The COVID-19 pandemic has highlighted the urgent need to address lags in American pharmaceutical manufacturing. An investment of $5 billion over five years will improve U.S. pharmaceutical manufacturing infrastructure, including the development of new technologies that will enable the responsive, end-to-end, on-demand production of up to half of the Food and Drug Administration (FDA) list of 223 essential medicines by year two, and the entire portfolio by year five. Spearheading improvements in domestic manufacturing capacity, coupled with driving the advancement of new adaptive, on-demand, and other advanced medicine production technologies will ensure a safe, responsive, reliable, and affordable supply of quality medicines, improving access for all citizens, including vulnerable populations living in underserved urban communities, rural areas, and tribal territories.

Challenge and Opportunity

Urgent Need to Strengthen U.S. Pharmaceutical Manufacturing

COVID-19 has served as a wake-up call and an opportunity to bring pharmaceutical manufacturing into the 21st century. Production factory closures, shipping delays, shutdowns, trade limitations, and export bans have severely disrupted the supply chain. Yet the demand for vaccines and COVID-19 treatment options worldwide continues to increase. However, recent advances in manufacturing technology can be deployed to create a 21st century domestic pharmaceutical manufacturing economy that is distributed, flexible, and scalable, while producing consistent high-quality medicines that Americans rely on.

To improve national security and achieve the goal of medicine production self-sufficiency, the Biden-Harris Administration has an opportunity to address legacy issues plaguing the pharmaceutical manufacturing industry and usher in a technology revolution that will leapfrog our legacy 19th century industrial manufacturing processes. The Biden-Harris Administration should prioritize:

Improving the domestic production of small-molecule medicines, including Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs) in order to reduce dependence on foreign manufacturers. China and India together supply 75- 80 percent of the APIs imported to the U.S.¹ In March, during the largest spring spike in U.S. COVID-19 cases, India restricted the export of 26 APIs as well as finished pharmaceuticals. The U.S is the leading market for generic pharmaceuticals, with 9 out of every 10 prescriptions filled being for generic drugs in 2019, and a projected market value of $415 billion by 2023.² An aggressive race to the bottom in terms of price has driven the vast majority of supply chain manufacturing overseas, where lower production costs and government subsidies, particularly for exports, benefit foreign suppliers.

Improving the scale, efficiency, and effectiveness of domestic biopharmaceutical manufacturing. The past decade has ushered in a significant shift in the nature of pharmaceutical products: there is now a greater prevalence of large molecule drugs, personalized therapeutics, and a rise in treatments for orphan diseases. New approaches to developing vaccines, such as the mRNA COVID-19 vaccine, are setting a new paradigm for future vaccines using DNA, RNA, adenoviruses, and proteins. There is an urgent need to scale up the domestic manufacturing of biologics, including vaccines, to address biomedical threats. In addition, innovation in manufacturing technology is critical to improving both scalability and time to market. New technology will improve yields while lowering costs and reduce waste through green chemistry.

Additional benefits associated with establishing a robust domestic manufacturing base, including distributed manufacturing capability, include:

Reducing vulnerabilities associated with an over-reliance on centralized manufacturing and processing models. In the food industry, a COVID-19 outbreak in just a few chicken and pork processing plants led to a nationwide shortage of these important foods. A more flexible, resilient distributed manufacturing model, such as one utilizing additive manufacturing and 3-D printing, would have prevented the need for such a disruptive response. 3-D printing, for example, has successfully delivered more than 1,000 parts to local hospitals during the pandemic.

Improving the reliability of facilities and the quality of products for the U.S. market through the development and deployment of advanced manufacturing technologies. Low-cost, offshore manufacturing raises quality risks; more than half of FDA warning letters issued between 2018 and 2019 were sent to facilities in India or China.4 There are numerous examples of risks to both the health and security of U.S. citizens in the recent past. In 2007, a Chinese company deliberately contaminated the blood thinner Heparin and 246 Americans died. In 2015, the FDA banned 29 products after inspecting a Chinese pharmaceutical factory, although it exempted 14 products over U.S. shortage concerns. And in 2018, a Chinese vaccine maker sold at least 250,000 substandard doses of vaccine for diphtheria, tetanus, and whooping cough.

