It is exciting to live in a time when medicines are advancing quickly to new levels.
Gene therapies are in the process of revolutionizing medicine with the ability to replace faulty genes in a targeted fashion. Only recently have the tools matured enough to make this possible.
So far, organizations researching these therapies currently focus on rare diseases affecting smaller groups of people.
Two significant factors are holding back this industry from being able to treat more complex diseases and larger populations:
- Manufacturing Overhaul - the complexity of gene therapy production and applications regarding safety and effectiveness require the entire process to be optimized and streamlined to ensure success on a broader scale.
- Regulatory Stakeholder Participation - regulators, such as the FDA, lack newer development guidelines that allow researchers to know what particular practices to put in place during their research and clinical trials.
These manufacturing and regulatory processes are out of date.
A revamp to accommodate these fast-paced medical advances is necessary for geneticists to continue to heal the world on higher levels.
Read an article about this on Forbes: