From Global AMR Priorities to Preclinical Reality: Reflections from GAMRIC 2026

What should we really be looking for when developing the next generation of antibacterial therapies?

After three days at GAMRIC 2026 in Lisbon, this question remains particularly relevant. The Global AMR Innovators Conference brought together scientists, biotech companies, clinicians, funders, public health organizations and other stakeholders working across the antimicrobial development pathway.

Among the discussions we attended, the WHO perspective on Target Product Profiles for new antibacterial agents was particularly relevant to our work at Vibiosphen. The message went beyond identifying which pathogens should receive greater attention. It raised a broader question for the AMR community: are we designing antimicrobial development programs around the products that patients and healthcare systems actually need?

Starting with the clinical need, not only the molecule

In March 2026, the World Health Organization published new Target Product Profiles (TPPs) for antibacterial agents addressing three major areas of unmet need:

• severe multidrug-resistant Gram-negative infections;

• antibiotic-resistant Gram-positive infections in immunosuppressed and critically ill patients;

• community-acquired and healthcare-associated bacterial meningitis.

These TPPs define desired characteristics including intended use, target populations, pharmacokinetics, safety, efficacy, route of administration, stability, access and affordability.

What was particularly interesting during the GAMRIC discussions was the practical philosophy behind this approach. A TPP encourages developers to think about the characteristics required of the final therapeutic product early in development. This may sound obvious, but it has important consequences for preclinical research.

Instead of first asking: “How can we demonstrate that our candidate works?” the development process can begin with a different question: “What would this candidate need to achieve to address its intended clinical need?”

From there, the experimental strategy can be designed backwards.

A perspective that strongly resonates with preclinical development

For us at Vibiosphen, this was one of the strongest connections between the WHO session and our daily work with antimicrobial developers.

Consider a candidate intended to treat severe multidrug-resistant Gram-negative pneumonia. Demonstrating activity against the target pathogen is essential, but an MIC alone cannot answer the complete development question.

Which resistant strains should be included? Is the activity bacteriostatic or bactericidal? How rapidly does bacterial killing occur? Can resistance emerge under treatment?

What exposure is required? Does the compound reach the relevant compartment? Does antibacterial activity translate into reduced bacterial burden in the lung? And how does this microbiological effect influence inflammation and disease progression?

These questions progressively connect antimicrobial activity to therapeutic relevance. This is precisely where preclinical strategy becomes more than a succession of standardized assays.

From MIC to the infection site

One recurring theme across antibacterial development is the difficulty of translating promising in vitro activity into meaningful in vivo efficacy. The MIC remains a fundamental measurement, but it represents bacterial susceptibility under defined experimental conditions.

A patient, however, is not a microplate. At the infection site, the microorganism encounters a complex environment shaped by nutrient availability, host cells, immune pressure, bacterial density, tissue architecture and antimicrobial exposure. The bacterial phenotype itself can change.

For developers, the question therefore becomes not only whether a candidate inhibits a pathogen, but whether the observed activity remains relevant as experimental complexity progressively increases. A translational development strategy can consequently connect several layers of evidence:

Susceptibility → Killing kinetics → Resistance → PK/PD → Infection model → Bacterial clearance → Host response

Each layer reduces a different area of uncertainty before clinical development.

The right model starts with the right question

This perspective also changes how we think about infection models. There is no universally "best" model for an antimicrobial candidate. The relevant model depends on the question the development program needs to answer.

For a therapy targeting Pseudomonas aeruginosa pneumonia, pulmonary bacterial burden may be central. For a systemic infection, bacterial dissemination and survival may become more important. For an immunocompromised population, the interaction between antimicrobial activity and host immune status may need particular consideration.

Likewise, pharmacokinetics can become critical when the site of infection presents a distribution challenge. The experimental design should therefore follow the intended clinical context rather than the opposite.

Where Vibiosphen fits into this translational continuum

This discussion at GAMRIC strongly echoes the way we approach antimicrobial development at Vibiosphen. As a preclinical CRO specialized in infectious diseases and microbiology, our role is not simply to perform isolated assays. We work with developers to build a progression of experimental evidence around the biological and translational questions of their candidate.

This can begin with microbiological characterization through MIC/MBC determination, time-kill kinetics, combination studies or susceptibility testing across relevant bacterial strains. The program can then progress towards PK/PD investigations and in vivo infection models, integrating quantitative bacterial burden with pharmacological, inflammatory, molecular or histological endpoints when scientifically relevant.

Our bacterial models include pathogens that are central to current AMR priorities, including Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli, Staphylococcus aureus and Streptococcus pneumoniae.

The objective is not to generate the largest possible dataset. It is to generate the evidence required to answer the next development question.

Preclinical models as decision-making tools

This may ultimately be one of the most important take-home messages from GAMRIC. Preclinical research should not only demonstrate efficacy. It should help developers make decisions.

Should the candidate progress? Which indication is most relevant? Which bacterial population should be targeted? What dose and exposure should be investigated? Which combination could be considered? Which biological limitations need to be understood before entering the clinic?

A well-designed preclinical program can help answer these questions progressively, before development becomes considerably more expensive and complex. In that sense, preclinical models are not simply validation tools. They are decision-making tools.

From global priorities to experimental design

The WHO Target Product Profiles provide a global perspective on what future antibacterial therapies should achieve. The challenge for developers is to translate those objectives into experimental evidence. And this is where the discussions we had and heard at GAMRIC become particularly tangible for our work at Vibiosphen.

Global priorities need to become development strategies. Development strategies need to become experimental questions. And experimental questions need models capable of generating meaningful answers. For us, this is one of the essential bridges between global AMR strategy and preclinical science.

And after GAMRIC 2026, it is also a useful reminder that fighting antimicrobial resistance is not only about discovering more antimicrobials. It is about developing the right therapies, for the right infections, supported by the right evidence.

Reference

World Health Organization. Target product profiles for new antibacterial agents: severe multidrug-resistant Gram-negative infections, antibiotic-resistant Gram-positive infections in immunosuppressed and critically ill patients, and community-acquired and health care-associated bacterial meningitis. Geneva: WHO; 11 March 2026. ISBN 978-92-4-012118-8.

WHO publication and full report