Promising innovations to bend the AMR curve (Part II)

Nurture vs Nature — Why a proactive AMR ecosystem will count

The challenge of Antimicrobial Resistance (AMR) requires cohesive and coordinated efforts to combat. There are promising innovations in the development pipeline which need to be accelerated through various checkpoints, and brought to the market faster if we are to challenge the status quo and bend the AMR curve in India and beyond.

Among the many promising solutions that are bubbling under, there are a few from India being developed by Module Innovations, Bugworks Research and GangaGen Biotechnologies - all a part of C-CAMP portfolio and also the only three in Asia to be funded and supported by CARB-X. To enable lab-to-market expansion of these solutions it will be imperative to synchronize and streamline our efforts to iron out the disjointed, repetitive and fragmented initiatives that have so far been bottlenecks in fast-tracking high potential solutions.

Thinking it through

Innovators are key stakeholders in rolling out interventions that could potentially have a high impact in combating the threat of AMR. Incorporating their views and opinions on how their work can be scaled faster to reach the intended end-user is an important step forward in enabling this.

Expedited regulatory approval process, especially in the context of how rapid the COVID-19 interventions, diagnostics and vaccines, reached last mile healthcare in less than a year, can be accelerated in a healthcare emergency. The time period for entire clinical development and regulatory approval, which took 8–10 years till 2019, were reduced to a year indicating that it is possible to shave off at least 6–8 years to enable deployments of desperately needed drugs and devices to the patients. According to Dr Santanu Datta, CSO of Bugworks Research, these protocols and procedures should be put in place for AMR with equal rigour.

Sachin Dubey, CEO, and Dr Maya KV, Senior Scientist, both from Module Innovations, feel that product development in AMR is less lucrative as a business as the costs are high and rewards are low. Therefore, it is imperative that funding bodies come together to ensure continued support to small organizations and startups at all stages of Product Development. Another important aspect is the Access to clinical samples and bacterial strains for testing products that should be made easy and free flowing globally. They feel that a consortium of clinical partners, engineering designers, regulators and policy makers brought under one roof would help them propel product validations fast.

Solutions in AMR would be beneficial for Low- and Middle-Income Countries (LMICs) in general where most of these innovations could make a huge difference. Echoing the sentiment Dr. T.S Balganesh, President of GangaGen Biotechnologies opines that “Ability for small organizations like GangaGen to carry out ‘clinical development’ in LMICs will definitely help in reaching target populations faster”.

Positioning India as a leader for efforts against AMR

India accounts for >50% of the global AMR burden. A decade back India recorded a mammoth 12.9 billion units of antibiotic consumption, which has only risen amidst the COVID pandemic. While it is important to promote and support R&D for novel antimicrobials and faster diagnostic tests, creating Awareness amongst the masses about the perils of AMR will play a key role. In India, where there is a shortage of doctors and lack of access to quality diagnostics, pharmacist driven antibiotics consumption is rampant. Funding organizations in this less rewarding business is vital, so Module Innovations feels that the government of India needs to take urgent steps to ensure that the products see light of the day, and are accessible to all. They further state that collaboration across agencies around the globe would be vital as there is no dearth of will and scientific temper to bring out solutions and fight AMR together. “Bacteria know no boundaries. We must fight AMR at a global level and not local level” adds Usman Khan, COO at Module Innovations.

Dr Datta of Bugworks believes that the urgency brought on by AMR behooves us to address this matter aggressively. He feels that India should not only foster more innovation in the discovery of novel drugs, but also innovate in terms of regulatory approval process and in terms of financial returns for the innovator. He adds that antibiotics are a unique product class, where the use of novel drug, and therefore its sales volumes, maybe severely restricted, posing a huge financial risk to a small company. This could deter innovators from taking on challenges in AMR altogether. A potential financial model where payments for the novel antibiotics is based on value and not volume, something, he thinks, can only be supported by public funds as a social responsibility.

AMR is clearly not a stand-alone problem, it’s rather a challenge that has emerged due to an overlap of different factors involving human health, animal health and the environment. These factors become a major deterrent in countries like India where the monitoring of the use and disposal of antibiotics might not be tightly regulated. Dr. Balganesh of GangaGen emphasizes on the need for a well-rounded approach. He adds, “The current status of the AMR landscape was long predicted but the abyss is a result of a poor understanding of the ‘One health’ interdependency. While on one hand we de-escalate the use of antibiotics through rapid reliable diagnostics; a coordinated approach involving all stakeholders will make the difference”.

Left Image Source: https://www.thebureauinvestigates.com/stories/2018-12-19/antibiotic-use-falls-on-us-farms-after-ban-on-using-drugs-to-make-livestock-grow-faster Right Image Source: https://www.europeanpharmaceuticalreview.com/article/115074/limiting-antibiotic-manufacturing-discharge-in-indian-wastewater/

Tying up loose ends

The inputs from the three companies that are spearheading solutions in AMR point to various local and global level lacunae, or rather opportunities, that need to be tied together for small innovators and organizations to truly contribute to the national and global efforts to combat AMR. Viewing the challenges through their lens may offer invaluable insights on how enabling frameworks can be created and actioned, not just in India, but that can be replicated across the globe to fight a common threat, and hopefully avoid the next pandemic!

Disclaimer: The blog is a compilation of information on a given topic that is drawn from credible sources; however this does not claim to be an exhaustive document on the subject. It is not intended to be prescriptive, nor does it represent the opinion of C-CAMP or its partners. The blog is intended to encourage discussion on an important topic that may be of interest to the larger community and stakeholders in associated domains.

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