C6 - Superdrugs for superbugs: Antibiotics of the future

Conference Hall B1

Organised by FIP’s Industrial Pharmacy Section, in collaboration with the Clinical Biology Section, the Community Pharmacy Section, the Hospital Pharmacy Section, the Social and Administrative Pharmacy Section and the YPG

Chairs

Prateek Jain (Biopharma Insights, India) and Cody Midlam (Willis Towers Watson Health and Benefits, USA)

Introduction

The imminent threat of a post-antibiotic era is upon us; and it is going to take us back to the days when people died of common infections. The present 700,000 global deaths each year due to antimicrobial resistance (AMR), will rise to approximately 10 million each year by 2050. Two major bodies that vouch for the stand against AMR are the World Health Organization and US Centers for Disease Control and Prevention (CDC). WHO’s plan for action on AMR includes public-private research and development partnerships, and international collaborations to expedite the research and innovation. The CDC has invested in combating AMR by means of education and improvement of antimicrobial stewardship (AMS) in several countries. The goal is to cut down inapt prescription of antibiotics at doctors’ offices by 50% and hospitals by 20%. An AMS programme is employed to enable the judicial use of antibiotics by improvement and measurement of the “four Rs”: the right antibiotic, at the right dose, at the right time, for the right duration. Effective AMS can promote positive patient outcomes, contain the resistance development, and reduce healthcare costs.

An extremely important marker for success here is a strong-selfless collaboration among the research industries, academia, hospitals, and community. AMR has sparked an urgency in new drug development as the industry endeavours for novel solutions to fight infectious diseases. Many new antimicrobials, such as cefiderocol, sulopenem, etc., have demonstrated high potency against resistant microbes like carbapenem-resistant Enterobacteriaceae, multidrug-resistant Pseudomonas, Acinetobacter, etc. These molecules are in the Phase II and Phase III clinical development and this session will look at the results. In addition, there are ongoing developments in novel areas such as immunotherapy, toxoid-based vaccines and anti-body drug conjugates.

The industry is taking aggressive measures to fight highly resistant pathogens. Nearly half of companies with products on the market are involved in AMR surveillance. Companies fighting the battle against microbes include Melinta, Merck, Shionogi, Polyphor, Achaogen, Tetraphase, etc. With new incentives such as GAIN act, CARB-X funding, etc., companies that had lost interest in the antibiotics research are now motivated to discover new molecular entities.

There is further scope for discussion of other solutions that could augment antibiotic development. Discussion will be around topics such as: how the US Food and Drug Administration and the European Medicines Agency can design clinical trials that cater to the needs of both US and EU markets to save time and money in drug development; and aggressive approaches of antibiotic development similar to development of medicines for communicable diseases that have been cured.

Programme

12:30 – 12:35 Introduction by the chairs

  1. 12:35 – 13:00 Revenge of the fallen: The industry fights back with research and development of new antibacterials
    Zeeshan Khan (Kings College Hospital Dubai, UAE)
  2. 13:00 – 13:25 Challenges and opportunities in antimicrobial stewardship: The need for innovation and collaboration
    Vaiyapuri Subramaniam (Pharmaceutical Compounding & Management Standards Consulting, USA)
  3. 13:25 – 13:50 Emerging and non-traditional approaches of antimicrobial drug development
    Prateek Jain (Biopharma Insights, India)

13:50 – 13:55 Conclusion by the chairs

13:55 – 14:00 Room refresh

Learning Objectives

At the end of this session, participants will be able to:

  1. Express new insight into developments for treating Gram-negative and Gram-positive infections
  2. Outline the guidelines for successfully seeking funding and partnership, and the CARB-X initiative
  3. Identify the non-traditional approaches to antimicrobial drug development, including biologic drugs and combination treatments
  4. Describe the ways in which pharmacists can support drug development by collaborating with research industries, academia, hospitals, community and policymakers.

Type of session: Knowledge-based