The pharmaceutical industry’s evolution from one that relies on the high revenue of blockbuster drugs to one that focuses on the unmet needs of smaller patient populations has changed the paradigm of drug development. It has also driven a rise in innovation over the past several years, due to the advances in technology that have generated new opportunities in the laboratory and in the body.
Scientists learn more and more each day about how to produce products that can transform patient care. The breakthrough therapy drug designation (BTD) made possible by the FDA’s Safety and Innovation Act in 2012 creates even more potential for the treatment of many diseases.
Its fast-track status paves the way for novel drugs to make it to market more quickly, giving renewed hope to those waiting on medications that could mean the difference between life and death. However, while the review process is expedited for a BTD, the expectation of the FDA remains unchanged when it comes to safety and efficacy. Proof of a drug’s profound clinical effect must be accompanied by a development and manufacturing strategy that can deliver a consistent level of quality in the face of any market demand.
An approach well known for its emphasis on process understanding, process control, and risk mitigation is Quality by Design (QbD). While there are many benefits to QbD, there is longstanding skepticism about applying its tools and principles to drug development. This is due to not only the time and financial commitment required for successful implementation but also because of an industry that is well known for being risk averse.
Nonetheless, as pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.
