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.
Toronto, ON (PRWEB) October 28, 2014
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 level of allergen exposure, and the spatial and temporal validation of EECs. Inflamax Research has been a leader in helping to develop the validation and operating standards for EECs. A review of the studies that demonstrate how EEC models provide accurate and precise research outcomes that are representative of those collected in the field will be the focus of her talk.
“The use of a well-controlled clinical model such as the allergy EEC model provides important insights into the actions of putative disease-modifying immunotherapies. This model makes possible the controlled yet naturalistic allergen challenge, which allows for real clinical assessment and screening of patients for immunotherapy trials, and allows for yearly follow-ups to examine whether immunotherapies can provide long standing benefit,” says Dr. Salapatek. “Regulators and researchers need to examine these data rationally. This will encourage rigorous testing of immunotherapies and their timely evaluation towards treatment of allergy sufferers.”
About Dr. Salapatek
Dr. Salapatek is an expert in the field of allergy research and designing studies for very specific regulatory requirements to prove safety and efficacy. She is an advocate for a model like the EEC in the conduction of small pilot-sized and proof-of-concept studies to large-scale global pivotal studies with seasonal follow-up, which are particularly useful to the study immunotherapies.
About Inflamax Research
Inflamax Research has been a leader in developing the validation and operating standards for EECs.
Briefly, they offer:
- 100 Bed Phase I Clinic
- 6 Environmental Exposure Chambers (EEC’s)
- Mobile EEC Option (mEEC™)
- Accelerated Proof-of Concept Studies
- Late Stage, Multi-center Global CTM Group
- Data Management, Stats, Medical Writing Services
- Regulatory Assistance
- Protocol Consultation and Study Design advice
Please contact Cynthia Day O’Brien for more information or to schedule a time to speak with Dr. Salapatek.