Well, good day to everyone joining us and welcome to today's X talks webinar. Today's talk is entitled Reproducibility Studies. Key questions for IVD manufacturers. When selecting a lab testing partner, my name is Samaya and it's my pleasure to be your X talk host for today. Today's webinar will run for approximately 60 minutes. This presentation includes a Q and A session with our speakers. This webinar is designed to be interactive and webinars work best when you're involved. So please feel free to send questions and comments using the questions, chat box in your control panel. This chat box is located in the control panel on the right hand side of your screen. If you require any assistance, you can contact me at any time by sending a message using this chat panel. At this time, all participants are in listen only mode. Please also note that this event will be recorded and made available for streaming on xox.com. At this point. I'd like to thank Quest diagnostics who develop the content for this presentation. Access the reach expertise and renowned quality of quest for every milestone of your project from R and D consulting through clinical trials commercialization and post launch surveillance together they have the power to deliver better outcomes. Now, it's my pleasure to introduce our speakers for today's event. And our first speaker is Greg Bashoff. Greg. Greg Bashoff serves as senior Director of IVD Services and Innovation at Quest Diagnostics. He has more than 15 years of experience in the molecular diagnostic lab industry. His career began in the lab and he has held positions in sales training and product management. Greg is a graduate of Boston University where he received a B A in Biology. And our next speaker is Doctor Neelam Deman. Doctor De Men, has 24 years of clinical research experience in the immunogenetics of vaccines, including a clinical microbiology fellowship at Mayo Clinic in Rochester, Minnesota. She is a scientific expert in molecular infectious disease and women's health and is actively engaged in multiple clinical trials with a special interest in rapid molecular diagnostics for sepsis. Dr Dean is widely published, serves as a scientific reviewer for multiple internal scientific journals and has presented at a variety of national and international conferences. So now without further ado, I like to pass control to our speakers. So Greg, whenever you're ready, you can go ahead and get started. Ok. Thank you very much Samaya. And I wanted to welcome everyone on behalf of Doctor Damon and myself uh to our webinar today. Uh We're very excited to um be speaking with you today. Um And I'm very excited uh to be uh speaking with Doctor Damani and I have been working together for the, the past six years in various capacities. So I'm very excited to share this webinar with you today. Um So today, we'll be discussing um some key considerations for choosing a laboratory partner for IVD studies. Um So the the flow of the, the conversation will be, I will share some of the background around quest uh and to orient ourselves and a little bit of the regulatory framework um behind if uh IV Ds, then I'll pass it over to Doctor Damon uh to discuss some of the specifics about these uh key questions and some of the services that Quest provides. Uh And as Maya said, at the end, we'll have a Q and A session. Um And then I think by the end of this presentation, I'm really uh hoping and I believe you will be able to see that quest is uniquely positioned to meet these um key needs that IVD manufacturers have uh to be successful in their submissions and commercialization. So if we could go to the next slide, please? Great. Thank you. Um So first, I wanted to just ground us in some of the uh the F the FDA regulation here. Um So I, I will not read the quotes uh to you, but these are from uh directly from the FDA and the regulation. Um But I think that the, the important thing here to highlight is IVD manufacturers when they're developing new assays, new instruments, new um tubes, whatever it might be, new collection devices um require uh reproducibility studies with a minimum of two external laboratory partners in order to demonstrate the robustness and reliability of the testing. Um and also to make sure that once the assay or the platform is in a commercial setting, um that those results are consistent with the results that uh happened in the the device trial. So um that's our, that's our regulatory framework. And again, I think we'll have a, a great conversation about how quest can meet some of those key needs for IBD manufacturers. Um So if we move to the next slide, we've got a polling question and this is for the audience. So uh so maya could you please uh bring up the polling question uh so that we can start the polling? Thank you, Greg. That does bring us to a poll question audience members. And that poll question is on your screens. Now, that question is what is the biggest challenge you have with lab partners executing device trials? And your options are sample acquisition enrollment or identifying labs with the appropriate predicate device or throughput timelines or data delivery. So go ahead and click on the option that suits you best. And that question again is what is the biggest challenge you have with lab partners executing device trials and your options are sample acquisition enrollment or identifying labs with the appropriate predicate device or throughput timelines or data delivery. So audience members, I'll give you a couple more seconds to answer that and then we'll go ahead and see the results. I see that the majority have voted. So let's go ahead and see the results now and the results are as follows. So 15% of audience members voted for sample acquisition enrollment. 38% of audience members voted for identifying labs with the appropriate predicate device. 