NIIMBL sets priority topics for U.S. Roadmap
December 19, 2017
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) hosted a Vision Workshop in Baltimore on November 29 and 30 to begin the development of a U.S. Biopharmaceutical Manufacturing Roadmap. The goal of the two-day event was to capture high-level perspectives of the broad biopharmaceutical industry landscape, establish three priority topics to be roadmapped that can complement existing roadmaps, and form the topic teams who will develop the document.
After robust and engaging discussions, participants selected gene therapy, vaccines, and ADC/bispecifics (antibody-drug conjugates/bispecific antibodies) as the first three topics to include in the U.S. Roadmap.
The U.S. Roadmap will inform future NIIMBL project calls by establishing technical, workforce and regulatory areas of interest to the biopharmaceutical industry and complement existing roadmaps in cell therapies, lyophilization, and antibodies which also inform priorities for NIIMBL.
The Vision Workshop brought together a diverse set of perspectives as more than 70 participants, representing more than 40 organizations, attended the event. Joining federal participants from NIST, FDA, and NIH, were both NIIMBL members and non-members from a variety of sectors including biomanufacturers, suppliers, and academic institutions.
'We were excited to see the engagement, enthusiasm and broad range of perspectives from the participants at the Vision Workshop. Bringing together diverse insights from biomanufacturers, suppliers, academic institutions and federal agencies gave us a strong foundation on which to build our roadmapping efforts,” said Ruben Carbonell, NIIMBL Chief Technology Officer.
Facilitated by the BioPhorum Operations Group (BPOG), the two-day workshop served as a forum for attendees to share perspectives on the biopharmaceutical landscape as well as on technical, workforce, regulatory science, and standards issues. The perspectives of each participant were collected, grouped and consolidated through a structured information capture process. A series of votes throughout the process eventually led to the three priority topic areas. In addition, attendees also formed teams who will collaborate to develop the roadmap for each of the priority topics. In early 2018, topic teams will meet to begin the process of developing the U.S. roadmap. The first edition is expected to be published by late 2018.
NIIMBL and BPOG announced in September that they have entered into a collaborative agreement to develop a U.S.-specific roadmap for the biopharmaceutical industry. You can read more information about the U.S. Roadmap efforts here.