SCOPE 2023: Concerns for Clinical Operations Professionals in 2023

Overcoming the illusion of knowledge in clinical research can enhance decision-making, training, and project success—helping ensure trials run smoothly and effectively.

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.

Case study highlights how clinical operations teams can overcome complex regulatory and operational hurdles to finish a trial on time and on budget.

Interim results from the global MATTERHORN study mark the first time an immunotherapy has demonstrated statistically significant event-free survival in a Phase III trial for resectable gastric and gastroesophageal junction cancers, signaling a potential shift in standard perioperative care.

In the Phase III IMforte trial, Tecentriq (atezolizumab) and Zepzelca (lurbinectedin) reduced the risk of disease progression or death by 46% as a first-line maintenance therapy for patients with extensive-stage small cell lung cancer.

Phase III data presented at ASCO 2025 and published in The New England Journal of Medicine show that Pfizer’s Braftovi (encorafenib), combined with Erbitux (cetuximab) and mFOLFOX6, significantly improves overall survival and progression-free survival in treatment-naïve patients with BRAF V600E-mutant metastatic colorectal cancer—potentially establishing a new first-line standard-of-care for this high-risk population.