During a global pandemic, the pharmaceutical industry must juggle the need for speed and the need to protect patient safety. A strong regulatory strategy makes it possible to accelerate drug development without getting slowed down by compliance considerations.
Because COVID-19 potentially affects the lungs, the heart, the gastrointestinal system, the liver, and so many other systems in the body, the breadth of medicines that might be effective against it is huge. Drug companies representing every corner of the pharmaceutical industry have responded to COVID-19, from developers of cutting-edge mRNA vaccine platforms to manufacturers of historically low-profile “commodity drugs.” As of this writing, there are 140 COVID-19 vaccines under development, with study subjects volunteering by the thousands. The insights uncovered from all of this research will impact not only COVID-19 patients but also patients across other diseases.
Accelerated drug development is not without risks. When the FDA launched their Coronavirus Treatment Acceleration Program (CTAP) in early May “to move new treatments to patients as quickly as possible,” experts watched with some trepidation. Sure enough, regulators have just revoked their emergency use authorization of chloroquine phosphate and hydroxychloroquine sulfate, citing too many adverse events and too few known benefits against COVID-19. This goes to show that however great the emergency, safety, and efficacy, testing cannot be fast-tracked without risking further harm to human health.
Meanwhile, we are relying on imperfect, non-pharmaceutical interventions to minimize the disease’s spread. We are at a critical inflection point between the need for speed and the need to protect patient safety. We will not know the outcome for some time. One thing is certain, however: our current health crisis is teaching us how to prepare for a faster, safer, and more flexible pharmaceutical response to the next one. These lessons will reshape our industry in significant ways.
To seize the full potential of these trends, drug developers need one thing above all else: a strong, detailed, forward-thinking regulatory strategy. This is the key to marshaling the best of our industry’s evolving scientific methodologies, platform technologies, and processes in the fight against life-threatening diseases. With such a strategy in place and with expert guidance to help you put it into action, you will have what you need to increase your response time in the face of unexpected health crises.
The big idea:
Why a regulatory strategy is necessary:
The big idea:
Why a regulatory strategy is necessary:
The big idea:
Why a regulatory strategy is necessary:
Some predictions claim that we could have safe and effective COVID-19 vaccines and treatments by Christmas. But even conservative predictions indicating that we will have a vaccine in eighteen months would beat historic vaccine development timelines by several years. Only time will tell if we succeed at moving that quickly while successfully managing the significant risks involved.
What we know for sure is that this crisis has changed the world of drug development.
A strong and proactive regulatory strategy is key to that mobilization effort, and will play an increasingly important role in shaping the future of our industry—wherever that future may take us.
Three essential strategies, from the earliest planning stages through your project’s maturity, will help position your ATMP facility for success.
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