Been There, Done That: Now Let Me Help You Do That! Sometimes retirement isn't what it used to be. For Dr. Barry Gause, it's simply a change of hats. Formerly a clinical investigator for NCI's Medical Oncology Program, he now is Director of the Clinical Research Directorate (CRD), SAIC-Frederick, Inc.'s newest directorate.
The directorate has been designed to support NCI by strengthening and expanding SAIC-Frederick, Inc.'s Clinical Research Monitoring Program to provide regulatory and clinical trials management support for human clinical trials, ensure patient safety and consent, and oversee compliance with applicable regulations and guidelines. Currently, only about 3% of adult cancer patients enroll in clinical trials; SAIC-Frederick, Inc., manages more than 300 clinical trials around the world, bringing lead-edge treatments to patients in underserved areas and helping improve treatments for all patients through data collected from the trials.
To some degree, Dr. Gause has “been there, done that.” Having worked at NCI-Bethesda, he knows the program, the protocols, and the people. He is still involved with the Bethesda program, seeing patients and attending on wards. “This enables me to identify needs with which SAIC-Frederick, Inc., can help, such as finding personnel needed for the program, developing and managing biological assays, harvesting and managing biopsies, and making biological agents through the Biopharmaceutical Development Program. We're already doing some of these things, and others will be expanded as the need arises,” Dr. Gause said in a recent interview.
Been There…Expanding a Program Indeed, part of Dr. Gause's role is to assist NCI in continuing to build the Medical Oncology Program. This may include incorporating some of the newer types of therapy and monitoring protocols that will be prevalent in the next decade or so, such as molecular targeting agents and vaccines. He will also be involved in writing and monitoring protocols, instituting management systems, and hiring and managing personnel.
“It's a great opportunity, for both NCI and the SAIC-Frederick, Inc., contract,” Dr. Gause said. “There's so much we can do to help. Working with a contractor, who can hire people through a work order, rather than first creating the position and then hiring staff, gives the NCI and NIH more flexibility. They need to know the skill and expertise that our researchers have to do biological assays, monitoring, research, and other tasks in support of their projects.”
Done That…Handling Administrative Details Another familiar area for Dr. Gause is that of scientific writing, assisting NCI in writing protocols, and moving protocols through the system rapidly. Dr. Gause knows firsthand that principal investigators juggle many responsibilities. “They deal with patients, develop and design the ‘skeletons' for protocols, follow patients, make sure data is handled properly—it would be so helpful to the PI if someone else could handle many of these tasks. For example, one of the most frustrating things principal investigators deal with is all the administrative details needed to walk the protocol through various committees for approval. SAIC-Frederick, Inc., physicians can move the protocol through the system faster, saving the PI a lot of time and allowing him to turn his attention to other priorities. Naturally, safeguards will be in place so that the PI can check on progress and be assured that everything is being done correctly,” Dr. Gause said.
Developing New Approaches to Cure Cancer When infected with bacteria, most of us develop antibodies that kill the foreign invaders (bacteria) but not our own body's cells. However, unlike foreign bacteria, cancer cells are our own cells in mutated form and traditionally, therapies that target cancer cells may also attack nearby normal cells. That's because many adult cancers divide more slowly than the normal cell does. “So, when you use drugs and chemotherapy agents that just target those cells that are dividing, you see a lot of toxicity, because you're killing the normal cells at the same time,” Dr. Gause explained.
Newer approaches—molecular targeting therapies—try to determine how a mutation changes the cell and how to target only the cancerous cells. Then the researcher has another issue to consider, said Dr. Gause: “Even if you develop an agent that targets the area, are you really hitting the target?”
Phase Zero Initiative As part of that focus on novel approaches to cancer research, Dr. Gause and the staff at CRD will implement the Phase Zero Initiative, a new level of clinical trials. “Phase 0 studies are designed to provide support to monitor the studies biologically, clinically, and to collect data. NCI-Frederick is an ideal place to put together a program for Phase 0,” he said.
Still in the planning stages, Phase 0 will evaluate molecular agents that target a specific protein or series of proteins that are responsible for a cell's malignant activity. Study groups will likely consist of fewer than 10 people. The focus is simply on whether the agent hits the intended target. “Once you have seen that it's hitting your target, you can then move the study into a Phase 1 or 2 or Phase 3 clinical trial,” Dr. Gause said.
Dr. Gause said a low dose of the molecular targeting agent is introduced into the patient's bloodstream. “Whatever is safe in animals, particularly mice, drop down 10% before trying in humans. Mice can tolerate greater doses than people can,” he said. It's important to actually inject the agent into the patient, rather than to treat tissue outside the living body, because you can learn much more “by observing the reaction in living, in vivo tissue, in someone's system,” he said.
Another problem that may arise when studying a new therapy is that you may think that what you're doing is having an effect, when it really isn't. For example, if you dose the patient with an agent that you know targets a particular protein, and you get a response, you may think it must be because the agent hit the target. Many times, Dr. Gause said, you find that the protein didn't have anything to do with the response.
“And with Phase 0, you're not even looking for a response, just to see if the agent hits the target. Sometimes they may hit the target, but you get no response—no side effect, no reaction. Nothing happens. Sometimes they don't hit the target and something can happen. Because you're doing a number of biological assays to see whether the drug hits the target, this kind of study requires a lot of coordination and support—the half-life of the agents may be very short, so you need to take your biopsy and harvest your cells at the appropriate time. If you don't, you may miss the time frame in which to get the results,” he said.
No Stranger to NCI-Frederick Dr. Gause is no stranger to NCI-Frederick. From 1991 through 1996, he was a clinical investigator with its Biological Response Modifiers Program (now the Clinical Services Program). In 1996, he transferred to Bethesda to develop and run clinical trials, manage the outpatient clinic for the Medical Oncology Branch, and direct the fellowship training program.
Dr. Gause said that the move back to Frederick has been a good one: “I can look back at what I would have liked to have had when I was in that position and apply the things I know are needed to this new program to help the investigators. I know from personal experience the frustration that PIs deal with, since I dealt with it myself. This position allows me to take advantage of what I know and look at things from a different angle. I like to do things in a different way; I like challenges.”
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National Cancer Institute at Frederick
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Sometimes retirement isn't what it used to be. For Dr. Barry Gause, it's simply a change of hats. Formerly a clinical investigator for NCI's Medical Oncology Program, he now is Director of the Clinical Research Directorate (CRD), SAIC-Frederick, Inc.'s newest directorate.