Decentralized Trials & Research Alliance Grows, Partnerships in Site Conduct, Trial Diversity, More

October 7, 2021 | Decentralized trials around the world; partnerships with Eli Lilly, Great Ormond Street Hospital for Children, UNC Chapel Hill, Bristol Myers Squibb; and mergers and acquisitions. Plus: new products from Sensyne Health, Egnyte, and more.

BEKHealth has announced the introduction of Galileo, what they believe is the most advanced trial and research network level feasibility solution. Galileo enables research networks to accurately and efficiently evaluate clinical trial protocols in a standardized way across all locations. Galileo is the latest in BEKHealth’s expanding portfolio of solutions designed to automate and streamline clinical research processes and improve business performance. By providing real-time visibility across a system’s entire patient network, users can expand the number of trials they perform and the access in underserved locations. Galileo is the first tool that can be used by any health care professional to rapidly, comprehensively, and accurately determine if a research network location is suitable for a clinical research trial protocol in a matter of hours. It provides organizations who are seeking to expand research the ability to proactively evaluate untapped disease states and work more collaboratively with sponsors. Press release.

ObvioHealth, a global Virtual Research Organization (VRO), has launched a clinical trial in Australia, using a combination of in-home data collection methods that will reduce, and in some cases, eliminate the need for follow-up visits to clinics. The randomized, double-blind, placebo-controlled trial with Anatara Lifesciences will evaluate the safety and efficacy of a Gastrointestinal Re-Programming complementary medicine (GaRP) for participants with irritable bowel syndrome—diarrhea subtype (IBS-D). Patients will report the severity of IBS-D symptoms and anticipated relief, quality of life, treatment adherence and changes in health status through ObvioHealth’s easy-to-use smartphone application. All data from the app flows into the ObvioHealth platform, where it is monitored in real time, allowing the study team to quickly detect possible adverse events and issues with protocol adherence. Clinical assessments will be performed during in-home visits by a study nurse to measure vitals and perform sample-collection. Patients who wish to be assessed at a clinic will have access to a research center nearest them during the treatment period. The unique study design and use of ObvioHealth’s technology for virtual data capture removes barriers to recruitment, allowing enrollment to occur anywhere in Australia, even rural areas, and diversifying the study population. Press release.

Curavit Clinical Research, a virtual contract research organization (VCRO) that designs and executes decentralized clinical trials (DCTs), announced today that it has joined the Decentralized Trials & Research Alliance (DTRA) to further the advancement and adoption of decentralized clinicals. Curavit Clinical Research has also announced the appointments of Jay Collier, as chief operating officer (COO), and Candice Del Rio, as director of clinical operations. The company also expanded its sales team with the hiring of Chris O’Shaughnessy, as vice president of business development, as well as Troy Hall and Bill Dreyer, as directors of business development. The expansion comes as DCTs continue their steady growth, punctuated by Curavit’s doubling its revenue since 2020. Press release

Elligo Health Research has acquired ClinEdge, a research practice management and clinical services organization for clinical research sites, pharma companies, and clinical research organizations. The transaction includes GuideStar Research and BTC of New Bedford. ClinEdge delivers best-in-class site conduct and patient access solutions through highly differentiated trial acceleration strategies for clinical study programs. The integration of Elligo and ClinEdge presents an unprecedented opportunity for technology to eliminate long-standing trial conduct pitfalls and bottlenecks that primarily impact patients’ service, accelerate research by supporting sites, improve the patient experience, and make research more accessible. The transaction of $135 million was funded through new co-lead investors Morgan Stanley Expansion Capital (MSEC) and Ally Bridge, along with participation from Norwest Venture Partners and existing investors. Press release.

ViroCell Biologics and Great Ormond Street Hospital for Children NHS Foundation Trust (“GOSH”), a world leading children’s hospital, have announced a new partnership that will immediately address the global viral vector manufacturing bottleneck for clinical trials. ViroCell, a Contract Development and Manufacturing Organization (“CDMO”), is addressing the global viral vector supply demand imbalance that constrains the manufacture of novel cell and gene therapies. As part of the partnership with GOSH, ViroCell will more than double the UK’s lentivirus vector manufacturing capacity for clinical trials in 2022 and secure the coveted position as the first UK CDMO to be able to deliver AAV vectors to the cell and gene therapy (“CGT”) markets. The production of the vectors will take place in GOSH’s Zayed Centre for Research into Rare Disease in Children. The ViroCell team’s track record of manufacturing more than one hundred viral vectors for clinical trials over the last 20 years coupled with the Zayed Centre for Research’s state-of-the-art clean room suites will enable ViroCell and GOSH to dislodge the logjam that currently prevents promising, novel cell and gene therapies from entering clinical trials. Press release.

