Q. How did the lab come to be located in St Louis?
A. Historically, there has been a lab in St Louis probably for at least 50 years, maybe 60 years, though I’ve heard rumors that it started out as a meat laboratory. About 15 years ago, one of the deputy commissioners wanted the lab to move to Laurel, MD, and we all said what people of my generation said about the Vietnam War: “Hell no, we won’t go.”
And fortunately, we had some very powerful senators and congressmen and of course, no legislator wants a federal laboratory moved out of his or her territory, so they got it written in the budget bill that the FDA can’t spend money to even plan to move this laboratory out of the St Louis regional area.
We think it’s advantageous to be 800 miles from headquarters. These days we have really good communication, and we video conference for meetings, so it seems to work okay.
Q. How much influence do you have when it comes to the adoption of new analytical methods?
A. I don’t make regulatory decisions; I’m only a lab guy but at least they listen to me — usually.
Q. Do you work regularly with groups like IPAC-RS and EPAG?
A. I have, well, yeah, I’ve worked with IPAC-RS, not so much as I used to with PQRI. I was on I think at one time I was on 4 PQRI committees. One of them was the chi square committee, and I was part of the leachables and extractables team. I’m also doing some work with the nasal subgroup of EPAG, testing a couple of prototype inlet ports for cascade impaction of nasal drugs.
Q. What types of analyses have you developed for OINDPs?
A. For example, I presented a poster at AAPS on abbreviated impactor use for DPIs. You probably are aware that IPAC-RS has come to the agency and said, “You know it’s fine to use the Andersen or the NGI to fully characterize the drug, but gosh that’s an awful lot of work when you are doing batch release.” There’s been a fair amount done on MDI’s by people like Jolyon Mitchell, David Christopher, and Terry Tougas, but not much done on DPIs.
If we characterize the inhaler with the full gold standard cascade impaction method, and then we validate that with an impactor that only has two stages, we get the coarse fraction; we get the fine fraction; we measure the ratio of those, and we think that ratio along with the total impactor sized mass could be used to characterize the drug sufficiently for batch release. We think we’ll see any changes that could affect performance.
I had a postdoc in the lab last year, and we picked some DPIs with different resistances and carried out testing with the full NGI, an abbreviated NGI, and also the Copley Fast Screening Impactor. I think the data look pretty good.
