On September 12, 2022, President Biden issued an Executive Order (“E.O.”) announcing the National Biotechnology and Biomanufacturing Initiative, a “whole-of-government” effort to further biotechnology and biomanufacturing innovations in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security. The White House subsequently announced that the Initiative would cost $2 billion. If successful, the Initiative could have sweeping impacts across the entire biotechnology research and development (“R&D”) lifecycle. A summary of the E.O., its requirements, and key takeaways are set forth below.
The world has been almost singularly focused on the 2019 coronavirus for more than 18 months now, but the fact remains that we still face an array of other known pathogens with pandemic potential and any number of unknown pathogens that could pose a similar risk. These threats have periodically been an area of congressional focus since the 2009 H1N1 influenza pandemic, and most recently a bill for the Disease X Act would renew this focus and direct it at new, currently unknown viral threats. The bill is poised to be a key piece of legislation in ongoing and future biodefense initiatives and pandemic preparedness.
Continue Reading The Next Pandemic: New Bill Looks Ahead to Counteract Novel Threats
Last week, the White House Office of Science and Technology Policy (“OSTP”) issued a request for information (“RFI”) to learn how the Government can more effectively “support scientific discovery, the development of technological advances, and increase the impact of a vibrant bioeconomy on the Nation’s vitality and our citizens’ lives.” 84 Fed. Reg. 47561 (Sep. 10, 2019). The Bioeconomy is the “infrastructure, innovation, products, technology, and data derived from biologically-related processes and science that drive economic growth, promote health, and increase public benefit.” Id. To establish guiding principles to promote and protect the U.S. Bioeconomy, OSTP is seeking input from interested parties, including “those with capital investments, performing innovative research, or developing enabling platforms and applications in the field of biological sciences, to include healthcare, medicine, pharmaceuticals, biotechnology, manufacturing, energy production, and agriculture.” Id. Of particular interest to government contractors, OSTP is seeking information regarding opportunities for public-private partnerships, infrastructure investments, and best practices for data sharing and data protection. Id. at 47562. Responses are due on or before 11:59 pm on October 22, 2019. We have included the specific topics on which OSTP seeks input below.
Continue Reading White House Seeks Input from Biotech Stakeholders on Bioeconomy
Late last month, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAI) was signed into law. The Act is a much anticipated reauthorization of the Pandemic and All-Hazards Preparedness Act, originally passed in 2006. The legislation is a key development in strengthening the country’s ability to respond to bio-threats, disasters, and other national emergencies by defining federal program initiatives and funding states and private researchers. PAHPAI-authorized grants allow for the research and development of biodefense measures and the stockpiling of preparedness supplies.
Continue Reading PAHPAI Reauthorizes Key Biodefense Initiatives and Provides Opportunities for Industry Partners