18-Jan-2018 – Conference Summary for the EUFEMED conference, London, May-2017

 

Conference summary

The first formal conference of the EUropean Federation for Exploratory MEdicines
Development (EUFEMED) held in London was the result of a collaborative effort of
its founding associations: the Association for Applied Human Pharmacology (AGAH;
Germany), the Association for Human Pharmacology in the Pharmaceutical Industry
(AHPPI; UK), the Belgian Association of Phase-I Units (BAPU; Belgium), and Club
Phase-I (France). The conference focused on innovation and risk management
in early clinical drug development. Among other innovations, immunotherapy in
oncology and inflammatory diseases were discussed as well as the importance of
adaptive trial designs in early clinical drug development. Consideration was given
to assessing and mitigating risk in early clinical drug development, and included a
preconference workshop. Different measures to minimize risks in healthy volunteers
and patients in first-in-human trials were discussed in addition to the importance
of non-clinical data, the need for reliable biomarkers, improved communication on
adverse events (AEs) and well-trained study sites with ready access to intensive care
units and clinical specialists. The need for a European-wide system for prevention of
over-volunteering was also discussed. The conference provided opportunity to discuss
these developments and concerns and the changing regulatory environment with
stakeholders from academia, industry, and regulatory agencies including the European
Medicines Agency (EMA). Presentations given by invited speakers are published on
http://www.eufemed.eu/london-conference-2017/.

A more extensive report has been published in Frontiers in Pharmacology 2018; 8: article 901 (click the logo below).