October 31, 2018 | October was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from BioIVT, Veeva Systems, PAREXEL, and more.

BioIVT announced that it has acquired Clinical Trials Laboratory Services (CTLS). CTLS provides dedicated high-quality serum, plasma and blood collection services. It also offers full-service cell processing capabilities on site. All CTLS employees will join BioIVT and CTLS' London headquarters will become the primary site in Europe for donor collections. This acquisition increases BioIVT's capacity to produce fresh peripheral blood mononuclear cells and other immune cell subsets such as natural killer cells, B cells, and T cells to meet clients' research needs. It also enables BioIVT to ship fresh blood and blood-derived products to researchers anywhere in Europe within 24 hours. Financial details about this transaction were not disclosed. Press release

Veeva Systems introduced its first application specifically built for clinical research centers, Veeva Vault SiteDocs. The new solution will help sites more effectively manage regulatory documentation and trial information to speed clinical research. Now clinical research centers can reduce the administrative burden of executing studies by streamlining document and trial processes for site qualification, study activation, and investigator site file management. “We’re pleased to partner with Veeva and have the opportunity to leverage an innovative solution that’s designed for how sites work,” said Jeff Kingsley, founder and CEO, IACT Health, in a press release. “Veeva Vault SiteDocs gives greater visibility into regulatory document status and makes it easier for the clinical research community to conduct high-quality, compliant clinical trials.” Veeva Vault SiteDocs provides sites a single application for managing trial documents and processes to speed study activation. With continuous visibility into document quality, completeness, and accuracy, Vault SiteDocs gives clinical research centers a full view into study progress for improved compliance and inspection-readiness. Press release

PAREXEL announced that it has developed several new solutions that take a patient-centric approach to addressing drug development. Built on the Perceptive Cloud platform and leveraging PAREXEL’s relationship with Microsoft, the solutions incorporate mobile and wearable technology to increase access to data and improve the patient experience in clinical research. The first solution is designed to enable health care staff and first line clinicians to communicate time-sensitive events to study staff. Leveraging Microsoft Azure App Services, the technology will generate health alerts through data transmission from mobile devices, gathered at the patient home or in the field and forwarded automatically whenever there is connectivity. Staff and investigators will then be automatically informed and could proactively address any threat to patient safety, potentially decreasing risk of patient mortality and morbidity. PAREXEL has also initiated several projects that expand innovation in the application of mobile medical devices in clinical trials. Specifically, PAREXEL’s Patient Sensor Solution capabilities now include an expanded list of connected medical devices, and integrations with DataLabs, PAREXEL’s electronic data capture technology, and ClinPhone RTSM, PAREXEL’s interactive response solution for randomization and trial supplies management. The Sensor Solution utilizes advanced Artificial Intelligence (AI) technology to support predictive monitoring of patient compliance and has been expanded to manage larger volumes of data transfer. Press release

Fabric Genomics announced that it is offering select customers the option of using “Build 38,” the most current reference genome assembly, for their clinical genetic testing efforts. Technically known as GRCh38, this reference build has many advantages over previous iterations. Build 38 was released by the Human Genome Consortium to succeed Build 37, which had been the standard human reference genome since 2009. Build 38 is the most up-to-date representation of the human genome sequence. It repairs incorrect assemblies from Build 37, removes some incorrectly assigned pathogenic alleles, adds centromere sequences and improves the reference genome in critical gene-rich regions; it also increases the number of alternate loci, thus allowing for a more accurate representation of human variation. These improvements enable researchers to remove well-known errors that hinder automated clinical workflows, and gain access to areas of the genome that had been virtually unknown before. Press release

eClinical Solutions announced the latest version of elluminate is available for general use. This release of the platform incorporates feedback from numerous customers who use elluminate as a foundational platform to support a modern digital clinical data strategy. Since 2012, elluminate has been used by clinical operations, data management, and medical monitoring to provide meaningful analytics at the study, program and organizational level. This latest version of elluminate extends the out of the box visualizations to include additional data sources, providing end users with greater flexibility and ease in solving business problems: for example, combining clinical and operational data to better track and plan site payments. In addition to the expanded analytics capabilities, the latest version of elluminate includes numerous intelligent features and enhancements across the platform. The Data Central module, used by data managers and medical reviewers for efficient data review of all data in a trial or program, now has expanded smart filtering, external issue management workflow and greater support for incremental review. The Mapper module, used by data analysts and programmers to map data without writing code, has new automation capabilities. The core platform data integration capabilities have also been enhanced to provide users with curated, high quality data in real-time. Press release

