By Dr Stephanie-Jayne Jones
Making new products available for sale for appropriate use is the objective of Pharmaceutical industry research and development.
Why do you need Pharmora?
Medicines development background
When a manufacturer discovers a new medicinal product there is a long process of development before it reaches patients in real world. Many products that seem to have amazing potential fail to achieve the required standard in early non-clinical development even before they are investigated in clinical studies. Many of those that make it to clinical trials will not be successful. Some products make it all the way through years of clinical development, only to be rejected by the regulatory agencies, or make it to the marketplace, and find the licence is withdrawn shortly afterward.
Reasons for failure
There are many reasons for these failures in the medicines development process. Sometimes the efficacy of the product is simply not good enough, particular if there are other products in this therapy area already on the market. Ideally this should be detected as early as possible in the development process before the manufacturer spends unnecessary investment.
Sometimes a medicine has unexpected safety issues that only become apparent during late development, or when it is marketed. But is there a way to predict these issues earlier? Could they even be prevented? Can a product be successful if it has safety issues, for example using a risk management plan?
Preventing failure
Identifying early which investigational products have inadequate efficacy or an unacceptable safety profile, and stopping further development, is key to reducing costs.
Characterising the safety profile as early as possible and providing the right data to support the licence is key to speeding the medicine to market and maximising profits, which can then be used to fund more research and development to find new medicines.
These sound like opposites, but they both rely on the same factor: collecting the right data throughout the development process.
How Pharmora can help will be explained in Part 2…
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