Newswise — WINSTON-SALEM, NC - May 15, 2024 - The RegenMed Development Organization (ReMDO) announced today a new initiative titled Regulatory NavigatOR: a groundbreaking space aimed at providing unparalleled regulatory and scientific counsel to product developers navigating the complexities of the regenerative medicine pipeline. The announcement was made at their annual Regenerative Manufacturing Innovation Consortium (RegMIC) meeting in Charlotte, North Carolina. Conference participants joined to hear from stakeholders, leaders, and researchers about upcoming projects and roadmaps for the future.
The Regulatory NavigatOR is poised to offer invaluable guidance to researchers and industry members at every stage of translation, offering assistance in understanding and engaging with the Food and Drug Administration (FDA) from inception to market approval. With a focus on pre-submission strategies and support throughout early and late-stage product development, the NavigatOR will be instrumental in streamlining regulatory processes and facilitating successful interactions with the FDA.
Led by seasoned industry veterans, Dr. Steven Bauer and Dr. Stephen Sawyer, the Regulatory NavigatOR boasts an impressive experience in regenerative medicine FDA product review, policy development, and regulatory advising. Dr. Bauer served at the FDA for 31 years, with 16 as Branch Chief for Cellular and Tissue Therapies. Dr. Sawyer served as a distinguished FDA researcher and reviewer specializing in regenerative medicine.
"Our mission with the Regulatory NavigatOR is to empower participants with the knowledge and expertise needed to navigate transition to market with confidence," said Steve Bauer, PhD, Chief Regulatory Science Affairs Program Officer for ReMDO. "By leveraging our team's extensive experience and insights gained from years of FDA service, we aim to provide tailored guidance that accelerates the pipeline."
"In addition to regulatory support, the NavigatOR will spearhead FDA research efforts in collaboration with the Wake Forest Institute for Regenerative Medicine, aimed at enhancing scientific strategies for potency assays and other complex facets of regenerative medicine product characterization," added Dr. Stephen Sawyer.
"The goal of the NavigatOR is to not only facilitate regulatory compliance but also drive innovation and advance the field of regenerative medicine,” said Dr. Anthony Atala, Director for the Wake Forest Institute for Regenerative Medicine.
The Regulatory NavigatOR will offer guidance on a wide array of FDA engagements, including CBER CAAT meetings, INTERACT meetings, pre-IND meetings, device pre-submission meetings, accelerated regulatory pathway meetings, and various interactions throughout the IND and BLA application processes.
RegMIC, an industry-led organization, is made up of more than 60 entities who are focused on making the advancement of the regenerative medicine field a reality. “The consortium is based on the philosophy that pooling the talents, resources and ideas of members to tackle industry challenges offers the smoothest and most rapid path to advanced manufacturing,” explained Joshua Hunsberger, PhD, Chief Technology Officer for ReMDO. RegMIC identifies and develops consensus on manufacturing challenges through road-mapping efforts and provides guidance on strategic funding areas.
For more information on the Regulatory NavigatOR and how it can support a product journey through the regenerative medicine regulatory landscape, please visit http://remdo.org.
About RegMIC: RegMIC is an industry-led organization dedicated to accelerating the development and commercialization of regenerative medicine therapies. The organization convenes industry leaders, researchers, and innovators to address critical challenges and advance the field. For more information, visit https://remdo.org/society/#RegMIC.
About ReMDO: The RegenMed Development Organization (ReMDO) is a 501(c)3 non-profit with a mission to help deliver on the promise of regenerative medicine by advancing research to de-risk technologies, promoting progress of biomanufacturing scale-up and automation to make technologies more affordable, and speeding up the translation to clinical practice. For more information, visit http://remdo.org.
About Wake Forest Institute for Regenerative Medicine: The Wake Forest Institute for Regenerative Medicine is recognized as an international leader in translating scientific discovery into clinical therapies, with many world firsts, including the development and implantation of the first engineered organ in a patient. Over 500 people at the institute, the largest in the world, work on more than 40 different tissues and organs. A number of the basic principles of tissue engineering and regenerative medicine were first developed at the institute. WFIRM researchers have successfully engineered replacement tissues and organs in all four categories – flat structures, tubular tissues, hollow organs and solid organs – and 16 different applications of cell/tissue therapy technologies, such as skin, urethras, cartilage, bladders, muscle, kidney, and vaginal organs, have been successfully used in human patients. The institute, which is part of Wake Forest University School of Medicine, is located in the Innovation Quarter in downtown Winston-Salem, NC, and is driven by the urgent needs of patients. The institute is making a global difference in regenerative medicine through collaborations with over 500 entities and institutions worldwide, through its government, academic and industry partnerships, its start-up entities, and through major initiatives in breakthrough technologies, such as tissue engineering, cell therapies, diagnostics, drug discovery, biomanufacturing, nanotechnology, gene editing and 3D printing.
Media contact: Emily Gregg, [email protected]
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