News

The meeting held in Berlin was well attended with about 140 experts from the pharmaceutical and biotech industry, representatives of regulatory authorities and the CRO industry. The meeting was well structured and organized with six indepedent and non-overlapping symposia.

Among those there have been two symposia of special interest for MLM.

Symposium 1 addressed the role of biomarkers in clinical development of oncological immunotherapies. Dr. Metzger, Qiagen, stressed the future role of liquid biopsies for the diagnosis and treatment of cancer. Dr. Cannarile, Roche, elaborated on the combination of checkpoint inhibitors with immunotherapeutics addressing tumor-associated macrophages. In this setting, biopsies taken from tumor tissues are very important to assess the therapeutic efficacy.

Symposium 6 addressed the challenges in first-in-man (FIM) studies after the serious incident with the compound BIA 102474 in 2016. Dr. Gnadt-Vogt, Curevac, and Dr. Lehmann, formely BfArM now independent regulatory expert, discussed the specific precautions that have to be made in order to protect participants of FIM studies. Notably, the EMA is working on a revised guideline (EMEA/CHMP/SWP/28367/07 Rev. 1) and requests to analyse the pharmacokinetics of a new drug candidate in SAD and MAD studies after each cohort before the next dose level is applied. This will have a major impact on the conduct of FIM studies. The demand to provide bioanalytical data after each cohort also directly affects the work conducted by central and bioanlytical labs. This task can only be fulfilled by labs that are flexible and fast.