Accelerated Drug Developmentis an approach where FDA expedites the approval process and give the final approval in less time as compared to drugs in traditional approval. The program is implemented for medicines that are critical for the treatment of serious conditions that have previously been not developed.
An important element in accelerated drug approvals are surrogate markers, used to correlate outcomes of a drug. The FDA uses surrogate markers to ensure the efficacy of the developed drug before giving approval under accelerated drug approval.
However, even after giving accelerated approval based on surrogate markers, clinical studies are necessary to correlate the results with clinical outcomes. If at this stage, the drug fails to prove its clinical benefit, the FDA can withdraw approval of that drug.
The contrary to the accelerated drug development is full approval that follows all steps i.e. discovery & development, preclinical research, clinical research, FDA Drug review and FDA post-market drug safety monitoring, and could take more than six months for final approval.
What are the FDA guidelines regarding the Accelerated Approval?
The current and relevant FDA guideline is “Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics”. In it, the FDA describes many forms of expedited approval programs, including the Accelerated Approval.
The current applicable guidance is finalized in May of 2014. However, FDA has issued draft guidance on this subject, which is distributed for comments and feedback.
What is the meaning of the term “serious condition”, and what type of drug fulfils these criteria?
Serious Condition
The major aim of accelerated approval is to speed up the availability of therapies for serious conditions as soon it is established that the drug’s therapeutic effects are sufficient, without digging deep into the complexity of clinical trials.
But what justifies the definition of a serious condition? The FDA has also provided the answer to that.
According to the FDA guideline and in its section III – A (1), a serious diseases or condition is a medical condition
· That impacts day–to–day functioning.
· A persistent or recurrent condition, that is not irreversible
· If left untreated, it will progress from a less severe to a more serious condition based on factors such as day-to-day functioning and survival.
Drug characteristics for treating serious conditions
According to this guideline, the drug for the treatment of serious conditions must possess the following characteristics
· The drug intended for the diagnostics or treatment must have improved outcomes for the patients or end users.
· The drug must be able to prevent or mitigate side effects related to a serious treatment. For example. Infection in patients undergoing immunosuppressive therapy
· a drug intended for diminishing or avoiding serious adverse effects related to available therapy targeting serious illness, such as less cardiotoxic than available cancer therapy
· a drug for preventing a serious condition or to reduce the likelihood of progression to a more serious condition
Strategies to facilitating Accelerated Drug Development
Let’s discuss some strategies to facilitate accelerated drug development
Using the latest Technology to support accelerated drug development
Latest technologies, such as Artificial Intelligence – AI and Machine Learning ML, can be used to replicate and create experimental data, which is critical in the development of pharma drug products. One downside of traditional experimentation is that it requires time and effort to support the under-developed drug. And for the drugs under the accelerated program, time is critical and traditional experimentation cannot be implemented.
AI and ML can create experimental data models for studying the effect of the drug under consideration. They can design the target drug substance model without practically and physically making them. Additionally, they can also be used to predict the outcome and side effects related to a particular drug product.
High-throughput screening
High-throughput screening - HTS is a method where ...
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