Medicine manufacturers: Is your new drug a commercial success waiting to happen? Learn the 5 critical steps—from understanding the mechanism to checking the competition—to validate your medicine and de-risk your R&D investment. Stop hoping and start proving its market worth.
Knowing whether you’ve figured out a medicine that will be capable of selling is always a challenge. Not only are there safety and regulatory hurdles, but the market is complex and always changing. Sometimes, medicines have a long lifespan and plenty of time to make money, but sometimes they don’t, and that’s okay.
The purpose of this post is to provide you with some guidance if you want to develop one inside your healthcare business. You’ll learn what to do and what to look out for.
Proving Your Medicine’s Value Beyond the Clinic.
- Start with your why
- Understand the mechanism
- Run small experiments
- Ensure you can reproduce results
- Check the competition
Start With Your Why
The first step is to start with your why. You have to figure out what problem or unmet need in the marketplace your drug will solve.
These days, there are drugs for almost every situation and condition. Therefore, you’ll want to focus on making something that is more effective, has fewer side effects, or both.
Understand The Mechanism
After that you don’t want to be flying blind. Instead, you want to ensure that you understand the mechanism behind the drug and what, essentially, is making it so effective.
The best way to do this is to get to grips with the molecular structure and biodynamics. The BioPharmaSpec GmbH testing facility explains how this can be done.
Then, you want to see how it works in cells and potentially patients. You should take note of things like how it changes gene expression and whether it has an effect on inflammation.
Run Small Experiments
The next step is to run small experiments. You need some sort of pilot testing.
One of the best ways to do this these days is to provide regulators with in silico screening. You model how you think a drug will work on a computer to rule out candidates that are less promising.
If you can get the drug into animals or people, that’s even better. Then, you can test whether the mechanisms that theoretically work actually do well in practice. The more you do this, the faster you can move the development through various clinical trials. During this process, measure all the relevant biomarkers and make sure that everything adds up.
Ensure You Can Reproduce Results
Of course, if you want to develop something that is acceptable in the eyes of the authorities, it needs to be reproducible in other labs. If that doesn’t happen, then the drug probably won’t be able to go to market.
The way to do this is to standardize everything. Obviously, you want the dose to be the same, but also things like the production methods and even delivery materials. Small variables like these can make a difference.
Check The Competition
Finally, make sure you check the competition so see what they’re doing. Ideally, you want a drug that you’re allowed to develop without impinging on anyone else’s IP but that also fills a niche in the market.
You should be solving a problem that needs to be solved because other drugs that try to do so are too expensive or ineffective.