Improving access for vulnerable populations living in underserved urban communities, rural areas, and tribal territories. COVID-19 created unprecedented pressure on the federal system when requests from 56 State, Local, Tribal, and Territorial (SLTT) authorities nearly simultaneously requested medical supplies. According to testimony presented by the RAND Corporation, the quantities of material in the Strategic National Stockpile (SNS) were not nearly enough to fill all of the requests, resulting in a heated competition and a failure to deliver products to all of the different parts of the United States equitably.

Reducing critical drug shortages that have plagued U.S. health systems for more than a decade. With COVID-19 cases on the rise, and hospitalizations increasing in more than 40 states, critical drug supplies are waning, with 29 out of 40 drugs used to combat the coronavirus currently in short supply. In addition, 43% of 156 acute care medicines used to treat various illnesses are running low. In 2019 the U.S. experienced 186 new drug shortages; 82% of which were classified as being due to “unknown” reasons, largely because of the intentional opacity and secrecy of the upstream supply chain. According to the Center for Infectious Disease Research and Policy (CIDRAP) the U.S. health system spends more than $500 million a year on estimated costs related to drug shortages, with approximately $200 million in direct costs and up to $360 million on indirect costs.

Stabilize pricing by enabling ‘just in time’ manufacturing capability that reduces the need to stockpile large supplies of medicines and is more responsive to surges in demand. Furthermore, complex supply chains, procurement mechanisms, and the consolidation of U.S. buyers create ‘pay-to-play’ schemes that contribute to chronic drug shortages by driving manufacturers out of the market and contribute to price volatility. New technologies that enable responsive and efficient approaches to surges in demand, or to address drug shortages, will also stabilize pricing over time. Today, one in four Americans cannot afford their medication. Mylan, for example, increased the price of EpiPen by more than 500%, from $94 for a two-dose pack in 2007 to $608 in 2018.

21st Century Problems Require 21st Century Solutions

Advanced manufacturing technologies such as continuous flow, which allows for drugs to be produced in a continuous stream, can reduce the time it takes to manufacture a drug and ensure quality through advanced controls and process analytic technologies. These technologies can enable remote monitoring during production and real-time release testing. In addition, miniaturized manufacturing units that could easily fit in existing pharmacies would facilitate a distributed network for producing medicines that is flexible enough to rapidly pivot and make any therapeutic required for national security or emergency preparedness with short lead times. A distributed network of on-demand pharmaceutical manufacturing devices will improve supply availability without the need to stockpile large quantities of medications.

Automation will play a key role in advanced pharmaceutical manufacturing, as will 3-D printing. Automation will reduce manufacturing overheads and ensure quality, scalability, and increased outputs. It allows advanced connectivity of equipment, people, processes, services, and supply chains. The 3-D printing of pharmaceutical products, meanwhile, is accelerating following the FDA’s approval of the first 3-D printed drug in 2015. This technology accommodates personalized doses and dosage forms and other emerging technologies that enable bespoke tablet sizes, dosages, and forms (suspension, wafers, gel strips, etc.) to optimize patient compliance and ease of use. Another major advantage is the possibility of redistributed manufacturing–printing medicine much closer to the patient. 3-D printing and on-the-spot drug fabrication will have major implications in medical countermeasures and for medications with limited shelf-life.

Finally, investing in advanced biopharmaceutical manufacturing infrastructure and innovation would establish the capacity to produce domestically through a network of high-tech, end-to-end manufacturing and development solutions, which will ensure that the medicines of today and tomorrow, such as new vaccines, can be made quickly, safely, and at scale.

