Standardizing IG Therapy with Dr. Luba Sobolevsky & Dr.Amy Clarke
Kip Theno: [00:00:00] Welcome to the Road to Care podcast hostedby SamaCare, where we'll talk with key opinion leaders, physicians,administrators, manufacturers, venture capitalists, and legislators to gettheir insights on the state of healthcare today. And where we see it evolving.SamaCare's prior authorization platform is free to clinics, ensuring patientsget on the right therapy at the right time.
Together we can simply make things right.
Kip Theno: Welcome back everybody to the Road to Care podcast hosted by SamaCare. And today our special guests are Luba Sobolevsky and Amy Clarke, who are doing fantastic workin the complex world of IG therapy. Dr. Luba Sobolevsky is the president and CEO of the Immunoglobulins National Society, IgNS. The central healthcare organization in the field of IG therapy and biologics.
In her executive role, Dr. Sobolevsky oversees the advancementof clinical standards, resources, education, certification, accreditation,patient advocacy, and strategic [00:01:00]alliances. She holds a PharmD degree from the University of SouthernCalifornia, and a BA from the University of California in Los Angeles. Dr.Sobolevsky's career spans diverse leadership roles across healthcare, including clinical practice, education, and the pharmaceutical industry.
She has been actively engaged in research and publication in areas such as optimizing immunoglobulin practice and patient experience, health equity, healthcare team competencies, and the improvement of screening and diagnosis of rare diseases. Amy DNP, RN, IgCN®. Dr. Clarke is the ChiefClinical Officer of the Immunoglobulins National Society.
Again, IgNS. She brings more than 30 years of nursing and clinical operations expertise and is a nationally recognized leader in the immunoglobulin therapy. Dr. Clarke has been actively involved with IgNS for over 14 years. Serving as an executive advisor and past president. Most recently, Dr. Clarke served as vice president of clinical nursing practice at Optum [00:02:00] Infusion Pharmacy, a subsidiary of UnitedHealth Group.
She has held leadership roles across specialty home infusionorganizations and has co-authored multiple publications on best practices andIG therapy. As a national expert in specialty biologics and clinical practice,Dr. Clarke has presented at numerous national and international conferences.
Well, doctors, thank you so much for joining the Road to Care podcast, and I was gonna do the doctor, doctor and say, name that movie, but I, maybe some folks won't get, but
we're super pleased to have you here, you know, in our, in our pre-show conversations. This was this is a complex in IG therapy, part of medicine that I really was not aware of.
And so looking forward to, to hearing about the history and the future state of what you all are doing and the great work that you're doing.And I think we'll just start where we usually do career journey and founding genesis of IgNS. And we'll start at the beginning and love to hear your journeys and journeys into medicine and Luba,
what, what drew you to, to immunology and biologics?
Luba Sobolevsky: Thanks Kip and it's great to be here with you today. Well [00:03:00] it started really with my interest in education of clinicians for a long time, way before I got my PharmD. It was a different career, but yeah interested in educating clinicians, developing different educational offerings programs, and really realizing.
The rigor and the continuity of training that lifelong clinicians, like physicians, nurses, pharmacists, really need that. It doesn't end with your degree and your residency or fellowship and the need to advance skills and education. Staying up to date really was very evident to me early, early in my career.
And even during pharmacy school, I worked in a medicaleducation field and traveled and took all my finals early, and my professorsdidn't love that, but I really understood my path and my passion very early onbefore I even knew what I would do with that. And so [00:04:00]I, after my PharmD, I did a postdoc fellowship in the pharma industry.
I had some clinical experience as well, and that all led me tothis point. But while in pharma, I really understood that as an industry wewere focused on investing into physician driven initiatives, investigatorinitiated trials, continuing medical education, supporting differentfellowships, all prescriber focused.
But when we are talking about IG therapy, which we'll talk alot about, I'm sure today. In such a complex field, the disproportionate burdenof disease and really therapy management falls on the shoulders of the entireclinical team, and more specifically the nurse, pharmacist and physician kindof triangle.
And so it's impossible to silo out a single type of healthcareprofessional. It is also really bad practice [00:05:00]to really pull the resources into one type of clinician and not the others. Andso the idea, that this field of highly complex immune mediated disorders thatIG therapy is, and a life-saving therapy that is lifelong as well, needs to bestandardized.
And we need to develop an entire system of education andtraining and standards that began to crystallize. And that's led me to startingIgNS decade and a half ago.
Kip Theno: That's agreat story by, by the way, doctor, teachers, like you said, they don't likewhen you beat the curriculum, so congratulations on that.
You showed them. But, and, and then of course, I mean, we willget to, to the fusion of both of you and IgNS and what, what you all are doingover there. But Amy, you know, nursing, clinical leadership into IG therapy.Let's hear your.
Amy Clarke: Well, Iwas in infusion therapy. I was treating [00:06:00]bone marrow and stem cell transplant patients where IG is central to thatpopulation as their white counts recover.
And I really fell in love with IG therapy. Then, of course, it was only intravenous at the time. And as my practice broadened and I began to see patients with other conditions like multiple sclerosis, I began to clue in on how the patient felt during their infusion, not just how it was helping, why they, why they were getting IG therapy, but what they were telling me or what they were telling the pharmacy team about how they felt.
And there was very little evidence, of educational offerings back then. You could read a very.Small print prescribing information or package insert, and that was all you had. That was what you were left with. But I read as much as I possibly could wherever I could find it. Of course, you couldn't easily go and find journal articles online back then.
Even less about subcutaneous ig and I was privileged to be able to fly around the country [00:07:00] teaching doctors and other nurses and patients and pharmacists.
About this therapy as I learned as the manufacturers learned about these novel therapies. And I just immersed myself in anything I could find. So it was complete serendipity when I met Luba in 2011 and I knew already at that point that I had really leaned into educating. Clinicians and patients, so that that journey, patients receiving therapy for life, was one that patients wanted to continue versus abandon, which we see so often in so many therapies.
And it just clicked. And I've, I really excited that I was ableto do that. My doctoral project was around patient outcomes related to howclinicians interact with IG and I'm really glad to be here.
Kip Theno: Well, thank, thank you, doctor, and, I'm starting to pick up the breadcrumbs of howIgNS got started, but I would love, I think, and we can maybe take this [00:08:00] two ways, starting IgNS, what was that impetus that, that made that happen for you all?
And then maybe take that into the next level of the mission, but then also what you're finding are the barriers that you're trying to solve with the organization.
Luba Sobolevsky: Yeah, I think that really, it's kind of the confluence right of multiple things, but it started early in my career as I was mentioning, kind of realizing the investment as an industry into education and the expectations that we had of nurses and pharmacists to deliver and to have certain level of competencies, while not really putting in place any of those resources for them. That was all always problematic to me, and it never really made sense.
And then meeting national experts like Amy, and we've [00:09:00] never been apart since 2011. Really understanding that from my standpoint from the manufacturer's standpoint, from the clinician standpoint, from the provider standpoint, all of this was coming together and starting to build a clear picture.
That we were as a field in this most complex area of practice,IG therapy, right, disease modifying, plasma derived biologic, treating patients who have the most complex immune mediated disorders and often multiple disorders. We had a clear and significant lack of standards of practice. So we had diagnostic criteria always, right?
We knew what dose to prescribe, but beyond that, there was absolutely nothing to standardize care what happens to the patients before, during, after, in between infusions, we had absolutely nothing in terms of a [00:10:00]comprehensive or systematic educational system for IG therapy, we couldn't train clinicians in a systematic way.
In a standardized way. There was nothing available. And so wehave the most complex therapy, the most complex patients, and yet as anindustry we have absolutely no resources for clinicians responsible for patientsafety, for treatment efficacy, for adherence, and for good patient outcomes.And so as this began to really take shape, the idea of that this is a hugeissue, a huge lack in our industry.
We did, at IgNS, what we always do at the beginning is do our research. So we did a benchmark survey and we pulled around 400 nurses and pharmacists, and had a variety of questions, but mainly our point was to understand how every clinician who we're talking to, how these [00:11:00] clinicians are trained, onboarded, how their continuing education occurs, what are the resources that are in their hands when they're being sent to treat patients with IG .And to our, dismay, but not surprisingly, the results showed in over 95% of cases. I remember this, like we did this yesterday, this is 15years ago now, that over 95% of clinicians, excuse me, pharmacists and nurses reported that in fact they did receive education and training. But when we asked them. How, what their training, what it consists of.
The answers were shadow another clinician and read the package insert. So our industry was in such a state of lack and and critical gaps that the clinicians accepted that reading [00:12:00] the package insert from the manufacturers and following another clinician, who no one trained by the way inIG therapy,
was an appropriate onboarding exercise was an appropriate typeof training, competency development, and there was absolutely nothing in place for continual continuous education of clinicians. Meaning when they had to get their CEs to maintain their licensure, they were able to do. Those programs in absolutely any clinical field like hypertension or diabetes that have nothing to do with IG therapy, and that gave us the blueprint for what to do next.
We took that survey report and we went to work. The first thing we did was develop the standards of practice and the standards of practice are.They're intimately tied to clinical medical [00:13:00]standards, any pharmacy and infusion nursing standards that were in place, but nothing was in place specific to IG therapy practice.
And so with the between coordinating the levels of evidence for every single standard and guideline, we also had to develop a robust consensus on. The guidelines and standards that had no published literature, evidence, or anything. It was all clinical practice. So we really got together a stellar team of experts, immunologists, neurologists, rheumatologists, nurses, pharmacists who've been in practice for a long time, and really spent about 18months developing the first ever standard.
As a result, we have the only legally defensible standard of practice in IG therapy that's been. Updated and brought to obviously the current state, incorporating all the research, all the new [00:14:00] indications, all the changes in the field, and we do that on an annual basis. We then developed a robust educational program, including conferences and our online webinar programs.
Certification came next, right? Certification. Our IG certified nurse, IG Certified Pharmacist Credential, IGCN and IGCP is a formal credential and it was necessary to develop it because it's a metric of competency, which we didn't have before, right? If we have the standards, we have the education, now we need a metric.
We need a metric of compliance with the standards. We need a method of understanding the level of education and training these clinicians have, and they now were able to show, to demonstrate, and validate their competency specifically in IG therapy. Most importantly, the certification [00:15:00] established IG therapy as a clinical specialty that now requires a particular
type of specialized education, training, attainment of competencies, utilization of the standards, continuous education. And we also have a full suite of resources for clinicians and for providers as well, of course. Another really important arm of IgNS I just want to touch on is our IgNS Patient 360, which is a patient-focused arm of our association that focuses on patient outcomes research, and we work with a variety of providers.
On this, our advocacy education and support for patients receiving IG therapy lifelong. And we have really been successful in getting that off the ground about eight years ago. So it's something we feel so strongly about, and this is all of our "why".When you ask why [00:16:00] we keep doing what we're doing, this is our why, is because we are touching
patients understanding their issues, understanding intimately well the lack of various resources, lack of education, training, whatever it may be that they're experiencing as a patient, that gives us a roadmap to incorporate new educational programs for clinicians to address those continuous gaps.
And also at the same time, develop patient-focused resources,patient-focused education to empower our patients and ensure that our patientsare partners in this decision making process along their journey with IGtherapy. So that's how all of that kind of came together over the last 15years.
Kip Theno: Well, and let's be honest, I mean, you all are moving mountains and I got it so quick and[00:17:00] clear the passion you lasered in on the lack and the lags of the education and knowledge gaps that you're trying to solve, that were pretty massive. And so Amy, I'm gonna ask you, I'm gonna maybe flip the script here a little bit, that. That's, there's that part of it. And then the space is evolving so rapidly with all the new biologics, all the new novel therapies.
Now, with everything you just said, look, first of all, thank you for doing that for those patients and what you're doing. I'm not an IG patient, but I'm a patient and it's more than concerning to know that in that segment there was so many gaps in you're solving those, but now you've got this whole breed of new biologics and novel therapies coming out and emerging, and I know you wanna speak to some of those, but also, doesn't that will that also create new knowledge gaps that you all are gonna solve too? And Amy, maybe you can take that one.
Amy Clarke:Absolutely. This pipeline, I mean, it's been a bullet train over the past several years, and as these emerging therapies and novel therapies come out, like FCRN inhibitors and the growth in complement [00:18:00] inhibitors and ways that we administer IG therapy, there's now facilitation with human recombinant hyaluronidase that creates.
More knowledge necessary in order to effectively select the product , evaluate the patient for risk, administer the therapy, mitigate any adverse reactions that occur at bedside.Having those clinicians have the wherewithal to know that they need to distinguish each of these unique therapies based on the individual risks they're watching for.
Not to mention the sheer number of diagnoses that IG therapy is used for. We're now starting to see that in the monoclonal antibodies and the other biologics. That are coming out. So absolutely there is that knowledge gap. And when you couple that with the high variability in sight of care and how we nail down education in each of those [00:19:00] sites, home is very different.
Than how we would approach it for ambulatory infusion centersor in the hospitals. Because you could have an ambulatory infusion center thatis doing acute care like antibiotics and 50 other biologics. How do we makethat education accessible to those clinicians as well as ensuring that thepatients can be can advocate for themselves and are knowledgeable so that theycan be an active participant in the care being provided.
But all that being said adding all of these therapies for thediagnoses that, that we're seeing them added to inflammatory neuromusculardisorders other types of autoimmune disorders is an amazing advancement in thisspace because we need to have more targeted care.
We need to identify what we're going to do with the plasma. Thepotential impact to plasma supply that's coming along, and we can talk aboutthat as well where [00:20:00] we see this spacegoing.
Kip Theno: Thank you,doctor. And I want to go back to the standardization piece, right? It's amazingto me that modeling out standardizations that it's not. Kinda unilateral acrossthe board in medicine, and I get it, but how are you tackling thatstandardization specifically with all these different sites of care?
How are you helping them? And then what about the patients?Where is the education coming from when it goes to the patient's journey?
Amy Clarke: Sostandardization of any kind involves taking the algorithm that you're givenand. Embedding it into your organizational needs. Standards aren't they don'tgo into the million because we need organizations to look at their local andaccreditation requirements, state boards, all of those pieces, [00:21:00] but take those standards, embed them intopolicy, and then educate organizationally.
That is where you begin to tackle standardization. One of thethings I've always seen as a risk from implementation of standards or any newknowledge is the existing institutional knowledge, which can become a realbarrier to accepting that science changes what we know about medicine and howit's administered changes.
