In his presentation Dr. Greb, president and CEO of Focus Clinical Drug Development GmbH (Neuss, Germany), summarizes pertinent issues of early phase development of biologicals.
He points out that careful analysis of the molecular situation is required and that the relevant target structures and species need to be chosen in preclinical evaluation of the compounds activity.
You may wish to download Dr. Greb’s presentation for your personal use. To order a complimentary copy of Dr. Greb’s presentationon specific challenges in human pharmacology trials with biologicals enter your email address below and press the submit button:
A detailed complimentary copy of Dr. Greb’s presentation can be ordered by entering your email address below and pressing the submit button:
“FOCUS Immunology Laboratories Heidelberg” offer testing of biomarkers for immune cell functions tailored to the specific requirements of a given clinical trial.
For further information please contact Dr. Eddy Bruyns at eddy.bruyns@focus-cdd.com.
In a recent issue of “Nature Biotechnology” (Volume 28, Nr. 4, April 2010) Cormac Sheridan featured the status of biologicals development in 2009. From this and the associated specific articles on monoclonal antibody development it is obvious that biologicals are gaining more and more importance for sustaining the new products pipelines of pharmaceutical companies.
The development of new biologicals is associated with specific challenges. Some relate to the immunogenic and immune-modulatory properties of biologicals. Some keywords are „immunogenicity testing”, “cytokine storm”, “species-specificity of ligand-receptor interactions and down-stream signaling”.
In view of these challenges FOCUS has developed specific testing packages with an emphasis on immuno-modulatory activities of novel drug candidates.
The following testing packages have recently been defined:
- Specific immune system package
- Innate immune system package
- Immune activity screening package for novel and established compounds
- Cytokine modulation package for immuno-modulators, esp. immuno-suppressive compounds
- Immuno-stimulation package for immune-modulators, vaccines and oncology drugs
- Biologicals testing package, esp. for new biological entities (NBEs)
A comprehensive summary can be found in the white paper to be downloaded here.
Source: Cormac Sheridan, „Fresh from the biology pipeline-2009“ Nature Biotechnology Volume 28 Number 4 April 2010
Dr. Eddy Bruyns and Dr. Matthias Baumann of FOCUS CDD have summarized information on biomarkers of innate immune system functions. They provide latest information on assay systems for innate immune system parameters (Toll-like receptors [TLR], NOD-like receptors) and the implementation of such assays as PD biomarkers in exploratory clinical studies.
Finally case studies and a compilation of pertinent literature is provided.
To order a complimentary copy of the FOCUS expert report on biomarkers of innate immune system functions enter your email address below and press the submit button:
A detailed complimentary copy of FOCUS’ expert report can be ordered by entering your email address below and pressing the submit button:
“FOCUS Immunology Laboratories Heidelberg” offer testing of biomarkers for immune cell functions tailored to the specific requirements of a given clinical trial.
For further information please contact Dr. Eddy Bruyns at eddy.bruyns(at)focus-cdd.com.
The overall intent of exploratory clinical studies is to provide information that allows assessing the clinical feasibility of new drug candidates early in the development process. Exploratory clinical trials therefore aim at early evaluation in humans of pharmacokinetic and and phamacodynamic profiles of novel compounds.
The doses applied in such studies are too low to be therapeutic or even to allow any meaningful PD assessment by conventional methods. Therefore, sensitive and specific (“surrogate”) PD markers – “biomarkers” – are required.
In an expert report, Dr. Eddy Bruyns, Dr. Matthias Baumann and Dr. Maikel Raghoebar of FOCUS have compiled information on the use of biomarkers in exploratory clinical studies and they provide a summary of the pertinent regulatory background.
They point out that PD biomarkers are feasible in many therapeutic areas, yet they are especially useful in the development of drugs for anti-inflammation and immuno-modulation. This is exemplified by several case studies.
To order a complimentary copy of the FOCUS expert report on the use of biomarkers in exploratory clinical studies enter your email address below and press the submit button:
A detailed complimentary copy of FOCUS’ expert report can be ordered by entering your email address below and pressing the submit button:
“FOCUS Immunology Laboratories Heidelberg” offer testing of biomarkers for immune cell functions tailored to the specific requirements of a given clinical trial.
For further information please contact Dr. Eddy Bruyns at eddy.bruyns@focus-cdd.com.
Friday, July 16, 2010
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