Tissue based diagnosis and research with Chen Liu

Transcript

• 00:17Welcome back, this session is
• 00:19being recorded. Thank you.
• 00:24Hi, my name is Michael Kaplan.
• 00:25I'm chair of the Department of Cellular
• 00:28and Molecular Physiology at Yale and
• 00:30it's my great pleasure to introduce our
• 00:32next speaker which is Doctor Chen Lu,
• 00:34MD, PhD, who's the Anthony and
• 00:37Brady Professor of Pathology,
• 00:38the Chair of Pathology and the
• 00:40Chief of Pathology at Yale,
• 00:42New Haven Hospital in the
• 00:44Yale School of Medicine.
• 00:45Chen is an expert in hepatitis
• 00:47and in liver tumors and his topic
• 00:50today is going to be tissue
• 00:52based diagnosis and research.
• 00:54Chen.
• 00:55Thank you Mike. Thank
• 00:59you for the introduction.
• 01:09OK, you see my slides right. Good.
• 01:14OK, first of all, I want to thank Mike and
• 01:18Mario for the opportunity to speak here.
• 01:21So although I would like to speak today
• 01:24is about this new entity, it's called
• 01:26Youth School Medicine Ball repository.
• 01:29So with the approval from D.
• 01:31Nancy Brown. So this why I signed
• 01:34repository is officially in business.
• 01:36So the goal for this,
• 01:38the bar repository is to establish a
• 01:43coordinated biorepository that that allows
• 01:45for the alignment of collected tissue,
• 01:48plasma serum and genetic samples
• 01:51and clinical data and using common
• 01:55process and information system.
• 01:57So the here are the five listed five
• 02:01major goals for the YM Bowery Pastor.
• 02:04For his two support overall by medical
• 02:08research and clinical trials on Yale
• 02:11campus and the others support focused
• 02:14research and clinical programs.
• 02:16That's including PPG's centers, et cetera.
• 02:19I think that's where the liver
• 02:21center could be part of it,
• 02:23and then to serve community
• 02:25health initiatives.
• 02:26In other words, we will.
• 02:27Be ready and to help some community health
• 02:32initiative and then this is become a
• 02:35school's asset to enable development of
• 02:39innovative diagnostics and therapeutics.
• 02:42And finally,
• 02:43and this repositor will advocate
• 02:46for systemized and standardize
• 02:49how we release and accurate human
• 02:53specimens and data at Yale.
• 02:55So this is the scope of the
• 02:58work in the YMCA repository.
• 03:00One is General General Bowl banking intake,
• 03:04acquisition,
• 03:05processing,
• 03:05storage and distribution.
• 03:07That's the basic function of the
• 03:09power repository and the other
• 03:11very important section of this
• 03:14file repository is investigator
• 03:16initiated or program initiated.
• 03:18The tissue banking you have heard
• 03:20from Mario and there is really
• 03:23liver cancer or a bank and.
• 03:25That within the liver sender.
• 03:27So certainly this will be the place
• 03:29we can thinking about model would be
• 03:32the best way to collaborate with the
• 03:34liver center and then the other action.
• 03:36Is clinical trial support and
• 03:38then the other is, you know,
• 03:41exists existing biobanks support.
• 03:43So one of the key things is of this bank.
• 03:46What was going to be highlighted here?
• 03:49So CAP accreditation also which is College
• 03:52of American pathologists accreditation.
• 03:55So why do we have to do that?
• 03:56So that's the key point.
• 03:58So the CP file repository accreditation
• 04:00program was is that you know what
• 04:03you know was approved by the CMS.
• 04:05You know this is CMS as you know,
• 04:08Center for medical Medicare service.
• 04:10So in 2019.
• 04:11So basically with this
• 04:14you know approval the CMS,
• 04:17will you know recognize and
• 04:20the CPAP acquitted?
• 04:21Accredited Tissue bank will be part
• 04:24of Clear Certified laboratory.
• 04:26In other words,
• 04:26if you with this you know CP
• 04:29creditation many of the clear certified
• 04:31laboratory testing can be rendered.
• 04:34So basically it you know the CMS
• 04:37rendered the the confidence in
• 04:39specimen the you know province
• 04:43clinical laboratory director may
• 04:45accept specimen for testing for
• 04:48a banking because a formal clear
• 04:51approval requirement.
• 04:52The specimen collection integrity has been,
• 04:54you know,
• 04:55in place and it's also has established
• 04:58confidence in Preanalytical
• 05:00variable tracking and control.
• 05:02For samples used in drug trials,
• 05:04with associated biomarker development.
• 05:06So this is also very important for this.
• 05:09For Yale about repository to be engaged in
• 05:12clinical trials and also for pharmaceutical
• 05:15trials and also this with its approval,
• 05:18this really improves alignment
• 05:21of accreditation preparation.