So we are working with other organizations like the National Infusion Center Association,to support their standards. We work with other organizations such as the Infusion Nurses Society, um, to makesure that where our spaces touch one another that we have that collaboration.
Luba Sobolevsky:Yeah, and I think that's a really critical piece that has worked so well forIgNS because we are really vertically [00:22:00]focused, right?
So what's really served us very well in terms of how we connectto the industry and how we work with other associations and why is that we areorganized vertically.
We focus on a therapy right on IG therapy space, which is verydifferent. Most other institutions practices, trade associations are focused ona trade. Medical, pharmacy, nursing, or even site of care, home infusion,infusion center and so forth. And because we are vertical, focusing on IGtherapy and we're the central standard setting association in IG therapy, wehave really forged strong alliances and collaborations across the board fromthe clinical institutional perspective and also from the associationperspective where we are the provider of education, of specialized training, ofspecialized, resources and [00:23:00]certification in IG therapy. And so these collaborations, as Amy was pointingout, have been really significant in delivering not only the resources standardcertification, but the rationale the education of the field about why this isneeded, why IG therapy is a clinical specialty, why this is so needed, andreally essential to patient safety, to patient, to treatment efficacy.
So that's been something that we're very proud of at IgNS. Justthe sheer number of these collaborative streams. It's not easy to come in 15years ago into a therapy area that has been running along, running on fumes.But running, right? And just treating patients and not having education, andthere were lots of gaps and huge amount of strain on the clinician side and onthe provider side, but that's what they had to [00:24:00]do.
And for us to come in and change it, change the conversation, provide the standards, but really make the case that certification is critically needed to ascertain. Competency, right? That education is critically needed in the field that you're practicing in order to provide the safest level of care in IG therapy.
So that's been a huge priority for us, and I think we've been very successful.
Kip Theno: Well, no, you have, and I mean you're IgNS is known for, from inception, literally creating those standards and certifications. And I think I'd love to hear how are you tying all this in? Because when you think about that, you've got the role of the clinician, evidence-based literature reviews, consensus of experts, psychometrics, evaluations, validation and updating, and then the impact.
So that's kind of a lot. That's a mouthful. But when you take all of that, how is your organization tackling all that? And then using all the resources and partnerships at your disposal [00:25:00]to make sure that gets out into the light.
Luba Sobolevsky: There are two really major ways we do that and Amy jump in to, from your perspective.
One is interdisciplinaryor interdisciplinary approach. The other is transparency. What I mean is thatfrom the beginning we were an interdisciplinary focused organization. All theeducation we have developed. To date is really, targeting three differentpreviously siloed healthcare professional types, physicians, nurses,pharmacists.
We've never, aside from the certification where you do need toassess specific nursing and pharmacy skills, we have never developed programswith one particular. HCP type in mind because that doesn't work in [00:26:00] practice. And there is so much literatureand research now to point out that education standards, resources, those needto be developed with the actual, the reality of practice in mind.
So if a nurse and a pharmacist work together 90% of the time, and there's that back and forth with documentation and patient assessments, and there is a stream of communication going between the nursing and pharmacy teams and then to the providers, to the physician, then education needs to incorporate that approach, otherwise it doesn't work.
And so that's what we've done on the one hand. So our approach to all of the information out of igNS is that we look at it exactly as it will be utilized by audience by the end user, if you will. Second is transparency.We share the results of our benchmarking surveys. We share our very [00:27:00] prolific patient outcomes research with the industry.
That includes manufacturers. That includes. Specialty infusion and infusion centers, providers, that includes physicians and physician groups and multi-specialty clinics. We publish all these, these data that point to our successes, obviously improvements in the field, but also to our failures, our gaps, and our areas that need a lot more attention and focus.
And we work very closely with the industry members who work.Hard to ensure that we have products with which to treat patients. We have developed industry based resourcesand ED education and seminars. We have a very strong. Business forum program atour conference, for example, where we have members of the manufacturing,whether it's device or product [00:28:00]leadership teams, and brandteams sit side by side with the leadership teams of specialty infusion andinfusion center companies, and it's astounding to learn how little they knowabout each other's business.
On a more detailed level, not just the high level that we all think we know, and that is very powerful. We share our patient data, we share our clinical outcomes data, and we have these robust programs where we bring to light the most important things impacting our patients, and we get to work in trying to figure out how to make their lives easier, how to get better access to treatment, what we need to change in terms of
clinical practice, and it's really that straightforward. We really listen to our field and we share information, and we are very multidisciplinary in terms of the [00:29:00]approach to everything we do. Anything to add, Amy?
Amy Clarke: I mean, I would just add that the patient is the fourth pillar, in that group because the patient voice, when you consider shared decision making, ensuring that those clinicians know how to.
Effectively educate the patient on what their options are and how the patient should , provide feedback on their journey is incredibly important. And we build that into the education that we provide. So not only do we stress the interdisciplinary component of it, but we stress how important shared decision making.
And then if you take the data that we're gathering from our patient surveys, that helps inform where we see additional gaps in education.Not just the feedback we're getting from clinicians, but from patients as well, which is where standards are reviewed and updated, where the educational approach that we have is also geared to address.
How the patient perceives their [00:30:00]care being provided to them, and this journey that they're on for life.
Kip Theno: And that's, that's amazing because I want to zoom the lens out a bit to maybe a broader map of the world for stakeholder engagement. You mentioned some of them doctors, patient access stakeholders, manufacturers, pharmaceutical companies, payers, legislators, what.
What has been the response from them and is it moving fast enough? I mean, are they helping, are they chomping at the bit to kind of solve this, or is it still kind of a glacial pace, especially on the legislation side?
Luba Sobolevsky: In my experience in the IG manufacturer world, these companies, it takes them nine to 12 months to go from a vial of plasma to a vial of product. So they're [00:31:00]invested into the patient journey and to the patient success.
And so they have been extremely supportive, extremely forthcoming with sharing their knowledge and their observations, as well as in their desire to learn from IgNS and really understand, what the issues, key issues impacting patients are they really truly have this patient commitment and it's incredible to be part of that, to be in the industry where the patient is truly number one. So from that standpoint, there's a lot of support.
Luba Sobolevsky: And on the provider side, I think that we've had a lot of interest, a lot of alignment. There are organizations who have [00:32:00]been those early adopters, right from the very, very beginning when the first standards were just released, the first certification programs were just launched.
It's been incredible to witness such a high number of providers who started coming to IgNS when we had, you know, 120 people in the audience who witnessed our growth to now having these huge conferences and thousands of members, but also their businesses have grown and flourished from a single pharmacy to a multinational mid-size enterprise now, and this happens so often.
And of course there are challenges. There are a lot of challenges with like with any field in investment into. Your clinicians investing into training, education, competency, because again, it's only been [00:33:00] if you think about it, we've been around for so long, but not really. If you think of other healthcare trade organizations, it's 15 years is not such a long time and for decades and decades we had no standards, we had no certifications. So certainly we still have organizations that are trying to get by without fully investing into elevating their standards and elevating the care and elevating the practice.But we are working through those challenges and we certainly are able to.
Provide and support any organization and any provider or individual clinician, even with a full suite of resources they need to improve practice. Amy, anything from your perspective?
Amy Clarke: I was just thinking more from my perspective on, we talked previously, I [00:34:00] think about asking our clinicians to do more with less. And organizations that invest in standardizing their practice according to the evidence that is out there and elevating their clinicians by supporting advanced certifications and their education are able to distinguish themselves from other organizations. And in part that's due to patient feedback, prescriber feedback, but from the outcomes data that they collect and that information coming from those providers is also going to the manufacturers and going to payers so that they can see, where benchmarks, are
Luba Sobolevsky: being laid. And, and that's a great pointactually, Amy.
Luba Sobolevsky: In fact, in the past five years I've beenmore in more meetings with the manufacturers that I can count where they'veasked IG and S to create a metric by which they can measure.
A provider's [00:35:00] expertisein IG therapy as a whole, they're really keen on making sure that the end pointwhere the drug ends up wherever it is, whether it's an infusion center or it'sa specialty pharmacy or infusion company that. At the end of the day, theclinician who infuses the IG therapy that they spent years in development andyears in production, year over year. Every single vial that takes a year toproduce, that ends up in the most capable hands of educated, certifiedclinicians. And that metric is something we are working on right now. Weare developing a distinction program in IG therapy with a CHC, so that'lllaunch in January of 2026. You heard it here first.
But it'll be a true [00:36:00]metric that a provider can use to differentiate themselves on the businessside. 'Cause that's really the only differentiator that counts is the expertisethey have with IG therapy and how they ensure safety, efficacy, adherence, andthe best infusion experience and best patient outcomes.
And so that is coming and that's something we're very excitedabout. We need to shift the burden of education, training, resources,competency from being on the shoulders of the individual clinicians to theproviders. And that shift is happening and there has been more interest in thisprogram than anything that we've ever done to date.
So we know. Back to your original think Very good question,Kip. What's the uptake [00:37:00] like? How'sthe industry responding? We can see how the industry is responding in theinterest that we now have in this accreditation distinction program. So that'svery encouraging to me. It's a great pulse check on what's going on.
Kip Theno: Yeah. Andby the way, you know, status quo equals inertia and that's not a good thing.And you guys are creating that momentum shift. I love to hear that.
Kip Theno: So in thefinal minutes we have here on the show, doctors next five to 10 years, IGtherapy, biggest challenges, big greatest opportunities for you all and forthis market and the patients.
Amy Clarke: For me, it's three parts. It's a rapidly aging workforce. So as we educate clinicians who then become mentors for the less experienced clinicians coming through, they are aging out and moving toward retirement, at a fast [00:38:00] pace.
And at that same fast pace, more than 4 million baby boomers have turned 65 each year for the past several years and will continue to do so until 2030. And you take an older patient, you have secondary immunodeficiencies and hematological malignancies, transplant needs, all of these things were igs used. So we will need more plasma donations in order to solve for X. When we look at the amount of IG that is going to be necessary to service this patient population, along with the clinicians needed to administer the therapy.
So again, going back tothe novel therapies, that's why I'm so excited about what pipeline looks like because there is a need to solve for targeted therapies so that IG can be usedwhere there are no options.
Luba Sobolevsky: Yeah. And then I totally agree with that. And to add to this, there are kind of two things that concern [00:39:00] me in addition to what Amy was pointing out.
One is that we still have a huge diagnostic delay in these rare diseases that IG therapy treats. In some cases it takes, in some disease states, like primary immune deficiency, it takes 10 to 17 years, and that's been corroborated by every organization that's done research, including IgNS, 10 to 17 years to get a diagnosis.
And this has a lot to do with how fragmented our healthcare system is. Patients are being seen in urgent care, emergency rooms, and even their primary care physicians. And none of these entities coordinate, collaborate, or even talk to each other. And so in certain disease states there's a 70 to 90% under diagnosis.
So we need to get a whole lot better in restructuring our healthcare system [00:40:00] to allow for this coordination of care or else our rare disease patients will continue to suffer for decades on end. So that's a huge issue. And then if we. Correct this and all of the associations including IgNS are working very hard on improving the diagnosis, the treatment access, and it is improving incrementally, and then we're going to have a lot more patients to treat.
In fact, the pharma industry is increasing supply significantly year over year due to increased demand. Which is relating back to what Amy was pointing out, better diagnostic criteria, aging patient population. So all of that is growing. In fact, this IG industry was projected by Forbes to grow over 40% in the next decade.
And so we then need, imagine this just in all of this the, just the sheer [00:41:00] scale of this very specialized therapy space. Growing that much that quickly. Our standardization of this therapy, of our practice, of our clinical care needs to go way up. We need to really address it, both on a granular level, but on a very, on a large scale as well.
So from the ground up, top down, every approach. If we're gonnagrow 40 to 50%. We need to address the challenges we have now when we have ahuge under-diagnosis and really are still growing into standardizing this fieldas a whole. So that really, if something keeps me up at night, it's this.
And at the same time I wanna end at a positive note. We have a very [00:42:00] cohesive,a very strong industry in the IG therapy space, and I know we all want the samething is for our patients who are on this life-saving therapy lifelong, to havethe best experience at every infusion and to have the best outcomes, and tohave the best quality of life they can and to really thrive.
To thrive despite theirchallenges and despite their diagnosis. And certainly IgNS has committedto continuing our work and we will do long term. And I know that we have thesupport and the backing of this industry as well.
Kip Theno: Uh, Amyand Luba, I just first. So grateful to have you both on the program, but even more importantly for the work that you were doing and that you've outlined today.
And before I get to the very quick Easter egg question, you said it Luba, we gotta get a whole lot better, right? Quote unquote. So in that, with that spirit in mind, what is the best contact for you and [00:43:00] Amy and IgNS so that we can get the word out as soon as this show goes live?
Amy Clarke: Um,info@ig-ns.org.
Luba Sobolevsky:Right. And ig-ns.org is our website and all information is on there. And yeah,we look forward to. Having more of these conversations.
Kip Theno: Well, wewill definitely have you back. We're gonna keep a watchful eye and get this outto the masses for the Road to Care podcast. And listen, we're serious businessof healthcare.
I get that. But at the beginning, I said "Doctor, doctor,doctor". I said, name that movie and we gotta have a little fun now at theend. The reason I did that is this is the first show in all of our episodeswhere I've had two doctors on and I had to do it just to see. So can do eitherone of, you know, the movie reference or not.
Amy Clarke: I should,because my husband says it all the time, and he's at the dentist right now, soI can't answer the [00:44:00] question.
Kip Theno: I like himalready. Well, the movie, the movie of course is, is Spies Like Us, one of thegreats of Chevy Chase, Dan Aykroyd.
Luba Sobolevsky: SoI'm great. I love it.
Kip Theno: That isone of the best scenes anyway.
Listen back to the serious note. Amy Luba, doctors, thank you so much for your time today on the Road to Care podcast. We can't wait to get this episode out, and we look forward to hearing from you again. Thank you so much.
Luba Sobolevsky: Thank you for having us on. It was a pleasure.
Kip Theno: Thank you for joining the Road to Care podcast, hosted by SamaCare, the leader in prior authorization technology and services, where through a script to therapy operating system, we enable connectivity with clinics, payers, and manufacturers focused on optimizing patient care. Tune in next time as together we can make things right.
Enjoy the music written, produced, and recorded by [00:45:00] Jamestown.
