Smilow Cancer Hospital Town Hall | March 27, 2024

Transcript

• 00:00Hi folks. I am coming to you
• 00:03live from just getting off I-95,
• 00:06so if I seem a little distracted,
• 00:09please give me your forbearance.
• 00:13We have a great agenda this evening.
• 00:16Tracy and I will be giving
• 00:18our usual clinical updates.
• 00:20We have a terrific and timely
• 00:23presentation on Workplace safety
• 00:25and we will be hearing from our
• 00:29multidisciplinary team who will be
• 00:31sharing details about our rapidly
• 00:34developing multidisciplinary
• 00:36cellular therapy program.
• 00:38I'm going to jump right into the
• 00:41the clinical updates and details and
• 00:43I'm going to say one of the things
• 00:47that I am I enjoy most and is most
• 00:50gratifying is welcoming new faculty
• 00:53and experts to the Cancer Center.
• 00:56And I am particularly excited to share
• 00:59news of the arrival of Doctor Tracy
• 01:02Battaglia to Smilo and the Cancer Center.
• 01:08And I can't tell since I'm
• 01:10driving if Tracy's picture is up,
• 01:14but I hope that slides up.
• 01:16Tracy is a is a internist by clinical
• 01:22background, but she is also a
• 01:27a cancer care equity expert and
• 01:30researcher and an expert in
• 01:33clinical cancer care navigation.
• 01:36She comes to us from Boston University
• 01:39and Boston Medical Center where she
• 01:42was the Director of the Women's Health
• 01:44Initiative and also the Director of
• 01:47the Avon Breast Cancer Initiative.
• 01:50And I think Tracy's arrival is
• 01:53particularly timely as we have
• 01:56learned that CMS and major payers
• 01:59will be supporting reimbursement for
• 02:03cancer care navigation services.
• 02:06So I think her leadership and
• 02:08expertise combined with these
• 02:10additional resources will be a
• 02:12unique opportunity for us to augment
• 02:15these services for our patients.
• 02:18So I I think all of you will
• 02:20probably have a chance to meet Doctor
• 02:23Battaglia as she makes her rounds
• 02:25and the organization and please
• 02:28join me in in welcoming her.
• 02:33The next slide that I can't see
• 02:36but I think is probably up is
• 02:40our update on clinical trials.
• 02:42I think it is a good point in our
• 02:45history to show that we've really come
• 02:48through a very significant downturn
• 02:50in our clinical trials accrual and
• 02:54we are now on a significant upswing.
• 02:58And I'd like to give a big shout
• 03:00out and word of gratitude to Dr.
• 03:02Ian Crop, Alyssa Gateman and
• 03:05Adam Roschka who've LED A-Team,
• 03:08an expanding team of of the clinical
• 03:12trials staff as well as all of our
• 03:15investigators and division chiefs who
• 03:18have deployed A robust portfolio of
• 03:21trials and we're really putting patients on.
• 03:25So I think it's something we could
• 03:27all celebrate and be proud of.
• 03:32The other thing that I want to take a
• 03:34minute to, to call out and ask people
• 03:36to do if they have not already is to
• 03:40get on Toximity and vote of course for
• 03:44Smilo and Yale Cancer Center as the
• 03:47premier cancer treatment center on U.S.
• 03:50news and world reports.
• 03:52The Doximity voting is closing very soon.
• 03:55So I think that window of
• 03:58opportunity is rapidly closing.
• 04:00So please take the opportunity.
• 04:05So with that,
• 04:06I think I'll pass it over to you, Tracy.
• 04:11Thank you. So we just wanted
• 04:13to mention that on March 19th,
• 04:15we celebrated our certified nurses.
• 04:17It's it's a national day to celebrate
• 04:19certified nurses through the
• 04:21American Nurses Credentialing Center.
• 04:23And so we have over 200 certified
• 04:26registered nurses in our Smilo sites
• 04:29and organization and we have over 30
• 04:32AP PS with specialty certification.
• 04:36So those are really great numbers and we
• 04:38have continued to increase those each year.
• 04:41So thank you to all the nurses for
• 04:43all they do and the professionalism
• 04:46they bring with their certification.
• 04:48We also just want to mention that and
• 04:52thank the the cancer registry team.
• 04:54National Cancer Cancer Registrar
• 04:57Week is April 8th through the 12th
• 05:01and this is the team pictured here.
• 05:04The the registry team really plays
• 05:08a vital role in the fight against
• 05:10cancer and their work really helps
• 05:12to continuously improve the quality
• 05:13of care we provide to our patients
• 05:16across the organization.
• 05:17The cancer data that they collect
• 05:19helps provide valuable insights
• 05:21to understand our cancer outcomes
• 05:24and they play important roles,
• 05:27sometimes unseen and collecting data
• 05:29that will impact Cancer Research and
• 05:31treatment programs for future generations.
• 05:33So great shout out to the team and if
• 05:35you see any of them during this week,
• 05:38please make sure you thank them
• 05:39for all that they're doing.
• 05:44We are now gonna turn it over to
• 05:47Nick Proto and Stephanie McGuire.
• 05:50We, as in we in Smilo as well
• 05:53as the organization had a lot
• 05:56of feedback and comments through
• 05:58the Glint survey about concerns
• 06:00related to personal safety,
• 06:02security and you know,
• 06:04there's been a number,
• 06:05there's a lot of events going on
• 06:07and so the organization is taking
• 06:09a lot of action in relation to
• 06:11the concerns with employee safety.
• 06:13And so thank you Nick and Stephanie
• 06:15for joining tonight to share some
• 06:17of the work that you're doing
• 06:18in this forum.
• 06:20Thank you, Tracy.
• 06:21So I'm gonna be speaking on
• 06:23behalf of myself and Tom Mendillo,
• 06:25who's the operations Manager who is
• 06:27tied up at another meeting right now.
• 06:29I'll be doing the presentation on
• 06:31security and safety initiatives
• 06:33that we are currently doing at
• 06:35Yellow Haven Hospital and has been
• 06:37ongoing initiatives every year.
• 06:39And Stephanie's gonna talk about the
• 06:42electronic physical security infrastructure.
• 06:43She manages the infrastructure from infant
• 06:46security to all the cameras and carriers.
• 06:49Anything that's not people,
• 06:51Stephanie manages from a security standpoint,
• 06:54very well versed and educated in
• 06:57electronic physical technology and is
• 07:00always looking at bigger and better
• 07:03ways to secure our institutions.
• 07:06So if you could progress the
• 07:07slide for me Stephanie,
• 07:09so I want to talk to you about
• 07:11communication and collaboration.
• 07:13You know,
• 07:14aside from our patients and visitors
• 07:17arriving with a high level of anxiety,
• 07:20there are considerable increases in
• 07:22behavioral health and substance abuse
• 07:24patients arriving in our facility.
• 07:26And they're not just showing
• 07:27up at our Salem Tunnel,
• 07:28one floors in Salem Tunnel 5 and Yale
• 07:31physician Yale's Saint Ganswick Hospital.
• 07:32They're showing up on all
• 07:34the patient care units.
• 07:35They're coming in with medical issues
• 07:37and then it's escalation and our staff
• 07:39are getting injured or getting assaulted.
• 07:42And, you know,
• 07:42aside from the high level of anxiety,
• 07:44there are also societal issues
• 07:45that are going on.
• 07:47There's the political climate.
• 07:48There's St.
• 07:48violence, COVID, the cost of living,
• 07:51the wars in Gaza, in Ukraine, you know,
• 07:54mass shootings around the country.
• 07:56There are a lot of things happening in our
• 07:58society that are affecting our patients,
• 08:00our employees and visitors
• 08:02who are coming in there.
• 08:03We're seeing a spike in a lot of crime
• 08:05and we're seeing a spike in a lot of
• 08:09things that are going on in
• 08:11and around the hospital.
• 08:12I want to talk to you about some of
• 08:13the initiatives that we're doing
• 08:14and some of the things that we could
• 08:16all do to keep the institution safe.
