How Can Expanded Access Help Patients and Researchers?

Sonal Munsiff, MD, had a patient in a unique and difficult situation. The patient had a recurrent MRSA infection in their artificial knee joint, but common antibiotics were ruled out. Surgery was not an option because of past procedures. For a time, it appeared that amputation was the only path forward, but the patient steadfastly refused that option. There had to be another way.

Munsiff looked into alternatives. She learned how the Tailored Antibacterials and Innovative Laboratories for phage Research (TAILOR) at the Baylor College of Medicine uses phages, which are viruses that infect and kill bacteria, leaving human cells unharmed. TAILOR can isolate bacteria-killing phages and match them up with patient-specific bacterial infections. With a proper match, TAILOR could develop a therapy that could be injected at the sight of infection to eliminate it over time.

There was only one problem: the treatment was not FDA approved. Munsiff did what many researchers at the University do when they need Investigational New Drug (IND) approval: she reached out to Joan Adamo, PhD, at the Office of Regulatory Support (ORS).

“I was aware that this would need an IND approval, so I immediately approached Joan Adamo and her office to assist me in the process,” Munsiff said.

Adamo is the director for Regulatory Support Services at the Office of Regulatory Support. Part of her job is helping physicians and researchers utilize expanded access—a process of getting FDA approval to treat patients suffering from life-threatening diseases or conditions with investigational medical products that are not otherwise available.

“This treatment had to be made very specifically for Dr. Munsiff’s patient,” Adamo said. “The patient’s combination of an intense MRSA infection, the inability to get antibiotics to the infection site within the bone and crevices of the artificial joint, and the patient’s reluctance to amputate meant we had to get creative.”

The first step was to take an isolate of the bacterial infection. Munsiff sent the isolate to the TAILOR group at the Baylor College of Medicine, who screened through phages to find one that would kill the patient’s specific bacterial infection. The group then grew the virus for the treatment.

Meanwhile, Adamo started the process to seek FDA approval for this unique approach.

“It was not an approved drug, so we went through a different process,” Adamo said. “This was not a standard IND, either. This was one treatment for a single patient with unique needs in a specific situation.”

From planning to manufacturing the treatment to patient application, the situation needed to be safe for the patient and meet with the FDA’s standards. Navigating that process and paperwork is a specialty of the ORS.

“The staff was very helpful in getting all the documents together that were needed,” Munsiff said. “They sent templates and other examples to help us with the process and handled most contact with the FDA.”

In addition to IND approvals and expanded access, the ORS assists University faculty who are conducting research with FDA-regulated products and materials through training, templates for communicating with and navigating the FDA’s programs, and consulting and support through the lifecycle of study development and treatment approval.

“If you are working with something that needs FDA oversight or approval, we can guide you through those processes to give you the best shot at success,” Adamo said. “We hope faculty will reach out early and often to ask questions and get started.”

Visit the ORS page for contact information, a list of services, and educational opportunities for complying with federal policy in experimental drugs, devices, and preclinical laboratory studies.
 

Jonathan Raab | 7/15/2025