Issue link: https://www.e-digitaleditions.com/i/1420307
www.biopharminternational.com October 2021 eBook BioPharm International 5 tion-sharing around the now-current cri- sis of COVID-19 and its variants, it has shown itself to be an effective ally in the global response to the pandemic," he says. Ott also points out that polymer-based single-use bioprocessing systems have been critical to COV ID-19 vaccine research and production. FDA's further engagement with the single-use bio- processing industry, as represented by BPSA's 68 member organizations, is cer- tainly encouraged. "In sum, the FARS report is for- ward-looking, and documents the critical role of FDA in improving human-health outcomes, and represents true excellence in government, led by its 18,000 (plus) employees," Ott concludes. In its response to the FARS report, the BioPhorum Regulatory team, a group of senior chemistry, manufactur- ing, and controls (CMC) regulatory lead- ers from the biopharmaceutical industry composed of three member organizations and 61 participants, collectively agreed that the report has been globally posi- tively received when distributed through- out the team's member organizations' regulatory functions. Although the report primarily focuses on clinical and patient aspects of regula- tory sciences, there are some mentions of the CMC aspects of regulatory sciences that are most relevant to the BioPhorum Regulatory team. ACHIEVING ITS AIMS Among the topics in the FARS report most releva nt to t he BioPhor um Regulatory team are those relating to advanced manufacturing; physical stan- dards and reference materials; and scientific education, training, and com- munication. With regards to these top- ics of interest, and especially advanced manufacturing, the report provides good pointers to what is important to the development of innovative drug products, using modern manufacturing process approaches, such as continuous manufac- turing, mobile and modular manufactur- ing, and smart manufacturing. "The level of details to which the report goes is, however, high, and too high for industry to be able to feedback on whether they agree with the areas of priority when it comes to facilitating development or improved guidance for sponsors," states a BioPhorum Regulatory spokesperson. The principles described for standards, references, or education— while of interest—are not considered innovative, and in this way, are different from how industry is evolving. "For example, industry has gone from the model of developing standards based on shared experience and best practices to then approach standard organizations to get the standard ratified, to develop- ing the standard from the start with the standard organizations, for the benefit of quicker implementation. Innovation for the agency would be to join these discus- sions from the start as well, as opposed to waiting for the standards to be published and then initiate their own standards," the BioPhorum spokesperson explains. It is industry's experience that educa- tion of agency personnel varies, which results in uncertainty with regards to the outcome of regulatory reviews and inspections, especially when innova- tive technologies or ways of working are involved. "Pre-submission meetings are one way to address this uncertainty; however, there could be further oppor- tunity for exchanges between the agency and industry, for example, through more shared learning events that would involve both reviewers and inspectors," says the BioPhorum spokesperson. THOUGHTS ON FURTHER INCLUSION There are other aspects that could be further included in FARS, such as a more evident link to other FDA initia- tives such as its pharmaceutical quality assessment system, Knowledge-Aided Assessment & Structured Application, or International Council for Harmonisation Structured Product Quality Submissions. "The [FARS] report speaks of auto- mation, digitization, and artificial intel- ligence, which industry commends. However, regulatory guidance around data standards in quality areas is what industry would like to see now, as the current lack of regulatory guidance is a blocker to global and immediate imple- mentation of systematic data analysis that industry is ready or almost ready to implement. This is seen as a much short- er-term improvement but one that indus- try is not seeing now," the BioPhorum spokesperson says. In addition, implementation of inno- vative technologies on older products is seen as a major opportunity for industry, as older products benefit from long-term and experience-gained knowledge and understanding. The current regulatory landscape and its complexity for post-ap- proval changes, however, can make such implementation impractical. "Industry would therefore also like to see the agency prioritizing the implementation of innovative technologies through an easier process for post-approval changes," the BioPhorum spokeperson states. Finally, the report speaks of the role that an emerging technology team plays in the implementation of innova- tive technologies, where exchanges with industry are prioritized when innova- tive technology is linked to a specific product. This is not a reflection of how industry exclusively works, however. Industry sees the benefits of collabora- tion through industry groups, such as BioPhorum, for example, which allows collaborative thinking for the selection, implementation, and validation of inno- vative technologies. FDA working with sponsors and industry organizations more directly in that case will provide the most benefit rather than individ- ual sponsors only, Isabelle Lequeux, BioPhorum Regulatory lead, asserts. REFERENCES 1. FDA, "FDA In Brief: FDA Publishes Report on Focus Areas of Regulatory Science," Press Release, Jan. 11, 2021. 2. FDA, "2021 Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS)," www.FDA.gov (January 2021). BP Regulatory Sourcebook Innovation