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Office of IND Development and Regulatory Affairs (OIDRA) Bookmark and Share

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.


NEWS & UPDATES
  • The body’s immune system is usually adept at attacking outside invaders such as bacteria and viruses. But because cancer originates from the body’s own cells, the immune system can fail to see it as foreign. As a result, the body’s most powerful ally can remain largely idle against cancer as the disease progres...
  • On Jan. 1, 2015, five City of Hope patients who have journeyed through cancer will welcome the new year with their loved ones atop City of Hope’s Tournament of Roses Parade float. The theme of the float is “Made Possible by HOPE.” The theme of the parade is “Inspiring Stories.” Her...
  • Are you thinking about switching from traditional cigarettes to e-cigarettes for the Great American Smokeout? Are you thinking that might be a better option than the traditional quit-smoking route? Think again. For lung expert Brian Tiep, M.D., the dislike and distrust he feels for e-cigs comes down to this: Th...
  • Hematologist Robert Chen, M.D., is boosting scientific discovery at City of Hope and, by extension, across the nation. Just ask the National Cancer Institute. The institution recently awarded Chen the much-sought-after Clinical Investigator Team Leadership Award for boosting scientific discovery at City of Hope...
  • Great strides have been made in treating cancer – including lung cancer – but by the time people show symptoms of the disease, the cancer has usually advanced. That’s because, at early stages, lung cancer has no symptoms. Only recently has lung cancer screening become an option. (Read more about the risks...
  • Identifying cures for currently incurable diseases and providing patients with safe, fast and potentially lifesaving treatments is the focus of City of Hope’s new Alpha Clinic for Cell Therapy and Innovation (ACT-I). The clinic is funded by an $8 million, five-year grant from the California Institute for Regene...
  • Cancer is a couple’s disease. It affects not just the person diagnosed, but his or her partner as well. It also affects the ability of both people to communicate effectively. The Couples Coping with Cancer Together program at City of Hope teaches couples how to communicate and solve problems as a unit. He...
  • Chemotherapy drugs work by either killing cancer cells or by stopping them from multiplying, that is, dividing. Some of the more powerful drugs used to treat cancer do their job by interfering with the cancer cells’ DNA and RNA growth, preventing them from copying themselves and dividing. Such drugs, however, l...
  • During October, everything seems to turn pink – clothing, the NFL logo, tape dispensers, boxing gloves, blenders, soup cans, you name it – in order to raise awareness for what many believe is the most dangerous cancer that affects women: breast cancer. But, in addition to thinking pink, women should...
  • In February 2003, when she was only 16 months old, Maya Gallardo was diagnosed with acute myelogenous leukemia (AML) and, to make matters much worse, pneumonia. The pneumonia complicated what was already destined to be grueling treatment regimen. To assess the extent of her illness, Maya had to endure a spinal ...
  • Former smokers age 55 to 74 who rely on Medicare for health care services have just received a long-hoped-for announcement. Under a proposed decision from the Centers for Medicare and Medicaid Services, they’ll now have access to lung cancer screening with a low-dose CT scan. The proposed decision, announ...
  • City of Hope has a longstanding commitment to combating diabetes, a leading national and global health threat. Already, it’s scored some successes, from research that led to the development of synthetic human insulin – still used by millions of patients – to potentially lifesaving islet cell transplants. Diabet...
  • Dee Hunt never smoked. Neither did her five sisters and brothers. They didn’t have exposure to radon or asbestos, either. That didn’t prevent every one of them from being diagnosed with lung cancer. Their parents were smokers, but they’d all left home more than 30 years before any of them were diagn...
  • They may not talk about it, but women with cancers in the pelvic region, such as cervical cancer, bladder cancer and uterine cancer, often have problems controlling their urine, bowel or flatus. Although they may feel isolated, they’re far from alone. Many other women have such problems, too. In fact, nea...
  • Cancer that spreads to the liver poses a significant threat to patients, and a great challenge to surgeons. The organ’s anatomical complexity and its maze of blood vessels make removal of tumors difficult, even for specialized liver cancer surgeons. Following chemotherapy, the livers of cancer patients are not ...