September 2, 2022 • 24 mins
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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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Dori Gonzalez-Acevedo (00:49):
Good morning, Cisco. How are you?
Cisco Vicenty (00:51):
I am great. Thank you, Dory. It's it's really
great to be here. And it'sgorgeous. All
Dori Gonzalez-Acevedo (00:56):
right, so we are at the second day of
connects GMP University here inSan Diego. It's the first time
you've been in person for quitesome time.
Cisco Vicenty (01:05):
Well, since COVID, hit we've been on
restricted travel. So I don'tthink I could have been a better
place. The first travelopportunity we got back.
Dori Gonzalez-Acevedo (01:14):
That's great. That's wonderful. And
thank you for your support. Andbeing here at Connects yourself
as well as other colleagues havebeen here, right?
Cisco Vicenty (01:22):
This was a big opportunity. I actually, I
regret that we didn't getinternally, you know, now that
we are traveling again, there isstill the bureaucratic paperwork
that goes on to get it set upand approved. And they didn't
manage to get all that paperworkin time to even be here in
person, which you could havedone, it would have been a great
(01:43):
eye opening opportunity forthem. But they've been online,
and they've really been gettinga lot out of the sessions.
Dori Gonzalez-Acevedo (01:48):
That's great. Is there some first time
ft folks been?
Cisco Vicenty (01:51):
Absolutely, absolutely, um, you know, we've
been doing well, let me say wewere FDA, but mostly my
participation in some of theconnects things for a few years
now. Each of the sessions andthe different focus that they
bring is a new learningopportunity. But I think what I
(02:12):
found this one to provide was itgave insights into a lot of the
similar work that's going onthrough our partner drug center.
And it was good to come see theperspective of all people
responding to that. Not for thesake of, you know, anything
negative, but it's our learningopportunity, too, right? In some
(02:34):
cases, it's a good chance tosay, oh, there's not responding
well, we shouldn't do somethinglike we should redirect to the
other direction. Yeah.
Dori Gonzalez-Acevedo (02:39):
So actually having real life
feedback loop, not only in amaybe a form that someone
submits online, right, but youactually get to meet the people.
You hear other the circumstancesof which some of those issues
are coming up. And
Cisco Vicenty (02:53):
and you have a nice discussion with the the
even the people who are voicinga negative opinion or who are,
you know, maybe counter to anyof the points we've made or
tried to make, because when youdo have that discussion, real
time not in feedback throughlike the typical guidance or
docket processes that we've got,there's no context behind where
(03:15):
it's coming from. It's just themessage here, you really get a
chance to hear. But why is thatthe case? What is it that we're
not saying that's communicatingwhat you're saying? Because it's
aligned? We're in the same spot.
Right,
Dori Gonzalez-Acevedo (03:28):
right.
Yeah, I think that you were inthe think tank yesterday that I
led around quality metrics. AndI think that a lot of that
conversation was so rich, and weprobably could have talked a lot
lot longer, right? Because everysituation is, is unique. And
there's no one prescribed answerto solve a political issue. And
(03:49):
I think what was really helpfulfor the folks in the room to
hear your perspective on thatfrom a regulator perspective,
and then also hear from thesponsor side.
Cisco Vicenty (04:01):
Yeah, actually, you know, we I actually had a
chance to meet with my coworkers on top of the fact that
they've already had greatfeedback. Some of them have even
been quoting materials from thesessions or the slides or
talking about it in our internalchats. The session yesterday.
(04:24):
I've had the experience just bytime and fortune, but I think
it's the first time they sawthat industries are willing to
be open. And that was a greatsession and we had somebody who
was brave enough to share andhere's what we've got, even
though we were in the room. Andthat makes a difference because
an hour and people want to helpbut that kind of dynamic sharing
(04:47):
of information with thecompanies and I go back the the
say the one of the quotes thatcame out of it, your quote is
not proprietary. Exactly. And itwas enough that even somebody
wrote it down and said goodbye.
To me, right? It's true, right?
And the best people can helpeach other isn't necessarily us
at FDA. Right? It's you eachother the companies themselves,
(05:10):
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 tospeed up the same way. We move
forward.
Dori Gonzalez-Acevedo (05:23):
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 sponsorversus consultant or vendor side
and the, the, there's a healthycompetition, for me is really a
hard word, I really try todiscourage that word in that,
and I think you're aligned inthat it's a collaboration. And
(05:47):
even when you have a medical ortwo or three medical device
companies that produce the samesort of product, same intended
outcomes, all those sorts ofthings. It doesn't mean that we
can't have a collaborativeconversation about what makes
sense. If you have the patientin mind.
