Accelerating the American Scientific Enterprise

The Honorable Michael Kratsios
Director, Office of Science and Technology Policy 
The White House 
Washington, DC 20501

Re: Notice of Request for Information; Accelerating the American Scientific Enterprise; Docket No. OSTP-TECH-2025-0100

Thank you for the opportunity to provide input on accelerating the American scientific enterprise. The United States has long been the world’s engine for scientific discovery, but fragmented priorities, siloed data systems, outdated processes, and inconsistent coordination increasingly limit the pace at which discovery is translated into better health, economic growth, and national security.

The Milken Institute’s recommendations focus on structural reforms that would strengthen the scientific enterprise by improving coordination, reducing barriers, enabling risk-taking, and ensuring that scientific progress delivers tangible benefits for the public. Our responses are informed by our report, The Future of US Biomedical Research and Innovation: Recommendations for Action, from November 2025, which reflects extensive engagement across science, medicine, policy, industry, philanthropy, and patient communities, and offers a roadmap that is applicable across the broader scientific enterprise.

Question (i): What policy changes to Federal funding mechanisms, procurement processes, or partnership authorities would enable stronger public-private collaboration and allow America to tap into its vast private sector to better drive use-inspired basic and early-stage applied research?

To enable stronger public-private collaboration and better leverage private-sector capabilities at the early stages of discovery and development, federal policy should move beyond fragmented pilots and short-term funding toward sustained funding, data-sharing, and partnership models that align public-private investments. 

We recommend the following: 

1. Commission a National Life Sciences Strategy and Implementation Plan to align public and private investments around shared national priorities.

Public-private collaboration in biomedical research is currently hampered by misaligned incentives, unpredictable priorities, and fragmented decision-making. Private-sector actors (e.g., biopharmaceutical companies, investors, or philanthropies) make investment decisions years in advance, yet federal research priorities shift with agency budgets, leadership changes, and competing initiatives. Research priorities are set independently by NIH and other funders, while regulation, coverage, and reimbursement decisions are made separately by FDA and CMS with limited coordination. This fragmentation creates uncertainty that discourages long-term private investment in early-stage research, where commercial returns are distant and alignment with future federal priorities is unclear.

A comprehensive, five-year National Life Sciences Strategy and Implementation Plan would facilitate public-private collaboration by establishing predictable national priorities that all sectors can plan around. Modeled on NASA's Decadal Surveys, the strategy would provide a stable roadmap that signals to the private sector where federal research investments and regulatory focus are likely to align, reducing risk and encouraging private capital to flow toward prioritized areas. 

The strategy should be developed by an independent expert body, ensuring that private-sector perspectives shape priorities from the outset rather than being consulted after federal decisions are made. Rotating leadership and formal interagency liaison participation would ensure ongoing input from both sectors. A designated chair would be accountable for delivering the strategy, supported by a national coordinator within government to facilitate agency implementation, coordinate with private sector partners, provide mid-cycle updates, and ensure transparency through public reporting.

The purpose of the strategy is not to centralize scientific decision-making, replace investigator-initiated research, or direct private investment; rather, it aims to provide the cohesion, predictability, and alignment necessary for public- and private-sector actors to make complementary long-term commitments. 

2. Launch time-bound national data missions to facilitate public-private collaboration to address urgent scientific challenges. 

The private sector holds vast data assets and advanced analytics capabilities that are currently underutilized in addressing urgent national health challenges. These assets are largely disconnected from federal research infrastructure, largely because the complexity of public-private data is high. The White House should establish a national framework for data missions: large-scale, time-bound initiatives that bring together government, industry, academia, philanthropy, and patient groups to address urgent scientific and public health challenges. One to two missions could be launched annually to deliver results while also laying the groundwork for trusted collaboration around data sharing, analytics, and evidence generation across sectors.

