10 considerations to kick-start your drug development journey
Conceiving and developing a new drug from scratch can be one of the most satisfying experiences you can have. But it is challenging too – it’s by no means certain that your project will succeed and the more cutting-edge your technology, the higher the risk of failure.
Such failure can be easily absorbed by a large, established pharmaceutical business, but for a pharmaceutical start-up, it can result in the business folding before it gets off the ground.
With this in mind, start-ups need to do all they can to maximise their chance of success by minimising the risk of failure. There are no problem-free drug development projects but, with careful planning, start-ups can embark on their journey with confidence.
To help, we have come up with our top ten considerations to ensure your drug development project delivers on its promise:
1. Define your challenges and goals
At the beginning of your project, conduct risk analysis, define a target product profile (TPP) and build your regulatory strategy – this will smooth the development process for you down the road.
2. Pre-order your materials
Order enough active pharmaceutical ingredient (API) for your project from the start. API is expensive but it is even more costly to have your project delayed by a lack of material.
3. Coordination is key
Coordinate every aspect of your project, from API manufacture, to formulation development, to clinical trial material (CTM) manufacture and bioanalysis. This way you can minimise the risk of delays throwing your project timeline off course.
4. Don’t focus solely on your API
Never underestimate the importance of the dosage form and the package. The correct form and packaging can enhance the efficacy and profitability of your product so make sure you devote sufficient attention to this aspect of development.
5. Team work is crucial
Analytical chemistry is a crucial part of your development project, and key to its success. Without close collaboration between your analytical chemists and the rest of the team, you are likely to fail.
6. Plan for clinical trials in good time
Expect at least 12 months for the development and manufacture of drug product for a clinical trial and months for the manufacture of API. Use this timeline to plan your trials well in advance.
7. Your methods must be scalable
Manufacturing and control methods must work effectively at the manufacturing site. Make sure that you involve manufacturing experts early on so you can avoid potential problems that could delay your project.
8. Communication is vital
Deviations from the plan will occur. It is important that everyone on your team is able to communicate unforeseen issues as quickly as possible to account for changes rapidly and ensure the success of the project.
9. Work with experts
Find experienced partners to work with before embarking on your project. This will give you support when navigating the challenges of drug development.
10. Be enthusiastic
Make sure you have a lot of enthusiasm in the team and a steady supply of coffee. Good morale is crucial.
Simple steps to success
Not all drug development projects deliver. However, with a little time, patience and by following these simple considerations, you can ensure you have done all you can to maximise the chances of success. If you are a start-up and unsure how to go about your first drug development project, you can find more expert guidance in our white paper, Drug Development For Start-Ups.
Alternatively, you can talk to our expert team by visiting our contact page.