Plan of Action

The Biden-Harris Administration should launch a national adaptive pharmaceutical manufacturing initiative focused on the ambitious goal of achieving medicine production self-sufficiency. The Presidential Initiative should be led by an Ambassador who reports to the Secretary of Defense. The Secretary of Defense is already leading a whole-of-government effort to assess risk, identify impacts, and propose recommendations in support of a healthy manufacturing and defense industrial base – a critical aspect of economic and national security. The Department of Defense (DoD) coordinates these efforts in partnership with the Departments of Commerce, Labor, Energy, and Homeland Security, and in consultation with the Department of the Interior, the Department of Health and Human Services (HHS), the Director of the Office of Management and Budget, and the Director of National Intelligence.

Clear deliverables and timeline-dependent milestones are critical to the success of this initiative. New local manufacturing solutions — such as state-of-the-art facilities and devices for automated end-to-end pharmaceuticals to be deployed in a trailer — can augment ongoing efforts to reduce manufacturing ramp-up time, the need for strict environmentally controlled secure storage facilities, and waste from expired medications. Having stand-alone or mobile devices for automated end-to-end pharmaceuticals would empower local authorities to manage delivery and distribution protocols, ensuring that local populations have the lifesaving medicines they need when they need them.

To this end, the DoD, in collaboration with HHS and the FDA, should launch a national initiative to increase U.S. manufacturing capacity and accelerate the development of new technology, with an emphasis on the adoption of advanced analytical capabilities to ensure quality. These platforms should be able to produce precursors, APIs, and final drug products (small molecule and biologics) in multiple forms, enabling rapid response priority medicines on demand, targeting the creation of a self-sustaining domestic supply chain of the 223 medicines on the FDA Essential Medicines list, as well as new vaccines and medicines coming off patent in the next 5 years.

The establishment of a national pharmaceutical manufacturing network will facilitate a U.S. strategic asset that changes how we source, manufacture, and distribute medicines. This robust domestic network will mitigate drug shortages, ensure quality, and allow rapid response to emergency scenarios. Importantly, it re-establishes a domestic pharmaceutical manufacturing industry that relies less on overseas suppliers, advances our country’s innovation prowess, and will create thousands of new U.S. jobs.

Recommendations for the Department of Health and Human Services and the Department of Defense

To enable a more resilient, responsive and adaptive U.S. pharmaceutical supply chain and achieve medicine production self-sufficiency, the following actions are recommended.

First, sign an executive order that directs the formation of a Joint Interagency Task Force (JIATF) DoD, HHS and FDA, led by a Presidential appointee (Ambassador), with a $5 billion, 5-year funding commitment, to establish a more robust domestic responsiveness that includes advanced manufacturing technologies for biologics and small molecules. A key objective of the executive order and the formation of a JIATF is to ensure the U.S. can produce medicines stateside with improved responsiveness.

This initiative will:

• Identify a portfolio of products that can be rapidly deployed at a national, state or local level utilizing advanced manufacturing platforms, identify associated research and development agenda needs, and determine how this aligns with other initiatives such as the Strategic National Stockpile.
• Support targeted synthetic biology research and development to enable faster manufacturing of low-cost, on-demand vaccines and precision immunotherapies.
• Support the advanced development of green, modular, on-demand small-molecule manufacturing technologies that would accommodate small batch lines, with an ability to scale and produce higher volume when needed. • Support targeted advanced development of sensor technologies that can monitor online and real-time quality control.
• Support the acquisition and/or establishment of new U.S.-based manufacturing facilities.
• Support green technology solutions.
• Establish a center for excellence in advanced manufacturing at the FDA, to support and advance regulatory science.
• Identify new business models to support the economically sustainable domestic adoption and deployment of new manufacturing technology.
• Enact push and pull incentives to direct new medical countermeasure development funded by HHS (Biomedical Advanced Research and Development Authority, BARDA) and other federal agencies to utilize adaptive manufacturing practices as appropriate.