These missions should be enabled through federated learning models that allow public- and private-sector partners to collaborate on analytics without moving source data from existing secure environments. Each mission would harmonize data under common quality and governance standards and build a roster of reusable assets, including technical standards, governance frameworks, and contracting templates, which could lower the barriers for subsequent cross-sector data collaborations.

3. Improve timely access to federal datasets, including CMS and FDA data, for researchers. 

Private-sector researchers face significant barriers to accessing federal data needed for product development and real-world evidence generation. Timely access to federal datasets is essential to accelerating biomedical discovery, improving evidence generation, and supporting more efficient translation of research into clinical practice. CMS and FDA hold some of the nation’s most valuable health data assets, including longitudinal claims, quality and outcomes data, and post-market safety information. Yet access to these datasets is often slow, fragmented, and limited, significantly constraining their scientific value. 

Federal agencies should expand access to CMS and FDA data through secure environments with standardized and streamlined application and approval processes. Building on existing platforms, such as CMS’s Virtual Research Data Center and FDA’s openFDA, agencies should modernize these systems to improve timeliness, expand dataset coverage, and enhance analytic tools. 

By treating federal health data as core scientific infrastructure, the federal government can unlock their full value to researchers, innovators, and policymakers, accelerating the pace at which scientific insights translate into real-world benefits.

Question (ii): How can the Federal government better support the translation of scientific discoveries from academia, national laboratories, and other research institutions into practical applications? Specifically, what changes to technology transfer policies, translational programs, or commercial incentives would accelerate the path from laboratory to market?

Improving translation depends not only on scientific breakthroughs but also on strengthening the systems that connect discovery, evidence generation, regulation, and access.

We recommend the following:

1. Strengthen the national clinical research infrastructure, including expansion into community-based settings.

In the US, clinical research remains fragmented, costly, and difficult to scale, limiting both patient participation and the ability to generate timely, real-world evidence. While traditional experimental trials remain essential for establishing safety and efficacy, greater impact will come from modernizing the entire clinical research enterprise to better reflect how medical products perform in real-world settings.

A central priority should be strengthening national clinical research infrastructure and expanding research beyond major academic centers into community-based settings. The federal government should establish a National Agenda for Clinical Trials, informed by a public–private partnership that brings together government, industry, academia, and patient groups. This agenda would set clear priorities for modernizing trial infrastructure, addressing long-standing barriers to participation, and reducing delays in trial initiation.

Achieving this transformation will require investment in coordinated national infrastructure rather than isolated fixes. An Office of the National Clinical Trial and Research Coordinator (ONCTRC) within HHS, led by a national coordinator, could serve as a central hub to improve trial efficiency by identifying evidence gaps in areas of high unmet need, developing national research challenges, and providing technical support to new and community-based trial sites. To avoid further fragmentation, the ONCTRC should be designed in close coordination with NIH and FDA from the outset.

Finally, the federal government should build a national inventory of clinical trial and research capacity through a public–private partnership. Today, information on trial sites and capabilities is fragmented and often proprietary, limiting strategic planning. A transparent national inventory would identify gaps in capacity, guide targeted investment, and enable the US to run clinical trials more efficiently at scale, accelerating the path from laboratory discovery to real-world impact.

2. Reduce administrative barriers to clinical research that slow translation, particularly for patients, clinicians, and community-based research sites. 

Reducing administrative and regulatory barriers is essential to accelerating the translation of scientific discoveries into clinical practice. Today, complex and often duplicative requirements slow trial initiation, increase costs, and limit participation by patients, clinicians, and community-based research sites. Streamlining oversight, contracting, and documentation would not only improve efficiency but also expand access to clinical research and speed the movement of discoveries from laboratory to real-world use.

The federal government should continue building on recent progress to make clinical trial participation more accessible to all patients. FDA guidance encouraging broader eligibility criteria creates an opportunity to increase participation and improve representativeness. Through protocol review and the promotion of exemplar trials, FDA can help normalize broader inclusion across therapeutic areas.

