A National Cancer Institute-designated Comprehensive Cancer Center

Make an appointment: 800-826-HOPE
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
  • Patients with metastatic colorectal cancer often stop responding to the primary drugs used against the disease, leaving them with few options and little hope. Determined to increase those options, doctors and researchers at City of Hope are conducting two clinical trials that could lead to new treatments for pe...
  • Investigators working at City of Hope are making many significant inroads against many forms of cancer. To do that, they have to take a variety of approaches. Molecular oncology researchers focus on abnormal cancer-associated activity in a cell’s nucleus. One especially prominent factor in many breast and ovari...
  • In light of the new breast cancer screening guidelines, which call for women to have mammograms every other year from age 50 to 74, it’s more important than ever for women to understand their individual risk. On Monday, the U.S. Preventive Services Task force released new breast cancer screening guideline...
  • Cancer patients need, and deserve, more than medical care. They and their families need high-quality supportive care – that is, care that addresses their physical, emotional and spiritual well-being. Health care professionals increasingly understand this, but starting such programs from scratch isn’t easy...
  • Each year, City of Hope patients given another chance at life gather to pose for a picture like this one. Going on its 39th year, the celebration of patients free of blood cancers thanks to bone marrow or stem cell transplants has grown such that a photographer has to scale a cherry picker just to […]
  • Cancer patients who are participating in early-stage clinical trials need extra emotional and physical support due to their additional stress and often unique symptoms. Now an effort by researchers at City of Hope to create a model for such support has received a $6.8 million grant from the National Cancer Inst...
  • The need for improvements in treating malignant brain tumors has never been greater. Survival for many patients with these tumors are sometimes measured in just months. One reason that therapeutic options are limited is that traditional surgery is deemed too risky for many brain tumors, especially for those in ...
  • “Honestly, there’s nothing special about my story,” protested Daniel Samson, as he bounced Layla, his 3 1/2-year-old daughter, on his lap and put on a video for her to watch. “I just want to tell it for my own sake, and share it with other men who may be going through this chaos.” Samson spoke […]
  • As far back as he can remember, Jonathan Yamzon, M.D., wanted to be a doctor. “I knew it from the get-go,” he said, matter-of-factly. “I always envisioned it as the ideal; the supreme thing one could do with one’s life.” The youngest of six children, Yamzon was barely a toddler when his family moved to [&...
  • There’s never a “good” time for cancer to strike. With testicular cancer, the timing can seem particularly unfair. This disease targets young adults in the prime of life; otherwise healthy people unaccustomed to any serious illness, let alone cancer. And suddenly … “I can only imagine what they must...
  • Sure, a healthy lifestyle can lower a person’s risk, but the impact of specific actions is harder to tease out. Diet, exercise, tobacco use, nutritional supplements, alcohol consumption … How important are each of these factors, individually? Does strict adherence to (or rejection of) one get you a pass o...
  • Health care decisions are tough. They’re even tougher when you – or loved ones – have to make them without a plan or a conversation. National Healthcare Decisions Day, on April 16,  is a nationwide initiative to demystify the health care decision-making process and encourage families to start talking. Ult...
  • The statistics, direct from the American Cancer Society, are sobering: Cancer death rates among African-American men are 27 percent higher than for white men. The death rate for African-American women is 11 percent higher compared to white women. Hispanics have higher rates of cervical, liver and stomach cancer...
  • “Lucky” is not usually a term used to describe someone diagnosed with cancer.  But that’s how 34-year-old Alex Camargo’s doctor described him when he was diagnosed with thyroid cancer — the disease is one of the most treatable cancers at all stages. That doctor was ultimately proved righ...
  • Geoff Berman, 61, starts his day with the motto: “The sun is up. I’m vertical. It’s a good day.” Ever since he’s been in remission from lymphoma, Berman makes a special point of being grateful for each day, reminding himself that being alive is a gift. “I just enjoy living,” he said. “I give e...