#United States #Oklahoma City #Wheeler Bio #Pharmefex #ModularCMC

Wheeler Bio Partners with Pharmefex Consulting to Enhance IND Development

In a noteworthy move to bolster its capabilities in pharmaceutical development, Wheeler Bio, Inc., a U.S.-based contract development and biomanufacturing organization (CDMO), has recently announced a strategic partnership with Pharmefex Consulting. This collaboration is specifically designed to streamline the preparation of Investigational New Drug (IND) filings and regulatory submissions via the integration of Pharmefex's expertise into Wheeler's ModularCMC™ platform.

Enhancing Client Success with Strategic Collaboration

Wheeler Bio's initiative aims to enhance its ModularCMC™ platform. This platform is pivotal in supporting programs that are transitioning from discovery to IND-enabled First-in-Human clinical trials. The partnership integrates high-quality Common Technical Document (CTD) Module 3 documentation—crucial for IND submissions—thereby equipping clients with a comprehensive and robust support system.

Pharmefex Consulting is distinguished for its deep knowledge and capabilities in regulatory strategy and technical operations specifically within the biologics sector. This combined expertise—melding Pharmefex's regulatory proficiency with Wheeler's agile manufacturing process—creates a powerful alliance that addresses the pressing demands of biopharmaceutical innovators seeking to expedite the development of their novel therapies.

Patrick Lucy, President and CEO of Wheeler Bio, emphasized this need by stating, "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."

A Focused Approach to Biopharmaceutical Development

Wheeler Bio’s High-Science/High-Touch approach is anchored in a scientific team with extensive experience—having worked on over 1,400 unique molecules. Its ModularCMC™ platform is meticulously designed to accelerate the journey from drug discovery to clinical study initiation. The system prioritizes speed, agility, and scalability, advocating for high-touch involvement characterized by transparency, scientific rigor, and an overarching partner-centered mindset. This unique selling proposition aims to significantly shorten the drug development timeline while ensuring compliance with the highest regulatory standards.

Pharmefex Consulting’s Contributions

Pharmefex Consulting comes into this partnership armed with decades of collective experience related to CMC strategy, regulatory submissions, and technical operations for biologics, biosimilars, and advanced therapies. The firm, spearheaded by Ali Siahpush, Ph.D., is composed of a dedicated team of CMC consultants who will work in close collaboration with Wheeler Bio's scientific, manufacturing, and quality teams. This teamwork is aimed at streamlining the preparation and review of IND-enabling documentation, including risk assessments, analytical methods, and development reports, thereby ensuring that clients receive top-tier regulatory support.

Ali Siahpush expressed confidence in the partnership, stating, "We continuously seek innovative solutions which offer a strategic advantage to our clients as they endeavor to rapidly and efficiently advance their programs. We believe Wheeler Bio's ModularCMC platform offers such an advantage. This is why we are proud to partner with Wheeler Bio."

About Wheeler Bio

Wheeler Bio has forged its reputation as a pioneering contract development and manufacturing organization by launching the ModularCMC™ platform. This innovative system facilitates the rapid transition of antibody-based therapeutics from the discovery phase to clinical trials while ensuring scalability to support advanced development and commercialization needs. It employs systematic work packages that clearly define the drug development and manufacturing processes and culminate in cGMP products supported by a comprehensive CTD Module 3 for IND applications.

The mission of Wheeler Bio is clear: to accelerate the translation of groundbreaking drug discoveries into clinical solutions that can ultimately impact patients' lives positively.

About Pharmefex Consulting

Pharmefex, founded in 2014, stands as a leading provider of strategic, technical, and regulatory consulting services tailored for biologics and advanced therapies. With extensive expertise spanning all CMC aspects—from process and analytical development to quality and regulatory affairs—Pharmefex is focused on propelling clients through the complexity of drug development, ultimately enhancing their chances for success in bringing innovative solutions to market.

For more information regarding this partnership, please contact Wheeler Bio or Pharmefex Consulting directly.