Simplifying informed consent is another critical lever. FDA’s 2023 guidance emphasizing plain language and accessibility should be reinforced through joint efforts between the FDA and the HHS Office for Human Research Protections (OHRP) to standardize consent templates and expand the use of electronic consent. eConsent enables multimedia explanations, multiple languages, and asynchronous review, reducing burden on sites while giving patients more flexibility and understanding. Clear, harmonized guidance would reduce uncertainty for sponsors and Institutional Review Boards (IRBs) and support broader adoption.

Clearer reimbursement and coverage policies are also necessary to lower barriers for patients. Trial participation often involves costs such as travel, childcare, and lost wages, yet uncertainty around permissible reimbursement, especially for Medicare and Medicaid beneficiaries, discourages participation. CMS should provide clearer guidance on routine care coverage and participant reimbursement, with FDA and OHRP aligning standards to reduce inconsistency and give sponsors greater confidence in supporting patient participation.

Finally, administrative burdens on sponsors and sites must be reduced to ensure trials remain feasible, especially for community-based sites. FDA and OHRP should issue joint guidance to clarify overlapping requirements, align definitions of minimal risk, and explore single submissions that satisfy both safety reporting and continuing review. Broader adoption of single IRBs and reliance agreements would streamline multisite studies. Additional reforms should include standardized contracts and liability frameworks, clearer guidance on Form FDA 1572 to prevent over-documentation, and streamlined Medicare coverage analysis through standardized approaches. 

Question (vi): What reforms will enable the American scientific enterprise to pursue more high-risk, high-reward research that could transform our scientific understanding and unlock new technologies, while sustaining the incremental science essential for cumulative production of knowledge?

Accelerating the scientific enterprise requires encouraging scientific risk-taking while sustaining the incremental research that enables cumulative progress.

We recommend the following:

1. Identify national scientific grand challenges to focus coordinated, long-term investment on transformative opportunities. 

As part of a National Life Sciences Strategy and Implementation Plan (see response to Question (i)), the federal government should identify a limited number of national scientific grand challenges in the life sciences to focus sustained, coordinated investment on transformative opportunities. Integrating grand challenges within a national strategy would ensure that they are selected based on scientific opportunity and population health needs, rather than as isolated initiatives.

These grand challenges should be explicitly designed as generational efforts, comparable in ambition and impact to the Human Genome Project, rather than as collections of incremental projects. They should target foundational scientific questions whose resolution would fundamentally reshape medicine and public health, and whose complexity and risk exceed the capacity of individual investigators, institutions, or agencies acting alone. A national strategy would provide the governance framework needed to align agencies, coordinate funding, and sustain investment over time.

2. Reform NIH to support risk-taking.

To support high-risk, high-reward research at scale, NIH must be structurally equipped to tolerate uncertainty and long time horizons. The NIH intramural research program should be reimagined as a platform for bold, cross-cutting research that requires stable federal infrastructure, interdisciplinary teams, and a higher tolerance for scientific failure than is feasible in traditional extramural grant programs. Intramural programs are uniquely positioned to serve as a vehicle to experiment with alternative approaches, including team-based science and long-horizon projects that do not fit conventional funding mechanisms.

At the same time, the NIH director should be provided with meaningful flexible funding authority (e.g., an expanded Common Fund or other discretionary resources) to advance cross-institute initiatives, respond to emerging scientific opportunities, and support rapid learning across the NIH. This authority would enable strategic alignment and timely action where institute-specific funding structures are limited.

Finally, peer review processes should be recalibrated to better recognize transformative and interdisciplinary proposals and to reduce structural bias toward incremental research. Review should be explicitly situated within mission and programmatic context, ensuring that funding decisions reflect scientific priorities. 

Question (vii): How can the Federal government support novel institutional models for research that complement traditional university structures and enable projects that require vast resources, interdisciplinary coordination, or extended timelines?

Certain scientific challenges require institutional models that provide national-scale coordination, long time horizons, and shared infrastructure beyond what individual universities can support.