38% of audience members also voted for throughput timelines and then 8% of audience members voted for data delivery. So thank you everyone for participating. Back to you, Greg. Great. Thank you very much and, and I, I really appreciate the, the uh input and feedback from the, the polling. So uh certainly understood that uh the throughput and timelines and and predicate device identification were the two highest categories. And again, I think we'll show today that um Quest Diagnostics has an excellent offering here to be able to assist um uh some of the uh uh to be able to assist IVD manufacturers in that uh those device trials. So first, let's talk a little bit about um quest overall. Um So, you know, this is Quest by the numbers if you will. So we are uh the largest um uh laboratory services provider in the country. Um We see over 100 and 40 million patients per year and do over 500 million tests annually. Um So this is complemented by our broad reach in laboratories. Um our ability to acquire samples through not only our 12,000 phlebotomists and 2200 patient service centers, but also some of our logistics. Uh So not only do we utilize um kind of the the the commercial carriers uh to help us transport uh samples. But importantly, we have our own fleet of not only vehicles but over 20 aircraft that we use to uh move uh samples around the country. Could go to the next slide, please. Ok. Could you build this out Sumaya, please? Yeah, good believe it's one more. Great. Thank you so much. So this, you know, this is just a quick map of the coverage that we've got across the US um from regional response labs to patient service centers where we have our phlebotomists. We also have mobile phlebotomists that can meet patients where they are uh to draw their s um And we also have an advanced diagnostic center of excellence that I'll touch on in the next slide. But this is really the power of quest the big network with and we can bring all of these resources to bear to assist our uh and partner with our IVD manufacturers and their device trials if you could go to the next slide, please. So these are some of our key uh laboratories that we work with as we're working on um these IVD uh clinical trials. So a couple of therapeutic areas that I'll highlight here. Uh So first in oncology, OP PA in the, in the Seattle area area. Med Fusion in Lewisville, Texas, our Nichols Institute in San Juan Capistrano, Southern California. Um and a new acquisition that quest has recently made haystack oncology in Baltimore, Maryland, performing MRD testing. Um Additionally, we've got infectious disease expertise at Med Fusion and SJ uh so San Juan Capistrano Nichols Institute, um Reproductive Health and uh expertise at RRA Source and Neurology, uh expertise at Athena Diagnostics. And the last piece of infrastructure I'll mention is our biorepository which is located in uh Memphis Tennessee. We could go to the next slide, please. So quest is uh platform agnostic. We, we work and utilize. We work with and utilize multiple platforms and instrumentation and devices uh kind of across the board. So I think that the uh the message I wanted to make sure uh came across here is, you know, we have, if, if you are looking for a predicate device, if you are looking for a particular platform to use in your trial, um that the vast majority of the time we've already got it up and running in our laboratories and we've already had the um you know, the, the experience and have expertise in that platform, big side, please. So, drilling down here, some of our core um IVD services. Um So we break this into three parts. So diagnostic development where we work directly with the IVD manufacturer to show reproducibility where we have our dedicated laboratory staff uh bring up instrument and assay uh and uh and uh run samples and those samples could either be uh provided by the IVD manufacturer or acquired uh through remnant sample collection from our vast uh network of um of samples. Um The next is predicate device, substantial equivalents. So that is as we discussed earlier on in the webinar um kind of utilizing our menu of more than of thousands of tests in a across all therapeutic areas um to utilize as a comparator or a predicate device. Um We also have the ability and staffing to bring up new essays or verify essays uh that are FDA approved if we do not happen to have it on our menu. And final finally, the clinical availability uh which is our sample acquisition, our remnant sample acquisition as well that we can enroll in uh in trials. Um our clinical results to both physicians and patients. So we are a clinical laboratory. Um So we do provide um that service as well. And finally, uh our sample co excuse me, sample collection kit uh capabilities where if that is a requirement for the study, we can certainly provide those services. So, next slide please. So this I think is getting into the the core of our presentation here and I'll be handing off the um the discussion to Doctor Demon for the next slide. But these are the the key areas um that we have, you know, through, through our experience of more than 100 studies. These are some of the key areas that we've experienced with our IBD part uh manufacturing partners um where there are uh really um uh key areas of focus. So first is a dedicated team with scientific and medical expertise. So ensuring that uh the the partner that the IVD manufacturer chooses um is able to meet the demand of the trial access to a diverse range of samples. So, not only are we able to run the clinical testing, but can we make, can we actually enroll uh samples into the trial? Um Access to a broad range of instruments, as I mentioned, uh we have uh a massive array of instruments at our disposal that we can leverage for IBD trials. Um Next is our quality management system to ensure that we are meeting all of the regulatory requirements for the, the study um and scalability and D data delivery system. So, ensuring that if it's a large trial, can the laboratory actually meet those expectations of sample volume and the ebbs and flows of samples? Um can we do large batches at one time? Um And then on the data delivery side, the experience with the electronic data capture systems