SCOPE 2023: Concerns for Clinical Operations Professionals in 2023

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Dr. Hanne Bak, Senior Vice President of Preclinical Manufacturing and Process Development at Regeneron speaks about her role at the company as well as their work with monoclonal antibodies, the regulatory side of manufacturing, and more.

At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.

AI as an accelerator for data-centric, process-centric, and human-centric clinical research.

Peter Ronco, CEO, Emmes, shares his long-term vision for artificial intelligence in clinical research, from making automation routine to improving drug discovery, transforming regulatory oversight, reducing animal testing, and promoting ethical, equitable data use worldwide.

Navigating a complex drug development landscape, sponsors must rethink their approach to risk in study design and execution.