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Inflamax Research to Present Data Demonstrating Validation of Environmental Exposure Chambers for Pivotal Allergy Research at the Paul-Ehrlich Institute in Germany
Dr. Anne Marie Salapatek will be discussing the validation of environmental exposure chambers (EECs) for use in pivotal clinical trials and how this clinical approach should be examined rationally for its utility in pivotal immunotherapy testing for allergies.
Inflamax Research Inc., a full-service CRO, announced today that their Chief Scientific Officer, Dr. Anne Marie Salapatek, has been invited to speak at the 14th International Paul-Ehrlich Institute Seminar on Allergen Products for Diagnosis and Therapy: Regulation and Science, held in Bad Nauheim, Germany from October 29th to November 1st, 2014. The international seminar has been an expert forum and medium for discussion for scientists and regulators for approximately 30 years. This year’s event will address industry standardization and regulatory issues related to diagnostic and therapeutic allergen products.
Dr. Salapatek will review the validation methods utilized for EEC clinical trials, including the selection of ...Read Full Story
Dr. Anne Marie Salapatek, CSO at Inflamax Research, will be presenting clinical trial data demonstrating the utility of Environmental Exposure Chambers in asthma and allergic rhinitis research at upcoming 2014 European Respiratory Society conference in Munich, Germany, September 6-10.
Inflamax Research Inc., a full-service CRO, announced today that their Chief Science Officer, Dr. Anne Marie Salapatek, will be presenting clinical trial data demonstrating how Environmental Exposure Chambers (EECs) can be utilized for the development of clinical trial programs aimed at showing safety and efficacy without the need for costly, large scale field studies.
The data being presented, across three poster presentations, is a representation of study design types that demonstrates how baseline allergic rhinitis symptoms can be provoked consistently out of allergy season. Patients are treated with an investigational or already-approved product, and then provoked again post-treatment to determine...Read Full Story
Dr. Anne Marie Salapatek, President & Chief Scientific Officer of Inflamax Research, will be presenting results of a meta-analysis outlining statistically significant correlations between house dust mite symptoms in the traditional Field trial approach and those collected from patients in the Environmental Exposure Chamber (EEC). These findings support the use of EEC allergen challenge approach for pivotal testing.
Dr. Salapatek, an internationally renowned scientist with expertise in allergy, asthma and EEC clinical trials, is an invited speaker at the EAACI meeting. “This data shows that conducting studies in the EEC provides the best research option that reduces the variability seen in field trials whilst providing an accurate read of a therapy’s efficacy, and importantly also which well reflects that seen in the traditional field trial approach”, states Dr. Salapatek. These findings are to be presented at the 2014 The European Academy of Allergy and Clinical Immunology (EAACI) Congress in Copenhagen, Denmark on June 10th at 1:30 pm.
Dr. Salapatek will also be presenting a poster demonstrating that correlations between skin prick tests (SPT) and specific IgE levels in patients vary...Read Full Story
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Released October 24, 2013
The CDM team has experience with electronic data capture services, having built, released, and “locked” 375
databases since 2006 in multiple study designs and therapeutic areas. All team members are members of the
Society for Clinical Data Management (SCDM) and all have achieved their Certified Clinical Data Manager
The utilization of CDISC and CDASH standards provides the industry-standard data exchange
models which facilitates submission for FDA requirements. In addition to a full complement of data
management services, including web-based fully compliant 21 CFR Part 11 electronic data capture capability
via secure Internet access, Inflamax Research Inc. has integrated its e-Source data capture in the clinic
seamlessly into good data management practices...Read Full Story