and um the patient data reporting as well. So I think these are the key uh topics that we'll be talking today, Doctor Demon will be speaking to each of these in in detail. Um So without further ado, uh let me please hand over the presentation to Doctor Demon. Um Thank you Greg. Uh So before we uh dive deeper into each of these areas that Greg has mentioned, uh I would like to express the point of view of the clinical microbiologists and scientists in me. Um I like to see it in a way like, you know, windshield is bigger and the rearview mirrors are small when I participate in an IVD clinical trial, as API I get a full windshield view of what is in the pipeline in my area of expertise in my field. I get to access the latest and the greatest technology I get to evaluate it as a participant on the trial, I get to do my early assessment based on my experience and I need, I can make an informed decision whether this technology or this um uh platform will meet the need of my clinical laboratory. So as I go through these slides, you will not only learn what the key considerations are for selecting a lab partner for your IVD studies, but most of you may also be a part of uh performing these clinical studies and what my aim is to provide you an understanding of what is required of you and your institute to be a successful provider or participant of a clinical trial. So let's start with the principal investigator, the principal investigator, you know, uh in a sense is the spine of the study. Um uh you know, the principal investigator is responsible for the conduct of the study for protocol and oversees the staff and execution of the study. And you know, it is the responsibility of the principal investigator that the study is performed. Um uh within the regulations is the results are delivered on time. Uh And you know, uh all the criteria that have been laid out by the protocol are met. We at quest have a trained and both certified M DS and phd S and multiple disciplines. Just to name a few infectious diseases. We have two laboratories or two areas. Conventional microbiology and mal dedicated to infectious diseases and genetics and oncology, flow cytometry, chemistry, LC, MS, electron Microscopy immunology, hematology, coagulation, uh cytogenetics and an atomic pathology to name a few. Now, given, you know, uh all these uh individuals are, are fully trained. They have a breadth of experience in, in clinical diagnostics, make them a good uh fit to be api uh if required to be serving on a, on a clinical trial. Uh They are all engaged and all steps from pre award uh such as feasibility and qualification through the award and conduct and close up of the study. Uh Most of the studies are uh straightforward, you know, requiring uh maybe a single P I at a given site. Uh but the real cap uh capacity or capability of the lab partner uh is important to evaluate when you know it comes to complex studies. Uh multisite studies that may require patient result reporting as a standard of care along with the investigational device reporting, uh it starts to get even more complicated when you have multiple clinical sites enrolling patients from different geographical areas. And you know, say uh you need a state license censures for reporting patient results. A good example is a woman health study uh where maybe you would require a molecular platform for testing. You require cytology, histology, immuno histochemistry reporting may be required. We as quest are able to provide all these services uh with a wider network of our laboratories and pathologists to our part to our Ameri partners in the same location so that the pressure samples such as, you know, tissues or biopsies don't have to be stripped outside the facility also based on the expertise or the um you know, the area of uh the investigation on the trial required. We are able to provide co hybrid model for expertise such as, you know, uh addition of CPIS to to the trial to meet the needs of of the, of the trial. In addition to that we have fleet of ground and air carriers. So, you know, the pressure samples uh are handled uh with full integrity. Uh Another example that comes to my mind is, you know, um a combination where uh you know, you may require molecular flow cytometry and cytogenetics testing uh for uh genetics or oncology study. As most of these require comprehensive reporting. Uh Again, you know, we offer comprehensive uh studies under the same clear lab and you know, uh these samples can be handled uh uh under um under the same roof. Um Next is dedicated lab staff. So obviously, you know, we know that although the principal investigator is responsible for the, for the overall um uh you know, oversight of the of the trial, we do need um you know, a breath of uh dedicated staff. It takes a village to run these trials. So laboratory personnels uh perform a laboratory testing. Uh They are involved in completing case report forms, whether they are electronic forms or manual forms, uh worksheets that come with the protocols. Uh These are lab person that are uh involved in receiving logging, shipping samples, uh and study materials and help with accountability and ordering of the su supplies. In addition to that you need infrastructure uh that can support honest brokers because you cannot have uh honest brokers. Uh same as the testing personnel, they have to be different individuals to serve as honest brokers on, on the study, to maintain uh the deidentify of the samples. So we have trained and certified individuals that are certified in good clinical practices. Human subjects, hi a requirements, shipping of biohazards materials and specimens and any other areas of the study uh as per the protocol. Uh as you all must be aware, shipping of hazardous material is regulated by us, Department of Transportation and International uh Air Transport Association. And we have certifications uh around those. Uh In addition to that, we can leverage the um the workforce on our clinical site uh to um uh to conduct the, uh conduct the trials. Uh We