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Drug development is a challenging industry to get into. There are large risks and the need for funding is significant.
However, the reason that a lot of companies fail is that they learn critical, timeless lessons too late.
Here are some of the lessons that they don’t learn and what you should do instead if you have one of these businesses.
The FDA Is Not The Enemy
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The FDA will often come off as the enemy for a lot of drug development businesses. After all, it’s the entity that sets all the rules and files all the complaints. Because of this, a lot of startups treat it as a kind of obstacle or gatekeeper.
However, that’s not the way to view it. The best companies actually see it as a stakeholder or a partner in the enterprise. This fundamental approach tends to make the FDA much more cooperative and ensures that proper dialogue can take place at every stage. Making the whole experience more human and relationship-focused boosts the experience and may actually help get things done faster.
Testing Purity Is Critical
Testing purity of drugs is also critical for startups. Medicines must contain the exact amounts and quantities stated on the label, and they shouldn’t have contaminants. This is something that medical authorities always look for before approving any drug or medicine.
Fortunately, options like the BioPharmaSpec GmbH characterization facility exist. These are easy to use and they provide results quickly, showing you what to do next.
Running Out Of Money Is What Usually Happens
Another lesson is that running out of money is normal in a lot of biotech startups. The problem isn’t usually the science and R&D, it’s the fact that there’s just no money coming into the business for many years.
Getting around this requires having a proper funding structure in place. Venture capitalists should understand that the money they’re putting in probably won’t come back out for five years or more. That’s usually how long it takes to get a drug to market, and it can often take longer. Therefore, the idea behind the drug has to be completely sound and stand a strong chance of succeeding in the marketplace.
Manufacturing Isn’t Ever Later
Another hard-learned lesson is the fact that manufacturing should never be “later.” It should always be “now.”
The reason for this is that it takes a long time to scale drug manufacturing. Things like chemistry and controls should be in place years in advance so that facilities are ready to ramp up production once approval is given and the drug is cleared for mass usage.
Key Decision Makers May Decide Your Fate
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Finally, drug development companies often realize too late that key decision makers decide their fate. For example, clinicians themselves will often get behind successful drugs, and shirk those that don’t meet their criteria. Then, they will share this knowledge with their circle of peers, influencing more doctors. For this reason, it is essential to understand these dynamics and work with them before release.