CCA-09: Advancing Regulatory Science for Products of Biotechnology and Biomanufacturing

Imagine a world where advances in regulatory science keep abreast with the rapid advances in biotechnology so that regulators continue to have the information and data necessary to support regulatory decision-making to ensure that consumers can have ready access to safe, and effective products of biotechnology. Regulatory decision-making driven by shared tools, standards, approaches, and data from regulatory authorities, scientists, and industries enables innovation to reach the market more efficiently. The impact of such a collaborative approach could be vast, bolstering a bioeconomy that fosters global leadership in sustainable and efficient innovation and enabling products of biotechnologies to be accessible, available, and beneficial to all.

The United States has employed a science-and-risk-based regulatory system for the products of biotechnology for over 40 years. These risk-based regulatory systems rely on the review of scientific data that demonstrate that regulatory requirements have been met. To continue to further the development and availability of safe products of biotechnology, it is also essential to promote research to advance the development of the tools, standards, and approaches that support regulatory decision-making – known as regulatory science. As biotechnology innovation rapidly advances, regulatory science must also advance so that regulatory authorities have the data and information necessary to continue to enable science-based regulatory decision-making.

CASA-Bio stakeholders representing government, industry, and non-profit sectors, identified areas of mutual interest where concerted effort among them may lead more quickly to the realization of the envisioned future. These are a few of their ideas. Advancing regulatory science to continue to support science-based and risk-based regulatory assessments of products of biotechnologies is needed with a focus on environmental, animal, and human health impacts. Such efforts should aim to support adaptive and informed regulatory frameworks that not only protect public health and the environment but also foster innovation and technological progress in the bioeconomy. Multidisciplinary research efforts can be undertaken to support biotechnology risk analysis across multiple classes of products, including development of new paradigms for assessing, managing and mitigating risk. Finally, research and development can produce new tools and strategies for engaging the public in biotechnology regulation.

As a member of the R&D community, you too are a CASA-Bio stakeholder, and providing your insight on R&D projects that undergird this sub-theme and lead to solutions is critical. Your ideas will matter! Your individual project ideas and those developed as part of the collaborative Town Hall process will be combined to produce an aggregate view. This view will help us understand not only the interests of the R&D community, but also what they are willing to do to advance the bioeconomy. Topics among the R&D project ideas we receive will help government, industry, and non-profit stakeholders see the potential of the US R&D community to address critical future needs and help define topics for future exploration through workshops and roadmapping.