Podcast produced by JFACTOR, visit https://www.jfactor.com/
Together, we can make healthcare right. Here are some of the outstanding healthcare organizations and associations championing patient health mentioned in this episode:
Standardizing IG Therapy with Dr. Luba Sobolevsky & Dr.Amy Clarke
Kip Theno: [00:00:00] Welcome to the Road to Care podcast hostedby SamaCare, where we'll talk with key opinion leaders, physicians,administrators, manufacturers, venture capitalists, and legislators to gettheir insights on the state of healthcare today. And where we see it evolving.SamaCare's prior authorization platform is free to clinics, ensuring patientsget on the right therapy at the right time.
Together we can simply make things right.
Kip Theno: Welcome back everybody to the Road to Care podcast hosted by SamaCare. And today our special guests are Luba Sobolevsky and Amy Clarke, who are doing fantastic workin the complex world of IG therapy. Dr. Luba Sobolevsky is the president and CEO of the Immunoglobulins National Society, IgNS. The central healthcare organization in the field of IG therapy and biologics.
In her executive role, Dr. Sobolevsky oversees the advancementof clinical standards, resources, education, certification, accreditation,patient advocacy, and strategic [00:01:00]alliances. She holds a PharmD degree from the University of SouthernCalifornia, and a BA from the University of California in Los Angeles. Dr.Sobolevsky's career spans diverse leadership roles across healthcare, including clinical practice, education, and the pharmaceutical industry.
She has been actively engaged in research and publication in areas such as optimizing immunoglobulin practice and patient experience, health equity, healthcare team competencies, and the improvement of screening and diagnosis of rare diseases. Amy DNP, RN, IgCN®. Dr. Clarke is the ChiefClinical Officer of the Immunoglobulins National Society.
Again, IgNS. She brings more than 30 years of nursing and clinical operations expertise and is a nationally recognized leader in the immunoglobulin therapy. Dr. Clarke has been actively involved with IgNS for over 14 years. Serving as an executive advisor and past president. Most recently, Dr. Clarke served as vice president of clinical nursing practice at Optum [00:02:00] Infusion Pharmacy, a subsidiary of UnitedHealth Group.
She has held leadership roles across specialty home infusionorganizations and has co-authored multiple publications on best practices andIG therapy. As a national expert in specialty biologics and clinical practice,Dr. Clarke has presented at numerous national and international conferences.
Well, doctors, thank you so much for joining the Road to Care podcast, and I was gonna do the doctor, doctor and say, name that movie, but I, maybe some folks won't get, but
we're super pleased to have you here, you know, in our, in our pre-show conversations. This was this is a complex in IG therapy, part of medicine that I really was not aware of.
And so looking forward to, to hearing about the history and the future state of what you all are doing and the great work that you're doing.And I think we'll just start where we usually do career journey and founding genesis of IgNS. And we'll start at the beginning and love to hear your journeys and journeys into medicine and Luba,
what, what drew you to, to immunology and biologics?
Luba Sobolevsky: Thanks Kip and it's great to be here with you today. Well [00:03:00] it started really with my interest in education of clinicians for a long time, way before I got my PharmD. It was a different career, but yeah interested in educating clinicians, developing different educational offerings programs, and really realizing.
The rigor and the continuity of training that lifelong clinicians, like physicians, nurses, pharmacists, really need that. It doesn't end with your degree and your residency or fellowship and the need to advance skills and education. Staying up to date really was very evident to me early, early in my career.
And even during pharmacy school, I worked in a medicaleducation field and traveled and took all my finals early, and my professorsdidn't love that, but I really understood my path and my passion very early onbefore I even knew what I would do with that. And so [00:04:00]I, after my PharmD, I did a postdoc fellowship in the pharma industry.
I had some clinical experience as well, and that all led me tothis point. But while in pharma, I really understood that as an industry wewere focused on investing into physician driven initiatives, investigatorinitiated trials, continuing medical education, supporting differentfellowships, all prescriber focused.
But when we are talking about IG therapy, which we'll talk alot about, I'm sure today. In such a complex field, the disproportionate burdenof disease and really therapy management falls on the shoulders of the entireclinical team, and more specifically the nurse, pharmacist and physician kindof triangle.
And so it's impossible to silo out a single type of healthcareprofessional. It is also really bad practice [00:05:00]to really pull the resources into one type of clinician and not the others. Andso the idea, that this field of highly complex immune mediated disorders thatIG therapy is, and a life-saving therapy that is lifelong as well, needs to bestandardized.
And we need to develop an entire system of education andtraining and standards that began to crystallize. And that's led me to startingIgNS decade and a half ago.
Kip Theno: That's agreat story by, by the way, doctor, teachers, like you said, they don't likewhen you beat the curriculum, so congratulations on that.
You showed them. But, and, and then of course, I mean, we willget to, to the fusion of both of you and IgNS and what, what you all are doingover there. But Amy, you know, nursing, clinical leadership into IG therapy.Let's hear your.
Amy Clarke: Well, Iwas in infusion therapy. I was treating [00:06:00]bone marrow and stem cell transplant patients where IG is central to thatpopulation as their white counts recover.
And I really fell in love with IG therapy. Then, of course, it was only intravenous at the time. And as my practice broadened and I began to see patients with other conditions like multiple sclerosis, I began to clue in on how the patient felt during their infusion, not just how it was helping, why they, why they were getting IG therapy, but what they were telling me or what they were telling the pharmacy team about how they felt.
And there was very little evidence, of educational offerings back then. You could read a very.Small print prescribing information or package insert, and that was all you had. That was what you were left with. But I read as much as I possibly could wherever I could find it. Of course, you couldn't easily go and find journal articles online back then.
Even less about subcutaneous ig and I was privileged to be able to fly around the country [00:07:00] teaching doctors and other nurses and patients and pharmacists.
About this therapy as I learned as the manufacturers learned about these novel therapies. And I just immersed myself in anything I could find. So it was complete serendipity when I met Luba in 2011 and I knew already at that point that I had really leaned into educating. Clinicians and patients, so that that journey, patients receiving therapy for life, was one that patients wanted to continue versus abandon, which we see so often in so many therapies.
And it just clicked. And I've, I really excited that I was ableto do that. My doctoral project was around patient outcomes related to howclinicians interact with IG and I'm really glad to be here.
Kip Theno: Well, thank, thank you, doctor, and, I'm starting to pick up the breadcrumbs of howIgNS got started, but I would love, I think, and we can maybe take this [00:08:00] two ways, starting IgNS, what was that impetus that, that made that happen for you all?
And then maybe take that into the next level of the mission, but then also what you're finding are the barriers that you're trying to solve with the organization.
Luba Sobolevsky: Yeah, I think that really, it's kind of the confluence right of multiple things, but it started early in my career as I was mentioning, kind of realizing the investment as an industry into education and the expectations that we had of nurses and pharmacists to deliver and to have certain level of competencies, while not really putting in place any of those resources for them. That was all always problematic to me, and it never really made sense.
And then meeting national experts like Amy, and we've [00:09:00] never been apart since 2011. Really understanding that from my standpoint from the manufacturer's standpoint, from the clinician standpoint, from the provider standpoint, all of this was coming together and starting to build a clear picture.
That we were as a field in this most complex area of practice,IG therapy, right, disease modifying, plasma derived biologic, treating patients who have the most complex immune mediated disorders and often multiple disorders. We had a clear and significant lack of standards of practice. So we had diagnostic criteria always, right?
We knew what dose to prescribe, but beyond that, there was absolutely nothing to standardize care what happens to the patients before, during, after, in between infusions, we had absolutely nothing in terms of a [00:10:00]comprehensive or systematic educational system for IG therapy, we couldn't train clinicians in a systematic way.
In a standardized way. There was nothing available. And so wehave the most complex therapy, the most complex patients, and yet as anindustry we have absolutely no resources for clinicians responsible for patientsafety, for treatment efficacy, for adherence, and for good patient outcomes.And so as this began to really take shape, the idea of that this is a hugeissue, a huge lack in our industry.
We did, at IgNS, what we always do at the beginning is do our research. So we did a benchmark survey and we pulled around 400 nurses and pharmacists, and had a variety of questions, but mainly our point was to understand how every clinician who we're talking to, how these [00:11:00] clinicians are trained, onboarded, how their continuing education occurs, what are the resources that are in their hands when they're being sent to treat patients with IG .And to our, dismay, but not surprisingly, the results showed in over 95% of cases. I remember this, like we did this yesterday, this is 15years ago now, that over 95% of clinicians, excuse me, pharmacists and nurses reported that in fact they did receive education and training. But when we asked them. How, what their training, what it consists of.
The answers were shadow another clinician and read the package insert. So our industry was in such a state of lack and and critical gaps that the clinicians accepted that reading [00:12:00] the package insert from the manufacturers and following another clinician, who no one trained by the way inIG therapy,
was an appropriate onboarding exercise was an appropriate typeof training, competency development, and there was absolutely nothing in place for continual continuous education of clinicians. Meaning when they had to get their CEs to maintain their licensure, they were able to do. Those programs in absolutely any clinical field like hypertension or diabetes that have nothing to do with IG therapy, and that gave us the blueprint for what to do next.
We took that survey report and we went to work. The first thing we did was develop the standards of practice and the standards of practice are.They're intimately tied to clinical medical [00:13:00]standards, any pharmacy and infusion nursing standards that were in place, but nothing was in place specific to IG therapy practice.
And so with the between coordinating the levels of evidence for every single standard and guideline, we also had to develop a robust consensus on. The guidelines and standards that had no published literature, evidence, or anything. It was all clinical practice. So we really got together a stellar team of experts, immunologists, neurologists, rheumatologists, nurses, pharmacists who've been in practice for a long time, and really spent about 18months developing the first ever standard.
As a result, we have the only legally defensible standard of practice in IG therapy that's been. Updated and brought to obviously the current state, incorporating all the research, all the new [00:14:00] indications, all the changes in the field, and we do that on an annual basis. We then developed a robust educational program, including conferences and our online webinar programs.
Certification came next, right? Certification. Our IG certified nurse, IG Certified Pharmacist Credential, IGCN and IGCP is a formal credential and it was necessary to develop it because it's a metric of competency, which we didn't have before, right? If we have the standards, we have the education, now we need a metric.
We need a metric of compliance with the standards. We need a method of understanding the level of education and training these clinicians have, and they now were able to show, to demonstrate, and validate their competency specifically in IG therapy. Most importantly, the certification [00:15:00] established IG therapy as a clinical specialty that now requires a particular
type of specialized education, training, attainment of competencies, utilization of the standards, continuous education. And we also have a full suite of resources for clinicians and for providers as well, of course. Another really important arm of IgNS I just want to touch on is our IgNS Patient 360, which is a patient-focused arm of our association that focuses on patient outcomes research, and we work with a variety of providers.
On this, our advocacy education and support for patients receiving IG therapy lifelong. And we have really been successful in getting that off the ground about eight years ago. So it's something we feel so strongly about, and this is all of our "why".When you ask why [00:16:00] we keep doing what we're doing, this is our why, is because we are touching
patients understanding their issues, understanding intimately well the lack of various resources, lack of education, training, whatever it may be that they're experiencing as a patient, that gives us a roadmap to incorporate new educational programs for clinicians to address those continuous gaps.
And also at the same time, develop patient-focused resources,patient-focused education to empower our patients and ensure that our patientsare partners in this decision making process along their journey with IGtherapy. So that's how all of that kind of came together over the last 15years.
Kip Theno: Well, and let's be honest, I mean, you all are moving mountains and I got it so quick and[00:17:00] clear the passion you lasered in on the lack and the lags of the education and knowledge gaps that you're trying to solve, that were pretty massive. And so Amy, I'm gonna ask you, I'm gonna maybe flip the script here a little bit, that. That's, there's that part of it. And then the space is evolving so rapidly with all the new biologics, all the new novel therapies.
Now, with everything you just said, look, first of all, thank you for doing that for those patients and what you're doing. I'm not an IG patient, but I'm a patient and it's more than concerning to know that in that segment there was so many gaps in you're solving those, but now you've got this whole breed of new biologics and novel therapies coming out and emerging, and I know you wanna speak to some of those, but also, doesn't that will that also create new knowledge gaps that you all are gonna solve too? And Amy, maybe you can take that one.
Amy Clarke:Absolutely. This pipeline, I mean, it's been a bullet train over the past several years, and as these emerging therapies and novel therapies come out, like FCRN inhibitors and the growth in complement [00:18:00] inhibitors and ways that we administer IG therapy, there's now facilitation with human recombinant hyaluronidase that creates.
More knowledge necessary in order to effectively select the product , evaluate the patient for risk, administer the therapy, mitigate any adverse reactions that occur at bedside.Having those clinicians have the wherewithal to know that they need to distinguish each of these unique therapies based on the individual risks they're watching for.
Not to mention the sheer number of diagnoses that IG therapy is used for. We're now starting to see that in the monoclonal antibodies and the other biologics. That are coming out. So absolutely there is that knowledge gap. And when you couple that with the high variability in sight of care and how we nail down education in each of those [00:19:00] sites, home is very different.
Than how we would approach it for ambulatory infusion centersor in the hospitals. Because you could have an ambulatory infusion center thatis doing acute care like antibiotics and 50 other biologics. How do we makethat education accessible to those clinicians as well as ensuring that thepatients can be can advocate for themselves and are knowledgeable so that theycan be an active participant in the care being provided.
But all that being said adding all of these therapies for thediagnoses that, that we're seeing them added to inflammatory neuromusculardisorders other types of autoimmune disorders is an amazing advancement in thisspace because we need to have more targeted care.
We need to identify what we're going to do with the plasma. Thepotential impact to plasma supply that's coming along, and we can talk aboutthat as well where [00:20:00] we see this spacegoing.
Kip Theno: Thank you,doctor. And I want to go back to the standardization piece, right? It's amazingto me that modeling out standardizations that it's not. Kinda unilateral acrossthe board in medicine, and I get it, but how are you tackling thatstandardization specifically with all these different sites of care?
How are you helping them? And then what about the patients?Where is the education coming from when it goes to the patient's journey?
Amy Clarke: Sostandardization of any kind involves taking the algorithm that you're givenand. Embedding it into your organizational needs. Standards aren't they don'tgo into the million because we need organizations to look at their local andaccreditation requirements, state boards, all of those pieces, [00:21:00] but take those standards, embed them intopolicy, and then educate organizationally.
That is where you begin to tackle standardization. One of thethings I've always seen as a risk from implementation of standards or any newknowledge is the existing institutional knowledge, which can become a realbarrier to accepting that science changes what we know about medicine and howit's administered changes.
