The Rise of Connected Data: 7 R&D Life Sciences Predictions for 2023

Simplicity and technology intersect to streamline drug development

The intersection of operational simplification and technology advancement will create cross-functional efficiency across clinical, regulatory, quality, and safety. This will enable biopharmas to create a more streamlined drug development process rooted in lean process execution and higher-quality data.

Connected data across the development lifecycle will enable different functions to coordinate decisions, and a common technology framework will eliminate duplicate data capture and inefficient processes. Automated workflows, data reuse, common training, and a simpler technology experience will help companies to adapt quickly to changing market conditions and deliver products more efficiently to the market.

By connecting disparate teams, processes, and systems into one operating model, organizations will deliver new products to patients with greater speed and efficiency.

Patient choice will push sponsors toward operational excellence

Umbrella, adaptive, and platform trials are now mainstream ways to show treatment success but they’ve made protocol design increasingly complex. And even with technology to facilitate data collection from diverse sources, companies still struggle to manage non-conventional data at scale.

In 2023, the volume of data collected from patients will increase – and border on the intrusive. Sponsors running oncology and diabetes trials, for example, will ask for more information on patients’ real-life movements to demonstrate their quality of life, as well as efficacy and safety.

We’re entering a new era of patient choice, and it will be for data management to balance scientific endeavor with operational excellence. Leading companies will help patients understand how their data contributes to the greater good and give them real-time access to their own health data insights during studies.

Patients will choose how to participate in studies from one day to the next, whether in person or through digital methods, based on their daily health status and personal preference, in addition to age, location, and condition. Companies committed to patient-centric trials will reassess their technology and processes to achieve the dual objectives of advancing digital clinical trials and managing data holistically.

Safety will create a single source of truth for content management

In 2023, companies will broaden their focus beyond safety data to include all the content and documents that come with it. Teams will develop, review, approve, and track content and documents more closely than ever, right down to version history and user access. Improved control reduces the risk of misinformation, or having teams send outdated or incorrect information to partners.

Having a single source of truth, not only for data but for documents and content, will enable more content sharing and review to occur in real time. As safety’s sphere of influence grows, this approach will put content ownership and control directly in safety’s hands. It will result in better, faster, and more informed decisions, not only in safety but in areas where safety collaborates with quality, clinical, and regulatory functions.

Technology and data access control will strengthen quality partnerships

As companies began collaborating more closely with contract partners, a pioneering few invited preferred CDMOs into their quality networks. Others were too concerned about security and data access to take this approach. This will change.

Encouraged by technical innovations that permit seamless access and granular control over information, more biopharmas and CDMOs will invite suppliers to participate in key processes within their quality management systems. CDMOs will also increasingly invite their customers directly into their QMS, quality documentation, and training systems for better visibility and real-time sharing of information.

This approach will make it easier for smaller innovators to accept products, sign off and approve batches, review quality events, and share quality data. Over time, companies will develop distinct information-sharing strategies, training programs, and new processes tailored to each partner.

Regulatory pressure will drive innovation in data management and submissions

Increasing regulatory pressure will lead to more agile, connected data approaches that allow companies to ensure global compliance. For example, one company that implemented new digital approaches to manage its regulatory data had 40 small RIM system releases in one year – up from one big change every five years before implementation.

In addition, the long-anticipated shift from document to data-based regulatory submissions will soon take place, starting with new FDA and industry initiatives that will use data management approaches for manufacturing CMC submissions. In 2023, more companies will focus on developing the systems, infrastructure, and skill sets required to work with data-based submissions. Far from a trivial effort, it will require a whole new operating model and significant organizational change.

Nimble medtech companies will thrive despite sustained margin pressure

The medtech sector consolidated this year, and acquisitions will continue against a challenging backdrop. The delayed care backlog from the pandemic could dissuade investment as costs rise faster than reimbursement rates and add downward pressure to margins. To weather all of this, medtech companies are currently focused on becoming more efficient but will need to double down in 2023 to remain competitive.

Supply chain fragility and sourcing will continue to be significant industry pain points, while the expected regulatory rebound in audits and on-site visits will challenge operational efficiency. Companies that still rely heavily on paper, or are siloed, will fail to spot problems with quality or supplier management until it is too late and will accrue costs that could be avoided with better insights. While digital systems can give companies a competitive edge, the right KPIs must be in place for early visibility of supply bottlenecks.

Companies are best placed to succeed if they can use the data collected from connected medical devices, companion apps, and other software to improve the customer journey. However, given the FDA is likely to update the regulatory framework for using software in medical diagnosis, data strategies need to strike a balance between customer innovation and potential privacy concerns.

Data will unlock clinical and economic value in Europe’s challenging landscape

Launching a new drug has always been fraught with risks, and the pandemic raised the stakes. Emerging and mid-sized companies launching products in Europe are also navigating a healthcare ecosystem that is complex and fragile due to regulatory and cost pressures. With no margin for error, teams will need to rethink their data strategy to quickly unlock clinical and economic value.

In 2023, successful companies will be more deliberate in how they access, manage, and learn from data ahead of a product launch. In R&D, data ownership will be critical to understanding the market landscape as fast as possible. Sponsors will insource data management even as they outsource trials, so they can improve how they track and use trial execution data. On the commercial side, teams will seamlessly integrate proprietary, external, and public data sources to identify the potential patient population for a new treatment.

Clinical, commercial, and market access teams will start working together sooner to share insights and accelerate the launch process. With an early view of market viability, leading companies will be able to monetize new products quickly and at scale across Europe.