Cisco Vicenty (06:07):
I absolutely, I think that is, you know,
something that we need to do amuch better job collectively
promoting right? Prior to FDA, Iworked in semiconductor, and
there's not a lot, thecompetition's are tight, the
margins are tight. And even withall that, you know, our biggest
(06:29):
competitors were also ourbiggest partners on prod. Right.
Right. Yeah, it was. That's howyou did things.
Dori Gonzalez-Acevedo (06:35):
Yeah. And I would have thought, you know,
with COVID, and hopefully, someof the better outcomes of COVID
are higher collaboration effortsacross the supply chain. We had
another session earlier in theday around supply chain and the
effects and Denise and I were apart of that with Brian and his
group. And, and I think that howto capitalize on the things that
(06:58):
we had to do during COVID intomaking it to be Amanda, kind of
a mandatory, ingrained part ofhow we operate moving forward.
So what are some of thosethings?
Cisco Vicenty (07:09):
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 withtheir suppliers, right? It
wasn't so much a push anymorefor who's gonna give me the
cheapest price is okay, we arein this together, we either all
(07:30):
swim or we all sink, we need tocollaborate, we need to build a
stronger partnership, we need tohave stronger communication.
With a lot of the companiesstarting to implement more
technology, because remoteworkers were there. They're
trying to get that shift going.
That mindset started topermeate, are they starting to
(07:51):
permeate down into the supplychains, right, and their
suppliers? How do we make thempart of our system? So it's not
a discrete process? So we canget more?
Dori Gonzalez-Acevedo (08:03):
Not us in them conversation. But we
conversation?
Cisco Vicenty (08:07):
Yeah, you want that continuous flow of
information? Right, becausethat's how you prepare for the
next issue.
Dori Gonzalez-Acevedo (08:13):
So one of the things that we were talking
about in the think tankyesterday was how to enroll
folks that are not currently inthe rooms here at Connects, you
know, here at FDIC, though, youknow, because those sorts of
initiatives are volunteer basedinitiatives and with your new
VIP program, is the first wordis voluntary. Yeah, exactly.
(08:33):
It's basically how do we, as anindustry enroll? Get folks on
board? Are you somebody?
Cisco Vicenty (08:42):
So, you know, we did it in some of the programs,
and we recognize that there is aneed, right? When we as an
agency offer a anacknowledgement, right, we
recognize what the company isdoing and the exchange of
information, we get in adifferent format that we could
say this satisfies what we'relooking for, from this set of
(09:03):
regulatory activities. Let'sscale back, what we look at or
what we see, that offers a anincentive, right, that first
kickoff value, here's why Iwould do this, I don't want to,
you know, I, we're gonna gothrough this. And I'm sure
somebody is going to hear itfrom FDA and say, You really
shouldn't have said it that way.
But the reality is, it's true.
(09:24):
You know, one of the things thatwe've done is, okay, you've
given us this information,you're going through these
maturity assessments. You cansee even where there's dips, but
we see the progress and theprogression. If there's no other
major signals going on, thatbecomes part of our risk based
planning. We don't need to goand inspect the site. That's a
(09:44):
huge incentive for a lot ofcompanies, just even that
portion. But there's a lot morewe can do. There's a lot more we
can really dynamically thinkdifferently about how we
approach the regulations. Sothat's the start but as we found
even with our VIP company, Andwe've said it multiple times.
All that is, is your initialkickstart, right? That's your
(10:06):
that's your marketing phase foryour CEO. Why would I play?
Well, you get this and thatsaves us X X X X, most of the
company who've been enrolled inthe VIP program don't even
consider those benefits anymore,because they've started to gain
so much of their value fromtheir process improvements.
That's, and that's, by scalesbigger than whatever we're
offering.
Dori Gonzalez-Aceve (10:27):
Absolutely.
