EU Innovation and Competitiveness
Program Co-Chairs Iman Barilero, Johnson & Johnson PRD, and Marie Dray, International Regulatory Affairs Group USA, opened the first plenary session with introductions, sharing their vision of what the 18th Annual DIA EuroMeeting is all about: continuing themes throughout the meeting, including pediatrics, advanced therapies, technology platform, pharmacovigilance, risk management planning, and the involvement of patient groups.
Program Co-Chairs Iman Barilero, Johnson & Johnson PRD, and Marie Dray, International Regulatory Affairs Group USA, opened the first plenary session with introductions, sharing their vision of what the 18th Annual DIA EuroMeeting is all about: continuing themes throughout the meeting, including pediatrics, advanced therapies, technology platform, pharmacovigilance, risk management planning, and the involvement of patient groups.
Marie Dray mentioned that the EuroMeeting will continue Afssaps, involve patient groups, and develop the European Forum-asking regulators questions and discussing what is optimal regulation. Iman Barilero discussed the overall theme of the current environment for innovation and competitiveness in Europe.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
