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Tutela Strategies, LLC Safety | Security | Compliance
Resources

Publications, reports, and practical resources

A curated set of works on biosafety, biosecurity, compliance, and research governance. Links open external publications.

The common thread across these pieces is implementation, what holds up in real organizations, what fails quietly, and what makes oversight workable for the people responsible for safety and accountability.

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Articles
Briefing Deck

Considerations for NIH’s Initiative to Modernize and Strengthen Biosafety Oversight

Jan 29, 2026 • Presentation • David Gillum, PhD

A practical set of considerations for NIH’s modernization effort, focused on what makes oversight implementable: risk frameworks that match today’s research, clearer decision support for Institutional Biosafety Committee (IBCs), and learning systems that improve consistency without turning oversight into paperwork.

Centralizing High-Risk Pathogen Research Raises New Concerns

Jan 22, 2026 • STAT • David R. Gillum

An examination of proposals to centralize high-risk pathogen research and why concentrating work in fewer locations may undermine resilience, workforce development, and practical biosafety capacity.

Understanding Biosafety Practitioner Perspectives

Dec 10, 2025 • Politics and the Life Sciences (Cambridge) • David R. Gillum, Christine Knight, Kathleen M. Vogel

A look at what biosafety practitioners actually experience in their roles, and what that means for training, organizational support, and better governance.

Better Biosecurity for the Bioeconomy

Fall 2025 • Issues in Science and Technology • David R. Gillum

Examines how biosecurity must evolve alongside a rapidly expanding bioeconomy, emphasizing implementation, incentives, and governance that works in real institutions.

Why Implementation Gaps Could Undermine Synthetic Nucleic Acid Oversight

Oct 28, 2025 • Frontiers in Bioengineering and Biotechnology • David R. Gillum, Rebecca L. Moritz

A practical look at how real-world implementation can make or break oversight, and what helps programs work without turning into paper compliance.

A Possible Turning Point for Research Governance in the Life Sciences

Jul 22, 2025 • mSphere • David R. Gillum

A fast-moving moment for U.S. life sciences oversight, and what “workable governance” looks like when it has to function in real institutions.

Balancing Innovation and Safety: Frameworks and Considerations for the Governance of Dual-Use Research of Concern and Potential Pandemic Pathogens

Jun 5, 2025 • Applied Biosafety • David R. Gillum

A clear framing of how oversight has evolved, plus a practical approach to governance that supports innovation while strengthening safety and security.

Thrown in the Deep End: The Dual-Use Saga

Jun 5, 2025 • Applied Biosafety • Rebecca L. Moritz

A candid reflection on managing dual-use research challenges, including the practical realities of communication, teamwork, transparency, and scrutiny.

Memo to Trump: Create a New Biosafety and Biosecurity Agency to Oversee Research

Jan 17, 2025 • Bulletin of the Atomic Scientists • David Gillum, Gregory D. Koblentz, Rebecca Moritz, Antony Schwartz

A case for fixing fragmented oversight through clearer accountability, coordination, and a structure designed for implementation.

A Risky Review of Research

Oct 21, 2024 • Pandora Report • Gregory D. Koblentz, David Gillum, Rebecca Moritz

A critique of the Risky Research Review Act, focused on how broad definitions and duplicated processes can create burden without improving outcomes.

Establishing a National Biosafety and Biosecurity Agency for the United States

Oct 17, 2024 • Frontiers in Bioengineering and Biotechnology • David R. Gillum, Rebecca Moritz, Gregory D. Koblentz

Proposes a national agency model to unify oversight, streamline requirements, and strengthen safety, security, and compliance.

Bridging Biosafety and Biosecurity Gaps: DURC and ePPP Policy Insights From U.S. Institutions

Sep 25, 2024 • Frontiers in Bioengineering and Biotechnology • David R. Gillum, An Tran, Jennifer Fletcher, Kathleen M. Vogel

Survey evidence from U.S. institutions on how DURC and enhanced potential pandemic pathogen (ePPP) policies are implemented in practice, including how staffing, resources, and reporting mechanisms relate to higher-risk research and effective oversight.

Seven Opportunities for Effective Biosafety and Biosecurity Governance

Aug 2024 • Health Security • David R. Gillum, Antony Schwartz, Randy A. Albrecht, Rebecca L. Moritz

Seven concrete opportunities to improve governance and reporting in ways that strengthen oversight and still work for real organizations.

The ‘Risky Research Review Act’ Would Do More Harm Than Good

Jul 19, 2024 • STAT • David Gillum, Rebecca Moritz, Gregory D. Koblentz

A clear argument that broad, unclear review rules can slow research and create confusion without meaningfully improving safety.

The COVID Pandemic Spurred a Revision of US Pathogen Research Rules. Will It Help?

Jun 2024 • Bulletin of the Atomic Scientists • David R. Gillum, Randy Albrecht, Antony Schwartz, Rebecca L. Moritz

A look at updated U.S. oversight rules for certain categories of pathogen research and what the changes could mean for implementation.

Effectively Implementing Biosecurity Policies

Apr 21, 2023 • Science • David R. Gillum, Rebecca L. Moritz, Antony Schwartz

A short, high-impact piece on what makes biosecurity policies actually work in practice, not just on paper.

The Making of a Biosafety Officer

Spring 2023 • Issues in Science and Technology • David Gillum

A human, readable look at how biosafety professionals learn the work, and why that practical knowledge matters for better training and better rules.

Biosafety Needs to Redefine Itself as a Science

Spring 2023 • Issues in Science and Technology • Antony Schwartz, Andrea Vogel, Mary Brock

Argues that biosafety should be treated as an evidence-based science of risk assessment and mitigation (not just compliance), proposing an updated definition and calling for investment in training, research capacity, and institutional support.

Charting a New Course for Biosafety in a Changing World

May 23, 2022 • Issues in Science and Technology • David Gillum, Rebecca Moritz, Yong-Bee Lim, Kathleen Vogel

A practical case for modernizing biosafety so it keeps pace with a changing bioeconomy, with emphasis on real incentives and real implementation.

Why Gain-of-Function Research Matters

Jun 21, 2021 • The Conversation • David Gillum, Rebecca Moritz, Megan J. Palmer, Sam Weiss Evans

A plain-language explainer of what “gain of function” means, why some researchers use it, and how safety, security, and oversight frameworks shape debates about risks, benefits, and alternatives.

Adaptation of Research Infrastructure to Meet the Priorities of Global Public Health

Jan 7, 2021 • Frontiers in Bioengineering and Biotechnology • Rebecca L. Moritz, David R. Gillum

Reflects on how institutions adapted biosafety programs, facilities, and processes to rapidly support SARS-CoV-2 research, highlighting practical risk-mitigation approaches and lessons for future public health emergencies.

Embrace Experimentation in Biosecurity Governance

Apr 10, 2020 • Science • Sam Weiss Evans, Jacob Beal, Kavita Berger, Diederik A. Bleijs, Alessia Cagnetti, Francesca Ceroni, Gerald L. Epstein, Natàlia Garcia-Reyero, David R. Gillum, … and Mark W. J. van Passel

Argues that rethinking and testing assumptions about the relationship between biological research, security, and society through experimentation can improve biosecurity governance.

Promoting Biosecurity by Professionalizing Biosecurity

Feb 21, 2020 • Science (Policy Forum) • Rebecca L. Moritz, Kavita M. Berger, Barbara R. Owen, David R. Gillum

Argues that professionalization, through formal credentials, standards, and career pathways, could strengthen biosecurity policy and improve day-to-day practice.