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What is the process of drug development?

Niugini BioMed team
Dr Bomai Kerenga, chairman & CEO of the controversial Niugini Biomed and some of his research  team at a news conference on Friday

| PhD student, Auckland

AUCKLAND - Reading the news on Covid-19 drug production in PNG has prompted me to offer my take on it.

Those people who are familiar with drug research and development will agree with that screening for possible drug leads is just the start to developing a drug.

There has to be research done and data available on the pharmaco-kinetic and pharmaco-dynamic profile of the drug.

Drug screening is the most basic step.

Based on what I read in the Post Courier newspaper, I get the impression that the academics [behind the Niugini BioMed company] have done simulations using existing drug molecules that are likely to have some drug activity against Covid19.

In a drug development timeline, this is the most basic step – you screen a whole heap of possible molecules and come up with a few potential candidates.

After this step, the real drug development research happens in the lab.

Is the drug safe? What’s the mechanism of its action? How is it absorbed, broken down, distributed in the body and excreted?

What is the best dosage to give? What are the side effects? How does it work in different groups of people? If there are existing treatments, does this one do better? How do you dispense it – by mouth, injection or by some other means?

After these parameters are determined, the next stages involve clinical research and finally a review by regulatory authorities to get approval to be used as a ‘drug’.

These steps can take up to 10 years, and one must have an equipped and accredited laboratory in order for the developed drug to be recognised by the regulatory authorities.

Because of the current pandemic situation, teams around the world are fast-tracking processes to find a possible vaccine for Covid-19.

Covid-19, being a virus, makes it hard to find a drug cure – the virus is always several steps ahead, mutating and changing.

Not only that, but unlike bacteria which have their own machinery to survive, viruses tend to use the body as their host for replication.

The development of a drug that targets only the virus without causing toxicity to the human host has proven difficult.

Hence, many scientists worldwide are sticking to vaccine and not drug development.

While I believe in Papua New Guinea taking the lead in drug research and development, I strongly feel that the way to go is to build the necessary infrastructure, get accreditation and look at developing drugs that target common illnesses in our country.

A well thought-out plan with solid financial backing would do – not a novelty concept for Covid-19 which, quite frankly, based on past virus outbreaks, could quickly resolve just as it appeared, making this endeavor for naught.

[This is my personal view as a citizen (with pharmaceutical science and pharmacology background) and does not represent that of any organization that I am associated with]


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Lindsay F Bond

Attitude PNG?
In what order?
A is for ask
M is for mask
T is for task
C is for cask
B is for bask
D is for drug
V is for vast
E is for education....

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