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Office of IND Development and Regulatory Affairs (OIDRA)

The Office of IND Development and Regulatory Affairs (OIDRA) helps City of Hope investigators interact with governmental regulatory agencies and remain in compliance with United States Food and Drug Administration (FDA) requirements.
 
Part of the Center for Applied Technology Development, the OIDRA represents an extremely important component for shepherding therapies and other biomedical technologies through complex regulatory processes.  Having an in-house office to handle the bureaucracy and stringent regulations that accompany new drug development allows City of Hope investigators to focus on their core competency: research.
 
Suenell Broyer, director of the OIDRA, has extensive experience in regulatory affairs, including investigational new drug (IND) applications, clinical trial services, quality control, promotion and labeling.
 
The OIDRA provides investigators tools such as document templates and a database of all active IND applications, which generates reminders to investigators to fulfill necessary IND commitments. These measures facilitate submissions to the FDA and, in so doing, help streamline the translation of basic research into patient clinical trials. The OIDRA has been well received by the FDA, and represents a paradigm shift in how institutions oversee and manage clinical trials.
 

Office of IND Development and Regulatory Affairs

Office of IND Development and Regulatory Affairs (OIDRA)

Office of IND Development and Regulatory Affairs (OIDRA)

The Office of IND Development and Regulatory Affairs (OIDRA) helps City of Hope investigators interact with governmental regulatory agencies and remain in compliance with United States Food and Drug Administration (FDA) requirements.
 
Part of the Center for Applied Technology Development, the OIDRA represents an extremely important component for shepherding therapies and other biomedical technologies through complex regulatory processes.  Having an in-house office to handle the bureaucracy and stringent regulations that accompany new drug development allows City of Hope investigators to focus on their core competency: research.
 
Suenell Broyer, director of the OIDRA, has extensive experience in regulatory affairs, including investigational new drug (IND) applications, clinical trial services, quality control, promotion and labeling.
 
The OIDRA provides investigators tools such as document templates and a database of all active IND applications, which generates reminders to investigators to fulfill necessary IND commitments. These measures facilitate submissions to the FDA and, in so doing, help streamline the translation of basic research into patient clinical trials. The OIDRA has been well received by the FDA, and represents a paradigm shift in how institutions oversee and manage clinical trials.
 

Meet the Staff

Office of IND Development and Regulatory Affairs

Contact Us
For inquiries concerning the CBG manufacturing facility and collaborative opportunities please contact:
 
Larry A. Couture, Ph.D. or
David Hsu, Ph.D.
Center for Applied Technology Development
City of Hope
1500 E. Duarte Road
Duarte, CA 91010
626-256-8728
Center for Applied Technology Development (CATD)
The Sylvia R. and Isador A. Deutch Center for Applied Technology Development (CATD) offers broad expertise in technology transfer and licensing, biologics manufacturing, quality assurance and regulatory affairs.

Beckman Research Institute of City of Hope is internationally  recognized for its innovative biomedical research.
City of Hope is one of only 41 Comprehensive Cancer Centers in the country, the highest designation awarded by the National Cancer Institute to institutions that lead the way in cancer research, treatment, prevention and professional education.
Support Our Research
By giving to City of Hope, you support breakthrough discoveries in laboratory research that translate into lifesaving treatments for patients with cancer and other serious diseases.
 
 
 
 
Learn more about City of Hope's institutional distinctions, breakthrough innovations and collaborations.


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