So we are working with other organizations like the National Infusion Center Association,to support their standards. We work with other organizations such as the Infusion Nurses Society, um, to makesure that where our spaces touch one another that we have that collaboration.
Luba Sobolevsky:Yeah, and I think that's a really critical piece that has worked so well forIgNS because we are really vertically [00:22:00]focused, right?
So what's really served us very well in terms of how we connectto the industry and how we work with other associations and why is that we areorganized vertically.
We focus on a therapy right on IG therapy space, which is verydifferent. Most other institutions practices, trade associations are focused ona trade. Medical, pharmacy, nursing, or even site of care, home infusion,infusion center and so forth. And because we are vertical, focusing on IGtherapy and we're the central standard setting association in IG therapy, wehave really forged strong alliances and collaborations across the board fromthe clinical institutional perspective and also from the associationperspective where we are the provider of education, of specialized training, ofspecialized, resources and [00:23:00]certification in IG therapy. And so these collaborations, as Amy was pointingout, have been really significant in delivering not only the resources standardcertification, but the rationale the education of the field about why this isneeded, why IG therapy is a clinical specialty, why this is so needed, andreally essential to patient safety, to patient, to treatment efficacy.
So that's been something that we're very proud of at IgNS. Justthe sheer number of these collaborative streams. It's not easy to come in 15years ago into a therapy area that has been running along, running on fumes.But running, right? And just treating patients and not having education, andthere were lots of gaps and huge amount of strain on the clinician side and onthe provider side, but that's what they had to [00:24:00]do.
And for us to come in and change it, change the conversation, provide the standards, but really make the case that certification is critically needed to ascertain. Competency, right? That education is critically needed in the field that you're practicing in order to provide the safest level of care in IG therapy.
So that's been a huge priority for us, and I think we've been very successful.
Kip Theno: Well, no, you have, and I mean you're IgNS is known for, from inception, literally creating those standards and certifications. And I think I'd love to hear how are you tying all this in? Because when you think about that, you've got the role of the clinician, evidence-based literature reviews, consensus of experts, psychometrics, evaluations, validation and updating, and then the impact.
So that's kind of a lot. That's a mouthful. But when you take all of that, how is your organization tackling all that? And then using all the resources and partnerships at your disposal [00:25:00]to make sure that gets out into the light.
Luba Sobolevsky: There are two really major ways we do that and Amy jump in to, from your perspective.
One is interdisciplinaryor interdisciplinary approach. The other is transparency. What I mean is thatfrom the beginning we were an interdisciplinary focused organization. All theeducation we have developed. To date is really, targeting three differentpreviously siloed healthcare professional types, physicians, nurses,pharmacists.
We've never, aside from the certification where you do need toassess specific nursing and pharmacy skills, we have never developed programswith one particular. HCP type in mind because that doesn't work in [00:26:00] practice. And there is so much literatureand research now to point out that education standards, resources, those needto be developed with the actual, the reality of practice in mind.
So if a nurse and a pharmacist work together 90% of the time, and there's that back and forth with documentation and patient assessments, and there is a stream of communication going between the nursing and pharmacy teams and then to the providers, to the physician, then education needs to incorporate that approach, otherwise it doesn't work.
And so that's what we've done on the one hand. So our approach to all of the information out of igNS is that we look at it exactly as it will be utilized by audience by the end user, if you will. Second is transparency.We share the results of our benchmarking surveys. We share our very [00:27:00] prolific patient outcomes research with the industry.
That includes manufacturers. That includes. Specialty infusion and infusion centers, providers, that includes physicians and physician groups and multi-specialty clinics. We publish all these, these data that point to our successes, obviously improvements in the field, but also to our failures, our gaps, and our areas that need a lot more attention and focus.
And we work very closely with the industry members who work.Hard to ensure that we have products with which to treat patients. We have developed industry based resourcesand ED education and seminars. We have a very strong. Business forum program atour conference, for example, where we have members of the manufacturing,whether it's device or product [00:28:00]leadership teams, and brandteams sit side by side with the leadership teams of specialty infusion andinfusion center companies, and it's astounding to learn how little they knowabout each other's business.
On a more detailed level, not just the high level that we all think we know, and that is very powerful. We share our patient data, we share our clinical outcomes data, and we have these robust programs where we bring to light the most important things impacting our patients, and we get to work in trying to figure out how to make their lives easier, how to get better access to treatment, what we need to change in terms of
clinical practice, and it's really that straightforward. We really listen to our field and we share information, and we are very multidisciplinary in terms of the [00:29:00]approach to everything we do. Anything to add, Amy?
Amy Clarke: I mean, I would just add that the patient is the fourth pillar, in that group because the patient voice, when you consider shared decision making, ensuring that those clinicians know how to.
Effectively educate the patient on what their options are and how the patient should , provide feedback on their journey is incredibly important. And we build that into the education that we provide. So not only do we stress the interdisciplinary component of it, but we stress how important shared decision making.
And then if you take the data that we're gathering from our patient surveys, that helps inform where we see additional gaps in education.Not just the feedback we're getting from clinicians, but from patients as well, which is where standards are reviewed and updated, where the educational approach that we have is also geared to address.
How the patient perceives their [00:30:00]care being provided to them, and this journey that they're on for life.
Kip Theno: And that's, that's amazing because I want to zoom the lens out a bit to maybe a broader map of the world for stakeholder engagement. You mentioned some of them doctors, patient access stakeholders, manufacturers, pharmaceutical companies, payers, legislators, what.
What has been the response from them and is it moving fast enough? I mean, are they helping, are they chomping at the bit to kind of solve this, or is it still kind of a glacial pace, especially on the legislation side?
Luba Sobolevsky: In my experience in the IG manufacturer world, these companies, it takes them nine to 12 months to go from a vial of plasma to a vial of product. So they're [00:31:00]invested into the patient journey and to the patient success.
And so they have been extremely supportive, extremely forthcoming with sharing their knowledge and their observations, as well as in their desire to learn from IgNS and really understand, what the issues, key issues impacting patients are they really truly have this patient commitment and it's incredible to be part of that, to be in the industry where the patient is truly number one. So from that standpoint, there's a lot of support.
Luba Sobolevsky: And on the provider side, I think that we've had a lot of interest, a lot of alignment. There are organizations who have [00:32:00]been those early adopters, right from the very, very beginning when the first standards were just released, the first certification programs were just launched.
It's been incredible to witness such a high number of providers who started coming to IgNS when we had, you know, 120 people in the audience who witnessed our growth to now having these huge conferences and thousands of members, but also their businesses have grown and flourished from a single pharmacy to a multinational mid-size enterprise now, and this happens so often.
And of course there are challenges. There are a lot of challenges with like with any field in investment into. Your clinicians investing into training, education, competency, because again, it's only been [00:33:00] if you think about it, we've been around for so long, but not really. If you think of other healthcare trade organizations, it's 15 years is not such a long time and for decades and decades we had no standards, we had no certifications. So certainly we still have organizations that are trying to get by without fully investing into elevating their standards and elevating the care and elevating the practice.But we are working through those challenges and we certainly are able to.
Provide and support any organization and any provider or individual clinician, even with a full suite of resources they need to improve practice. Amy, anything from your perspective?
Amy Clarke: I was just thinking more from my perspective on, we talked previously, I [00:34:00] think about asking our clinicians to do more with less. And organizations that invest in standardizing their practice according to the evidence that is out there and elevating their clinicians by supporting advanced certifications and their education are able to distinguish themselves from other organizations. And in part that's due to patient feedback, prescriber feedback, but from the outcomes data that they collect and that information coming from those providers is also going to the manufacturers and going to payers so that they can see, where benchmarks, are
Luba Sobolevsky: being laid. And, and that's a great pointactually, Amy.
Luba Sobolevsky: In fact, in the past five years I've beenmore in more meetings with the manufacturers that I can count where they'veasked IG and S to create a metric by which they can measure.
A provider's [00:35:00] expertisein IG therapy as a whole, they're really keen on making sure that the end pointwhere the drug ends up wherever it is, whether it's an infusion center or it'sa specialty pharmacy or infusion company that. At the end of the day, theclinician who infuses the IG therapy that they spent years in development andyears in production, year over year. Every single vial that takes a year toproduce, that ends up in the most capable hands of educated, certifiedclinicians. And that metric is something we are working on right now. Weare developing a distinction program in IG therapy with a CHC, so that'lllaunch in January of 2026. You heard it here first.
But it'll be a true [00:36:00]metric that a provider can use to differentiate themselves on the businessside. 'Cause that's really the only differentiator that counts is the expertisethey have with IG therapy and how they ensure safety, efficacy, adherence, andthe best infusion experience and best patient outcomes.
And so that is coming and that's something we're very excitedabout. We need to shift the burden of education, training, resources,competency from being on the shoulders of the individual clinicians to theproviders. And that shift is happening and there has been more interest in thisprogram than anything that we've ever done to date.
So we know. Back to your original think Very good question,Kip. What's the uptake [00:37:00] like? How'sthe industry responding? We can see how the industry is responding in theinterest that we now have in this accreditation distinction program. So that'svery encouraging to me. It's a great pulse check on what's going on.
Kip Theno: Yeah. Andby the way, you know, status quo equals inertia and that's not a good thing.And you guys are creating that momentum shift. I love to hear that.
Kip Theno: So in thefinal minutes we have here on the show, doctors next five to 10 years, IGtherapy, biggest challenges, big greatest opportunities for you all and forthis market and the patients.
Amy Clarke: For me, it's three parts. It's a rapidly aging workforce. So as we educate clinicians who then become mentors for the less experienced clinicians coming through, they are aging out and moving toward retirement, at a fast [00:38:00] pace.
And at that same fast pace, more than 4 million baby boomers have turned 65 each year for the past several years and will continue to do so until 2030. And you take an older patient, you have secondary immunodeficiencies and hematological malignancies, transplant needs, all of these things were igs used. So we will need more plasma donations in order to solve for X. When we look at the amount of IG that is going to be necessary to service this patient population, along with the clinicians needed to administer the therapy.
So again, going back tothe novel therapies, that's why I'm so excited about what pipeline looks like because there is a need to solve for targeted therapies so that IG can be usedwhere there are no options.
Luba Sobolevsky: Yeah. And then I totally agree with that. And to add to this, there are kind of two things that concern [00:39:00] me in addition to what Amy was pointing out.
One is that we still have a huge diagnostic delay in these rare diseases that IG therapy treats. In some cases it takes, in some disease states, like primary immune deficiency, it takes 10 to 17 years, and that's been corroborated by every organization that's done research, including IgNS, 10 to 17 years to get a diagnosis.
And this has a lot to do with how fragmented our healthcare system is. Patients are being seen in urgent care, emergency rooms, and even their primary care physicians. And none of these entities coordinate, collaborate, or even talk to each other. And so in certain disease states there's a 70 to 90% under diagnosis.
So we need to get a whole lot better in restructuring our healthcare system [00:40:00] to allow for this coordination of care or else our rare disease patients will continue to suffer for decades on end. So that's a huge issue. And then if we. Correct this and all of the associations including IgNS are working very hard on improving the diagnosis, the treatment access, and it is improving incrementally, and then we're going to have a lot more patients to treat.
In fact, the pharma industry is increasing supply significantly year over year due to increased demand. Which is relating back to what Amy was pointing out, better diagnostic criteria, aging patient population. So all of that is growing. In fact, this IG industry was projected by Forbes to grow over 40% in the next decade.
And so we then need, imagine this just in all of this the, just the sheer [00:41:00] scale of this very specialized therapy space. Growing that much that quickly. Our standardization of this therapy, of our practice, of our clinical care needs to go way up. We need to really address it, both on a granular level, but on a very, on a large scale as well.
So from the ground up, top down, every approach. If we're gonnagrow 40 to 50%. We need to address the challenges we have now when we have ahuge under-diagnosis and really are still growing into standardizing this fieldas a whole. So that really, if something keeps me up at night, it's this.
And at the same time I wanna end at a positive note. We have a very [00:42:00] cohesive,a very strong industry in the IG therapy space, and I know we all want the samething is for our patients who are on this life-saving therapy lifelong, to havethe best experience at every infusion and to have the best outcomes, and tohave the best quality of life they can and to really thrive.
To thrive despite theirchallenges and despite their diagnosis. And certainly IgNS has committedto continuing our work and we will do long term. And I know that we have thesupport and the backing of this industry as well.
Kip Theno: Uh, Amyand Luba, I just first. So grateful to have you both on the program, but even more importantly for the work that you were doing and that you've outlined today.
And before I get to the very quick Easter egg question, you said it Luba, we gotta get a whole lot better, right? Quote unquote. So in that, with that spirit in mind, what is the best contact for you and [00:43:00] Amy and IgNS so that we can get the word out as soon as this show goes live?
Amy Clarke: Um,info@ig-ns.org.
Luba Sobolevsky:Right. And ig-ns.org is our website and all information is on there. And yeah,we look forward to. Having more of these conversations.
Kip Theno: Well, wewill definitely have you back. We're gonna keep a watchful eye and get this outto the masses for the Road to Care podcast. And listen, we're serious businessof healthcare.
I get that. But at the beginning, I said "Doctor, doctor,doctor". I said, name that movie and we gotta have a little fun now at theend. The reason I did that is this is the first show in all of our episodeswhere I've had two doctors on and I had to do it just to see. So can do eitherone of, you know, the movie reference or not.
Amy Clarke: I should,because my husband says it all the time, and he's at the dentist right now, soI can't answer the [00:44:00] question.
Kip Theno: I like himalready. Well, the movie, the movie of course is, is Spies Like Us, one of thegreats of Chevy Chase, Dan Aykroyd.
Luba Sobolevsky: SoI'm great. I love it.
Kip Theno: That isone of the best scenes anyway.
Listen back to the serious note. Amy Luba, doctors, thank you so much for your time today on the Road to Care podcast. We can't wait to get this episode out, and we look forward to hearing from you again. Thank you so much.
Luba Sobolevsky: Thank you for having us on. It was a pleasure.
Kip Theno: Thank you for joining the Road to Care podcast, hosted by SamaCare, the leader in prior authorization technology and services, where through a script to therapy operating system, we enable connectivity with clinics, payers, and manufacturers focused on optimizing patient care. Tune in next time as together we can make things right.
Enjoy the music written, produced, and recorded by [00:45:00] Jamestown.
