2nd Annual Government Biotechnology Innovation Summit
Overview
G2G attended the Second Annual Government Biotechnology Innovation Summit from September 4-5. This event is a forum for leaders to discuss how the government employs biotechnology for national security purposes, including biodefense initiatives, surveillance of infectious diseases, and the prevention and response to biological threats. The Summit explored investing in research and development, establishing regulations and guidelines, and collaborating with academia and industry to harness the potential of biotechnology to improve health, safety, and preparedness.
Featured Speakers
- Office of Science and Technology Policy (OSTP)
- National Security Commission on Emerging Biotechnology (NSCEB)
- Advanced Research Projects Agency for Health (ARPA-H)
- Food and Drug Administration (FDA)
- Biomedical Advanced Research and Development Authority (BARDA)
- Department of Defense (DoD) and other entities
Theme and Executive Order
A major theme of the event was ongoing movement towards a whole-of-government approach to advancing biotechnology, biomanufacturing and the bioeconomy across strategic sectors. A major driver of this effort is President Biden’s September 2022 Executive Order (EO) on this topic, which directs various federal departments to corral resources to advance research, facilitate strategic data curation, augment manufacturing capabilities, enable workforce development, and streamline regulations among other activities. Individual entities have a degree of autonomy in meeting goals outlined in the EO, but OSTP is a key player in coordinating implementation through the National Bioeconomy Board.
A major outcome of the EO is the Distributed Bioindustrial Manufacturing Program (DBIMP), a DoD-led consortium, which is focused on strategic investments to secure domestic defense industrial base and supply chains by leveraging biotechnology and biomanufacturing for non-medical use cases. The five defense material priority areas are: Food, Fuel, Fitness, Fabrication, and Firepower.
- A total of 30 awards are expected under this program this year with $23 million allocated so far
- Projects are for planning phase or pilots to demonstrate commercial viability
- Successful demonstrations can receive larger follow-on awards (~$100 million) to build out US-based bio-industrial manufacturing facilities
- Examples of projects awards include development of protein-based textiles, new fuel additives, chemical coatings, and lubricants
ARPA-H and BARDA
Representatives of different agencies provided insights on the distinct ways they support biotechnology
- ARPA-H is committed to supporting projects that are neither aligned with the priorities of traditional public biomedical research funding sources nor with venture capital. Of note, is ARPA-H’s unique regulatory and reimbursement authority which can ease the burdens for novel biotechnology products that have no precedent. The agency emphasizes outcome-based contracts and accelerated award timelines relative to grants. This delivery model is something that it shares with BARDA, whose mission centers on development of medical countermeasures (MCMs) against public health threats, including diagnostics, medical devices, therapeutics, vaccines and digital health technologies.
- A wide array of BARDA programs, including several led by aligned consortia, support MCM innovators with technology sourcing, wraparound support, market research capabilities and links to venture partners. BARDA Ventures for example, has developed partnerships with the Global Health Investment Corporation (GHIC) to support companies that have MCMs developed for multiple use cases, in order to expand their commercial viability outside of emergency use. In tandem to these efforts, the FDA has sought to leverage its regulatory powers to incentivize innovation in the biotechnology sector via various programs. This includes the START pilot program to address unmet medical needs in rare disease, the Accelerated Approval program that facilitates use of surrogate endpoints to move forward approvals and the AMT designation program to encourage adoption of advanced manufacturing technologies.
Artificial Intelligence and Machine Learning
The role of artificial intelligence (AI) and machine learning (ML) in driving next generation biotechnology advancements was a major topic of discussion throughout the summit. AI/ML advances are already allowing us to model biological systems, accelerate drug discovery and advance patient care among other applications. However, data management and infrastructure remain a key bottleneck that poses a challenge to US growth and dominance in this space. An enormous amount of data is being generated and curated by the biotechnology sector and is complemented by large public data repositories. However, the United States is not treating this data as a strategic asset that can be leveraged. In contrast, adversarial nations, like China have much clearer goals in managing and utilizing data across the private and public spheres, albeit in a way that does not align with American values, particularly in relation to safeguarding privacy. Therefore, developing a national data strategy must be a priority for the government.
Policy Tools
In addition to shining a light on biotechnology investments, programs, opportunities and challenges, the Summit also highlighted the need to advance policy tools to empower both the Executive Branch and Congress to implement a coordinated vision for this space.
- NSCEB, is authorized to review of how advancements in emerging biotechnology will shape current and future activities of the DoD. It is comprised of four Members of Congress and industry subject matter experts. NSCEB issued an interim report in December 2023, will issue a final report in December 2024 with its policy recommendations, and will continue to work through 2026.
- Several NSCEB policy recommendations have already been incorporated into the National Defense Authorization Act and other bills recently introduced in Congress. A key goal of policies under consideration is that they potentiate initial government investment in spaces where there is a gap between national security needs and market incentives, while helping to crowd private investment over the longer term. A major hurdle to achieving these goals, is that government has had a lack of understanding and vision setting of the biotech space.
- Private sector innovators are largely unaware of public resources and incentives to help them expand and minimize practices contrary to national interest, such as offshoring. Public private partnerships (PPPs) were cited as a key vehicle to better match industry subject matter expertise with societal challenges.
In Closing
The Summit offered unique insights into the technical, logistical and policy considerations of the US Government as it develops a streamlined biotechnology strategy. G2G routinely attends forums such as these to keep apprised of developments that impact biotech innovators and changemakers. Stay tuned for updates in this space!