have dedicated CLSS and uh and lab assistants which we can share for conducting the competitor or the predicate device testing. These are trained and competent for clinical testing. And this actually makes a very cost-effective and efficient workflow for conducting clinical trials because we can piggyback on our clinical runs, any predicate or competitor testing that may be required for the study which keeps the overall operational cost of the study low. The next is quality and reg regulatory. So, um in addition to, you know, the Tria lab uh quality department, we have a dedicated team of quality and regulatory, which is responsible for systematic monitoring and evaluation of the various aspects of the study, like the processes, the services, uh the facilities uh and maximize the probability that the standard of quality and this uh can be attained uh and delivered to the to the sponsor. Uh some other key elements uh of our Q MS are uh you know, taking care of liens and uh credentialing so that, you know, all our um uh pathologists, the, the physicians. Uh the pis that are serving on the, on the study have appropriate licenses and credentials, uh disaster recovery, uh proficiency testing, document control training and competency, um sample chain of custody and any process improvements that can uh make, you know, your, your trial more efficient and keep the cost of uh uh trial low. Our quality team ensures uh um quest continued excellence in services and reducing any identified obstacles throughout the process. And uh just to mention, you know, our laboratory is C A clear and is 015189 accredited. And for clinical trials, we follow the same standard of regulatory vigorous as we do for the clear. Next, we do have uh a scientific R and D team. These are phd scientists that are available on case by case basis if a new asset development or validations are warranted to uh meet the needs of the study. And lastly, but not the least project management, you know, we have study coordinators, study managers that are liaison between the sponsor and the and the site. They interact with the study monitors during visit, work with the IRB and we work with both institutional and third party I RBS. Um um you know, whatever the requirement of the of the study is, we work with clinical uh recruitment sites. If there are any that are recruited patient specimens from the clinical sites uh with uh these are the individuals that conduct the status update meetings. Uh They develop the workflows with the assistance of the P I. Uh they handle day to day uh inquiries and close out the queries for the study. Uh They are also responsible for ordering the reagents and other commodities and maintain study by uh study files and accountability of the reagents and the specimens. And um outside the scope of this dedicated team, we do have a business development team, a dedicated business development team for clinical trials uh who are responsible for uh initial uh uptake of the, of the, of the trial. Uh get it approved and fully executed. Uh NDAS uh any um you know, material transfer agreements, any M SAS and statement of work even before uh we initiate the study. Uh Next slide, please can be moved to the next slide. Thank you. Um In addition to that, there may be some studies that are more complex than others and we do uh on need basis, provide expert consultation so we can leverage on our medical and scientific expertise uh in across different therapeutic areas or diagnostic technologies overall. Within quest we have about 650 M DS and phd S that uh you know, can uh their expertise can be leveraged uh if there is a need uh for the study. Uh Again, we have uh uh uh regulatory and compliance department and this department can also provide regulatory consultations such as risk assessments. Uh any consultation with P ma 5 10-K emergency use authorization or uh ite filings. And last, but not the least, we have a commercial and education support. Uh We have about 1500 business development professionals that serve the clear lab and, you know, we can partner with the sponsor and support the commercialization pathway of the end product. Uh One example that I can provide here is, you know, there's a lot of um um uh direct to consumer um women health testing uh trials that are coming in the pipeline. And with our partnership, uh we can uh you know, we, we do have a direct to consumer uh wing where we can, you know, support the commercialization pathway for uh for certain trials on the basis. Uh Next slide, please. Now Greg uh touched on this, you know, just the breadth of the samples that we see. So we process more than 1 million samples a day and that is a lot of samples. So uh he also touched about all the, all the services that we can uh provide uh and that can be shared for uh these clinical trials such as our footprint of patient services centers, the mobile uh teams, the bio banking and just given the breadth and depth of testing we do and the esoteric nature of our business where you know, we are serving tertiary care at hospitals. We are, we are serving uh bone marrow and solid organ transplant hospitals. We have access to rare disease conditions with abnormal values that may be required to conduct a study next slide please. So, here are um just some of the therapeutic areas. Uh And I would, you know, I would not go through all the areas, but I would like to touch some areas uh specifically uh women health, infectious disease and oncology where we see the highest number of diagnostic clinical trials coming through. So, infectious disease, you know, we are a full service laboratory with routine and esoteric testing uh for, for molecular ID. Uh we actually process about um 15,000 blood culture specimens uh in a single day just at, at, at our Lewisville site. And we serve uh Baylor Scott and White and we serve Salmon's Transplant Center which uh serves both a solid organ and trans on patients. So you can imagine, you know, the kind of esoteric uh organisms that we see are the rare organisms we see in our