From Lab to Patient: A New Pharma Drug’s Journey

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Overview

New Pharma: In the second of our 3 posts on the healthcare continuum, we look at what it takes to bring a new drug to market and how to speed that up.

Getting new pharmaceutical drugs from the laboratory to the patients who need them is a long and expensive journey. According to the Pharmaceutical Journal1;

“New drugs that make it to market will have taken around 12 years and cost around £1.15bn.”

mRNA and the new dawn

As always, it begins with money. Researchers at a university use grants from the government or from industry to explore a disease or condition. Then, at least in days gone by, they experiment with natural compounds extracted from, and mirrored on, the plant and marine world, looking for promising avenues.

They still do that of course. But they now use computer modelling to explore the structures of genes and proteins as well. Which is how Pfizer and Moderna were able to produce their Covid vaccines. And both the speed and efficacy of that development is certain to radically transform this entire landscape.

Clinical trials, phase 1

Before testing anything on humans, potential compounds are first tested on animals and using computer modeling. The few that get through this stage are then submitted to the regulatory boards for approval for testing on humans. Which then happens in three stages.

In phase 1, about 50-100 healthy volunteers are tested to make sure that the drug is safe and to confirm that what it did in animals is replicated in humans.

Clinical trials, phase 2

Phase two is, in many ways, the critical stage. The drug is now given to between 100-500 patients suffering from the condition in question. These patients are carefully monitored to find out what the best way to administer the drug is, whether as a tablet, cream, or intravenously. And what the side effects are.

Because the more serious the condition, the stronger the drug will have to be. So there will be side effects.

There are then two costs that always need to be weighed up. What’s the percentage of patients who are likely to benefit, compared to those who mightn’t? And how severe are the side effects that some will suffer from, in order for that majority of patients to benefit from those significant improvements?

Discovering what those pros and cons are begins during this second phase.

Clinical trials, phase 3

Now that you have a better understanding of what the drug’s benefits and complications are, and how best to administer it, you need to gather as much data as possible in order to secure approval from the regulator. So phase 3 sees the drug tested on 1,000-5,000 (or more) people, and across multiple territories.

And, wherever possible, all tests should be randomized and double-blind. So neither the patient nor those organizing the tests know whether what they’re being given is the drug or a placebo.

Finally, the drug is now ready to be put forward for approval, whether that be to the FDA in the US, the EMA in the EU, or wherever the market is that the drug is going. And often, that authority will ask for a fourth phase, for specific groups who mightn’t have been included in the previous trials, such as pregnant women or children.

All of which explains why a new pharmaceutical drug can be so expensive. As;

“For every 25,000 compounds that start in the laboratory, 25 are tested in humans, 5 make it to market and just one recoups what was invested.”1

Speed means technology

What’s changed in the wake of the pandemic is the speed at which all of that can now happen. Thanks to technology, that ten-year development process has been fast-tracked down to barely 12 months. And not just for the one vaccine, but for a whole suite of them.

All of which means that the battle for supremacy in the pharmaceutical industry is going to be fought over speed. Your success will be measured by how quickly you can develop and then distribute your new drug. And the key to speeding all of that up is your ability to harness technology.

That has two components. Your ability to gather and process data. And to then give everyone on all the different teams real-time access to all that data. And what that depends on is the software you use, internally.

Which is why the largest and most successful pharmaceutical companies have become so careful about managing technology. Because it’s simply not possible to get a new drug to market with the kind of speed needed unless you have the right software to manage it all.

Source

    1. https://pharmaceutical-journal.com/article/feature/drug-development-the-journey-of-a-medicine-from-lab-to-shelf

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