AI and ML in Clinical Trials; Risk Management Software Update; Synthetic Control Arms; Decentralized Clinical Trials; More

April 28, 2022 | AI and ML in clinical trials, patent for minimum residual tumor detection, T-cell receptor engineering for cancer treatment, award given for COVID-19 clinical trial activities, synthetic control arms and decentralized trials, and more.

The Canopy Cancer Collective, a national nonprofit organization that strives to fuel better treatments and outcomes for pancreatic cancer patients, has awarded The Tisch Cancer Institute at Mount Sinai a $500,000 grant to support continued innovation in its multidisciplinary treatment of pancreatic cancer. The Canopy Cancer Collective partners with leading health care institutions to create new patient-centric learning health networks, connecting top medical care providers, cancer researchers, and wellness specialists to formulate and foster best practices in cancer care all while empowering patients throughout their cancer journey. Mount Sinai is among 14 centers nationally to receive the grant. In April, Mount Sinai is launching the Center of Excellence for Pancreatic Cancer Multidisciplinary Team (Pancreas MDT) at Mount Sinai West, and The Tisch Cancer Institute is launching the Center of Excellence for Pancreatic Cancer at Mount Sinai. The Pancreas MDT will have a team of specialists who are national leaders in the field who will provide the highest-quality diagnostic tools, treatment, and care for patients with pancreatic cancer. In a one-day visit with the multidisciplinary team, patients will receive an individualized treatment plan that would otherwise take weeks elsewhere. Patients will also have access to innovative therapies through clinical trials at multiple locations throughout the Health System. Press release.

Personalis announced the issuance of a key US Patent related to its industry-leading minimal residual disease (MRD) and recurrence platform, NeXT Personal. The patent, US Patent No. 11,299,783, entitled “Methods and Systems for Genetic Analysis,” was issued on April 12, 2022. The patent claims novel methods for a partially personalized assay, combining both tumor-informed and prespecified (tumor naïve) content. Tumor-informed methods can provide high sensitivity for detection of MRD. They can also support tracking of variants specific to an individual patient’s cancer, such as those targeted by specific therapies or which are thought to elicit an immune response. Prespecified, tumor-naïve content can include variants not detected on initial sequencing of a tumor, but which may emerge and confer drug resistance as a tumor evolves. It can also include driver mutations of a second primary tumor, which may arise independently during the course of the initial cancer. The patent is a member of a family that broadly describes Personalis’ foundational work relating to the development of personalized assays for disease identification and tracking. Press release.

Enablon released Version 9.4 of its integrated risk management platform. Designed for organizations of all sizes, Version 9.4 of the Enablon Vision Platform features enhancements that will enable greater collaboration and integration, streamline communications and mobility, and more. Version 9.4 of the Enablon Vision Platform empowers organizations to collaborate in a new way to manage risk. It builds on a foundation that’s designed to deliver a comprehensive 360° view of risk by breaking down silos between EHS, risk, sustainability, and compliance; integrating processes of safety, risk, and operations; connecting workers through mobility; and predicting and preventing incidents. Press release.

Venomtech is collaborating with Charles River Laboratories, International Inc. to help drug developers explore venom-derived compounds for a wide range of therapeutic targets. This newly formed collaboration will bring together Venomtech’s biology expertise and vast venom-derived peptide library with Charles River’s drug development and screening knowhow, providing pharmaceutical manufacturers with a one-stop service to explore this unique natural resource. Venomtech’s Targeted-Venom Discovery Array libraries provide researchers with a straightforward solution to rapidly screen thousands of individual venom fragments, with each array specifically designed to maximize hits for a specific target. Through the new collaboration, Charles River will be able to use this innovative resource—closely supported by Venomtech—to accelerate its clients’ pipelines, addressing difficult therapeutic targets, uncovering new mechanisms of action, and minimizing off-target effects. Press release.

Standard BioTools launched the Hyperion+ Imaging System for high-plex spatial imaging, providing lower limits of detection as well as improved sample capacity and time to results. The Hyperion+ Imaging System provides researchers with a deep understanding of disease and response to treatment, with the ability to stratify subjects by linking high-plex data to outcomes in clinical studies. The system can process 100-plus samples per week, performing at twice the speed of the current Hyperion Imaging System, with a 1.6x lower limit of detection. This enables detection of dim markers, an advantage that can be critical for lower-expressing markers often used in translational studies. Results of a study using the Hyperion+ Imaging System to improve understanding of the biology and pathophysiology of the tumor microenvironment in pancreatic invasive ductal adenocarcinoma (PDAC) were presented in a poster session at the annual meeting of the American Association for Cancer Research (AACR) in New Orleans in April. Press release.