blood cultures. So, um if there, you know, there are a lot of sepsis trials that are going on and with this population, we are very well situated to support these uh sepsis trials. Women has again to touch on direct to consumer. There is a huge drive for uh you know, uh uh providing uh uh patient care from the comfort of uh or providing women health care from the comfort of the home uh by providing, you know, self connect or direct to consumer testing. And uh again, uh partner with Quest, not only uh uh gives a sponsor, uh our um our white um network of samples uh through our patient collection centers, but also a strategy of how you may partner in, you know, commercializing some of these uh upcoming uh women health strategies and oncology. So, you know, we are oncology Center of Excellence. Um uh you know, we offer um um broad and disease specific panels for both solid organ and bone marrow transplant. And uh also uh provide um uh you know, uh have access to uh some rare mutations uh in, in genes that may uh be critical in developing new diagnostics or oncology. In addition to that, we have a very good presence in neurology, cardio uh dermatology, nephrology. So given, you know, our, our, our footprint, we are able to uh provide uh therapeutic testing for diverse range of samples uh that come through our adult next slide, please. So um as, as, as Greg alluded to, you know, uh when we are conducting uh these clinical trials, you need at least two laboratory partners. Uh and you need uh what is what is called a predicate or a competitor device and a competitor method. And we can support a broad range of competitor devices and methodologies to support your trials. And there have been times where quest alone has been able to provide uh both the labs that you require for your testing under different clear li licenses. So uh in a sense, we are serving as your one stop shop for all uh requirements to conduct your, your studies. So we have a whole array of in-house instrumentation, all major technologies and platforms from most major manufacturers. If we don't have, we have ability to support any others. Um especially, you know, when it comes to really large instrumentation uh where, you know, space may be challenged for academia uh or you know, other smaller laboratories, we have ample space and exhaustive technical expertise to set them up, validate them uh in in the timeline, uh actually very aggressive timelines. For most part, when you, when you are competing in the market space, we are able to accomplish that next like beast. So here is a snapshot of uh the device methodologies and the competitor devices and this in, in no way, you know, is, is a true depiction of what we have. But I am gonna uh you know, walk you through a few of the areas and showcase some of the ex through some of the ex example, how we are able to uh to help uh sponsors and uh pharma and vendors uh for uh for meeting the needs of their clinical tribes. So for microbiology, uh we, we have a complete uh C and vast black automation. Uh And the reason I mentioned that is, you know, we are well situated to do uh some operative experience or human factor. Studies that may be required uh for a microbiology automation. Another uh hot area as I have mentioned is sepsis. You know, there's a lot of um a lot of trials in pipeline for sepsis. Uh just because of the nature of of, of this condition and you know how it is raised against time to uh to get to better diagnostics and uh you know, uh sooner uh uh targeted therapy in case of sepsis. So, in our microbiology lab, we support culture, we have uh nucleic acid amplification techniques and also mass spectrometry. So kind of a wide uh range of comparator devices and methodologies that you may need if you're doing a sepsis study uh for molecular genetics. Again, you know, as I mentioned, we uh we do have, you know, disease plastic panels for both heen malignancy and um uh solid uh organ transplant uh by both NGS mostly and then also certain markers by real time PC R, uh we also offer specialized testing such as minimal residual disease, tumor mutation burden and fusion gene rearrangements and exon skipping events for solid tumor, which makes us very well situated to conduct uh molecular genetics and oncology, clinical trials. Malala ID uh is my area of expertise. And II I do wanna comment that in, in the last three years, this area has, has totally exploded given COVID and then monkeypox. Uh and recently you all guys are hearing about measles. So, you know, there's never a dull moment in molecular ID. Uh We have uh pretty much all leading technologies uh and platforms that are required for molecular ID testing. Um So, uh say, you know, there's a SARS CO V two trial uh that needs to be conducted. Uh You know, we, we have um uh you know, m major or leading uh platforms such as Cobas and Hologic. And in addition to that, we have Quest LDT. So we've seen trials where, you know, they wanna use uh two predicate methods for comparison and a third for a tiebreaker. And we are able to prove right, you know, all three methodologies uh within our scope of work, which makes it really easy for the sponsor uh to, to conduct their trial and also makes it um you know, cost-effective because you're not shipping specimens from one side to the other. And sometimes these specimens are, you know, sparse also, um when we were uh you know, uh doing these COVID trials, uh again, um the turnaround time was of a sense because everybody was competing uh to uh provide better diagnostics uh during this pandemic. And, you know, uh for most part, it was, it was hard to maintain in the supply chain and demand of testing. But we recognize that, you know, uh uh clinical trials are equally important as diagnostic testing. Uh So, you know, we were able to support these clinical trials for new uh uh investigational use, authorization or emergency use authorization during that time. Uh The other uh area that I would like to highlight is low cytometry. We do um uh as I, as I said, you know, we sell