Podcast produced by JFACTOR, visit https://www.jfactor.com/
Together, we can make healthcare right. Here are some of the outstanding healthcare organizations and associations championing patient health mentioned in this episode:
Standardizing IG Therapy with Dr. Luba Sobolevsky & Dr.Amy Clarke
Kip Theno: [00:00:00] Welcome to the Road to Care podcast hostedby SamaCare, where we'll talk with key opinion leaders, physicians,administrators, manufacturers, venture capitalists, and legislators to gettheir insights on the state of healthcare today. And where we see it evolving.SamaCare's prior authorization platform is free to clinics, ensuring patientsget on the right therapy at the right time.
Together we can simply make things right.
Kip Theno: Welcome back everybody to the Road to Care podcast hosted by SamaCare. And today our special guests are Luba Sobolevsky and Amy Clarke, who are doing fantastic workin the complex world of IG therapy. Dr. Luba Sobolevsky is the president and CEO of the Immunoglobulins National Society, IgNS. The central healthcare organization in the field of IG therapy and biologics.
In her executive role, Dr. Sobolevsky oversees the advancementof clinical standards, resources, education, certification, accreditation,patient advocacy, and strategic [00:01:00]alliances. She holds a PharmD degree from the University of SouthernCalifornia, and a BA from the University of California in Los Angeles. Dr.Sobolevsky's career spans diverse leadership roles across healthcare, including clinical practice, education, and the pharmaceutical industry.
She has been actively engaged in research and publication in areas such as optimizing immunoglobulin practice and patient experience, health equity, healthcare team competencies, and the improvement of screening and diagnosis of rare diseases. Amy DNP, RN, IgCN®. Dr. Clarke is the ChiefClinical Officer of the Immunoglobulins National Society.
Again, IgNS. She brings more than 30 years of nursing and clinical operations expertise and is a nationally recognized leader in the immunoglobulin therapy. Dr. Clarke has been actively involved with IgNS for over 14 years. Serving as an executive advisor and past president. Most recently, Dr. Clarke served as vice president of clinical nursing practice at Optum [00:02:00] Infusion Pharmacy, a subsidiary of UnitedHealth Group.
She has held leadership roles across specialty home infusionorganizations and has co-authored multiple publications on best practices andIG therapy. As a national expert in specialty biologics and clinical practice,Dr. Clarke has presented at numerous national and international conferences.
Well, doctors, thank you so much for joining the Road to Care podcast, and I was gonna do the doctor, doctor and say, name that movie, but I, maybe some folks won't get, but
we're super pleased to have you here, you know, in our, in our pre-show conversations. This was this is a complex in IG therapy, part of medicine that I really was not aware of.
And so looking forward to, to hearing about the history and the future state of what you all are doing and the great work that you're doing.And I think we'll just start where we usually do career journey and founding genesis of IgNS. And we'll start at the beginning and love to hear your journeys and journeys into medicine and Luba,
what, what drew you to, to immunology and biologics?
Luba Sobolevsky: Thanks Kip and it's great to be here with you today. Well [00:03:00] it started really with my interest in education of clinicians for a long time, way before I got my PharmD. It was a different career, but yeah interested in educating clinicians, developing different educational offerings programs, and really realizing.
The rigor and the continuity of training that lifelong clinicians, like physicians, nurses, pharmacists, really need that. It doesn't end with your degree and your residency or fellowship and the need to advance skills and education. Staying up to date really was very evident to me early, early in my career.
And even during pharmacy school, I worked in a medicaleducation field and traveled and took all my finals early, and my professorsdidn't love that, but I really understood my path and my passion very early onbefore I even knew what I would do with that. And so [00:04:00]I, after my PharmD, I did a postdoc fellowship in the pharma industry.
I had some clinical experience as well, and that all led me tothis point. But while in pharma, I really understood that as an industry wewere focused on investing into physician driven initiatives, investigatorinitiated trials, continuing medical education, supporting differentfellowships, all prescriber focused.
But when we are talking about IG therapy, which we'll talk alot about, I'm sure today. In such a complex field, the disproportionate burdenof disease and really therapy management falls on the shoulders of the entireclinical team, and more specifically the nurse, pharmacist and physician kindof triangle.
And so it's impossible to silo out a single type of healthcareprofessional. It is also really bad practice [00:05:00]to really pull the resources into one type of clinician and not the others. Andso the idea, that this field of highly complex immune mediated disorders thatIG therapy is, and a life-saving therapy that is lifelong as well, needs to bestandardized.
And we need to develop an entire system of education andtraining and standards that began to crystallize. And that's led me to startingIgNS decade and a half ago.
Kip Theno: That's agreat story by, by the way, doctor, teachers, like you said, they don't likewhen you beat the curriculum, so congratulations on that.
You showed them. But, and, and then of course, I mean, we willget to, to the fusion of both of you and IgNS and what, what you all are doingover there. But Amy, you know, nursing, clinical leadership into IG therapy.Let's hear your.
Amy Clarke: Well, Iwas in infusion therapy. I was treating [00:06:00]bone marrow and stem cell transplant patients where IG is central to thatpopulation as their white counts recover.
And I really fell in love with IG therapy. Then, of course, it was only intravenous at the time. And as my practice broadened and I began to see patients with other conditions like multiple sclerosis, I began to clue in on how the patient felt during their infusion, not just how it was helping, why they, why they were getting IG therapy, but what they were telling me or what they were telling the pharmacy team about how they felt.
And there was very little evidence, of educational offerings back then. You could read a very.Small print prescribing information or package insert, and that was all you had. That was what you were left with. But I read as much as I possibly could wherever I could find it. Of course, you couldn't easily go and find journal articles online back then.
Even less about subcutaneous ig and I was privileged to be able to fly around the country [00:07:00] teaching doctors and other nurses and patients and pharmacists.
About this therapy as I learned as the manufacturers learned about these novel therapies. And I just immersed myself in anything I could find. So it was complete serendipity when I met Luba in 2011 and I knew already at that point that I had really leaned into educating. Clinicians and patients, so that that journey, patients receiving therapy for life, was one that patients wanted to continue versus abandon, which we see so often in so many therapies.
And it just clicked. And I've, I really excited that I was ableto do that. My doctoral project was around patient outcomes related to howclinicians interact with IG and I'm really glad to be here.
Kip Theno: Well, thank, thank you, doctor, and, I'm starting to pick up the breadcrumbs of howIgNS got started, but I would love, I think, and we can maybe take this [00:08:00] two ways, starting IgNS, what was that impetus that, that made that happen for you all?
And then maybe take that into the next level of the mission, but then also what you're finding are the barriers that you're trying to solve with the organization.
Luba Sobolevsky: Yeah, I think that really, it's kind of the confluence right of multiple things, but it started early in my career as I was mentioning, kind of realizing the investment as an industry into education and the expectations that we had of nurses and pharmacists to deliver and to have certain level of competencies, while not really putting in place any of those resources for them. That was all always problematic to me, and it never really made sense.
And then meeting national experts like Amy, and we've [00:09:00] never been apart since 2011. Really understanding that from my standpoint from the manufacturer's standpoint, from the clinician standpoint, from the provider standpoint, all of this was coming together and starting to build a clear picture.
That we were as a field in this most complex area of practice,IG therapy, right, disease modifying, plasma derived biologic, treating patients who have the most complex immune mediated disorders and often multiple disorders. We had a clear and significant lack of standards of practice. So we had diagnostic criteria always, right?
We knew what dose to prescribe, but beyond that, there was absolutely nothing to standardize care what happens to the patients before, during, after, in between infusions, we had absolutely nothing in terms of a [00:10:00]comprehensive or systematic educational system for IG therapy, we couldn't train clinicians in a systematic way.
In a standardized way. There was nothing available. And so wehave the most complex therapy, the most complex patients, and yet as anindustry we have absolutely no resources for clinicians responsible for patientsafety, for treatment efficacy, for adherence, and for good patient outcomes.And so as this began to really take shape, the idea of that this is a hugeissue, a huge lack in our industry.
We did, at IgNS, what we always do at the beginning is do our research. So we did a benchmark survey and we pulled around 400 nurses and pharmacists, and had a variety of questions, but mainly our point was to understand how every clinician who we're talking to, how these [00:11:00] clinicians are trained, onboarded, how their continuing education occurs, what are the resources that are in their hands when they're being sent to treat patients with IG .And to our, dismay, but not surprisingly, the results showed in over 95% of cases. I remember this, like we did this yesterday, this is 15years ago now, that over 95% of clinicians, excuse me, pharmacists and nurses reported that in fact they did receive education and training. But when we asked them. How, what their training, what it consists of.
The answers were shadow another clinician and read the package insert. So our industry was in such a state of lack and and critical gaps that the clinicians accepted that reading [00:12:00] the package insert from the manufacturers and following another clinician, who no one trained by the way inIG therapy,
was an appropriate onboarding exercise was an appropriate typeof training, competency development, and there was absolutely nothing in place for continual continuous education of clinicians. Meaning when they had to get their CEs to maintain their licensure, they were able to do. Those programs in absolutely any clinical field like hypertension or diabetes that have nothing to do with IG therapy, and that gave us the blueprint for what to do next.
We took that survey report and we went to work. The first thing we did was develop the standards of practice and the standards of practice are.They're intimately tied to clinical medical [00:13:00]standards, any pharmacy and infusion nursing standards that were in place, but nothing was in place specific to IG therapy practice.
And so with the between coordinating the levels of evidence for every single standard and guideline, we also had to develop a robust consensus on. The guidelines and standards that had no published literature, evidence, or anything. It was all clinical practice. So we really got together a stellar team of experts, immunologists, neurologists, rheumatologists, nurses, pharmacists who've been in practice for a long time, and really spent about 18months developing the first ever standard.
As a result, we have the only legally defensible standard of practice in IG therapy that's been. Updated and brought to obviously the current state, incorporating all the research, all the new [00:14:00] indications, all the changes in the field, and we do that on an annual basis. We then developed a robust educational program, including conferences and our online webinar programs.
Certification came next, right? Certification. Our IG certified nurse, IG Certified Pharmacist Credential, IGCN and IGCP is a formal credential and it was necessary to develop it because it's a metric of competency, which we didn't have before, right? If we have the standards, we have the education, now we need a metric.
We need a metric of compliance with the standards. We need a method of understanding the level of education and training these clinicians have, and they now were able to show, to demonstrate, and validate their competency specifically in IG therapy. Most importantly, the certification [00:15:00] established IG therapy as a clinical specialty that now requires a particular
type of specialized education, training, attainment of competencies, utilization of the standards, continuous education. And we also have a full suite of resources for clinicians and for providers as well, of course. Another really important arm of IgNS I just want to touch on is our IgNS Patient 360, which is a patient-focused arm of our association that focuses on patient outcomes research, and we work with a variety of providers.
On this, our advocacy education and support for patients receiving IG therapy lifelong. And we have really been successful in getting that off the ground about eight years ago. So it's something we feel so strongly about, and this is all of our "why".When you ask why [00:16:00] we keep doing what we're doing, this is our why, is because we are touching
patients understanding their issues, understanding intimately well the lack of various resources, lack of education, training, whatever it may be that they're experiencing as a patient, that gives us a roadmap to incorporate new educational programs for clinicians to address those continuous gaps.
And also at the same time, develop patient-focused resources,patient-focused education to empower our patients and ensure that our patientsare partners in this decision making process along their journey with IGtherapy. So that's how all of that kind of came together over the last 15years.
Kip Theno: Well, and let's be honest, I mean, you all are moving mountains and I got it so quick and[00:17:00] clear the passion you lasered in on the lack and the lags of the education and knowledge gaps that you're trying to solve, that were pretty massive. And so Amy, I'm gonna ask you, I'm gonna maybe flip the script here a little bit, that. That's, there's that part of it. And then the space is evolving so rapidly with all the new biologics, all the new novel therapies.
Now, with everything you just said, look, first of all, thank you for doing that for those patients and what you're doing. I'm not an IG patient, but I'm a patient and it's more than concerning to know that in that segment there was so many gaps in you're solving those, but now you've got this whole breed of new biologics and novel therapies coming out and emerging, and I know you wanna speak to some of those, but also, doesn't that will that also create new knowledge gaps that you all are gonna solve too? And Amy, maybe you can take that one.
Amy Clarke:Absolutely. This pipeline, I mean, it's been a bullet train over the past several years, and as these emerging therapies and novel therapies come out, like FCRN inhibitors and the growth in complement [00:18:00] inhibitors and ways that we administer IG therapy, there's now facilitation with human recombinant hyaluronidase that creates.
More knowledge necessary in order to effectively select the product , evaluate the patient for risk, administer the therapy, mitigate any adverse reactions that occur at bedside.Having those clinicians have the wherewithal to know that they need to distinguish each of these unique therapies based on the individual risks they're watching for.
Not to mention the sheer number of diagnoses that IG therapy is used for. We're now starting to see that in the monoclonal antibodies and the other biologics. That are coming out. So absolutely there is that knowledge gap. And when you couple that with the high variability in sight of care and how we nail down education in each of those [00:19:00] sites, home is very different.
Than how we would approach it for ambulatory infusion centersor in the hospitals. Because you could have an ambulatory infusion center thatis doing acute care like antibiotics and 50 other biologics. How do we makethat education accessible to those clinicians as well as ensuring that thepatients can be can advocate for themselves and are knowledgeable so that theycan be an active participant in the care being provided.
But all that being said adding all of these therapies for thediagnoses that, that we're seeing them added to inflammatory neuromusculardisorders other types of autoimmune disorders is an amazing advancement in thisspace because we need to have more targeted care.
We need to identify what we're going to do with the plasma. Thepotential impact to plasma supply that's coming along, and we can talk aboutthat as well where [00:20:00] we see this spacegoing.
Kip Theno: Thank you,doctor. And I want to go back to the standardization piece, right? It's amazingto me that modeling out standardizations that it's not. Kinda unilateral acrossthe board in medicine, and I get it, but how are you tackling thatstandardization specifically with all these different sites of care?
How are you helping them? And then what about the patients?Where is the education coming from when it goes to the patient's journey?
Amy Clarke: Sostandardization of any kind involves taking the algorithm that you're givenand. Embedding it into your organizational needs. Standards aren't they don'tgo into the million because we need organizations to look at their local andaccreditation requirements, state boards, all of those pieces, [00:21:00] but take those standards, embed them intopolicy, and then educate organizationally.
That is where you begin to tackle standardization. One of thethings I've always seen as a risk from implementation of standards or any newknowledge is the existing institutional knowledge, which can become a realbarrier to accepting that science changes what we know about medicine and howit's administered changes.