• 08:18I want to talk about rounding,
• 08:19Tricare system and educational
• 08:21safety huddles.
• 08:23We have a we require our officers
• 08:26to round 6500 rounds per month
• 08:28on every patient care unit.
• 08:29That's a documented tract performance
• 08:32improvement initiative that we require
• 08:35officers to do every single month.
• 08:37That gives us an opportunity to
• 08:39communicate with clinical staff and team
• 08:41up at our off shift clinical leaders
• 08:43on the off shift and on weekends.
• 08:45In addition to that we do the
• 08:47three tiers of rounding.
• 08:48The first one is we call direct,
• 08:50the 2nd is intuitive and the
• 08:52third is indirect.
• 08:53The direct rounding deals directly with BRA,
• 08:55said Rossitool.
• 08:56If you don't know what it is,
• 08:58it's those patients who have a
• 09:00propensity for escalation of violence.
• 09:03We get a list of those patients twice a day,
• 09:069:00 in the morning and 9:00 at night.
• 09:08And those officers who are on
• 09:10patrol go up to those units and
• 09:12talk to clinical staff to see
• 09:14what the patients are doing,
• 09:15making sure there's no escalation.
• 09:17And try to be proactive before the
• 09:20patient does escalate or get violent.
• 09:22There's the intuitive rounding
• 09:24and the intuitive rounding
• 09:25is our victims of violence.
• 09:27We have numerous victims of violence
• 09:29here on any given day and it's
• 09:32community violence with shooting
• 09:33victims and stabbing victims.
• 09:35The we have numerous victims of
• 09:37domestic violence and we also have
• 09:39issues on our maternity floors
• 09:41where their risk of injury of a,
• 09:43I'm sorry, risk of a patient being,
• 09:45you know,
• 09:46taken out against the Guardian's best wishes.
• 09:49And it's usually some kind of
• 09:52domestic distribute between two
• 09:53parties responsible for that child.
• 09:56So the risks are very high in some
• 09:58of these areas and we make sure
• 10:00that the indirect rounding and the
• 10:02intuitive rounding goes up on all
• 10:04those patient care units every day,
• 10:06numerous times a day on every shift.
• 10:09We also do safety huddle talks.
• 10:11It's a an abbreviated version
• 10:12of what I'm giving you today.
• 10:14We go on the patient care units
• 10:16and we talk to patient to our
• 10:18employees and clinical staff and we
• 10:20talk about situational awareness.
• 10:23We talk about St.
• 10:24awareness and things that are happening
• 10:25around the hospital and what we could
• 10:27do together and want to keep them safe,
• 10:29to keep our patients safe and to
• 10:31work with security for reporting
• 10:33whether they see something that
• 10:34may be a potential risk for the
• 10:37hospital or somebody's safety.
• 10:38The next thing I want to talk about is St.
• 10:40Outreach,
• 10:40the Hospital Violence Intervention Program.
• 10:42These are people in the community
• 10:44who did not have great pasts with
• 10:47the law but have done their time and
• 10:49are now working with the community,
• 10:51with the police,
• 10:52with Hospital Protective Services,
• 10:54with Yale University Police
• 10:56Department to turn the lives of
• 10:58children and kids and teenagers
• 11:00in our communities around and not
• 11:03have the recidivism of shootings
• 11:05and victims of violence etcetera.
• 11:07So when we get victims of violence,
• 11:09they show up at our emergency
• 11:11departments and they work with my
• 11:13team and tell us is it gang related,
• 11:16is it gang, is it drug related,
• 11:19is it random act of violence,
• 11:20is it domestic violence?
• 11:23So we end up getting the information
• 11:25and that's important to our emergency
• 11:27departments so they could provide the
• 11:30care to that patient without being
• 11:32hindered by risk of retaliation.
• 11:35And it also follows up to the
• 11:37patient care unit where we house or
• 11:39we treat the patients of violence.
• 11:41And we have to lock down the patient
• 11:44care units to make sure staff
• 11:46are safe and that victim is safe.
• 11:49The COMSTAT participation in
• 11:50New Haven Police Department.
• 11:51I work with the Chief of Police myself,
• 11:53Tom and Steph.
• 11:54We meet with the chief every other
• 11:56Thursday at a COMSTAT meeting.
• 11:58We also meet with the Yale University
• 12:00Chief of Police Anthony Campbell
• 12:02and Bonnar Cease on a regular basis.
• 12:04Anything that goes on here,
• 12:06we have open communication.
• 12:07We're a phone call away and
• 12:09we talk very frequently.
• 12:11I want to talk about a workplace
• 12:12violence tracker in it,
• 12:13but before I talk about the tractor,
• 12:14I wanna the tracker.
• 12:16I wanna tell you about what
• 12:17actually initiated us to do this.
• 12:19A number of years ago we had an an employee,
• 12:22a nurse who was assaulted and
• 12:26the we took a report,
• 12:29patient assaulted the nurse.
• 12:30We took the report.
• 12:31We called the New Haven Police
• 12:32Department and the New Haven Police
• 12:34Department showed up and took the
• 12:35report and then asked the nurse for her
• 12:38home address and her home phone number.
• 12:40And the nurse said I'm not gonna give you
• 12:42my home address and home phone number.
• 12:43I'm gonna give you my work
• 12:44address and work phone number.
• 12:45And the police said no,
• 12:47if you don't give me your home
• 12:48address and home phone number,
• 12:49we're not documenting it and
• 12:50we're not gonna affect an arrest.
• 12:52So they walked away and I came in
• 12:54the next day and I found out about
• 12:55it and I called the district manager
• 12:57and I said what is happening?
• 12:59Why did this happen?
• 13:00And he said Nick, it doesn't come from us,
• 13:02it comes from the chief of police.
• 13:04So I called the chief and I said
• 13:06why is this happening?
• 13:07And he said, Nick, it doesn't come from me,
• 13:09It's an order from the state's
• 13:11attorney's office.
• 13:11So I called the state's attorney and
• 13:13I asked to meet with him, which I did.
• 13:15And I said,
• 13:16why are you making this rule that
• 13:18people get assaulted in the hospital,
• 13:20are not being their their,
• 13:23their crimes are not being recorded and
• 13:26there's no consequences for the offender.
• 13:28And he said,
• 13:28because if they don't give their
• 13:30home address and home phone number
• 13:32when the court appearance comes
• 13:33on and we're looking for that person to
• 13:35give a statement as to what happened,
• 13:37we can't reach them because it's occurring
• 13:39on evenings and nights and the courts
• 13:41aren't open on evenings and nights.
• 13:42And this is causing a backlog
• 13:45in our judicial system.
• 13:47And I said, well, this is not fair.
• 13:48I said you gotta overturn that.
• 13:50And he said absolutely not.
• 13:52I'm not gonna overturn it.
• 13:54So I have a friend of mine
• 13:55who's a judge in Hartford,
• 13:57from the judge.
• 13:58And I was talking to him about it and
• 14:00he connected me with the judge in New Haven.
• 14:03And I spoke to the judge in his chambers.
• 14:04And I said when I was a police officer for
• 14:0720 years in New Haven and I was assaulted,
• 14:09I never had to give my home address and home
• 14:11phone number with the risk of retaliation.
• 14:13I never required firefighters to give it
• 14:15and neither did I require AMR to give it.
• 14:18Why are we allowing this for healthcare
• 14:21workers who work in a world class
• 14:25hospital giving world class care to
• 14:27give their home address and home phone
• 14:29numbers and put their lives at risk?
• 14:31And he said you make a good point.
• 14:33I'll let you know in two days.
• 14:35I'll render a decision.
• 14:36I'll let you know in two days.
• 14:38He called me in 2 1/2 hours and overturned
• 14:40the state's attorney's decision.
• 14:42And now the police are coming here.
• 14:44Now when I talk about the collaboration
• 14:46with the judicial system,
• 14:47that's what I'm talking about.
• 14:48And this prompted Tom Mondillo and
• 14:50myself and Stephanie to put together
• 14:52something called the Violence Tracker.