We recommend the following:

1. Build federated interagency data ecosystems linking NIH, FDA, CMS, and CDC to enable national-scale analysis while preserving stewardship within agencies. 

The federal government should link the strengths of CDC, NIH, FDA, and CMS into a health data ecosystem built on a federated model. Today, each agency maintains valuable datasets, including CDC’s public health surveillance data, NIH’s research repositories and knowledge bases, the FDA’s safety and adverse event data, and CMS’s claims. However, these resources are siloed and inconsistently connected. Thus, analyses that require combining evidence, such as linking regulatory safety data with real-world claims, are often insufficient.

To overcome this challenge, the federal government should build on ongoing modernization efforts across HHS, such as Data COUNTS, and establish a coordinated interagency platform that enables federated analytics across agency data. This platform would allow secure queries across multiple datasets while the data remain under the stewardship of each agency responsible for its use. Common standards for access, privacy, and interoperability would ensure consistency, and privacy-preserving technologies would protect patient trust.

By transforming today’s fragmented platforms into a federated, interagency data ecosystem, the US could combine the full breadth of federal health data without creating a single data warehouse, unlocking national-scale insights while respecting agency authority.

Question (viii): How can the Federal government leverage and prepare for advances in AI systems that may transform scientific research—including automated hypothesis generation, experimental design, literature synthesis, and autonomous experimentation? What infrastructure investments, organizational models, and workforce development strategies are needed to realize these capabilities while maintaining scientific rigor and research integrity?

The adoption of AI in scientific research depends on foundational investments in data quality, regulation, and workforce capacity.

We recommend the following:

1. Establish national standards for data quality and support for clinicians and health systems to meet those standards so that AI systems are trained on quality data. 

Physicians and other providers have long been the primary source of health data (e.g., electronic health records, lab results, and public health reports). Most of the data are collected for billing and compliance purposes rather than in service of patient care or research. The result has been errors and inconsistencies in data collected, incomplete records, and delays in reporting. 

Federal networks need substantial investment to clean and harmonize provider-generated data. Meanwhile, providers, who remain the frontline generators of health data, face rising burdens complying with a patchwork of duplicative reporting requirements. Interoperability rules have improved the infrastructure for data exchange. Yet, much of what flows through that infrastructure remains of low quality and is largely unusable. Without national standards and appropriate incentives, including financial incentives, data quality will continue to vary widely, especially in smaller and under-resourced practices, and the burden remains on clinicians.

The federal government should establish national data-quality standards that set baseline expectations for timeliness, completeness, and accuracy of data. These standards should also support and incentivize providers to automate cleaning, deduplication, and record linkage at the point of data entry. To make this implementable, grants should be available to under-resourced providers to upgrade systems, offer technical assistance to help providers meet standards, and implement value-based payment adjustments that reward providers for contributing high-quality, analysis-ready data.

2. Build AI workforce capacity through a Service Corps combined with expanded public-private rotational programs. 

Realizing AI's transformative potential in scientific research requires workforce skills the federal government currently lacks. The federal government should evaluate the potential for a Service Corps modeled on ROTC, where participants receive scholarships, stipends, or loan repayment in exchange for three to five years of federal service in AI-related roles. In parallel, the government should expand rotational and exchange programs that allow mid-career AI professionals to move fluidly among government, academia, and industry through one- to two-year positions—enabling the federal government to access private-sector AI capabilities on urgent projects, transfer knowledge about federal research priorities to industry partners, and create a community of professionals who can effectively bridge sectors throughout their careers. (See response to Question (x) for additional detail on workforce recommendations).

Question (ix): What specific Federal statutes, regulations, or policies create unnecessary barriers to scientific research or the deployment of research outcomes? Please describe the barrier, its impact on scientific progress, and potential remedies that would preserve legitimate policy objectives while enabling innovation.

Unnecessary administrative and regulatory complexity continues to slow research and disproportionately limits participation by smaller and community-based institutions.

