Research and Development, R&D, particularly in drug development for big pharma has always proven to be a problem. While 2016 helped to smooth over various problems and helped to digitize certain aspects of big pharma, drug development is one which still faces various problems to this day.
While the pressure has definitely increased to improve different aspects in R&D, industry key players feel pressured, having to not only address various problems but also do their best to offer customer-centric services and retain a competitive edge in the market as well. The following are some areas that still continue to challenge big pharma, particularly when faced with drug development.
Regulation
One of the most cumbersome processes when it comes to developing and approving new drugs is adherence to regulation. Unfortunately, a rather stringent regulatory environment often places a lot of pressure on the development. This often means having to deal with additional costs and bigger delays in development time that makes patent expiry a huge problem.
Since patents are applied for very early in the drug development process, it often means that by the time the drug is introduced in the market, there are barely 10 years or so left in the 20 year patent. This leaves a very little window for the drug to recoup the investment made in it by big pharma.
Counterfeiting
The high costs in regulation and the added pressure of recouping the amount invested in the drugs means that there are certain drugs with exceedingly high price tags. Due to this factor, it is common for there to be counterfeit drugs as well that cause a significant amount of losses on an annual basis. Not only do counterfeit drugs cause a loss in profits, but they also pose a threat to anyone buying them.
These usually contain different substandard ingredients that can have an adverse affect on the person trying them. Luckily, the Falsified Medicines Directive – FMD is already working with different manufacturers to incorporate serialization in their production process. By focusing on serializing, the FMD is hoping to incorporate a track and trace identification process to safely track the drug and identify signs of tampering.
Formulation
To ensure that the drugs being produced are effective, one has to pay attention to the content it contains. In a previous study, it was found that even in lipid-based formulations – LBF, the chances of increasing the bioavailability or solubility of the ingredients that make a direct impact in the body is low. On a regular basis, there are only 40% of drugs with good solubility while around 70% of drugs are still classified as poorly soluble.
This factor greatly cuts down on the effectiveness of a drug that is being developed or released into the market. Additional research is still necessary to improve this factor but the data showcases that around 60% of drugs that are still in the developmental phase showcase low signs of positive bioavailability. Even different drugs that have been released into the market showcase challenges in their bioavailability.