• 14:54And quite simply,
• 14:55it's a four pronged effect.
• 14:56It's confidence that our staff
• 14:58are going to report.
• 14:59We go up to 100 different patient care
• 15:03units a couple times a year and we give
• 15:06safety talks and we encourage our staff.
• 15:09If you feel threatened,
• 15:10if you come to work and you feel
• 15:12threatened if you are assaulted,
• 15:14if you are groped,
• 15:15if you're sexually assaulted,
• 15:17we want to know about it.
• 15:18You have to call us.
• 15:19We want to be the conduit
• 15:21to local law enforcement.
• 15:22We'll document it and we will be the
• 15:24conduit to local for law enforcement.
• 15:26It's accountability for the police
• 15:28and the judicial system to follow
• 15:30through with these types of complaints.
• 15:32It's consequences for the
• 15:33offender and most importantly,
• 15:35it's closure for the victimized employee.
• 15:37We have lieutenants who work every shift.
• 15:39They find out the status
• 15:40and disposition of the case.
• 15:42They meet with our employees and
• 15:43they let them know what the status
• 15:45and disposition of the case is.
• 15:47I tell our employees the
• 15:48morning safety huddles.
• 15:49If you go to Home Depot tonight and they
• 15:51don't have a part to your house and you
• 15:53kick the person who is not helping you,
• 15:55chances are you're not leaving Home Depot,
• 15:57not in handcuffs.
• 15:58If you go to a restaurant tonight and
• 16:00they don't give you your meal on time and
• 16:02you slap the waiter or the waitress,
• 16:04you're not leaving the restaurant,
• 16:06not in handcuffs.
• 16:06So why do you think you could come to
• 16:09a medical facility and and and slap,
• 16:11abuse, threaten and assault our staff
• 16:13and not be held accountable for it?
• 16:16So we drew a line in the sand
• 16:18with this violence tracker.
• 16:19Again, it's the confidence,
• 16:21the accountability of the consequences
• 16:23and the closure for each event and
• 16:26everything is documented and tracked.
• 16:29I also serve on the Workplace Balance
• 16:31Risk Assessment Committee and we have
• 16:33a Joint Commission standard which
• 16:35we go up and do risk assessments
• 16:37on every patient care unit and
• 16:39look at gaps and opportunities.
• 16:41And Department of Homeland Security,
• 16:43which is DHS and the FBI are
• 16:46very close to us.
• 16:48Department of Homeland Security comes
• 16:49here every five years and they do a risk
• 16:52assessment on the entire institution.
• 16:54They come with a team of people and
• 16:55they look at gaps and opportunities
• 16:57and we take that and we make the
• 16:59department work with Stephanie
• 17:00McGuire and her team to make the
• 17:02department more secure and safer.
• 17:04The FBI is in the city of New Haven,
• 17:06so it's good to have open
• 17:08collaboration with them.
• 17:09They work with us.
• 17:10We've had we had a bomb threat
• 17:12going back about 14 months ago where
• 17:15somebody called them for bomb threats
• 17:16over a or over a 12 hour period.
• 17:20We called the Joint Terrorist Task Force.
• 17:22They sent somebody up here and they
• 17:26investigated and four weeks ago
• 17:28that person got 7 years in prison.
• 17:30We recently had another bomb threat
• 17:33that happened 3 weeks ago and they're
• 17:36investigating that right now.
• 17:37But somebody had called in that
• 17:39there was a ammonium nitrate bomb
• 17:41around Yellow Haven Hospital.
• 17:44And that the person who made the call,
• 17:47actually,
• 17:47he actually sent an e-mail to the
• 17:49mayor of the city of New Haven saying
• 17:51that he's gonna find me on New Haven
• 17:53Hospital and that he was going to
• 17:54shoot at doctors who were leaving the
• 17:57facility because they killed his daughter.
• 17:59So we have the FBI working on this and we're
• 18:02actually tracking this through the dark web.
• 18:04So more to come on that,
• 18:06but those are,
• 18:07those are that's the
• 18:08collaboration that we have.
• 18:09This is a communication we have with staff.
• 18:12This is the ongoing communication
• 18:13we have with the community,
• 18:14with local law enforcement,
• 18:16with projects that are going on
• 18:18within the hospital which includes
• 18:20risk assessments and being part of
• 18:22workplace violence committee on a
• 18:24hospital and a health care setting.
• 18:27Next slide please Stephanie.
• 18:30So this gives you a an idea of the
• 18:33breadth and scope of what we do.
• 18:35We are at at we currently have
• 18:38presence at 10 offsite locations.
• 18:41However we're we're with the technology
• 18:44that the security technology
• 18:47Stephanie currently operates at
• 18:49over 104 offsite locations for
• 18:51approximately 10.8 million square feet,
• 18:53thousands of people into
• 18:55our facilities every day.
• 18:56We have numerous victims of violence.
• 18:59Stephanie, I don't know if you want to
• 19:00talk about the electronic infrastructure
• 19:02at these locations and what we have
• 19:04here and what we're trying to do to
• 19:06make this the institution safer.
• 19:07If you want to talk about the
• 19:09technology now and then I'll get
• 19:10into the last part of the slides.
• 19:13Sure. Thanks, Nick.
• 19:14And apologies for not being on camera.
• 19:16I'm not feeling my best.
• 19:17I'm like minutes, hours,
• 19:19days away from giving birth so
• 19:22I am home resting and again just
• 19:25not feeling or looking my best.
• 19:26So apologies for not being on camera.
• 19:29But again Nick,
• 19:30thanks for for kicking this over.
• 19:32As he said,
• 19:33we have a very robust physical
• 19:36security security technology system
• 19:39that's not only located
• 19:41within the four walls of each campus,
• 19:43but we have a heavy presence
• 19:45in our ambulatory sites too.
• 19:46So for those of you that frequent
• 19:49the off site Smilo centers,
• 19:52you know that we have panic
• 19:54devices and we have cameras and we
• 19:56have card readers to keep those
• 19:58satellite locations safe as well.
• 20:00So we have over 1700 cameras,
• 20:04we have over 2800 card readers we have.
• 20:08Over 2500 links, panic devices,
• 20:10which are the panic devices that
• 20:11are located on your keyboards.
• 20:13As Nick mentioned before,
• 20:15we have a very robust infant security
• 20:17system which we actually just
• 20:19transitioned over as I'm noticing
• 20:21we're we're looking at the PowerPoint.
• 20:23We have transitioned from a Stanley
• 20:26product which was formerly called Hugs
• 20:28to a new program by Guard RFID called
• 20:31Top Guard that was completed about
• 20:33two weeks ago because we do have,
• 20:36you know,
• 20:36that's one of our most precious
• 20:38populations with over 6000 babies birthed
• 20:42annually at the York Street campus.
• 20:45We have over 100 emergency blue
• 20:47phones which I'll get into talking
• 20:49about some initiatives regarding blue
• 20:51phones on the exterior in a moment.
• 20:53We have close to 3000 alerts users,
• 20:58which we will also talk about
• 21:00in a future slide,
• 21:01which is the mobile panic device system.
• 21:04And dispatch receives or can receive
• 21:07up to 10,000 alarms that are monitored.
• 21:13So between panic alarms,
• 21:16between fire alarms,
• 21:18environmental alarms,
• 21:19pharmacy alarms,
• 21:19there's quite a bit of action that comes
• 21:22in through both of our dispatch centers.
• 21:27Thank you, Steph.
• 21:27If you go to the next slide, please?
• 21:30Sure. So I'd like to give you the
• 21:34breadth and scope of what we do.
• 21:35This is sort of like an eye
• 21:37chart and I you know it.
• 21:38You know we monitor,
• 21:39we have performance improvement initiatives
• 21:41that we monitor on a daily basis,
• 21:43almost on an hourly basis and
• 21:45we calculate them by the year.
• 21:47The the calls between here and St.
• 21:49Rayfield Campus, we average about
• 21:51150,000 calls for service a year.