Eyevensys has entered into strategic engagements with US-based medical device manufacturers Phillips-Medisize and Minnetronix Medical to develop the next generation of the company’s core technology. Eyevensys has developed a non-viral gene therapy ocular drug delivery platform with a proprietary Electrotransfection System designed to deliver DNA plasmids encoding therapeutic proteins into the ciliary muscle and sustainably treat major eye diseases. Both components of the Electrotransfection System, the electrical pulse generator and the ocular device, are included in the multi-year engagements established with Eyevensys. Eyevensys has embarked on the development of a new generation of system devices focusing on optimizing their ease-of-use and manufacturability. Phillips-Medisize will be responsible for Ocular Device design optimization and the high-volume manufacturing capability to support the commercial launch, and Minnetronix Medical will fulfill the same responsibilities for the Pulse Generator component. Work at both contract manufacturers has been initiated. Press release.

NervGen Pharma Corp., a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, has announced a partnership with Imeka Solutions, currently the only neuroimaging company that combines artificial intelligence and diffusion imaging to obtain high resolution images of white matter in the brain. NervGen intends to utilize Imeka’s imaging technology as a sensitive pharmacodynamic biomarker for its lead compound, NVG-291, in its Phase 1b/2 clinical trials. Additionally, the companies are submitting non-dilutive grants that support combining their technologies in preclinical and clinical studies for various conditions related to central nervous system damage. Press release.

UK Biobank, a large-scale biomedical database and research resource, has launched a uniquely powerful and innovative research platform that allows approved researchers to access and analyze the entire UK Biobank database securely, in the cloud, from anywhere in the world. It is designed to accommodate the vast and increasing scale of genomics and healthcare data pertaining to UK Biobank’s 500,000 participants. This new Research Analysis Platform (RAP), enabled by DNAnexus and powered by Amazon Web Services (AWS), exponentially increases the scale and accessibility of the world’s largest and most comprehensive biomedical database for researchers around the world to advance understanding of human disease. While the growth of the UK Biobank resource has created an unparalleled opportunity for medical research there have been some limitations with collating, storing, and accessing data at this scale. The new cloud-based platform removes these barriers and will accelerate both the speed and scale of health-related research. Press release.

Care Access, the world’s leading decentralized research organization (DRO), has expanded its partnership with global biopharma leader Eli Lilly and Company (Lilly) to broaden patient access to clinical trials and increase representation of minority group members, including African American, Hispanic, and LatinX populations. Lilly has tapped Care Access in its phase III breast cancer clinical trial, eMonarcHER, designed to evaluate the safety and efficacy of Abemaciclib (LY2835219) in participants with hormone receptor positive and human epidermal receptor 2 positive, high risk, early breast cancer who are taking hormone therapy after surgery. Oncology clinical trials have historically under-enrolled minority group members due to geographical barriers, cultural differences, and a persistent distrust in health care. To increase enrollment, particularly of black women, Care Access will use its dedicated Patient Access team to establish and foster local community partners including health care systems, physician groups, diversity-focused groups, advocacy groups, and community centers that serve underrepresented minority populations. Building on its work with Lilly through highly successful COVID-19 trials, Care Access will take a three-pronged approach: first, Care Access will create partnerships with surgical and medical oncologists in underrepresented minority groups to serve as PIs for the trial, helping set up and run a research program within their oncology practice. This lessens the administrative or regulatory burdens on physicians that come with running a research program. Second, Care Access will establish community-based partnerships through its Patient Access team to better reach trial gatekeepers and patients. Third, Care Access will educate patients through its Patient Education team so they can make informed decisions on whether to participate in the trial based on their medical needs. Press release.

Exact Sciences has entered into a collaboration agreement with the National Surgical Adjuvant Breast and Bowel Project (NSABP), a cooperative group founded by the National Cancer Institute (NCI). Working together, Exact Sciences and the NSABP plan to conduct a prospective, multicenter validation study with stage II and III colorectal cancer (CRC) patients, demonstrating the ability of Exact Sciences' ctDNA test to detect MRD. The study, called CORRECT-MRD II, is expected to enroll approximately 750 patients at 35 study sites in the U.S. and Canada and is part of Exact Sciences' global initiative to generate clinical validation data for its tumor-informed MRD liquid biopsy test. Press release.

SAS and the University of North Carolina at Chapel Hill are teaming up to transform the drug development process to prevent infectious disease threats from turning into a pandemic like COVID-19. The partnership is focused on the work of the University’s Rapidly Emerging Antiviral Drug Development Initiative (READDI) which is developing broad spectrum antiviral drugs to have on the shelf to prevent future pandemics. To advance their work, SAS research and development teams are applying advanced machine learning techniques to integrate multiple biological data sets from the deep lung environment of severely ill COVID-19 patients. These analyses will be used by Carolina researchers to identify targets for new COVID-19 antiviral drugs. While the initial focus of the joint team is on addressing new treatments for COVID-19, READDI and SAS will continue to work together to meaningfully accelerate drug discovery for other antiviral drugs. Press release.

COMPASS Pathways, a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has acquired an intellectual property (IP) portfolio including patent applications covering a variety of psychedelic and empathogenic substances. The IP was developed together with inventor Matthias Grill PhD, founder and CEO of MiHKAL GmbH in Basel, Switzerland, who will be working with COMPASS on an exclusive research project to develop new product candidates. The substances covered in the IP portfolio include a variety of psychedelic and empathogenic compounds, some of which are prodrugs—pharmacologically inactive compounds which are metabolized inside the body to produce an active drug. The new substances include novel derivatives of known compounds, increasing the confidence in therapeutic effects and safety profile while offering optimized characteristics. Press release.

