FDA's Chris Watts on New Directions for PAT at FDA

In this interview with Emil Ciurczak during IFPAC, Dr. Chris Watts discusses pharma PAT and where it is going, within FDA and the industry.

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To hear the audio file of this conversation, click the Download Now button following the transcript below.

EC: I’m talking with Dr. Chris Watts of the FDA. What’s your title?

CW: Team Leader for standards and technology, Office of Pharmaceutical Sciences (OPS).

EC: All these changes keep coming. OK now, here’s a real tough question to start off with. How do you like your new digs over at the old Office of Naval Research facility?

CW: They’re fantastic. I really like having most of our people in one location, especially for OPS.

EC: Instead of having people running around and telecommuting?

CW: Yes. We’re waiting for generics to get out there and biotech products. But most of the CDER people are already there.

EC: I’ve heard the laboratory facilities there are really outstanding.

CW: Yes, the laboratories are right there and we have a great lab space… where we can do the process-based research using process equipment, not just lab-scale equipment.

EC: I was just telling Moheb [Nasr] that most people in the industry only see the regulatory face of FDA, but they don’t realize, or never knew, the quality of people that you have working in the labs.

CW: True, and that’s where Moheb came from.

EC: You could take any of these people and they’d be at home anywhere, at any university or industrial or academic research center anywhere in the world. I remember a fellow in Laurel a few years back doing MS MS MS work on estrogens, female replacement hormone research work… At the time, MIT didn’t have some of the equipment that he was using. It was really cutting-edge.

CW: Our labs, some of the people in St. Louis, we're going to present some great posters. Robbe has done some good work, and Chris Ellis, and the entire OTR lab staff. And did you know that we now have a new OTR director, too: Vince Vilker?

EC: Now everyone else will know, too. I get CDER’s daily newsletter. It is a wonderful resource, especially for me as a consultant. I love to mine the CDER web site. I can’t tell you how many excellent slides I’ve found up there and referred to in my courses.

CW: And it’s all public information.

EC: Making the law transparent gives people a lot more confidence.

CW: It really helps do away with “podium policies.”

EC: Last year when you and Ali were kind enough to be interviewed for this magazine… I guess he’s off somewhere else in the world on another mission… We can’t be selfish and keep everyone from FDA here. There have been some changes… I’m assuming that a large number of other companies have given intent to do PAT. You’d said there were no plans to change the guidance or to reissue another PAT guidance. But I guess “do it the best you can scientifically” doesn’t need to be improved.

CW: Absolutely. But we did get a lot of questions about PAT vs. QbD and whether the Agency was losing interest in PAT. If anything, we’re more interested in PAT than ever before. And it’s not just the new drugs. The most encouraging thing to me is… well, consider IFPAC. In the four or five years that I’ve been coming to this conference, the progression in the discussion on PAT in pharma has gone far beyond the academic exercise … "This is what we could do, and this is what we may do” to “This is what we’ve done and this is what we’re going to do tomorrow and this, the next day.”

EC: So we’re not doing what I’ve always referred to as “PAT by PowerPoint”?

CW: Exactly. And, by the way, we use that phrase all the time. David Radspinner and I did a session just this morning. We said, when we put this session together, pharma’s made significant progressions in applying PAT. We said, “We know PAT by PowerPoint,” but we want good, strong examples of what has actually been done. It was a good session, and there have been a couple of really strong sessions at this year’s conference.

EC: Originally in 1998 — I was reminiscing with Moheb — he was in an IFPAC session that I was organizing in San Diego. In those days, I had one session in the morning, and Rick Cooley had one in the afternoon, and that was it for the week. Everyone went off to the gaming tables or to Lake Las Vegas in between. But look at the program now, with all the three, four, five concurrent sessions. Large as I am, I can’t split myself up to attend them all. It is almost frustrating. It has really exploded.

CW: You can’t keep up with everything that’s happening. The excitement for us is the variety of PAT projects. The perception in the industry is that the large pharma companies are the only ones doing PAT. In fact, while the large ones are obviously very active, we have some really great examples of PAT being done by smaller companies, by generics manufacturers.

EC: Other than by Ajaz's team at Sandoz?

CW: We also see more biotech examples. It’s encouraging to see the breadth and depth of activity in the pharma industry.

EC: I see biotech more and more and am getting contacts here and abroad. I used to laugh about NIR. People used to ask me about three uses… but PAT has given it new life. Tell me about EMEA. They seem to be pretty neutral regarding PAT. They’re not against it, but they’re not pushing it like FDA.

CW: I know they’re active in it. We’re all on the same page re: discussions of ICH Q8.There are no philosophical differences. They’re supporting it, but different regions may have different regulations by which they have to operate. Moheb and Helen have both been very active in maintaining links with EMEA, meeting with EMEA and discussing PAT with them. On more than one occasion, PAT has been the specific subject of meetings.

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