May 27, 2020 | May was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from NHS, Deep Lens, SDL, and more.

NHS patients will benefit from easier access to clinical research opportunities, following a £7 million (roughly $8,575,945) government investment to launch five new regional Patient Recruitment Centers (PRCs) across England. The five new centers are distributed across the country to provide opportunities for patients in regions across England who may not previously have been able to take part in cutting edge clinical studies. The centers will be managed by the National Institute for Health Research (NIHR) and run by NHS trusts. They will provide dedicated space, purpose-designed facilities and medical expertise to deliver clinical research within NHS hospital sites, with the aim of increasing the number of studies being run across England. The centers will increase the NHS’s capacity to deliver vital research for patients, while decreasing the time it takes to set-up late-phase commercial trials within the NHS - improving the UK’s competitiveness in the global market and providing opportunities for patients to benefit from early access to innovation. Press release

Deep Lens has integrated proprietary molecular data parsing and management technology into the company’s award-winning clinical trial screening and enrollment platform, VIPER. This breakthrough integration will enable cancer care teams, clinical trial sponsors, and trial coordinators to immediately and automatically match patients based on the genetic profile of their cancers to the best precision therapies and oncology clinical trials. The company worked with the University of Miami Office of Technology Transfer to exclusively license the technology. A team from Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, and UHealth Information Technology developed an engine to leverage new ways of consuming and normalizing molecular genetic test results from companies, such as Caris Life Sciences, Foundation Medicine, Guardant Health, NeoGenomics, Tempus, and more, to automate and expedite the patient screening process. “Our office facilitates transfer of university innovations for the benefit of the university community and the public,” said Bin Yan, Director of the Office of Technology Transfer, in a press release. “So, it was a natural fit to work with Deep Lens and integrate our two differentiated technologies to solve a real problem in clinical trial recruitment: limited time and resources for physicians and care teams.” Press release

MMS Holdings announced that a successful collaboration with Shanghai-based Green Valley Pharmaceutical resulted in gaining U.S. Food & Drug Administration (FDA) approval of an Investigational New Drug (IND) application for the GV-971 international multi-center Phase 3 clinical study in the treatment of patients with Alzheimer’s disease. GV-971 is an orally administered mixture of acidic linear oligosaccharides derived from marine brown algae. Preclinical studies on its mechanism of action show that GV-971 improved the cognitive function by inhibiting neuroinflammation via targeting dysbiosis of gut microbiota in AD transgenic mouse models. In a completed 36-week Phase 3 clinical trial conducted in China, GV-971 showed a rapid initial gains in cognition with sustained improvement across over the study in mild-to-moderate Alzheimer’s patients that was statistically significant comparing to the placebo. Green Valley’s novel therapy was approved by the National Medical Products Administration (NMPA) and launched in China last year. Building on Green Valley’s successful application for GV-971 as the first Alzheimer’s drug approved in China in 17 years, MMS and Green Valley partnered closely to support an additional Phase 3 study and development plan to meet the requirements of US regulations. Press release

SDL announced it has advanced its partnership level with Veeva Systems. SDL Translation Management System (TMS) is integrated with the Veeva Vault RIM Suite, a cloud-based Regulatory Information Management (RIM) system. The combination of SDL’s network of in-house certified medical translators with SDL’s translation management technology provides a fully-integrated set of translation capabilities within Veeva Vault RIM. This integration enables Veeva Vault RIM customers to automate multilingual tasks relating to regulatory document submissions, engagement with health authorities and product registration. As a result, customers can increase speed to market for new medical products, and minimize errors and inconsistencies attributed to manual translation processes. “Any biopharmaceutical company looking to market a product internationally has to provide and maintain local in-language versions of their medicinal product information and corresponding communications with the various health authorities,” Christophe Djaouani, EVP at SDL, said in a press release. “It’s an incredibly complex task. Our partnership with Veeva helps organizations overcome these challenges by integrating rapid, secure translation capabilities within their existing regulatory information management system.” Press release

Transparency Life Sciences (TLS) announced the debut of a novel patient-centric protocol builder for clinical trials called Transparency Protocol Crowdsourcing (TPC). A combination of technology and service, TPC engages patients, physicians, and researchers to contribute to the setup and design of trials using a proprietary online survey tool. The results are then analyzed using AI-enabled natural language processing and TLS’ proprietary advanced analytic tools to help sponsors draft protocols more relevant to patient needs and clinical practice. The technology, once implemented, can also help understand patient behavior utilizing historical data thereby enhancing engagement. “People are becoming more involved with their health care choices and have always been motivated to enroll in clinical trials to help find new treatment options that will benefit everyone, so it’s only appropriate that trial sponsors incorporate a diversity of patient voices and rethink their approach to protocols, design and other parts of the trial that could benefit from patient input,” said Harry Glorikian, chief executive officer of Transparency Life Sciences, in a press release. “By using a tool like TPC, The pharma and biotech companies gain capabilities to help speed up the process while satisfying key guidelines and reducing the overall trial cost.” Transparency Life Sciences recently received two grants from AWS - the first as part of the Activate Founders and the other from the Jumpstart program. Both programs offer TLS the opportunity to accelerate its broader development activities of bringing unique digital tools to the world of clinical trials. Press release

FairJourney Biologics and Iontas announced the combination of their operations to create an international platform and provide their industry leading services to global biopharma. The Group will offer antibody discovery and engineering services using both phage and mammalian display technologies and fully validated immune and naïve libraries, continuing to operate from labs in Porto, Portugal and in Cambridge, UK. The combination enables antibodies to be identified without the need for additional optimization, thereby reducing the risk of delays during development and subsequent scale up to manufacturing. The transaction has been facilitated by investment from GHO Capital, the European specialist investor in healthcare, in support of FairJourney’s strategy to broaden its service offering and geographic footprint to better serve an international client base. Press release