• 05:23And the inspection process for the repository
• 05:25affiliated with CAP accredited laboratory.
• 05:28For example, the yield pathology lab
• 05:31and also the hospital hospital clinical
• 05:34laboratories that they all clear,
• 05:36certified and also CAP accredited.
• 05:38So this is part of the extension of
• 05:42the accredited laboratory and then the
• 05:45you know why SM repository is almost
• 05:48become a seamless extension of the.
• 05:51You know the current.
• 05:53Clinical laboratory,
• 05:54so what's the current status right now?
• 05:56There is no CP credit about
• 05:59repository in Connecticut school.
• 06:01We just look at the our neighbors.
• 06:03Massachusetts has one which is tough and
• 06:06Rhode Island 0 New York has three Mount
• 06:09Sinai and NYU and Memorial Sloan Kettering,
• 06:12New Jersey, has one.
• 06:13If we should rockers.
• 06:17So the water they you know you knows about
• 06:21repository organizational structure.
• 06:23We basically this is an entity in.
• 06:26This is an entity under the Dean
• 06:29and Deputy Deans for research,
• 06:32so the repository is supervised by executive
• 06:35committee appointed by the Deputy Deans.
• 06:38So this executive committee will
• 06:40have wide representation from all
• 06:42the departments and stakeholders,
• 06:44so there will be a director to
• 06:46run this operation and certainly.
• 06:47But the other piece it would
• 06:49be like operational manager,
• 06:50pathologists and data managers
• 06:53coordinators for compliance,
• 06:54and the consenting and the
• 06:56technical staff in this repository,
• 06:58so I would just use this chart to highlight
• 07:01the overall organizational structure.
• 07:04You can see the you know the director
• 07:06round the three major operations.
• 07:08Here is 1 the operation and the pre at.
• 07:12You know pre collections you know
• 07:14activity including consenting
• 07:16regulatory affairs and customer
• 07:17service and then the operational
• 07:20piece with the technical piece and to
• 07:22have the space and the procurement,
• 07:24tissue characterization,
• 07:25storage,
• 07:26distribution and then the one very
• 07:29important piece is the data management.
• 07:32So within this data management
• 07:33we will establish.
• 07:35Honest broker program with the honest
• 07:38broker honest broker program which
• 07:41will facilitate many many of the
• 07:44you know studies and really shorten
• 07:47the IRB approval process for many,
• 07:50many of legislators.
• 07:51This is a very important part.
• 07:54So now I've seen in terms of patient
• 07:57consenting and regulatory affairs.
• 08:00So we one of the key initiative or
• 08:02main tasks for this bout repository
• 08:05is to establish universal,
• 08:07consenting process.
• 08:07So we're working with the IRB
• 08:09and the hospital and also clinic
• 08:12and hopefully we'll establish the
• 08:14universal consenting process.
• 08:15Basically at the time of patient
• 08:17checking in in our facility,
• 08:19so they will automatically,
• 08:20you know, have you know,
• 08:22provided the opportunity
• 08:23to participate in the bio.
• 08:25Thank you and then,
• 08:26as I mentioned, you know this.
• 08:28As you know,
• 08:28the you know tissue banking
• 08:30is heavily regulated,
• 08:31regulated and through different
• 08:33agencies and honest program,
• 08:36honest broker program as I mentioned
• 08:39will really facilitate the internal
• 08:41research process and due to increase
• 08:44the banks usage and without too
• 08:47many you know regulatory. Burden.
• 08:53So what did the banker will do?
• 08:54OK, as this will be,
• 08:57I would call it the products from the West,
• 08:59and so one is certainly we will
• 09:02have developed the capacity
• 09:04and technology to annotate and
• 09:06process archive and fresh samples.
• 09:09This is all inclusive.
• 09:10For example,
• 09:11the fresh samples including blood
• 09:13and solid tissues and one of
• 09:15the key features the better.
• 09:16Will you know,
• 09:17get involved is to have a paired sample.
• 09:20In other words,
• 09:21you know we'll establish the
• 09:22tissue and blood.
• 09:23As a pair,
• 09:24because this is going to be very important,
• 09:26in particular for genetic study.
• 09:28So the bank also collect live tissue,
• 09:31and for organelle cultures
• 09:32and the PDX PDX mice.
• 09:34In other words,
• 09:35the two you know either tumor
• 09:38tissue or normal tissue can
• 09:40actually be starred in a live.
• 09:42You know,
• 09:42stage for many,
• 09:43many years in. In other words,
• 09:45you know this would be down the road.
• 09:47Allow some of the tissue
• 09:49recovered for biological study.
• 09:51So the bank also thinking
• 09:52about it to establish.
