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Querying the queries: An AI approach to manage clinical data quality

Latent Dirichlet allocation diagram image from Wikipedia.

High-quality clinical trial data serves as the foundation for analysis, submission, approval, labeling and marketing of a compound under study. Widely used throughout the industry, data cleaning ensures that the process deployed to collect data is consistent and accurate.

Challenges in collection include data errors during manual data entry, i.e., spelling and transcription mishaps, range, and text errors, which impact coding. Automated edit checks can prevent the entry of inaccurate information, but they cannot detect all potential data entry issues.

Numerous manually generated queries put pressure on time and cost. Applying AI (artificial intelligence) techniques to understand the context of these queries may improve automated edit checks and offer opportunities to add checks or processes to identify issues earlier in the studies. Additionall…

Baxter touts data supporting use of machine learning for infusion pump programming

Baxter (NYSE:BAX) announced today that data shows the potential for machine learning supporting decision-making with infusion pump programming.

Deerfield, Illinois-based Baxter presented the data from a retrospective study — part of a collaboration with MedAware aimed to develop next-generation dose error reduction software — at the American Society of Health-System Pharmacists (ASHP) 2021 Midyear Clinical Meeting.

Get the full story at our sister site, Drug Delivery Business News.

9 predictions for pharma in 2022

Image courtesy of Pixabay

The pharma industry has been slower to embrace technologies such as AI and digital technology than many less-regulated sectors. The COVID-19 pandemic has changed the equation, forcing pharma companies to become more agile and open-minded in approaching drug discovery and development, including managing evolving clinical trials.

In this article, several experts offered their predictions of the trends that will be most meaningful in 2022.

1. Digital components drive new pharma value

Jaydev Thakkar

In 2022, a growing number of pharmaceutical companies will recognize how their products could deliver significantly improved outcomes with a digital component, predicted Jaydev Thakkar, chief operating officer of Biofourmis, which offers digital therapeutics and care-at-home solutions powered by AI. “This digital component c…

SimBioSys secures $15 million in Series A funding for computational oncology software

The developer of a cloud-based application for oncology care and research, SimBioSys, has raised $15 million in Series A funding. Genoa Ventures and Northpond Ventures led the funding round, which also involved AV8 Ventures, Heritage Medical Group, and Mayo Clinic.

SimBioSys also announced that existing investors and its founders participated in the financing, raising a total of $21 million.

The company plans on using the funds for the development and commercialization of its TumorScope software platform. In particular, the company plans on using the funding to digitize and model treatment options for a number of solid tumors, including in breast cancer.

TumorScope is a cloud-based application that virtualizes cancer in three dimensions. The company reports that it can accurately simulate how a patient’s tumor will respond to a variety of therapies following diagnosis. “Simulating a response before prescribing treatment is a significant stride in p…

AWS and pharma heavyweights join forces on AI-based drug discovery lab

The goal of using AI to transform drug discovery and development may not be novel. But a recent alliance is unique in both the stature of companies belonging to it and its choice of an innovation model.

Big Pharma firms AstraZeneca (LON:AZN), Merck KGaA (ETR: MRK), Pfizer (NYSE:PFE) and Teva (NYSE:TEVA) will partner with Amazon Web Services Inc. (NSDQ:AMZN) and the Israel Biotech Fund (IBF) on what they term a “first-of-its-kind innovation lab” known as AION Labs.

“The launch of AION Labs will provide an opportunity for the healthcare and life sciences industry to uncover new ways to reduce the time and cost for discovery, facilitate open collaboration and interoperability, and ultimately improve patients’ health outcomes,” said Dan Sheeran, director of healthcare and life sciences at Amazon Web Services, in a statement.

AION Labs has also formed a strategic partnership with the biomedical research institute BioMed X (Heidelberg, Germany).

The lab…

ConcertAI and Janssen deepen data-science collaboration

A multi-year partnership between Janssen Research & Development (NYSE: JNJ) and ConcertAI (Cambridge, Mass.) will focus on using real-world data and AI for oncology applications involving multiple cancer types.

ConcertAI will work “almost an extension of [Janssen’s] R&D development process,” said Jeff Elton, CEO of the company. The two companies’ teams will work closely together with ConcertAI providing data, technology and clinical data scientists.

The two companies began working together in late 2019 and have since partnered on a number of programs, some of which progressed to the clinic, regulatory submissions and regulatory approvals.

Elton said that the recent collaboration is “a major expansion of what we first put into place in 2019.”

ConcertAI and Janssen are also working together to support clinical trial diversity. “We’ve been using some specialized data sets to ensure that clinical trials didn’t unwittingly exclude certain racia…

Insilico Medicine hooks up with Arvinas

Insilico Medicine (Hong Kong) has entered into an R&D pact with Arvinas (NSDQ:ARVN) to explore applications of Insilico’s AI technology to PROTACs.

