This year, ASPET announced that 13 awardees would participate in the 2025–26 Washington Fellows program. The program’s mission is to enable developing and early-career scientists interested in science policy to learn about and become more engaged in public policy issues. This year’s class focused on a diverse variety of issues to further their interest in government and science policy, culminating in actionable policy briefs, and we are proud to present portions of their briefs below. To access the full brief, click on the PDF links below. And to learn more about this year’s class of Washington Fellows, visit the program’s site.
Enhancing Trust in Science by Addressing the Reproducibility Crisis in Biomedical Research
By Kofi Frimpong-Manson, PhD, Department of Anesthesiology and Perioperative Medicine, Rutgers, The State University of New Jersey
Executive Summary
Biomedical research has had a significantly positive impact on drug discovery and development. However, there is ample evidence from researchers and policy analysts that highlights challenges with the reproducibility of scientific findings. In an international cross-sectional survey involving biomedical researchers, over 70% agreed there is a reproducibility crisis. Most of these scientists also indicated that there was little institutional support for conducting replication studies, with institutions favoring novel research. The National Institutes of Health (NIH) emphasizes scientific rigor in grant applications and published work, but there are gaps in statistical-method education and in the incentives for replication studies.
This policy brief recommends three actionable strategies that should be adopted by the NIH to help curb the reproducibility crisis:
- NIH allocates more funding resources for replication research and creates institute-specific working groups to determine which studies require replication.
- The NIH establishes division-specific working groups to develop tailored statistical decision-making frameworks aligned with the methodological needs of each research area.
- The NIH establishes cross-institute working groups to develop mechanisms for statistical literacy certification.
These recommendations align with the NIH’s commitment and federal priority to strengthen the reliability of taxpayer-funded biomedical research.
Encouraging But Governing Artificial Intelligence in Pharmacology: A Congressional Framework for Responsible Biomedical Innovation
By Khalid Garman, MD, MSc, PhD, National Institutes of Health
Executive Summary
Artificial intelligence (AI) is increasingly used in pharmaceutical research to help identify drug candidates, predict safety risks, and improve early-stage decision-making. These tools have the potential to shorten development timelines and reduce costs, although their impact varies across applications. At the same time, AI introduces challenges related to data quality, transparency, reproducibility, and accountability, areas that fall within Congress’s oversight responsibilities.
Federal agencies, including the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the National Institute of Standards and Technology (NIST), are actively supporting AI in biomedical research and developing standards to guide how these systems are tested, validated, and used. Scientific organizations have also emphasized the need for transparency and human oversight in AI-enabled research. Internationally, regulators are beginning to align on best practices, including joint efforts by the FDA and European Medicines Agency (EMA) to outline guiding principles for AI in drug development.
Despite these developments, U.S. governance remains fragmented. Limited coordination across agencies and inconsistent expectations for AI validation create uncertainty for both industry and academia.
This brief proposes an “encourage but govern” framework: promote responsible AI adoption while strengthening coordination and oversight. By mandating interagency collaboration, tying federal funding to transparency standards, and supporting targeted pilot programs, Congress can help ensure AI complements rigorous scientific practice while maintaining U.S. leadership in biomedical innovation.
Streamlining Federal Oversight of Scheduled Substances to Advance Biomedical Research
By Kellen Henning, Epidemiology at the University of Texas Medical Branch
Executive Summary
Research involving controlled substances is essential for discoveries in biomedical science across numerous fields, including pharmacology, neuroscience, pain research, and infectious disease. Despite this importance, researchers seeking to conduct new federally compliant research involving Schedule I and II substances face substantial administrative barriers that delay or prevent scientific progress. Investigators must navigate multiple layers of approval, including DEA registration, institutional review, and limited sourcing options, often resulting in approval timelines that extend for many months. These delays increase research costs, disrupt grant timelines, and discourage investigators, particularly early-career researchers, from pursuing critical lines of inquiry that could lead to medical advances.
While the Controlled Substances Act appropriately prioritizes maintaining security of substances, current regulatory processes often impose unclear requirements that do not proportionally enhance safety outcomes relative to their administrative burden. As a result, the pace of biomedical research involving controlled substances does not match an increasing scientific need.
This policy brief recommends targeted, process-level reforms within the DEA’s existing framework to reduce unnecessary administrative burden on researchers while maintaining rigorous oversight. By streamlining registration procedures and expanding access to approved research-grade substances, the federal government can accelerate biomedical research without compromising regulatory integrity.