The, you know, the guidance iswhether or not they come out or
not, yeah, I don't even want toget into because at the end of
the day, right, I think thatwhat I hear on the ground, like
that's on the ground, there'sstill a really big disconnect
between internal companyauditors, like, folks, their
(10:49):
internal quality, internalauditing programs, and what FDA
is expecting or asking of, andthat conversation is really hard
to navigate. So I was wonderingif 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 howwe communicate, because I
guarantee if and when theguidance or any guidance that we
do come out comes out thatculture shift, or that culture
that's already great, andcompany isn't gonna believe it,
(11:29):
it's just not going to buy thatthat's really what we're saying
in that guidance. You know, I'vehad cases where we've done and
talked about the material orwhat's coming out in the
guidance. And here's what weexpect, and have people
literally in the room tell usthat's not what FDA wants,
right? How do you go about kindof changing that mindset, when
you've got FDA telling you,here's what it is, right? And
(11:51):
someone says, No, that's notwhat you want. You know, we've
got, I guess, we got some workto do on our end to train up our
investigators to be more in thiscase, but I can assure you that
a lot of what the investigatorsto look for done has never
really amounted to what isdriving this type of cultural
(12:12):
reaction and industry. Yeah. Soit is, you know, getting the
message out, getting more thingsexposed, letting people know
that it's safe to come and talkto us directly. If they have
questions. Even if it's, youknow, a situation where you're
not in alignment, or you feelthat there's a disagreement
within your own company'sregulatory groups and what
(12:32):
you're pushing for. Come talk tous, you don't need to go through
the regulatory groups to do it.
And that we've done right, we'vegone to meetings with the
EXPLAIN between the groups whosay, this is okay, right, we've
looked at process changes thatthey've made and reviewed them
and given them you need awritten paper that says this is
okay, here's a written test.
(12:53):
This is within, you know, lookslike it is in compliance with
what we're looking for in theregs. And that helps move the
needle, but it's company bycompany. Right?
Dori Gonzalez-Acevedo (13:02):
Right. As it is, it's an individual thing
and part of my dinnerconversation with some folks
last night, right, that thatcompany value structure is
formed in many of these cases,decades ago, yes. And in order
to, you can't change companyculture, if it's, you know, 100
(13:23):
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 withand see some preclinical and
clinical folks, and the amountof innovation that they're
bringing to the table is soexciting to me. It's just mind
blowing, and how embracing ofchange that they are, and what
(13:48):
they're spinning up and allthose sorts of things. And yet,
unfortunately, comes to whenthey ready to dip into the
commercial side, right? It'sthey are getting hit with this
roadblock of old qualitymindset, again, whether it's
internal auditors or evenexternal auditors that are
(14:09):
brought from the industry, rightand come in and do it's,
there's, so I'm wondering, I'mjust brainstorming, like how to
spark interest in the newgeneration. Because I think that
even hearing some of we weretalking about there's kind of
three phases of career right,your beginning stage and middle
(14:31):
and your end. There's somereally wonderful beginning stage
folks here, how to inspire andget them excited and wanting to
enter in an arena where it'salready heavily, you know, kind
of situated in a rut. I don'thow 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 thatI 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
(15:16):
know, one of the things thatcame out of a case for quality
VIP session was this idea of howto get more people interested in
quality, especially at thecollege levels. So they created
a quality certificate programthat is focused on quality, I'm
talking compliance, it is allthe elements on quality of
making the value case. But oneof the things that I know early
(15:40):
on, we talked about needing wasa portion of that program that
was built around having peoplejust tell the story, right? That
risk story, that value story,because that's where the quality
professionals seem to lack andyou don't learn that until
you've been in industry for awhile.
Dori Gonzalez-Acevedo (16:02):
You don't, right, that's been the,
as I'm on the latter part of mycareer, trying to figure out
ways to get all of thatknowledge, all of those
learnings in a consumable way,right, so that we can really,
truly inspire the collaborationand thought provoking ways that
everyone on the regulator sidereally wants to see. And is
(16:23):
needed, right, in order to dothe really cool stuff that is
has been ideated out there andwanting to bring to patients.
Yeah.
Cisco Vicenty (16:31):
And you've got all this. You know, like you
said, all these fresh ideas asfresh perspective coming in
people who are comfortable withtechnology, right from the
onset, who want to bring that tothe table know how to bring it
to the table in the right way. Ithink giving them because
they're always going to hit thatsame wall. And because they're
(16:53):
young, they're fresh, they'realways going to be seen as just
not having been there longenough to know what really
matters, right. So armed themwith the tools to have a
different conversation thatbypasses 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 mayget them to get more traction?
(17:13):
Yeah, yeah.
Dori Gonzalez-Acevedo (17:16):
So what makes you excited about what's
coming up in FDA? What are youguys working on? What is like,
really?
Cisco Vicenty (17:21):
Oh, my goodness.
So I don't know if, um, youknow, people collected even
paying a lot of attention. I didsee some mention of it here.