uh hematological uh malignancies uh testing and we do cell analysis and imaging and we do have 10 colors flow cytometry uh to support that. Uh So given this, you know, in, in uh combination with other areas that are listed on this slide. Uh We do have a pretty comprehensive offering of diverse methodologies and competitor devices. Next slide, please. For quality management, we do have a solid uh foundation, you know, be equipment maintenance, calibration, and validation, uh documentation, providing guidance on study design, statistical analysis, result, interpretation. Uh We can provide uh all that and you know, uh we, we have experience uh from our, our clear lab testing uh and validations uh to back that up. Next slide, please. Now, these are, these are uh some of the key uh highlights of our quality management plan. You know, we, we have good documentation practices. Uh protocol trainings are provided to our, our uh um uh our uh you know, uh our employees not only by the sponsor but internally by our management team. Uh a separate area for uh for um sample receipt and verification from the clear lab uh for diagnostic development specimens, um uh equipment maintenance, documentation with complete uh temperature uh and humidity monitoring for these instruments, supply logs um uh key, uh you know, uh key access to, to the area with study binders, um and, and a whole program to support, you know, project management. Uh also oversight of institutional review. We work with uh pretty much all the third party I RBS. Uh and, uh, you know, the IRB uh selection is defined by the study and then, uh I touched a little bit on that, you know, uh all certifications for, for shipment uh with, with uh in compliance with the regulatory next slide, please. Scalability. So I think by this time, uh you have a fairly good idea that, you know, uh we uh we have, we can, we can leverage our, our uh footprint to uh very quickly scale up uh the testing or the throughput uh required for staff. And I remember from, you know, the initial whole question, this was one of the, the pain points where, you know, the turnaround time or the scalability was an issue and we are able to very quickly partner with our sister laboratories to provide uh the the results in timely fashion. Next slide, please. And last but not the least is the data delivery. So we've worked with pretty much all uh major uh you know, uh electronic data capture systems such as E Clinical Medidata, Omnicom Wheeling and with all major lis and hospital information systems. Uh So, uh you know, depending on the need of the of the study, uh whether it's sponsor uh electronic data capture system or you know, uh we have to develop our own reporting system, we have capability of uh of developing that. And also for the trials that do need uh patient specimen testing and standard of care reporting. We have seamless client interface for test order and resulting capabilities for standard of care. Next slide please. So this is kind of an overview of the lab based IBD testing services that we provide. And again, this is not an exhaustive list. Uh but you know, 510 KP MA uh for validations, competitor studies, reproducibility lod studies. Um uh If there is a method development and reference testing required, we we're able to support that, we are able to do post approval studies like clinical validity outcome studies, cost-effective studies and human factor studies. Uh Again, you know, uh with our uh with our huge um uh uh sample base, we are able to do um just you know, remnant sample collection and the identification for trial enrollment by repository and long term uh storage studies um specimen collection kit. So this is something uh I think which is which is very unique and complimentary for the for the trials. We do have our in-house kitting facility and we also have quest qualified vendors if there are complex kits that need to be assembled uh to meet the need of the study, and then we already test uh touched on our patient service centers and mo um mobile ph bot for sample uh acquisition uh for for these studies. Uh next slide, please. So this is my uh my closing slide before I give it back to, to grad. But this just walks you through our IVD clinical workflow. And we uh we work very closely with the sponsor, walking hand in hand uh to uh make sure that they have a successful outcome of their study. So it starts with ND A and MS A and then we will do a feasibility. This is all prett even before we, we start, you know, uh uh the, the contracting uh process. Uh the site qualification, you know, uh uh and site visit if the sponsor wants to, to conduct that budgeting and contracting. Uh and, and, and, you know, uh developing the standard uh the statement of works. Um We do have a pretty uh rapid turnaround time of 1 to 2 weeks. Uh If everything aligns with our statement of work and contracting, once uh we uh once the trial is awarded, we have a ha warm uh handoff to the study manager. Uh The study manager develops the study plan. There's hippo meetings with the operations at the lab. Uh There's Memar competency testing for study operators, uh supply procurement and inventory log set up. Uh Specimen management is set up financial and accounting is set up. Uh IRB is set up uh and uh sample enrollment testing uh uh uh is initiated uh, pretty much for all trials as required. Um, uh, we have a regular cadence of meetings with the sponsor where we report the data, uh, or we report, you know, um, any issues, uh, or, uh, uh, or other, uh, you know, uh, updates that are required for the meeting. And at the, at the time of the close up, you know, uh, we, uh, we conduct a close out visit with the sponsor of the IRB, close out and, and you know, uh maintain the study documents and the binders for the required period of time required as per the study and the regulations. So, with that, uh I will pass it back to my co-host uh Greg and um uh we will be after his closing remarks, we will be ready for questions. Ok, thanks so much, Doctor Dean. Could we go