Breaking Barriers to Access Psilocybin-Assisted Therapies in the U.S.: Federal Rescheduling and State-Level Reform in Washington
By Lauren E. Honan, PhD, University of Texas Health Science Center at San Antonio
Executive Summary
Major depressive disorder (MDD) poses a massive public health burden in the U.S. and first-line therapeutics to treat MDD are lacking in efficacy. Emerging evidence from clinical trials demonstrates psilocybin-assisted therapy can provide immediate, sustained relief from MDD symptoms. Despite promising results, psilocybin is classified as a Schedule I substance with no currently accepted medical use in the U.S. This classification presents significant barriers to research and access to psilocybin-assisted therapy.
The following interventions are recommended to facilitate access to psilocybin-assisted therapies:
- Encourage local policy makers in Washington to support adoption of legislation to create legal regulatory frameworks following the Oregon Psilocybin Services model to facilitate state-level access to psilocybin-assisted therapy.
- Support federal rescheduling of psilocybin under the Controlled Substances Act by encouraging the National Psychedelics Association and the psychedelic research community to prepare statements to introduce at key stages in the rescheduling process.
These actions will significantly reduce regulatory barriers to psilocybin research and facilitate rapid adoption and access to psilocybin-assisted therapy in Washington State, allowing potentially-life saving care to be accessed by communities who need it most.
Stronger Together: Why Animal Models Remain Essential Alongside FDA-Backed Non-Animal Approaches
By Dawn Jessup, PhD, University of Michigan School of Medicine
Executive Summary
The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for the regulation and approval of investigational new drug applications as well as establishing guidelines, and together with the NIH effectively dictate how those data are ideally collected. Recent policy changes at both institutions have marked a significant and concerning departure from the critical and long-standing support for the use of animal subjects in research studies in favor of non-animal models (NAMs). While the use of animal-model alternatives should always be encouraged where appropriate, computational models and so-called organ-on-a-chip technologies have not yet reached a level of reliability and reproducibility to fully replicate the complexity of life and its underlying mechanisms in a whole organism on their own.
To more effectively reduce the dependence on animal models of human disease which may not fully capture the human pathology, regulatory and funding agencies which oversee scientific research should focus on expanding current programs aimed at developing humanized (i.e. containing or expressing human genes of interest) animal-models that may provide a more translatable platform for drug development and disease research.
Furthermore, existing resources which have historically funded and evaluated research proposals centered on the development of both animal and non-animal model approaches are spread across a multitude of agencies and centers. Unifying these resources under a central office, such as CDER’s Office of New Drugs, would create a more streamlined and efficient pathway for the development of these emerging tools. Moreover, a centralized office would be better equipped to establish and enforce a reasonable set of criteria for standardizing NAMs and humanized models going forward.
To address these issues, this brief recommends:
- Investing in Humanized Animal Models as a Transitional Bridge
- Establish a Centralized Office for Preclinical Model Oversight
- Require Rigorous Validation of NAMs Before Phasing Out Animal Requirements
Protecting and Optimizing the Established Program to Stimulate Competitive Research (EPSCoR) to Stabilize United States Research Capacity and Workforce
By Zari McCullers, Penn State College of Medicine
Executive Summary
NSF EPSCoR’s stated mission is to “enhance the research competitiveness of targeted jurisdictions…by strengthening STEM capacity and capability.” The target jurisdictions referenced are states, US territories and commonwealths whose five-year share of NSF funding has been less than or equal to 0.75% of total NSF funding. By stimulating the STEM research output of these target jurisdictions, EPSCoR promotes strides towards a uniformly “world class” research infrastructure in the US, in direct alignment with the FY2027 OMB/OSTB R&D priority crosscutting actions—see “Build the S&T Workforce of the Future and Expand and Make Accessible World-Class Research Infrastructure.” Despite a mission that stands firmly in long-held goals of OMB and OSTP across administrations, EPSCoR, as a Broadening Participation program, has faced shuttered working capacity (including funding and workforce), causing uncertainty in the long-term stability of the program.
To address these challenges, this brief recommends NSF:
- Implement a uniform EPSCoR Impact & Engagement Dashboard to standardize outcome reporting and strengthen accountability and congressional visibility.
- Establish formal stabilization policy mechanisms, including a dedicated continuity funding structure and rapid reinstatement protocols, to protect EPSCoR investments during fiscal disruptions.
- Rebuild and modernize EPSCoR’s administrative workforce to ensure effective program oversight and implementation.
Regulatory Gaps and a Risk-Based Framework for Managing Pre- and Probiotic Effects on Drug Metabolism
By Kiana Miyamoto, PhD, UC San Diego
Executive Summary
Prebiotics and probiotics are now a routine part of everyday wellness, with millions of Americans using them alongside prescription medications. Emerging evidence from the field of pharmacomicrobiomics demonstrates that gut microbes are not passive passengers; they actively shape how the body processes drugs, thereby altering bioavailability, absorption, efficacy, and toxicity. Yet probiotic products remain in a grey area regulated based on their marketed use as superfoods or dietary supplements, rather than as biologically active agents capable of meaningfully changing drug and treatment responses and side effects.