Key milestones and deliverables of this initiative include the following:

1. By year 2, ensure that 50% of the FDA’s Essential Medicines are manufactured from end-to-end in the United States, to include starting materials and APIs.
2. By Year 5, the FDA will have the capability to manufacture all Essential Medicines in the United States.
3. In this same time frame, the quality of every dose of the medicines produced can be provided to the FDA for oversight.
4. All starting materials are sourced domestically or from trusted allied nations.

Conclusion 

Expanding critical U.S. pharmaceutical manufacturing infrastructure and establishing an adaptive, transparent on-demand pharmaceutical manufacturing capability guarantees safe, secure, high-quality, and reliable supply of affordable drugs and would create thousands of new U.S. high-paying jobs. By utilizing green technology, it could reduce hazardous material waste by as much as 30 percent over conventional manufacturing. It would also improve transparency and supply chain efficiencies that could reduce shortages, lower costs, and improve the quality of medicines. A distributed, modular, on-demand manufacturing network capable of making biologics and small molecules cannot be disrupted by the loss of centralized facilities, natural disasters, pandemics, or adversarial actions. New local on-demand manufacturing solutions will reduce manufacturing ramp-up time, the need for strict environmentally-controlled secure storage facilities, and waste from expired medications. It will empower local authorities to manage delivery and distribution protocols, ensuring that local populations have the lifesaving medicines they need when they need them. In addition, it would offer the potential to improve warfighter resilience and recovery by providing the groundwork for producing medicines on demand, and at the point of care, whether it be on a C-5, submarine, or at a forward combat support hospital.

Summary

The Biden-Harris Administration should establish a National DeepTech Capital Fund (NDTC Fund) to bridge capital gaps and enable more DeepTech entrepreneurs to bring promising and beneficial technologies to market. 

Greater investment in DeepTech is critical in order to return the United States to the forefront of advanced science and technology research and development (R&D). “DeepTech” refers to companies and innovators building science-based, or R&D-based, products and services including hardware and advanced materials, robotics, manufacturing, and biotech. U.S. government investment in technology has declined by two-thirds in the past decades. Private capital typically eschews investment in advanced technologies, due to a combination of the additional expertise needed for and risks inherent to advanced-technology investment. Silicon Valley’s early days were cushioned by government risk capital at a time when the private sector could not see the value of investing in R&D. But relying entirely on Silicon Valley to drive investment in innovation has led the U.S. to a point where it risks being replaced by other innovation centers such as China. A National DeepTech Capital Fund would encourage and enable investment in companies building solutions to society’s greatest challenges, while ensuring that the United States remains at the center of global innovation.

Summary

Science and technology (S&T) must play a prominent and strategic role at all levels of United States foreign policy. On Day One, the Biden-Harris Administration should reinvigorate and reassert U.S. strength in science, technology, and data-driven decision making. S&T issues at the Department of State (Department) have historically been concentrated into specific offices and personnel, which has constrained the use of S&T as a tool to advance U.S. foreign policy goals. On Day One, the Administration can better identify, allocate, and elevate S&T issues and personnel throughout the Department. Building and rewarding diverse teams with the right mix of skills is good management for any organization, and could create significant progress toward breaking down the silos that prevent the realization of the full benefits of the S&T expertise that already exists among U.S diplomatic personnel.

Summary

This transition document provides over 25 actionable recommendations on the future of the United States Patent and Trademark Office (USPTO), in order to support future federal leadership and enable their success. The document is the result of collaboration between the Day One Project and a group of veteran policymakers who convened virtually to produce recommendations related to the following three categories:

1. Identifying specific policy and governance ideas that can be pursued in the first days and months of the next administration.
2. Gathering “lessons learned” from those who have previously served in government to learn from past challenges and better inform future initiatives.
3. Understanding key science and technology staffing and “talent” needs, and related challenges for the USPTO that can be addressed in the next administration.

The document also includes a cover memo which highlights some of the overarching key considerations for the future of the USPTO.