So we are working with other organizations like the National Infusion Center Association,to support their standards. We work with other organizations such as the Infusion Nurses Society, um, to makesure that where our spaces touch one another that we have that collaboration.
Luba Sobolevsky:Yeah, and I think that's a really critical piece that has worked so well forIgNS because we are really vertically [00:22:00]focused, right?
So what's really served us very well in terms of how we connectto the industry and how we work with other associations and why is that we areorganized vertically.
We focus on a therapy right on IG therapy space, which is verydifferent. Most other institutions practices, trade associations are focused ona trade. Medical, pharmacy, nursing, or even site of care, home infusion,infusion center and so forth. And because we are vertical, focusing on IGtherapy and we're the central standard setting association in IG therapy, wehave really forged strong alliances and collaborations across the board fromthe clinical institutional perspective and also from the associationperspective where we are the provider of education, of specialized training, ofspecialized, resources and [00:23:00]certification in IG therapy. And so these collaborations, as Amy was pointingout, have been really significant in delivering not only the resources standardcertification, but the rationale the education of the field about why this isneeded, why IG therapy is a clinical specialty, why this is so needed, andreally essential to patient safety, to patient, to treatment efficacy.
So that's been something that we're very proud of at IgNS. Justthe sheer number of these collaborative streams. It's not easy to come in 15years ago into a therapy area that has been running along, running on fumes.But running, right? And just treating patients and not having education, andthere were lots of gaps and huge amount of strain on the clinician side and onthe provider side, but that's what they had to [00:24:00]do.
And for us to come in and change it, change the conversation, provide the standards, but really make the case that certification is critically needed to ascertain. Competency, right? That education is critically needed in the field that you're practicing in order to provide the safest level of care in IG therapy.
So that's been a huge priority for us, and I think we've been very successful.
Kip Theno: Well, no, you have, and I mean you're IgNS is known for, from inception, literally creating those standards and certifications. And I think I'd love to hear how are you tying all this in? Because when you think about that, you've got the role of the clinician, evidence-based literature reviews, consensus of experts, psychometrics, evaluations, validation and updating, and then the impact.
So that's kind of a lot. That's a mouthful. But when you take all of that, how is your organization tackling all that? And then using all the resources and partnerships at your disposal [00:25:00]to make sure that gets out into the light.
Luba Sobolevsky: There are two really major ways we do that and Amy jump in to, from your perspective.
One is interdisciplinaryor interdisciplinary approach. The other is transparency. What I mean is thatfrom the beginning we were an interdisciplinary focused organization. All theeducation we have developed. To date is really, targeting three differentpreviously siloed healthcare professional types, physicians, nurses,pharmacists.
We've never, aside from the certification where you do need toassess specific nursing and pharmacy skills, we have never developed programswith one particular. HCP type in mind because that doesn't work in [00:26:00] practice. And there is so much literatureand research now to point out that education standards, resources, those needto be developed with the actual, the reality of practice in mind.
So if a nurse and a pharmacist work together 90% of the time, and there's that back and forth with documentation and patient assessments, and there is a stream of communication going between the nursing and pharmacy teams and then to the providers, to the physician, then education needs to incorporate that approach, otherwise it doesn't work.
And so that's what we've done on the one hand. So our approach to all of the information out of igNS is that we look at it exactly as it will be utilized by audience by the end user, if you will. Second is transparency.We share the results of our benchmarking surveys. We share our very [00:27:00] prolific patient outcomes research with the industry.
That includes manufacturers. That includes. Specialty infusion and infusion centers, providers, that includes physicians and physician groups and multi-specialty clinics. We publish all these, these data that point to our successes, obviously improvements in the field, but also to our failures, our gaps, and our areas that need a lot more attention and focus.
And we work very closely with the industry members who work.Hard to ensure that we have products with which to treat patients. We have developed industry based resourcesand ED education and seminars. We have a very strong. Business forum program atour conference, for example, where we have members of the manufacturing,whether it's device or product [00:28:00]leadership teams, and brandteams sit side by side with the leadership teams of specialty infusion andinfusion center companies, and it's astounding to learn how little they knowabout each other's business.
On a more detailed level, not just the high level that we all think we know, and that is very powerful. We share our patient data, we share our clinical outcomes data, and we have these robust programs where we bring to light the most important things impacting our patients, and we get to work in trying to figure out how to make their lives easier, how to get better access to treatment, what we need to change in terms of
clinical practice, and it's really that straightforward. We really listen to our field and we share information, and we are very multidisciplinary in terms of the [00:29:00]approach to everything we do. Anything to add, Amy?
Amy Clarke: I mean, I would just add that the patient is the fourth pillar, in that group because the patient voice, when you consider shared decision making, ensuring that those clinicians know how to.
Effectively educate the patient on what their options are and how the patient should , provide feedback on their journey is incredibly important. And we build that into the education that we provide. So not only do we stress the interdisciplinary component of it, but we stress how important shared decision making.
And then if you take the data that we're gathering from our patient surveys, that helps inform where we see additional gaps in education.Not just the feedback we're getting from clinicians, but from patients as well, which is where standards are reviewed and updated, where the educational approach that we have is also geared to address.
How the patient perceives their [00:30:00]care being provided to them, and this journey that they're on for life.
Kip Theno: And that's, that's amazing because I want to zoom the lens out a bit to maybe a broader map of the world for stakeholder engagement. You mentioned some of them doctors, patient access stakeholders, manufacturers, pharmaceutical companies, payers, legislators, what.
What has been the response from them and is it moving fast enough? I mean, are they helping, are they chomping at the bit to kind of solve this, or is it still kind of a glacial pace, especially on the legislation side?
Luba Sobolevsky: In my experience in the IG manufacturer world, these companies, it takes them nine to 12 months to go from a vial of plasma to a vial of product. So they're [00:31:00]invested into the patient journey and to the patient success.
And so they have been extremely supportive, extremely forthcoming with sharing their knowledge and their observations, as well as in their desire to learn from IgNS and really understand, what the issues, key issues impacting patients are they really truly have this patient commitment and it's incredible to be part of that, to be in the industry where the patient is truly number one. So from that standpoint, there's a lot of support.
Luba Sobolevsky: And on the provider side, I think that we've had a lot of interest, a lot of alignment. There are organizations who have [00:32:00]been those early adopters, right from the very, very beginning when the first standards were just released, the first certification programs were just launched.
It's been incredible to witness such a high number of providers who started coming to IgNS when we had, you know, 120 people in the audience who witnessed our growth to now having these huge conferences and thousands of members, but also their businesses have grown and flourished from a single pharmacy to a multinational mid-size enterprise now, and this happens so often.
And of course there are challenges. There are a lot of challenges with like with any field in investment into. Your clinicians investing into training, education, competency, because again, it's only been [00:33:00] if you think about it, we've been around for so long, but not really. If you think of other healthcare trade organizations, it's 15 years is not such a long time and for decades and decades we had no standards, we had no certifications. So certainly we still have organizations that are trying to get by without fully investing into elevating their standards and elevating the care and elevating the practice.But we are working through those challenges and we certainly are able to.
Provide and support any organization and any provider or individual clinician, even with a full suite of resources they need to improve practice. Amy, anything from your perspective?
Amy Clarke: I was just thinking more from my perspective on, we talked previously, I [00:34:00] think about asking our clinicians to do more with less. And organizations that invest in standardizing their practice according to the evidence that is out there and elevating their clinicians by supporting advanced certifications and their education are able to distinguish themselves from other organizations. And in part that's due to patient feedback, prescriber feedback, but from the outcomes data that they collect and that information coming from those providers is also going to the manufacturers and going to payers so that they can see, where benchmarks, are
Luba Sobolevsky: being laid. And, and that's a great pointactually, Amy.
Luba Sobolevsky: In fact, in the past five years I've beenmore in more meetings with the manufacturers that I can count where they'veasked IG and S to create a metric by which they can measure.
A provider's [00:35:00] expertisein IG therapy as a whole, they're really keen on making sure that the end pointwhere the drug ends up wherever it is, whether it's an infusion center or it'sa specialty pharmacy or infusion company that. At the end of the day, theclinician who infuses the IG therapy that they spent years in development andyears in production, year over year. Every single vial that takes a year toproduce, that ends up in the most capable hands of educated, certifiedclinicians. And that metric is something we are working on right now. Weare developing a distinction program in IG therapy with a CHC, so that'lllaunch in January of 2026. You heard it here first.
But it'll be a true [00:36:00]metric that a provider can use to differentiate themselves on the businessside. 'Cause that's really the only differentiator that counts is the expertisethey have with IG therapy and how they ensure safety, efficacy, adherence, andthe best infusion experience and best patient outcomes.
And so that is coming and that's something we're very excitedabout. We need to shift the burden of education, training, resources,competency from being on the shoulders of the individual clinicians to theproviders. And that shift is happening and there has been more interest in thisprogram than anything that we've ever done to date.
So we know. Back to your original think Very good question,Kip. What's the uptake [00:37:00] like? How'sthe industry responding? We can see how the industry is responding in theinterest that we now have in this accreditation distinction program. So that'svery encouraging to me. It's a great pulse check on what's going on.
Kip Theno: Yeah. Andby the way, you know, status quo equals inertia and that's not a good thing.And you guys are creating that momentum shift. I love to hear that.
Kip Theno: So in thefinal minutes we have here on the show, doctors next five to 10 years, IGtherapy, biggest challenges, big greatest opportunities for you all and forthis market and the patients.
Amy Clarke: For me, it's three parts. It's a rapidly aging workforce. So as we educate clinicians who then become mentors for the less experienced clinicians coming through, they are aging out and moving toward retirement, at a fast [00:38:00] pace.
And at that same fast pace, more than 4 million baby boomers have turned 65 each year for the past several years and will continue to do so until 2030. And you take an older patient, you have secondary immunodeficiencies and hematological malignancies, transplant needs, all of these things were igs used. So we will need more plasma donations in order to solve for X. When we look at the amount of IG that is going to be necessary to service this patient population, along with the clinicians needed to administer the therapy.
So again, going back tothe novel therapies, that's why I'm so excited about what pipeline looks like because there is a need to solve for targeted therapies so that IG can be usedwhere there are no options.
Luba Sobolevsky: Yeah. And then I totally agree with that. And to add to this, there are kind of two things that concern [00:39:00] me in addition to what Amy was pointing out.
One is that we still have a huge diagnostic delay in these rare diseases that IG therapy treats. In some cases it takes, in some disease states, like primary immune deficiency, it takes 10 to 17 years, and that's been corroborated by every organization that's done research, including IgNS, 10 to 17 years to get a diagnosis.
And this has a lot to do with how fragmented our healthcare system is. Patients are being seen in urgent care, emergency rooms, and even their primary care physicians. And none of these entities coordinate, collaborate, or even talk to each other. And so in certain disease states there's a 70 to 90% under diagnosis.
So we need to get a whole lot better in restructuring our healthcare system [00:40:00] to allow for this coordination of care or else our rare disease patients will continue to suffer for decades on end. So that's a huge issue. And then if we. Correct this and all of the associations including IgNS are working very hard on improving the diagnosis, the treatment access, and it is improving incrementally, and then we're going to have a lot more patients to treat.
In fact, the pharma industry is increasing supply significantly year over year due to increased demand. Which is relating back to what Amy was pointing out, better diagnostic criteria, aging patient population. So all of that is growing. In fact, this IG industry was projected by Forbes to grow over 40% in the next decade.
And so we then need, imagine this just in all of this the, just the sheer [00:41:00] scale of this very specialized therapy space. Growing that much that quickly. Our standardization of this therapy, of our practice, of our clinical care needs to go way up. We need to really address it, both on a granular level, but on a very, on a large scale as well.
So from the ground up, top down, every approach. If we're gonnagrow 40 to 50%. We need to address the challenges we have now when we have ahuge under-diagnosis and really are still growing into standardizing this fieldas a whole. So that really, if something keeps me up at night, it's this.
And at the same time I wanna end at a positive note. We have a very [00:42:00] cohesive,a very strong industry in the IG therapy space, and I know we all want the samething is for our patients who are on this life-saving therapy lifelong, to havethe best experience at every infusion and to have the best outcomes, and tohave the best quality of life they can and to really thrive.
To thrive despite theirchallenges and despite their diagnosis. And certainly IgNS has committedto continuing our work and we will do long term. And I know that we have thesupport and the backing of this industry as well.
Kip Theno: Uh, Amyand Luba, I just first. So grateful to have you both on the program, but even more importantly for the work that you were doing and that you've outlined today.
And before I get to the very quick Easter egg question, you said it Luba, we gotta get a whole lot better, right? Quote unquote. So in that, with that spirit in mind, what is the best contact for you and [00:43:00] Amy and IgNS so that we can get the word out as soon as this show goes live?
Amy Clarke: Um,info@ig-ns.org.
Luba Sobolevsky:Right. And ig-ns.org is our website and all information is on there. And yeah,we look forward to. Having more of these conversations.
Kip Theno: Well, wewill definitely have you back. We're gonna keep a watchful eye and get this outto the masses for the Road to Care podcast. And listen, we're serious businessof healthcare.
I get that. But at the beginning, I said "Doctor, doctor,doctor". I said, name that movie and we gotta have a little fun now at theend. The reason I did that is this is the first show in all of our episodeswhere I've had two doctors on and I had to do it just to see. So can do eitherone of, you know, the movie reference or not.
Amy Clarke: I should,because my husband says it all the time, and he's at the dentist right now, soI can't answer the [00:44:00] question.
Kip Theno: I like himalready. Well, the movie, the movie of course is, is Spies Like Us, one of thegreats of Chevy Chase, Dan Aykroyd.
Luba Sobolevsky: SoI'm great. I love it.
Kip Theno: That isone of the best scenes anyway.
Listen back to the serious note. Amy Luba, doctors, thank you so much for your time today on the Road to Care podcast. We can't wait to get this episode out, and we look forward to hearing from you again. Thank you so much.
Luba Sobolevsky: Thank you for having us on. It was a pleasure.
Kip Theno: Thank you for joining the Road to Care podcast, hosted by SamaCare, the leader in prior authorization technology and services, where through a script to therapy operating system, we enable connectivity with clinics, payers, and manufacturers focused on optimizing patient care. Tune in next time as together we can make things right.
Enjoy the music written, produced, and recorded by [00:45:00] Jamestown.
