June 29, 2023 | Walgreens and Freenome team up to advance clinical studies; ObjectiveHealth announces new AI tool to optimize clinical trial performance; Saama deploys AI solutions to automate key clinical development processes; American Gene Technologies launch new company that solely focuses on HIV cure research; and more.  

Insilico Medicine announced that it has completed the first dose in patients in the Phase II clinical trial of INS018_055, marking the world's first anti-fibrotic small molecule inhibitor discovered and designed using generative AI, initiating Phase II clinical trials for further evaluation. Press release. 

The Ataxia Center at the University Hospital Bonn and DZNE have been awarded the title “Ataxia Center of Excellence” by the US National Ataxia Foundation (NAF) for their patient care and research – as the only organization in Europe. The foundation represents patient interests and is one of the world’s major non-governmental funders of ataxia research. These rare brain diseases are characterized by progressive loss of balance and coordination, accompanied by slurred speech. It is estimated that this condition affects around 16,000 women and men in Germany. Press release. 

OM1 has launched OM1 Aspen, its novel, automated study platform for evidence generation. OM1 Aspen is a comprehensive offering that is distinguished by the company’s proprietary data sourcing, processing, and enrichment technologies—including electronic medical records harmonization, image management, advanced medical text processing and linkage—to deliver a more efficient, cost-effective, and scalable approach to research. With automation as its guiding principle, OM1 Aspen is transforming research with flexible, reusable infrastructure; leveraging advanced data acquisition, processing, and linkage technologies; streamlining large studies; and creating powerful evidence networks. In addition, OM1 Aspen meets the high bar required for using real-world data and generating real-world evidence for regulatory purposes, including being fit-for-purpose, transparent, and traceable. Press release. 

Medable and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard announced a comprehensive toolkit for Institutional Review Boards (IRBs)/Ethics Committees (ECs) to standardize decentralized clinical trial (DCT) ethics review. The first-of-its-kind toolkit provides a common framework, tools, and best practices for uniform ethical review and approval and provides a roadmap for the ethical conduct of DCTs. Such standardization will simplify, streamline, and speed the IRB/EC process—a key step towards more efficient, patient-centered research execution. The DCT IRB/EC Toolkit encompasses 13 guides (organized around three themes of people, data collection, and data oversight), addressing each common element of a decentralized trial. These range from electronic consent (eConsent), electronic clinical/patient-reported outcomes assessment (eCOA/ePRO), wearable devices, remote telehealth visits, and more. Press release.  

Saama has launched its unified platform of SaaS-based products to accompany its existing portfolio of customized solutions and services. The Saama platform deploys its artificial intelligence (AI)- and machine learning (ML)-enhanced solutions to automate key clinical development processes and provide a holistic view of trial operations and patient progress in one location. By applying AI and advanced analytics to key clinical development processes, Saama’s platform eliminates manual, resource-intensive activities, allowing life science organizations to optimize productivity as well as gain deeper insights into patients’ behaviors and their real-time response to treatments. Press release.  

Walgreens and Freenome announced a multi-year relationship to advance clinical studies of Freenome’s blood-based tests for the early detection of cancer. Walgreens will combine its national footprint, patient insights, compliant recruitment technology and local infrastructure to engage diverse patient populations in Freenome’s multi-cancer research program. Working together with technology provider Curebase, Walgreens will initially recruit patients across diverse populations for Freenome’s Sanderson Study, which aims to evaluate blood-based early detection tests for multiple cancers. Using Curebase’s platform, Walgreens will deliver targeted outreach to potentially eligible patients and caregivers of all backgrounds via text, email or in-person consultation at the pharmacy. After completing a pre-screen, eligible patients are invited to enroll in the study. Walgreens healthcare providers will then perform a single blood draw at one of the company’s clinical trial locations and conduct a telehealth patient follow-up one year after their participation. Walgreens and Freenome will also work together on building risk-prediction models and population health software. The aim is to help close existing care gaps and identify people who are eligible and stand to benefit from standard-of-care cancer detection testing. Press release.  

SomaLogic and Citogen, the Longwood Group’s customer services and support unit, are collaborating to establish SomaLogic’s first authorized site in Spain. As part of the agreement, Citogen will offer the 7,000-plex SomaScan Assay and provide SomaScan data to their customers in Southern Europe supporting biological research across an array of disciplines including clinical research, population health studies and nutrigenomics. Press release.  

BC Platforms announced the addition of one of Brazil’s leading cardiology centers, Hospital do Coração (HCor), to its Global Data Partner Network, BCRQUEST.COM, to drive insights into drug discovery and development through analytics and realize the potential of real-world data worldwide. HCor possesses valuable longitudinal patient data, including on cardiovascular conditions such as atrial fibrillation, heart failure, and stroke. Today, BCRQUEST.COM holds rich real-world data from more than 65 million patient lives on 6 continents including North America, South America, Europe, Africa, Asia and Australia. Since 2021, HCor has made significant strides in digitalization by implementing an electronic medical records system and integrating technology across various sectors of its operations. Press release.  