Cresset Discovery Services is collaborating with the University of Newcastle, Australia, to focus on drug reprofiling against oncology targets. The work will build on research led by award-winning molecular biologist, Associate Professor Nikola Bowden. Nikola is co-Director of the Centre for Drug Repurposing and Medicines Research and leads the DNA repair group. The overall aim of her research is to deliver personalized diagnosis and treatment to cancer patients, with a focus on DNA repair and drug repurposing in melanoma and ovarian cancer. Repurposing existing drugs offers a promising solution to cancer patients in need of more immediate treatment. Having prior knowledge of a drug’s safety, dosing and side effects can significantly shorten research and development timelines. Press release.

Sensyne Health has launched SENSIGHT, an AI enabled global data analytics platform for the healthcare and life sciences sectors. SENSIGHT is built on a rapidly growing deep and broad set of anonymized and de-identified patient data derived from the research partnerships Sensyne has entered into with NHS Trusts and US health systems that currently covers 22.5 million patients across a range of disease areas. The power and affordability of the SENSIGHT platform represents a disruptive shift in how the life science and healthcare communities will access and leverage clinical data insights, collaborate with their colleagues, and advance the state of care and discovery. The platform provides clinicians, research academics and life science professionals with an instant AI research capability to analyze health insights across a curated common data environment, underpinned and protected by a rigorous information governance and security framework. No direct patient data is, or ever will be, shared on SENSIGHT. The platform instead rapidly interrogates Sensyne’s deep diverse datasets and delivers intelligent analytics and data-driven insights, not the data itself. Subscribers will be screened to ensure legitimate interest, with only those in accredited companies and organizations being accepted. Researchers can communicate and collaborate with each other on the platform, creating a virtual scientific research network that connects professionals across the healthcare and life sciences industries creating a community with common interests in particular research fields or areas of unmet medical need. Press release.

Egnyte has announced Egnyte for Life Sciences eTMF, a new product to manage trial master file data for the clinical development functions at life sciences companies. Egnyte for Life Sciences eTMF is a 21 CFR Part 11 compliant solution that reduces document processing time while maintaining compliance and audit readiness. With Egnyte for Life Sciences eTMF, clinical development professionals can easily create an eTMF to manage the thousands of documents collected through a trial and ensure those documents are properly stored and managed so they’re audit-ready. The product can also apply automation and artificial intelligence to monitor misindexed documents and sensitive personal information and to protect against potential ransomware attacks. Egnyte for Life Sciences eTMF solution enables clinical development professionals to stay on track with milestones, maintain control of trial information, be audit-ready and compliant, and accelerate TMF creation. Press release.

Medidata, a Dassault Systèmes company, and Labcorp Drug Development have entered into an agreement using the Medidata Sensor Cloud. Medidata will receive and process medical-grade sensor data within drug, vaccine, and device trials across Labcorp Drug Development’s clinical trial portfolio, enhancing their decentralized clinical trial (DCT) offerings. Sensor Cloud is a transformative platform for managing a broad range of sensor and digital health technology data and establishing interoperability with other clinical data sources. Launched earlier this year, Sensor Cloud integrates seamlessly with the Medidata Clinical Cloud and supports remote, continuous patient data collection from both Medidata and third-party, medical-grade sensors. In addition, Labcorp and Medidata will use Sensor Cloud to co-develop digital biomarkers across a broad array of medical devices and therapeutic areas. The goal of this first-of-its-kind collaboration is to build a library of digital biomarkers that can be used to advance therapeutic research and create new, digital diagnostics. The first project will be an at-home version of the Six Minute Walk Test (6MWT), which is widely used in clinics to measure functional capacity in patients with heart failure, pulmonary conditions, physical function disorders and rare diseases. Press release.

CG Oncology has announced a clinical trial collaboration to evaluate the safety and efficacy of CG0070, an oncolytic immunotherapy, in combination with OPDIVO (nivolumab), Bristol Myers Squibb’s anti-PD-1 therapy, for the treatment of metastatic urothelial cancer in a Phase 1/2 clinical study. CG0070, CG Oncology's lead immuno-oncology candidate, is in an ongoing Phase 3 monotherapy study and has been administered in over 100 patients to date for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). CG0070 is based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroying various cancer cells, including bladder tumor cells, through their defective retinoblastoma (Rb) pathway. Press release.

Medrio and PHASTAR have partnered to leverage metadata surrounding electronic patient-reported outcomes (ePRO) for advanced data visualization, providing insight into patient compliance and burden. PHASTAR ran a pilot with 33 volunteers completing EQ-5D, a health-related measure of quality-of-life questionnaire, to understand how metadata may be used effectively to monitor ePRO data collection during a study. The PHASTAR team used Medrio ePRO for initial data collection and Medrio’s Export API to funnel the ePRO and metadata into PHASTAR’s data visualization tool, PHIZUAL. Press release.