We recommend the following:

1. Harmonize overlapping oversight requirements across FDA and OHRP.

Oversight of clinical research remains fragmented across the FDA and OHRP, particularly with respect to IRBs, informed consent, and safety reporting. Although each agency serves distinct statutory roles, overlapping and inconsistently applied requirements create duplication, delay trial initiation, and increase administrative burden for sponsors and sites.

FDA and OHRP should issue joint guidance to harmonize overlapping requirements, standardize expectations for informed consent, align definitions of minimal risk, and clarify reporting obligations. Where appropriate, the agencies should explore mechanisms that allow single submissions to satisfy both FDA and OHRP, reducing duplicative processes while preserving participant protections.

In addition, broader and more consistent adoption of single IRBs and reliance agreements would significantly reduce administrative burden for multisite research. FDA and OHRP should standardize requirements and formally endorse widely used reliance templates. International models, including Australia’s National Mutual Acceptance program, demonstrate that shared review can improve efficiency without compromising ethical oversight.

2. Clarify and narrow documentation and contracting requirements that exceed their original intent. 

Over time, documentation and contracting requirements for clinical research have expanded beyond their original purpose, increasing cost and complexity without clear benefit. Multisite trials are frequently delayed by lengthy, customized contract negotiations and inconsistent liability frameworks, creating barriers for new entrants and community-based sites. NIH- and FDA-endorsed standardized master contracts and template agreements would provide a common, trusted framework that reduces negotiation time and uncertainty.

Similarly, documentation requirements, such as Form FDA 1572, have become over-applied. Intended to identify individuals making a direct and significant contribution to trial data, the form is often interpreted to include every local provider or laboratory, discouraging participation by community-based sites and making decentralized trials difficult to pursue. FDA should clarify who must be listed to reduce unnecessary documentation and support broader engagement in research.

Finally, Medicare coverage analysis (MCA) remains a source of redundancy and delay. Each trial site typically conducts its own MCA to determine which services qualify as routine care, even in multisite studies using identical protocols. CMS should streamline this process by allowing standardized MCAs for multisite trials or issuing clear templates, reducing duplicative efforts while maintaining appropriate billing safeguards.

Question (x): How can Federal programs better identify and develop scientific talent across the country, particularly leveraging digital tools and distributed research models to engage researchers outside traditional academic centers?

Sustaining scientific leadership requires identifying, developing, and retaining talent across the country, not only within traditional academic centers.

We recommend the following:

1. Create a National Biomedical Service Corps to support education and training in exchange for federal service commitments in critical scientific areas. 

Building on past precedents, including the National Health Service Corps, a new Biomedical Service Corps would support graduate students and professionals in areas identified as critical gaps in the current biomedical workforce.

A national biomedical service corps could be structured around an education-first, service-second model of the ROTC, where participants receive scholarships, stipends, or loan repayment in exchange for committing to a defined period of public service. While addressing financial barriers that deter many from pursuing government careers, this approach creates a clear and predictable pathway into federal roles. Placement could be strategically targeted to fill areas of greatest national need. Recruitment should prioritize candidates from geographically diverse institutions to broaden participation in biomedical careers.

For such a program to succeed, it would need broad national commitment and steady support over time. A reliable funding model is essential for maintaining training pipelines and fostering confidence in the program’s stability among participants. 

Mentorship, professional growth opportunities, and clear career paths would help ensure that federal service is a fulfilling duty and an attractive choice for those who wish to stay beyond the initial term. With sustained support, a biomedical corps could become a lasting pipeline of talent that strengthens the federal workforce and accelerates the translation of discovery into health impact.

2. Encourage greater mobility between government, academia, and the private sector, such as by expanding rotational and exchange programs. 

Agencies often lag in hiring for emerging fields because lengthy processes and rigid pay scales make it difficult to compete with industry. The federal government should create stronger mechanisms for career mobility between government and the private sector to accelerate knowledge transfer and innovation. 

