- Wheeler Bio has announced a strategic partnership with Pharmefex Consulting to enhance its ModularCMC™ platform with regulatory expertise for IND submissions.
- The collaboration will provide biopharmaceutical innovators with combined CMC development and regulatory strategy support.
Wheeler Bio, Inc., a U.S.-based contract development and biomanufacturing organisation (CDMO), has formed a strategic partnership with Pharmefex Consulting to strengthen regulatory support for clients progressing from discovery to Investigational New Drug (IND) submissions.
The agreement integrates Pharmefex’s experience in Chemistry, Manufacturing, and Controls (CMC) strategy and regulatory submissions into Wheeler’s ModularCMC™ platform. The collaboration aims to provide high-quality Common Technical Document (CTD) Module 3 documentation to support IND filings, enabling biopharmaceutical innovators to advance programmes efficiently towards First-in-Human trials.
Patrick Lucy, President and CEO of Wheeler Bio, said: “Biopharmaceutical innovators are seeking platform approaches that enable rapid progression of their innovative molecules. Adding Pharmefex’s deep regulatory capabilities to our ModularCMC platform lives up to that mandate.”
Wheeler Bio’s scientific team has worked collectively on more than 1,400 molecules and offers contract manufacturing services through a platform designed to maximise speed, agility, and scalability. The partnership with Pharmefex, led by founder Ali Siahpush, Ph.D., brings additional expertise in biologics, biosimilars, and advanced therapies to complement these capabilities.
Pharmefex consultants will collaborate with Wheeler’s manufacturing, scientific, and quality teams to prepare and review IND-enabling documentation, including risk assessments, analytical methods, and process development reports. According to Siahpush, “We believe Wheeler Bio’s ModularCMC platform offers such an advantage. This is why we are proud to partner with Wheeler Bio.”
