Executive Summary

Bacteriophage therapy offers life-saving potential against drug-resistant infections but remains limited by scientific and clinical complexity, uncertainty in dosing burden, scalable manufacturing, fragmented data collection processes, unclear regulations and accessibility gaps. ASM Health’s Phage Therapy Coordination Initiative will streamline data collection, align regulatory pathways and support multicenter trials. By uniting science, clinical practice and policy, ASM aims to move phage therapy from isolated use to scalable national readiness. This coordinated approach can unlock scalable, equitable and regulatory-aligned access to phage therapies. 

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Problem: A Fragmented Field With Life-Saving Potential

Bacteriophage therapy shows promise for treating multidrug-resistant infections, but progress is stalled by the following challenges:

System-Level Problems

• Inconsistent regulatory review pathways and unclear federal guidance.
• Fragmented data from compassionate use cases and trials.
• Lack of harmonized protocols for clinical use and large-scale manufacturing.
• Limited clinician access outside of academic settings.
• Gaps in infrastructure to support scalable and equitable use.

Scientific and Operational Challenges (Scale‑Up and Logistics)

• Scientific complexity and personalization: the phage–host biology is heterogeneous and often patient‑specific; identifying, characterizing and adapting effective phages remains difficult to standardize at scale.
• Treatment burden and delivery constraints: frequent dosing regimens and multi‑day courses create staffing, workflow and adherence challenges in both inpatient and outpatient care.

Phage therapy is evolving rapidly, but without coordination, to address both system-level problems and scientific and practical delivery challenges, its impact will remain confined to isolated success stories.

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Scientific Approach: A National Framework for Phage Therapy Readiness

ASM Health proposes a flagship initiative to coordinate phage therapy access, evidence generation and regulatory engagement across the U.S. and globally.

Core Components:

• Compassionate Use Registry
  • Launch a centralized registry to standardize clinical data from phage-treated patients, including safety, efficacy, resistance patterns and long-term outcomes.
  • Connect the centralized registry to a reference database to inform guidelines for federal agencies and global regulators, as well as the larger scientific community, so that each instance builds on and extends existing knowledge.
• Clinical Trial Network
  • Support multi-site studies on phage-antibiotic combinations, engineered phages and delivery methods.
  • Prioritize inclusion of pediatric, immunocompromised and under-resourced populations.
  • Enable consistent trial design and harmonized endpoints.
• Regulatory and Policy Alignment
  • Convene regulators to co-develop guidance.
  • Align on use cases (compassionate, emergency, standard-of-care) and data requirements.
  • Generate a shared regulatory roadmap.
• Phage Manufacturing and Quality Standards
  • Engage key manufacturing stakeholders in industry and academia to develop scalable and compliant manufacturing protocols.
  • Define quality control, GMP-readiness and phage characterization benchmarks.
• Global Collaboration and Equity
  • Ensure inclusion of LMIC partners in trial design and access frameworks.
  • Create a data-sharing model to accelerate global regulatory convergence.
  • Facilitate equitable deployment of phage therapies where antibiotic resistance burdens are highest.

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Strategic Role for ASM Health

ASM-H is uniquely positioned to lead this initiative by:

• Serving as a trusted, neutral platform to unify science, policy and clinical practice.
• Leveraging the annual ASM Microbe meeting, ASM Health Council and member base to convene key stakeholders.
• Coordinating across public, academic and private sectors to standardize tools, trials and guidance.

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Impact

Short-Term 

• Streamlined data collection and compassionate use protocols.
• Accelerated regulatory clarity and trial harmonization.
• Clearer guidance for clinicians considering phage therapy.

Mid-Term

• Expanded access to phage therapy beyond academic centers.
• Broader, more inclusive clinical trials.
• Defined standards for manufacturing and product quality.

Long-Term

• Regulatory approvals of microbiome-sparing, adaptive phage therapeutics.
• U.S. leadership in evolutionary medicine and AMR innovation.
• Global evidence base to support responsible phage therapy integration.
• Guidelines for phage engineering when there isn’t a match in existing libraries.

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How We Will Execute

ASM Health will deliver an integrated phage therapy agenda through a science first, consortium-driven model focused on standardization, clinical validation, regulatory alignment and equitable scaleup:

• Set Priorities and Roadmaps: define gaps across indications, delivery routes, product classes, dosing, synergy and logistics. Maintain living roadmaps tied to pilots and multisite validation.
• Standardize Clinical Use and Matching: publish playbooks and lab standards for host range testing, resistance monitoring and synergy assays.
• Influence Regulation and Reimbursement: convert registry and trial outputs into playbooks and convene roundtables to align on regulatory and payer pathways.
• Secure Funding and Partnerships: scout funding and package proposals for trials, manufacturing scale-up and LMIC deployment.
• Publish and Share Knowledge: translate pilot outputs into white papers, playbooks, benchmarking notes and peer reviewed publications.
• Data and Standards Infrastructure: apply FAIR/GA4GH standards, enable federated sharing and run a sandbox for host range prediction and resistance forecasting.
• Convene and Build Consensus: align academia, industry, regulators and payers on endpoints, QC/QA, metadata, interpretation and responsible use (including compassionate use governance vs. clinical trials).
• Consulting and Advisory Services: offer neutral consulting on regulatory and clinical strategy (presubs/Qsubs, protocol design, endpoints, IRB/ethics, CLIA/CAP scaffolds, CMS/reimbursement evidence) under clear COI guardrails.
• Engage Industry: provide curated scientific matchmaking and real-world validation via the Trial Network and Registry. Use tiered participation for in-kind support and early career funding.
• Measure Impact: track funding wins, validation milestones, multisite reproducibility, workforce trained, publications/playbooks, regulatory/payer acceptance, time-to-phage match, dosing adherence, cold chain integrity and patient outcomes.

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Call to Action

Phage therapy offers a powerful tool against drug-resistant infections—but only if we move from isolated cases to coordinated systems.

ASM Health invites partners to:

• Join the Compassionate Use Registry and Clinical Trial Network.
• Co-develop regulatory and manufacturing standards.
• Sponsor and participate in ASM-H sponsored Phage Therapy Initiative.

Let’s move phage therapy from the margins to the mainstream—together.
 

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Interested in Joining Us?

Be among the first to shape ASM-H initiatives—if you’re driving cutting-edge research or product innovation in the area of phage therapy, reach out to us for early access.