Case for Quality, with Cisco Vicenty

Recorded at the KENX GMP University in San Diego, Dori welcomes special guest and FDA Case For Quality Program Manager, Cisco Vicenty. They sit down together to to recap some important takeaways from the conference, as well as to discuss what is being done to enhance collaboration between the industry and regulators to help drive a shift in mindset and advance innovation in life sciences.

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*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.

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Transcript

Dori Gonzalez-Acevedo: 0:49

Good morning, Cisco. How are you?

Cisco Vicenty: 0:51

I am great. Thank you, Dory. It's it's really great to be here. And it's gorgeous. All

Dori Gonzalez-Acevedo: 0:56

right, so we are at the second day of connects GMP University here in San Diego. It's the first time you've been in person for quite some time.

Cisco Vicenty: 1:05

Well, since COVID, hit we've been on restricted travel. So I don't think I could have been a better place. The first travel opportunity we got back.

Dori Gonzalez-Acevedo: 1:14

That's great. That's wonderful. And thank you for your support. And being here at Connects yourself as well as other colleagues have been here, right?

Cisco Vicenty: 1:22

This was a big opportunity. I actually, I regret that we didn't get internally, you know, now that we are traveling again, there is still the bureaucratic paperwork that goes on to get it set up and approved. And they didn't manage to get all that paperwork in time to even be here in person, which you could have done, it would have been a great eye opening opportunity for them. But they've been online, and they've really been getting a lot out of the sessions.

Dori Gonzalez-Acevedo: 1:48

That's great. Is there some first time ft folks been?

Cisco Vicenty: 1:51

Absolutely, absolutely, um, you know, we've been doing well, let me say we were FDA, but mostly my participation in some of the connects things for a few years now. Each of the sessions and the different focus that they bring is a new learning opportunity. But I think what I found this one to provide was it gave insights into a lot of the similar work that's going on through our partner drug center. And it was good to come see the perspective of all people responding to that. Not for the sake of, you know, anything negative, but it's our learning opportunity, too, right? In some cases, it's a good chance to say, oh, there's not responding well, we shouldn't do something like we should redirect to the other direction. Yeah.

Dori Gonzalez-Acevedo: 2:39

So actually having real life feedback loop, not only in a maybe a form that someone submits online, right, but you actually get to meet the people. You hear other the circumstances of which some of those issues are coming up. And

Cisco Vicenty: 2:53

and you have a nice discussion with the the even the people who are voicing a negative opinion or who are, you know, maybe counter to any of the points we've made or tried to make, because when you do have that discussion, real time not in feedback through like the typical guidance or docket processes that we've got, there's no context behind where it's coming from. It's just the message here, you really get a chance to hear. But why is that the case? What is it that we're not saying that's communicating what you're saying? Because it's aligned? We're in the same spot. Right,

Dori Gonzalez-Acevedo: 3:28

right. Yeah, I think that you were in the think tank yesterday that I led around quality metrics. And I think that a lot of that conversation was so rich, and we probably could have talked a lot lot longer, right? Because every situation is, is unique. And there's no one prescribed answer to solve a political issue. And I think what was really helpful for the folks in the room to hear your perspective on that from a regulator perspective, and then also hear from the sponsor side.

Cisco Vicenty: 4:01

Yeah, actually, you know, we I actually had a chance to meet with my co workers on top of the fact that they've already had great feedback. Some of them have even been quoting materials from the sessions or the slides or talking about it in our internal chats. The session yesterday. I've had the experience just by time and fortune, but I think it's the first time they saw that industries are willing to be open. And that was a great session and we had somebody who was brave enough to share and here's what we've got, even though we were in the room. And that makes a difference because an hour and people want to help but that kind of dynamic sharing of information with the companies and I go back the the say the one of the quotes that came out of it, your quote is not proprietary. Exactly. And it was enough that even somebody wrote it down and said goodbye. To me, right? It's true, right? And the best people can help each other isn't necessarily us at FDA. Right? It's you each other the companies themselves, there's nothing in what they do. That is the secret sauce. Right? Right. It's that engagement, that sharing that everybody learns everybody comes up to speed up the same way. We move forward.

Dori Gonzalez-Acevedo: 5:23

Yeah, I think it's, you know, being I've been on both sides, right? Not, but not on the regulator side. But both sides of a sponsor versus consultant or vendor side and the, the, there's a healthy competition, for me is really a hard word, I really try to discourage that word in that, and I think you're aligned in that it's a collaboration. And even when you have a medical or two or three medical device companies that produce the same sort of product, same intended outcomes, all those sorts of things. It doesn't mean that we can't have a collaborative conversation about what makes sense. If you have the patient in mind.

