Genelux is an oncolytic virus company that was formed in 2001 and has been conducting clinical trials since 2009. The company completed four Phase 1 studies which have enabled it to design what CEO Thomas Zindrick describes as an advanced clinical program.
After the clinical tragedy in France in January, the French Health Ministry has found blame with the two companies involved in the trial, noting Bial and Biotrial were at fault on several counts. The EU has guidelines in place to ensure that does not happen again.
In May 2014, I interviewed Mithra Bindhu of India-based Asiatic Clinical Research to get an update on performing clinical trials in that country. The DCGI (Drug Controller General of India) had recently attempted to overhaul the entire system, which took a long time, complicated the process of conducting trials in India, and caused some sponsors to question the value of doing business there. Has the situation changed?
The recent clinical research tragedy in France that resulted in the death of one patient and the hospitalization of four others shocked many who work in the clinical research space. The adverse effects experienced by the previously healthy patients, reportedly involving deep brain bleeds, were both rare and disturbing.
In today’s drug development environment, a successful CRO relationship is critical to project success. You need to make faster and better product development decisions. Seamless and timely access to study information can help.
Assessment of biosimilarity during non-clinical and clinical trials requires specific bioanalytical procedures. The concentration of the biosimilars and their reference compounds is established using pharmacokinetic (PK) methods. By BARRY van der STRATE, PhD, Associate Director of Science, Large Molecules, PRA Health Sciences; CHAD BRISCOE, PhD Executive Director of Science & Innovation Bioanalytical Services, PRA Health Sciences
ICON is one of the world’s largest providers of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies.
The clinical pharmacology team at ICON Development Solutions (ICON) has extensive experience in the design, study conduct and interpretation of clinical pharmacology studies across all major therapeutic areas.