Biotech business development is extremely difficult with several issues that need to be wrestled in order to increase the chances of success. Even when these are resolved, there are no guarantees with the outcome. This is a business with high risks that many prefer to shy away from. It is also a gamble that can pay off like no other so it could be worthwhile for those with an appetite for adventure. Below are just some of the many challenges that biotech companies, with or without the help of lifesci advisors must face, particularly when they are grappling with the development of essential vaccines:
Lengthy Development Process
Vaccines cannot be made overnight. Even if there is a pressing need for them like today while we face a pandemic, it is impossible to develop an effective solution in a lab without going through a lengthy development process. There are no shortcuts. Trying to cut corners will only lead to dangerous side effects, ineffective treatments, possible fatalities, and a ruined reputation. Vaccine candidates will have to go through phases to test different aspects such as safety, effectiveness, proper dosage, and so on. Only when all of the requirements have been satisfied can they be deemed ready to produced on a mass scale for commercial use.
Massive Resource Requirements
The entire process typically takes many years. A 10-year development cycle is not uncommon. Five years is considered to be fast. Some infectious diseases still don’t have a vaccine even after decades of attempts because of lack of funding or technical difficulties. Massive resources are needed to keep the efforts going throughout the timeframe. Sometimes investors put back due to lack of progress. The disease itself may disappear due to other control measures such that vaccine developments are halted. Even so, the findings can prove to be useful for future diseases. Biotech companies will just have to make sure that their projects are not wasted.
Companies that are able to present successful trials still cannot sell their vaccines unless they are able to hurdle government regulations. There are different ones in each country so businesses need to note the various standards that are in place. Governments may also negotiate different prices for their constituents. They might insist that they get a vaccine ahead of other countries if they gave funding for the initial phases of research. Some will respect intellectual property while others won’t. Given all these, biotech companies need to be extremely careful in how they navigate the geopolitical landscape.
Another big challenge is getting the public to view the vaccines and other drugs as a positive development that can be of great use. Although this has always been the logic behind vaccines, there are many who view them with harsh skepticism. Perhaps they had less than ideal encounters with vaccines in the past including side effects. It can be difficult to convince these to accept the medical solution despite all of the tests that validate safety. The company must work with the government and communities leaders to increase acceptance.