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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.


NEWS & UPDATES
  • Cancer cells are voracious eaters. Like a swarm of locusts, they devour every edible tidbit they can find. But unlike locusts, when the food is gone, cancer cells can’t just move on to the next horn o’ plenty. They have to survive until more food shows up — and they do. Mei Kong, Ph.D., assistant […]
  • On Jan. 1, 2015, six 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.” Repr...
  • When 25-year-old Angelina Mattos was diagnosed with Stage 4 oral cancer earlier this year, she learned that her only hope of survival was through the removal of her tongue, a surgery that leaves people without the ability to talk or eat normally, sometimes permanently ending their ability to speak. After hearin...
  • Two years ago, Joselyn Miller and her family sat together as stem cells from her brother’s bone marrow were infused into her – a precious gift of life that the family is excited to have the chance to pass to another patient in need. Today, the stem cell recipient is healthy. Her 23-year-old son Rex, who […...
  • Even as the overall rate of oral cancers in the United States steadily declines, the rate of tongue cancer is increasing — especially among white females ages 18 to 44. An oral cancer diagnosis, although rare, is serious. Only half of the people diagnosed with oral cancer are still alive after five years, accor...
  • Sometimes cancer found in the lungs is not lung cancer at all. It can be another type of cancer that originated elsewhere in the body and spread, or metastasized, to the lungs through the bloodstream or lymphatic system. These tumors are called lung metastases, or metastatic cancer to the lungs, and are not the...
  • When it comes to research into the treatment of hematologic cancers, City of Hope scientists stand out. One study that  they presented this week at the annual meeting of the American Society of Hematology suggests a new standard of care for HIV-associated lymphoma, another offers promise for the treatment of re...
  • Patients with HIV-associated lymphoma may soon have increased access to the current standard of care for some non-HIV infected patients – autologous stem cell transplants. Impressive new data, presented Monday at the annual meeting of the American Society of Hematology (ASH) in San Francisco, indicate that HIV-...
  • On Jan. 1, 2015, six 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 Rose Parade is “Inspiring Stories.”...
  • The holidays can create an overwhelming urge to give to people in need — especially to sick children and families spending the holidays in a hospital room. That’s a good thing. Holiday donations of toys and gifts can bolster the spirits, and improve the lives, of people affected by illness, and hospitals ...
  • On Jan. 1, 2015, six 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.” Here...
  • Cancer has a way of “talking” to the immune system and corrupting it to work on its own behalf instead of defending the body. Blocking this communication would allow the immune system to see cancer cells for what they are – something to be fought off – and stop them from growing. A breakthrough Scientists [R...
  • On Jan. 1, 2015, six 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.” By V...
  • On Jan. 1, 2015, six 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.” The ...
  • On Jan. 1, 2015, six 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.” In 2...