler’s ModularCMC platform is designed to streamline the path from discovery to clinical study initiation, offering maximum speed, agility, and scalability while providing a High-Touch approach based on timely transparency, scientific rigor, and a true partnering mindset.

“Biopharmaceutical innovators are seeking platform approaches that enable rapid progression of their innovative molecules,” said Patrick Lucy, President and CEO of Wheeler Bio. “Adding Pharmefex’s deep regulatory capabilities to our ModularCMC platform lives up to that mandate.”

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