Key Points
- The Phage Therapy Coordination Network kickoff convened clinicians, researchers, regulators and manufacturers to pinpoint where phage therapy access breaks down today-and identify where coordinated action could make the biggest near- and medium-term impact.
- The group agreed that the biggest constraints are operational, not scientific.
- There was broad alignment on phage therapy's promise; the consistent challenge is the system's ability to deliver it reliably-especially around capacity, uneven standards and fragmented handoffs.
- The longest bottlenecks were tied to isolate handling, phage screening/matching, optimization and producing clinical‑grade material-often exceeding the time spent on regulatory paperwork.
- Progress depends on building shared infrastructure that increases trust, adoption and speed.
- Emmanuel Allwell, University of Tennessee, Knoxville.
- Kelly Bachta, M.D., Ph.D., Northwestern University.
- José Bila, Ph.D., Precise Health.
- Paul Bollyky, M.D., DPhil, Stanford University.
- Daniel Czyz, Ph.D., University of Florida.
- Lia Danelishvili, Ph.D., Oregon State University.
- Charlie Mo, Ph.D., University of Wisconsin-Madison.
- Kyung Moon, Ph.D., NIH/NIAID.
- Vivek Mutalik, Ph.D., Lawrence Berkeley National Lab.
- Gauri Rao, PharmD, M.S., University of Southern California.
- Jennifer Schwartz, Ph.D., Intralytix.
- Austen Terwilliger, Ph.D., Baylor College of Medicine.
- Paul Turner, Ph.D., Yale University.
- Daria Van Tyne, Ph.D., University of Pittsburgh/Pittsburgh Phage Program.
- Eric van der Helm, Ph.D., SNIPR BIOME.
- Katherine Wetzel, Ph.D., Georgia State University.
The meeting was designed to surface where the system breaks down today and where coordinated action could make the greatest impact in the near- and medium-term. PTCN members were pre-assigned to 4 structured virtual break-out rooms to collaboratively dissect near-term patient access, regulatory perspectives, commercial considerations and scaling for long-term access. Moderators guided the separate discussions with pre-formulated prompts intended to pinpoint the most significant bottlenecks and inefficiencies.
What emerged most clearly from the kickoff was not disagreement about the scientific promise of phage therapy, but convergence around where the current system breaks down operationally. Across all breakout groups, participants repeatedly pointed to screening and production capacity, uneven standards and fragmented handoffs as the dominant constraints on patient access.
Patient Access Today: A Funnel, Not a Pipeline
Multiple PTCN members shared that although patients and clinicians are actively seeking experimental phage therapy today, most of these requests are not fulfilled. As part of the root cause analysis, several potential drivers were considered in the break-out group discussions: regulatory compliance, clinical justification, phage matching and acquisition and institutional barriers.
PTCN members were aware of the single patient investigational new drug (spIND) and emergency investigational new drug (eIND) regulatory pathways that enable experimental use of personalized phage therapy today in the absence of FDA-approved therapeutics. The researchers and clinicians described their experience with this regulatory process and the limitations of existing shared resources, like IND templates that set unrealistic expectations. The clinician participants validated that most phage therapy requests were clinically warranted, even suggesting that phage therapy may have value earlier in the course of treatment rather than as a last-resort option. However, the regulatory pathways are specifically intended for serious or life-threatening infections where standard treatment with antibiotics has failed. Participants noted that the time to deploy personalized phage therapy often exceeds the window of opportunity to save patients with life-threatening infections.
At the same time, the field is pursuing broader FDA approval through the biological license application (BLA) pathway, primarily focused on fixed, off-the-shelf phage products that can be evaluated in randomized controlled clinical trials. These efforts are essential for demonstrating the safety and effectiveness of phage therapy, thereby unlocking routine clinical adoption. However, even if approved, fixed phage products will only address a fraction of the unmet medical need and not necessarily replace IND use. For example, patients with rare pathogens, evolving resistance, complex biofilms or highly individualized infections may require IND-enabled personalized or semi-personalized phage approaches. Therefore, participants generally agreed that co-existence of both the IND and BLA pathways is essential to serve all patient segments.
