Pathology Grand Rounds: February 2, 2023 - Andre l. Moreira MD, PhD

February 10, 2023

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Impact of Biorepository on Translational Research: Role of the Pathologist - by Andre I. Moreira, MD, PhD

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00:00OK. Hello everyone and welcome
00:02to pathology grand rounds.
00:04So this week we have the pleasure
00:06of welcoming a new speaker,
00:08Doctor Andre Moreira.
00:09And so doctor Andre Moreira has
00:11a long CV amongst many things.
00:14He's a professor of pathology
00:15at the New York University.
00:17He's the director of surgical pathology,
00:19director of the Center for Biospecimen
00:22Research and Development and
00:24Director of Thoracic Pathology
00:25in the same institution.
00:27He has over 190 publication
00:29has been very active.
00:30The field of thoracic pathology done
00:33many contributions in lung cancer,
00:35non tumor lung pathology,
00:37but also mesothelioma,
00:39thymoma and other related diseases.
00:42I realize now he has a lot of expertise
00:43in transplant pathology and and other
00:46areas that are very prominent at NYU.
00:50So he's clinical expertise is very,
00:52very prominent.
00:53He has trained many people.
00:55A few months ago I visited NYU and
00:58I realized that he actually has
00:59other skills that we didn't know.
01:02And because of that I requested
01:03him to speak about a slightly
01:05different topic this time.
01:06So he will not do the
01:08traditional pathology based,
01:10you know,
01:11morphology centered or
01:13clinically oriented talk,
01:14but he will talk about another
01:16operation he has been running
01:17for the last six years,
01:19which is a a
01:20very important and frequently underestimated
01:22by repository operation.
01:24So what he has been doing is supporting
01:26the whole institution in collecting,
01:29processing and distributing
01:30biospecimens for research.
01:32And this is a substantial
01:33operation he will talk about.
01:35And I think the role of the pathologist
01:37in this type of operations I think
01:40is very important and it's something
01:42worth learning about and noting.
01:44So without further ado,
01:46I welcome Doctor Moreda and thank you.
01:49Thank you, Kurt,
01:51for the introduction and for the
01:53invitation to talk to you today.
01:54So as I said,
01:56what I'm going to talk today is not very
02:00traditional even for a grand rounds,
02:02but I think it is interest especially
02:05for pathologists to see different areas
02:07that we can be involved and act on.
02:10So the outline of the talk,
02:13I'm going to say why there is a
02:16need for human tissue biospecimens.
02:18A little bit about collection,
02:21banking processing and distribution,
02:23and I'm talking mostly about
02:26the model that I use at NYU.
02:29Some financial considerations and the
02:32challenges that inevitable will come.
02:36So in the classical research model
02:40we go for invitro observations,
02:42testing in cell lines and then
02:45move to animal models.
02:48That is an easy experimentation and
02:50can manipulate the system much easier
02:53than anything else than in humans.
02:55And then basically used to
02:57formulate your questions,
02:58your hypothesis and then you need
03:00to go to human for a confirmation
03:03and validation of your findings.
03:05So the problem with this approach is
03:08that it takes a very long time and
03:11and there are a lot of issues that
03:14why we still need human at the end.
03:16For instance,
03:17cell lines,
03:18we know that they don't have a stable genome.
03:20They may not be representative of the disease
03:23that they originally came from or even from
03:26the organ that they originally come from.
03:29So everybody that have
03:30worked with cell lines,
03:31I mean there's a very well
03:33known ovarian cell line,
03:35there is not a single ovarian.
03:36More that looks like those cells,
03:38but that's where they come from.
03:41So the observations may not translate
03:43very well to clinical cases or
03:46especially to a general population.
03:48In the animal models,
03:50we have different physiologies,
03:52therefore there is a very
03:54different response to stimuli.
03:56What you can expect from humans.
03:58There is a great variation in
04:01morphology and especially for tumor.
04:03I'll show you some examples
04:05and again the observations.
04:07Cannot be.
04:08They may not translate very well to the
04:11clinical practice or to the patients
04:13due to difference in Physiology,
04:15general population,
04:16genomic variations and everything else.
04:19So this is just some examples.
04:22I'm talking about lung cancer
04:23because as he said,
04:24that's what I work most of the time.
04:27So in in animals.
04:30In most or many models of lung cancer
04:34in in in mice you can modify you can
04:39increase the expression of 1 gene
04:41gave Ross P53 any other gene that you
04:44want to express it will always form
04:47exactly the same the same tumor it
04:49start with a very small round nodule
04:52very well behaved that there is nothing
04:55like that in humans and if you live long
04:58enough they will have a little bit of.
05:00Angela formation. And like here,
05:03so you know, it sort of starts to
05:06recapitulate the human tissue.
05:07But when you look at lung cancer,
05:09it is completely variable.
05:11There is a very high
05:14heterogeneity in morphology.
05:15These patterns are very much mixed
05:19and in lung cancers in humans,
05:21every single pattern has a different meaning,
05:24different prognostic significance,
05:26which you cannot reproduce in mice, OK.
05:31So then there is has been this.
05:34Shift in for translational research.
05:39So this came mostly after the the TCG
05:42study that looked at all the the genome,
05:46the human genome so and it became available.
05:49So it was much easier to investigate and
05:51have that as a platform to investigate human
05:54genomes and in in the disease as well.
05:57So a lot of technologists especially
06:00molecular technologists can now do
06:02paraffin embedded tissue which is.
06:04There's a large,
06:06much larger amount of samples than if
06:09you use fresh tissue or frozen tissue
06:12specifically collected for research.
06:14And again,
06:15most of my clients they need
06:17now fresh tissue,
06:18so they create xenograft models.
06:22Though so the collection of fresh tissue
06:26from human for experimental pathology
06:29or experimental models in the rise.
06:32This is very important for drug development
06:35and for personalized medicine because again,
06:38you can start one lung cancer,
06:40it's not going to be exactly
06:41like the other one,
06:42so they need.
06:43That human variation in order to look at the
06:47genomic and personalized medicine in them.
06:50So we need a comprehensive human tissue
06:53banking that can increase utilization.
06:56We need to have a very well characterized
06:59population for the scientists to
07:00investigate and these samples need
07:02to have clinical rotation so they can
07:05correlate with whatever they find.
07:08So just going to show 2 examples of
07:10this is a recent paper that basically
07:13talked about the need of fresh human
07:16tissue for human research.
07:18And here they create,
07:20they're basically specifically talking
07:21about Zeno graph.
07:23What is the how, how they.
07:26Organize their research.
07:28Some, not all, tumors that we try
07:30to create a scenographic will grow.
07:32We know that.
07:34But those that grow are becoming a very
07:37important source for DNA fingerprinting,
07:40genomic variations.
