EMA Releases a Reflection Paper on the Role of AI in Drug Development The European Medicines Agency (EMA) has released a reflection paper outlining its thoughts on integrating artificial intelligence (AI) in supporting the progression, oversight, and utilization of human and veterinary medicines. This document covers AI’s application from drug discovery to post-authorization. Part of the HMA-EMA Big Data Steering Group’s efforts, this paper is a collaborative endeavor Read more
Cromos Pharma Contemplates Complex International GMO Research Program Regulations Cromos Pharma has received the groundbreaking approval to conduct the first Genetically Modified Organism (GMO) clinical trial. This pioneering accomplishment not only underscores the company’s commitment to scientific advancement but also prompts a comprehensive reflection of the intricate regulatory landscape governing GMO trials in the US and EU. Initiating the first GMO clinical trial in Read more
Decentralized Clinical Trials: Balancing the Promise and Pitfalls in Cost, Recruitment, and Patient Satisfaction Decentralized clinical trials (DCTs) have emerged as a transformative solution in clinical research, leveraging remote technologies to streamline processes, boost patient satisfaction, and expedite recruitment. However, the potential pitfalls of increased costs and compromised recruitment and patient satisfaction warrant careful consideration by biotech professionals. This synthesis delves into the complex landscape of DCTs, addressing both Read more
Clinical Research Focus. 19th Edition Addressing the Underrepresentation of Older Adults in Cancer Clinical Trials: Advancing Inclusion for Improved Care The underrepresentation of older patients in cancer clinical trials poses a significant concern as it limits the generalizability of trial results to the broader population, particularly older adults who are affected by cancer more frequently. Various factors contribute to the Read more