Myriad Genetics announced an agreement with The University of Texas MD Anderson Cancer Center to support research focused on metastatic renal cell carcinoma treatment selection and response. The project will use Myriad’s minimal residual disease (MRD) testing platform, a tumor-informed high-definition assay that detects circulating tumor DNA (ctDNA). Myriad is working together with Chad Tang, MD and Pavlos Msaouel, MD, PhD at MD Anderson. The research team will investigate the use of Myriad’s MRD testing platform as a non-invasive tool to inform treatment selection, surveillance, and radiotherapy treatment response in individuals with metastatic renal cell carcinoma (RCC). There currently is a lack of non-invasive testing platforms available for RCC, and MRD tests based on exome sequencing of the tumor may not track enough variants to be sufficiently sensitive. The goal of this research is to determine if patients with RCC will benefit from a comprehensive genome-wide approach to MRD with this platform. Press release.  

American Gene Technologies (AGT) launched a new company—Addimmune—to continue to develop gene and cell therapy technologies to cure HIV. Addimmune will focus solely on advancing an HIV cure, building upon more than a decade of work by AGT that led to a successful Phase 1 HIV gene and cell therapy clinical trial. Addimmune aims to create tremendous benefits for HIV patients, payers, and the public. Its gene therapy technology has the power to transform millions of lives. The new company’s name represents a fusion of two fundamental concepts: using gene and cell therapy to add new capacity to the human T cell to create an improved immune system to fight HIV. Press release.  

ObjectiveHealth has launched ObjectiveScreen, a cutting-edge artificial intelligence (AI) feasibility and recruitment platform that optimizes clinical trial performance and outcomes through superior patient identification, prequalification, and retention. Powered by ObjectiveHealth’s cloud-based, proprietary AI and machine-learning (ML) algorithms, ObjectiveScreen allows clinical trial sites to connect directly with patient electronic health records (EHRs). Patient health risks are stratified against evidence-based physiologic and molecular biomarkers so users can identify in real time the most qualified candidates for specific clinical trials. In addition to EHR analysis, ObjectiveScreen can review other patient data, including risk factors and demographic data such as age, gender, ethnicity and socioeconomic status, which can help identify candidates who may not have a diagnosis. The technology saves clinical sites considerable administrative time managing candidate records. ObjectiveScreen also fosters patient engagement by simplifying and streamlining appointments and communication. Press release.  

Mural Health announced a strategic partnership with ClinOne, the leading provider of adaptive clinical trial experience solutions. The move will integrate Mural Link, a next generation patient payments and participant management platform, into ClinOne’s patient support and trial management technology. The partnership will further streamline site-level operations and improve the participant journey. Both companies are using technology to help sponsors overcome the stubborn challenges of drug development, including poor recruitment and retention, by focusing product design on the participant (the end-user). Both companies are also committed to reducing the administrative burden that clinical research sites can experience when sponsors require multiple technology platforms. Press release.  

Yseop launched Copilot, the world’s most secure content automation solution for regulated industries and next-generation of the Augmented Analyst platform. The multimodal platform is a leap forward for life sciences firms looking to address their automation requirements and empowers scientific writers to be more strategic and productive with their resources in a closed, secure environment. Yseop Copilot supercharges productivity and keeps scientific writing in-house for quality control. With Yseop Copilot, scientific writers across hundreds of clinical trials have slashed writing times and improved the consistency and reliability of reports in record time. Press release.  

BC Platforms announces the acquisition of 4Pharma Ltd, a contract research organization providing medical research services to pharmaceutical, biotechnology, and medical device companies. Financial details are not disclosed. The acquisition expands BCP’s global service offering for accelerating the translation of innovations into clinical practice. In addition, 4Pharma customers will benefit from additional services in the field of RWD through the BC Platforms technology. It grows BCP’s capabilities in providing ‘data intelligence’ analytics services to its clients. Press release.  

eClinical Solutions has expanded artificial intelligence (AI) and machine learning (ML) capabilities within the elluminate IQ offering. Embedded in elluminate Data Central—the elluminate Clinical Data Cloud’s data management workbench providing seamless access to comprehensive trial data across systems and sources—elluminate IQ Review (eIQ Review) enables data management teams to leverage these advanced AI/ML capabilities to conduct data review in a more efficient, scalable way. Press release. 

Wheeler Bio and Charles River Laboratories announced an agreement to implement RightSourceSM at Wheeler Bio’s current good manufacturing practice (cGMP) biologics manufacturing facility in Oklahoma City, OK. Deployed on-site at a client’s facility, RightSourceSM is a flexible biologics testing lab operated and managed by Charles River, making fast, reliable quality control (QC) more accessible to a broader reach of companies like Wheeler Bio. Wheeler Bio and Charles River will work in close collaboration to set up a cGMP testing lab at Wheeler Bio’s ultra-modern Oklahoma City facility. This platform-based satellite lab will be operated by Charles River employees who will utilize Charles River’s quality management systems, test methods, and standard operating procedures (SOPs) to support all QC testing needs for Wheeler Bio. Press release.