to the next slide, please? Great. So, um I'm hoping that this, you know, that we were able to answer some of the initial questions that we posed at the beginning and again, going back to the, the polling results. Uh So the throughput and timelines were, was a big one. and also finding laboratories with the appropriate instrumentation or predicate devices. Um And there, there were certainly uh some on the sample acquisition and data delivery as well. So uh we, we hope that we've answered not only those, those uh initial uh kind of challenges that were posed by the audience. Um where or where the audience feels, uh those challenges lie. But um also some of the broader questions that we've talked about. So, um you know, sample of ability, uh a network data delivery, um expertise, uh dedicated staff and laboratory space. So all of these are, are pieces that quest can bring uh to your IVD trials. Um And we are very much looking forward to partnering with you. Uh as as you go through the um you know, your regulatory submission and development process. So I wanted to thank everyone very much and with that, uh so maya could we please move to uh the Q and A session? Well, thank you very much for that insightful presentation. And yes, that does bring us to A Q and A. So audience members can still continue sending in questions. I've already received some questions. So let's start off with those. And our first question is what are common challenges you see in device trials? So maybe I can start with this one and Doctor Damon if you would like to uh to chime in as well. So I think one of the, one of the things that we've seen um depending on the, the sponsor is uh the getting contracting ready to go and, and getting all of our um our staffing aligned is really dependent on the protocol. So having a protocol upfront. So once we've got that um squared away and ready to go, um we can really execute quite quickly. I think one of the, you know, one of the other things is uh that I, I think we excel at that we've heard from uh sponsors that we've worked with is not only the diversity of type of testing required, but the staffing to be able to support it. So that um we have done uh for example, what we uh lovingly call kind of um rescue projects where um there might have been a contract previously where a laboratory was not able to perform all of the um you know, all of the uh uh requirements for a particular program. Um And then we, you know, after speaking with a sponsor, we would be able to perform those requirements and, and uh really meet the needs of that study. So I think those are a couple of areas that I've, I've seen. Um but Doctor Demon, are there any particular examples that you might have as well? Absolutely. To uh to add to Greg's uh uh points? I think um uh sometimes uh we face challenges and we totally understand why it is required. But, you know, sometimes protocols evolve over a period of time and, you know, um uh that's where I think we, we, we are very flexible, we know that if we are not ready to be flexible, then, you know, be ready to be irrelevant. And then we, you know, we really work with our partners to make those modifications and, and for most part, you know, for the betterment of the final product. Um uh but that may sometimes take, you know, uh addition time uh for new statement of work to be issued uh and protocols to be approved. So that is where, you know, um uh for a well thought out protocol, it is straightforward. But if we, if we continue to make changes as we want, then, you know, that may uh that is doable but sometimes challenging. Thank you, Greg and thank you, Doctor Dean. And our next question is how can labs and IVD manufacturers work better together? Thank you. Would you like to start this one? And then I'll, I'll support. Absolutely. So I think this partnership is, is, is very, very important. Uh You, you definitely want a team up upfront. Uh And I think clinical trials is, is uh a great avenue to get that critical um technical and scientific and medical input upfront. And I can, I can kind of give you uh an example, you know, uh whenever we have opportunity to work with a sponsor, we pay very, very close attention to. Are there any pre analytical processing steps involved? Because we know that, you know, once uh this goes out in the market, uh pre to control any pre analytical process is the biggest challenge. So when we work with our vendors, you know, and, and, and we are able to provide input, we, we try to make it as easy for the end user as possible as um as easy for the lab as possible by making those early adjustments in the product before it is already approved and it is too late to make those changes. So I think it is very, very important to have that partnership also, you know, what is medically relevant. Um you know, there there is a theoretical understanding but we in clinical laboratories, we we do see, you know, we are very close to the patient samples. And I think, you know, to get that uh initial scientific input is also very critical uh in the asset design and the inclusion or exclusion of certain markers on the, on the uh on the panels or on, on the diagnostic uh uh essays. OK. I, I think the I would, I would support all of those points, Doctor Demon and, and maybe just sum up by saying communication is key. Um so communication upfront of what the scope of the program is. Communication throughout the execution of the program and communication once the program has closed. Um So I, I would say that there, we've, we've realized that uh a number of um either um you know, speed bumps, maybe along the way could be avoided just by um ensuring that that communication is there. And I think as Doctor Demon alluded to it in previously in the present, you know, that's why we really value. Um And, and uh and, and uh support the communication through not only uh our pis but also our uh study management staff um that are, you know, dedicated folks just to uh supporting these types of programs. So having that clear, clear line of