PMID- 29387006
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221222
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 8
DP  - 2017
TI  - EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and 
      Risk Management.
PG  - 901
LID - 10.3389/fphar.2017.00901 [doi]
LID - 901
AB  - 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/.
FAU - Van Bortel, Luc
AU  - Van Bortel L
AD  - Belgian Association of Phase-I Units, Antwerp, Belgium.
FAU - Sourgens, Hildegard
AU  - Sourgens H
AD  - Association for Applied Human Pharmacology, Hamburg, Germany.
FAU - Breithaupt-Grogler, Kerstin
AU  - Breithaupt-Grogler K
AD  - Association for Applied Human Pharmacology, Hamburg, Germany.
FAU - Caplain, Henri
AU  - Caplain H
AD  - Club Phase-I, Paris, France.
FAU - Donazzolo, Yves
AU  - Donazzolo Y
AD  - Club Phase-I, Paris, France.
FAU - Klingmann, Ingrid
AU  - Klingmann I
AD  - Association for Applied Human Pharmacology, Hamburg, Germany.
FAU - Hammond, Michael
AU  - Hammond M
AD  - Association for Human Pharmacology in the Pharmaceutical Industry, London, United 
      Kingdom.
FAU - Hardman, Timothy C
AU  - Hardman TC
AD  - Association for Human Pharmacology in the Pharmaceutical Industry, London, United 
      Kingdom.
FAU - Stringer, Steffan
AU  - Stringer S
AD  - Association for Human Pharmacology in the Pharmaceutical Industry, London, United 
      Kingdom.
FAU - de Hoon, Jan
AU  - de Hoon J
AD  - Belgian Association of Phase-I Units, Antwerp, Belgium.
LA  - eng
PT  - Journal Article
DEP - 20180117
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC5776107
OTO - NOTNLM
OT  - conference report
OT  - early phase clinical drug development
OT  - innovation in drug development
OT  - risk mitigation
OT  - the EUropean Federation for Exploratory MEdicines Development (EUFEMED)
EDAT- 2018/02/02 06:00
MHDA- 2018/02/02 06:01
PMCR- 2018/01/17
CRDT- 2018/02/02 06:00
PHST- 2017/10/15 00:00 [received]
PHST- 2017/11/27 00:00 [accepted]
PHST- 2018/02/02 06:00 [entrez]
PHST- 2018/02/02 06:00 [pubmed]
PHST- 2018/02/02 06:01 [medline]
PHST- 2018/01/17 00:00 [pmc-release]
AID - 10.3389/fphar.2017.00901 [doi]
PST - epublish
SO  - Front Pharmacol. 2018 Jan 17;8:901. doi: 10.3389/fphar.2017.00901. eCollection 
      2017.