How the FDA Conducts a Clinical Trial Inspection: An Interview With Former FDA Inspector Patrick Stone

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have Patrick Stone with us as always. He is our favorite ex-FDA auditor, who is always kind, always comes online and talks to us about his experiences at FDA investigating and auditing multiple sites, multiple sponsors and not multiple manufacturers. Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast. With host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com. Darshan: Welcome Patrick, tell us more about yourself before we jump in. Patrick: Sure. I was with FDM for 13 years. For the past nine years, almost 10 now, I've been assisting with the manufacturing of drugs, but lately I've been assisting more with the clinical research side, the good clinical practice side. And there's been a lot of new orphan drugs and fast track drug sponsors that have needed assistance. So that's typically where I'm at right now, assisting sponsors make their way to market, if everything looks safe and effective. Darshan: Okay. We're talking about sponsors coming to market. We're talking about what steps they take. Here's my first question, Patrick, in these times of COVID, have things slowed down in sponsors bringing products to market? Patrick: I think they have accelerated from my perspective, because what I'm seeing is more sponsors are coming to consultants like myself, to get things done in a different way. We can do more virtually, we're finding out for the past seven months, than we could traveling around chasing compliance per se. In my guesstimation, I would say there's more because there's two factors involved in that. One is, the FDA is a lot more collaborative these days, and they're providing a little more assistance and consulting in a certain way, not pure consulting, but they're not telling sponsors, "Look, you figure it out. We'll talk to you later," that's not their approach anymore. Darshan: Okay. Patrick: Their approach is, "Let's work on this. Let's see if we can get this done compliant," and they're in a little more collaborative vein per se. You see a lot more sponsors or a lot more organizations that are bringing products to market that, per se, would have taken a little longer or would have needed more money now because of the fast track and the abridging per se, we're not shortening things, but we're somewhat abridging them from an FDA review standpoint. It would make sense that you would see a flood of products trying to emerge in that type of setting. Darshan: Before we talk about the quote unquote, abridging process, again, speaking as someone who follows the industry, who follows clinical research, do you think this is a result of the new FDA commissioner, or do you think this is just the direction the industry was headed and the FDA is finally accepting it? Patrick: The commissioner has some parts to do with that. They're part of a cabinet and the cabinet direction stipulate some of this, but I think what we're seeing more of is the actual centers are opening up their avenues and they're really the ones that drive this, CDRE, CBRE, they're the driving forces for whether a product makes it or not, not necessarily the commissioner, the commissioner just gives them kind of a direction, but I think what we've seen in the last three to four years with the right to try, and would say even six to seven years ago, a little further than that, it seemed like the administrations are wanting the long process of approval to be abridged, to be shortened in the way that is safe and that we still follow the quality by design specifications that are laid out and in the 21 CFR. Darshan: Quick question. And again, I have to admit,