07:43See absolutely models and and
07:46drug and testing of drugs as well.
07:49This is another paper just to show
07:52again the limitations of mouse.
07:54We have a mouse here,
07:56but basically this is a study
07:58on Melanoma where we we do not
08:01have a mouse model for Milano.
08:03OK,
08:04so basically we provided in biorepository.
08:07This is a paper from NYU that
08:10I'm not involved as an author,
08:11but the BIOREPOSITORY provided
08:13the tissue for this study.
08:16Basically they look at metastatic
08:18Melanoma metastatic from.
08:20Brain metastasis from,
08:21not from the brain tissue and what
08:25they notice there is a different
08:27expression in protein and basically
08:29suggests that whenever the Melanoma that
08:31establishes itself in the brain,
08:33they secrete. Upload best,
08:37better that suppresses inflammation that
08:40allows certain metastasis to take hold.
08:42So again showing even the same tumor the
08:46same disease location is very important.
08:48So it is important to have an
08:50annotation where it comes from,
08:52where is the source so that can allow the
08:55scientists to make those discoveries.
08:57So what is biobanking?
09:00It is a systematic procurement,
09:03processing, annotation,
09:05storage and distribution of
09:08biospecimen for research activity.
09:11Biobanking of human specimens in many
09:13institutions is part of a broader
09:16strategy to support an advanced,
09:18high impact biomedical research.
09:21OK, I'll show you that there are some.
09:24Very different types of biobanks.
09:28When I arrived at NYU,
09:29everybody was doing their
09:31own biobanking side.
09:32There is someone doing this,
09:34someone doing that,
09:35but there is no correlation.
09:37There is no integration of that
09:40material in that resource.
09:42OK.
09:42So that's why it is important to
09:44have one institutional component
09:45that can really serve for multiple
09:48purposes and that will allow,
09:50and I'll show you some examples
09:52later allow for more.
09:54Grant support and and everything else.
09:57So there are very many different
10:00types of vibank.
10:01Excuse me, there is no specific.
10:04One model fits all.
10:06There are biobanks that are more.
10:09Towards precision medicine,
10:11others about population based and
10:13others are disease specific, OK,
10:16so there is no specific model but
10:18they can function all of this.
10:21There are initiatives and we are
10:23the biobank for those initiatives.
10:26So the for instance an example,
10:29there is a group of investigators
10:32that NYU that is collecting.
10:35Samples from patients with Asian descent,
10:39OK,
10:40There's a big part of our
10:42National Health Institute,
10:43so we are the biorepository for them.
10:46So that is more of a population based.
10:48There is a group that collects lupus brino
10:51biopsies from lupus that's more like a
10:54disease specific disease biobanking.
10:56But again they can all be
10:59integrated into the.
11:00Deep central biorepository.
11:03So what is the most important thing of
11:07biobanking today is informed consent.
11:09So we need to have an informed consent
11:12for patients that will allow them.
11:14To collected material that
11:16will be used for research.
11:18The biobanking needs to conform to local,
11:21regional and federal regulations.
11:23I unfortunately,
11:25unfortunately I work in New York
11:27that's tightly regulated all the labs.
11:29So my lab is inspected by New York State,
11:32by the CHP and we have a lot of
11:35paperwork to fill that we will
11:38fulfill all of these regulations.
11:40One important thing of our bank is
11:43the standard and quality assurance,
11:45and that's extremely important.
11:47I'll give you 2 very bad examples
11:51when I was a postdoc.
11:53I come from Brazil and I was doing
11:56my PhD and there was an investigator
11:59at the time that was doing fantastic
12:02discoveries in large smania.
12:05And he was saying that,
12:07you know,
12:07a lot of the things that he
12:08was finding Leishmania were
12:10very similar to the crusade.
12:12So basically like a cross link
12:14between the two institutions,
12:15the two parasites.
12:16And then one day someone said maybe
12:18you should look at your leishmania.
12:20And in fact he was working with the cruise.
12:23That's why he was finding all those things.
12:25So if you don't know what you're looking at,
12:28you may be completely
12:29wrong in your discoveries.
12:30So that is extremely important to
12:32the quality assurance and quality
12:34control of everything you're working,
12:36especially, you know, human tissue.
12:40So data integration annotation is
12:43also very important because you
12:45want to be able to offer the the,
12:48the investigators very well
12:50annotated samples.
12:51I'll go more little bit about annotations.
12:53It can varies a lot but you need to make
12:56sure that what you're saying is what it is,
12:58OK and give the basic information
13:00and there are also financial
13:02considerations for a biobank,
13:04it is a very expensive endeavor and
13:06also the model that we use at NYU,
13:09but it's not the same.
13:10That you can see in every single biobank.
13:15So specifically for NYU,
13:17those are the missions that we have
13:19is basically to maintain and expand
13:22the human biospecimen repository
13:24with clinical pathologic connotation.
13:27Of patients that signed universal concern.
13:29So we have a universal consent
13:31that patients are offered.
13:33It doesn't matter where they come from,
13:35which disease they have.
13:36So they offer that consent and if they allow
13:40we can we can collect leftover tissue,
13:43OK or blood.
13:44So this can be from surgeries or even
13:47blood that goes for a clinical test.
13:50There is leftover.
13:51I can collect that material as long
13:53as the patient signed the consent.
13:59There all the consent.
14:00So it's like a clinic or hospitals
14:04everywhere, everywhere. Yeah.
14:06So originally the consent was.
14:10We when I started we the most of
14:12the need was to to collect patient
14:15to consent patients with cancer.
14:18So in the cancer centre registration the
14:20patients would come in and then offer the
14:23consent as part of their registration then.
14:26But patients can come from many different
14:29areas so then we have to adapt and evolve.
14:33So now we have patients that can be
14:35concentrated in the registration office,
14:38they can be consented in the clinical.
14:40Office by the nurse by the registration
14:42desk of of the faculty practice and they
14:45can and I have one person now that is
14:49located in the pre surgical area and
14:52he consents everybody before surgery.
14:54It's not very efficient but it's
14:55still we still get some patients.
14:57So it has to be multiple focal unless
14:59you have one area that everybody comes.
15:07Another thing is to simulate collaborations
15:09with between NYU and outside institutions
15:12and apply high quality standards for
15:15those biased by vice presidents.
15:17So my bar repository as I said is a
15:20biorepository accredited by the the CAP
15:23by College of American Pathologists.
15:25We were inspected every two years and we
15:28hold at the same standards as a clinical lab.
15:31So the CAPS certification
15:33basically gives you a. Clear.
15:36It's not that clear.
15:38We cannot do tests,
15:39but it's a clear equivalent meaning
15:41that if I have a tissue there
15:43that is needed for clinical tests,
15:45that is OK to take my tissue for
15:48the clinical test because it has
15:51hold over the same standards.
