By Clinical Research Team 

January 28, 2025 | A new UTHealth Houston project plans to engage community partners to improve the design of clinical trials; Advarra releases a Study Collaboration solution; 23andMe launches new clinical research product; more.

23andMe Holding Co. has launched Discover23, a new research offering enabling authorized collaborators to securely access the power and diversity of the 23andMe research cohort through a Trusted Research Environment (TRE) developed by Lifebit. Discover23 provides analysis-ready genome-wide association studies (GWAS) conducted on 1000+ disease and condition cohorts curated from 4.7B phenotypic data points by 23andMe’s expert scientists. Biopharma collaborators will be able to access summarized results of analyses conducted using data stripped of personal identifiers within 23andMe’s TRE, where authorized researchers are provided with highly secure, isolated workspaces to leverage 23andMe research findings while ensuring the protection of participant privacy. Press release.   

Clinigen has announced a strategic partnership with Tepsivo, a pioneering global digital Pharmacovigilance (PV) services provider.  As part of the partnership, Clinigen has acquired a minority stake in Tepsivo. At the heart of Tepsivo’s offering is its cutting-edge PV platform and proprietary automated PV software powered by artificial intelligence and other digital innovations. The complete PV solution has been designed as a single integrated platform, and leverages Tepsivo’s established global network and central coordination to provide a more cost-effective, modern, and efficient approach in managing global PV systems. Tepsivo helps pharmaceutical and biotechnology clients across multiple regions to improve compliance and optimize pharmacovigilance operations. Press release.  

Cancer Research UK, Cytovation and the Norwegian Cancer Society have signed an agreement to bring Cytovation’s lead asset, CY-101, into a multi-national Phase 2 clinical trial for patients with adrenocortical carcinoma (ACC). This rare and aggressive cancer, which affects the adrenal glands, has limited treatment options and an urgent need for new therapies. Under the agreement, Cancer Research UK’s Centre for Drug Development (CDD) will sponsor, design and deliver the Phase 2 trial and Cytovation will be responsible for providing CY-101 for the clinical trial. Cancer Research Horizons, Cancer Research UK’s innovation arm, will manage the commercial relationship between the three parties. The Norwegian Cancer Society’s support provides access to the additional resources, patients and sites required for trials in rare diseases. Due to the rarity of ACC, the clinical trial will run across multiple sites in the UK and Europe, to ensure robust patient recruitment. Press release.  

The U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s supplemental New Drug Application (sNDA) for SPRAVATO (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. MDD is one of the most common psychiatric disorders, with an estimated 21 million adults in the U.S. living with the disease. This approval, which was granted following FDA Priority Review, is supported by positive results from the randomized, double-blind, multicenter, placebo-controlled study in which SPRAVATO alone showed a rapid and superior improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score vs. Placebo. Press release.   

In an effort to close the gap in neurological outcomes for underserved populations, a UTHealth Houston project funded with $2.9 million from the National Institutes of Health (NIH) will engage community partners to improve the design of clinical trials. Neurologic conditions including stroke, Parkinson’s disease, and vascular cognitive impairment and dementia contribute to the leading causes of death and disability in the U.S. The goal of the project is to build an infrastructure for community-engaged research interventions for those three neurologic conditions affecting brain health. The project will establish a Brain Health Equity Collaborative to facilitate the academic and community partnerships for clinical trial development. The collaborative will include a community advisory board to review consent forms, assessment questions, and other components of a research trial to ensure they are relatable to a wide range of patients. A community oversight committee will ensure that patient and caregiver voices are being heard and that trials are adhering to protocols for community engagement. Press release  

Advarra has released its Study Collaboration solution to accelerate study startup by automating workflows, improving real-time visibility, and fostering seamless collaboration and engagement among research stakeholders. The new offering combines the Longboat technology acquired by Advarra in 2020, which now has over 225,000 users, with Advarra's study startup delivery program and industry-adopted single sign-on capabilities. The Advarra Study Collaboration solution is provided by clinical trial sponsors and CROs to research sites to enable seamless collaboration on critical processes such as feasibility assessments, document exchange, site training, milestone tracking, and enrollment planning to shorten the time from site selection to recruitment. The solution includes two products, Advarra Study Startup (SSU) and Advarra Enroll, which work seamlessly together to guide study teams through the site activation process and improve enrollment planning and tracking during study startup and throughout trial conduct. The solution is supported by a multi-year technology investment aimed at further improving site activation speed and compliance. Press release.   

Diaceutics and Cornerstone AI have launcheda strategic partnership to enhance the accuracy, completeness and usability of data from the DXRX laboratory network. The collaboration integrates Cornerstone AI's proprietary lab data algorithms with Diaceutics' real-world data ecosystem, generating LOINC assignments to deliver faster, more accurate, and clinically meaningful insights. Laboratory data, often disjointed and inconsistent, remains a major hurdle in implementing precision medicine initiatives. By combining Cornerstone AI's advanced data quality and enhancement technology with Diaceutics' expertise in real-world data, the partnership addresses this challenge head-on improving overall data integrity. These advancements offer pharmaceutical, biotech, and diagnostics companies a stronger foundation for clinical development, faster market access, and better patient outcomes—delivering significant value across the healthcare ecosystem. Press release.  

H1 has acquired Ribbon Health, advancing its mission by fueling its expansion into the health plan, provider system, and digital health sectors. Ribbon Health’s platform will join the H1 family of products as H1 for Health Plans & Digital Health, providing insurers, providers, and digital health companies alike with accurate, real-time provider data. The products it has unveiled are: H1 for Medical, which helps medical affairs teams identify and engage Key Opinion Leaders (KOLs) to promote adherence to evidence-based medicine; H1 for Clinical, which supports clinical teams in identifying sites, principal investigators (PIs), and participants while advancing diversity, equity, and inclusion in the trial process; and H1 for Commercial, which accelerates patient access by facilitating the development and successful launch of new medical therapies and technologies. Press release.