Podcast produced by JFACTOR, visit https://www.jfactor.com/
Together, we can make healthcare right. Here are some of the outstanding healthcare organizations and associations championing patient health mentioned in this episode:
Standardizing IG Therapy with Dr. Luba Sobolevsky & Dr.Amy Clarke
Kip Theno: [00:00:00] Welcome to the Road to Care podcast hostedby SamaCare, where we'll talk with key opinion leaders, physicians,administrators, manufacturers, venture capitalists, and legislators to gettheir insights on the state of healthcare today. And where we see it evolving.SamaCare's prior authorization platform is free to clinics, ensuring patientsget on the right therapy at the right time.
Together we can simply make things right.
Kip Theno: Welcome back everybody to the Road to Care podcast hosted by SamaCare. And today our special guests are Luba Sobolevsky and Amy Clarke, who are doing fantastic workin the complex world of IG therapy. Dr. Luba Sobolevsky is the president and CEO of the Immunoglobulins National Society, IgNS. The central healthcare organization in the field of IG therapy and biologics.
In her executive role, Dr. Sobolevsky oversees the advancementof clinical standards, resources, education, certification, accreditation,patient advocacy, and strategic [00:01:00]alliances. She holds a PharmD degree from the University of SouthernCalifornia, and a BA from the University of California in Los Angeles. Dr.Sobolevsky's career spans diverse leadership roles across healthcare, including clinical practice, education, and the pharmaceutical industry.
She has been actively engaged in research and publication in areas such as optimizing immunoglobulin practice and patient experience, health equity, healthcare team competencies, and the improvement of screening and diagnosis of rare diseases. Amy DNP, RN, IgCN®. Dr. Clarke is the ChiefClinical Officer of the Immunoglobulins National Society.
Again, IgNS. She brings more than 30 years of nursing and clinical operations expertise and is a nationally recognized leader in the immunoglobulin therapy. Dr. Clarke has been actively involved with IgNS for over 14 years. Serving as an executive advisor and past president. Most recently, Dr. Clarke served as vice president of clinical nursing practice at Optum [00:02:00] Infusion Pharmacy, a subsidiary of UnitedHealth Group.
She has held leadership roles across specialty home infusionorganizations and has co-authored multiple publications on best practices andIG therapy. As a national expert in specialty biologics and clinical practice,Dr. Clarke has presented at numerous national and international conferences.
Well, doctors, thank you so much for joining the Road to Care podcast, and I was gonna do the doctor, doctor and say, name that movie, but I, maybe some folks won't get, but
we're super pleased to have you here, you know, in our, in our pre-show conversations. This was this is a complex in IG therapy, part of medicine that I really was not aware of.
And so looking forward to, to hearing about the history and the future state of what you all are doing and the great work that you're doing.And I think we'll just start where we usually do career journey and founding genesis of IgNS. And we'll start at the beginning and love to hear your journeys and journeys into medicine and Luba,
what, what drew you to, to immunology and biologics?
Luba Sobolevsky: Thanks Kip and it's great to be here with you today. Well [00:03:00] it started really with my interest in education of clinicians for a long time, way before I got my PharmD. It was a different career, but yeah interested in educating clinicians, developing different educational offerings programs, and really realizing.
The rigor and the continuity of training that lifelong clinicians, like physicians, nurses, pharmacists, really need that. It doesn't end with your degree and your residency or fellowship and the need to advance skills and education. Staying up to date really was very evident to me early, early in my career.
And even during pharmacy school, I worked in a medicaleducation field and traveled and took all my finals early, and my professorsdidn't love that, but I really understood my path and my passion very early onbefore I even knew what I would do with that. And so [00:04:00]I, after my PharmD, I did a postdoc fellowship in the pharma industry.
I had some clinical experience as well, and that all led me tothis point. But while in pharma, I really understood that as an industry wewere focused on investing into physician driven initiatives, investigatorinitiated trials, continuing medical education, supporting differentfellowships, all prescriber focused.
But when we are talking about IG therapy, which we'll talk alot about, I'm sure today. In such a complex field, the disproportionate burdenof disease and really therapy management falls on the shoulders of the entireclinical team, and more specifically the nurse, pharmacist and physician kindof triangle.
And so it's impossible to silo out a single type of healthcareprofessional. It is also really bad practice [00:05:00]to really pull the resources into one type of clinician and not the others. Andso the idea, that this field of highly complex immune mediated disorders thatIG therapy is, and a life-saving therapy that is lifelong as well, needs to bestandardized.
And we need to develop an entire system of education andtraining and standards that began to crystallize. And that's led me to startingIgNS decade and a half ago.
Kip Theno: That's agreat story by, by the way, doctor, teachers, like you said, they don't likewhen you beat the curriculum, so congratulations on that.
You showed them. But, and, and then of course, I mean, we willget to, to the fusion of both of you and IgNS and what, what you all are doingover there. But Amy, you know, nursing, clinical leadership into IG therapy.Let's hear your.
Amy Clarke: Well, Iwas in infusion therapy. I was treating [00:06:00]bone marrow and stem cell transplant patients where IG is central to thatpopulation as their white counts recover.
And I really fell in love with IG therapy. Then, of course, it was only intravenous at the time. And as my practice broadened and I began to see patients with other conditions like multiple sclerosis, I began to clue in on how the patient felt during their infusion, not just how it was helping, why they, why they were getting IG therapy, but what they were telling me or what they were telling the pharmacy team about how they felt.
And there was very little evidence, of educational offerings back then. You could read a very.Small print prescribing information or package insert, and that was all you had. That was what you were left with. But I read as much as I possibly could wherever I could find it. Of course, you couldn't easily go and find journal articles online back then.
Even less about subcutaneous ig and I was privileged to be able to fly around the country [00:07:00] teaching doctors and other nurses and patients and pharmacists.
About this therapy as I learned as the manufacturers learned about these novel therapies. And I just immersed myself in anything I could find. So it was complete serendipity when I met Luba in 2011 and I knew already at that point that I had really leaned into educating. Clinicians and patients, so that that journey, patients receiving therapy for life, was one that patients wanted to continue versus abandon, which we see so often in so many therapies.
And it just clicked. And I've, I really excited that I was ableto do that. My doctoral project was around patient outcomes related to howclinicians interact with IG and I'm really glad to be here.
Kip Theno: Well, thank, thank you, doctor, and, I'm starting to pick up the breadcrumbs of howIgNS got started, but I would love, I think, and we can maybe take this [00:08:00] two ways, starting IgNS, what was that impetus that, that made that happen for you all?
And then maybe take that into the next level of the mission, but then also what you're finding are the barriers that you're trying to solve with the organization.
Luba Sobolevsky: Yeah, I think that really, it's kind of the confluence right of multiple things, but it started early in my career as I was mentioning, kind of realizing the investment as an industry into education and the expectations that we had of nurses and pharmacists to deliver and to have certain level of competencies, while not really putting in place any of those resources for them. That was all always problematic to me, and it never really made sense.
And then meeting national experts like Amy, and we've [00:09:00] never been apart since 2011. Really understanding that from my standpoint from the manufacturer's standpoint, from the clinician standpoint, from the provider standpoint, all of this was coming together and starting to build a clear picture.
That we were as a field in this most complex area of practice,IG therapy, right, disease modifying, plasma derived biologic, treating patients who have the most complex immune mediated disorders and often multiple disorders. We had a clear and significant lack of standards of practice. So we had diagnostic criteria always, right?
We knew what dose to prescribe, but beyond that, there was absolutely nothing to standardize care what happens to the patients before, during, after, in between infusions, we had absolutely nothing in terms of a [00:10:00]comprehensive or systematic educational system for IG therapy, we couldn't train clinicians in a systematic way.
In a standardized way. There was nothing available. And so wehave the most complex therapy, the most complex patients, and yet as anindustry we have absolutely no resources for clinicians responsible for patientsafety, for treatment efficacy, for adherence, and for good patient outcomes.And so as this began to really take shape, the idea of that this is a hugeissue, a huge lack in our industry.
We did, at IgNS, what we always do at the beginning is do our research. So we did a benchmark survey and we pulled around 400 nurses and pharmacists, and had a variety of questions, but mainly our point was to understand how every clinician who we're talking to, how these [00:11:00] clinicians are trained, onboarded, how their continuing education occurs, what are the resources that are in their hands when they're being sent to treat patients with IG .And to our, dismay, but not surprisingly, the results showed in over 95% of cases. I remember this, like we did this yesterday, this is 15years ago now, that over 95% of clinicians, excuse me, pharmacists and nurses reported that in fact they did receive education and training. But when we asked them. How, what their training, what it consists of.
The answers were shadow another clinician and read the package insert. So our industry was in such a state of lack and and critical gaps that the clinicians accepted that reading [00:12:00] the package insert from the manufacturers and following another clinician, who no one trained by the way inIG therapy,
was an appropriate onboarding exercise was an appropriate typeof training, competency development, and there was absolutely nothing in place for continual continuous education of clinicians. Meaning when they had to get their CEs to maintain their licensure, they were able to do. Those programs in absolutely any clinical field like hypertension or diabetes that have nothing to do with IG therapy, and that gave us the blueprint for what to do next.
We took that survey report and we went to work. The first thing we did was develop the standards of practice and the standards of practice are.They're intimately tied to clinical medical [00:13:00]standards, any pharmacy and infusion nursing standards that were in place, but nothing was in place specific to IG therapy practice.
And so with the between coordinating the levels of evidence for every single standard and guideline, we also had to develop a robust consensus on. The guidelines and standards that had no published literature, evidence, or anything. It was all clinical practice. So we really got together a stellar team of experts, immunologists, neurologists, rheumatologists, nurses, pharmacists who've been in practice for a long time, and really spent about 18months developing the first ever standard.
As a result, we have the only legally defensible standard of practice in IG therapy that's been. Updated and brought to obviously the current state, incorporating all the research, all the new [00:14:00] indications, all the changes in the field, and we do that on an annual basis. We then developed a robust educational program, including conferences and our online webinar programs.
Certification came next, right? Certification. Our IG certified nurse, IG Certified Pharmacist Credential, IGCN and IGCP is a formal credential and it was necessary to develop it because it's a metric of competency, which we didn't have before, right? If we have the standards, we have the education, now we need a metric.
We need a metric of compliance with the standards. We need a method of understanding the level of education and training these clinicians have, and they now were able to show, to demonstrate, and validate their competency specifically in IG therapy. Most importantly, the certification [00:15:00] established IG therapy as a clinical specialty that now requires a particular
type of specialized education, training, attainment of competencies, utilization of the standards, continuous education. And we also have a full suite of resources for clinicians and for providers as well, of course. Another really important arm of IgNS I just want to touch on is our IgNS Patient 360, which is a patient-focused arm of our association that focuses on patient outcomes research, and we work with a variety of providers.
On this, our advocacy education and support for patients receiving IG therapy lifelong. And we have really been successful in getting that off the ground about eight years ago. So it's something we feel so strongly about, and this is all of our "why".When you ask why [00:16:00] we keep doing what we're doing, this is our why, is because we are touching
patients understanding their issues, understanding intimately well the lack of various resources, lack of education, training, whatever it may be that they're experiencing as a patient, that gives us a roadmap to incorporate new educational programs for clinicians to address those continuous gaps.
And also at the same time, develop patient-focused resources,patient-focused education to empower our patients and ensure that our patientsare partners in this decision making process along their journey with IGtherapy. So that's how all of that kind of came together over the last 15years.
Kip Theno: Well, and let's be honest, I mean, you all are moving mountains and I got it so quick and[00:17:00] clear the passion you lasered in on the lack and the lags of the education and knowledge gaps that you're trying to solve, that were pretty massive. And so Amy, I'm gonna ask you, I'm gonna maybe flip the script here a little bit, that. That's, there's that part of it. And then the space is evolving so rapidly with all the new biologics, all the new novel therapies.
Now, with everything you just said, look, first of all, thank you for doing that for those patients and what you're doing. I'm not an IG patient, but I'm a patient and it's more than concerning to know that in that segment there was so many gaps in you're solving those, but now you've got this whole breed of new biologics and novel therapies coming out and emerging, and I know you wanna speak to some of those, but also, doesn't that will that also create new knowledge gaps that you all are gonna solve too? And Amy, maybe you can take that one.
Amy Clarke:Absolutely. This pipeline, I mean, it's been a bullet train over the past several years, and as these emerging therapies and novel therapies come out, like FCRN inhibitors and the growth in complement [00:18:00] inhibitors and ways that we administer IG therapy, there's now facilitation with human recombinant hyaluronidase that creates.
More knowledge necessary in order to effectively select the product , evaluate the patient for risk, administer the therapy, mitigate any adverse reactions that occur at bedside.Having those clinicians have the wherewithal to know that they need to distinguish each of these unique therapies based on the individual risks they're watching for.
Not to mention the sheer number of diagnoses that IG therapy is used for. We're now starting to see that in the monoclonal antibodies and the other biologics. That are coming out. So absolutely there is that knowledge gap. And when you couple that with the high variability in sight of care and how we nail down education in each of those [00:19:00] sites, home is very different.
Than how we would approach it for ambulatory infusion centersor in the hospitals. Because you could have an ambulatory infusion center thatis doing acute care like antibiotics and 50 other biologics. How do we makethat education accessible to those clinicians as well as ensuring that thepatients can be can advocate for themselves and are knowledgeable so that theycan be an active participant in the care being provided.
But all that being said adding all of these therapies for thediagnoses that, that we're seeing them added to inflammatory neuromusculardisorders other types of autoimmune disorders is an amazing advancement in thisspace because we need to have more targeted care.
We need to identify what we're going to do with the plasma. Thepotential impact to plasma supply that's coming along, and we can talk aboutthat as well where [00:20:00] we see this spacegoing.
Kip Theno: Thank you,doctor. And I want to go back to the standardization piece, right? It's amazingto me that modeling out standardizations that it's not. Kinda unilateral acrossthe board in medicine, and I get it, but how are you tackling thatstandardization specifically with all these different sites of care?
How are you helping them? And then what about the patients?Where is the education coming from when it goes to the patient's journey?
Amy Clarke: Sostandardization of any kind involves taking the algorithm that you're givenand. Embedding it into your organizational needs. Standards aren't they don'tgo into the million because we need organizations to look at their local andaccreditation requirements, state boards, all of those pieces, [00:21:00] but take those standards, embed them intopolicy, and then educate organizationally.
That is where you begin to tackle standardization. One of thethings I've always seen as a risk from implementation of standards or any newknowledge is the existing institutional knowledge, which can become a realbarrier to accepting that science changes what we know about medicine and howit's administered changes.