• 21:54I talked about the building checks that
• 21:56we do, the rounding up on the floors.
• 21:58We average anywhere between 6000
• 22:01and 7500 rounds pounds per month,
• 22:03which is required as performance
• 22:05improvement initiative.
• 22:06I want to take your line,
• 22:07your eyes to line number four.
• 22:10It says number of patient interactions.
• 22:12Those aren't. Those aren't patient problems.
• 22:14Those are interactions.
• 22:15Those are.
• 22:16They gives us an opportunity to make
• 22:20that right when we approach a patient
• 22:23and they're highly escalated or highly,
• 22:25you know,
• 22:26they're 1° above boiling point.
• 22:28It's up to us to deescalate that or
• 22:31redirect that patient to comply with the
• 22:34medical care that they're going to receive.
• 22:37We do about of the redirects we
• 22:42we interact with about 32,500 /
• 22:45a thirteen month period.
• 22:46If you look at line number six,
• 22:48look at the number of those patients
• 22:50that end up in restraints 19101,
• 22:53that's less than 5% of the patients that
• 22:57we interact with that end up in clinical
• 22:59restraints at the request of a physician.
• 23:02So we hire retired police officers to patrol
• 23:05and to respond to these types of calls.
• 23:08They bring a skill set,
• 23:10they bring a discipline and they bring
• 23:12a certain level of communication,
• 23:14problem solving and critical thinking
• 23:17to every patient interaction.
• 23:18Most of our patient interactions are in
• 23:21the adult emergency departments and our
• 23:23behavioral health and our YPH buildings.
• 23:25They know us by name and there
• 23:27are many patients who call us on
• 23:29a first name basis and we have
• 23:31a good rapport with them.
• 23:32We also have opportunities to
• 23:34empower clinical staff and they
• 23:36have opportunities to empower us to
• 23:38sometimes step back from a patient
• 23:40'cause they may be escalating
• 23:42and we tell them the same thing.
• 23:44You may wanna step back.
• 23:45This is gonna escalate.
• 23:46We don't want you to get hurt.
• 23:47So these are the types.
• 23:48We put a lot of emphasis on the number
• 23:50of patient interactions and the number
• 23:52of patient restraints to show our successes.
• 23:55But look in line #7 where it has
• 23:57patient number of patient safety checks.
• 23:59You know how difficult it is to
• 24:01put your hands on a patient who
• 24:03has a mental illness or behavior,
• 24:05health issue or substance abuse issue
• 24:07or may have Alzheimer's or the onset
• 24:10of of dementia to put your hands on
• 24:12them to check for weapons or drugs.
• 24:14We do that 16,000 times over the course
• 24:18of a year and very rarely does that escalate.
• 24:22So you have to have really
• 24:23good communication skills and
• 24:25problem solving techniques in order
• 24:26to put your hands on somebody,
• 24:28search them and get them to comply
• 24:30so the clinical staff could do the
• 24:32care that is provided they they
• 24:34need to provide for that staff.
• 24:36So these are some of the things that
• 24:37we do and these are the numbers.
• 24:38Again, it's just an eye chart,
• 24:39but it's something that we track and
• 24:41we report out on a monthly basis and
• 24:43something that we hold and as a P I,
• 24:45I and hold all our officers accountable for.
• 24:48Next slide please, Steph.
• 24:54So New Haven crime statistics, again,
• 24:57you know, why is this important to us?
• 24:59You know, I get emails from the chief
• 25:02almost on a daily basis from the Yale
• 25:04University and Yale New even hospital.
• 25:06While things that are
• 25:07going on around the city,
• 25:08there are a lot of protests based on the
• 25:10wars that are going on around the country.
• 25:13You know, for or against certain countries.
• 25:15There are a lot of protests
• 25:17on the New Haven Green,
• 25:18not a concern to Yellow Haven Hospital.
• 25:21We are not the focal point.
• 25:22However, we can become the focal point.
• 25:25If somebody gets hurt at once,
• 25:27there's any kind of a risk involved.
• 25:30Once there's an assault,
• 25:32once there's somebody that at that
• 25:34location that needs medical attention,
• 25:36that shows up at our front door and
• 25:38our emergency department and that will
• 25:40bring family and friends and protesters
• 25:43to the front doors of our institution.
• 25:45It will also bring media
• 25:46and a police presence.
• 25:48So although I'm not concerned about
• 25:50the protests that are going on,
• 25:52you know,
• 25:53anything that has a potential for violence
• 25:55that may show up at our front doors.
• 25:56It's important that we're in close
• 25:58communication with the chief at both
• 26:00the hospital and the university.
• 26:02I wanna know about the about the confirmed
• 26:04shots that are fired every day or every year.
• 26:07I wanna get the rolling numbers.
• 26:09I wanna know about the aggravated assaults,
• 26:11the assault with the firearm,
• 26:12the the robberies,
• 26:14the murder victims.
• 26:15These patients show up at our front doors.
• 26:18They bring friends and sometimes
• 26:20they bring foes who come in here
• 26:22and want to try to do harm to
• 26:24that patient or patient's family.
• 26:27I know a big thing on the glint
• 26:29was the thefts from or of autos.
• 26:31This is something that's been
• 26:33going on nationwide.
• 26:34We've seen an increase and thefts from
• 26:38autos from our parking lots and garages.
• 26:40We're not exempt from any other
• 26:42city or town or any other parking
• 26:44lot or garage in the city.
• 26:45New Haven.
• 26:45I know everyone's seen an uptick in this.
• 26:47It's sort of started levelling out
• 26:50but we have put New Haven police,
• 26:53New Haven Parking Authority because
• 26:55Yale New Haven Hospital does not
• 26:56own any of our lots and garages.
• 26:58So we encourage the parking authority to
• 27:00round and put personnel in these areas
• 27:02and we also encourage our officers to
• 27:04go there especially during peak times
• 27:06to show a presence in the lots and
• 27:08garages to make sure that our staff,
• 27:11our patients and visitors
• 27:12are safe on the lot.
• 27:14They are some of these
• 27:15are opportunistic crimes.
• 27:16We just arrested 214 year old kids
• 27:19today in our two house street garage.
• 27:21Were checking door handles of cars
• 27:24walking around and they're also
• 27:26involved in other things that
• 27:28they admitted to today as well.
• 27:29But just so you know,
• 27:30do not leave anything of value in your car.
• 27:33We are in a high end call for
• 27:35police service
• 27:35area. We are, we are in a great community.
• 27:38I got to tell you, I work in the
• 27:40streets in New Haven for 20 years.
• 27:4295% of this community are great people
• 27:45but we have 5% are out for all the wrong
• 27:47things and all the wrong reasons and that's
• 27:49the reason why we got to lock the doors.
• 27:50Be careful walking to
• 27:51and from from your cars.
• 27:53Take advantage of shuttles of
• 27:55security escorts of police escorts
• 27:57from Yale University.
• 27:59Take advantage if you're going to walk.
• 28:00It's getting lighter later now,
• 28:02so take advantage.
• 28:02If you're going to walk to your vehicle,
• 28:04walk in groups, safety and numbers.
• 28:07I know, I know Yale University
• 28:09has an app for your phone.
• 28:11We also have one for Yale New
• 28:13Haven Hospital for our employees.
• 28:14It's called Alert CC app.
• 28:17That's definitely talking about in a minute,
• 28:19but you need to take precautions.
• 28:21You can be viewed as a target,
• 28:23but you do not have to be a victim,
• 28:25so take precaution.
• 28:26We need the eyes and ears of
• 28:28every one of our employees to
• 28:29keep our institutions safe.
• 28:31There was an incident about about two
• 28:34months ago where one where one of our
• 28:36employees parked their vehicle at a
• 28:37lot on the office in Rayfield Campus
• 28:39and as she was exiting her vehicle
• 28:41she was approached by a homeless woman
• 28:43who asked for her the keys for her car.
• 28:46When she refused to give the keys over to
• 28:49this woman they engaged in a struggle.
