Last Updated on August 9, 2024
Prasanna Shroti is an expert in Regulatory Information Management Systems who has been working with Gilead Sciences, Inc. for close to a decade, and his contributions to RIMS have been enormous. However, this isn’t the direction he expected his career to take.
At least at first, Shroti took a job in healthcare simply because it was the right choice to support his family. But with time and experience, he recognized that, at its core, the healthcare industry is about serving people.
“This thought process, I feel more than anything, has helped me achieve whatever success I do have; this has always kept me working to provide my best. At the end of the process, there is some family, some person whose life is bettered. I have also been blessed to have worked with several talented mentors, managers, and colleagues who have recognized my strengths and helped me work on my many weaknesses. Looking back, I feel glad to have been a part of this journey, but I feel like I have a lot more to offer to enrich people’s lives through technology in healthcare.”
Enriching lives through healthcare is exactly what Shroti has been able to do with his career so far, especially with Gilead. Allow us to give a brief rundown of his projects with the company. He was the Technical Lead for a Regulatory Document Management System replacement project with a multi-million dollar budget that allows the company to prepare Health Authority electronic submissions for drug approvals, streamlining processes relevant to all of Gilead’s products since 2018, including, notably, the COVID-19 drug Remdesivir (AKA Veklury), which went on to save lives during the pandemic. This is a fascinating project, and we’ll have more details on this later in the article.
Shroti was also the Delivery Lead for an LCT upgrade project for Gilead that helps the company comply with changes to the standards of health labels on medicines. This implementation has been described as the gold standard by MHRA, the UK health authority.
Additionally, Shroti was the Technical Lead for a multimillion-dollar aggregate spend project that enables Gilead to comply with Health Care Professional (HCP) spend-related laws in the US and the EU.
Shroti also has a wealth of advanced professional experience beyond his regulatory work. This includes some particularly interesting projects and activities, such as his virtual reality (VR) work. He actually led the creation of VR tours of multiple Gilead buildings and manufacturing plants. Shroti also contributed to a VR requirements document in collaboration with BioPhorum, a consortium of biotechnology companies that provide guidance relevant to VR adoption. Shroti subsequently delivered a presentation of the contents of this document at an ISPE (International Society for Pharmaceutical Engineering) conference.
Each project leads to a positive, real-world impact, and that’s what drives Shroti to take on sophisticated RIMS challenges. We invite you to read on to learn more about why RIMS matters and how it helps companies like Gilead bring vital medications to market.
Global RDMS implementation at Gilead
It’s important to emphasize just how complex healthcare regulatory systems are and that complexity is driven in large part by the inherent complexity and variation in healthcare regulations from country to country and, in some cases, region to region.
Because major pharmaceutical companies like Gilead conduct their operations at an international level, they need to have accurate, up-to-date information on the regulations relevant to each market. This, in itself, is a major undertaking, but a few years ago, Shroti was tasked with playing a key role in choosing and implementing an entirely new system.
The choice of technology was made in collaboration with other department stakeholders within Gilead, but this was only the first step of a much more difficult journey.
As Technical Lead on the project, Shroti had to consider how this global implementation at Gilead would be executed and how the new system would mesh with the existing Gilead “technology landscape,” with respect to company-wide publishing and regulatory approvals.
But beyond how the new system would fit within the company and its operations, the migration from old to new was essentially a project in itself.
There was a lot to consider, to say the least. During our conversation, Shroti detailed some of the most important questions the team asked itself.
“Is there a supported path to take us from the legacy system to the new one? No. Do we know someone who has done this before? No. Are there any critical submissions from life-saving drugs planned that would be adversely impacted by migration delays? Yes.”
In a nutshell, Shroti and his team needed to migrate nearly two million documents and millions of pieces of metadata. It had to be done without mistakes, without the loss of any data whatsoever, and it all had to take place within a 48-hour window.
That’s right. Just two days to completely transition to a new system, or more accurately, a new set of systems, and any missteps could be a matter of life or death.
The next step was for Shroti to carefully formulate a migration methodology and architecture, develop migration scripts with the team, align the scripts to document migration rules, find a way to verify all data, and finalize migration and verification scripts.
In a slightly ironic twist, Shroti also had to document the fact that Gilead’s new Regulatory Information Management Systems were following all relevant regulations. At long last, the final step was to work with various teams across different geological locations to actually implement the migration.
After all this, the biggest question we had for Shroti was, basically, how did he pull it off?
Effective project leadership for high-budget projects
Leading such an enormous project with such serious real-world consequences would be intimidating for just about anyone, and as we mentioned at the start, this is the kind of thing Shroti does on a regular basis.
“It can definitely get stressful leading a huge implementation for a global company, especially when you understand your work goes into medicines that can save the lives of so many people around the world. But the scope of the project can also help you de-stress. Knowing the importance of your work lets you look at the big picture and helps you to focus on your own role and how it’s helping people lead healthier lives. That’s always a rewarding thought that helps me de-stress and focus on execution.”
When it comes to the more grounded, day-to-day leadership decisions, Shroti explained that he holds to certain leadership principles that have served him well through the years.
“Competent people work best when given freedom and treated with respect. Second, relevant data is always the best solution to every problem. And finally, more often than not, you need to get down into the weeds of the problem and then go ten thousand feet up to find the best approach. These philosophies have led to me being a hands-on lead who provides flexibility to people in terms of work locations, hours, and technical approach while still holding them accountable to delivery and timelines, keeping the bigger picture in mind.”
Shroti also gave credit to health authorities around the world who have improved their processes for communicating upcoming changes, which gives companies sufficient time to prepare and adapt.
He also mentioned that, in terms of the more technical decisions in his work, companies with a “compliance-based mindset” go to the front of the line. To comply with regulations, technology products need to track very specific types of data and factors with perfect accuracy, so choosing the partners is key to overall success.
Considering numerous perspectives
In his regulatory information work, as well as throughout his career, Shroti has recognized and respected the value of multiple perspectives.
In RIMS, considering the perspectives of different employees and different departments is a necessity. Everyone is affected by these decisions, so it’s important to know what they need and what input they have to offer.
“We have to consider how each of these group’s priorities and requirements from our applications would evolve over time. We also have to consider potentially conflicting priorities. Generally speaking, the best way to align these perspectives is to put them in light of the company’s goals, missions, and priorities. This needs to be accompanied by a healthy dose of relevant data.”
But this consideration for the value of differing perspectives reaches well beyond Shroti’s RIMS work. For him, perspectives are what allow for the creation of successful and impactful businesses.
I live in the San Francisco Bay Area, and there are so many examples here of people starting from scratch and building companies that not only make money but also change people’s lives for the better in almost unimaginable ways! I hope that one day I can add to that, sharing my own perspective and ideas to serve people better.
