How One Life Science Company Leveraged Real-World Data to Save Money, Time and Support a Regulatory Filing

Key takeaways:

• Understand the strategic need for a data and analytics partner that provides the right standardized data to help improve research, support development and save time and money.
• Understand how to leverage real-world data (RWD) and evidence consistent with regulatory agency requirements.
• Learn how you can use PINC AI™ Healthcare Data (PHD) to gain more in-depth, patient-level, longitudinal data to make your research process more efficient.

For more on this topic:

• Learn more about PINC AI™ Applied Sciences (PAS) and PINC AI™ Healthcare Data.

Life sciences companies are re-thinking how they develop medical solutions. The COVID-19 pandemic highlighted the need to do things differently ranging from decentralized clinical trials to increasing the use of real-world data (RWD) and real-world evidence (RWE) to improve clinical trials, reduce research timelines, accelerate development and meet regulatory approvals.

However, RWD/RWE is complicated and life sciences companies need access to huge volumes of standardized datasets on patients, disease states, demographics and comparative findings – which is why more than 80 percent of them stated their intent to enter into partnerships with data science companies this year.

Identifying a strategic data partnership is necessary to accelerate real-world data and evidence capabilities. The right partnership can help a life science company achieve actionable information by connecting them with multiple health systems and patients through data and scalable solutions. Having the ability to act on the data by turning it into provider-level actions that benefit patients is critical to their success.

Here are three ways one life science company partnered with PINC AI^™ Applied Sciences (PAS) to leverage PINC AI^™ Healthcare Data (PHD) to save money, time and support their product’s expansion.

1. RWE Can Support Savings

It’s true — many pharmaceuticals and devices can take around 10 years and cost upwards of $1 billion to bring to market. Using RWD/RWE can save time, provide proof of efficacy, help to enhance clinical trial design, feasibility, and execution, and improve life cycle management by reducing resources required for post-market surveillance studies.

One life science company wanted to streamline their processes, save money and avoid more randomized clinical trials (RCTs). By using RWE to support their device’s expanded indications for use, they were able to avoid additional RCTs and reduced their launch research spend up to $3 million dollars.

The company wanted to better understand their device and the safety, outcomes and benefits to patients from utilization. Understanding these factors would allow the life science company to expand indications to align with outcomes and generate RWE to expand its device utilization.

Their research started with data analysis that would help provide evidence needed to support a regulatory filing for expanded device indications. The life science company sought to identify patients that could potentially benefit from their device if it had expanded indications. One of their goals was to understand current evidence-based indications for their device and determine if there was any option for label modification while maintaining device safety and effectiveness.

The life science company worked with the PAS team to utilize PINC AI^™ Healthcare Database (PHD) to inform their efforts.

The life science company used a standardized PHD dataset to help confirm that the use of their device with expanded indications could have similar safety and positive patient outcomes. They were able to leverage the PHD to help inform their regulatory filing ensuring that the right patients could benefit from their device.

2. RWD/RWE Can Help Reduce Time to Market

Filing for expanded indications or regulatory approval takes time. Over the last few decades, inefficiencies in medical solution development have amounted to not only money the life sciences industry spent (from research to launch) but also in poorer overall outcomes for patients, who experienced a rigid clinical trial environment. Incorporating RWD/RWE helps bind clinical development with the realities of healthcare ranging from comorbidities to complexities.

This life science company was able to use the PHD dataset to help support their device’s expanded indications for use and reduce their time to market by approximately 18 months.

They leveraged the PHD, to help accelerate new indications on their older device that saved them time and investment in a traditional RCT. They were able to utilize the monetary and time savings achieved to invest in new innovative opportunities.

RWD/RWE offers the speed needed to help rebuild drug and device pipelines. In the last few years, new drug and device development has been sluggish as companies 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.

This year, life sciences companies are experiencing pressure to rapidly produce drugs, devices and therapies that fuel profits at a pace that can only come from utilizing RWD/RWE.

3. RWD/RWE Can Help Support Approvals and Regulations

It is prudent 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.

Thanks to the 21st Century Cures Act, more regulatory agencies are recognizing the promise of RWD/RWE. When combined with clinical trial research, it can shorten the regulatory approval process and increase the chances of U.S. Food and Drug Administration (FDA) and European Union Medical Device Regulation approvals.

The life science company gathered insights from the PHD dataset and used it to help support their Breakthrough Designation request and their 510(k) regulatory filing, also known as premarket notification.

When a company submits an FDA 510(k) notification, its goal is to demonstrate that the new product that’s about to be brought to market is substantially equivalent to another legally marketed device. During this process, the device needs to meet specific criteria set by the FDA such as:

• The device has the same intended use and technological characteristics as the predicate device.
• The product has the same intended use as the predicate device, yet has different technological characteristics and does not raise and new questions regarding safety and effectiveness.
• The data submitted to the FDA can demonstrate that the device is at least as safe and effective for use in patients as the marketed device.

The PHD data set helped this life science company prove that their device, with expanded indications, was substantially equivalent to using the predicate device, thus clearing their product of further RCTs and testing.

RWD/RWE and the Future of Discovery

RWD/RWE is shifting how life sciences companies discover new therapy targets and identify opportunities for repurposing existing medical solutions. These datasets provide the information needed to better understand the efficacy, safety and cost while supporting regulatory requirements needed for existing or potential new treatment options.

Data is a powerful and necessary tool to providing a more representative view of medical solution development, healthcare costs, resource utilization and enhancing clinical performance.

As medical solution development and expanded indication methods evolve, the power of RWD will continue to prove key in improving outcomes, generating patient-centered clinical trials, uncovering data-driven insights and expediting solution time to market.

Learn how you can utilize PINC AI™ Healthcare Data in research and outcome improvement efforts to help support smarter healthcare decisions.

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