Cisco Vicenty: 6:07

I absolutely, I think that is, you know, something that we need to do a much better job collectively promoting right? Prior to FDA, I worked in semiconductor, and there's not a lot, the competition's are tight, the margins are tight. And even with all that, you know, our biggest competitors were also our biggest partners on prod. Right. Right. Yeah, it was. That's how you did things.

Dori Gonzalez-Acevedo: 6:35

Yeah. And I would have thought, you know, with COVID, and hopefully, some of the better outcomes of COVID are higher collaboration efforts across the supply chain. We had another session earlier in the day around supply chain and the effects and Denise and I were a part of that with Brian and his group. And, and I think that how to capitalize on the things that we had to do during COVID into making it to be Amanda, kind of a mandatory, ingrained part of how we operate moving forward. So what are some of those things?

Cisco Vicenty: 7:09

Yeah, there's, Wow, there's so much that that, first of all happened in that, in that capacity, right? People rethinking how they engage with their suppliers, right? It wasn't so much a push anymore for who's gonna give me the cheapest price is okay, we are in this together, we either all swim or we all sink, we need to collaborate, we need to build a stronger partnership, we need to have stronger communication. With a lot of the companies starting to implement more technology, because remote workers were there. They're trying to get that shift going. That mindset started to permeate, are they starting to permeate down into the supply chains, right, and their suppliers? How do we make them part of our system? So it's not a discrete process? So we can get more?

Dori Gonzalez-Acevedo: 8:03

Not us in them conversation. But we conversation?

Cisco Vicenty: 8:07

Yeah, you want that continuous flow of information? Right, because that's how you prepare for the next issue.

Dori Gonzalez-Acevedo: 8:13

So one of the things that we were talking about in the think tank yesterday was how to enroll folks that are not currently in the rooms here at Connects, you know, here at FDIC, though, you know, because those sorts of initiatives are volunteer based initiatives and with your new VIP program, is the first word is voluntary. Yeah, exactly. It's basically how do we, as an industry enroll? Get folks on board? Are you somebody?

Cisco Vicenty: 8:42

So, you know, we did it in some of the programs, and we recognize that there is a need, right? When we as an agency offer a an acknowledgement, right, we recognize what the company is doing and the exchange of information, we get in a different format that we could say this satisfies what we're looking for, from this set of regulatory activities. Let's scale back, what we look at or what we see, that offers a an incentive, right, that first kickoff value, here's why I would do this, I don't want to, you know, I, we're gonna go through this. And I'm sure somebody is going to hear it from FDA and say, You really shouldn't have said it that way. But the reality is, it's true. You know, one of the things that we've done is, okay, you've given us this information, you're going through these maturity assessments. You can see even where there's dips, but we see the progress and the progression. If there's no other major signals going on, that becomes part of our risk based planning. We don't need to go and inspect the site. That's a huge incentive for a lot of companies, just even that portion. But there's a lot more we can do. There's a lot more we can really dynamically think differently about how we approach the regulations. So that's the start but as we found even with our VIP company, And we've said it multiple times. All that is, is your initial kickstart, right? That's your that's your marketing phase for your CEO. Why would I play? Well, you get this and that saves us X X X X, most of the company who've been enrolled in the VIP program don't even consider those benefits anymore, because they've started to gain so much of their value from their process improvements. That's, and that's, by scales bigger than whatever we're offering.

Dori Gonzalez-Acevedo: 10:27

Absolutely. The, you know, the guidance is whether or not they come out or not, yeah, I don't even want to get into because at the end of the day, right, I think that what I hear on the ground, like that's on the ground, there's still a really big disconnect between internal company auditors, like, folks, their internal quality, internal auditing programs, and what FDA is expecting or asking of, and that conversation is really hard to navigate. So I was wondering if you can shed some insight on that

