November 30, 2016 | News, products, and partnerships from around the clinical trial and healthcare community including news from Takeda, CluePoints, Mayo Clinic, and more.

BioCision today announced the formation of MedCision, an independent company focused on automation of pre-clinical and clinical processes. “The formation of MedCision is driven by a critical need in the market – innovative, standardization technologies and solutions for translational, clinical and point-of-care settings,” said Rolf O. Ehrhardt, BioCision CEO in a statement. “MedCision will be a leader in developing and commercializing innovative instruments for crucial processes in the post-manufacturing cell and gene therapy space.” The creation of MedCision as a stand-alone company with a dedicated management team will provide the necessary focus and foundation for long-term value generation in the clinical tools space. Commercialization of the ThawSTAR cell thawing platform will initially be the focus of MedCision. Press release

iSpecimen announced that it has entered into an agreement with the Mayo Clinic Center for Individualized Medicine. Under the agreement, iSpecimen will serve as the exclusive channel partner for the Mayo Clinic Cancer/Normal Serum Biobank, connecting biomedical researchers with the samples and associated data for their studies. The Cancer/Normal Serum Biobank, located on Mayo Clinic’s campus in Rochester, Minnesota, includes approximately 130,000 frozen vials of serum from about 17,000 unique, consented patients. The samples were collected between 1975 and 1990 across 85 different malignant and benign conditions. iSpecimen, which works to procure annotated samples for life science researchers, will manage the serum inventory and associated data through its cloud-based technology solution, matching researchers to the right samples to fuel their studies. Press release

Cerner announced a telehealth agreement with American Well, a leading national telehealth company. Together, the companies will deliver a virtual health care experience that will integrate the American Well platform with Cerner’s electronic health record (EHR). The integration will enable providers to manage the health and care of patients beyond the walls of the health system. “Cerner and American Well share the belief that all aspects of health care delivery should be unified, continuous and patient-centered. Together, we’re committed to developing a long-term strategy to align American Well’s telehealth technologies, services and programs to deliver an enhanced user experience within the Cerner EHR and ecosystem,” said Don Bisbee, senior vice president at Cerner. Press release

PAREXEL launched an Identification of Medicinal Products (IDMP)-focused solution for biopharmaceutical companies. LIQUENT InSight for IDMP is the newest module added to PAREXEL’s Regulatory Information Management (RIM) platform. PAREXEL’s LIQUENT InSight for IDMP allows biopharmaceutical companies to collect their data in a comprehensive and holistic manner.  It is fully compliant with the five ISO IDMP standards defining product and registration data and details for investigational and registered medicinal products.  In addition, PAREXEL Consulting’s subject matter experts work with clients to develop a comprehensive IDMP strategy that ensures globally standardized data. Press release

Schulman IRB announces its Central Oncology Review (COR) division is open for business. COR, which is led by Michele Russell-Einhorn, VP of Oncology, and Judith Carrithers, Director of Oncology Services, provides collaborative, flexible IRB review services for oncology research organizations seeking a more advanced level of partnership and service integration from a central IRB. This service represents Schulman’s response to requests from institutional research centers. Press release

Definiens announced a program collaboration with Takeda to enable comprehensive tissue-based analysis in clinical trials. Definiens’ products and services deepen the understanding of disease biology and the immune system to advance clinical trials. By using knowledge-driven biomarker analysis in combination with VeriTrova, the company’s new cloud-based digital pathology platform, Definiens seamlessly translates research to clinical knowledge to the next generation of diagnostics. Press release

Seattle Genetics and Takeda announced completion of patient enrollment in the ECHELON-2 clinical trial. ECHELON-2 is a global phase 3 randomized trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in patients with previously untreated CD30-positive mature T-cell lymphoma (MTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on several types of non-Hodgkin lymphoma, including subsets of MTCL, as well as Hodgkin lymphoma. ADCETRIS is currently not approved for the frontline treatment of MTCL.  Press release

CluePoints announced a new Data Quality Oversight service, RADAR, aimed at helping sponsors achieve a data-driven understanding of risks to an inspection-ready level. As regulators insist that sponsors adopt more comprehensive quality oversight methodologies, this new service looks to move away from antiquated processes to a more rigorous statistical approach to operational quality assurance including preparation for site inspections. CluePoints’ RADAR service harnesses the advanced statistical interrogation of clinical and operational study data to identify investigative sites with a preponderance of anomalous, missing or inconsistent data that may require inspection readiness action. The company’s Data Analysts conduct a comprehensive assessment using the software to identify these higher-risk sites and data which may have escaped detection previously. This rigorous approach is anticipated to benefit sponsor submissions by identifying anomalous sites along with the nature and extent of potential data issues. Press release

Exco InTouch announced that it has been granted a US patent corresponding to its mobile health solutions, including methods for providing condition-specific adaptive content and health support for patients, healthcare professionals and other stakeholders in the healthcare industry. Exco InTouch’s modular approach to building digital health solutions, enables configuration and delivery of disease management programs that can support all stakeholders in the care pathway – patients, caregivers, healthcare professionals, providers and payers. Press release