Last month the Obama administration released the National Bioeconomy Blueprint, a broad plan to continue fostering research and development of medical therapies and devices, biofuels and next-generation biological manufacturing processes.
The report states that the current growth of the bioeconomy is due in large part to genetic engineering, DNA sequencing, and automated high-throughput manipulations of biomolecules. Expansion of emerging technologies in synthetic biology, proteomics, and bioinformatics are core to goals for furthering the bioeconomy.
The blueprint outlines five strategic imperatives for a bioeconomy with the potential to generate new markets and economic growth:
- Support R&D investments that will provide the foundation for the future bioeconomy.
- Facilitate the transition of bioinventions from research lab to market, including an increased focus on translational and regulatory sciences.
- Develop and reform regulations to reduce barriers, increase the speed and predictability of regulatory processes, and reduce costs while protecting human and environmental health.
- Update training programs and align academic institution incentives with student training for national workforce needs.
- Identify and support opportunities for the development of public-private partnerships and precompetitive collaborations—where competitors pool resources, knowledge, and expertise to learn from successes and failures.
The report highlights on-going initiatives to meet these goals. Highlighted examples applicable to biodefense include:
Improving Predictions of Vaccine and Drug Toxicity and Efficacy
NIH, the Defense Advanced Research Projects Agency (DARPA), and the Food and Drug Administration (FDA) have launched a collaborative research initiative to develop a “chip” that reproduces human physiological responses to drugs and vaccines. Designed to engage academic, industry, and government scientists, this five-year, $140 million effort aims to develop technologies that quickly provide molecular signals of toxicology and efficacy The goal is to accelerate drug discovery and development while decreasing the testing of drugs and vaccines in animals.
Improving Homeland Security with Biological Research
DHS Science and Technology (S&T) Directorate is leading the development of a genomics-based approach to microbial forensic analysis which will allow identification and characterization of any microbial organism. This would include “unknown” organisms, such as emerging, engineered, chimeric, or purely synthetic organisms.
Establishment of the genomics approach involves development and refinement of several intersecting technologies including bioinformatic analysis, metagenomic analysis, and comparative genomics. DHS and the National Center for Biotechnology Information will establish a comprehensive catalog of genomes that covers the full diversity of pathogens to enable new capabilities with applications to the fields of public health, homeland security, food safety, and medical diagnostics.
Transforming Manufacturing through Bioinnovation
A substantial number of recent promising biomanufacturing opportunities led the Administration to recognize the value in investing in emerging technologies that can create high-quality manufacturing jobs and enhance global competitiveness. In support of this, DARPA launched its Living Foundries Program, which is designed to harness biology as a revolutionary manufacturing platform for the flexible and rapid production of new or improved high-value materials, fuels, medicines, devices, and capabilities for the Department of Defense.
This effort seeks to develop the tools, capabilities, and methodologies to create a transformative shift in the ability to engineer biology through the integration of ideas, tools, and approaches from the biological, computational, and engineering fields. Living Foundries aims to compress the biological design-build-test cycle and expand by 100-fold the complexity of systems that can be designed and engineered.
Transforming the FDA Archives into a Driver of Discovery and Development
The FDA currently houses one of the largest known repositories of clinical data, including safety, efficacy, and performance information, and an increasing amount of post-market safety surveillance data. Integrating and analyzing these data could revolutionize the development of new patient treatments and allow researchers to address fundamental scientific questions about how different patients respond to a therapy.
FDA is rebuilding its information technology and data analytic capabilities and establishing “science enclaves” that will allow for the analysis of large, complex datasets while maintaining proprietary information. In addition to potential new therapies for patients, these efforts will result in significant and demonstrable reductions in costs to drug and medical device developers.
Forging Scientific Advancement with Integrated Cyberinfrastructure
The future bioeconomy relies on collaborations among biologists, scientists from other disciplines, and engineers, and the ability of these teams to harness so-called “big data”—extremely large, complex datasets that are difficult to store, analyze, and visualize—in fields of direct relevance to the bioeconomy. For example, the size of DNA sequencing databases is reported to be increasing by a factor of 10 every 18 months, and doing comparisons of complex DNA datasets, such as DNA sequences of organisms found in the human gut, can take days of computing time. Realizing the full value of “big data” for the bioeconomy will require new partnerships between public and private sectors, and strategic efforts to shape the national bioeconomy research agenda.
In February 2011, the NSF announced an agency-wide crosscutting effort, Cyberinfrastructure Framework for 21st Century Science and Engineering, to provide a comprehensive, integrated infrastructure to accelerate research and education and new functional capacities in computational and data-intensive science and engineering.
Exploring New Discoveries for Potential to Treat Neurological Diseases
After the 2007 discovery of so-called induced pluripotent adult stem (iPS) cells, NIH moved quickly to better understand these cells’ potential to assist development of cell-based models for drug discovery and new therapies. The generation of iPS cells from human somatic cells (such as fibroblasts, cord blood, and peripheral blood) has enormous potential for revolutionizing our understanding of disease mechanisms and spurring progress in therapeutic discovery.
NIH funded several consortia to develop iPS cell lines neurological disorders and has built resources quickly and begun to characterize these cells as models of disease. The data from this work are freely available to scientists in industry as well as academic researchers with the goal of spurring the maximum innovation from a single investment.
The report further outlines biofuel and agricultural efforts as well as intramural technology cooperation initiatives and goals for accelerating technology transfer between the public and private sectors.
Read the rest: National Bioeconomy Blueprint (.pdf)