So we are working with other organizations like the National Infusion Center Association,to support their standards. We work with other organizations such as the Infusion Nurses Society, um, to makesure that where our spaces touch one another that we have that collaboration.
Luba Sobolevsky:Yeah, and I think that's a really critical piece that has worked so well forIgNS because we are really vertically [00:22:00]focused, right?
So what's really served us very well in terms of how we connectto the industry and how we work with other associations and why is that we areorganized vertically.
We focus on a therapy right on IG therapy space, which is verydifferent. Most other institutions practices, trade associations are focused ona trade. Medical, pharmacy, nursing, or even site of care, home infusion,infusion center and so forth. And because we are vertical, focusing on IGtherapy and we're the central standard setting association in IG therapy, wehave really forged strong alliances and collaborations across the board fromthe clinical institutional perspective and also from the associationperspective where we are the provider of education, of specialized training, ofspecialized, resources and [00:23:00]certification in IG therapy. And so these collaborations, as Amy was pointingout, have been really significant in delivering not only the resources standardcertification, but the rationale the education of the field about why this isneeded, why IG therapy is a clinical specialty, why this is so needed, andreally essential to patient safety, to patient, to treatment efficacy.
So that's been something that we're very proud of at IgNS. Justthe sheer number of these collaborative streams. It's not easy to come in 15years ago into a therapy area that has been running along, running on fumes.But running, right? And just treating patients and not having education, andthere were lots of gaps and huge amount of strain on the clinician side and onthe provider side, but that's what they had to [00:24:00]do.
And for us to come in and change it, change the conversation, provide the standards, but really make the case that certification is critically needed to ascertain. Competency, right? That education is critically needed in the field that you're practicing in order to provide the safest level of care in IG therapy.
So that's been a huge priority for us, and I think we've been very successful.
Kip Theno: Well, no, you have, and I mean you're IgNS is known for, from inception, literally creating those standards and certifications. And I think I'd love to hear how are you tying all this in? Because when you think about that, you've got the role of the clinician, evidence-based literature reviews, consensus of experts, psychometrics, evaluations, validation and updating, and then the impact.
So that's kind of a lot. That's a mouthful. But when you take all of that, how is your organization tackling all that? And then using all the resources and partnerships at your disposal [00:25:00]to make sure that gets out into the light.
Luba Sobolevsky: There are two really major ways we do that and Amy jump in to, from your perspective.
One is interdisciplinaryor interdisciplinary approach. The other is transparency. What I mean is thatfrom the beginning we were an interdisciplinary focused organization. All theeducation we have developed. To date is really, targeting three differentpreviously siloed healthcare professional types, physicians, nurses,pharmacists.
We've never, aside from the certification where you do need toassess specific nursing and pharmacy skills, we have never developed programswith one particular. HCP type in mind because that doesn't work in [00:26:00] practice. And there is so much literatureand research now to point out that education standards, resources, those needto be developed with the actual, the reality of practice in mind.
So if a nurse and a pharmacist work together 90% of the time, and there's that back and forth with documentation and patient assessments, and there is a stream of communication going between the nursing and pharmacy teams and then to the providers, to the physician, then education needs to incorporate that approach, otherwise it doesn't work.
And so that's what we've done on the one hand. So our approach to all of the information out of igNS is that we look at it exactly as it will be utilized by audience by the end user, if you will. Second is transparency.We share the results of our benchmarking surveys. We share our very [00:27:00] prolific patient outcomes research with the industry.
That includes manufacturers. That includes. Specialty infusion and infusion centers, providers, that includes physicians and physician groups and multi-specialty clinics. We publish all these, these data that point to our successes, obviously improvements in the field, but also to our failures, our gaps, and our areas that need a lot more attention and focus.
And we work very closely with the industry members who work.Hard to ensure that we have products with which to treat patients. We have developed industry based resourcesand ED education and seminars. We have a very strong. Business forum program atour conference, for example, where we have members of the manufacturing,whether it's device or product [00:28:00]leadership teams, and brandteams sit side by side with the leadership teams of specialty infusion andinfusion center companies, and it's astounding to learn how little they knowabout each other's business.
On a more detailed level, not just the high level that we all think we know, and that is very powerful. We share our patient data, we share our clinical outcomes data, and we have these robust programs where we bring to light the most important things impacting our patients, and we get to work in trying to figure out how to make their lives easier, how to get better access to treatment, what we need to change in terms of
clinical practice, and it's really that straightforward. We really listen to our field and we share information, and we are very multidisciplinary in terms of the [00:29:00]approach to everything we do. Anything to add, Amy?
Amy Clarke: I mean, I would just add that the patient is the fourth pillar, in that group because the patient voice, when you consider shared decision making, ensuring that those clinicians know how to.
Effectively educate the patient on what their options are and how the patient should , provide feedback on their journey is incredibly important. And we build that into the education that we provide. So not only do we stress the interdisciplinary component of it, but we stress how important shared decision making.
And then if you take the data that we're gathering from our patient surveys, that helps inform where we see additional gaps in education.Not just the feedback we're getting from clinicians, but from patients as well, which is where standards are reviewed and updated, where the educational approach that we have is also geared to address.
How the patient perceives their [00:30:00]care being provided to them, and this journey that they're on for life.
Kip Theno: And that's, that's amazing because I want to zoom the lens out a bit to maybe a broader map of the world for stakeholder engagement. You mentioned some of them doctors, patient access stakeholders, manufacturers, pharmaceutical companies, payers, legislators, what.
What has been the response from them and is it moving fast enough? I mean, are they helping, are they chomping at the bit to kind of solve this, or is it still kind of a glacial pace, especially on the legislation side?
Luba Sobolevsky: In my experience in the IG manufacturer world, these companies, it takes them nine to 12 months to go from a vial of plasma to a vial of product. So they're [00:31:00]invested into the patient journey and to the patient success.
And so they have been extremely supportive, extremely forthcoming with sharing their knowledge and their observations, as well as in their desire to learn from IgNS and really understand, what the issues, key issues impacting patients are they really truly have this patient commitment and it's incredible to be part of that, to be in the industry where the patient is truly number one. So from that standpoint, there's a lot of support.
Luba Sobolevsky: And on the provider side, I think that we've had a lot of interest, a lot of alignment. There are organizations who have [00:32:00]been those early adopters, right from the very, very beginning when the first standards were just released, the first certification programs were just launched.
It's been incredible to witness such a high number of providers who started coming to IgNS when we had, you know, 120 people in the audience who witnessed our growth to now having these huge conferences and thousands of members, but also their businesses have grown and flourished from a single pharmacy to a multinational mid-size enterprise now, and this happens so often.
And of course there are challenges. There are a lot of challenges with like with any field in investment into. Your clinicians investing into training, education, competency, because again, it's only been [00:33:00] if you think about it, we've been around for so long, but not really. If you think of other healthcare trade organizations, it's 15 years is not such a long time and for decades and decades we had no standards, we had no certifications. So certainly we still have organizations that are trying to get by without fully investing into elevating their standards and elevating the care and elevating the practice.But we are working through those challenges and we certainly are able to.
Provide and support any organization and any provider or individual clinician, even with a full suite of resources they need to improve practice. Amy, anything from your perspective?
Amy Clarke: I was just thinking more from my perspective on, we talked previously, I [00:34:00] think about asking our clinicians to do more with less. And organizations that invest in standardizing their practice according to the evidence that is out there and elevating their clinicians by supporting advanced certifications and their education are able to distinguish themselves from other organizations. And in part that's due to patient feedback, prescriber feedback, but from the outcomes data that they collect and that information coming from those providers is also going to the manufacturers and going to payers so that they can see, where benchmarks, are
Luba Sobolevsky: being laid. And, and that's a great pointactually, Amy.
Luba Sobolevsky: In fact, in the past five years I've beenmore in more meetings with the manufacturers that I can count where they'veasked IG and S to create a metric by which they can measure.
A provider's [00:35:00] expertisein IG therapy as a whole, they're really keen on making sure that the end pointwhere the drug ends up wherever it is, whether it's an infusion center or it'sa specialty pharmacy or infusion company that. At the end of the day, theclinician who infuses the IG therapy that they spent years in development andyears in production, year over year. Every single vial that takes a year toproduce, that ends up in the most capable hands of educated, certifiedclinicians. And that metric is something we are working on right now. Weare developing a distinction program in IG therapy with a CHC, so that'lllaunch in January of 2026. You heard it here first.
But it'll be a true [00:36:00]metric that a provider can use to differentiate themselves on the businessside. 'Cause that's really the only differentiator that counts is the expertisethey have with IG therapy and how they ensure safety, efficacy, adherence, andthe best infusion experience and best patient outcomes.
And so that is coming and that's something we're very excitedabout. We need to shift the burden of education, training, resources,competency from being on the shoulders of the individual clinicians to theproviders. And that shift is happening and there has been more interest in thisprogram than anything that we've ever done to date.
So we know. Back to your original think Very good question,Kip. What's the uptake [00:37:00] like? How'sthe industry responding? We can see how the industry is responding in theinterest that we now have in this accreditation distinction program. So that'svery encouraging to me. It's a great pulse check on what's going on.
Kip Theno: Yeah. Andby the way, you know, status quo equals inertia and that's not a good thing.And you guys are creating that momentum shift. I love to hear that.
Kip Theno: So in thefinal minutes we have here on the show, doctors next five to 10 years, IGtherapy, biggest challenges, big greatest opportunities for you all and forthis market and the patients.
Amy Clarke: For me, it's three parts. It's a rapidly aging workforce. So as we educate clinicians who then become mentors for the less experienced clinicians coming through, they are aging out and moving toward retirement, at a fast [00:38:00] pace.
And at that same fast pace, more than 4 million baby boomers have turned 65 each year for the past several years and will continue to do so until 2030. And you take an older patient, you have secondary immunodeficiencies and hematological malignancies, transplant needs, all of these things were igs used. So we will need more plasma donations in order to solve for X. When we look at the amount of IG that is going to be necessary to service this patient population, along with the clinicians needed to administer the therapy.
So again, going back tothe novel therapies, that's why I'm so excited about what pipeline looks like because there is a need to solve for targeted therapies so that IG can be usedwhere there are no options.
Luba Sobolevsky: Yeah. And then I totally agree with that. And to add to this, there are kind of two things that concern [00:39:00] me in addition to what Amy was pointing out.
One is that we still have a huge diagnostic delay in these rare diseases that IG therapy treats. In some cases it takes, in some disease states, like primary immune deficiency, it takes 10 to 17 years, and that's been corroborated by every organization that's done research, including IgNS, 10 to 17 years to get a diagnosis.
And this has a lot to do with how fragmented our healthcare system is. Patients are being seen in urgent care, emergency rooms, and even their primary care physicians. And none of these entities coordinate, collaborate, or even talk to each other. And so in certain disease states there's a 70 to 90% under diagnosis.
So we need to get a whole lot better in restructuring our healthcare system [00:40:00] to allow for this coordination of care or else our rare disease patients will continue to suffer for decades on end. So that's a huge issue. And then if we. Correct this and all of the associations including IgNS are working very hard on improving the diagnosis, the treatment access, and it is improving incrementally, and then we're going to have a lot more patients to treat.
In fact, the pharma industry is increasing supply significantly year over year due to increased demand. Which is relating back to what Amy was pointing out, better diagnostic criteria, aging patient population. So all of that is growing. In fact, this IG industry was projected by Forbes to grow over 40% in the next decade.
And so we then need, imagine this just in all of this the, just the sheer [00:41:00] scale of this very specialized therapy space. Growing that much that quickly. Our standardization of this therapy, of our practice, of our clinical care needs to go way up. We need to really address it, both on a granular level, but on a very, on a large scale as well.
So from the ground up, top down, every approach. If we're gonnagrow 40 to 50%. We need to address the challenges we have now when we have ahuge under-diagnosis and really are still growing into standardizing this fieldas a whole. So that really, if something keeps me up at night, it's this.
And at the same time I wanna end at a positive note. We have a very [00:42:00] cohesive,a very strong industry in the IG therapy space, and I know we all want the samething is for our patients who are on this life-saving therapy lifelong, to havethe best experience at every infusion and to have the best outcomes, and tohave the best quality of life they can and to really thrive.
To thrive despite theirchallenges and despite their diagnosis. And certainly IgNS has committedto continuing our work and we will do long term. And I know that we have thesupport and the backing of this industry as well.
Kip Theno: Uh, Amyand Luba, I just first. So grateful to have you both on the program, but even more importantly for the work that you were doing and that you've outlined today.
And before I get to the very quick Easter egg question, you said it Luba, we gotta get a whole lot better, right? Quote unquote. So in that, with that spirit in mind, what is the best contact for you and [00:43:00] Amy and IgNS so that we can get the word out as soon as this show goes live?
Amy Clarke: Um,info@ig-ns.org.
Luba Sobolevsky:Right. And ig-ns.org is our website and all information is on there. And yeah,we look forward to. Having more of these conversations.
Kip Theno: Well, wewill definitely have you back. We're gonna keep a watchful eye and get this outto the masses for the Road to Care podcast. And listen, we're serious businessof healthcare.
I get that. But at the beginning, I said "Doctor, doctor,doctor". I said, name that movie and we gotta have a little fun now at theend. The reason I did that is this is the first show in all of our episodeswhere I've had two doctors on and I had to do it just to see. So can do eitherone of, you know, the movie reference or not.
Amy Clarke: I should,because my husband says it all the time, and he's at the dentist right now, soI can't answer the [00:44:00] question.
Kip Theno: I like himalready. Well, the movie, the movie of course is, is Spies Like Us, one of thegreats of Chevy Chase, Dan Aykroyd.
Luba Sobolevsky: SoI'm great. I love it.
Kip Theno: That isone of the best scenes anyway.
Listen back to the serious note. Amy Luba, doctors, thank you so much for your time today on the Road to Care podcast. We can't wait to get this episode out, and we look forward to hearing from you again. Thank you so much.
Luba Sobolevsky: Thank you for having us on. It was a pleasure.
Kip Theno: Thank you for joining the Road to Care podcast, hosted by SamaCare, the leader in prior authorization technology and services, where through a script to therapy operating system, we enable connectivity with clinics, payers, and manufacturers focused on optimizing patient care. Tune in next time as together we can make things right.
Enjoy the music written, produced, and recorded by [00:45:00] Jamestown.
Podcast produced by JFACTOR, visit https://www.jfactor.com/
Together, we can make healthcare right. Here are some of the outstanding healthcare organizations and associations championing patient health mentioned in this episode:
