Fast-Tracking Development: How Life Sciences Will Drive Speed in 2025

Marc Gabriel
Vice president
Veeva RIM

Last year, FDA approved 50 novel drugs and made significant progress confirming existing medicines for new uses and patient populations. Of the novel drugs, 52% were for rare diseases.¹

With approximately 7,000 diagnosed rare diseases,² more work lies ahead to accelerate drug development, regulatory approvals, and manufacturing. Biopharmas and global agencies are now prioritizing initiatives and innovations to drive speed across product development with an emphasis on getting new treatments in the hands of doctors and patients. Here are four trends that will accelerate drug development in 2025.

Simultaneous submissions will trim approval timelines

Once a necessary reality, sequential submissions should now be viewed as an outdated obstacle to getting medicines to patients quickly.

The regulatory veterans will remember the not-so-distant past when submissions were packed up, sealed, and mailed to health authorities, resulting in trucks filled with boxes of documents on their way for review. Even as the industry adoption of digital solutions increases, the volume and complexity of submissions continues.

Ashley McMillan
Senior director
Strategy
Veeva Systems

The process remains largely sequential, with regulatory teams seeking approval in core markets first and slowly expanding to other regions over time. This approach leaves patients in downstream markets–often smaller and underserved–on the short end for new medicines, waiting longer for treatments.

The increased use of newer methods to complete submissions, like active dossiers, representing the outcomes of complex submission processes, will let teams use prior submissions faster and more efficiently. These advancements, paired with more companies and health authorities investing in closing the gap to simultaneous submissions, will increase regulatory speed, with submission processes that once took five years or more taking much less time. These incremental improvements will add up for both regulatory staff and patients.

Health authorities will speed submissions with common data

While regulatory teams have been streamlining the submission process with regulatory data offices and data stewardship, health authority (HA) approvals remain labor-intensive. Inefficiencies in the process, like similar questions submitted by different HAs at different times and in different languages, create serious risks and contribute to a global duplication of effort.

In the coming years, industry-wide initiatives will establish regulatory reliance pathways–agreements between multiple HAs to streamline common submission and review processes. Global access to common submission data and Q&As will lead to faster submissions, better collaboration, and increased efficiencies for sponsors and HAs. These initiatives will need to be carefully balanced to ensure safety, compliance, and the integrity of the local decision-making authority.

QA and QC will come together to remove bottlenecks

Even though quality assurance (QA) and quality control (QC) business processes are connected, the legacy technologies supporting them are not. With advanced systems and processes, leading companies are connecting QA, QC, and partners through a common solution. The industry’s investment in digital quality will shorten testing time and speed product time to market.

Quality organizations will unify their data and applications to move their reporting and analytics forward for greater insights. The advancement will deliver metrics so quality teams can proactively manage risks and identify and address bottlenecks much earlier than ever before.

An example is having QA and QC data available at the batch decision point. Traditionally, this is not a given for most companies, but the visibility allows teams to make more informed decisions and release batches faster. Another way unifying data will change how quality teams work is by having a single source of data. This will standardize collaboration with partners, eliminating manual work and the risk of data errors.

By automating labor-intensive tasks before commercializing, early-stage companies can scale while driving cost efficiencies. More companies will bring together QA and QC together, laying a foundation for biopharmas to apply impactful AI use cases in years to come.

Complete and reliable pharmacovigilance data will power advanced automation

Safety professionals continue to tackle an age-old question: how to do more with less while maintaining high quality. With growing data volumes and fewer resources, AI holds promise. Yet, inconsistent and disconnected data sources create risk.

Pharmacovigilance teams will solidify their data foundations with standardized, end-to-end safety processes to effectively support AI. Cross-functional workflows will remove manual data transfers and deliver clear data traceability to the source. By simplifying and standardizing their technology landscape, companies will lay the foundation to accelerate automation and AI innovation.

This end-to-end data flow also opens the door for improved collaboration across organizations. For example, processes like timely reporting of serious adverse events (SAEs) from clinical data capture (EDC) applications to safety can be shared automatically with more complete data.

Innovating for patients with speed

As the race to deliver medicines for rare diseases and underserved populations steams ahead, life sciences are investing in innovative processes and connected technology as an accelerator. Simultaneous regulatory submissions will become time savers, health authorities will align on common data, unified QA and QC will become table stakes, and data will fuel automation in pharmacovigilance. This year's advancements will shape the future of drug development and accelerate the delivery of medicines to patients waiting for new treatments.

Sources

1. FDA, Advancing Health Through Innovation: New Drug Therapy Approvals 2024, 2024
2. NIH National Library of Medicine, How Many Rare Diseases Are There?, 2020