Andy Studna, Senior Editor

DeOliveira, senior director, global regulatory operations, Cerevel (now part of AbbVie) highlights her experience in regulatory operations and how to address increased oversight from regulators.

In a fireside chat with ACT editor Andy Studna, Burks, vice president, site solutions highlights her career path and streamlining workflows between sites and sponsors.

Across two clinical trials in the QWINT program, efsitora showed non-inferior A1C reduction compared to other frequently used daily insulins.

Latest version offers a streamlined site-centric experience to simplify relationships with study sponsors.

Aixial, a contract research organization, will migrate data onto the Medidata Platform to streamline access.

Latest Phase II data of Valneva and Pfizer’s VLA15 are consistent with those reported following the first booster dose.

In the final part of this video interview, Jim Murphy, CEO of Greenphire discusses the role of artificial intelligence, using trusted data, and simplifying protocols.

First FDA submission of nipocalimab is based on positive results from the Phase III Vivacity-MG3 program.

In part 4 of this video interview, Jim Murphy, CEO of Greenphire highlights some trends he is currently seeing such as travel reimbursement and minimizing out of pocket costs.

The Phase III V-MONO clinical trial met its primary endpoints, demonstrating Leqvio (inclisiran) monotherapy as superior to placebo and ezetimibe.

In part 3 of this video interview, Jim Murphy, CEO of Greenphire addresses the increasing complexity of trial protocols and how it is affecting patient access.

In part 2 of this video interview, Jim Murphy, CEO of Greenphire discusses how access to data can impact elements such as budgeting and enrollment.

The clinical program consists of two studies, MELODY-2 and MELODY-3, from which results are expected in Q4 2025.

In the first part of this video interview, Jim Murphy, CEO of Greenphire touches on how changing trends in enrollment are creating obstacles with modeling costs.

First-in-class option to reduce frequency and severity of VMS due to menopause will now be evaluated in women with breast cancer receiving adjuvant endocrine therapy.

Observational cohort study evaluated nearly 900 school-age children to identify how these symptoms vary by age and how they can assist in future research of long COVID.

New vaccine is tailored to the KP.2 strain, based on regulatory guidance for upcoming fall and winter season.

Trial will evaluate Galapagos’ GLPG5101, an autologous CD19 CAR-T cell therapy product candidate.

In the third and final part of this conversation, Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara sheds light on industry collaboration and what elements of trial design have the greatest impact on diversity.

The pivotal Phase III OASIS 1 and 2 studies both met all primary endpoints with elinzanetan reducing symptoms over 12 weeks compared to placebo.

In part 2 of this conversation, Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses the guidance and how it will affect sponsors moving forward.

In part 1 of this video interview, Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara highlights how IROs are bringing care directly to patients and making them feel more comfortable.

Approval is based off results from the Phase III MARIPOSA study, which showed Rybrevant in cominbation with Lazcluze reduced the risk of disease progression or death by 30% versus osimertinib.

Valued up to $100 million, the collaboration will conduct clinical trials over a five-year period with the goal of strengthening decentralized models.

In the fifth and final part of this video interview, Melissa Easy, VP commercial, digital products & solutions, IQVIA shares what excites her most about the future of clinical technology.

Incyte’s Monjuvi (tafasitamab) met its primary endpoint of progression free survival in the study.

In part 4 of this video interview, Melissa Easy, VP commercial, digital products & solutions, IQVIA highlights how the regulators are addressing new technology with updated guidances.

In part 3 of this video interview, Melissa Easy, VP commercial, digital products & solutions, IQVIA touches on how the right technology for your study should alleviate site burden and improve data quality.

In part 2 of this video interview, Melissa Easy, VP commercial, digital products & solutions, IQVIA discusses how advancements in technology are creating challenges with integration and how they can be addressed.

In part 1 of this video interview, Melissa Easy, VP commercial, digital products & solutions, IQVIA highlights how patients, sites, and sponsors can benefit from recent advancements such as AI and LLMs.