How digital pathology can transform the value of clinical trial information

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The field of pathology is gradually going digital, marking a pronounced shift from the traditional use of glass slides, a practice that dates back to the Victorian era. Digital pathology uptake reached an “exponential” pace in the wake of the pandemic, noted Dr. Monika Lamba Saini, director of pathology, at Q2 Solutions, an IQVIA subsidiary.

Adoption has grown from a negligible amount to roughly 15% over the past five years, said David West, CEO of Proscia, a digital pathology company, and a Q2 Solutions partner. The Digital Pathology Association notes that adoption in recent years has been brisk, hovering between 27% and 37% growth from 2021 to 2023, with the pandemic serving as an accelerant. Growth is cooling but is still brisk. According to Proscia’s 2023 Life Sciences Digital Pathology Adoption Survey, 70% of life sciences organizations were using digital pathology, with an additional 53% of t…

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NLP in drug discovery and the quest for the ‘right’ research elements

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In drug discovery and development, data sources are as diverse as they are plentiful. There are comprehensive databases brimming with molecular targets, cellular processes, genomic sequences, proteomic profiles, and metabolite patterns that shed light on disease pathways. Data possibilities in the patient care realm are similarly vast, spanning electronic medical records, imaging datasets, and even patient-reported outcomes and adverse events reported on social media. The biomedical research site PubMed has tens of millions of research articles and studies. 

Yet, it’s easier to drown in such turbulent data volumes than it is to swim. Various estimates over the past decade have projected that 80% of healthcare data are unstructured. “There’s a huge amount of information that’s not standardized,” said Jane Reed, director of life sciences with Linguamatics, an IQVIA company.…

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How AI-based technologies improve clinical trial design, site selection and competitive intelligence

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Clinical trials form the cornerstone of evidence-based medicine and are essential to establishing the safety and efficacy of new drugs. However, only some of the information in clinical trial reports is well-structured and searchable via keywords; much of the information is buried in unstructured text.

In the past, uncovering actionable insights from this unstructured text meant that documents such as clinical trial reports had to be searched and read individually, a process that can be time-consuming and subject to human error. It is estimated that 80% of clinical data is unstructured and difficult to analyze.

To overcome these limitations, life sciences companies are using natural language processing (NLP), an artificial intelligence-based technology that extracts and synthesizes high-value information hidden in unstructured text. NLP-based text mining solutions can an…

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Benefits of adding a case collection system upstream of AE intake

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While numerous types of technology have a rightful place in life sciences to cut down on errors, decrease costs and boost efficiency, the adverse event intake and collection process remains primarily manual. It’s common for organizations to use software to support adverse event intake, but end-user intervention is often necessary to collect, input and share data.

This practice poses a problem because pharmacovigilance is a team sport. Patients, patient support programs, local representatives of a life science organization, healthcare providers and pharmacovigilance physicians are all needed to contribute to and review an adverse event report before it gets sent to a government regulatory agency. It is critical to gather and understand these insights before reporting is underway.

Beyond this workflow challenge, organizations often face a problem of scalab…

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Connect the puzzle pieces of IVDR with confidence

Understand the latest changes to IVDR and the impact for IVD manufacturers

By IQVIA MedTech

Approximately 70 percent of today’s medical decisions are dependent on lab-based diagnostic test results and related devices in use, regulatory authorities aim to further strengthen critical oversight on devices in development and use. In May 2017, the European Commission announced the new In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 to improve the quality, safety and reliability of IVDs.

Replacing In Vitro Diagnostic Directive (IVDD) 98/79/EC that have been in place for more than 20 years, the updated regulation gave IVD manufacturers a five-year transition period to ensure compliance, whether it be for a currently available IVD or for those in development. Changes and updates were to be fully applicable on May 26, 2022 in the European Union. However, in October 2021, the European Commission proposed a tiered roll out of the IVDR, given obvious …

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The future of pharmacovigilance: Assessing the role of ML, NLP and other technologies

Image from Roberto Sorin via Unsplash

The field of pharmacovigilance has evolved significantly in recent years. While regulatory authorities have long favored technologies such as artificial intelligence and machine learning for monitoring patient safety, the trend has accelerated during the pandemic. “I’ve never seen as much advancement as I have in the last two years,” said Marie Flanagan, director, offering management, Vigilance Detect at IQVIA.

Flanagan predicted that regulators’ interest in AI and ML for pharmacovigilance will catalyze growing interest across the pharma industry in 2022 and beyond. The pandemic has demonstrated to regulators and life science companies that the technologies can help make sense of exploding volumes of pharmacovigilance data points.

“If we look at just the user vigilance database in the past two years — as of last week, 64% of all infor…

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Medable installs new chief strategy officer 

Direct-to-patient clinical trial company Medable (Palo Alto, California) has added MaryAnne Rizk to its executive team.

Rizk formerly worked at IQVIA as a senior vice president, digital R&D strategy. She is also an adjunct professor at the Steven Institute of Technology (Hoboken, New Jersey) and a managing partner at Rizk Management Consulting.

In August, Rizk was named a PharmaVoice 100 leader.

She is also a member of the Healthcare Businesswomen’s Association, Prix Galien Foundation Digital Advisory Board and Society for Clinical Research Sites (SCRS) Innovation Council.

The startup Medable has continued to grow rapidly during the pandemic, scoring another $78 million in funding to help it continue ​​advancing clients’ digital and decentralized clinical trials.

In her role at Medable, Rizk will work to bolster the company’s strategic partnerships and innovation ecosystem.

She will also endeavor to improve clinical trial diversi…

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Biosimilars adoption growing, but the market remains nascent

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While biosimilar adoption remains at an early stage in the U.S., biosimilar adoption is ticking up. Biosimilar penetration for Roche’s Avastin (bevacizumab) is especially high at 69%. In addition, biosimilars for Genentech’s Herceptin and Amgen’s Neupogen have also achieved a market penetration of 57% and 62%, respectively, according to IQVIA data based on late June sales data.

One of the chief factors limiting the size of the biosimilars market, however, is the limited number of biosimilars on the market. While the Affordable Care Act included biosimilar provisions, only 33 biosimilars have won FDA approval since 2015. The agency approved ten of those in 2019.

The Biosimilars Council estimates that biosimilars could save the U.S. as much as $130 billion by 2025.

For now, however, overall adoption remains at a nascent stage. “Various factors have likely influe…

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