Contributors

• Margo A. Bagley
• Sharon Barner
• Brian Cassidy
• Colleen V. Chien
• Mark Allen Cohen
• Ayala Deutsch
• Ben Haber
• Philip G. Hampton
• Justin Hughes
• David J. Kappos
• Quentin Palfrey
• Arti K. Rai
• Teresa Stanek Rea
• Robert L. Stoll
• A. Christal Sheppard
• Saurabh Vishnubhakat
• Stephen Yelderman

Summary

The next administration should launch national Place-Based Public-Private Partnerships for Innovation (P4I) to supercharge American innovation by leveraging the power of proximity and partnerships, and in so doing, lay the foundation for a new and more inclusive era of American prosperity.

The P4I initiative will catalyze the formation and growth of vibrant Innovation Zones (IZs), creating powerful points of convergence that weave together place-based investments with educational, research, entrepreneurship, and economic supports to advance inclusive economic development from the American heartland to the coasts. IZs will catalyze the public-private development of mixed-use innovation hubs that house and support: training programs to prepare diverse and resilient labor forces; advanced research and development (R&D) activities undertaken by partnerships between universities and industry; and, incubators, accelerators, and investor groups to incubate, grow, and retain high-tech businesses.

P4I should be implemented by an interagency committee convened by the White House Office of Science and Technology Policy (OSTP) under the auspices of the President’s Council of Advisors on Science and Technology (PCAST). An interagency initiative will be critical for success, mobilizing federal agencies that share responsibility for all aspects of innovation and economic development policy, including STEM R&D, formation and growth of U.S. innovation industries (small to large), and innovation-based economic and workforce development.

Summary

Convergence is a compelling novel paradigm and a potent force for advancing scientific discovery via transdisciplinary collaboration. It is also a useful framework for multi-sector partnerships. The Biden-Harris Administration should form a Convergence Directorate at the National Science Foundation (NSF) to accelerate research and innovation and help ensure U.S. leadership in the industries of the future.

In forming the Directorate, NSF should:

• Commit resources that are commensurate with the importance of the Directorate’s mission.
• Provide the sustained focus needed to realize the tremendous potential of convergence.
• Ensure that the Directorate is organized to reflect the principles of convergence in its structure and operations.

Summary

The United States Agency for International Development (USAID) tackles some of the toughest challenges in some of the toughest places on earth, including fighting global pandemics, growing economic prosperity, strengthening democratic institutions, and providing humanitarian relief. USAID plays an important role in addressing global development problems that initially lack effective, scalable, and sustainable solutions. Yet USAID’s activities allow little room for the risk taking or iteration needed to drive significant improvements and encourage disruptive new ideas, with most programs implemented through detailed plans with rigid designs.

Imagine if the pace of progress for global development could match the breakneck pace of advances in the tech sector. The next administration should assess where current USAID interventions are inadequately meeting global need, applying best practices from innovation to improve programs accordingly. This will include shifting to outcomes-based performance metrics, dedicating budget for experimentation, establishing incentives that encourage risk-taking, linking payments with outcomes, and conducting ex-post evaluations of scale and sustainability.

Summary

To bolster competition, entrepreneurship, and innovation, the next administration should facilitate business-to-business (B2B) data sharing between startups and data-rich, established companies. Asymmetry in the digital economy is an existing market failure that, if left unchecked will continue to intensify to the detriment of consumer choice and our collective security.

Leveling the playing field requires policy to remove barriers to entry created by data advantages and to promote market competition through increased access to big data. Specifically, we propose that the Small Business Administration’s Office of Investment and Innovation establish a data-sharing program that gives entrepreneurs access to the data they need to improve algorithms underpinning their products and services. This would support a thriving and diverse ecosystem of startups that could in time yield valuable new markets and products.

