Merck's Approach to Protocol Development, Abbvie on DHTs - CTV Newsletter

CONFERENCE COVERAGE

At the?2024 SCOPE Summit, Laura Galuchie , Senior Director and TransCelerate BioPharma Inc. Program Lead at 默克 provided a fresh perspective on the future of clinical trials. Her session, centered around strategic protocol development, likened the process to crafting a narrative, reminding us that every good story, or in this case, every effective protocol, starts with a fundamental idea.

At the?2024 SCOPE Summit, AbbVie ’s Digital Science Head, Michelle Crouthamel DBA , presented compelling case studies on Aleve PM and Bellerophon Therapeutics, demonstrating the transformative power of Digital Health Technologies (DHTs) in clinical trials. Her insights highlighted DHT’s role in enhancing research efficiency and the necessity for standardized industry metrics to evaluate their impact at Abbvie.

At the?2023 Medidata NEXT conference, prominent figures like Michelle Hartman from South Broward Research, Adam Kinsey from Merck, Michael Buckley from Memorial Sloan Kettering Cancer Center, and Jimmy Bechtel from the Society for Clinical Research Sites (SCRS) gathered to discuss the evolving landscape of the latest?clinical trial tech.

EXECUTIVE INTERVIEWS & ARTICLES

In the rapidly evolving landscape of digital health technology in clinical trials (DHT), Jeremy Wyatt tt, CEO of?ActiGraph, envisions a transformative future. ActiGraph’s strategic focus extends to leveraging wearable DHTs for more precise passive data collection from clinical trial participants to post-marketing surveillance and real-world evidence data collection, enhancing patient care across the clinical research landscape.?

PathAI emerges as an enterprise transforming clinical trials with groundbreaking precision in the dynamic field of AI-driven pathology. Ben Glass, VP of Product and Translational Research, and Saumya Pant, Vice President of Clinical Development Services and Biopharma Laboratory, discuss how PathAI’s innovative use of AI in pathology is not just enhancing the accuracy of diagnoses but reshaping the entire clinical trial process.?

In an engaging interview with Kerri Weingard, co-founder of Verified Clinical Trials (VCT), the conversation delves into the innovative solutions devised by VCT to combat the issue of duplicate participant enrollments in clinical trials. Weingard shares insights into VCT's comprehensive database and technology system designed to ensure the integrity of clinical trial data and the safety of participants. Highlighting the importance of early detection and prevention of duplicate participation, she also discusses VCT's commitment to patient privacy, adherence to global data protection regulations, and future plans for enhancing clinical trial management through advanced technology.

CLINICAL TRIAL NEWS

The European Commission (EC) has expanded approval of Reblozyl (luspatercept), a first-in-class treatment for patients with disease-related anemia, for the first-line treatment of adult patients with anemia due to very low to intermediate risk myelodysplastic syndromes (MDS).The decision is based on the Phase 3 COMMANDS study which demonstrated that Reblozyl almost doubled the percentage of patients achieving transfusion independence and a higher hemoglobin count.

D&D Pharmatech, a biotech company, has been granted Fast Track designation by the US Food and Drug Administration (FDA) for its DD01 drug, aimed at treating adults with non-alcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH)

Rocket Pharmaceuticals, a late-stage biotechnology company, has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for RP-L102, its gene therapy for Fanconi Anemia (FA). The EMA’s acceptance marks significant progress in the company’s aim to bring this potential treatment to patients affected by this rare genetic disorder.?