In the heat of the COVID-19 pandemic, major pharmaceutical companies around the world were hard at work developing treatments for the virus, which had become the most serious global health risk in decades.
But what many people didn’t realize at the time was that discovering a potential treatment was only the first step of the process. Potential treatments couldn’t simply be released for public use without extensive testing and oversight.
Guidelines and regulations regarding medication safety standards are complex. This isn’t bureaucracy for bureaucracy’s sake. These regulations are designed to protect citizens who will eventually receive and use the medication.
While no medication is without potential risks and side effects, testing and regulations ensure that patients and medical professionals are fully aware of the associated risks and complications with other medications or pre-existing medical conditions.
Pharmaceutical companies dedicate substantial internal resources to understanding relevant regulations and making sure that their medications adhere strictly to these regulations.
This is an aspect of pharmaceutical development that is rarely talked about, but it carries a fair amount of fascination and a great deal of logistics and planning on the part of pharma professionals.
Prasanna Shroti is currently the Associate Director of Regulatory Information Systems for Gilead Sciences, Inc., a leading American biopharmaceutical company. He was able to provide us with an in-depth look at the intricacies of his work and his collaborative efforts to improve Gilead’s systems even further.
But first, let’s start with a more accurate overview of Shroti’s work.
“In my current position, I am responsible for providing technical and architectural oversight for all of the different Regulatory Systems at Gilead. These are critical Gilead systems that are required for Gilead to get approval for the life-saving drugs that Gilead produces. My inputs are a critical piece in deciding our more than $25 million implementation roadmap for Regulatory Information Management (RIM) systems.”
This planning portion of Shroti’s role involves thinking strategically about how Gilead’s interconnected systems can be further evolved on a technical level. Of course, this work isn’t happening in isolation. Shroti regularly collaborates with stakeholders from various departments within Gilead, including Regulatory Affairs, Regulatory Operations, IT, and Medical Writing.
But we’ll return to future considerations later in the article. In the here and now, Shroti has been instrumental in the approval of Gilead’s life-saving pharmaceuticals. In particular, he contributed in a major way to a vital COVID-19 treatment.
Remdesivir approval
Remdesivir is a COVID-19 medication, more specifically a broad-spectrum intravenous antiviral medication.
Following development, remdesivir had to begin the long process of approval. Though the approval process varies from country to country in terms of the small strokes, there are broad-stroke norms across the board.
A crucial component of any approval process is to maintain highly detailed records of the medication’s development. The purpose of these records, of course, is to serve as proof that the company has adhered to all the necessary guidelines and regulations.
The process of maintaining these records is referred to as the Regulatory Document Management System or RDMS. Shroti was personally responsible for implementing, migrating, and maintaining the RDMS.
“Without this new system, Gilead would not have been able to obtain approval. I worked as the technical lead that implemented this system for Gilead Sciences after migrating this system from the old vendor. In addition, I provided support for this system during the filing phase of remdesivir where we made sure that the system was up and running properly.”
Once again, this illustrates how carefully pharmaceutical companies have to proceed when developing a new medication and especially when they’re preparing to release a successful medication for widespread use.
Every single step of the process needs to be well-documented, and each regulatory body needs to be provided with a specific set of information based on its unique standards. And as Shroti pointed out, not being able to provide this information could lead to a life-saving medication getting caught up in red tape.
Managing multiple systems
As you might expect, managing multiple systems relevant to numerous regulatory bodies around the world is complicated work, and we felt compelled to ask Shroti whether there’s a risk of getting lost in the weeds, so to speak.
Hhe explained that enabling information flow is key.
“For Gilead, our guiding star is bringing transformative therapies to patients in need. For us in Regulatory Systems, this translates into having a set of systems that allows Regulatory Information to flow as quickly as possible among our systems to the FDA and other health authorities around the globe.”
Based on this understanding, Shroti and his teammates work on creating an ecosystem that compartmentalizes systems, projects, and initiatives based on their significance to the drug approval process.
“Once the systems have been allocated their roles and priorities, we get started on a roadmap that determines where you see each system in that roadmap. This then determines what gets worked on with what priority. This roadmap needs to be clear, not just in your own head but across the entire team so that we all execute towards the same vision.”
This coordinated effort also depends heavily on speaking with various stakeholders throughout different departments, and Shroti shared his highly effective approach to conducting these conversations and making sure that everyone is on the same page.
Communicating with stakeholders
Not only does Shroti have to coordinate with multiple stakeholders, who all have their own professional perspectives, but he also has to communicate the relative priority of each topic.
Shroti’s solution is to stick with clarity at all times.
“My approach is to be as clear, objective, and data-oriented as possible since that is generally the easiest way to move people towards a decision and communicate the priority of the conversation really well. The most important skill here is to understand the person behind the stakeholders since there is no one-size-fits-all approach to communication. Some people prefer to get news as soon as it happens, while others prefer their updates periodically. Some people deal better with the written text and some are better with voices and words.”
But these individual considerations are all integrated into Shroti’s crisp and direct communication approach. He also mentioned that the various communication channels currently on offer in the modern workplace, such as Microsoft Teams, Slack, Zoom, email, and slide presentations, represent a variety of options for any given situation. Not every communication channel will be appropriate for every stakeholder or for every conversation.
For anyone wrestling with stakeholder communications within their own companies, Shroti offered several key pieces of advice that he’s found helpful.
“Do your homework. This is by far the most important. If you understand the topic you want to talk about and have done your research, then invariably, even if you start on a wrong note, you will have the ability to claw the conversation to the point where it is relevant to all stakeholders. Understand relationships between different stakeholders. Understand what each stakeholder’s objectives and biases are. Be direct and clear, and address the important topics first.”
These concepts are ultimately relevant to all kinds of professional communications, and the good news is that, once you get to know the people you’re working with and talking to, these individual choices will become more intuitive. You’ll know right away how to share a specific piece of information with a specific person.
For Shroti’s line of work, efficiency of communication is all the more important, since it is directly related to the speed at which medications can reach the people who need them.
In fact, when we asked Shroti about some of the typical challenges he encounters from day to day, he spoke to what is essentially a communication issue or, from another perspective, a lack of understanding.
“The most common challenge relates to people simply not knowing what the problem is and what the objective is. But once you articulate the problem and the objective well enough, people in a company such as Gilead are smart enough to figure out a solution. So in many ways, the higher up you go, the more important it becomes to be a ‘spotlight,’ where you just show people the problem and let them figure it out.”
Any lack of understanding has to be highlighted through conversations, whether virtual or in person. The assumption that everyone on the team fully understands the current problem can be a dangerous one. And once a lack of understanding is revealed, it has to be addressed as quickly as possible. Otherwise, you’ll have team members spinning their wheels, which wastes time and resources.
Every conversation and every system at Gilead supports achieving real-world goals, and keeping sight of those goals is an important part of Shroti’s work routine.
Real-world impact
With work as complex as pharmaceutical development and regulatory systems management, there’s a risk of not being able to see the forest through the trees.
This is why Shroti and many other members of the Gilead team make sure to remind themselves and each other of their ultimate goals.
“Sometimes it can be hard to remember the impact of our work during the day-to-day grind. This is where having constant reorientation or planning sessions helps put the effect and objectives into mind. It is also equally important to celebrate past achievements and put them in context.”
It’s all too easy for a shift to feel like just another day at the office, but for companies like Gilead, the effects of their work reach far beyond the walls of headquarters.
We hope this conversation has given our readers a new understanding of the immense amount of work that goes on behind the scenes when a new medication is being created and approved.
Every step is vital, every conversation is crucial, and the leading pharma companies are keenly aware of this every single day.
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