| Duressi’s Odyssey
AUCKLAND - In October last year the term ‘drug repurposing’ became known in Papua New Guinea after a company, Niugini Biomed Ltd, stated it was developing its own Covid-19 drug.
As a person with a keen and professional interest in drug development and clinical studies, I’m eager to find out what happened to this proposal by my fellow Papua New Guineans.
In the meantime, while I wait, I want to share some information about what it means to ‘repurpose’ drugs and the necessary steps that would be taken to run clinical trials in PNG.
Drug repurposing means finding new therapeutic uses for existing drugs.
In other words, medicines already approved and used for treating specific diseases are studied to see if they can treat other conditions.
For a drug to be repurposed we must first undertake pre-clinical screening to determine if it may suitable for use against a different disease.
Then clinical studies and trials are required to understand such things as how it works in the human body and how it affects other diseases.
There are two approaches to pre-clinical screening: the traditional approach through laboratory experiments and the computational approach using computer modelling to screen for possible indicators of other uses.
The limitation of the traditional approach is that it can take 10 years or more to get a result.
The computational approach takes a shorter time (three to six years) but has limitations, including not having full access to all biological and structural databases, and patent issues around existing drugs.
After the clinical studies are concluded, the next step involves clinical trials in which the medicine is given to humans and its effects monitored, recorded and understood.
In PNG, before health-related research is initiated, a proposal must be submitted to the Medical Research Advisory Committee (MRAC), a research ethics committee within the National Department of Health whose members are experts in various health disciplines.
In the case of clinical trials, the Pharmaceutical Services Standards Branch is also involved. This branch is the drug regulatory arm of the National Department of Health.
Both these high level expert groups deliberate on the science and the ethics of the study and determine if it should be approved or not.
Repurposing of all drugs in PNG must include the totality of this process before any drugs would be approved for a different clinical use.