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GKM (Gesellschaft für Therapieforschung mbH) is an independent, family-owned contract research organization (CRO). GKM provides a comprehensive portfolio of CRO services for the pharmaceutical industry, manufacturers of medical devices and academia. Founded in 1981, GKM is headquartered in Munich, more
in.vent Clinical Services (ICS) is a holistic service provider for diagnostic studies and IVD validation. ICS was founded with regard to the EU in-vitro diagnostics regulation (IVDR). This law strongly increases the complexity of the IVD validation process and demands a re-validation of already CE more
We at Inamed believe that being proactive and flexible, is key to success in meeting our clients’ needs. Having established an environment that fosters this approach with our teams, we believe people are our greatest asset and understand that best performances come from individuals who know they are more
In the treatment of SARS-CoV-2, the virus that causes COVID-19, antiviral drug remdesivir has emerged as a promising candidate. Remdesivir works by disrupting the virus's ability to replicate, but its exact mechanism has remained a mystery. Using advanced computational simulations, researchers at th more
APEIRON Biologics AG announced the launch of a Pilot investigator-initiated clinical trial (IIT) with APN01, a recombinant human angiotensin-converting enzyme 2 (rhACE2), to treat patients with severe coronavirus infection in the People's Republic of China. The randomized, unblinded trial will treat more
A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha. The trial regulatory sponsor is th more
Biomarkers are currently changing the way we diagnose and treat diseases. Today pharmacodynamic biomarkers are widely used in the industry elaborating optimal dosing of new drugs and predictive biomarkers have an enormous potential for companion diag more
Case studies on ultra sensitive bioanalysis of biologics with challenging molecular characteristics and the need for broad assay range are discussed. more
As a consumer, it’s easy to be oblivious to the amount of time, work, and money that goes into the development of a drug. The cost of developing a drug that goes on to gain marketing approval was estimated to be $2,558 million in 2014, and the process can commonly last longer than a decade. Addition more
Today’s graphic looks at science in general, rather than just chemistry. It’s in a similar vein to the Rough Guide to Spotting Bad Science posted last year, but this time looking at the hierarchy of different types of scientific evidence. You might think science is science, but some evidence is rank more
Viruses, Vol. 10, Pages 351: Resistance Development to Bacteriophages Occurring during Bacteriophage Therapy Viruses doi: 10.3390/v10070351 Authors: Frank Oechslin Bacteriophage (phage) therapy, i.e., the use of viruses that infect bacteria as antimicrobial agents, is a promising alte more
In the fight against antibiotic-resistant infections, a decades-old approach based on bacteria-slaying viruses called phages has been sidelined by technical hurdles, dogged by regulatory confusion, and largely ignored by drug developers in the West. But 2 years ago, researchers at the University of more
Antibiotic development is frequently plagued by the rapid emergence of drug resistance. However, assessing the risk of resistance development in the preclinical stage is difficult. By building on multiplex automated genome engineering, we developed a method that enables precise mutagenesis of multip more
AIDS Clinical Trials Group The AIDS Clinical Trials Group (ACTG) is the largest HIV clinical trials organization in the world, playing a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV and AID ... more
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