Cisco Vicenty: 11:08

I honestly, and this is where I am. That's feedback. You've heard too, oh, well, 100%, open to any ideas on how we drive culture shift how we communicate, because I guarantee if and when the guidance or any guidance that we do come out comes out that culture shift, or that culture that's already great, and company isn't gonna believe it, it's just not going to buy that that's really what we're saying in that guidance. You know, I've had cases where we've done and talked about the material or what's coming out in the guidance. And here's what we expect, and have people literally in the room tell us that's not what FDA wants, right? How do you go about kind of changing that mindset, when you've got FDA telling you, here's what it is, right? And someone says, No, that's not what you want. You know, we've got, I guess, we got some work to do on our end to train up our investigators to be more in this case, but I can assure you that a lot of what the investigators to look for done has never really amounted to what is driving this type of cultural reaction and industry. Yeah. So it is, you know, getting the message out, getting more things exposed, letting people know that it's safe to come and talk to us directly. If they have questions. Even if it's, you know, a situation where you're not in alignment, or you feel that there's a disagreement within your own company's regulatory groups and what you're pushing for. Come talk to us, you don't need to go through the regulatory groups to do it. And that we've done right, we've gone to meetings with the EXPLAIN between the groups who say, this is okay, right, we've looked at process changes that they've made and reviewed them and given them you need a written paper that says this is okay, here's a written test. This is within, you know, looks like it is in compliance with what we're looking for in the regs. And that helps move the needle, but it's company by company. Right?

Dori Gonzalez-Acevedo: 13:02

Right. As it is, it's an individual thing and part of my dinner conversation with some folks last night, right, that that company value structure is formed in many of these cases, decades ago, yes. And in order to, you can't change company culture, if it's, you know, 100 years old,

Cisco Vicenty: 13:24

it's tough.

Dori Gonzalez-Acevedo: 13:26

It's really hard. And so, you know, on the flip side, I do work with and see some preclinical and clinical folks, and the amount of innovation that they're bringing to the table is so exciting to me. It's just mind blowing, and how embracing of change that they are, and what they're spinning up and all those sorts of things. And yet, unfortunately, comes to when they ready to dip into the commercial side, right? It's they are getting hit with this roadblock of old quality mindset, again, whether it's internal auditors or even external auditors that are brought from the industry, right and come in and do it's, there's, so I'm wondering, I'm just brainstorming, like how to spark interest in the new generation. Because I think that even hearing some of we were talking about there's kind of three phases of career right, your beginning stage and middle and your end. There's some really wonderful beginning stage folks here, how to inspire and get them excited and wanting to enter in an arena where it's already heavily, you know, kind of situated in a rut. I don't how do we do that?

Cisco Vicenty: 14:52

That's actually a great question to think about. So there's stuff that you know, we could collectively do to try to You know, courses like these, can we get it even earlier in to the university classes? Right. You know, one of the things that I think I don't know if you're familiar with, you know, Xavier's program in their quality certificate, the know, so they created a program. You know, one of the things that came out of a case for quality VIP session was this idea of how to get more people interested in quality, especially at the college levels. So they created a quality certificate program that is focused on quality, I'm talking compliance, it is all the elements on quality of making the value case. But one of the things that I know early on, we talked about needing was a portion of that program that was built around having people just tell the story, right? That risk story, that value story, because that's where the quality professionals seem to lack and you don't learn that until you've been in industry for a while.

Dori Gonzalez-Acevedo: 16:02

You don't, right, that's been the, as I'm on the latter part of my career, trying to figure out ways to get all of that knowledge, all of those learnings in a consumable way, right, so that we can really, truly inspire the collaboration and thought provoking ways that everyone on the regulator side really wants to see. And is needed, right, in order to do the really cool stuff that is has been ideated out there and wanting to bring to patients. Yeah.

Cisco Vicenty: 16:31

And you've got all this. You know, like you said, all these fresh ideas as fresh perspective coming in people who are comfortable with technology, right from the onset, who want to bring that to the table know how to bring it to the table in the right way. I think giving them because they're always going to hit that same wall. And because they're young, they're fresh, they're always going to be seen as just not having been there long enough to know what really matters, right. So armed them with the tools to have a different conversation that bypasses that right. Give them what they need to say. Okay, great. When was the last time you saved the million dollars? Because this will save? You may get them to get more traction? Yeah, yeah.

Dori Gonzalez-Acevedo: 17:16

So what makes you excited about what's coming up in FDA? What are you guys working on? What is like, really?

