The pharmaceutical industry has historically been known for being risk-averse. But the rapid response to Covid-19, especially the development of a vaccine to minimise the impact of the virus within about a year of the pandemic’s outbreak, illustrates how the pharmaceutical industry can remain nimble when needed. Which begs the question – is this the way forward for drug development?
Mario Moreira is the lead advisor new And has nearly two decades of experience applying agile in the enterprise. He focuses on digital transformation for companies in the pharmaceutical industry and helping clients reduce time-to-market for drug development. In an interview, he offers some insights into how the pharmaceutical industry is using the principles of value, process and quality to drive the industry forward.
What is agile?
Agile is not a thing to do, but a way of being, focused on achieving your desired business outcomes. Its purpose is to help you grow a thriving business, bring valuable products and experiences to the market, embrace the power of employees and partners, while managing stability and growth.
“In order to achieve desired business outcomes, a combination of tools, techniques, practices, methodologies, processes, mindsets and concepts is required,” says Moreira. “That being said, agile itself is nothing more than a set of values and principles. At Emergn, we will These are incorporated into our guiding principles, represented by words like value, process, quality.”
- value: Provide value early and often
- flow: Optimize end-to-end workflow
- quality: Provide quality through quick feedback
Moreira noted that Emergn’s perspective has helped some of their pharmaceutical clients cut drug development times by months or even years. Over-interpretation of GXP standards, mainly around accountability and traceability, is one area that is slowing down pharma companies. By evaluating potential overinterpretations of regulatory guidance, organizations can act faster.
“We found that some internal processes add six months to a year to the drug discovery process, and they have nothing to do with actual compliance. Some of these processes stem from the political or emotional positions of senior executives — and have not been for years. Questioned because company profits are on track, there is no reason to question the process. This way of working is more typical of larger organizations than smaller biotech companies.”
“Organizations typically take a rigorous approach to all internal processes, especially those that drive innovation. Pharmaceutical companies will of course accept regulatory interpretations of regulations, but that doesn’t mean it’s the most efficient way to deploy. Part of that is regulatory The department’s job is to make sure the product is safe and effective. We have to be aware of that. So when they advise teams, they tend to have an overly restrictive set of procedures to mitigate risk.”
Moreira notes that this approach tends to unnecessarily hinder departments and teams’ procedures, which are often too numerous to slow down the workflow. Ultimately, it undercuts the value of work and affects both patients and healthcare providers.
Pharmaceutical companies need to reframe the approach, he said. Emergn works with regulatory and compliance departments to enable a more modern and flexible way of working, building relationships with regulatory teams and encouraging them to be more innovative, thus making the drug discovery process work more efficiently.
Agile in action
Moreira highlighted an example of Emergn working with a pharmaceutical company to apply modern working methods to advance the commercialization of non-Covid vaccines. Moreira noted that Computer Software Assurance (CSA) is another agile solution that encourages suppliers and regulatory firms to apply critical thinking and consider information and objective evidence in a more rational flow. CSA uses principles such as risk-based testing, unscripted testing, and continuous performance to focus on how companies can accelerate.
“We are providing physicians with a digital solution that makes it easier for them to discuss this vaccine with patients by improving the way users access vaccine information via smartphones. With the AB test, we optimize the accessibility of this data on mobile devices sex and seeing an uptick in the number of people being vaccinated.”
Moreira acknowledges that while many big pharma companies are implementing agile principles, it is limited to experiments or pilots. However, smaller companies tend to embrace these principles because they tend to have a smaller number of products and focus on staying lean.
How a vaccine development response to Covid-19 informs agility in the pharmaceutical process
Moreira noted that Covid-19 has helped the pharmaceutical industry understand the importance of an end-to-end view of work. Efforts to develop vaccines reflect and embrace the principle of optimizing processes on a larger scale, which Emergn represents and helps companies implement.
One advantage pharmaceutical companies have when they start developing a vaccine is that they already have a wealth of information about the severe acute respiratory syndrome (SARS) coronavirus that can be used in the first phase of vaccine development. But the remaining phases represent new territory. This is an opportunity to share information and collaborate internally.
“The benefits of pharmaceutical companies and industry regulators becoming hyper-collaborative and open to larger experiments have partly led to faster breakthroughs. If we are to extract a silver lining from Covid-19, it is our understanding of how to accelerate pharmaceutical The industry’s drug discovery cycle.”
“There is now this new end-to-end baseline available. Moderna and Pfizer will share some of these insights with others as the pharmaceutical industry looks at vaccine development more broadly. I think this crisis has actually helped the entire pharmaceutical industry, Because they now have a whole new end-to-end view of accelerating vaccine development.”
Applying Agile in Pharma
Moreira noted that agility in pharma is best applied to any aspect of pharma work that has some degree of uncertainty and/or is found when the path forward is unclear.
“Actually, we’re guessing, but we’re doing it with a data-driven approach. The same applies to drug discovery. Building a path to certainty through discovery is an important part of an agile mindset. If we’re trying to figure out To understand how gene therapy works, we need to go through a variety of different experiments — it’s not a straight line.
The only part of the pharmaceutical industry where agile will not be applied is the vaccine production line. At that point, you know exactly what the elements of the treatment are and what process works, in which case we can bring more traditional methods to work. “
The pharmaceutical industry’s race to develop vaccines and treatments for Covid-19 is encouraging. It has also done a lot in raising public awareness of the biopharmaceutical industry. The industry has all the tools it needs to deliver life-changing medicines faster and more efficiently. It will be exciting to see how companies are adopting agile values and principles in the pharmaceutical industry to develop and commercialize medicines for chronic and rare diseases with better outcomes for patients.
photo: Claudio Ventrera, Getty Images