But, you know, within the deviceside, there's been a focus for,
you know, these maturityactivities and a different way
of assessing an organization sothat we can actively help them
drive improvements and not be onthe end of compliance. Right.
(17:45):
And not saying that complianceis bad negative never said
that's the case. It's just anissue of the way we've
approached it collectively,industry and FDA, it's a binary
activity, you're either in, oryou're out, right? It's not,
there's not a scale of Right.
(18:06):
Um, so why don't we helpcompanies just be better focused
on the better patient outcomebecause that compliance will
happen. So we've done that, andwe're working on that within the
Center for Devices. But cedarhas been talking about that for
a while. And they've got variousactivities they've done to try
to get to that point. But nowthey seem to be ramping up,
(18:27):
we've been collaborating andsharing information connecting
them with the same resourceswe've had. And it's taken a bit
more impetus there. So that'sbig, I think, last I saw, I
think even Veterinary Medicineswas developing something along
those lines. So it's starting toget traction, the idea of
(18:50):
finding another way to evaluatea 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 guysrecruiting? 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 newskill set. I think actually, our
investigators are really wellequipped to do this. We need to
give them the training and thetools, right to be able to do
that. And the reality of matteris there's got to be some
(19:24):
adjustment in some legalauthorities, right? Because the
way they're written and nowthey're just kind of handcuffed
to one paradigm. Right, right.
And they are actually reallywell equipped to have a
completely different discussion.
And I think they want to havethat discussion. Most of them
do, right and when you getreally good investigator we hear
all the time, someone will sayI'm going to close a notebook.
(19:46):
Now this is not the record,right? And the company's value
that but there's things thatneed to be modified to get
there. What we also need to dothough is that It isn't a one
sided activity, right? We needto get industry understanding
(20:08):
what it means to be focusing onmaturity approach. One of the
big things that we've also beenworking on and this is not just
FDA, this is every manufacturinginitiative within the US, right
is all coming down from theWhite House, we must get more
advanced manufacturing in thesecompanies. Yeah. more
(20:29):
technology, more implementation,more machine learning more AI.
We've got several programs thatare cross cutting across the
agency that are focused on howdo we bring more technology to
manufacturers? Because that'salso part of that journey.
Right, right. information, data,that's your keys to speed and
(20:50):
control and knowing what's goingon with your product. Right.
Dori Gonzalez-Acevedo (20:54):
That's the hard part. Yeah. Strategic
assessments for a lot ofcompanies, it's having those
slower conversations, askinglots of questions that they
might not the stakeholders, atleast in the room might not know
the answers to. And then we haveto figure out who does know this
stuff? Who is doing the work,right? I know, like on the sales
(21:17):
side of folks don't often wantto slow down those conversations
for variety of reasons. And theyand then on the customer side,
or the sponsor side, we have allthese other projects we have to
do, how do we fit this otherthing in? Right? So I tried to
argue there's a space forquality everywhere. Yeah, there
is to my it has to beeverywhere. It has to be
everywhere. Right? And so do yousee it, you know, any better or
(21:42):
worse, whether that qualityfunction 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 somethingthat has evolved over time
across the regulated industries,right? It's that breaking out
and siloing of quality, becauseof the way the regs are written,
right? There's a quality owner,right? You know, they own all
(22:11):
these people management,exactly. They own the
enforcement of things, right,instead of the value
proposition, and that's uniqueto the life sciences, you go to
any other industry, and qualityhas to be integrated everywhere,
right? Most quality teams, verylean, because their role is more
(22:33):
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 developmentside, right? It's often when
we're wanting to build an Agileteam. We don't have enough as QA
folks representative, becauseit's always, oh, well, you know,
you can manage five projects,because it only should be like
10% of your time. And you shouldbe able to divide it up and
manage all these things. But noone really gets to the heart of
(23:00):
you need to be all invested.
Cisco Vicenty (23:01):
Yeah, exactly.
Yeah. You if you go in thatroute, fine. But everyone's all
in because now everybody owns apiece of it. Right?
Dori Gonzalez-Acevedo (23:08):
Yeah.
Awesome. Well, I don't want totake up too much of your time. I
know we have a whole nother restof the day, full day, and I
really appreciate you sittingdown with us.
Cisco Vicenty (23:17):
Thank you. Thank you for the opportunity. It's
been so long. I will leave inthe show
Dori Gonzalez-Acevedo (23:21):
notes folks can reach out encouraged
to reach out to the FTAs that'swhat you're saying. And what's
the message we want to hear if Iremember buddy is call when you
need help.
Cisco Vicenty (23:31):
Absolutely.
