TransCelerate Launches Two New Global Initiatives
TransCelerate BioPharma has established two new global initiatives in the clinical trials area. Both initiatives - Placebo / Standard of Care Data Sharing and Electronic Labels for Clinical Trials (e-Labels), are made possible through the collaboration of participating Member Companies.
The Placebo / Standard of Care Data Sharing Initiative is to create a framework for data sharing that allows for the leverage of data from previous studies respecting boundaries of informed consent. It offers the potential for more rapid understanding of safety signals to better manage patient safety during clinical trials, as well as identify statistical techniques that may deliver more accurate study design and statistical power calculations. The platform will be provided to Member Company biostatisticians to hopefully lead to improved protocol development, reduction in protocol amendments and a better understanding of disease models to identify the right targets. The goal is to maximize the value from the data generated from a patient participating in a clinical trial, as well as the R&D investment.
The e-Labels Initiative will support TransCelerate Member Companies in establishing an innovative information channel: Electronic Labels (e-Labels). This initiative will work to enhance label utility for patients, provide more consistent labeling approaches for sites and offers the potential to reduce clinical labeling timelines and provides cost efficiencies for sponsors. The Initiative, in collaboration with Regulatory Agencies, will develop guidance to facilitate implementation of e-Labeling.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
March 31st 2025Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
Phase II ALPACA Trial Shows Lepodisiran Produces Significant, Sustained Lipoprotein(a) Reductions
March 31st 2025Eli Lilly’s lepodisiran, an investigational siRNA therapy, achieved significant and durable reductions in lipoprotein(a) levels, a major genetic risk factor for cardiovascular disease.