15:53So I'll talk about compliance in
15:56IRB and the HIPAA requirements
15:58which is very important.
16:00And so HIPPA is health insurance
16:03portability and Accountability act.
16:06It's a privacy rule.
16:07So privacy rules patients is very important,
16:10setting limits and boundaries and
16:12the release of medical information
16:14and holds violators accountable.
16:16So it is very important that one
16:18to establish it holds true for
16:21all these regulatory issues.
16:22And has direct implication for research
16:25and patient information, of course.
16:28So.
16:29Patient consent is the major
16:32tenant of biorepository.
16:33All samples are collected under an IRB
16:38approved HIPAA compliant consent form.
16:42So our consent form is the way it was
16:45created is mostly for leftover tissue.
16:48There are many variations from
16:51other biobanks.
16:52I can tell you briefly, but for for
16:54us the participation is voluntary.
16:56The patient is approached,
16:57if they want to consent,
16:59they will consent and they can also
17:01choose what they want to consent.
17:03So we can use leftover tissue
17:06and leftover blood.
17:07We cannot use it for biopsies because
17:09biopsies are not leftover tissue.
17:11So I cannot.
17:12Select any biopsy for research.
17:14So if there is a biopsy for research,
17:16the patient needs to sign a
17:18specific consent for that protocol.
17:20OK, the Biorepository will will be able to.
17:24Take that sample process and
17:26distribute as well,
17:27but it's not part of our universal concept.
17:30There is a voluntary donation of blood.
17:32The patients can say one single blood draw,
17:36multiple blood draws.
17:37They can opt which is that they want to
17:40do one thing that is embedded in the.
17:44And and my consent,
17:46we cannot consent children.
17:48So it's only adults.
17:50So the consent allows for linkage
17:52of clinical information.
17:53So everything that the patient's
17:56clinical history, presentations,
17:58radiology, molecular tests,
18:01pathology tests,
18:02anything else is available to
18:04the investigation because the
18:06consent allows for that.
18:07There is no specific project,
18:09so it can be used by many different projects,
18:12according to the investigators.
18:13And if they need to do cell line,
18:16develop xenograft genetic tests,
18:18everything is already.
18:20Written in the consent,
18:21so the patient allowed for all that, OK.
18:24So there is a coronation of risk
18:27and benefits and one thing that
18:29our RB ask is that the results
18:32are not released to the to the.
18:34Patients or anything,
18:35but in fact we don't know.
18:38What is going to be used.
18:39So we don't want to say that we're
18:40going to allow you to see your results
18:42because we have no idea how it's going
18:44to be used and what they are going
18:45to be looking for and protection
18:47of HIV is extremely important.
18:49Most of the specimens that
18:51deidentified and are distributed to
18:53the investigator the identified.
18:55So they they have the clinical information
18:58but they do not know anything about
19:01that patient apart from. Sex age.
19:05But I cannot give them the ear.
19:07The patient was born any date is a PHIK,
19:10but it's 60 years old. It's OK, OK.
19:14Patient can withdraw consent at any
19:17moment and some patients do withdraw consent.
19:20So how is interaction with the RFP,
19:23so everything that is a prospective
19:25collected collection needs to have
19:28higher be approval which falls under
19:30our protocol and everybody else that is
19:33doing intervention like clinical trials.
19:35So the patient needs to sign consent
19:38retrospective studies that is what
19:40our my with the biobank becomes now
19:43after it has been retrospective.
19:45The tissue delegates the realization
19:46is easier to get an IRB approval
19:49the patient or the investigator.
19:50They're not need to have a specific
19:52consent from that patient because
19:54the material is already there.
19:55So a waiver of consent from the
19:57RV is easier to everything.
19:59You just need to indicate what they can get.
20:03The clinical information and so
20:04if that is approved by the IRB,
20:06I can release that information
20:08to the investigate, OK.
20:12So basically. There are three
20:16levels of RB that we need to follow.
20:19Some investigators have a
20:23approved protocol from the RB that
20:25allows them for identification.
20:28So an example COVID test,
20:30there was someone that wants to see
20:33the the COVID variation and they needed
20:35to have the ZIP code of the patient
20:38to see where those strains work.
20:40So that is a Phi.
20:42So they need to get a special
20:45dispensation from this the IRB to
20:47receive HIV OK or DEIDENTIFIED.
20:49This is boss majority so it's it's
20:52an easier process and they they are
20:54just provide them the samples with
20:57the clean connotations that they
20:59need and anonymized especially there
21:01is no identifier to like someone
21:03just asked I need them lung cancers,
21:06so that's it then lung cancers.
21:07That specimen cannot be traced traced back.
21:10If the investigator wants to go
21:12back to see what they are,
21:14there is no way they can do that, OK.
21:17And each one of them has different
21:19level of scrutiny from the art.
21:22So another important thing is
21:24no compromise of clinical care
21:26that's your pathology is come in.
21:28We are the ones that really know how
21:30to triage these these samples and.
21:34If if the material comes to pathology,
21:37it's a small tumor I need
21:40that entire tumor for.
21:42For diagnosis, there is going to be
21:44no collection for the biorepository.
21:46OK, so we have that built-in
21:49concerns this one other thing that
21:51we did is that we do not allow
21:54anymore and let's say we with the
21:57institution in general and I had
21:59the support of the institution.
22:03Basically, we do not allow anybody to
22:06collect samples from the OR. But before,
22:09surgeons would do their collection,
22:11and then nobody knows what it was.
22:15Luckily or unluckily, we had a couple of.
22:20Missteps that led to RCA and then was easier
22:23for the institution to say this is not about,
22:27OK, so that is, I say,
22:30very bad for the patient,
22:31but at least I now can control that process.
22:36And a pathologist also can create the
22:39optimal collection technique that is
22:41important for the viral part part.
22:43So the patients go to the ER,
22:46the tissue is resected,
22:47it comes to pathology with process decide
22:49if it can be collected or not and and then
22:52we collect according to the protocol if
22:54there is something that they need fresh.
22:57Sometimes some investigators need
22:59samples in a specific media.
23:01So we do the collection according to what
23:04the investigator needs and we always create.
23:07Control a frozen section control slide
23:09because we need to make sure that
23:11whatever we give into that person to
23:14that investigator is exactly what they say.
23:16So you can take a piece of tissue,
23:18they look, they think there's lung cancer,
23:20but it's just inflammatory very tomorrow.
23:23So I need to make sure that
23:25what I give is what it is, OK.
23:27So I always do a frozen section of every.
23:30So in this protocol need to to
23:33annotate the schematic time.
23:35One of the problems that we have there
23:37is that investigator would say it
23:39needs to be collected like immediately
23:41we cannot go to pathology and then
23:44collect because the RNA will die.
