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Hi ,
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In the rapidly evolving world of synthetic biology, where the blueprints of life are written, edited, and rewritten, the intertwined realms of biosecurity and bioethics are more critical than ever. Synthetic biology promises revolutionary advancements—from biofuels to personalized medicine. Yet, with such profound power comes the responsibility to wield it wisely.
Biosecurity ensures that synthetic biology tools and outcomes don't inadvertently harm human health, the environment, or biodiversity. It addresses concerns about accidental releases, containment measures, and potential misuse in nefarious ways. Concurrently, bioethics grapples with the moral implications and philosophical quandaries of engineering life. Questions about the sanctity of life, the limits of human intervention, and the long-term repercussions of our innovations loom large.
The ascendancy of the bioeconomy is intrinsically linked to the endorsement and guidance of policymakers and regulatory bodies. The regulatory milieu for synthetic biology remains in flux, encapsulating many sectors such as alimentary production, energy, material synthesis, and pharmaceuticals derived from living entities. Furthermore, bioeconomy-oriented policies are pivotal in stewarding natural ecosystems, conserving biodiversity, and ensuring biosecurity. In an epoch characterized by climatic perturbations, dwindling resources, and burgeoning global health threats, formulating cogent, resilient, informed policy and biosecurity frameworks becomes indispensable for realizing sustainable economic paradigms.
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News & Insights:
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Sessions at SynBioBeta 2024:
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DNA Synthesis and Biosecurity: A New U.S. Government Framework. In October 2023, the White House released an Executive Order on AI that included significant new rules for DNA synthesis, including a requirement that U.S. government funding can only be used to purchase synthetic DNA from vendors who conduct biosecurity screening. That same month, updated Guidance from HHS
was released on how biosecurity screening by DNA providers should be conducted. This panel will discuss these new rules, updates on how the new requirements are being implemented, and what it means for the DNA synthesis industry in the U.S. and internationally.
Beyond the Bold Goals: Turning the Vision for the Bioeconomy into Reality. The release of the Biden Administration E.O. was a crucial step in support of a national strategy for biotech and biomanufacturing in support of the bioeconomy. But as we move into a constrained funding environment and an election year, how do we sustain the momentum at the Federal and State level? What can we learn from approaches to other emerging technologies, like A.I., about garnering national attention for the next
generation of biotech innovation to harness the great promise and mitigate the risks? How do we reframe the biotech and biomanufacturing sectors of tomorrow to break down silos, streamline regulations, and coalesce around creating new opportunities? This is a chance to bring thought leaders from inside and outside government to focus on the following steps to move vision into actionable reality.
Biosecurity in DNA Synthesis: Establishing Screening Standards. The U.S. government’s new Executive Order on AI requires that government funding only be used to purchase synthetic DNA from vendors who conduct biosecurity screening. But what does it mean to conduct biosecurity screening? What counts as “good enough” DNA sequence screening? How can we compare sequence screening tools? Standards development is a collaborative process, and the SynBioBeta community can participate in it.
Expanding the US Bioeconomy: Federal Progress on the U.S. National Biotechnology and Biomanufacturing Initiative. With the launch of the U.S. National Biotechnology and Biomanufacturing Initiative by President Biden’s Executive Order in 2022, federal agencies have joined together to propel advancements in the nation’s ability to innovate, develop, commercialize, and scale products in the bioeconomy. In this session, leaders across the federal government will highlight progress in expanding the U.S.
bioeconomy with programs, activities, and funding. With over two billion dollars in funding announced with the Initiative, federal agencies are investing in growing the bioeconomy along the entire pipeline, from early-stage research to workforce training to biomanufacturing facility construction. Representatives from the White House, Department of Energy, Department of Commerce, Department of Defense, U.S. Department of Agriculture, and National Science Foundation will attend.
Expanding the US Bioeconomy: Federal Progress on the U.S. National Biotechnology and Biomanufacturing Initiative. The Coordinated Framework for the Regulation of Biotech Products in the U.S. combines a patchwork of regulations from the FDA, EPA, and USDA that cover specific types of products, use cases, and types of risks. However, this patchwork approach leaves significant gaps. Panelists will explore case studies for how voluntary approaches can help reduce risks and instill confidence in novel
products. Attendees will be engaged in a brainstorming process to determine where new approaches might be helpful, such as ensuring the environmental safety of microbes engineered for use as cosmetics or dietary supplements or preventing allergen hazards when expressing animal proteins in plants.
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