Awesome. Thank you
Good morning, Cisco. How are you?
Cisco Vicenty (00:51):
I am great. Thank you, Dory. It's it's really
great to be here. And it'sgorgeous. All
Dori Gonzalez-Acevedo (00:56):
right, so we are at the second day of
connects GMP University here inSan Diego. It's the first time
you've been in person for quitesome time.
Cisco Vicenty (01:05):
Well, since COVID, hit we've been on
restricted travel. So I don'tthink I could have been a better
place. The first travelopportunity we got back.
Dori Gonzalez-Acevedo (01:14):
That's great. That's wonderful. And
thank you for your support. Andbeing here at Connects yourself
as well as other colleagues havebeen here, right?
Cisco Vicenty (01:22):
This was a big opportunity. I actually, I
regret that we didn't getinternally, you know, now that
we are traveling again, there isstill the bureaucratic paperwork
that goes on to get it set upand approved. And they didn't
manage to get all that paperworkin time to even be here in
person, which you could havedone, it would have been a great
(01:43):
eye opening opportunity forthem. But they've been online,
and they've really been gettinga lot out of the sessions.
Dori Gonzalez-Acevedo (01:48):
That's great. Is there some first time
ft folks been?
Cisco Vicenty (01:51):
Absolutely, absolutely, um, you know, we've
been doing well, let me say wewere FDA, but mostly my
participation in some of theconnects things for a few years
now. Each of the sessions andthe different focus that they
bring is a new learningopportunity. But I think what I
(02:12):
found this one to provide was itgave insights into a lot of the
similar work that's going onthrough our partner drug center.
And it was good to come see theperspective of all people
responding to that. Not for thesake of, you know, anything
negative, but it's our learningopportunity, too, right? In some
(02:34):
cases, it's a good chance tosay, oh, there's not responding
well, we shouldn't do somethinglike we should redirect to the
other direction. Yeah.
Dori Gonzalez-Acevedo (02:39):
So actually having real life
feedback loop, not only in amaybe a form that someone
submits online, right, but youactually get to meet the people.
You hear other the circumstancesof which some of those issues
are coming up. And
Cisco Vicenty (02:53):
and you have a nice discussion with the the
even the people who are voicinga negative opinion or who are,
you know, maybe counter to anyof the points we've made or
tried to make, because when youdo have that discussion, real
time not in feedback throughlike the typical guidance or
docket processes that we've got,there's no context behind where
(03:15):
it's coming from. It's just themessage here, you really get a
chance to hear. But why is thatthe case? What is it that we're
not saying that's communicatingwhat you're saying? Because it's
aligned? We're in the same spot.
Right,
Dori Gonzalez-Acevedo (03:28):
right.
Yeah, I think that you were inthe think tank yesterday that I
led around quality metrics. AndI think that a lot of that
conversation was so rich, and weprobably could have talked a lot
lot longer, right? Because everysituation is, is unique. And
there's no one prescribed answerto solve a political issue. And
(03:49):
I think what was really helpfulfor the folks in the room to
hear your perspective on thatfrom a regulator perspective,
and then also hear from thesponsor side.
Cisco Vicenty (04:01):
Yeah, actually, you know, we I actually had a
chance to meet with my coworkers on top of the fact that
they've already had greatfeedback. Some of them have even
been quoting materials from thesessions or the slides or
talking about it in our internalchats. The session yesterday.
(04:24):
I've had the experience just bytime and fortune, but I think
it's the first time they sawthat industries are willing to
be open. And that was a greatsession and we had somebody who
was brave enough to share andhere's what we've got, even
though we were in the room. Andthat makes a difference because
an hour and people want to helpbut that kind of dynamic sharing
(04:47):
of information with thecompanies and I go back the the
say the one of the quotes thatcame out of it, your quote is
not proprietary. Exactly. And itwas enough that even somebody
wrote it down and said goodbye.
To me, right? It's true, right?
And the best people can helpeach other isn't necessarily us
at FDA. Right? It's you eachother the companies themselves,
(05:10):
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 tospeed up the same way. We move
forward.
Dori Gonzalez-Acevedo (05:23):
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 sponsorversus consultant or vendor side
and the, the, there's a healthycompetition, for me is really a
hard word, I really try todiscourage that word in that,
and I think you're aligned inthat it's a collaboration. And
(05:47):
even when you have a medical ortwo or three medical device
companies that produce the samesort of product, same intended
outcomes, all those sorts ofthings. It doesn't mean that we
can't have a collaborativeconversation about what makes
sense. If you have the patientin mind.