23:47I'm going to be a little bit.
23:49Sarcastic,
23:50but my answer to this investigators
23:52is if you work with something that
23:54needs to be collected immediately
23:56you should not be working with
23:58human tissue because even if the
24:00surgeon collect it is not immediate.
24:02They need to.
24:03The most important thing is the patient.
24:05Well, so it is not they cannot stop
24:07what they're doing, collect everything,
24:09freeze them centrally,
24:10investigate.
24:11The most important thing is impatient.
24:13So there is always the challenge
24:15and a cultural change for the
24:17investigators to understand how this.
24:20Dynamics work and it's just
24:22always a tug of war.
24:24Everybody that has invested doing
24:27anything with humans know how it is so.
24:31How we minimize the the the this process so?
24:35We receive, I'll show later how the
24:38integration is with IT,
24:40but everybody that is consented,
24:43we have a system that will
24:45annotate and and search all the
24:47patients that go for surgery.
24:48So we receive in 24 hours before the surgery.
24:52So these patients ABC will come for surgery.
24:55So the day of surgery someone
24:57in my team will call to the OR
24:59provide them with the lease and say
25:01these are the patients ABC that
25:03we need that material once it is.
25:05Removed from the patient,
25:07it comes to pathology immediately
25:08and we use like the same system
25:11as the frozen section.
25:12So there is a Courier that brings
25:14that material directly to pathology
25:16as if it was a frozen section.
25:18Then the EPA or if there is a pathologist
25:21that is involved will collect the
25:23sample and the biorepository is also
25:25not notified of the collection.
25:27They are there, they collect the
25:29material and they distribute,
25:30freeze, whatever they need to do.
25:31So that will minimize the scheming time
25:34and we annotate when it was removed.
25:37The war annotates when it was removed,
25:39and we annotate when it was frozen,
25:41so we have some control.
25:44So again the pathology examination
25:45and we do the quality control
25:47and assurance of patient care.
25:49Once again, if you cannot collect,
25:51it will not be collected.
25:53It doesn't matter if it's device,
25:54gene or research that wants that tissue,
25:57the answer is no, OK.
25:59And they understand, OK.
26:03So how the patient is consented?
26:07As I said briefly,
26:08we have many different mechanisms.
26:10The entire consent process is electronic,
26:13so once they sign the electronic format,
26:18that material. And go here.
26:21So there is a lot of things that goes on,
26:23but there is a system that we use,
26:25it's called home base.
26:27It goes through interface with lab
26:29vantage which is our biorepository data
26:33manager and interferes with EPIC which
26:36is our medical records that we use.
26:40And research Navigator,
26:41which is all the research that I've
26:44done are registered in research,
26:46not paid. So this,
26:47then once this and this talks constantly.
26:50Once again, the patient is identified.
26:53They will send.
26:55A message to CBD,
26:56which with the people and they will do what I
27:00said organized with you are with pathology,
27:02inform everybody,
27:03collect the sample and then freeze,
27:05OK and everything is
27:07entered in like advantage,
27:08which is our management system.
27:11It's a big graphic,
27:12but it's basically simply,
27:13simply that's how it works.
27:16So Dubai's personal process,
27:18whenever we see,
27:20when we still look at the
27:22patient identification,
27:22make sure that patient is consented.
27:25There is a notification of excision.
27:27The collection is is done,
27:30the tissue is acquired and distributed
27:33and processed according to the.
27:35So the tissue management?
27:38Yes,
27:39you have a sense of what is the fraction
27:41of patients that are you know you're
27:43capturing with this system relative
27:45to the ones that could provide.
27:48Uh. That's a good question of.
27:53Let me can say that from the
27:55patients that signed the consent,
27:56not everybody goes to surgery. OK.
27:59So from the patients that signed the consent,
28:02we have about 40,000
28:04people already consented.
28:06For the entire institution,
28:08about 10% of them go to surgery
28:10and we have the tissue collected.
28:12So that's why we have now one person
28:16in in the OR that will collect,
28:19will do target consent.
28:22The target consent means
28:24most of our investigators,
28:26they are working with lung cancer,
28:29pancreatic cancer, Melanoma,
28:31colon cancer.
28:32So if the patient is listed for any of of
28:35these and they are not consented before,
28:37so that person will consent.
28:40So I cannot tell you exactly
28:42how many patients we skip,
28:44but up let's let's say like 10% we collect
28:48about 10% of everybody that goes to the.
28:51And we also collecting transplant.
28:53I'm just talking about cancer,
28:54but he collects for.
28:56For non cancer as well,
28:58OK.
28:58So Andrew is your follow up that
29:01question not gross specimen show up.
29:04So do you have separate about
29:07specific person to look at the tissue
29:10first or you have your a resident
29:13is the routine PSA that will grow
29:16that will process the specimen
29:19and if there is a clinical trial
29:21or specific project so then the
29:24pathologist on their trial or on that.
29:26Protocol is notified and
29:28then very often they are.
29:30They want to do the collection themselves.
29:33But but yes there is it is not a
29:36specific person for the viral post
29:38story I everybody in the biorepository
29:41they they don't have the ability
29:44to grow they're not PA so they
29:46would I would for patient care I
29:48would not allow them to they're
29:50not allowed to to cut insurance.
29:52So in other words your bowel
29:56pastor shares mythology person.
29:59So it is very much embedded in the
30:02pathology and what institution.
30:04Was present. And I said the institution,
30:07because everything else for the
30:09biorepository is an institutional resource.
30:12So the institution pays the
30:15salary of 1 PA of course,
30:17if you have 10 PA's and all
30:2010 PA's will will collect,
30:22there is one PA that is paid by
30:24the institution for that function.
30:26So that's how we we get everybody
30:29to cooperate, yes.
30:34So. Whenever we we we collect
30:37and we once we collect,
30:39we enter into lab vantage with
30:42diagnostic information I do not have.
30:45The annotation is something a
30:48little bit complicated because.
30:50You can make a very extensive
30:53annotation the investigators.
30:54Are not interested in that
30:56they they want something else.
30:57OK, so that is very common.
30:59So what we do is that we do
31:01a minimal annotation like
31:03diagnosis if there is recurrence,
31:05if the patient has been treated or not,
31:07very simple annotations.
31:08And then if the investigator wants
31:11something with a more extensive
31:14annotation like molecular notations,
31:15then we provide the identifier the.
31:20The the Biorepository identifier which
31:22is not the patient identifier, right.
31:25It's a number that is generated
31:27by the system.
31:29Then we provide that to the data
31:31for and the data core we extract
31:34the clinical information that the
31:36situation the investigator wants.
31:38So in a way we don't have,
31:40I don't need to have someone creating
31:43a lot of annotations because it
31:45varies a lot by every different user.
