COVID-19 impacted all areas of our lives over the past year. We caught up with the Regulatory Operations team to see how working from home, regulatory changes, and technology challenges impacted them and how they see this experience changing the industry in the future.
- Shermayne Nicolaou, Head of Regulatory Project Management and Submission Operations
- Maria Sclafani, Sr Regulatory Project and Submission Manager
- Efi Sergi, Associate Director, Regulatory Project and Submission Management
- Melanie Hasek, Associate Director, Regulatory Publishing
What changes have you noticed to the operational externalization model due to COVID-19?
Shermayne: 2020 turned out to be one of our busiest years. We saw greater appreciation for dedicated roles like Regulatory Project and Submission Managers, focused purely on upstream planning. We all felt like we were racing against time, and we noticed our clients emphasizing the need for well-designed timeline plans using dynamic software specific to linking submission dependencies. The timeline plans enabled various scenarios to be mapped according to the chosen accelerated filing pathway and facilitated rapid decision-making across the business.
Clients started to seek earlier interactions with the health authorities for advice and in response were needing to mobilize submission teams quickly. We leveraged our Embedded Partnership Models to allow for focused prioritization, so there were no conflicting priorities. Since we had established a remote working model prior to COVID-19, we were able to direct submission teams virtually with ease since we have been operating in a virtual environment all along.
The pandemic has left us reflecting and rethinking what we once considered a “mandatory” technical requirement and best practice. A new baseline has been set, which will impact the industry, health authorities, and vendors when designing submission plans. Regulatory Operations, known as the fire-fighters in our industry, will need to pivot quickly and ensure they enforce upfront planning to allow downstream publishing activities to be less arduous.
In your experience, what advice would you give when planning for a dual initial filing related to Covid-19?
Maria: From the very start of the project, try to better understand the corporate strategy and timeline expectations. There are different available pathways with regulatory authorities, some of which were introduced specifically for COVID-related therapies to fast track development. Understand the requirements for these different pathways or submission types and be realistic about the milestones. Sometimes the time required for additional steps on certain fast-track pathways will not result in time savings in the long run. Determining the best path based on the availability of these requirements (eg, INDs, BLAs, EUAs) can save a lot of time on starting and stopping.
As with all submissions, it’s important to have as much information and content frontloaded as possible. Finally, strong leadership is needed more than ever to align the various teams functionally and globally around processes, roles, responsibilities, trigger points, scenarios, content, and resources.
What is the most noticeable change to how we manage accelerated non-COVID to COVID submission projects?
Efi: There are three main areas where I see the most noticeable changes: acceleration, risk management, and communication. Let’s take a look at each of these individually.
First, we have acceleration. The timing from trigger to submission is a fraction of what would be considered an accelerated timeline in a pre-COVID world. There is little room to accommodate any changes as they are highly likely to impact the critical path and delay the entire project.
Next, we look at risk tolerance or risk management. Risk identification, assessment, and management have become more important than ever. We may need to accept and/or mitigate risks resulting from skipping certain steps in the end-to-end submission process that we would otherwise consider mandatory.
Finally, communication channels in a virtual environment are different for many of our clients. We’ve seen a shift to informal and verbal communication channels for seeking quick information or trying to resolve a discrepancy, especially when meeting in person is not an option. We noticed an increased use of instant messaging tools, phone calls, and video conferencing.
To hear more perspectives on supporting COVID-19 projects, join our session “Project Management in Times of Crisis” at DIA 2021 Virtual Global Annual Meeting, where I will be sharing lessons learned from preparing and submitting an IND application for a COVID-19 treatment candidate.
How do we adjust what we do to meet tightened/reduced timelines (SLAs)?
Melanie: The newest buzz phrase in my world has become “fit-for-purpose.” If the documents have some basic form of navigation (TOCs, bookmarks, and internal links) and pass validation criteria, they are used as-is, without additional remediation or effort to make sure all I’s are dotted and Ts crossed. Other opportunities to streamline include reducing the amount of external linking that is done, particularly from the M2 Summaries out to M3, M4, and, most importantly, M5. In addition, offering training to authors on efficiently reducing the number of repeated references, particularly on the same page, will save time. Another suggestion is to partner with regulatory agencies to reset their technical expectations. We will be looking for opportunities to comment on guidance documents as they are developed to challenge requirements versus those that are “nice to have.”
What are your thoughts related to the reliance on technology to support these applications in a virtual world?
Shermayne: Regulatory Operations personnel are very comfortable working in validated regulatory systems and environments. Over the years, we may have accepted a less than optimal performance speed or older laptops with limited RAM. However, our working environment was stretched beyond its natural ability to cope. Partnering with IT to support our infrastructure became critical like never before.
The reliance on true collaboration tools, such as Microsoft Teams or SharePoint, became key. The naysayers who prefer to share documents over email were forced into compliance to work efficiently in a virtual world. But it wasn’t just the companies that had to adjust their reliance on technology, but also individual employees, who may not have fast broadband at home and had to make some adjustments to their at-home work environment. There is no anxiety like submitting eCTD dossiers through a household internet provider and watching a 20GB submission slowly upload to the FDA gateway!
We all experienced meetings disrupted by VPNs that drop or poor-quality connections as everyone in the household is sharing the same internet service. We accepted these disruptions; however, there was still an underlying urgency that we needed the technology to get our jobs done, work compliantly, and maintain quality. The sub-standard infrastructure we may have accepted before clearly is no longer enough.
What are your biggest concerns for a publishing team as the new expectations set during the global pandemic become the new normal?
Melanie: My biggest concern is that the new normal will be quick turnaround submissions with documents coming in days before the submission is due. Publishers have always had their timelines tested and reduced when other team members do not complete their tasks within the project deadlines. We are experiencing the overall timeframe from receipt of the first document to submission reduced even further. This could lead to an increase in burnout and a decrease in morale for publishers.
But this begs the question: if timelines are to remain curtailed, how can we make the process more efficient? We need to rethink the acceptable standards for the health authorities and partner with them to update a relatively antiquated system. We must advocate for revamping the system, considering the technologies we have all become accustomed to over the past year and the industry’s ability to rapidly develop new drugs. It’s like we’ve all been sprinting, but now we need to learn how to run more efficiently so we can sustain ourselves through a marathon.
PRA’s Global Regulatory Affairs team strategically shortens approval timelines and efficiently gets your products to market and beyond. We are committed to keeping our clients abreast of changes in the regulatory landscape to ensure patients are protected and your goals stay on track.
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