August 31, 2023 | Phastar appoints a new CEO amid organization changes and growth plans; Celltrion opens a Global R&D Center in South Korea for research capabilities and technologies spanning all areas of biopharmaceutics; Clario and AliveCor, Standigm and Nashville Biosciences, C2i Genomics and the Tel Aviv Sourasky Medical Center (Ichilov) announce partnerships; more. 

Phastar announced the appointment of Graham Clark as the new Chief Executive Officer. Amid ambitious growth plans and organizational changes, Clark will succeed Andrew MacGarvey as CEO and further boost the paradigm shift in delivery of world-class data quality oversight. MacGarvey will assume the Chief Operating Officer (COO) role, maintaining his Board position. Press release. 

Clario has expanded its collaboration with AliveCor to continue enabling trial participants to collect medical-grade six-lead ECG readings in the comfort of their own homes through KardiaRx, a clinical-trial-focused app. This technology enables pharmaceutical and biotech customers to consider decentralized and hybrid clinical trial strategies in study protocols that would have otherwise been limited to on-site evaluations. Press release. 

Standigm announced that it is collaborating with Nashville Biosciences, a wholly-owned subsidiary of Vanderbilt University Medical Center (VUMC), on early drug discovery research. Under the terms of the agreement, Standigm will use Nashville Bioscience's extensive, de-identified genomic and clinical data to build new, customized AI models for drug discovery. The mission of the collaboration is to accelerate early-stage drug discovery. Press release. 

C2i Genomics announced its collaboration with the Tel Aviv Sourasky Medical Center (Ichilov), Israel's leading multidisciplinary healthcare institution. Together, the organizations will provide precision oncology clinical testing using C2inform, C2i Genomics' whole genome minimal residual disease (MRD) test to improve cancer detection and monitoring nationwide. Through the partnership, C2i Genomics' and its whole-genome-based assay will be integrated into a nationwide healthcare system for the first time. With Ichilov Hospital Labs serving as the reference lab for cancer hospitals across Israel, C2inform tests will become accessible to the entire population of Israel, accounting for nearly 10 million people. Through this collaboration, sequencing with WGS of circulating tumor DNA (ctDNA) and matched tumors of cancer patients will be performed by Ichilov's Pathology Institute. Press release. 

Celltrion opened a Global R&D Center in South Korea to support breakthrough therapies. The center offers research capabilities and technologies spanning all areas of biopharmaceutics, including the identification of candidate substances for new drugs, stem cell development, and expression through genetic recombination, mass production of biopharmaceutical products, equivalency evaluation for product approval, and research of product characteristics and mechanism. Press release. 

Certara announced a partnership with the Drugs for Neglected Diseases initiative (DNDi). DNDi, through its Data Management and Biostatistics (DMB) Centre in Nairobi, will leverage Certara’s data science platform, Pinnacle 21 Enterprise, to standardize data from multiple clinical data sources. This strategic approach aims to optimize data flow, expediting the analysis and submission of new treatments for health authority review, and is in line with DMB’s objective of adopting standard data exchange formats to support regulatory approval. Press release. 

Editas Medicine and Azzur Cleanrooms on Demand (COD) announced the expansion of their multi-year contract to support the scaling of EDIT-301, Editas Medicine’s experimental cell therapy medicine under investigation for the treatment of severe sickle cell disease and transfusion-dependent beta thalassemia, from approval to commercialization. The expanded agreement includes compliant cleanroom space and labs services at Azzur’s COD site in Devens, Massachusetts. Editas Medicine has utilized Azzur’s services to execute pre-clinical and early-phase clinical manufacturing activities for its cell medicines, including EDIT-301 for the treatment of sickle cell disease and beta thalassemia, since 2020. Press release. 

Vital Biosciences introduced its revolutionary new product, the VitalOne. The VitalOne intends to make blood diagnostics ubiquitous by bringing more than 50 lab-grade test results that cover 95% of routine lab orders to primary care sites in the form of a simple device the size of a desktop computer. The VitalOne will allow doctors to test, diagnose, and treat patients in the course of a single visit. Patients receive their results within 20 minutes. The VitalOne is in late-stage development and is not yet available for sale. The underlying technology already has been tested and validated against thousands of samples versus gold-standard instruments with Vital’s lab partners. Press release. 

AliveCor announced a partnership with the Jefferson Narcotic Addiction Rehabilitation Program (NARP) and Thomas Jefferson University Hospital in Philadelphia to evaluate the benefits of QTc monitoring with KardiaMobile 6L for patients receiving methadone maintenance therapy for opioid use disorder. Press release.