31:48So we create this,
31:50this system is that we have a way to
31:53get the information that they want
31:55that will follow all the regulatory
31:57issues and patient identifiers
31:59and other which will be released,
32:01OK.
32:04So the the. The manager the the.
32:08The program manager also tracks
32:11all the genealogy of the specimen,
32:14if there is a split,
32:15if there are aliquots,
32:16if you already extracted the
32:18DNA RNA from that sample,
32:20everything enters,
32:20so we know exactly what
32:22happened to that material.
32:28So as I said, clean connotation
32:30is very variable depending a lot.
32:33We do very limited annotation
32:35and extensive annotation requires
32:38personal to mine the data and
32:40enter the clinical data set.
32:42I don't have one person to do
32:44that because it is a lot of work.
32:46So we basically refer to people
32:49that for the resource of the
32:50institution that already do that.
32:55But a minimal notation is important
32:57if patients want if an investigator
32:58wants someone that has never received
33:00chemotherapy or someone that
33:02received chemotherapy, so we cannot.
33:06How do you manage to maintain this
33:08update, you know like patients
33:10that died or patient had follow up
33:12or surgeries or other treatments
33:15because the the the program
33:17is integrated with EPIC.
33:20And that information is fed
33:22directly into the program,
33:23so the diagnosis that.
33:25That comes from pathology is integrated
33:28this staging we use the the CAP
33:31template so that can be uploaded
33:33into the into lab vantage as well.
33:36So then that data is extracted.
33:38If the recurrence is a little
33:40bit more tough to get because it
33:43is very often sometimes emote.
33:45They don't have a biopsy or something
33:47that tells it is a recurrence,
33:50but date of death is annotated
33:52because it goes straight into epic.
33:55The problem is if the patient dies.
33:57Outside of the system then
33:58there is no way I can tell,
33:59so they'll say the annotation
34:01is very minimal and not.
34:05Very extensive. Because of all these
34:08variations, one thing that we need
34:10to do is to make sure that we have a.
34:16What's the word look like?
34:18An inquiry or a quality control of the data?
34:22So once a year we need to reselect.
34:25Once a year, twice a year we
34:26select a few cases and make
34:28sure that the diagnosis that
34:30collected from Epic is accurate.
34:32So we sort of need to do
34:34a QA of the data, OK.
34:39Uh. So the investigators can request
34:44that material funded by repository.
34:47Again we have two system,
34:48one that does not allow for patient
34:51identifier and another one that allows
34:53for patient identifier depending
34:54again on the level of the RV.
34:57So then they explained if they want
35:00fresh frozen part of embedded tissue,
35:02whatever it is, blood,
35:04whatever it is that they put in
35:06the order and then we'll process.
35:08Ever before any distribution disease
35:10should be some quality assurance
35:13that again that what I'm given
35:15the investigator is what it is.
35:17Unfortunately I'm the one
35:18that does most of this,
35:20but other pathologists are helping.
35:22But sometimes as I said
35:25lung and is a big group,
35:27so I have to do all the lung quality
35:30control and we also assessed the
35:33patient consent form and assess the IRB.
35:37Four things that we're going to
35:39encounter as well with people that want
35:41to do things out of the biorepository,
35:43but they do not have an RP or the RB
35:45doesn't say that that's what they can do.
35:48So we have to do a little bit
35:49of regulatory and they'll go
35:51back to the investigator said.
35:52Your RP does not say anything about using
35:56bio specimen or using human tissue.
35:58So they need to go back to the IRB,
36:00amend the protocol and then we
36:03can distribute material.
36:05So the service that we do.
36:08How do you prioritize distribution?
36:10Let's say if you have like a ordinance,
36:13who decides who gets what and what priority?
36:16So do the. It is not much
36:22of a problem because.
36:24Very often, for instance,
36:25the pancreatic team that's
36:27assuming it's very active,
36:29so there is the head of pancreatic.
36:31If there is, if two investigators
36:33asking for the same sample,
36:34I can go to the head of the pancreatic
36:37program and say which one is more
36:40important here or we cannot find
36:42something else in general if the patient
36:45if one investigator has an NIH grant.
36:48That takes priority of someone that
36:50does not have an age grant or or
36:52doesn't have a funding institution.
36:54It's more important than NIH.
36:55But so we we we prioritized by the
37:02sourcing the fund of source and also
37:04if there is more more dispute we
37:06can go to the head of the program.
37:09If there is no way then
37:11I can make that decision.
37:13We have a government body
37:15that is I respond to the.
37:18Associating or translational research.
37:20So the bar repository is under the
37:24administration of the associate team.
37:27So that is the liaison building institution.
37:30So basically if there is a conflict
37:32that we need to then I can go to
37:34the associate Dean and said this is
37:35what I tried to receive a conflict,
37:37what can we do?
37:38And and then it is resolved in that sense.
37:41But there is a line of escalation
37:43that we can.
37:44But as I said,
37:45it is not very common because we
37:47can always offer another case.
37:49It it's very rare that someone
37:51needs a very specific patient.
37:53Correct for that specific protocol.
37:56But of course if someone has a specific
37:58protocol in that patient sign also
38:00consent but that specific protocol
38:02that is the one that goes not the patient,
38:05the other investigator that
38:06does not have that protocol.
38:07So there are different levels of
38:09of telling what is the government
38:11for that expense.
38:15So we have a fully.
38:17Histologist service that
38:18is mostly for research.
38:20We don't do any clear any
38:23tests there and we do.
38:25We can do everything embedding,
38:27cutting, frozen sections,
38:29HNE, immune Histology,
38:30immunohistochemical stains and
38:32TMA's for the investigators.
38:35We have a group that does nuclear
38:38gas extractions from blood,
38:39tissue frozen,
38:40whatever it is saliva and they
38:43can do RNA and DNA and this
38:46is also an automated process.
38:48Every single image that
38:50is distributed we scan,
38:51so there is also a virtual image of
38:55that material that can be used for.
38:58It is very a lot of AI or
39:01artificial intelligence and
39:02and digital pathology projects.
39:04So they can be used for that
39:06process and clinical trial support.
39:08Clinical trial support is mostly
39:10they need a archival biopsy to
39:13make sure the patient can enroll.
39:16So my team will go to pathology
39:19find that block process the block
39:21according to the the protocol
39:23and then send it to the directly
39:26to to the central lab.
39:28That is during the clinical
39:30trial or we go to collect a
39:32specific biopsy for that clinical
39:34trial process according to the
39:36protocol and do the distribution.
39:38So we sort of take care of all the
39:40tissue and blood before research.
39:46So this is a little bit of the distribution.
39:48So blood is the one that is mostly
39:51used because everybody. Yeah.
39:53Not everybody works with tissue.
39:55So percent of distribute,
39:57these numbers are already outdated,
39:59but I kept them anyway.
