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Denise Juliano, group vice president, PINC AI Applied Sciences, Premier Inc.

Recently, there has been a large boom in the use of real-world data (RWD) and real-world evidence (RWE), which is expected to become a $2.3 billion market by 2026, up from $1.2 billion in 2021. Life sciences companies are increasingly utilizing data to extract real-world insights to improve research studies and clinical trials, discover new treatments, and accelerate drug development with the goal to improve the future of healthcare.

However, it’s rare for life sciences companies to have access to the broad swaths of data that’s needed for discovery, research, and proof of value — that is, unless they have the right partner. This is why more than 80% of life sciences companies say they intend to enter into partnerships with data and data science companies in the coming year. Doing so makes good business sense for three key reasons.

1. The need for speed

Research indicates that the life sciences regulatory approval process can be dramatically shortened and much more successful when accompanied by RWD/RWE — no small task given that many therapies can take around ten years and cost upwards of $1 billion to commercialize. Similarly, companies are more likely to win FDA approval to make certain clinical claims when accompanied by RWD/RWE, something that often took more than four years in the past.

The improved speed that RWD/RWE affords is critical to rebuild pipelines. In the last few years, new drug and device development has been sluggish as companies understandably prioritized Covid-19 response over new cures. For proof, look no further than new drug approvals, where the FDA approved just 53 drugs in 2020 and 46 in 2021. As the nation emerges from the pandemic, life sciences companies will experience intense pressure to rapidly produce blockbuster therapies that fuel profits — speed that only comes with the data.

With innovation and savings at stake, life sciences companies will need to seek out timely, accurate, and standardized RWD/RWE to provide the proof needed to develop solutions and deliver effective treatments to patients, providers, and payers.

2. It’s formulaic

It has become more important for life sciences companies to invest in RWD/RWE as payers, regulatory bodies, and health systems increasingly demand proof that a medical solution delivers real value by doing what it is intended to do.

Increasingly, health systems are shifting to outcomes-based formularies that require proof of value across the entire episode of care and across diverse populations before they will approve utilization. Pharmacy benefit managers (PBMs) do similar reviews, and have excluded 846 medications from formularies, a barrier to utilization that spans multiple payers.

The right RWD/RWE can not only prove efficacy and help ensure inclusion as part of the formulary, but it could also go so far as to earn waivers from payers for prior authorization or other forms of utilization management, thereby expanding the market of eligible patients and payers that will cover the cost.

3. Research-ready collaboration

The Covid-19 pandemic highlighted the disproportionate burden of illness and death among racial and ethnic minorities, pushing researchers to seek more RWD/RWE on how different treatments affect different segments of the population after they hit the market.

This means that the evaluation and study process needs to be more expansive to include research-ready sites with a strong data infrastructure in place to find and engage diverse populations in a compressed timetable.

One such network is the PINC AIInnovation and Research Collaborative (PIRC), which is made up of a network of over 278 leading research hospitals across 38 states that all leverage shared clinical technology and data to enable faster identification of eligible patients and rapid-cycle research. For instance, this network has access to technology tools that combine natural language processing with machine learning to find patients who meet complex inclusion/exclusion (I/E) criteria for research studies or clinical trials. Mining unstructured and text-based notes, this technology can rapidly identify patients based on a host of demographic, socio-economic and social determinants and other indicators — searches that would otherwise be inaccessible to investigators without manual chart reviews.

Partnering with research-ready, tech-enabled networks such as the PIRC can help life sciences companies illuminate trends in diseases, run smaller clinical trials, access hard-to-find diverse patients and enhance clinical outcomes.

RWD/RWE will fundamentally change how life sciences companies develop, discover, commercialize, and receive reimbursement for drugs and therapies. Data helps uncover actionable insights and discover possible therapy targets, as well as identify opportunities for repurposing existing medical solutions. All the while, it supports smarter healthcare and drives efficiencies to improve health outcomes and provide better value overall. To get the most benefit out of RWD/RWE, finding the right partner is critical, requiring access to broad, standardized and clean datasets, research-ready testing networks, and artificial intelligence solutions to compress research timelines.

Learn more about how you can use PINC AI Healthcare Data to conduct evidence-based analyses of drugs, devices, and disease states, and accelerate medical solution development.

About the Author

Denise Juliano, group vice president, PINC AI Applied Sciences, Premier Inc.

With more than 30 years of industry experience, Denise leads the PINC AI Applied Sciences team in partnering with life sciences companies to create solutions to improve quality, lower costs, and promote healthier lifestyles.