Saama has appointed Bhaskar Sambasivan as Chief Executive Officer. Sambasivan succeeds Vivek Sharma, who is stepping down from his role for personal reasons after having successfully guided the company through a period of growth and expansion. As Saama CEO, Bhaskar will oversee the continued growth of the business as well as innovation in Saama’s AI-enabled SaaS products and solutions that support the full spectrum of clinical development within the life sciences industry. Bhaskar has also joined the company’s Board of Directors. Press release.   

Medidata and Sanofi Vaccines announced a collaboration to harness Medidata eCOA to deploy in vaccine studies. This builds on Medidata and Sanofi’s longstanding, successful experience using Medidata Rave EDC (electronic data capture). The collaboration will use an eDiary function within eCOA to create an eDiary library specific to Sanofi’s vaccines. This library will accelerate future study set-up times, improve efficiency, and increase data quality, while ensuring patients have access to eDiaries that are easy to use. Press release.   

Cencora PharmaLex has announced the general availability of psiXchange 3.0: the latest release of our software designed specifically to make complex clinical trial safety reporting more efficient and accurate, while reducing cost and effort. Some useful features include: Automation of the end-to-end distribution, tracking, and acknowledgement receipt process for business-critical clinical trial safety documents to Sites, Ethics Committees, Competent Authorities, Notified Bodies, and Institutional Review Boards for any defined country; the embedded psiQ “brain,” a comprehensive PV regulatory intelligence database actively updated by our global team of experienced PV experts and configurable with your own regulatory intelligence – making up-to-date clinical trial safety reporting expertise available at your fingertips for 55 countries, with more being added on a regular basis; and a user-friendly smart portal, supporting day-to-day business for recipients and enabling the viewing, downloading, and acknowledging of safety reports and overview of relevant safety information per study and site in real time – letting teams proactively manage receipt acknowledgements and oversee distribution from a central “source of truth”. Press release. 

Wasatch Biolabs launched a proprietary Targeted DNA Methylation Sequencing Service for researchers and clinical service providers. The technique is amplification and bisulfite conversion free, effectively bypassing the most common limitations of targeted methylation analysis and enabling WBL to create custom methylation panels that target an unprecedented hundreds-to-thousands of genomic loci of interest with an enrichment of 400-2300x. Press release. 

Biofourmis has entered four new agreements with top pharmaceutical companies, driven by Biofourmis' proven leadership and expertise in digital biomarker development and the strength of its comprehensive, device- and location-agnostic clinical trial solution. The new engagements focus on oncology therapies, further expanding Biofourmis' already diverse therapeutic portfolio that includes cardiovascular, pain, women's health, and immunology. Centered on developing digital biomarkers and safety monitoring algorithms, with a specific focus on cytokine release syndrome (CRS) detection, the oncology programs leverage cutting-edge data science and technology to enhance remote data collection, patient monitoring, and safety. Press release. 

DNAnexus and LORENZ Life Sciences Group have partnered to offer Trusted Regulatory Spaces—secure, cloud-native environments that improve the submission validation process and ease of sponsor-reviewer communication for human drug and biologics applications to health authorities. The engagement is highlighted by Project PRISM, a research collaboration between Industry and the U.S. Food and Drug Administration (FDA) to demonstrate the feasibility of collaborative regulatory submission validation and scientific review utilizing LORENZ’s eValidator solution deployed on precisionFDA, FDA’s production cloud platform built and powered by DNAnexus for multi-omics and real-world data regulatory science and review. The joint offering leverages in-production solutions that already meet the most stringent security, privacy, and data residency requirements and have been adopted by many leading global health authorities and life sciences organizations. Press release. 

Owkin announced it is working with Amazon Web Services (AWS) to transform drug discovery, de-risk and accelerate clinical trials, and develop AI diagnostics. Owkin will leverage AWS’s proven global infrastructure and secure, extensive, and reliable cloud platform to enhance data operations, optimize for operational excellence, and drive forward research in precision medicine. Press release. 

H1 has launched GenosAI Pro, a new addition to its conversational AI toolkit. Accessed inside of H1’s Trial Landscape platform, this next-generation tool transforms text and data into visual insights and actionable deliverables that help feasibility teams prepare diversity plans, healthcare provider and site biobooks, and presentation slides for trial design meetings or diversity plan development sessions. The system is built on OpenAI ChatGPT Enterprise, keeping data private and secure while delivering the most powerful conversational AI tool available to pharmaceutical companies, streamlining workflows, improving data-driven decision making, and ultimately optimizing clinical trial processes. Press release. 

The Innovation and Value Initiative (IVI), in partnership with the EveryLife Foundation for Rare Diseases, released a report, “Valuing Rare Disease Treatments in Healthcare: Real Experience, Real Impact,” as part of IVI’s Rare Disease Initiative. This effort was made possible through funding support from the Eugene Washington PCORI Engagement Awards Program, an initiative of the Patient-Centered Outcomes Research Institute (PCORI), and Alexion, AstraZeneca Rare Disease. This project explored common patient-centered outcomes across rare diseases, identified evidence gaps, and built consensus on addressing unique research challenges. Press release. 

Phesi has announced it has reached a critical milestone, with its AI-driven Trial Accelerator Platform now containing global data from more than 100 million patients. This unparalleled volume of data will allow sponsors to access data on patients with more than 4,000 indications, plan more successful trials, and simulate clinical development activity with a high degree of accuracy. Press release. 

Trialbee has announced its Omnichannel Network partnership with Massive Bio to help better connect cancer patients and their oncologists/hematologists to clinical trials. Both organizations share similar approaches to recruitment for cancer trials with an emphasis on patient-centered research coupled with total transparency to ensure sites have the information they need to follow-up with interested study candidates. Press release.