40:01But the distribution is sort of stable.
40:04So the blood is about
40:0680% or 90% distribution.
40:08The tissue is about 8020% distribution,
40:11which is good, but it means that we have
40:14a lot more tissue than we distribute
40:16and other fluids is is low utilization,
40:19but we don't collect a lot
40:20of other fluids anyway.
40:22So the. The the tissue.
40:25Another thing that I've I did
40:26not say is that, for instance.
40:30We had a surplus of thyroid
40:32and a surplus of prostate.
40:35Utilization of those two
40:37specimens at NYU is very low.
40:40So we've reached the plateau,
40:42no more collection.
40:43So even if the patient consent,
40:45we do not collect because we have a lot,
40:48unless there is a specific
40:49order for that patient,
40:50OK.
40:51So we can also decide when to
40:53stop collecting if you have enough
40:56of that material.
40:57So this is just the
41:00storage, you know like particularly
41:0330,000 block is a lot so are
41:05you are you handling that
41:06very good. I forgot to mention that too.
41:09So we have in house a few freezers.
41:13And then NYU contracted another
41:15outside vendor that we transferred
41:18the freezer to that facility.
41:20So they would do all the maintenance,
41:22the temperature maintenance of that material
41:25and once we need we just request that
41:28material should be brought back to NYU.
41:31So there is a freezer farm,
41:33there are many commercial entities that
41:36have that and you know you has a contract
41:39with one that is now in New Jersey.
41:41Of course this is expensive and that
41:43is that's why we try to use as much
41:46tissue as possible and link to the
41:48collection of cases that are not used,
41:50because it's a waste of resource to
41:52have all these material and pay for
41:55that without having any utilization.
41:57Yeah, but that is what I mean
41:59especially in Manhattan.
42:01It's not very space is a little bit,
42:04I don't know any other facilities
42:06I have been I I have a.
42:09Inspected other biorepositories
42:11through the CIP program and they have.
42:15A room full of freezes,
42:16but they have the space.
42:17That doesn't happen in New York.
42:22So just to illustrate the the
42:24nucleic acids we have automated,
42:26we have two automated machines that can do
42:28DNA and RNA extraction from large volumes.
42:31So the investigators really take
42:33advantage of that instead if
42:34they're doing one or two cases,
42:36they do it themselves,
42:37but they're doing 100 cases, 200 cases.
42:39It's easier to give it to us
42:41and we provide the DNA RNA,
42:44we do quality control and then we
42:46shift the entire material directly
42:48to the genomic center that will do.
42:51The sequencing for them.
42:54Just an example of how much
42:56clinical trials is increasing and
42:58we also increasing our support.
43:00This 2015 was before my time I came in
43:0316 and this is really always a growing
43:06number of clinical trials that we are
43:10involved in supporting these trials.
43:12So this is very quick workflow,
43:15the tissue comes or the blood comes.
43:18It goes to the biorepository.
43:20If there is an order for
43:21DNA or any extraction,
43:23we extract and then send it to distribution.
43:26If there is a fresh tissue,
43:28goes straight to distribution
43:30or stays in the biorepository
43:32and then it goes to Histology,
43:34then a process and then distribute.
43:37So everything is integrated and
43:39every single project is different.
43:41So it's not exactly the same for everybody.
43:44So why it's important to have certifications?
43:48Because that's an assurance of in the
43:50investigator that we are doing everything.
43:52So we are clap certified.
43:53We have a license by the the New York
43:56State and we also do proficiency tests
43:58from the integrated biobank of Luxembourg,
44:01which is supported by the International
44:05Society of Biorepository IDL.
44:08So we hold 11 certificates of
44:11proficiency that includes nucleic
44:12acid Histology and everything else.
44:15So you know something we do every two
44:17years to maintain to make sure that
44:19we're doing the right things and it
44:21increases the value and I have heard,
44:24I've heard, I have seen comments
44:26in grants that people say,
44:28you know this patient, this, this.
44:31Institution has a CAP accredited
44:34by a repository,
44:35so that's a plus for the
44:38grant support that they have.
44:41So this is basically our finances mostly.
44:44So 19% is supported by Grant,
44:48Grant based mostly the,
44:51the, the personnel.
44:53So we have some personnel that is
44:55highly specific for certain grants.
44:57Our biggest grants is the
45:00Cancer Center grant and also.
45:03Ischemic epic net and I'll
45:05show you some breakdown later.
45:07And this institutional support
45:09is still about 30 to 40%.
45:12It varies from year to year.
45:14So these are we don't make
45:16money by repository,
45:18we can just reduce the amount
45:20of loss from the institution or
45:22investment from the institution.
45:24But a lot of them,
45:26they still have some significant
45:27support and most of our resource
45:29comes from chargebacks.
45:31So every single process.
45:32What we do,
45:33we have to charge to investigate
45:35again cultural change because not
45:37everybody is interested in paying
45:38something that they could get for free.
45:40They think they can get for free,
45:42but they are not getting the quality in
45:44the material that they they have before.
45:49This is mostly the breakdown of
45:51the services or collections,
45:53how much will recover clinical trials.
45:56So this is all grant money from
45:58everything that we get and research.
46:00Archival is mostly recovering from the
46:04pathology archival material tissue that
46:07is used for research or for glucose.
46:11So why pathologists?
46:12We are the most qualified medical
46:15professionals to do this by banking job.
46:18We are very familiar with this
46:20requisition with the clinical
46:22implications and characterization of
46:23these organs of these tumors or tissue.
46:26And we are also very much familiar
46:28with the quality assurance process
46:30and quality standards for all this.
46:32So we are already practicing this.
46:35So that's why it is very important to have
46:38a pathologist involved and in my situation.
46:41As I said, it is very much associated
46:44with the Department of Pathology.
46:47So the challenge is with
46:48difficult to predict the future,
46:49we'll never know what you're collecting
46:51if that's going to be needed.
46:53So we need to be always flexible and
46:56adaptable to what comes during the COVID,
46:59the investigators in the center,
47:01they wanted PBMC, some COVID.
47:04So we collected the samples,
47:06processed PBMC and utilization 0
47:09because by the time they wanted this,
47:12they already wanted something else.
47:14So there is always a risk
47:16that what you collecting.
47:17Is not going to be used because
47:19it's very difficult to predict.
47:21As I said,
47:22basically in connotation we need to have
47:24support from a data core or someone that
47:27can mine epic to get more annotation.
47:30What's simple to collect
47:32we already went over.
47:34What is the technique that we need to invest?
47:38And it needs a lot of IT support
47:40for the data integration.
47:41Without institutional support,
47:42it's very difficult to have that IT
47:45integration and again institutional support
47:48and more important cultural change,
47:50because it will require a cultural
47:53change for the investigators,
47:54from the clinicians and everybody
47:56else involved in the process,
47:58which is not impossible.