By regulating protein function, PROTACS can optimize the sensitivity to drug-resistant targets, as an article in Signal Transduction and Targeted Therapy notes

Insilico and Arvinas will partner in designing treatment modalities for current and next-generation targets.

Founded in 2013, Arvinas is a pioneer of targeted protein degradation technology and related therapeutic applications.

Insilico Medicine was founded in 2014 to develop an AI-based platform for pharma and biotech.

“We look forward to collaborating with Arvinas in this innovative field and to building a lasting relationship,” said Alex Zhavoronkov, CEO of Insilico Medicine, in a statement.

How Olympus is using AI to find patients for its COPD device

Olympus recently announced its SeleCT Connect program, which uses diagnostic imaging AI to automatically screen which people might benefit from its Spiration valve system.

Spiration is an FDA-designated breakthrough device for treating chronic obstructive pulmonary disease (COPD) patients.

SeleCT Connect — offered as part of Olympus’ SeleCT quantitative computer tomography (QCT) analysis service — is available immediately to more than 9,000 U.S. healthcare through the Nuance AI Marketplace, a workflow-integrated cloud platform for diagnostic imaging AI algorithms.

Read the full story on our sister site Medical Design & Outsourcing.

How Olympus is using AI to find patients for its COPD device

Olympus recently announced its SeleCT Connect program, which uses diagnostic imaging AI to automatically screen which people might benefit from its Spiration valve system.

Spiration is an FDA-designated breakthrough device for treating chronic obstructive pulmonary disease (COPD) patients.

SeleCT Connect — offered as part of Olympus’ SeleCT quantitative computer tomography (QCT) analysis service — is available immediately to more than 9,000 U.S. healthcare through the Nuance AI Marketplace, a workflow-integrated cloud platform for diagnostic imaging AI algorithms.

Nuance Communications, which Microsoft is acquiring, and Olympus’ AI-based SeleCT analysis partner Imbio helped create the SeleCT Connect program.

SeleCT Connect automatically sends CT studies directly from physicians and radiologists’ picture archive and communication system (PACS) to the SeleCT QCT analysis service. Results automatically return to the patient record f…

Exploring pharma applications of Xilinx’s adaptive system-on-modules

Image courtesy of Xilinx

Earlier this year, Xilinx (San Jose, Calif.) launched its Kria line of adaptive system-on-modules (SOMs) for a host of AI applications, including in factory and healthcare environments. In terms of the former, the SOMs target digital twin, predictive maintenance and defect detection applications.

SOMs, which are small embedded boards about the size of a credit card, enable the abstraction of hardware functionality. As a result, developers can design at the board level rather than the chip level. For hardware designers, SOMs promise to avoid rudimentary design work. SOMs also enable software developers to begin work in parallel with a hardware team.

Smart factory applications related to vision AI are a core focus area for the first product in the Xilinx SOM portfolio, the Kria K26 SOM.

As a result, factory owners deploying SOMs can get smart factory projects up and runni…

Why Bioclinica tapped AI in immunotherapy trials early in the pandemic

An AI-based system proved its mettle in screening patients in immunotherapy trials, according to Dan Gebow, chief innovation officer at Bioclinica.

Early in the COVID-19 pandemic, developers of cancer immunotherapies worried that the novel coronavirus would interfere with their clinical trial results.

In previous years, the scientific community established that immunotherapy can rarely cause interstitial lung disease (ILD). An umbrella term covering several conditions such as pulmonary fibrosis that lead to scarring of the lungs, ILD also arises in some patients with COVID-19.

The fact that ILD can arise from COVID-19 and cancer immunotherapies complicated oncology clinical trials, recalled Gebow at Bioclinica, which provides clinical trial adjudication products and services. “Patients in immunotherapy clinical trials were showing up at the emergency room with some type of lung infection,” Gebow said. “You can imagine if you’re the pharmaceutical company…

Building a new foundation for oncology clinical trials

Photo by Anna Shvets from Pexels

The COVID-19 pandemic disrupted oncology clinical trials, and drug developers and regulators, including the FDA, continue to look for ways to catalyze clinical trial innovation. The FDA has been “vigilant as they always are to make sure that there is strong science, but they are much more open both in study design, alternative execution methods and the use of real-world evidence (RWE) and retrospective data,” said Jeff Elton, CEO of ConcertAI.

ConcertAI is now in a five-year collaboration with the FDA that involves RWE and AI to support regulatory decision-making. “One of the first projects is looking at cardiovascular adverse events that occur in [immuno-oncology]-treated patient populations,” Elton said.

One factor contributing to the evolution of oncology clinical trials is the change in interactions between sponsors and regulatory agencies. “It is materially diffe…