The next administration should rapidly create new Focused Research Organizations (FROs) to tackle scientific and technological challenges that cannot be efficiently addressed by standard organizational structures including academia, industry, National Laboratories, or Advanced Research Project Agencies (e.g., DARPA). FROs would be independent from existing universities or labs, focused on a single basic science or technology problem, and organized similarly to a startup. FROs would fill a key structural gap in our nation’s research and development (R&D) system, enabling major advances in areas that (i) require levels of coordinated engineering or system-building inaccessible to academia, (ii) benefit society broadly in ways that industry cannot rapidly monetize, and (iii) harbor opportunities for acceleration through innovative new technologies and processes. Each FRO would produce a well-defined tool or technology, a key scientific dataset, or a refined process or resource that would dramatically boost progress and help maintain U.S. competitiveness in a broad technological or scientific field. Relevant areas for FROs include brain mapping, climate technology, biological tool and reagent development, data generation for preventative medicine, novel antibiotic development, nanofabrication, and more.

Challenge and Opportunity

The U.S. government is ill-equipped to fund R&D projects that require tight coordination and teamwork to create public goods. The majority of government-funded research outside of the defense sphere—including research funded through the National Institute of Health (NIH), the National Science Foundation (NSF), the Defense Advanced Research Projects Agency (DARPA), and the Advanced Research Projects Agency–Energy (ARPA-E)—is outsourced to externalized collaborations of university labs and/or commercial organizations. However, the academic reward structure favors individual credit and discourages systematic teamwork. Commercial incentives encourage teamwork but discourage the production of public goods. As a result, the United States is falling behind in key areas like microfabrication and human genomics to countries with greater abilities to centralize and accelerate focused research.

The solution is to enable the U.S. government to fund centralized research programs, termed Focused Research Organizations (FROs), to address well-defined challenges that require scale and coordination but that are not immediately profitable. FROs would be stand-alone “moonshot organizations” insulated from both academic and commercial incentive structures. FROs would be organized like startups, but they would pursue well-defined R&D goals in the public interest and would be accountable to their funding organizations rather than to shareholders. Each FRO would strive to accelerate a key R&D area via “multiplier effects” (such as dramatically reducing the cost of collecting critical scientific data), provide the United States with a decisive competitive advantage in that area, and de-risk substantial follow-on investment from the private and/or public sectors. Some FROs would lay the engineering foundations for subsequent government investment in programs similar in scope to the Human Genome Project.

Individual FRO-like entities have previously been established only occasionally and through disparate mechanisms. Most recently, the National Quantum Initiative Act established five FRO- like centers within National Labs, each funded at $25 million per year, to pursue advances in quantum-information technology. However, there is no systematic, agile process for the conception and creation of similar centers in a variety of fields. Establishing any FRO-like entity currently requires Congressional approval—an onerous and time-consuming process.

We expect FROs to attract broad bipartisan and popular support due to their potential to spawn new industries and establish American leadership. Precedent supports this expectation. The National Quantum Initiative Act, for instance, was co-sponsored by the bipartisan coalition of Lamar Alexander (R-TX), John Thune (R-SD), and Bill Nelson (D-FL), and passed the Senate by unanimous consent.

Plan of Action

The next administration should support the rapid establishment of 16 new FROs: four per year for the next four years, totaling 16 FROs. The next administration should work with Congress to secure new funding for these FROs, and the White House Office of Science and Technology Policy (OSTP) should oversee the development of a cross-disciplinary program to conceive and launch the FROs.

Funding

The total program budget for 16 FROs should be roughly $1 billion, or about $25–75 million per FRO allocated over 5-7 years (e.g., roughly $5–15 million per FRO per year). This is roughly 10 times the funding level accessible via a typical academic grant, yet comparable in cost to a DARPA project or to a philanthropic project like the Allen Institute’s Mouse Brain Atlas (~$55 million). Moreover, this level of funding is similar to the funding needed by a Series A/B “hard tech” startup to achieve proof of concept for a new technology prior to commercialization. Funding should be authorized for the FRO program as whole rather than for each individual component. This will enable the program to move quickly and independently, in similar fashion to DARPA. Funding the program as a whole will also support cross-disciplinary FROs and FRO initiatives. Agencies such as NIH, NSF, the Department of Energy (DOE), the various ARPAs, or the “Directorate for Technology” proposed in the Endless Frontier Act could be involved in the FRO program and could solicit or put forward specific FROs.¹