Cenduit announced that biopharma industry executive Cindie Kazmer has joined the company as Senior Director of Project Management, with line management responsibility for U.S. operations in North America. Kazmer brings over 25 years of successful operations and engineering experience in the biopharma and medical device markets. Her expertise spans eClinical systems, cardiovascular medical devices, and medical informatics. Cenduit CEO Sam Osman explained in a press release, “We’re delighted to welcome Cindie Kazmer to Cenduit. Cindie’s career endeavors have focused on improving client satisfaction, quality and financial performance, while consistently driving efficiency and process improvements in the eClinical solutions industry.  We look forward to bringing her dynamic approach to help clients solve for their complex challenges in clinical trials.” Prior to Cenduit, Kazmer held various eClinical leadership roles at PAREXEL, Mills & Onello, Phillips Medical Systems, Agilent Technologies, and Hewlett Packard. Press release

BBK Worldwide announced Zaggo as a featured contributor to Clinical Notifier. Designed to help patients and caregivers find pathways to better healthcare, Clinical Notifier is a free web-based resource that provides the latest news, tools, educational content, and clinical study opportunities. As a contributor, Zaggo will provide content for the Resource Lab, which features information about clinical studies, tools and tips, and a caregiver's corner. The partnership reflects the commitment the two companies share to enhancing the patient experience and to educating and empowering healthcare consumers in making informed decisions about clinical research participation. Press release

Synpromics announced positive data presented today by a key partner, uniQure, at the European Society of Gene and Cell Therapy conference in Lausanne, Switzerland. The study used uniQure’s next-generation liver-directed gene therapy system that incorporates a short, highly-selective and powerful liver promoter that was developed by Synpromics. The study, the first conducted in an advanced pre-clinical model using technology developed by Edinburgh-based Synpromics, demonstrates that the promoter is at least eight-times more potent than the current industry standard, providing uniQure with a powerful tool from which to drive the development of a variety of liver-directed gene therapies. Commenting on the results, Michael L Roberts, Founder & CSO of Synpromics, said in a press release: “This is fantastic data and shows the translatability of our company’s technology to advanced disease relevant models. This is the culmination of a productive partnership with uniQure in which we have worked closely to deliver a highly selective promoter, whose performance has exceeded initial expectations. This promoter enables uniQure to develop safer, targeted gene therapies for liver disease.” Press release

The Australian oncology-focused biotech Kazia announced that it will collaborate with the Dana-Farber Cancer Institute to investigate the use of Kazia's potential new therapy for brain cancer, GDC-0084, in breast cancer that has spread to the brain. The phase 2 clinical trial will investigate the effects of GDC-0084 in combination with the current standard of care, Herceptin (trastuzumab), in patients with HER2-positive breast cancer that has metastasized to the brain. The study is estimated to recruit between 22 and 49 patients, and will take up to three years to complete. Kazia is developing GDC-0084 as a potential treatment for the primary form of brain cancer, glioblastoma multiforme. The drug targets the signaling pathway implicated in about 90% of glioblastoma cases, and is differentiated from other brain cancer treatments by its ability to cross the so called 'blood-brain' barrier that prevents many drugs from fully impacting the brain. Press release

SetPoint Medical announced the long-term, 24-month follow up data from its proof-of-concept study that support the continued clinical development of its proprietary bioelectronic device to treat patients with rheumatoid arthritis (RA). Results for the completed proof-of-concept study in Europe supported the initiation of a U.S. Food and Drug Administration (FDA) pilot Investigational Device Exemption (IDE) study evaluating SetPoint’s proprietary miniaturized microregulator, for which the company recently announced completion of enrollment. Murthy Simhambhatla, President and Chief Executive Officer of SetPoint Medical, said in a press release, “It’s exciting to see the development of our unique bioelectronic medicine solution progressing as a fundamentally different treatment option for rheumatoid arthritis. Current autoimmune disease treatments slow disease progression but have significant negative side effects, leave many patients with significantly diminished quality of life, have substantial compliance challenges and are extremely costly. Our alternative approach has the potential to improve upon each of these limitations ...” Press release

Eloxx announced positive data demonstrating that ELX-02 showed significant increases in CFTR functional assay (P<0.0001) and mRNA levels (P<0.05) across multiple CFTR nonsense mutations in cystic fibrosis patient-derived organoids. ELX-02 demonstrated significant forskolin-induced swelling (FIS) in cystic fibrosis patient-derived organoids carrying homozygous and compound heterozygous CFTR nonsense mutations. These findings were presented at the North American Cystic Fibrosis Conference in Denver, Colorado. “We are extremely pleased with the emerging profile of ELX-02, as the first read-through agent to demonstrate increases in CFTR function and mRNA in organoids derived from cystic fibrosis patients with nonsense mutations,” Neal Sharpe, Vice President of Translational Sciences at Eloxx, said in a press release. “There is a high unmet medical need among the estimated 13% of cystic fibrosis patients with a nonsense mutation, as they have a high burden of disease and few, if any, treatment options.” Press release