• 09:54Particular sign lines depending on
• 09:56the need from the investigators,
• 09:58so we will be able to derive really fresh
• 10:01thought lines and from the clinical specimen,
• 10:04and there is also molecular banking,
• 10:06so the samples will have the paired DNA,
• 10:10RNA and proteins ready and for
• 10:13the investigators use and then,
• 10:15as I mentioned earlier,
• 10:16you know we have the blood
• 10:18and solid tissue altogether.
• 10:20That means that there will be a
• 10:22system to isolate mononuclear.
• 10:24Cells and the tool using the baffle and
• 10:28the tool store those samples in the bag.
• 10:31So as I mentioned earlier,
• 10:34it is important for the data
• 10:36management you know for the bank.
• 10:38So this bank not only the tissue
• 10:39and the most you know,
• 10:41it's also for the diet.
• 10:42So the main software system for the
• 10:44bank we're using the freezer work to
• 10:47really coordinate the banks usage and
• 10:49then same time to integrate with the
• 10:52computational health platform which
• 10:53has been established at New Haven Hospital.
• 10:57So basically you know the epic,
• 10:58you know all the epic
• 11:00information can be pulled.
• 11:01Team and into create this.
• 11:03You know,
• 11:04you know we call the CHP platform
• 11:07so this will allow integration
• 11:10between tissue and data.
• 11:13So this is the you know the system.
• 11:15You know where is working really well,
• 11:18particularly over the past.
• 11:19You know year or two you know this,
• 11:21you know you know PHP system has provided
• 11:25important support for COVID related research.
• 11:27This is really credit to,
• 11:30you know, weigh the shores.
• 11:32And he has leading this,
• 11:34you know,
• 11:35PHP establishment.
• 11:36So weight is going to be part of the
• 11:39biobanking and he's going to lead
• 11:41the information management system.
• 11:44And I think this is going to be
• 11:46very powerful system to allow
• 11:47you know how to match.
• 11:49You know the tissue and make
• 11:50sure the tissue will have,
• 11:52you know, be well annotated.
• 11:55Space so right now,
• 11:56as as I speak now so we
• 11:59don't have this space yet,
• 12:01but hopefully next few months we're going
• 12:03to have a physical presence and our future.
• 12:07You know,
• 12:07the eventual place of this browser,
• 12:09Positor is most likely at the Temple St.
• 12:12You know the temple Medical Center,
• 12:13but temporarily we could probably
• 12:15going to have some other, you know,
• 12:18startup space and to be determined.
• 12:21So we have identified some candidates space.
• 12:23So the idea is in the
• 12:24next two or three months.
• 12:26So we have we will going to have
• 12:29the physical in operation and you
• 12:31know the the you know to really
• 12:33getting all the stops and the CP
• 12:37accreditation process to start it.
• 12:40And the last thing last point is funding.
• 12:44So how as you know how this
• 12:46bank is going to be funded?
• 12:48So this is really the you know,
• 12:49our aspirational goal.
• 12:51The goal is the bank should be,
• 12:54you know, eventually be 50% funded
• 12:57by the institution you know.
• 13:00This can be from, you know,
• 13:02the university support of in this case
• 13:04will be the Dean's office support.
• 13:06Either also grants,
• 13:08industrial industry collaboration.
• 13:10All the lines will be and then the other
• 13:1250% probably will come from the overall
• 13:15the user user user fees either program.
• 13:19You know, program focused.
• 13:21The banking and the worst is the you
• 13:24know users and we can do the chargeback
• 13:27and for the you know for that.
• 13:30So this is the end of my brief
• 13:33introduction with on this year.
• 13:35You know years ago medicine,
• 13:36but repository.
• 13:37I think this is going to be a shared
• 13:40resources and is going to have a you know,
• 13:42most standardized operation,
• 13:43and this certainly could be
• 13:45a very good resources for all
• 13:48the liver investigators here.
• 13:49And so we need to talk,
• 13:52you know,
• 13:52moving forward and looking forward
• 13:55the conversation to see how we can
• 13:57interact with the existing and the liver.
• 14:00Like the second out by Mario
• 14:02and you know I have to say,
• 14:06you know,
• 14:06the last slide is really credited
• 14:08to Nancy Brown,
• 14:10who has really initiated this whole thing
• 14:13and ** *** will support this repository.
• 14:17And then there there was
• 14:19a Task force committee.
• 14:20You know,
• 14:21you know within Task Committee committee
• 14:23and the Mario has been part of this
• 14:26committee and to set up this vision.
• 14:28I think I'm very excited.
• 14:30And I hope and with your support,
• 14:33this ISM repository will be
• 14:35really a great asset and a great
• 14:38resources for all the liver
• 14:40inside investigators here and I
• 14:43stopped that as I stopped there.
• 14:45Thank you very much for your attention.