Current FDA regulation is claim-based rather than biology-based. A live microbial product with the potential to inactivate a chemotherapy agent or reactivate a toxic drug metabolite can currently enter the market without interaction testing, without strain-level labeling, and without any systematic mechanism for monitoring harm. Additionally, clinicians lack guidance on probiotic use, and patients are unaware of the potential risks.
Sustaining HIV Research in the Context of Substance Use: Policy Strategies to Support ART Effectiveness and Public Health Equity
By Rodnie Colón Ortiz, Johns Hopkins University School of Medicine
Executive Summary
Human Immunodeficiency Virus (HIV) remains a significant public health challenge in the United States, especially among populations disproportionately affected by substance use. While antiretroviral therapies (ART) and pre-exposure prophylaxis (PrEP) have substantially reduced HIV transmission and improved life expectancy, these advances have contributed to a growing perception that HIV is no longer a pressing health concern. However, effective HIV prevention and treatment continue to depend on sustained research investment, accurate public education, and attention to biological and structural factors that influence outcomes beyond medication adherence alone.
Evidence indicates that ART vary in their distribution across tissues, including the central nervous system, and that the brain remains a pharmacologically challenging site for HIV treatment and eradication. Furthermore, substance use is prevalent among people with HIV and is associated with poorer neurological and clinical outcomes. Emerging studies suggest that substances of misuse may influence ART effectiveness through shared transport and metabolic pathways and dysregulation of the blood-brain barrier and neuroimmune signaling. Despite the relevance of these drug-drug interactions, existing efforts to integrate substance use into HIV research and policy frameworks are frequently challenged by the constantly evolving landscape of substance use. Periods of funding uncertainty and shifting research priorities can further disadvantage interdisciplinary work, which limits the ability to study poly-drug exposure under real-world conditions.
This policy brief proposes strategies for the US Department of Health and Human Services (HHS), through coordination by the National Institutes of Health Office of AIDS Research (NIH OAR), to strengthen combined research and public engagement at the intersection of HIV and substance use. These recommendations focus on reinforced integration of substance use considerations in HIV research frameworks, and evidence-based, community-engaged education efforts to address misinformation surrounding HIV, addiction, and treatment.
Preparing for the Silver Tsunami: Strategies to Mitigate Burden on the Healthcare System Due to Older Adults with Epilepsy
By Larissa Robinson-Cooper, University of Washington
Executive Summary
Adults over the age of 65 are at the highest risk of being newly diagnosed with epilepsy, and as the global population is aging rapidly, the number of older adults with epilepsy is set to increase dramatically. There are currently ~75,000 Washington State residents living with epilepsy, and this number will increase as the population ages. Older adults with epilepsy will present a substantial burden to health and social care systems. Many older adults experience their first seizure in chronic care facilities which do not always have protocols in place to manage care during and after the seizure. Additionally, Washington state’s main Epilepsy Centers are all located in the Puget Sound region, meaning older adults located in the eastern portion of the state must travel across state lines to reach the nearest center. To mitigate this impending burden on the healthcare system and improve access to care for older adults with epilepsy, I recommend the following state-funded initiatives:
- Allocate funding to the Epilepsy Foundation Washington to develop and disseminate a series of workshops on navigating an epilepsy diagnosis later in life.
- Increase funding for mobile care and non-emergency transportation services to improve access to epilepsy care for older adults.
- Fund the Community Pharmacist Epilepsy Services Program to provide training on improving treatment of older adults with epilepsy to community pharmacists, including those working in nursing homes.
Failing Before Heart Failure: Addressing Sex-Disparities in Cardiovascular Disease Treatment and Outcomes
By Sophia Salbato, University of California, Davis
Executive Summary
Cardiovascular disease is the number one cause of death for women in the United States (US). There are higher rates of cardiovascular disease misdiagnosis and delayed diagnosis for women compared to men, which contributes to sex-disparities in cardiovascular disease treatment and disease outcomes. This creates a cardiovascular disease gender gap that, if it persists until 2040, is estimated to cost 28 billion dollars and the loss of 1.6 million years of quality life. Despite women making up more than half of the US population, most medical schools do not include sex-specific medical training. Instead, most medical students are trained on primarily male data and case studies of male patients. The lack of requirements for sex-specific medical training has led to most physicians feeling underprepared to assess cardiovascular disease in women. This results in worse outcomes for women, including a lower chance of survival after a heart attack.
To fill this clinical gap and mitigate the burden of cardiovascular disease on human health, sex-specific cardiovascular curricula must be incorporated into national standards for physician training in the United States. This brief recommends the Liaison Committee on Medical Education (LCME) and the Accreditation Council for Graduate Medical Education (ACGME) update national standards for physician training in the US to incorporate sex-differences in cardiovascular health and disease.