communication, um not only to the the medical experts, but all the uh a also the operational staff is key. Great. Thank you. And we have another interesting question from an audience member. And that question is, can quest deliver both clinical reports to doctors and data to the IVD company so I can take that one. Yes, we, we absolutely can. Uh we have conducted uh several trials where standard of care data uh needs to be delivered to physicians and uh to multiple sites. Uh uh you know, uh multiple enrolling sites. So we are able to do that. And in addition to that, we are also able to provide deidentified data to the sponsor for their tracking for the study. So yes, we are able to deliver data to both uh standard of care to the physicians and the patients as well as to the sponsor. Great. Thank you once again. And our next question is how are projects set up? So maybe I could start this one and then uh Doctor Damon, I'll, I'll start on the, the contracting side and then Doctor Demon, maybe you can get into the um you know, once we, once we get the contract signed and moved into the laboratory. Um so I I can start. Uh So as Doctor Dean mentioned, we have dedicated uh uh support staff from a ABD and proposal management perspective to ensure that, that uh the scope of the project is understood completely. Um And uh once, once we've got that uh scope and feasibility done, so which laboratories will be we use? How will we operationalize this, what dedicated staffing is needed? Um Are we going to need to uh run samples through our, our um uh our uh laboratory uh operations group? All all of the these pieces put, get put together. Um And so once that is completed, we will present budget and uh sow to uh the sponsor. Um And once we align there, then uh there is a warm handoff with all of those project details uh to the uh the program and project management staff. So doctor Dean, I will hand it to you for uh the process after afternoon. Sure. So this handoff uh is, is referred to as uh an intake meeting. So this is where, you know, um uh we um uh on, on the operations and the lab side uh will pick it up from, you know, uh whatever the contract, the statement of work, the timelines uh and other requirements of the study are uh then we um uh we uh schedule the site initiation visits, we schedule the training, the competencies. Uh we assign, you know, the, the delegation of authority. Um you know, uh we, we set up uh what is required for the study, be it, you know, specimen enrollment, the identification, uh or, you know, um uh specimen received from another site uh or, or, you know, shipping specimens to another site. Uh And then we, you know, assign the operators. If there is a competitor testing involved, we coordinate with the lab operation to uh to assign uh you know, testing for competitor testing. And uh you know, uh and, and, and this is uh managed by a fully dedicated project manager assigned to the study uh who works very, very closely with the P I and their operations. And then as needed, we will engage it, we will engage quality, we will engage uh bioinformatics, uh you know, whatever is required for the study uh for, for its smooth uh conduct. Thank you. And we have another fantastic question from an audience member. And that question is, can two quest sites serve as two external lab partners? Uh Yes, Greg, you want to take that? I think we answered that during our presentation. Yes, absolutely. Yes. So we can um that's one of the benefits of, of partnering with uh larger laboratories is we've got multiple sites. Um And we've, we've done this uh very frequently uh in collaboration with sponsors. So not uh you know, we, we have multiple sites geographically that can help support these trials. Um And again, going back to the different instrumentation too. So if there are different instrumentation requirements, um you know, we have that support across the network. So um the answer to that is, is yes, we certainly can. Thank you so much. And our next question is, does Quest participate in scholarly activities related to clinical trials? Um I think, I think they mean like publications and, and presentations. Yes, absolutely. So we um you know, a A as P I uh I on, on these IBD clinical trials, I have a history of uh you know, partnering with our sponsors uh and uh um uh you know, presenting at national or international meetings and also peer reviewed publications uh that come out of uh these clinical trials. Uh So, yes, absolutely. Uh We uh we are a part of uh scholarly activities uh that uh are generated as a result of a trial. Wonderful. Well, thank you very much for all of these answers. We've reached the end of the Q and a portion of this webinar for audience members. Not to worry if you have more questions, if you have more comments, you can take down the email addresses on your screen. So go ahead and quickly jot that down. So if you have more questions, more comments, you can use um Greg's and Doctor Demon's emails up here. And also just wanted to let everyone know that we do have three handouts for this presentation. You can download two of them through the handouts tab in your control panel. So go ahead and click the handouts tab in your control panel and you can see those two and the third one, which is the white paper that's sent to you um using the chat box. So your chat box in your control panel, you will see that link and you can access the white paper using that link. So go ahead and do that as well. Thank you everyone for participating in today's webinar. You will be receiving a follow up email from X talks with access to the recorded archive for this event. A survey window will be popping up on your screen. Your participation is appreciated as it will help us improve of our webinars. Now please join us in giving a big thank you to our speakers today. So that's Greg Bashoff and Doctor Neelam Demon. So thank you very much for that fantastic presentation. We hope you found this webinar Informative. Have a great day everyone. Thank you very much. Thank you.