Clinical Trials Training Symposium

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DESCRIPTION (provided by applicant): The American Society of Gene & Cell Therapy (ASGCT) was founded in 1996 and is dedicated to the development of gene and cell therapies with a particular focus on professional and public education. In this application we are requesting support for junior investigator and trainee participation in the ASGCT Clinical Trials Training Symposium. This meeting will provide education regarding general issues in clinical trial design and implementation, as well as specific information regarding the conduct of human gene and cell therapy trials. In addition to the education goals, the meeting is meant to improve compliance and promote the protection of human subjects participating in translational research studies. The Proposed R13 grant is requested to provide support for junior investigator and trainee participation in the American Society of Gene & Cell Therapy (ASGCT) Clinical Trial Training Symposium. The society has previously conducted three Clinical Trial Training Symposia in 2001, 2002, and 2003. This was in response to adverse events that occurred in relation to gene therapy clinical trials and was aimed at educating investigators on the regulatory and ethical issues surrounding gene therapy. By 2003, most investigators involved with clinical gene therapy had attended the course. Since 2003, a significant number of individuals have entered the gene and cell therapy field as investigators working with a variety of novel viral vectors, new non-viral methods, oligonucleotide therapy, and inhibitory RNA's, which are being developed for clinical applications. Furthermore, the regulatory environment has changed significantly for both gene and cell therapy. Recognizing these factors, the Society is planning a Symposium in May of 2010. We are requesting $10,000 to reduce the costs for junior investigators and trainees to attend the Symposium. PUBLIC HEALTH RELEVANCE: Since 2003, a significant number of individuals have entered the gene and cell therapy field as investigators working with a variety of novel viral vectors, new non-viral methods, oligonucleotide therapy, and inhibitory RNA's, which are being developed for clinical applications. Furthermore, the regulatory environment has changed significantly for both gene and cell therapy. Recognizing these factors, the Society is planning a Symposium in May of 2010. We are requesting $10,000 to reduce the costs for junior investigators and trainees to attend the Symposium.