The future of regulatory submissions is faster, less expensive and requires a whole lot less paperwork, according to experts who spoke at the Drug Information Association's 2022 conference in June.
One of these experts is Mukesh Singhal, a senior manager of Deloitte's R&D and regulatory practices, says "regulatory intelligence" — the process of monitoring and analyzing regulatory information to create a drug development strategy — is the next step in bringing biopharma regulatory departments into a more streamlined process.
Singhal is focused on managing data in a way that gives an organization agency over when and how quickly it can be accessed — a critical part of compiling regulatory materials to submit to authorities like the U.S. FDA and the European Medicines Agency. And that means some of the old ways need to go out the window.
"In a sense, there has been a unidirectional view of meeting regulator needs and not necessarily pushing the bounds," Singhal tells PharmaVoice. "There's certainly a need on the industry side to make that process more efficient and on the regulator side to not only make it efficient, but also make it so that there are better lines of communication."
At the DIA conference’s keynote address, FDA Commissioner Robert Califf emphasized the importance of communication between industry and regulators, urging a movement toward "failing fast" to weed out less worthy candidates, allowing approved products to gain more attention.
Similarly, Singhal is looking to take pharma from a document-based system to one based on data and digital workflows for their regulatory processes to work faster and in a way that generates more insights without duplicating work.
"The paradigm for how submissions are done is changing," Singhal says. "It's a fundamental shift."
Here, Singhal talks about how pharma is beginning to embrace the shift to regulatory intelligence and how it could bring technology and strategy together for a more streamlined approach.
This interview has been edited for length and clarity.
PharmaVoice: Can you tell me about the concept of "regulatory intelligence" and how that differs from a more traditional approach?
Mukesh Singhal: I've been on this journey around regulatory intelligence for some time now. The industry is slowly, and more so recently, realizing the need to transform how they operate. Regulatory [departments] traditionally [have] been taking rolls of information that often sit in documents, and in most systems people have it in their spreadsheets, to compile into submission. There's not a common way to actually organize that [data], never mind to access it and actually generate insights. How do you better leverage all this information that you have access to and generate the insights that help with your strategies and your decision making when getting submissions and approvals?
What I've done over the past couple of years is think about how regulatory intelligence can inform the industry and transform organizations into insights-driven organizations so that they can better take advantage of this information. There's this journey within regulatory where you need information all the way from up-front strategy development into how you publish a submission. There's all this information, and what you're doing is compiling all of that so that the end users will have access to it at their fingertips to generate insights.
FDA Commissioner Robert Califf talked at DIA about the concept of "failing fast" to bring good products forward more quickly. How do you speed up the regulatory process without cutting corners?
You're not removing work as much as you're removing the excess work — the obstacles to work. You're removing duplication, the rework that often happens. As an example, when a person in a local market, let's say Brazil, is looking to do a submission, they might be interested in what Ecuador has done, what Uruguay has done — the surrounding markets will serve as inputs into what they might want to do. That process of research may take an individual days, weeks often — sometimes months. By having all the information at your fingertips, you're not removing that work.
What we're doing to reduce the duplication is like going from the white pages to Google, where everything is up-to-date and you're streamlining the process of getting information.
How much of this is strategic change versus a technological change?
It has to be both. As is the case with most transformational journeys, the technology is a core component of it to do things that weren't possible before. But to get the proper adoption of that technology, you need to think about everything. You can have the shiniest toy, but it's not going to do anything if you don't have the associated business processes, it's going to be a big shift for end users to now operate in this new way where information is coming in different ways.
What we are designing is a tool that end users, submission managers, regulatory strategists would use. And there are all these different moving pieces that need to come together alongside that technology.
Healthcare and pharma are often slow to adapt to these changes because of the regulatory process. What can pharma executives do to move more quickly to adopt these streamlined processes?
Partially driven by the pandemic and this need to move toward a virtual way of working, the digital transformation that people had on their road maps for a year or two years all happened within months. People recognized the need to digitally transform very quickly. And life sciences is no different. There are different considerations like regulatory requirements, and these are certain fundamental things that you can't avoid, so there's necessarily a more staged approach life sciences needs to take — but there is a full recognition that these technologies are out there. Artificial intelligence, machine learning, natural language processing are all part of the normal parlance now.
It's now more about thinking about how those technologies can be embedded into our ways of working and our daily processes. We at Deloitte and others in the industry are working actively with regulators, folks at the FDA and the EMA, to help them get more comfortable with what role technology is playing in that. It's not what we refer to as ‘removing humans from the loop.’ Humans are still helping to make the decisions, but they're being further informed by technology. Regulators are getting more comfortable and industry is coming very quickly alongside, so there's a natural confluence where technology is at an inflection point.
What is the old-fashioned thinking that pharma is employing now that should be done away with?
Specifically within regulatory, what you're seeing are major shifts from a traditional document-centric model to a data-centric and digital model. And that's the biggest fundamental shift so that you don't have to access information in silos — it's more accessible to everyone and it allows for more insights to be generated. By doing that, you get all of the downstream abilities to run analytics on your information to become an insights-driven organization. It's a foundational change that needs to happen. And I would say in the past five years, virtually everyone has recognized that need — where they are in the journey of actually moving toward that depends on the organization.
What are some of the obstacles for companies looking to adopt a regulatory intelligence model?
Some of the new players like startups have grown very quickly where they don't have volumes of data and information in their content management systems — they can immediately move to a data-centric model. Whereas when you are a large, top 10 pharma, you've got the legacy that you need to slowly shift away. And that's not only your systems and your documents, but all the people need to adapt to a new way of working. So it naturally takes big companies a lot longer. There are a lot of benefits that big companies have but they also require a little bit longer to move toward the newer ways of working.