CluePoints, a provider of risk-based study execution (RBx) and risk-based quality management Software for clinical trials, has won the Citeline Award for Excellence in Innovation in Response to COVID-19 – Clinical Trial Activities. The category recognizes the efforts of an individual, team, or company for innovative work in developing new treatments, technologies, processes, services, or solutions to address the pandemic. CluePoints took the award for deploying its risk-based quality management (RBQM) software to support the pivotal trial of the Pfizer/BioNTech BNT162b2 COVID-19 vaccine. Conducting the crucial trial was highly challenging as it included more than 40,000 people from a broad range of demographics across 150 global sites. To process and protect the integrity of the vast volumes of data generated by the trial, which recruited people at a rate of 5,000 a week, Pfizer worked with CluePoints to deploy an agile, real-time, risk-based monitoring approach. The central monitoring analytics, led by a core clinical study team and clinical data scientists, focused on an evolving set of study-specific key risk indicators, data quality assessments, and quality tolerance limits. Data was analyzed daily to allow quality issues to be identified and rectified in real time. Press release.

Charles River Laboratories International, Inc. has acquired Explora BioLabs Holdings, Inc. Based in San Diego, California, Explora BioLabs offers contract vivarium operation services, providing biopharmaceutical clients with turnkey in vivo vivarium facilities, management, and related services to efficiently conduct their early-stage research activities. Explora BioLabs currently operates more than 15 preclinical vivarium facilities, offering AAALAC-accredited, turnkey rental space in the Southern California, San Francisco, and Boston-Cambridge biohubs, with a planned expansion in Seattle in 2022. With over 100 employees, it also offers contract vivarium management, staffing, and regulatory solutions to manage clients’ research sites. The combined Explora BioLabs and Charles River operation is expected to include at least 25 vivarium facilities by the end of 2022, providing over 300,000 square feet of turnkey rental capacity in key biohubs, including expansions in the United States and internationally. Press release.

Plus Therapeutics, a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, announced that it has expanded its partnership with Medidata, a Dassault Systèmes company. The goal of the expanded partnership is to speed enrollment, improve patient access to an innovative therapy, and reduce clinical trial costs in Plus Therapeutics’ planned forthcoming Phase 2 registrational trial of Rhenium-186 NanoLiposome (186RNL) in recurrent glioblastoma (GBM). The partnership will utilize Medidata’s Synthetic Control Arm (SCA) platform that facilitates the use of historical clinical trial (HCT) data in a manner that historically has been favorably received by the U.S. Food and Drug Administration. Press release.

AiCure, an AI and advanced data analytics company focused on improving clinical trials, is expanding its global presence through partnerships, a new employee base, and key events. Through its contract research organization (CRO) partnership program, AiCure Partners for Excellence (AiPEX), AiCure is partnering with Qwince, an Italy-based technology and services company focused on helping organizations implement innovative solutions and advance healthcare. Leveraging Qwince's consulting experience in data science, pharmaceuticals, and technology, the partnership will aim to foster clinical and commercial opportunities for the deployment of AiCure's AI platform with pharmaceutical sponsors and government healthcare departments. It will also work with network pharmacy associations to leverage local pharmacies as an alternative to sites during clinical trials to improve convenience for patients. This partnership will empower Italian organizations to explore new endpoints and ways to assess patient behavior, as well as provide holistic, predictive insights for faster, more precise clinical trials and real-world observational studies. Press release.

Medidata announced that Labcorp has selected their technology platform to extend their 14-year partnership, the foundation of their initiative to co-develop digital biomarkers and expand the use and functionality of decentralized clinical trials. Labcorp Drug Development has developed its offerings on Medidata technologies, starting with Rave EDC (electronic data capture), Coder, and TSDV (targeted source data verification). Labcorp is now also using most of the Medidata Clinical Cloud platform, including eCOA (electronic clinical outcome assessment), RTSM (randomization and trial supply management), and Imaging. Press release.

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