Cisco Vicenty (06:07):
I absolutely, I think that is, you know,
something that we need to do amuch better job collectively
promoting right? Prior to FDA, Iworked in semiconductor, and
there's not a lot, thecompetition's are tight, the
margins are tight. And even withall that, you know, our biggest
(06:29):
competitors were also ourbiggest partners on prod. Right.
Right. Yeah, it was. That's howyou did things.
Dori Gonzalez-Acevedo (06:35):
Yeah. And I would have thought, you know,
with COVID, and hopefully, someof the better outcomes of COVID
are higher collaboration effortsacross the supply chain. We had
another session earlier in theday around supply chain and the
effects and Denise and I were apart of that with Brian and his
group. And, and I think that howto capitalize on the things that
(06:58):
we had to do during COVID intomaking it to be Amanda, kind of
a mandatory, ingrained part ofhow we operate moving forward.
So what are some of thosethings?
Cisco Vicenty (07:09):
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 withtheir suppliers, right? It
wasn't so much a push anymorefor who's gonna give me the
cheapest price is okay, we arein this together, we either all
(07:30):
swim or we all sink, we need tocollaborate, we need to build a
stronger partnership, we need tohave stronger communication.
With a lot of the companiesstarting to implement more
technology, because remoteworkers were there. They're
trying to get that shift going.
That mindset started topermeate, are they starting to
(07:51):
permeate down into the supplychains, right, and their
suppliers? How do we make thempart of our system? So it's not
a discrete process? So we canget more?
Dori Gonzalez-Acevedo (08:03):
Not us in them conversation. But we
conversation?
Cisco Vicenty (08:07):
Yeah, you want that continuous flow of
information? Right, becausethat's how you prepare for the
next issue.
Dori Gonzalez-Acevedo (08:13):
So one of the things that we were talking
about in the think tankyesterday was how to enroll
folks that are not currently inthe rooms here at Connects, you
know, here at FDIC, though, youknow, because those sorts of
initiatives are volunteer basedinitiatives and with your new
VIP program, is the first wordis voluntary. Yeah, exactly.
(08:33):
It's basically how do we, as anindustry enroll? Get folks on
board? Are you somebody?
Cisco Vicenty (08:42):
So, you know, we did it in some of the programs,
and we recognize that there is aneed, right? When we as an
agency offer a anacknowledgement, right, we
recognize what the company isdoing and the exchange of
information, we get in adifferent format that we could
say this satisfies what we'relooking for, from this set of
(09:03):
regulatory activities. Let'sscale back, what we look at or
what we see, that offers a anincentive, right, that first
kickoff value, here's why Iwould do this, I don't want to,
you know, I, we're gonna gothrough this. And I'm sure
somebody is going to hear itfrom FDA and say, You really
shouldn't have said it that way.
But the reality is, it's true.
(09:24):
You know, one of the things thatwe've done is, okay, you've
given us this information,you're going through these
maturity assessments. You cansee even where there's dips, but
we see the progress and theprogression. If there's no other
major signals going on, thatbecomes part of our risk based
planning. We don't need to goand inspect the site. That's a
(09:44):
huge incentive for a lot ofcompanies, just even that
portion. But there's a lot morewe can do. There's a lot more we
can really dynamically thinkdifferently about how we
approach the regulations. Sothat's the start but as we found
even with our VIP company, Andwe've said it multiple times.
All that is, is your initialkickstart, right? That's your
(10:06):
that's your marketing phase foryour CEO. Why would I play?
Well, you get this and thatsaves us X X X X, most of the
company who've been enrolled inthe VIP program don't even
consider those benefits anymore,because they've started to gain
so much of their value fromtheir process improvements.
That's, and that's, by scalesbigger than whatever we're
offering.
Dori Gonzalez-Aceve (10:27):
Absolutely.
