The pharmaceutical industry historically has been well known for being risk averse. But the rapid response to Covid-19, particularly the development of vaccines to minimize the effects of the virus within roughly one year of the pandemic’s onset, has illustrated how the pharma industry can be agile when it needs to be. It begs the question — is this the way forward for drug development?

Mario Moreira is a Principal Consultant with Emergn and has almost two decades worth of experience applying Agile in the enterprise. He focuses on enabling digital transformations for companies within the pharmaceutical industry, and has helped clients improve their time to market for drug development. In an interview he offered some insight on how pharma can utilize principles of Value, Flow and Quality to advance the sector.

What is Agile?

Agile is not a thing to do, but a way of being, focused on reaching your desired business outcomes. The intent is to help you develop a thriving business that provides valuable products and experiences to the market, embracing the power of employees and partners while managing for stability and growth. 

“In order to achieve the desired business outcomes, a combination of tools, techniques, practices, methods, processes, mindset, and concepts are embraced” said Moreira, “With that said, Agile in and of itself, is nothing more than a set of values and principles. At Emergn, we embraced these into our guiding principles represented by the words Value, Flow, Quality.” 

• Value: Delivering value early and often
• Flow: Optimizing the flow of work end-to-end 
• Quality: Delivering quality with fast feedback

Moreira noted that Emergn’s perspective has helped some of their pharma clients shave months and even years off of their drug development timeline. Over-interpretation of GXP standards, revolving primarily around accountability and traceability, is one area that has slowed pharma companies down. By evaluating the potential over-interpretation of regulatory guidance, organizations can move faster.

“We found that some internal processes would add six months to a year to the drug discovery process, and they had nothing to do with actual compliance. Some of these processes stemmed from a political or emotional standpoint from senior executives – and they went unquestioned for years, as corporate profits stayed on track and there was no reason to question the process. This way of working is more typical in larger organizations compared to smaller biotech companies.”

“Organizations generally take a strict approach to all internal processes, especially those driving innovation. Pharma companies will accept, of course, the regulatory department’s interpretations of the regulations, but it doesn’t mean it’s the most effective way to deploy. Some of this is because the regulatory department’s job, rightly, is to ensure the products are safe and effective. We have to be clear about that. So when they advise teams, they tend to adopt an overly strict set of procedures to mitigate risk.”

Moreira points out that this approach tends to needlessly stymie departments and teams with procedures that are often excessive which in turn slows down workflows. Ultimately it can chip away at the value of the work, impacting patients and healthcare providers.

He said pharma companies need to reframe this approach. Emergn engages with regulatory and compliance departments to enable more modern and agile ways of working, building relationships with regulatory teams to encourage them to be more innovative in order to enable the drug discovery process to work more effectively.

Agile in action

Moreira highlighted one example where Emergn worked with a pharma company to apply modern ways of working to advance the commercialization of a non-Covid vaccine. Computer Software Assurance, or CSA, another agile solution, encourages vendors and regulatory companies to apply critical thinking and consider information and objective evidence in a more rational flowing manner, Moreira noted. CSA leverages principles such as risk-based testing, unscripted testing, and continuous performance to focus on how companies can accelerate.

“We offered a digital solution to physicians to make it easier for them to discuss this vaccine with their patients by improving the way users could access information about the vaccine through their smartphones. Through AB testing, we optimized accessibility of this data on mobile devices and saw an upswing in the numbers of people getting the vaccine.”

Moreira acknowledged that although many big pharma companies are implementing principles of Agile, it is limited to experimentation or pilots. Smaller companies, however, tend to embrace these principles because they tend to have a smaller number of products and there is a focus on keeping things lean.

How vaccine development response to Covid-19 informs Agile in pharma processes

Moreira noted that Covid-19 has helped the pharma industry understand the importance of an end-to-end view of work. The effort to develop vaccines reflects and embraces, on a grander scale, the principles of optimizing flow, which Emergn stands for and helps companies implement.

One advantage pharma companies held as they began to develop vaccines was that they already had a lot of information on the severe acute respiratory syndrome (SARS) coronavirus for the first phase of vaccine development. But the remaining phases represented new ground. This was an opportunity to share information and collaborate internally. 

“The benefit of both pharma companies and industry regulators becoming highly collaborative and open to greater experimentation is what partly led to faster breakthroughs. If we’re to extract a silver lining from Covid-19, it’s that we got a glimpse into how to accelerate the drug discovery cycle in pharma.”

“Now there is this new end-to-end baseline that is available. Moderna and Pfizer will share some of these insights with others as the pharma industry looks at vaccine development more broadly. I think this crisis has actually helped the pharmaceutical industry in general, because they now have a whole new end-to-end view of accelerated vaccine development.”

Applying Agile in pharma

Moreira noted that agile in pharma is best applied to any aspect of pharma work that has some level of uncertainty and/or discovery when the way forward is unclear.

“Effectively, we’re guessing, but we’re doing it with data-driven methods. The same applies with drug discovery. Building a path towards certainty through discovery is very much part of the Agile mindset. If we’re trying to figure out how gene therapy might be effective, we need to embrace a variety of different experiments — this is not a linear path.

The only part of pharma where you wouldn’t apply Agile is in a manufacturing line for a vaccine. At that point, you know exactly the elements of a therapeutic and what process works, and in this case, we can bring more traditional methods to play.”

The pharma industry’s race to develop vaccines and treatments for Covid-19 has been inspiring. It’s also done much to improve the public perception of the biopharma sector. The industry has all the tools it needs to deliver life transforming drugs quicker and more efficiently. It will be exciting to see how companies adopt the values and principles of Agile in the pharma industry to develop and commercialize drugs for chronic conditions to rare diseases, and deliver better outcomes for patients. 

Photo: ClaudioVentrella, Getty Images