REMS Operational Challenges: Considerations in REMS Development and Long-term Management

Addressing data integrity and compliance concerns.

In 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.

The combination demonstrated non-inferiority to comparator antiretroviral therapies, meeting the primary efficacy success criterion in both trials.

Daejin 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.

Icotrokinra met all primary endpoints in the studies, demonstrating significant skin clearance and clinical remission.

A meta-analysis of 11 trials shows that Padcev (enfortumab vedotin-ejfv), both alone and in combination with Keytruda (pembrolizumab), significantly improves response rates and survival outcomes compared to conventional chemotherapy in metastatic urothelial carcinoma.