48:00It is possible.
48:01It creates a little bit of headache,
48:03but it changes, which is true for everything.
48:06It's not on for this so.
48:08Just institutional resource.
48:09I want to say that these are grants that.
48:13We have supported and you know has been
48:16very good in getting those grants.
48:18I'm not saying that it's only
48:20because of our repository.
48:21Of course there is science behind it,
48:23but the fact that there is a
48:26biorepository that is well annotated,
48:28it has been a plus for all these
48:31grams that that NYU has received.
48:35I have a question about
48:37the support relationship.
48:39So this four names your
48:43repository therefore facility or
48:45you have an independent group.
48:47It is, it is very good.
48:48What happened is a lot of the
48:50applications for this sport,
48:52they have the requirement
48:53to have a pathology.
48:54So very often there is
48:56a pathologist involved.
48:58There are two mechanisms that we can do.
49:00We can keep everything in the
49:02biorepository and then the
49:03investigators take from there.
49:05Or we do that for the Melanoma
49:08spore that all these samples are
49:10procured for us by abide the CBD and
49:14then we release immediately that
49:16sample to develop normally sport.
49:18So they have their own annotations
49:20and they're all by repository.
49:22So you can do both.
49:24You can keep everything in your central
49:26repository or you can procure the
49:28samples and then distribute to them.
49:30And of course they have the financial,
49:33you can do the charge back because they have.
49:35The financial support to give
49:37to the buyer repository.
49:38So there are just two models that we can do.
49:40Thanks for asking.
49:41I forgot to mention that and
49:43we do the same question.
49:44How do you handle investigators
49:46that are not there anymore or projects
49:49that started acquired samples or you
49:51made a distribution and then they leave
49:53the institution or the project ends,
49:55big problem. So this is a big problem
49:59for the institution and we have
50:02created a biospecimen policy for NYU.
50:04So basically now requires that every
50:07investigator that is collecting sample
50:10independent of the viral repository to
50:13have everything annotated in lab vantage.
50:16I'm I'm saying lab vantage,
50:17not a propaganda, anyone can use different,
50:19but that's the one and why
50:21you use this and I'm familiar.
50:23So everybody needs to enter all
50:25their specimens in advantage.
50:27So once the investigator leaves,
50:29that material comes to the viral repository.
50:32So then I'll be responsible
50:34for that material.
50:35And this is a major challenge because
50:38not everybody is making good annotations
50:40and good good keeping of that material.
50:44So that's part of the cultural
50:46change that I think that is has to
50:48come and it's slowly improving.
50:50But that was something that is still
50:53happening and it is always a problem
50:56with someone who has leaves and then
50:58they cannot take the samples and then
51:00the samples are useless because there
51:02is no annotation, don't know what it is.
51:05And so it.
51:08In a good way that it reinforced
51:10to the institution the need for
51:13a centralized biorepository that
51:14can be responsible for others.
51:16So you know what all these mishaps has been?
51:20Very good for the central
51:23Biorepository because basically yes.
51:25And very fortunate that we have the
51:28support of institutions says yes,
51:30you're the ones that need to
51:31take care of this.
51:33Well, another word, do you have like?
51:35Living in the institutional support,
51:37let's say, you know,
51:39during COVID or whatever reason you're not.
51:41Getting, you know, distribution
51:43events to to support yourself,
51:45you know, being able to charge.
51:47Do you have like a limit in the amount
51:49that the institution will support?
51:52I haven't encountered that even.
51:55Yeah, it works even during the COVID
51:58because a lot of the investigators, they.
52:01The labs were closed, so they switched
52:04a lot of their efforts into COVID,
52:07so everything that we're collecting,
52:08they would use.
52:11So for COVID specifically,
52:14the institution created a grant.
52:17That they were provided to the investigators,
52:20not outside the Grantwood
52:21institutional grant, so.
52:23Yes, I think the institution will take,
52:26I don't know what is their
52:28limit but they will do that.
52:30And I also know there is now an
52:33investigator a very big on genetics.
52:35So he's trying to get to create the
52:38genetic center at NYU and he's using a
52:41lot of he doesn't have specific grants
52:43for that generate preliminary data.
52:46So the institution is provide him
52:48with a grant to do that process
52:51and that includes by repository.
52:53So again it is.
52:55Of course, there's nothing to do with me.
52:57I'm not the one making those decisions,
52:58but the institution make the decisions to
53:01support investigators during that time.
53:03So again,
53:03that's that's what it is and that's
53:05the model that I've been working.
53:08So I can follow the question about
53:12the party, the investigator.
53:13Do you guys you know have an institutional
53:17or like a formal institutional policy,
53:20how you either allow certain investigator
53:22to carry some of these with them?
53:26There is a policy in general,
53:29I'm not aware that they allow
53:32investigators to take their samples
53:34with them because everything is
53:36considered institutional resource.
53:38If there is a situation like that.
53:41They're probably discussed
53:42with the Dean or the the,
53:45the, you know, I, I,
53:46I'm not part of that discussion,
53:47but there is a policy that institutes
53:50that everything needs to be cataloged
53:52in that specific system and that
53:54they cannot take their material out.
53:58Relations with the rest of the annotation.
54:01So it wasn't a PC system.
54:03Do you use the APR or is it
54:06we we was epic beaker?
54:09Think of that. I actually will
54:12see either waiting on it.
54:14Yes and no because we just had a transition
54:18between power path to epic beaker,
54:20so the whole system was created
54:24to interface with power pad.
54:27So now we bicker, we have to get again
54:29the IT support to change that material and
54:32then integrate with speaker. So it is a.
54:35We're now integrated with weaker,
54:37but there was that transition in the middle.
54:40Another talk talking about that you're OK.
54:45It is a. If you're going
54:48traffic because I'm I'm now,
54:49I'm used to it, it's fine,
54:52I'm very used to it and I've
54:53already forgot everything else.
54:54But it is a learning curve.
54:57It is a learning. Especially for
55:00the for the pathologist notebook,
55:01for the labs, it's more learning.
55:03I think that's all.
55:06Oh, just a just another example of
55:08a paper that used material from the
55:11biorepository that is published recently.
55:14But no.
55:15So just to conclude the bank can
55:17deliver quality specimens and a
55:19critical resource of the medical
55:21science is an invaluable resource
55:23to the increased needs of high
55:25throughput technologies and accuracy
55:27of data generated depending on
55:30the quality of the vice specimen,
55:32which is very, very important.
55:34So this is the team.
55:36We started with six people.
55:37We are now 24 excluding me,
55:4125 with me and we.
55:45That is the the team that we have right now.
55:49Thank you.
55:53Yeah, so something more important.
55:57I am just. Right now,
55:59I don't need to be there every day.