• 28:51The woman while the woman felt she
• 28:55was losing the struggle she reached in
• 28:56her pocket and she pulled out a knife.
• 28:58Our employees started to run away from
• 29:00the woman and the woman threw the knife
• 29:03that the employee thankfully missed her.
• 29:04But please think about this.
• 29:06Do not take any unnecessary if somebody
• 29:09asks for your purse or somebody asks
• 29:11for your computer keys to your car,
• 29:13please give them up.
• 29:15Your life is not worth a setting your
• 29:17your set of keys is not worth your life.
• 29:19So please turn them over.
• 29:21It's not worth it.
• 29:22They're desperate people out
• 29:24there taking desperate measures.
• 29:25And you know, we don't want to see,
• 29:27you know,
• 29:28one of the unthinkables happen to any
• 29:30of our employees from the the hospital
• 29:32or university or anybody for that matter.
• 29:34So please,
• 29:35if they're if you're asked to give something
• 29:37starting over and it could save your life,
• 29:39relinquish whatever you have and and please,
• 29:42it's not worth your life.
• 29:44Give it up and and and move on.
• 29:46Call the police and chances are very
• 29:48good it's on a camera somewhere.
• 29:50We'll be able to capture that.
• 29:52Next slide, please.
• 29:55So Stephanie,
• 29:55you want to talk about the alerts and links?
• 29:59Sure. So two pieces of technology
• 30:01that I wanted to review with you
• 30:03today and then we'll also get into
• 30:05some perspective technology and
• 30:07projects that we're working on.
• 30:09But these are two that are
• 30:10available to you right now.
• 30:13Sorry, it's Tracy. I just want to,
• 30:15I'm sorry, but like we're if you guys
• 30:18could try and just wrap up in the next
• 30:195 minutes or so because we do have
• 30:21another presentation, I apologize.
• 30:23Yes, no problem.
• 30:24So Alerts is a is an app that is
• 30:28available to all Yale New Haven
• 30:30Hospital employees right now.
• 30:32So Alerts you say now is a smartphone app.
• 30:35You can sign up through Infor
• 30:37under Quick Links.
• 30:38You go through a credentialing
• 30:40process and then you can download
• 30:42the app from the App Store.
• 30:44Basically there's three main features
• 30:47that we leverage with this app.
• 30:48Users can send a a photo or a video and
• 30:51it gets issued directly to Protective
• 30:53Services and you can text back and forth.
• 30:56We have canned reports under this
• 30:59kind of like a share problem which
• 31:03is suspicious person vehicle.
• 31:05You know you see the same car
• 31:08in the parking garage for five
• 31:10weeks and it's filled with dust.
• 31:11You can send a photo and and
• 31:13we'll check it out through to,
• 31:15you know,
• 31:16there's pan handlers in the garage
• 31:18or you see kids hitting door handles
• 31:20and you get something on video.
• 31:22You can share that with us.
• 31:25Two of the the more important features
• 31:27I would say is you can directly
• 31:30dial 911 through the app and the
• 31:32credentials that you sign in with.
• 31:34So we know Nick Proto just dialed 911.
• 31:37We have his telephone number because
• 31:38he signed up with that and we can
• 31:41follow up with him from the hospital
• 31:43perspective to make sure that our
• 31:45employee is OK and also file a report.
• 31:47And then you can also hit a panic button,
• 31:50which is not,
• 31:51does not go to 911 comes to us directly
• 31:54and we can follow up with you as well.
• 31:56So all of these features are are 24/7 365.
• 31:59As a Yale New Haven employee,
• 32:01you can use it on or off site.
• 32:03So whether you're working in
• 32:05New Haven or an ambulatory site
• 32:07or you're not working at all,
• 32:08if there's something happening
• 32:10in your community and you cannot
• 32:12safely call 911 and you feel
• 32:14like you need to be discreet,
• 32:16you can contact us and we can
• 32:18call the local PD on your behalf.
• 32:20So again,
• 32:20you can sign up through through
• 32:22info and I can provide more
• 32:24information and then links.
• 32:25We also talked about earlier
• 32:26on in the presentation,
• 32:27which is the computer keyboard panic
• 32:30system where if if you have it,
• 32:33get familiar where you can hit F1 and F-12.
• 32:36They're stickers about both of those
• 32:38what were referred to as hotkeys.
• 32:40If you're in a situation where you
• 32:43feel like behavior is escalating,
• 32:45you can discreetly hit both of
• 32:46those buttons at the same time and
• 32:49security is notified and we will
• 32:50call you because one dispatcher is
• 32:53calling to get more information.
• 32:54We're we're also dispatching an
• 32:57officer or group of officers to your
• 33:00area to help you in that situation.
• 33:02Quickly,
• 33:03I'll share with you that there
• 33:04are some other initiatives that
• 33:06we're currently working on under
• 33:08the executive sponsorship of Ann
• 33:10Diamond from Bridgeport Hospital.
• 33:12She gives a proof for Yale
• 33:13New Haven to get
• 33:14more robust infrastructure outside,
• 33:16which we're referring to as
• 33:17the safe walkway initiative.
• 33:18So as Nick discusses, you know crime
• 33:21in the community and parking lot crime.
• 33:23You will soon see more blue phones
• 33:26and more cameras and increase
• 33:28lighting between both campuses,
• 33:30especially as summer months are approaching.
• 33:31We know that folks like to walk
• 33:33versus utilizing the shuttle service.
• 33:35We will always say if you could wait
• 33:36for the shuttle, please take it.
• 33:38But in the event that you don't,
• 33:40we felt it was important to increase
• 33:43some technology across the way between
• 33:45both campuses and the parking lots.
• 33:48So that was something that
• 33:49was approved as well.
• 33:51As you know,
• 33:51we talked about Elerts being the current app.
• 33:54Everbridge is our current
• 33:56mass notification system.
• 33:57And Everbridge did come up with
• 33:59a very similar app as Elerts
• 34:01called Safety Connection.
• 34:02So we did receive funding for that.
• 34:04It has all of these features plus a few more,
• 34:08so it's definitely more robust.
• 34:10And with that they're allowing us
• 34:13to pilot 50 wearable panic devices
• 34:16that we will start in the home
• 34:19health Hospice region that will have
• 34:21cellular enabled chips in them.
• 34:23So you know rather than having
• 34:25to rely on the cell phone app,
• 34:27you can utilize this wearable
• 34:29badge and it will work the same
• 34:32way as it goes back to dispatch.
• 34:34So that I know that has been a hot topic
• 34:36with home health and B and A services.
• 34:38You know unfortunately we lost that
• 34:41nurse in Connecticut in the fall.
• 34:42So those are some other things that
• 34:44we're currently working on right now.
• 34:48Thank you, Stephanie and and Tracy I will,
• 34:51I will wrap it up with just
• 34:52a couple more comments.
• 34:54So if you have not seen this video,
• 34:56this is a called active
• 34:57shooter life threatening event.
• 34:58It's on in four.
• 34:59Please take a look at it.
• 35:01These horrific events are
• 35:02happening all over the country.
• 35:03It doesn't matter who you are,
• 35:04where you are, where you go,
• 35:05where you socialize, where you work.
• 35:07These coward events are happening everywhere.
• 35:11Please know, you know the concept of
• 35:14run height fight is still very active.
• 35:16Know to call 911 or 155
• 35:18wherever you're located.
• 35:19Run height fight is critical and
• 35:22know that there's going to be a
• 35:24very robust police and Protective
• 35:26Services response to isolate,
• 35:28contain and neutralize that
• 35:29threat as quick as possible.
• 35:31It will be a sad day in this hospital.
• 35:33Something like this happens,
• 35:34but we're taking every precaution,
• 35:36working with every department to keep the
• 35:38institution as safe as we possibly can.
• 35:40Look at this video.
• 35:41It's not a bad idea.
• 35:43And finally,
• 35:44and we could send this out to everyone,
• 35:46I think we send out safety tips twice a year.
• 35:50And these are just, you know,
• 35:51be aware of your surroundings.