The, you know, the guidance iswhether or not they come out or
not, yeah, I don't even want toget into because at the end of
the day, right, I think thatwhat I hear on the ground, like
that's on the ground, there'sstill a really big disconnect
between internal companyauditors, like, folks, their
(10:49):
internal quality, internalauditing programs, and what FDA
is expecting or asking of, andthat conversation is really hard
to navigate. So I was wonderingif 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 howwe communicate, because I
guarantee if and when theguidance or any guidance that we
do come out comes out thatculture shift, or that culture
that's already great, andcompany isn't gonna believe it,
(11:29):
it's just not going to buy thatthat's really what we're saying
in that guidance. You know, I'vehad cases where we've done and
talked about the material orwhat's coming out in the
guidance. And here's what weexpect, and have people
literally in the room tell usthat's not what FDA wants,
right? How do you go about kindof changing that mindset, when
you've got FDA telling you,here's what it is, right? And
(11:51):
someone says, No, that's notwhat you want. You know, we've
got, I guess, we got some workto do on our end to train up our
investigators to be more in thiscase, but I can assure you that
a lot of what the investigatorsto look for done has never
really amounted to what isdriving this type of cultural
(12:12):
reaction and industry. Yeah. Soit is, you know, getting the
message out, getting more thingsexposed, letting people know
that it's safe to come and talkto us directly. If they have
questions. Even if it's, youknow, a situation where you're
not in alignment, or you feelthat there's a disagreement
within your own company'sregulatory groups and what
(12:32):
you're pushing for. Come talk tous, you don't need to go through
the regulatory groups to do it.
And that we've done right, we'vegone to meetings with the
EXPLAIN between the groups whosay, this is okay, right, we've
looked at process changes thatthey've made and reviewed them
and given them you need awritten paper that says this is
okay, here's a written test.
(12:53):
This is within, you know, lookslike it is in compliance with
what we're looking for in theregs. And that helps move the
needle, but it's company bycompany. Right?
Dori Gonzalez-Acevedo (13:02):
Right. As it is, it's an individual thing
and part of my dinnerconversation with some folks
last night, right, that thatcompany value structure is
formed in many of these cases,decades ago, yes. And in order
to, you can't change companyculture, if it's, you know, 100
(13:23):
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 withand see some preclinical and
clinical folks, and the amountof innovation that they're
bringing to the table is soexciting to me. It's just mind
blowing, and how embracing ofchange that they are, and what
(13:48):
they're spinning up and allthose sorts of things. And yet,
unfortunately, comes to whenthey ready to dip into the
commercial side, right? It'sthey are getting hit with this
roadblock of old qualitymindset, again, whether it's
internal auditors or evenexternal auditors that are
(14:09):
brought from the industry, rightand come in and do it's,
there's, so I'm wondering, I'mjust brainstorming, like how to
spark interest in the newgeneration. Because I think that
even hearing some of we weretalking about there's kind of
three phases of career right,your beginning stage and middle
(14:31):
and your end. There's somereally wonderful beginning stage
folks here, how to inspire andget them excited and wanting to
enter in an arena where it'salready heavily, you know, kind
of situated in a rut. I don'thow 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 thatI 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
(15:16):
know, one of the things thatcame out of a case for quality
VIP session was this idea of howto get more people interested in
quality, especially at thecollege levels. So they created
a quality certificate programthat is focused on quality, I'm
talking compliance, it is allthe elements on quality of
making the value case. But oneof the things that I know early
(15:40):
on, we talked about needing wasa portion of that program that
was built around having peoplejust tell the story, right? That
risk story, that value story,because that's where the quality
professionals seem to lack andyou don't learn that until
you've been in industry for awhile.
Dori Gonzalez-Acevedo (16:02):
You don't, right, that's been the,
as I'm on the latter part of mycareer, trying to figure out
ways to get all of thatknowledge, all of those
learnings in a consumable way,right, so that we can really,
truly inspire the collaborationand thought provoking ways that
everyone on the regulator sidereally wants to see. And is
(16:23):
needed, right, in order to dothe really cool stuff that is
has been ideated out there andwanting to bring to patients.
Yeah.
Cisco Vicenty (16:31):
And you've got all this. You know, like you
said, all these fresh ideas asfresh perspective coming in
people who are comfortable withtechnology, right from the
onset, who want to bring that tothe table know how to bring it
to the table in the right way. Ithink giving them because
they're always going to hit thatsame wall. And because they're
(16:53):
young, they're fresh, they'realways going to be seen as just
not having been there longenough to know what really
matters, right. So armed themwith the tools to have a
different conversation thatbypasses 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 mayget them to get more traction?
(17:13):
Yeah, yeah.
Dori Gonzalez-Acevedo (17:16):
So what makes you excited about what's
coming up in FDA? What are youguys working on? What is like,
really?
Cisco Vicenty (17:21):
Oh, my goodness.
So I don't know if, um, youknow, people collected even
paying a lot of attention. I didsee some mention of it here.
But, you know, within the deviceside, there's been a focus for,
you know, these maturityactivities and a different way
of assessing an organization sothat we can actively help them
drive improvements and not be onthe end of compliance. Right.
