EMEA draft guideline for immunogenicity testing of biologicals – FOCUS provides appropriate services

Biological proteins (“Biologicals”) used as therapeutics may induce unwanted immune responses in treated patients. The EMEA has recently issued a draft guideline for immunogenicity assessment. Immunogenicity testing should be part of clinical efficacy and safety...

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Safety of phase I trials with monoclonal antibodies

In a recently published review in the International Journal of Clinical Pharmacology and Therapeutics Liedert and colleagues discussed the pertinent safety issues of phase I clinical...

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First-into-Man Trials as part of integrated Phase I/II development plans

At the AGAH workshop in Bonn on January 17th 2007, Dr. Wolfgang Greb (CEO of FOCUS Clinical Drug Development GmbH, FOCUS-CDD) summarized current strategies in the pharmaceutical industry and FOCUS’ solutions for First-in-Man (FIM) Trials. He pointed out that FIM-Trials have to be seen as as a segment of an individual, tailor-made development...

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Peptidomics® Technology identifies novel Alzheimers Disease Biomarkers

In a recent press release Digilab BiovisioN AG reported on the discovery and identification of novel biomarkers for Alzheimers Disease by using it’s proprietary Peptidomics^® technologies. A series of peptides was identified that differentiated between Alzheimers patients and both patients with primary dementia and normal cognitive...

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TGN1412: Final report of Expert Scientific Group (published Nov 30, 2006)

As a result of the TGN1412 incident in London, an Expert Scientific Group on Phase One Clinical trials (ESG) was organised in the UK, whose aim it was to review and examine what could actually be learnt from this event and what recommendations could be made to increase the safety of first-in-man trials.The ESG published its <LINK...

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