Hidden in Plain Sight: What New York Can Do About Metabolic-Disrupting Chemicals
By Nada Ahmed Selim, University of Rochester School of Medicine and Dentistry
Executive Summary
Metabolic-disrupting chemicals (MDCs), including bisphenols, phthalates, and PFAS, contribute an estimated $340 billion annually in national disease costs. These chemicals are grouped into “classes,” meaning families of compounds that share similar molecular structure and biological effects (for example, all bisphenols, including BPA, BPS, and BPF, act as endocrine disruptors despite differences between individual compounds). While the European Union banned BPA and hazardous bisphenols in food contact materials under hazard-based REACH regulations effective January 2025, the U.S. federal response remains fragmented and risk-based, enabling “regrettable substitution” where banned chemicals are replaced with similar alternatives. With 95% to 97% of Americans exposed but limited public awareness, New York has the opportunity to lead. This brief proposes three coordinated actions:
- A statewide consumer education campaign
- Strengthened chemical class disclosure requirements building on existing children’s product regulations
- Legislative establishment of a class-based regulatory framework for metabolic-disrupting chemicals.
Together, these recommendations leverage New York’s existing regulatory infrastructure and position the state as a national leader in chemical safety policy.
Strengthening U.S. Genetic Privacy Protections in the Age of Whole-Genome Sequencing
By Sherouk M. Tawfik, PhD, University of Connecticut
Executive Summary
Whole-genome sequencing and direct-to-consumer (DTC) genetic testing have become widely accessible in the United States, generating unprecedented volumes of sensitive genetic data. These technologies offer powerful opportunities for disease prevention, early diagnosis, and precision medicine. However, existing U.S. genetic privacy protections have not kept pace with the rapid expansion of commercial genetic testing and data sharing.
The Genetic Information Nondiscrimination Act (GINA) of 2008 prohibits genetic discrimination in health insurance and employment, but significant gaps remain. Life, disability, and long-term care insurers may legally request and use genetic information in underwriting decisions. Additionally, DTC genetic testing companies often share or sell de-identified genetic data, which can be re-identified, increasing the risk of misuse, discrimination, and unauthorized access.
These regulatory gaps have tangible public health consequences. Fear of genetic discrimination discourages individuals from pursuing clinically actionable genetic testing and reduces participation in biomedical research and clinical trials, particularly among minority populations. This erosion of trust slows scientific progress and exacerbates existing health disparities.
This policy brief recommends expanding federal protections against genetic discrimination and strengthening oversight of commercial genetic data practices. Updating GINA and enhancing enforcement mechanisms would protect consumers, restore public trust in genomic medicine, and ensure that advances in genetic technologies benefit public health without compromising privacy, equity, or fairness.
Improving Hypertension Detection in North Carolina Through Accurate and Accessible Blood Pressure Screening
By Drew Theobald, East Carolina University
Executive Summary
Hypertension affects over 122 million US adults, yet an estimated 1 in 3 remain unaware of their condition, and over half of those diagnosed do not have it under control. Hypertension is the leading cause of stroke, heart failure, and kidney disease, costing the US more than $131 billion annually. A core challenge is that hypertension is both underdiagnosed and misdiagnosed, due in large part to:
- Inaccurate blood pressure measurement practices in clinics
- Widespread use of non-validated home cuffs
- Limited access to screening in rural and underserved areas
- Underutilization of community-based screening infrastructure
North Carolina exemplifies these challenges, with a high hypertension burden and persistent rural barriers to routine screening and primary care access. Moreover, the state is well positioned for implementation, with an extensive network of federally qualified health centers, broad pharmacy access, and established public health surveillance systems that can be leveraged rather than built anew.
This brief outlines a set of practical, state-led policy actions that can be implemented using existing public health and Medicaid infrastructure to improve accurate and accessible hypertension detection.
Investing in Our Future: The Seattle Experiential Science Learning Fund
By Monica Tschang, University of Washington
Executive Summary
Over the past 13 years, Seattle school districts have implemented statewide science learning standards, but there has been no increase in budget to purchase necessary materials to facilitate enhanced learning. Rather, K-12 educators have grown used to steadily declining funds. For example, in 2025, Seattle schools were faced with statewide and Title I budget cuts. Teachers want to run labs and inquiry-based lessons, as education researchers recommend, but many lack equipment, consumable materials, or continued professional development to implement them. As a result, science instruction often defaults to worksheets or lectures, or teachers pay hundreds to thousands of dollars out of pocket. This means students in resource-rich schools often get robust lab experiences, while students in under-resourced communities get worksheets, creating an equity gap.
We cannot deliver high-quality science education without the materials and professional support required for hands-on learning. Here, I propose a policy to create a district-wide Experiential Science Learning Fund to ensure every student has access to high-quality, active, inquiry-driven science experiences.
