Thanks to the collaborative efforts of experts from the biopharmaceutical community, NIIMBL has published technology roadmaps for gene therapy, ADCs/bispecific antibodies, and vaccines. These roadmaps were developed for the benefit of the biopharmaceutical industry in the U.S. and globally. The roadmaps highlight technology needs, manufacturing challenges, and areas of opportunity in each of these product categories.
The documents are the result of NIIMBL’s ongoing roadmapping initiative, which began in the fall of 2017. The purpose of the initiative is to produce technology roadmaps on a regular cycle that address topics of interest to the biopharmaceutical community. The documents serve as a guide for technology innovation and shape NIIMBL technology project priorities.
NIIMBL invited subject matter experts from member and non-member organizations to participate in the development of these roadmaps. Individuals representing more than 40 organizations, including those from industry, academia, non-profits, and federal agencies, contributed their perspectives and expertise.
“Through these roadmaps, we set out to create a clear vision of innovation for biopharmaceutical manufacturing processes and platforms that will ultimately enhance access to the medicines that have the ability to improve and save lives. We are grateful to all of those who contributed their time, energy, and talent to this process,” said Kelvin Lee, NIIMBL Institute Director.
The program began with a Visioning Workshop last November during which participants identified the key market trends, business drivers, and technology gaps influencing biopharmaceutical manufacturing. Through a structured process of information capture, mapping, consolidation, and voting, participants selected gene therapy, ADCs/bispecifics, and vaccines as the priority topics for the first round of roadmapping. Topic teams met in-person and online over the next several months to take a deep dive into each product type and develop the roadmap content.
The process was facilitated by the BioPhorum Operations Group. Last year, NIIMBL and BioPhorum announced a collaborative agreement to develop NIIMBL roadmaps for the biopharmaceutical manufacturing industry. The NIIMBL roadmaps will form part of BioPhorum’s Global Technology Roadmap and will complement existing industry roadmaps.
While new technologies will enable better manufacturing capabilities, it is also important to consider the workforce and regulatory implications of these new technologies. To ensure these issues were addressed, topic teams included workforce and regulatory experts. Each roadmap includes a section focused on these topics.
The roadmaps, and the collaborative process by which they were developed, demonstrate the unique value proposition NIIMBL brings to the biopharmaceutical community. It provides an environment for stakeholders to discuss shared challenges and work together toward transformative solutions.
NIIMBL will soon convene the biopharmaceutical community for the next set of roadmaps. An informational webinar is set to take place on November 14. A face-to-face Visioning Workshop will take place in early 2019. Industry stakeholders are encouraged to participate. To learn more, contact NIIMBL Chief Technology Officer, Ruben Carbonell at [email protected] or Associate Institute Director, Chris Roberts at [email protected].
Download the NIIMBL roadmaps here.