• 35:52If you're confronted by an
• 35:54individual who's threatening,
• 35:55demanding,
• 35:55give over your possessions so you
• 35:57could read these and post them in your
• 36:00areas and remind staff during your huddles,
• 36:02during your safety talks,
• 36:03please remind staff of these things.
• 36:05It's a,
• 36:06it's a good reminder,
• 36:07you know every time you come to work,
• 36:09every time you leave and also at
• 36:10home with your families as well.
• 36:12So Tracy,
• 36:12I know we're out of time,
• 36:14but I just want to thank you for
• 36:16the opportunity you and Renee for
• 36:17putting this together and I want
• 36:19to thank everyone for listening
• 36:20and we are always here to support
• 36:22our staff and anything we could do,
• 36:24we look forward to working with you.
• 36:26Great,
• 36:27Nick and Stephanie, I appreciate it.
• 36:28Two questions that we'll just
• 36:30touch on quickly is will the
• 36:33return of metal detectors.
• 36:34I know we piloted metal detectors
• 36:36and we have Ellian asking if
• 36:39that's going to be implemented.
• 36:42We are working right now with Ann Diamond,
• 36:44who's our executive sponsor and we're
• 36:46putting together a business case.
• 36:48So early to determine whether or
• 36:49not that's going to come to fruition
• 36:51or not, but it's in process,
• 36:54right. And then the other one
• 36:55was around who makes the decision
• 36:57to search a patient and do we
• 36:59get patients consent for that.
• 37:02We search patients who have behavioral
• 37:04health, mental health issues and
• 37:06substance abuse issues for their safety
• 37:08and the safety of staff and that's
• 37:10at the request of clinical staff.
• 37:15Thank you both very much.
• 37:17We're now, we're now going to
• 37:19turn it over to the to the Stewart
• 37:21Seropian and his team who will
• 37:23talk about cellular therapies.
• 37:33Thanks. Can you hear me OK?
• 37:40Yes, we can
• 37:45just share my screen here.
• 37:51So I'm, I'm going
• 37:53to introduce the program I think quickly
• 37:55because I I want to give time for our
• 37:58our other speakers to tell you about
• 38:01our our recent fact accreditation.
• 38:03That'll be Alex Stormala, Program Manager.
• 38:06And then Doctor Sufi's going to talk
• 38:09about our our cell therapy products
• 38:13for hemologic malignancies and then
• 38:15Mike Kurwitz is going to tell us about
• 38:19cell therapy in solid tumors. So
• 38:25the the transplant and cell therapy program's
• 38:28the only program in Connecticut and it's
• 38:31been in existence couple of decades.
• 38:33So we do stem cell transplants of
• 38:36course and then more recently CAR T
• 38:39cell and other cell therapies and are
• 38:42now getting into the business of gene
• 38:44therapy for some hematologic disorders.
• 38:49So there's a lot of planning going
• 38:51on for new cell therapy products
• 38:54for sickle cell disease,
• 38:56thalassemia and a number of
• 38:59non malignant indications,
• 39:01rheumatologic diseases.
• 39:02So it's a pretty exciting time
• 39:05in the cell therapy field.
• 39:08The program's been around since the 90s.
• 39:11The adult program started then
• 39:13and then the pediatric program
• 39:15in its current form in 2011.
• 39:18The CAR T program is relatively young.
• 39:21It's now on its fifth year and he's just
• 39:25the beauty of our our program volumes
• 39:29and you can see on the right side there,
• 39:32we do about 200 procedures a year and
• 39:35the growing field is the CAR T cells.
• 39:38It was a little bit of a low
• 39:40with COVID a few years ago,
• 39:41but we're really quite busy with all
• 39:44these procedures and I think with time
• 39:46we'll see more of the cell therapies,
• 39:49perhaps less of some of the
• 39:53transplant procedures.
• 39:54So Harrison and Mike have to
• 39:57get a go over the product.
• 39:59So I'm not going to belabour this.
• 40:02There there are CAR T that are
• 40:04FDA approved for blood cancers
• 40:07and now there's tumor infiltrating
• 40:09lymphocytes for Melanoma.
• 40:10Down at the bottom you can see
• 40:13that there are a number of CAR T
• 40:17in development for non malignant
• 40:19diseases and as the the content
• 40:22experts for these types of therapies
• 40:24we will be involved in helping our
• 40:27colleagues in medicine try and develop
• 40:29these sorts of therapies as well.
• 40:31A number of gene therapies are
• 40:34are coming forward for inherited
• 40:36metabolic diseases as well.
• 40:38These are quite rare.
• 40:42So the program is a big program,
• 40:44there's a lot of departments involved
• 40:47and I'm going to show you pictures of
• 40:50our our team here as we go through this.
• 40:53So a pheresis where stem cells
• 40:55are are collected.
• 40:56That program is run by Chris Tormey and Alex.
• 41:01Cell processing is where cells
• 41:03go to be evaluated, frozen,
• 41:05thought out and delivered to our patients.
• 41:08This takes a lot of expertise.
• 41:10This is our cell processing team.
• 41:12They receive cells from the registry.
• 41:16Of course,
• 41:16there's a ton of providers on
• 41:19the adult and pediatric side,
• 41:22a lot of coordination, a lot of nursing.
• 41:24I can't put every picture of
• 41:27everybody in the program,
• 41:29but he's a bunch.
• 41:30The coordinators in particular are
• 41:33really what the sort of the the
• 41:35engine that keeps our programs going.
• 41:37We have great data management and
• 41:41pharmacy support and we have a very
• 41:44robust quality management program and
• 41:46this is now headed up by Lori Crouch
• 41:49and Alex is our program manager,
• 41:52really gets everything together
• 41:56for the entire program.
• 41:59All the people you just saw really
• 42:01she keeps keeps us afloat here.
• 42:03And I'm going to hand it over to Alex
• 42:06to tell us about our recent fact
• 42:10re accreditation for a few slides.
• 42:15Hi everyone. So, yes,
• 42:16I'm going to talk a little bit
• 42:19about our factor creation as it's
• 42:21an important part of the program.
• 42:23So FACT is the foundation for
• 42:26accretation of cellular therapies.
• 42:27It was a Co founded in 1996 by the
• 42:31International Society for Cell and Gene
• 42:34Therapies and the American Society for
• 42:37Transplantation and Cellular Therapy.
• 42:39So FACT establishes standard for
• 42:41high quality medical and laboratory
• 42:44practice in cell therapies.
• 42:46So that includes, oh, sorry,
• 42:49can you hear me? Yeah. OK.
• 42:53That includes auto and auto stem
• 42:56cell transplant and CAR T infusion.
• 42:58It will also include the tail and the gene
• 43:02therapies that includes also commercial
• 43:05product but also research product.
• 43:07The standards consist of clinical
• 43:10program requirement that go from
• 43:12nursing to provider training,
• 43:14specific SOP cell collection requirements
• 43:18such as cell product storage,
• 43:20temperature,
• 43:20humidity and cell processing
• 43:22requirements like safe handling
• 43:25and processing of the product.
• 43:27So the fact that creation is
• 43:29so important for our program
• 43:30because it elevates our position
• 43:32as a quality organization,
• 43:37it informs patient health insurance
• 43:39companies and government that our
• 43:41organization is dedicated to excellence
• 43:43in patient care and lab services
• 43:46and it's also in some cases required
• 43:48for patient care reimbursement
• 43:50from some government agencies
• 43:51and health insurance companies.
• 43:56Next slide please.
• 44:04So this is a quick road map to show
• 44:07how long it it took to get to the
• 44:10accretation which we should receive soon.
• 44:13It all started in June 2022.
• 44:15We do file a compliance application which
• 44:18we did in August states review by fact.
• 44:21They asked us For more information and
• 44:23they finally assembled their team in
• 44:25September of 2023 with the inspection
• 44:28that occurred in November of 2023.
• 44:30They extend a report that goes out for
• 44:33fact which was reviewed in December and
• 44:35we received more question in February.
• 44:38We just submitted our responses and now
• 44:41we are waiting for our accreditation.