(17:45):
And not saying that complianceis bad negative never said
that's the case. It's just anissue of the way we've
approached it collectively,industry and FDA, it's a binary
activity, you're either in, oryou're out, right? It's not,
there's not a scale of Right.
(18:06):
Um, so why don't we helpcompanies just be better focused
on the better patient outcomebecause that compliance will
happen. So we've done that, andwe're working on that within the
Center for Devices. But cedarhas been talking about that for
a while. And they've got variousactivities they've done to try
to get to that point. But nowthey seem to be ramping up,
(18:27):
we've been collaborating andsharing information connecting
them with the same resourceswe've had. And it's taken a bit
more impetus there. So that'sbig, I think, last I saw, I
think even Veterinary Medicineswas developing something along
those lines. So it's starting toget traction, the idea of
(18:50):
finding another way to evaluatea 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 guysrecruiting? 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 newskill set. I think actually, our
investigators are really wellequipped to do this. We need to
give them the training and thetools, right to be able to do
that. And the reality of matteris there's got to be some
(19:24):
adjustment in some legalauthorities, right? Because the
way they're written and nowthey're just kind of handcuffed
to one paradigm. Right, right.
And they are actually reallywell equipped to have a
completely different discussion.
And I think they want to havethat discussion. Most of them
do, right and when you getreally good investigator we hear
all the time, someone will sayI'm going to close a notebook.
(19:46):
Now this is not the record,right? And the company's value
that but there's things thatneed to be modified to get
there. What we also need to dothough is that It isn't a one
sided activity, right? We needto get industry understanding
(20:08):
what it means to be focusing onmaturity approach. One of the
big things that we've also beenworking on and this is not just
FDA, this is every manufacturinginitiative within the US, right
is all coming down from theWhite House, we must get more
advanced manufacturing in thesecompanies. Yeah. more
(20:29):
technology, more implementation,more machine learning more AI.
We've got several programs thatare cross cutting across the
agency that are focused on howdo we bring more technology to
manufacturers? Because that'salso part of that journey.
Right, right. information, data,that's your keys to speed and
(20:50):
control and knowing what's goingon with your product. Right.
Dori Gonzalez-Acevedo (20:54):
That's the hard part. Yeah. Strategic
assessments for a lot ofcompanies, it's having those
slower conversations, askinglots of questions that they
might not the stakeholders, atleast in the room might not know
the answers to. And then we haveto figure out who does know this
stuff? Who is doing the work,right? I know, like on the sales
(21:17):
side of folks don't often wantto slow down those conversations
for variety of reasons. And theyand then on the customer side,
or the sponsor side, we have allthese other projects we have to
do, how do we fit this otherthing in? Right? So I tried to
argue there's a space forquality everywhere. Yeah, there
is to my it has to beeverywhere. It has to be
everywhere. Right? And so do yousee it, you know, any better or
(21:42):
worse, whether that qualityfunction 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 somethingthat has evolved over time
across the regulated industries,right? It's that breaking out
and siloing of quality, becauseof the way the regs are written,
right? There's a quality owner,right? You know, they own all
(22:11):
these people management,exactly. They own the
enforcement of things, right,instead of the value
proposition, and that's uniqueto the life sciences, you go to
any other industry, and qualityhas to be integrated everywhere,
right? Most quality teams, verylean, because their role is more
(22:33):
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 developmentside, right? It's often when
we're wanting to build an Agileteam. We don't have enough as QA
folks representative, becauseit's always, oh, well, you know,
you can manage five projects,because it only should be like
10% of your time. And you shouldbe able to divide it up and
manage all these things. But noone really gets to the heart of
(23:00):
you need to be all invested.
Cisco Vicenty (23:01):
Yeah, exactly.
Yeah. You if you go in thatroute, fine. But everyone's all
in because now everybody owns apiece of it. Right?
Dori Gonzalez-Acevedo (23:08):
Yeah.
Awesome. Well, I don't want totake up too much of your time. I
know we have a whole nother restof the day, full day, and I
really appreciate you sittingdown with us.
Cisco Vicenty (23:17):
Thank you. Thank you for the opportunity. It's
been so long. I will leave inthe show
Dori Gonzalez-Acevedo (23:21):
notes folks can reach out encouraged
to reach out to the FTAs that'swhat you're saying. And what's
the message we want to hear if Iremember buddy is call when you
need help.
Cisco Vicenty (23:31):
Absolutely.
Awesome. Thank you
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