Despite workable FDA pathways, the majority of patient demand for phage therapy remains unmet, with patient access best represented as a funnel rather than a pipeline. Patients fall out at every stage-not because effective phages don't exist, but because fragmented processes lacking transparent coordination compound delays, confusion or abandonment at every hand-off. Across breakout groups, the longest delays were consistently attributed to isolate handling, phage screening and matching, optimization and production of clinical-grade material-often more than regulatory paperwork itself.
From Shared Challenges to Coordinated Action
After identifying these bottlenecks, the PTCN members coalesced around the following proposals for how ASM Health can expand patient access to phage therapy. Near-term emphasis is on accelerating IND use and developing shared infrastructure that would benefit BLA pathways. Importantly, the discussion did not converge on a single technical solution. Instead, it clarified where coordination (rather than new science) could most immediately improve reliability, speed and confidence across the phage therapy ecosystem.
1. Establish Trust in Personalized Phage Therapy
Developing clearer, shared expectations for safety, effectiveness and quality-through practical checklists or standards-could reduce uncertainty for regulators, hospitals and IRBs without constraining innovation. This includes phage therapy preparation methods, manufacturing standards, quality control, documentation and how diagnostics and phage‑matching reports support intended clinical use. The intent is to set the bar for what it takes to achieve clinical predictability without undermining the variety of approaches to phage therapy. This checklist can then become the foundation for regulatory confidence and institutional comfort around use of phage therapy.
2. Convert Trust Into Hospital Adoption
Hospitals and clinicians would benefit from concrete guidance on when and how to consider phage therapy, supported by operational playbooks, workflows and educational resources. Such a resource would define appropriate use (e.g., when to consider phage, patient eligibility, dosing and combination strategies, therapeutic monitoring and clinical response monitoring, clinical decision support tool, etc.) and delineate workflows (e.g., standard templates, implementation processes, communication materials, etc.). Adoption scales when hospitals know exactly what "responsible use" looks like, and this clear guidance intends to reduce legal, administrative and cognitive burden on clinician-evangelists.
3. Accelerate Access to a Trusted System
Once tools to catalyze product validation and hospital adoption are developed, speed becomes the limiting factor to patient access. Centralized or shared approaches to referral and triage, isolate characterization, phage matching, manufacturing validation, regulatory navigation and clinical decision-making support during course of treatment could reduce delays and patient drop‑off while improving reliability. The goal is to increase the volume and probability of flowing from patient identification to successful delivery phage therapy, while reducing the time to do so.
What "Better" Could Look Like
The kickoff discussion also helped clarify what meaningful improvement in patient access could look like in practical terms. Several candidate coordination projects emerged repeatedly across breakout discussions. These included: clinician‑facing eligibility and workflow guidance to reduce uncertainty; minimum viable testing, manufacturing and quality benchmarks that are realistic despite phage diversity; reusable IND starter materials paired with education for new sites; and pragmatic approaches to aggregating real‑world data by leveraging existing clinical registry models.
Imagine a Near Future Where:
- A clinician can send an isolate and receive an actionable phagogram.
- IND submission and review follow a predictable and transparent process.
- Phage products are validated to meet manufacturing standards and quality expectations.
- Safety, effectiveness and clinical utility data accumulate across institutions, supporting consideration of phage therapy alongside antibiotics-not only after failure.
Importantly, participants emphasized that progress toward this future does not require a Phase 3 trial tomorrow. Rather, it depends on sustained coordination across clinical, regulatory and operational domains. This is precisely the gap that the Phage Therapy Coordination Network aims to address.
With ASM Health serving as a neutral convener, the PTCN is positioned to translate these kickoff insights into a focused set of time-bound working groups over 1-3 years. Near-term priorities will be validated through a broader community survey, followed by definitions of clear project scopes, success measures and resourcing pathways for the highest-value coordination opportunities. The breakout groups underscored that coordination and shared infrastructure will require resources beyond volunteer effort. Potential pathways discussed included philanthropic support, public funding and pre‑competitive partnership models with clear governance boundaries.
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