Speed is good

The future of biopharma – key operational shifts to watch this year

Major medical advances, combined with the proliferation of new technologies, have created opportunities for biopharmaceutical companies to better tackle some of the greatest health challenges of our time, including treatments for rare diseases and cancer.

Building on this momentum, biopharmas are increasingly embracing transformative approaches to optimise drug development, improve patient outcomes and accelerate time-to-market.

Innovations in data management, regulatory submissions, clinical trials and quality assurance are reshaping the industry. While these advancements bring opportunities, they also require thoughtful execution to address inherent challenges.

Below are predictions that outline how biopharma companies will continue to push the boundaries of innovation and enhance operational excellence.

By embracing these strategies, organisations are primed to drive real progress in healthcare and deliver better outcomes for patients worldwide.

Today, the integration of adverse event data into safety cases varies greatly from fully automated workflows to time-intensive manual processes.

These inconsistencies slow drug development, placing a burden on patients and ultimately delaying access to critical treatments. In 2025, biopharma companies will prioritise process excellence to streamline content and data flows across R&D, ensuring greater efficiency and consistency.

As sponsors move away from disconnected, best-of-breed solutions, they will standardise and simplify processes.

Investments in R&D process standards will lead some companies to adopt workflow automation, while others may create dedicated process excellence teams to enhance efficiencies across clinical, regulatory, safety and quality functions.

These efforts will enhance collaboration, reduce inefficiencies and accelerate the delivery of innovative therapies to patients.

Patient enrolment and retention have long been challenges in clinical trials, with trial complexity, logistical barriers and participant fatigue contributing to high dropout rates.

These issues are particularly common with underrepresented populations, who often face limited access to trials due to geographic, socioeconomic and healthcare disparities.

This year, biopharma companies will take steps to address these gaps by offering more flexible and inclusive options for trial participation.

Sponsors will expand participant pools by providing more trial model options, such as a hybrid approach, allowing for remote onboarding and virtual visits.

These approaches aim to reduce the burden on participants and encourage broader representation in trials, particularly among typically underrepresented populations.

The US Food and Drug Administration’s new guidance on Diversity Action Plans requires sponsors to enrol underrepresented groups and provide demographic breakdowns in submissions.

This shift will drive changes in data processing and analysis to ensure clean, sufficient data for each subgroup. Unified data systems will enable sponsors to accommodate complex trial requirements while enhancing patient experiences.

Clinical research sites are under immense strain due to high staff turnover and the growing complexity of trials.

This reduces their ability to take on more trials. This year, sponsors will take a more proactive role in addressing these site capacity challenges by prioritising site engagement strategies that utilise technology and streamlined workflows.

With over half of research sites identifying multiple sponsor systems as a top challenge, the push for consistent, unified tools across trials will gain momentum.

By reducing administrative burdens and simplifying trial management, sponsors will free site staff to focus on patients, helping rebuild capacity and ensuring trials proceed without delays.

This will help ensure smoother trial operations and ultimately support the timely progress of clinical research.

Sequential submissions, once standard, are now seen as an outdated obstacle to timely patient access. Although digitalisation has streamlined some aspects of regulatory submissions, core markets often receive approvals first, delaying access in smaller markets.

New methods, such as active dossiers, will allow teams to reuse prior submissions more effectively. As more companies and health authorities embrace simultaneous submissions, timelines that once exceeded five years could be reduced significantly.

These advancements will improve access for underserved patient populations while alleviating regulatory workloads.

By prioritising global access and efficiencies, simultaneous submissions will redefine the landscape, ensuring that critical treatments reach patients faster while easing the burden on regulatory agencies worldwide.

Health authority approvals remain resource intensive, often slowed down by uncoordinated review frameworks and language barriers that create inefficiencies.

In the coming years, regulatory reliance pathways and industry-wide initiatives will drive collaboration among health authorities to streamline reviews and reduce bottlenecks.

The adoption of shared submission data and question-and-answer repositories will improve consistency, reduce duplication, accelerate approvals and, ultimately, speed up approval timelines. Sponsors and health authorities will need to balance these efficiencies with the integrity of local decision-making processes.

Quality assurance (QA) and quality control (QC) are integral to drug development, yet their processes often remain siloed. In 2025, companies will invest in unified digital quality systems, connecting quality assurance, quality control and external partners through shared technology.

This integration will streamline batch releases, reduce errors and proactively identify risks. Early-stage companies will also benefit from automation, allowing them to scale operations cost-effectively while laying the groundwork for AI-driven quality advancements.

Sponsors are increasingly prioritising contract research organisations (CROs) that provide continuous data transparency. In 2025, the industry will see a shift towards end-to-end data ownership, fostering more fluid collaboration between sponsors and CROs.

Transparent, real-time data sharing will improve decision-making in protocol design, site onboarding, rare disease participant identification and endpoint adjustments.

Emerging biotechs will benefit from enhanced oversight, enabling more agile operations. Greater data transparency will build trust across the clinical development ecosystem, improving trial outcomes and accelerating access to new medicines.

The trends shaping this year will mark a significant moment for biopharmas and biotechs. This year, we’ll witness the industry strive to balance innovation with operational excellence while tackling some of its key challenges including site capacity, regulatory complexities and patient diversity.

By embracing unified systems, streamlining workflows and fostering greater collaboration with regulators, sites and CROs, companies can accelerate timelines, enhance patient outcomes, and build a more resilient framework for the future of drug development.

This will lay the foundation for a more efficient and inclusive drug development landscape. These shifts represent not just incremental improvements but a transformation in how medicines are developed, tested and delivered to patients globally.

As biopharma companies continue to evolve, 2025 will be a year that advances industry standards, ensuring faster access to critical treatments and a more resilient future for healthcare everywhere.

Rik van Mol is Senior Vice President at Veeva Systems. Go to veeva.com