OKLAHOMA CITY, Sept. 9, 2025 /PRNewswire/ — Wheeler Bio, Inc., a U.S.-based contract development and biomanufacturing organization (CDMO), today announced it has established a strategic partnership with Pharmefex Consulting, an expert CMC consultancy with deep expertise in regulatory strategy and technical operations, focused on accelerating client success in Investigational New Drug (IND) filings and regulatory submissions.
This collaboration further enhances Wheeler’s ModularCMC™ platform by integrating the preparation of high-quality Common Technical Document (CTD) Module 3 documentation in support of IND submissions for programs advancing from discovery to IND-enabled First-in-Human clinical trials. Adding Pharmefex’s proven 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.
As a High-Science/High-Touch biologics CDMO, the Wheeler Bio scientific team is deeply talented with aggregate industry experience that includes working on over 1,400 unique molecules. Wheeler’s ModularCMC platform is designed to streamline the path from discovery to clinical study initiation, with maximum speed, agility and scalability while offering 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.”
Pharmefex Consulting brings decades of combined experience across CMC strategy, regulatory submissions, and technical operations for biologics, biosimilars, and advanced therapies. The Pharmefex team, including Ali Siahpush Ph.D., president and founder of Pharmefex Consulting, and his team of tactically experienced CMC consultants 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 —ensuring every client receives best-in-class regulatory support.
“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.” said Ali Siahpush.
About Wheeler
Wheeler Bio is a contract development and manufacturing pioneer who has established the ModularCMC™ platform that enables the rapid translation of antibody-based therapeutics from discovery to clinical studies while ensuring scalability in support of advanced development and commercialization. ModularCMC streamlines the path between drug discovery and clinical manufacturing through well-defined systematic work packages ultimately resulting in cGMP product supported by a comprehensive Common Technical Document (CTD) Module 3 for Investigational New Drug Applications (INDs). Wheeler’s High-Science/High-Touch approach combines cutting edge development and cGMP manufacturing technologies with a deeply experienced scientific team committed to timeline transparency, scientific rigor and a true partnering mindset. Wheeler Bio’s mission is to accelerate the translation of drug discoveries into clinical impact for our partners and the patients they seek to serve.
For Further Information:
Wheeler Bio, Inc.
Contact: [email protected]
About Pharmefex
Founded in 2014, Pharmefex is a leading provider of strategic, technical and regulatory consulting services for biologics, biosimilars and advanced therapies. Our team is composed of seasoned leaders and executives with decades of experience which are used to help our clients navigate and avoid costly mistakes. We specialize in CMC as a core competency, covering all aspects from process and analytical development to cGMP manufacturing, technology transfer, risk management, characterization, outsourcing and supply chain, as well as quality and regulatory affairs. To address the full spectrum of client needs, we collaborate closely with a select group of trusted partners in the non-CMC space supporting projects from early-stage development through to IND and BLA submission and into post-approval phase.
Our goal is to help clients accelerate product development and enhance their probability of success. We are driven by a mission to improve patient outcomes by increasing the success rates of innovative companies bringing new treatments to market, minimizing CMC timelines and reducing costs in the process.
For further information:
Pharmefex LLC
Contact: [email protected]
View original content to download multimedia:https://www.prnewswire.com/news-releases/wheeler-bio-and-pharmefex-consulting-announce-strategic-partnership-to-integrate-ind-drafting-and-cmc-support-into-wheelers-modularcmc-platform-302551293.html
SOURCE Wheeler Bio, Inc.
