CC Cuts Ribbon on New Pharmaceutical Development Service Facility
Episode # 36
Uploaded: February 17, 2010
Running Time: 6:36
SCHMALFELDT: From the National Institutes of Health in Bethesda, Maryland, this is CLINICAL CENTER RADIO. The problem: you're a scientist at a clinical research hospital, and you need an investigational drug that is not available from a commercial manufacturer. What do you do? Well, if you're the Pharmaceutical Development Service at the NIH Clinical Center – you make it yourself. The Clinical Center opened the doors for its new Pharmaceutical Development Service – or PDS – during a recent ribbon cutting. Dr. John I. Gallin, Clinical Center Director, was the master of ceremonies.
GALLIN: My hope is that this facility will have the capacity not only to meet the needs of all our intramural investigators, but also to help some of our extramural colleagues, that they also find this a valuable service. So before I cut the ribbon, I want to acknowledge Bob DeChristoforo, who is the head of the pharmacy department, and George Grimes, who is the head of the service.
SCHMALFELDT: Grimes commented on the utility of this new facility.
GRIMES: The Pharmaceutical Development Section meets with all of the investigators here at the Clinical Center to set up their investigational drug studies and we discuss the logistics of where the drug is coming from and how much is needed – different strengths and forms and labeling for blinded studies, all those practical things. And we either get the drugs from outside sources, drug companies, or we make the drugs ourselves. We have facilities to make tablets and capsules and injections of all sorts.
SCHMALFELDT: Grimes commented on how the new facility is better organized than its predecessor.
GRIMES: It's more of a square structure so it allows us to do some things we couldn't do in the more linear structure that we were in before that was 20-feet wide and 180-feet long. We have a lot more control over the cleanliness of our air and the cleanliness of our water in our new facility.
SCHMALFELDT: DeChristoforo echoed his colleague's comments.
DeCHRISTOFORO: I think the new facility will have an increased capacity, and as we said, modern equipment, and it also may allow us to be a little more efficient in making some of the products and certainly, as we just discussed, it is going to allow us to comply with FDA's current good manufacturing practices which have gotten stricter over the last years.
SCHMALFELDT: DeChristoforo and Grimes gave Clinical Center Radio a walking tour of the new facility.
DeCHRISTOFORO: So, as you can see here, we have a very big walk-in refrigerator. One of the things that we do here is we have a pharmacokenetic service. So we not only have keneticists that are trained with data analysis, but we also have a laboratory that is attached for pharmacokenetics, which is for phase one studies when they have to characterize a new drug with how it is excreted and metabolized. We can actually do some of the analytical work for some of the studies here.
GRIMES: In this area, we have a machine that puts film coats on tablets, and we need a machine like that for making drug and placebo type studies. The taste and color of tablets is problematic, that's why mostly right now we make capsules. But this thing right here will let us make tablets which we can make many more of than the capsules and allow us to put coats on to do the double blind studies. Here is a machine that most people describe as a popcorn machine, but it really is a capsule maker. We can make 50,000 or so capsules in an eight hour shift with this machine. We have been using this machine and its ancestors since I came here. It's very efficient but it takes all day to clean it and put it together, so we have to make a lot of capsules to make it worthwhile. We have about 30 studies that use this number of capsules.
SCHMALFELDT: Grimes said the uniqueness of the facility was a reflection of the uniqueness of the NIH Clinical Center.
GRIMES: It is unique in the sense that the Clinical Center is unique and there are so many studies here going on in so many different topics where a lot of the national research hospitals may specialize in things like eye disorders or cancer, the Clinical Center does everything. It makes for a lot of variety in the things we have to produce and the things we have to accommodate.
SCHMALFELDT: DeChristoforo shared Grimes' sense of enthusiasm for the new facility.
DeCHRISTOFORO: As far as what I'm really excited about the facility itself is that we now can show visitors a really kind of new facility, shiny equipment, new equipment and they were actually impressed with the old capabilities that we had, so I think they are going to be much more impressed with what we have now.
SCHMALFELDT: To learn more about the new PDS facility, or to read more about the groundbreaking medical research that goes on every day at the NIH Clinical Center, log on to http://clinicalcenter.nih.gov. From America's Clinical Research Hospital, this has been CLINICAL CENTER RADIO. In Bethesda, Maryland, I'm Bill Schmalfeldt at the National Institutes of Health, an agency of the United States Department of Health and Human Services.
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