Logistics

FRO organization and operations should be designed to make FROs as agile, flexible, and self- directed as possible. Each FRO should exist independent of existing organizations such as National Laboratories or labs at other government agencies and academic institutions. Each FRO would be run by a CEO/CTO and staffed by a centralized, startup-like team of well-trained professionals sourced from both industry and academia. This personnel structure will enable tighter alignment of team incentives and focus than would an externalized collaborative research program that uses existing entities (e.g., universities) as performers. This structure will also enable tighter alignment of incentives and focus than would a DARPA-like externalized effort coordinated by a single program manager (although some FROs could be created as an outcome or second stage of DARPA-like programs). Generally, FROs would rent commercial real estate for operations. In rare cases it may be appropriate for FROs to use National Lab facilities. Pay structure in FROs should be flexible to allow top talent to be recruited.

FROs should be expressly time-bound and outcome driven in order to prevent mission creep and organizational aging. This will require clear and pre-defined end-points/exits. As an FRO sunsets, stakeholders in that FRO’s outputs should be convened to maximize output deployment and uptake. Intellectual property should be out-licensed or released publicly for similar reasons. Transition support should be provided to outgoing FRO employees. Follow-on from FROs could include formation and/or incubation of new companies, larger public-sector projects, and/or creation of facilities designed to host and maintain FRO outputs (e.g., datasets or tools).

Mission Selection

FROs should pursue specific goals that, if achieved, will dramatically increase the R&D capacity and/or technological capabilities of the United States in a given field. To preserve the FRO program’s ability to pursue specific, focused innovation objectives, FROs would operate for defined time periods and would not ordinarily be renewed. Renewal would only be permitted in exceptional cases in which an FRO proves that an extension of that FRO would be as impactful as the initial investment. More frequently, we expect that an FRO might serve as proof of concept for a project or initiative that could then be separately pursued through an act of Congress or through a public-private partnership. All new FROs should meet following two criteria:

1. FROs should be transformative. While FROs might occasionally integrate existing methods to directly produce a new dataset or clinical/scientific outcome, FROs should generally focus on developing transformative new technologies, systems, or processes. These capabilities should reduce the cost and/or increase the speed and reliability of subsequent scientific, clinical, or other downstream efforts, substantially increasing the rate of overall science and technology development in the United States.
2. FROs should be focused. Each FRO should be established with a clear, goal-oriented purpose. FROs should driven by quantitative metrics and/or concrete design goals and should be limited in scope and duration. Serendipitous discoveries made during the course of FRO research that are outside of the mission scope should be shared freely with external researchers for follow-up. Though we expect FROs to work closely with universities, FROs must not become subject to academic incentives and must avoid mission creep. Although an FRO may maintain external (e.g., academic) advisors and consultants, core staff must be appointed full-time at the FRO.

To ensure efficient and decisive selection and oversight of FROs, a dedicated and innovative program manager—rather than a committee of peer reviewers—could be recruited to help drive the conception, selection and formation of a small number of FROs on the government side. DARPA similarly appoints program managers instead of committees to enable the embrace of visionary or divergent perspectives. Program managers should be willing to take risks on “moonshot” projects for which there is not a consensus on feasibility or likely value.

Please download the PDF version of this memo to view the FAQ Section.

Summary

The next Administration should accelerate federal basic and applied research investments over a period of five years to return funding to its historical average as a share of GDP.  While this ambitious yet achievable strategy should encompass the entire research portfolio, it should particularly seek to reverse the long-term erosion of collective investments in physical and computer science, mathematics, and engineering to lay the foundation for economic competitiveness deep into the 21st century. This proposal outlines a strategy and series of steps for the federal government to take to reinvigorate U.S. competitiveness by restoring research and development investments.