56:01Everything goes without me.
56:03But Sandra Mendoza is the manager
56:06and the assistant director,
56:08and she's really the person
56:10that maintains that,
56:11the whole structure functioning.
56:12So you need someone that
56:14has to be there every day.
56:16If you can have a pathologist,
56:17great, but not always easy to get a
56:20pathology should be that exclusively.
56:21But you know, once someone is
56:24trained and organized that is,
56:26it works extremely well.
56:28Thank you.
56:31Question. Yes please.
56:35And it was striking that you distribute
56:3720% of your tissue samples but it
56:40wasn't clearly how you decide what
56:42to to that is no ones working on
56:45sarcoma YouTube every what if I come
56:47to you and I play on 110 that Jason's.
56:52If you have that or how do you decide
56:54what you collect and what you described?
56:56So we collect everything from
56:58patients that signed the consent.
57:01So if there is a sarcoma,
57:02will collect the sarcoma if there is,
57:04even if there is nobody working
57:06on it or there is no need for it.
57:08What I stopped collectively is when
57:10I have like I think I have like 1000
57:13thyroids and thousands or more than 1000
57:15prostate cancer and nobody requests it.
57:18So I'm not going to order to get anymore.
57:21But for other cases like head and neck,
57:25head and neck is difficult to collect
57:28because nowadays most patients it's a
57:30tiny biopsy and then the patients get
57:33therapy and then they take it out.
57:35What is that over?
57:36Not always there is viable tumor there,
57:39but we collect from the head and neck.
57:41We have some salivary glands,
57:43we have sarcomas, we have a lot of.
57:47We have trust funds,
57:48we also collect the heart and lung
57:51transplant material liver transplant.
57:53So if the patient consent to recollect.
57:56Then when you do it like so we
57:58just keep it unless we have 1000
58:00prostates they're getting old.
58:02Are they still valuable.
58:03They're still valid with as long
58:05as they are annotated and we do
58:07periodic quality assurance and
58:09then if they if there is a problem
58:11then we have to throw them out.
58:13But in general they they
58:15maintained very well.
58:16They should if if you keep them in minus 80
58:19or liquid nitrogen they they stay very well.
58:21I did a A for a small project
58:24we note remember that.
58:26NYU had a sandy hurricane that came
58:31and basically destroyed and why you you
58:34were like almost one year without function.
58:37So there was already sample.
58:39This was before the Biorepository but there
58:41was some samples there already collected.
58:43So I wanted to see that material
58:46was still viable and useful.
58:48So we did a little project and we
58:50published in the BIOREPOSITORY
58:51during or whatever it is,
58:52but basically saying that
58:54it is good for Histology,
58:55immunohistology.
58:56RNA DNA extraction,
58:58everything that we need that
59:00issue is still useful.
59:02So it it is quite resistant this issue.
59:08So long you talk about whether you
59:12connect any tissue or PEX or PO.
59:18So basically the investigator will
59:21place an order so like they want.
59:27Small squamous cell carcinoma let's
59:29just OK and then when I have a case
59:33then we inform the the clinician the
59:35this the investigator we have today
59:37someone that is supposed to come for for.
59:41For excision that has squamous cell
59:43carcinoma, do you want the tissue?
59:45So they will say yes or no.
59:47Sometimes what investigates is tell
59:49me because these two processes say if
59:52the tissue comes until 3:00 o'clock
59:54in the afternoon, I'll take it.
59:56If the tissue comes 7:00 o'clock
59:57in the evening, I don't want it.
59:59I mean of course they need to
01:00:01also work their workflow,
01:00:03but that's how the the discussion
01:00:05is done for every single order that
01:00:08they displace and then once it comes
01:00:11we they give the protocol so they
01:00:13want to collect the tissue in RMI.
01:00:15We give them an RMI,
01:00:17each collect another sample,
01:00:19another fluid, another vehicle.
01:00:21We we doing that with you.
01:00:24So we we adapt to whatever the
01:00:27protocol of that investigator is.
01:00:30But that's how we we've been
01:00:32sending material.
01:00:33Most of the PDX that people are xenografts,
01:00:37that people working are
01:00:40again long and ponderous.
01:00:42So these are my biggest customers.
01:00:47So Andreas, this is another situation,
01:00:50I don't just pass it to CPR experience.
01:00:53So what what happens if someone
01:00:57investigator asking some?
01:00:59A solid material.
01:01:01Which started the organization,
01:01:04not the your bank,
01:01:05but it's part of the current case.
01:01:07In other words,
01:01:08it's like year or two years.
01:01:11So yeah, so that's why our system is
01:01:15integrated with the pathology system.
01:01:17So everything this was a decision
01:01:20of the Chair of pathology that every
01:01:23single specimen that is in the
01:01:25archival is available for research.
01:01:27So is there any time limit? Like
01:01:29there is no time limit,
01:01:31the only thing is that. Uh.
01:01:32In general, I make that determination,
01:01:35see if there is a biopsy and
01:01:38there is not enough material for
01:01:39what that investigator wants.
01:01:41I'll tell them this patient is not good.
01:01:43Maybe you have to find another one.
01:01:45If they just want an H&amp;E,
01:01:47which is easy,
01:01:50but I haven't encountered,
01:01:52I have encountered only one situation
01:01:54that it was a patient in a clinical
01:01:57trial for breast that they needed
01:01:59the material from the archival.
01:02:00So that material was given through
01:02:03the central lab and then another
01:02:06clinician that was not aware that
01:02:08that patient was in a clinical trial
01:02:11requested the test in that block.
01:02:13So, but again it has really nothing to
01:02:16do with me is basically saying informing
01:02:18putting the two clinicians together say
01:02:21this patient is part of a clinical trial,
01:02:23the material has been central clinical trial.
01:02:25So what we can do is to
01:02:28request the block back.
01:02:30We don't distribute blocks,
01:02:32we just do IC like a scan.
01:02:35But sometimes for clinical trials if
01:02:37there is only one block that's very
01:02:40important then we release the block.
01:02:42But then we can request a block back
01:02:44if there is a clinical situation,
01:02:45but that it's not very common but
01:02:48if the case is not signed out.
01:02:50We will not release the I have.
01:02:53We had one last week someone asked for.
01:02:5820 unstained slides from a case that
01:03:00was not signed either, said no,
01:03:02because I don't know what's going.
01:03:03You know,
01:03:04clinical care is the most important.
01:03:07After it is done, everything is done.
01:03:10If they order,
01:03:10all lung cancers go from molecular.
01:03:12After they've done everything and.
01:03:15If there is tissue left, you can use,
01:03:17otherwise so it's a daily.
01:03:20Case by case decision.
01:03:23Thank you.
01:03:25Thank you very much,
01:03:26Andrew. Again, thank you.