Cisco Vicenty: 17:21

Oh, my goodness. So I don't know if, um, you know, people collected even paying a lot of attention. I did see some mention of it here. But, you know, within the device side, there's been a focus for, you know, these maturity activities and a different way of assessing an organization so that we can actively help them drive improvements and not be on the end of compliance. Right. And not saying that compliance is bad negative never said that's the case. It's just an issue of the way we've approached it collectively, industry and FDA, it's a binary activity, you're either in, or you're out, right? It's not, there's not a scale of Right. Um, so why don't we help companies just be better focused on the better patient outcome because that compliance will happen. So we've done that, and we're working on that within the Center for Devices. But cedar has been talking about that for a while. And they've got various activities they've done to try to get to that point. But now they seem to be ramping up, we've been collaborating and sharing information connecting them with the same resources we've had. And it's taken a bit more impetus there. So that's big, I think, last I saw, I think even Veterinary Medicines was developing something along those lines. So it's starting to get traction, the idea of finding another way to evaluate a company's, you know, excellence in some ways. So

Dori Gonzalez-Acevedo: 18:55

does that need or require some new skill set at the FDA? Are you guys recruiting? What are you like? How are you handling that?

Cisco Vicenty: 19:04

I think it needs a couple of things in the Tom, not necessarily, you know, a new skill set. I think actually, our investigators are really well equipped to do this. We need to give them the training and the tools, right to be able to do that. And the reality of matter is there's got to be some adjustment in some legal authorities, right? Because the way they're written and now they're just kind of handcuffed to one paradigm. Right, right. And they are actually really well equipped to have a completely different discussion. And I think they want to have that discussion. Most of them do, right and when you get really good investigator we hear all the time, someone will say I'm going to close a notebook. Now this is not the record, right? And the company's value that but there's things that need to be modified to get there. What we also need to do though is that It isn't a one sided activity, right? We need to get industry understanding what it means to be focusing on maturity approach. One of the big things that we've also been working on and this is not just FDA, this is every manufacturing initiative within the US, right is all coming down from the White House, we must get more advanced manufacturing in these companies. Yeah. more technology, more implementation, more machine learning more AI. We've got several programs that are cross cutting across the agency that are focused on how do we bring more technology to manufacturers? Because that's also part of that journey. Right, right. information, data, that's your keys to speed and control and knowing what's going on with your product. Right.

Dori Gonzalez-Acevedo: 20:54

That's the hard part. Yeah. Strategic assessments for a lot of companies, it's having those slower conversations, asking lots of questions that they might not the stakeholders, at least in the room might not know the answers to. And then we have to figure out who does know this stuff? Who is doing the work, right? I know, like on the sales side of folks don't often want to slow down those conversations for variety of reasons. And they and then on the customer side, or the sponsor side, we have all these other projects we have to do, how do we fit this other thing in? Right? So I tried to argue there's a space for quality everywhere. Yeah, there is to my it has to be everywhere. It has to be everywhere. Right? And so do you see it, you know, any better or worse, whether that quality function is within the grander scheme of the leadership team? You know, siloed, outside, like, do you see?

Cisco Vicenty: 21:51

So that's the the biggest thing we think we're trying to combat is something that has evolved over time across the regulated industries, right? It's that breaking out and siloing of quality, because of the way the regs are written, right? There's a quality owner, right? You know, they own all these people management, exactly. They own the enforcement of things, right, instead of the value proposition, and that's unique to the life sciences, you go to any other industry, and quality has to be integrated everywhere, right? Most quality teams, very lean, because their role is more coaching, right? Educating, putting together the tool. And

Dori Gonzalez-Acevedo: 22:38

that's a great point, because then they don't have the numbers right, needed to support. And I see that on the software development side, right? It's often when we're wanting to build an Agile team. We don't have enough as QA folks representative, because it's always, oh, well, you know, you can manage five projects, because it only should be like 10% of your time. And you should be able to divide it up and manage all these things. But no one really gets to the heart of you need to be all invested.

Cisco Vicenty: 23:01

Yeah, exactly. Yeah. You if you go in that route, fine. But everyone's all in because now everybody owns a piece of it. Right?

Dori Gonzalez-Acevedo: 23:08

Yeah. Awesome. Well, I don't want to take up too much of your time. I know we have a whole nother rest of the day, full day, and I really appreciate you sitting down with us.

Cisco Vicenty: 23:17

Thank you. Thank you for the opportunity. It's been so long. I will leave in the show

Dori Gonzalez-Acevedo: 23:21

notes folks can reach out encouraged to reach out to the FTAs that's what you're saying. And what's the message we want to hear if I remember buddy is call when you need help.

Cisco Vicenty: 23:31

Absolutely. Awesome. Thank you