A recent example can be found in the Advanced Research Projects Agency for Health (ARPA-H), which required the rapid recruitment of talent from the private sector to launch its programs. It drew on a wide array of special hiring and pay flexibilities to do so. While some have questioned the high salaries associated with these flexibilities, they underscore a larger challenge: Federal compensation systems are poorly aligned with today’s scientific and technical labor market, forcing agencies to rely on exceptions.

To build the workforce of the future, agencies must proactively identify, adapt, and leverage the hiring tools available to them, ensuring that talent can move fluidly between sectors without losing career momentum.

Question (xii): What policy mechanisms would ensure that the benefits of federally-funded research—including access to resulting technologies, economic opportunities, and improved quality of life—reach all Americans?

The success of the scientific enterprise should be measured by its ability to improve health, opportunity, and quality of life for people across all communities.

We recommend the following:

1. Launch a National Public Educational Campaign on the power of data to enable breakthroughs.

The federal government should fund a dedicated, public-facing education initiative to lead a national campaign on the value of data to scientific advances. This initiative could be housed within a federally chartered organization. 

The focus of the initiative would be to build public understanding of how data enable scientific discoveries that improve health and prevent, treat, and cure diseases more effectively and efficiently. Governance of the initiative would be overseen by an advisory board, led primarily by patients and community representatives, supplemented by experts in research, clinical care, and ethics. 

Federal agencies, such as NIH, FDA, CMS, CDC, and ONC, would serve as liaisons to ensure consistency and alignment. The campaign’s deliverables would combine national resources with deep community partnerships. A central hub would provide plain-language explainers, myth-busters, case studies using multimedia, and multilingual materials. 

Locally based, trusted messengers (e.g., patient groups, community health centers, libraries, and faith-based groups) would not only cocreate materials on widely used platforms, such as social media, but also serve as critical community partners to demonstrate the value of engagement in research. Other disciplines, including communications and marketing, should be leveraged. CDC, NIH, FDA, and CMS could be tasked with curating compelling case studies through dynamic video messages, illustrating the impact of data sharing to show the public how their contributions have enabled biomedical progress.

2. Enable individuals to serve as active partners in research through patient-controlled data sharing. 

Federal policy should enable individuals to participate in research as active partners by giving them meaningful control over how their health data are accessed, shared, and used across studies. A patient-controlled health data wallet would provide individuals with a secure, user-centered tool to aggregate health information from multiple sources, manage permissions through dynamic consent, and authorize trusted sharing for care and research. This approach would reduce friction for patients and providers, improve the quality and representativeness of research datasets, and support more efficient recruitment for clinical studies—particularly for individuals with rare or complex conditions.

A health data wallet model would return tangible value to individuals by providing insights into their health, alerting them to relevant research and clinical trial opportunities, and reducing duplicative testing and administrative burden. Analogous to digital banking wallets, which allow consumers to securely manage financial assets and transact across institutions, patient-controlled data sharing would lower transaction costs across the health ecosystem, improve data liquidity, and enable researchers and innovators to develop more effective therapies grounded in patient-consented data.

The federal government should commission a neutral convener to design and pilot a patient-controlled health data wallet, building on existing federal initiatives. CMS’s Blue Button 2.0, Trusted Exchange Framework and Common Agreement (TEFCA), and NIH initiatives such as All of Us and Data COUNTS provide a strong foundation for testing governance models, technical standards, and consent mechanisms. As part of this effort, Congress should expand ONC’s statutory authority to include research as a permitted purpose under TEFCA. Doing so would allow individuals to authorize the secure transfer of their data directly from providers and payers into research environments, reframing TEFCA not only as an interoperability standard but also as trusted national infrastructure that empowers patients to shape and participate in biomedical research.

Conclusion

Thank you for the opportunity to provide input on this important initiative. We appreciate OSTP’s leadership and look forward to continued engagement as the administration advances policies to accelerate the American scientific enterprise and ensure that scientific progress delivers tangible benefits for all Americans. We welcome an opportunity to discuss these recommendations in further detail.