City of Hope has established the Office of IND Development and Regulatory Affairs (OIDRA) to help campus investigators interact with governmental regulatory agencies and remain in compliance with United States Food and Drug Administration (FDA) requirements. OIDRA is part of the Center for Applied Technology Development (CATD).
Under Larry Couture, Ph.D., senior vice president, the CATD has spearheaded efforts to build a complete infrastructure for translating promising experimental technologies to the clinic. By establishing the OIDRA, City of Hope brings an extremely important component for shuttling therapies and other biomedical technologies through complex regulatory processes, according to Couture.
“Moving promising experimental technologies to first-in-man trials requires meeting considerable regulatory requirements,” said Couture. “Having the OIDRA takes a cumbersome burden away from investigators and gives us in-house expertise to work with the FDA.”
Director Suenell Broyer leads the new OIDRA. Broyer, who joined City of Hope in February, has extensive experience in regulatory affairs, including investigational new drug applications (INDs), clinical trial services, quality control, and promotion and labeling. She agrees with Couture’s point.
”Investigators don’t always see the intricacies of the regulatory process,” said Broyer. “Our job is to reduce the time needed to get promising new technologies to patients.”
To ensure the process proceeds smoothly, Broyer plans to create a number of tools that should avoid common pitfalls and make submissions easier for investigators. These include document templates and a database listing all City of Hope INDs, as well as reminders to investigators to ensure they fulfill all IND commitments.
Broyer also will develop training programs, and she is recruiting staff with varying regulatory affairs backgrounds so the OIDRA can offer a complete range of skills. Toward these goals, she will be meeting with campus investigators who hold active INDs to assess their needs and how best to assist them and others in the process.
Broyer stresses the importance of viewing the FDA as an experienced partner, rather than a hurdle to overcome. At the FDA “everything is geared toward patient safety,” she said. “They’ve been around a long time, and they are just as concerned as we are. There are reasons for their actions.” She plans to leverage that experience and the considerable capabilities of City of Hope to accelerate the movement of laboratory discoveries to patient use.
”I think Suenell is an excellent addition to City of Hope,” Couture said. “Her skills and experience will make the OIDRA an indispensable tool for investigators.”
For her part, Broyer is impressed with City of Hope’s breadth of capabilities. “I don’t think everyone at City of Hope really understands how unique this institution is,” Broyer said. “When I told my industry colleagues I was coming here, they told me I landed my dream job.” The fact that researchers can move from lab to patients allows a unique, personal connection between the investigators and the patients on campus, she said. “You don’t find that at a contract research organization or biotech. The investigators here really own their projects from start to finish.”
Prior to joining City of Hope, Broyer held positions at Elan Pharmaceuticals Inc. and Quintiles Inc., both in San Diego, Calif. Investigators interested in contacting Broyer may email or call her at ext. 65815.