• 44:44So next slide.
• 44:46So this is a quick step shot of all
• 44:49the department and units that are
• 44:52participating in this fact accreditation.
• 44:54And I'm not going over everything,
• 44:57but there's many nursing units
• 45:00that are involved in patient,
• 45:02outpatient, the research team,
• 45:06yes, the West Pavilion,
• 45:10ORICUSEDS and really any area where
• 45:12herself the reputation may go could
• 45:14potentially be visited by fact
• 45:17and we'll have to work with us on
• 45:19the accreditation and next slide.
• 45:24So this is just a slide of the team
• 45:28working and under fact inspection and I
• 45:31just wanted to have that to say just a
• 45:34huge thank you to everybody involved.
• 45:36The inspection was a great success and
• 45:38it's because of you all. So thank you.
• 45:44OK, thanks Alex. We, we, in fact,
• 45:47I think had our best fact
• 45:50inspection in 20 years,
• 45:53really due to the work of
• 45:55all the people you see here.
• 45:57All right, we're going to turn
• 45:58it over to Irisa Sufi.
• 46:00She is an associate professor
• 46:01in our program and Clinical
• 46:03Director of our CAR T program.
• 46:05She's going to tell you about
• 46:09hematologic malignancy.
• 46:10So I'll stop sharing.
• 46:14Thanks, Stewart.
• 46:28So I've been leading the the cell therapy
• 46:33clinical program for heme malignancies
• 46:36and we are at a very exciting time in
• 46:40cell therapy for heme malignancies.
• 46:44As you can see here,
• 46:45we have 6 commercial products that were
• 46:48approved in the last several years and
• 46:51they have been approved across several
• 46:53different hematologic malignancies.
• 46:56Initially,
• 46:56the first approvals came in B cell,
• 46:59childhood B cell ALL and Diffuse
• 47:02large B cell lymphoma.
• 47:04The therapies were initially studied
• 47:06in the third line setting for high
• 47:09grade B cell lymphomas and subsequent
• 47:11to that they were moved to the
• 47:13second line for high risk patients.
• 47:15So we have now two products,
• 47:18Oxycaptogen and Lysocaptogen that are
• 47:20approved in the second line setting
• 47:23for patients who have aggressive
• 47:25diseases like primary refractory
• 47:26large cell lymphomas or large cell
• 47:29lymphomas that relapse within 12
• 47:31months of their upfront therapy.
• 47:33And these studies in the second line were
• 47:37actually compared to stem cell transplant.
• 47:40And as I'll show you in the next slide,
• 47:42there's been a significant improvement
• 47:44in both progression free and overall
• 47:46survival with these cellular therapies
• 47:48for aggressive lymphomas in patients who
• 47:51previously had very limited life expectancy.
• 47:55And subsequent to that,
• 47:56we now have approvals in mantle cell
• 47:59lymphoma after one line of therapy
• 48:01as well as third line for relapsed
• 48:04and refractory follicular lymphoma.
• 48:06And then finally,
• 48:07we have two new products that were more
• 48:11recently approved in multiple myeloma.
• 48:13So those were Ida,
• 48:15Captogen, occlusanal,
• 48:16siltacaptogen,
• 48:17Autoluso that have a different target than
• 48:21the CD 19 target in the B cell lymphomas.
• 48:24So the target in multiple myeloma is the
• 48:27BCMA and they have both been approved
• 48:30in the 4th and plus line setting.
• 48:32So these were patients that
• 48:34were very heavily pretreated.
• 48:35They had had exposure and
• 48:38resistance to multiple therapies
• 48:41including immunomodulating agents,
• 48:42proteasome inhibitors and monoclonal
• 48:45antibodies targeting CD38.
• 48:49And now we're waiting to hear from
• 48:51the FDA regarding even approvals
• 48:54in earlier line settings.
• 48:56The in just in March of this year
• 48:58actually the FD as Oncologic Drug
• 49:01Advisory Committee has voted in
• 49:03favour of both of these products
• 49:05based on a benefit risk profile
• 49:07analysis for earlier lines.
• 49:09So myeloma between one or three
• 49:13lines of therapy based on two
• 49:16large phase three studies,
• 49:17the KARMA 3 and Cartitude 4.
• 49:20So we're waiting to hear on those
• 49:22approvals for earlier lines of
• 49:24therapy and multiple myeloma.
• 49:26And we now as of this publication in New
• 49:29England Journal of Medicine just last year,
• 49:32we have randomized phase three data
• 49:35confirming overall survival advantage
• 49:37of chimeric antigen receptor cell
• 49:40therapy in the second line setting
• 49:42compared to stem cell transplant.
• 49:44So for for high risk patients this has
• 49:47already replaced at all of the stem cell
• 49:49transplant and has a survival benefit.
• 49:52So these therapies are not investigational,
• 49:55investigational.
• 49:55They are FDA approved and they
• 49:58have a very good track record
• 50:02with very good outcomes.
• 50:04So now I'm going to shift gears
• 50:06to the our research portfolio,
• 50:08which we have managed in parallel to
• 50:12all of these Commercial
• 50:146 commercial approvals.
• 50:15And with our clinical trial portfolio,
• 50:19we're trying to target populations that
• 50:23do not necessarily have an approved
• 50:27FDA product that we can administer
• 50:30or in cases where we think they might
• 50:33benefit from enrollment in a clinical
• 50:36trial because of maybe high risk
• 50:38features of their disease or patients
• 50:40who may have failed and progressed
• 50:43after upfront cortisol therapy with
• 50:46a commercially approved products.
• 50:48So my area is lymphoma here in
• 50:52blue and we have two very exciting
• 50:55clinical trials that are phase
• 50:57two multi institutional.
• 50:59One of the trials is studying by
• 51:02a specific Corti cell therapy.
• 51:04So instead of just targeting
• 51:06the CD 19 antigen,
• 51:08the cells target both CD19 and
• 51:11CD20 with the goal of decreasing
• 51:15the risk of resistance.
• 51:17And then now the study has an open arm
• 51:22for patients with primary CNS lymphoma
• 51:24and secondary CNS lymphoma that that
• 51:27who have failed a first line therapy.
• 51:30And so these patients as you probably
• 51:33all know have very limited options.
• 51:36So we're very excited about the
• 51:38opening of this arm on this study.
• 51:41And then for patients who
• 51:43progress after CD19 CAR,
• 51:45we have a very exciting phase two
• 51:48study with a new target which is CD 22.
• 51:52There's already very good phase one
• 51:54data with CD22 directed autologous CAR T
• 51:59cells in patients who have had CD19 cars.
• 52:03And based on that very promising
• 52:05phase one data,
• 52:06we have moved this to the second
• 52:09to the second phase and are
• 52:12investigating it at Yale as well.
• 52:15And then for multiple myeloma,
• 52:17Dr.,
• 52:18Barr is leading all of our cell
• 52:22therapy clinical trials and she
• 52:24has several both in the upfront
• 52:27and in the relapse setting.
• 52:29For example,
• 52:30here we have Cortitut 5 and this is
• 52:33a phase three study that's bringing
• 52:35cortisol therapy to the front line.
• 52:37So multiple myeloma patients who
• 52:39are not planned for immediate
• 52:41transplant and instead of getting
• 52:44their initial induction with VRD
• 52:46and going on prolonged maintenance
• 52:48with Lenalidomide and Revlimid,
• 52:51they have the chance to go onto a
• 52:54cortisol therapy with Silta Cell
• 52:56which is a one time therapy.
• 52:58And hopefully they can come off
• 53:00treatment and be monitored rather
• 53:03than remain on sort of indefinite
• 53:06maintenance therapy until progression.
• 53:09And then Dr. Gauda and Dr.
• 53:12Seropian are involved in the leukemia
• 53:14cellular therapy investigations
• 53:16and and we have several exciting
• 53:19phase one trials in the leukemia
• 53:21area as well for patients who
• 53:24are candidates for transplant.
• 53:26And then we have several studies
• 53:29in the pipeline.
