Antimicrobial resistance (AMR) is the ability developed by bacteria, viruses, parasites or fungi to fight and block the effect of antimicrobials including antibiotics, antivirals and antiparasitics that were developed to kill or control their growth. AMR is a global public health problem presenting a continually increasing threat on human and animal health. AMR is associated with extended illness duration, additional medical examinations, the use of expensive and potentially toxic drugs and increased stays in hospital as inpatients. This contributes to the economic burden of AMR estimated in the EU to €1.5 billion per year.
Due to this growing public health threat, the focus on the development of alternative forms of antimicrobials especially when it concerns the treatment of bacterial infections is increasing. Microbiotas, including microorganisms such as bacteria, yeasts, fungi, archaea, viruses and bacteriophages in particular, and bacteriocins are natural biological agents that are known to have antibacterial activity and are known to exhibit targeted microbial killing and can be considered narrow-spectrum in their activity. They are among the various options being explored to combat the problem of AMR.
Designing and bringing medicinal products based on bacteriophages, microbiotas (including bacteriophages), and bacteriocins to the market is perceived to be challenging as currently available guidance on anti-microbials lacks specific information regarding the development of these products.
Peri is a Medical Director with VCLS, She provides input into the drafting and critical review of clinical development plans including prospective drafting and gap analysis); critical review of clinical parts of EMA Scientific Advice, National Scientific Advice and Joint EMA-HTA bodies Scientific Advice briefing documents; responses to issues raised (by CHMP/National regulators)and corresponding presentations, critical review of clinical parts and significant benefit sections of ODD briefing documents and PIP briefing documents and the rehearsal of client presentations on clinical regulatory perspective for oral explanations when required.