Preparing for a Post-COVID-19 World in Quality and Regulatory

For many life sciences companies, restrictions posed by the COVID-19 pandemic drove rapid adoption of new technologies, establishing a foundation for digital transformation. Now the industry is re-examining its investments in key operations to see how efficiencies identified in 2020 can be realized, consolidated, extended, and improved.

Change has been particularly evident in regulatory affairs, not only for pharma companies but global regulatory agencies, which reviewed and approved new vaccines and emergency therapeutics at unprecedented speed in 2020. “Agile information storage, retrieval, and analysis is becoming more critical to enabling efficient regulatory review,” Roman Teply, project director, regulatory affairs operations and business excellence at CSL Behring, told attendees at the TOPRA Conference on September 23, 2021. The changes brought by digital transformation go far beyond technology and into process and culture, creating new opportunities for automation and robotics, he said.

As part of its vision for the future, CSL Behring’s parent company, CSL Ltd., is modernizing the way its global regulatory affairs divisions manage information and is connecting them more closely with quality operations. Made up of two very different companies—Behring, a biopharma company that includes a human blood plasma products division, and Seqirus, whose focus is on influenza vaccines—CSL started unifying business practices, end-to-end, before the COVID-19 pandemic struck.

In 2020, at the height of the COVID-19’s first wave, the company started a project to roll out Veeva Vault Quality Suite and Vault RIM Suite applications. CSL was already using Vault MedComms and Vault PromoMats in its business operations, and Vault CTMS and Vault eTMF in clinical operations and data management.

CSL’s leaders believe that seamlessly sharing information between quality and regulatory affairs will be key to enabling the company to meet evolving regulatory needs and to drive the values required. This integration was the first pillar in the company’s digital transformation strategy, Teply says, along with:

• Investing in digitalization for the long term
• Embracing change
• Creating value

Kicking off a major implementation across two functions and both companies during a global pandemic was not for the faint of heart, but, as Teply put it, “We didn’t want to hold up our digital transformation strategy.”

Insurance for the future

We expect our partnership with Veeva will help CSL improve agility and quality, said Ashley Burt, senior director and head of global regulatory operations at Seqirus. Both will be essential, not only to getting through the pandemic, but to weathering unforeseen events in the future without affecting the supply of medicines available to patients.

Having a digital transformation plan in place is crucial. “Technology has become a bit of an insurance policy against future pandemics. We figure that if we get the information management strategy right and handle it efficiently, we will be even better prepared to ride out any unforeseen crises in the future,” said Burt.

Aligning, consolidating, and standardizing processes that, until recently, have resided on different legacy systems, continues to be a challenge. At this point, Burt says, the company is evaluating how it needs to work, across all divisions, in the future. It is also determining how Veeva can enable and underpin processes to make them more efficient.

Burt expects CSL to benefit from Vault’s flexibility and to bring the company into a new, integrated state with common implementation practices and better user experience. “The pandemic taught us that investing in new technology and creating strategic partnerships will be crucial to maintaining a competitive edge and meeting new and emerging global regulatory requirements,” he said, emphasizing the need to share information efficiently across business areas, decrease submission cycle times, and respond with agility to regulatory questions and changing expectations.

Constant evaluation of regulatory strategies and changes

Like most companies, CSL faced significant challenges in 2020, as it worked to enable remote staff and ensure the safety of essential employees who operated in labs and manufacturing facilities. Seqirus had to ensure that enough flu vaccine could be supplied despite many headwinds created by the pandemic. “The experience forced us to evaluate regulatory strategies and changes, constantly, in light of what we could actually achieve within constraints posed by the pandemic,” he said.

For Seqirus, COVID-19 brought a renewed focus on mRNA vaccines and opportunities to consider the future of vaccines and their delivery, beyond cell-based types. It also led the company to new partnerships with groups that include the University of Australia in Queensland and Takeda, with whom CSL-Behring cofounded the COVID-19 Plasma alliance. “The very nature of our work in regulatory affairs has expanded during the pandemic,” Burt noted.

Even though COVID-19 continues, the world has moved on since 2020, Burt explained. “Regulators and internal stakeholders have already seen that expedited approval worked. Whether or not that model proves applicable in the real world is a different matter, but right now, expectations for acceleration and speed to delivery will continue.” Both Teply and Burt expect regulatory and quality platform integration to enable CSL to adapt to continuous change in the future.

To learn more about how Veeva is enabling organizations to bring these two domains together, read this product brief on the Vault Quality to RIM Connection.