• 53:30And I just wanted to highlight here
• 53:33a couple of studies that are also
• 53:37dual targeting antigens targeting
• 53:39both BCMA and GPRC 5D because in
• 53:43multiple myeloma now we're already
• 53:45getting patients who have progressed
• 53:48after antibody treatments that
• 53:50are already targeting BCMA.
• 53:52And so it's an exciting time for the
• 53:54patients to be able to participate in
• 53:57these studies that are dual targeting.
• 54:00And we are also taking patients
• 54:04who have high risk disease
• 54:06with certain genomic abnormalities and
• 54:09taking those patients that relapse
• 54:11within 12 months of their initial therapy
• 54:15including transplant and then enrolling
• 54:17them in these Corti trials as well.
• 54:20So if you do have patients with either
• 54:24early relapsed high grade lymphoma within
• 54:2712 months of their initial therapy or
• 54:31patients with multiple myeloma with
• 54:33high risk features who who also may
• 54:36have progressed within 12 months of
• 54:39their therapy or who have already
• 54:41had BCMA exposure and progressed,
• 54:43it's would be a good time for our
• 54:46team to evaluate them.
• 54:48And then finally as as Alex mentioned,
• 54:51this is indeed the multidisciplinary
• 54:53team effort.
• 54:53You can see here that the program
• 54:56does not function as a whole without
• 54:59each of these individual pieces.
• 55:01And we are also in very close
• 55:05collaboration with oncologists
• 55:06throughout the state who are both
• 55:09part of the SMILO network or outside
• 55:12of the network who do refer patients
• 55:15to us for cellular therapy.
• 55:16And we remain in close contact
• 55:19regarding bridging treatment while
• 55:21we can manufacture the cellular
• 55:23therapy products.
• 55:24And so with that,
• 55:27I am going to stop sharing and
• 55:29leave the rest of MIC.
• 55:34I think we're at the top of the hour here.
• 55:36I don't know if people are still on.
• 55:38Should I keep going?
• 55:39Yeah, lots of people are on.
• 55:40There's 88 people listening. So,
• 55:43OK, so I'll try to be brief.
• 55:47Are you guys seeing it?
• 55:48There we go. All right.
• 55:51So on the on on the solid side,
• 55:53we're also doing cell therapies
• 55:55just for very quickly.
• 55:57I just wanted to sort
• 55:58of give a sense of what,
• 56:00what it is for a patient to
• 56:01go through these therapies.
• 56:02They're pretty involved in that whether
• 56:04it's something called till therapy,
• 56:07which is tumor infiltrating lymphocyte
• 56:08therapy or whether it's CAR T or
• 56:10an engineered type cell therapy.
• 56:12You know you have to either take out
• 56:14a tumor or take out someone's cells,
• 56:16those cells and then and then T
• 56:18cells are are isolated from whatever
• 56:20you take out and then those are
• 56:23grown up in vitro for like a month.
• 56:25You know that there there are various
• 56:27times usually it's anywhere between
• 56:283 weeks and in fact in one trial
• 56:30it takes four months to make the
• 56:32product that you're going to make.
• 56:33And some of them are just growing up
• 56:35cells and making them very active
• 56:36and some of them are growing up cells
• 56:38and transfecting in adna construct
• 56:39to make some sort of protein that
• 56:43results in targeting the tumor.
• 56:46And so for patients,
• 56:47it's you know having something
• 56:49done to take T cells out,
• 56:51waiting for them and then right
• 56:53before they actually get the
• 56:54T cells put back into them,
• 56:56they have to get lymphodepletion,
• 56:57they have to get a chemotherapy,
• 56:58a pretty intense chemotherapy so
• 57:00that their body is ready for this.
• 57:02And for lack of time,
• 57:03I'm not going to go into it
• 57:04in too much more detail,
• 57:05but just a sense of what we have open
• 57:08right now in solid tumor cell therapies,
• 57:11we have all the ones in blue are open.
• 57:13So we have four different cell therapies
• 57:16open right now and you can see the
• 57:18diseases that they're covering.
• 57:19So at the moment we have things for
• 57:22smoking related non small cell Melanoma.
• 57:24We also have four other subsets
• 57:26of of non small cell and triple
• 57:28negative breast cancer and these
• 57:30are ones that express ROAR ONE.
• 57:33These are there's a CAR T trial
• 57:35and ROAR one is expressed about 40%
• 57:38of non small cell and about 60%
• 57:40of triple negative breast cancer.
• 57:41And we also have something called
• 57:43TCR TS sort of a variation on this
• 57:46and they also have a a number of
• 57:49diseases and this trial has four targets,
• 57:51but you have to be HLA mass to them.
• 57:53So it's somewhat complex.
• 57:55We hope to open soon.
• 57:57They're in the pipeline,
• 57:58something for renal cell carcinoma
• 58:00and some others.
• 58:01For example,
• 58:01one that that hits all K Ras G12V tumors,
• 58:04another that hits all her two
• 58:06positive tumors.
• 58:07What you'll notice is I have
• 58:08the sponsor down here,
• 58:09none of these are actually from Yale
• 58:12Science because we're probably not there yet.
• 58:14It's very expensive to
• 58:15get these things going.
• 58:16And so for the most part
• 58:18we're using industry sponsors,
• 58:19but we hope in the future to get Yale
• 58:21Science into patients because there
• 58:23are a lot of Yale scientists
• 58:25doing this kind of work.
• 58:26And finally, we have the first standard
• 58:28of care T cell therapy for solid tumors
• 58:30and that's for Melanoma and that was
• 58:32approved I think about a month ago.
• 58:33And we're probably going to have it open
• 58:35within the next month and know from
• 58:37other people that's probably the fastest
• 58:39of of maybe any site in the country.
• 58:41So that's exciting.
• 58:42Well, I'll leave it at that since
• 58:44people have to have to get out of here.
• 58:49Thank you. Thank you all the,
• 58:51I don't see any questions in the chat.
• 58:52If anyone had any questions
• 58:54for the cellular therapy team,
• 58:56please put them in the chat.
• 59:02If anyone has any questions
• 59:03about your patients by the way,
• 59:04just reach out to us directly.
• 59:06I mean I'll, I'll talk to anyone
• 59:08about any solid tumor stuff.
• 59:14So I guess I will say I don't
• 59:16have any particular questions.
• 59:18I I think it is just I hope others
• 59:22in our clinical
• 59:23community can get
• 59:25a sense of the promise and excitement
• 59:28that these therapies offer for
• 59:30many of our patients. You know
• 59:33as both Mike
• 59:34and Aris and and Stuart also
• 59:36alluded to, these are very
• 59:38complex therapies and they require
• 59:43kind of the resources,
• 59:44the deep expertise and coordination that
• 59:46only that centers like ours have to offer.
• 59:50But they truly offer hope and a
• 59:53unique therapeutic offering to a
• 59:55group of patients who are either
• 59:58not eligible for other therapies are
• 01:00:00failing other therapies and they
• 01:00:03also offer the hope of durable remission
• 01:00:08or even cure in situations that
• 01:00:11otherwise would would be hopeless.
• 01:00:13And I think that you know these are
• 01:00:16this team was very modest in the
• 01:00:20description of the and and
• 01:00:22even circumspect in their
• 01:00:23description but but this is. Really,
• 01:00:26I don't think it's overstating it to
• 01:00:28say we are on the threshold of a of
• 01:00:30a new era and this is just the tip
• 01:00:32of the iceberg we're talking about.
• 01:00:34So more to come, and it's great
• 01:00:37to be part of that. Yep.
• 01:00:41Which I, I forgot to say,
• 01:00:43the acknowledgement of actually the
• 01:00:44team who actually makes this happen.
• 01:00:46So these people should be up there,
• 01:00:48'cause they're amazing.
• 01:00:48They're the ones who actually make it
• 01:00:50possible for us do any of this stuff. Thanks.
• 01:00:58Thanks, Mike. I think
• 01:01:00we'll wrap up. Thanks everyone.