Podcasts about biologics

In this episode of Let's Combinate: Drugs + Devices host Subhi Saadeh welcomes back Andy Robertson, founder of CQE Academy. Andy shares his transformative journey involving CQE certification and how it boosted his confidence and expertise in quality engineering. They explore the practical applications of Design of Experiments (DOE), including a real-life example where Andy applied DOE concepts at work. Andy also discusses the value of various ASQ certifications, including CQE, CQA, CQM/OE and Six Sigma Green Belt, emphasizing their importance for career growth. The conversation extends to non-ASQ certifications such as PMP, highlighting their relevance for leadership roles. By comparing practices from various industries, including automotive and medical devices, they underscore the importance of cross-industry learning. Andy concludes by inviting listeners to join his courses to further their own professional development.00:00 Welcome and Introduction00:48 The Impact of CQE Certification02:23 Applying DOE in Quality Engineering05:42 Top ASQ Certifications13:35 Non-ASQ Certifications and Leadership15:55 Cross-Industry Learnings18:45 Conclusion and Contact InformationAndy Robertson is the founder of CQE Academy and a leading educator in the quality profession. With a background in medical devices and years of hands-on experience as a quality engineer, he built a global audience through his practical, passionate approach to teaching CQE, Green Belt, and quality systems fundamentals. Andy's work centers on helping professionals gain confidence, accelerate their careers, and master the core tools of quality through clear, accessible education.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Sciences Advisory Council, interview Evan S. Dellon, MD, and Elizabeth T. Jensen, PhD, about a paper they published on predictors of patients receiving no medication for treatment of eosinophilic esophagitis. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:52] Co-host Ryan Piansky introduces the episode, brought to you thanks to the support of Education Partners GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:14] Holly introduces today's topic, predictors of not using medication for EoE, and today's guests, Dr. Evan Dellon and Dr. Elizabeth Jensen.   [1:29] Dr. Dellon is an Adjunct Professor of Epidemiology at the University of North Carolina School of Medicine in Chapel Hill. He is also the Director of the UNC Center for Esophageal Diseases and Swallowing.   [1:42] Dr. Dellon's main research interest is in the epidemiology, pathogenesis, diagnosis, treatment, and outcomes of eosinophilic esophagitis (EoE) and eosinophilic GI diseases (EGIDs).   [1:55] Dr. Jensen is a Professor of Epidemiology with a specific expertise in reproductive, perinatal, and pediatric epidemiology. She has appointments at both Wake Forest University School of Medicine and the University of North Carolina at Chapel Hill.   [2:07] Her research primarily focuses on etiologic factors in the development of pediatric immune-mediated chronic diseases, including understanding factors contributing to disparities in health outcomes.   [2:19] Both Dr. Dellon and Dr. Jensen also serve on the Steering Committee for EGID Partners Registry.   [2:24] Ryan thanks Dr. Dellon and Dr. Jensen for joining the podcast today.   [2:29] Dr. Dellon was the first guest on this podcast. It is wonderful to have him back for the 50th episode! Dr. Dellon is one of Ryan's GI specialists. Ryan recently went to North Carolina to get a scope with him.   [3:03] Dr. Dellon is an adult gastroenterologist at the University of North Carolina at Chapel Hill. He directs the Center for Esophageal Diseases and Swallowing. Clinically and research-wise, he is focused on EoE and other eosinophilic GI diseases.   [3:19] His research interests span the entire field, from epidemiology, diagnosis, biomarkers, risk factors, outcomes, and a lot of work, more recently, on treatments.   [3:33] Dr. Jensen has been on the podcast before, on Episode 27. Holly invites Dr. Jensen to tell the listeners more about herself and her work with eosinophilic diseases.   [3:46] Dr. Jensen has been working on eosinophilic gastrointestinal diseases for about 15 years. She started some of the early work around understanding possible risk factors for the development of disease.   [4:04] She has gone on to support lots of other research projects, including some with Dr. Dellon, where they're looking at gene-environment interactions in relation to developing EoE.   [4:15] She is also looking at reproductive factors as they relate to EoE, disparities in diagnosis, and more. It's been an exciting research trajectory, starting with what we knew very little about and building to an increasing understanding of why EoE develops.   [5:00] Dr. Dellon explains that EoE stands for eosinophilic esophagitis, a chronic allergic condition of the esophagus.   [5:08] You can think of EoE as asthma of the esophagus or eczema of the esophagus, although in general, people don't grow out of EoE, like they might grow out of eczema or asthma. When people have EoE, it is a long-term condition.   [5:24] Eosinophils are a type of white blood cell, specializing in allergy responses. Normally, they are not in the esophagus. When we see them there, we worry about an allergic process. When that happens, that's EoE.   [5:40] Over time, the inflammation seen in EoE and other allergic cell activity causes swelling and irritation in the esophagus. Early on, this often leads to a range of upper GI symptoms — including poor growth or failure to thrive in young children, abdominal pain, nausea, and symptoms that can mimic reflux.   [5:58] In older kids, symptoms are more about trouble swallowing. That's because the swelling that happens initially, over time, may turn into scar tissue. So the esophagus can narrow and cause swallowing symptoms like food impaction.   [6:16] Ryan speaks of living with EoE for decades and trying the full range of treatment options: food elimination, PPIs, steroids, and, more recently, biologics.   [6:36] Dr. Dellon says Ryan's history is a good overview of how EoE is treated. There are two general approaches to treating the underlying condition: using medicines and/or eliminating foods that we think may trigger EoE from the diet.   [6:57] For a lot of people, EoE is a food-triggered allergic condition.   [7:01] The other thing that has to happen in parallel is surveying for scar tissue in the esophagus. If that's present and people have trouble swallowing, sometimes stretching the esophagus is needed through esophageal dilation.   [7:14] There are three categories of medicines used for treatment. Proton pump inhibitors are reflux meds, but they also have an anti-allergy effect in the esophagus.   [7:29] Topical steroids are used to coat the esophagus and produce an anti-inflammatory effect. The FDA has approved a budesonide oral suspension for that.   [7:39] Biologics, which are generally systemic medications, often injectable, can target different allergic factors. Dupilumab is approved now, and there are other biologics that are being researched as potential treatments.   [7:51] Even though EoE is considered an allergic condition, we don't have a test to tell people what they are allergic to. If it's a food allergy, we do an empiric elimination diet because allergy tests aren't accurate enough to tell us what the EoE triggers are.   [8:10] People will eliminate foods that we know are the most common triggers, like milk protein, dairy, wheat, egg, soy, and other top allergens. You can create a diet like that and then have a response to the diet elimination.   [8:31] Dr. Jensen and Dr. Dellon recently published an abstract in the American Journal of Gastroenterology about people with EoE who are not taking any medicine for it. Dr. Jensen calls it a real-world data study, leveraging electronic health record patient data.   [8:51] It gives you an impression of what is actually happening, in terms of treatments for patients, as opposed to a randomized control trial, which is a fairly selected patient population. This is everybody who has been diagnosed, and then what happens with them.   [9:10] Because of that, it gives you a wide spectrum of patients. Some patients are going to be relatively asymptomatic. It may be that we arrived at their diagnosis while working them up for other potential diagnoses.   [9:28] Other patients are going to have rather significant impacts from the disease. We wanted to get an idea of what is actually happening out there with the full breadth of the patient population that is getting diagnosed with EoE.   [9:45] Dr. Jensen was not surprised to learn that there are patients who had no pharmacologic treatment.   [9:58] Some patients are relatively asymptomatic, and others are not interested in pursuing medications initially or are early in their disease process and still exploring dietary treatment options.   [10:28] Holly sees patients from infancy to geriatrics, and if they're not having symptoms, they wonder why bother treating it.   [10:42] Dr. Jensen says it's a point of debate on the implications of somebody who has the disease and goes untreated. What does that look like long-term? Are they going to develop more of that fibrostenotic pattern in their esophagus without treatment?   [11:07] This is a question we're still trying to answer. There is some suggestion that for some patients who don't manage their disease, we very well may be looking at a food impaction in the future.   [11:19] Dr. Dellon says we know overall for the population of EoE patients, but it's hard to know for a specific patient. We have a bunch of studies now that look at how long people have symptoms before they're diagnosed. There's a wide range.   [11:39] Some people get symptoms and get diagnosed right away. Others might have symptoms for 20 or 30 years that they ignore, or don't have access to healthcare, or the diagnosis is missed.   [11:51] What we see consistently is that people who may be diagnosed within a year or two may only have a 10 or 20% chance of having that stricture and scar tissue in the esophagus, whereas people who go 20 years, it might be 80% or more.   [12:06] It's not everybody who has EoE who might end up with that scar tissue, but certainly, it's suggested that it's a large majority.   [12:16] That's before diagnosis. We have data that shows that after diagnosis, if people go a long time without treatment or without being seen in care, they also have an increasing rate of developing strictures.    [12:29] In general, the idea is yes, you should treat EoE, because on average, people are going to develop scar tissue and more symptoms. For the patient in front of you with EoE but no symptoms, what are the chances it's going to get worse? You don't know.   [13:04] There are two caveats with that. The first is what we mean by symptoms. Kids may have vomiting and growth problems. Adults can eat carefully, avoiding foods that hang up in the esophagus, like breads and overcooked meats, sticky rice, and other foods.   [13:24] Adults can eat slowly, drink a lot of liquid, and not perceive they have symptoms. When someone tells Dr. Dellon they don't have symptoms, he will quiz them about that. He'll even ask about swallowing pills.    [13:40] Often, you can pick up symptoms that maybe the person didn't even realize they were having. In that case, that can give you some impetus to treat.   [13:48] If there really are no symptoms, Dr. Dellon thinks we're at a point where we don't really know what to do.   [13:54] Dr. Dellon just saw a patient who had a lot of eosinophils in their small bowel with absolutely no GI symptoms. He said, "I can't diagnose you with eosinophilic enteritis, but you may develop symptoms." People like that, he will monitor in the clinic.   [14:14] Dr. Dellon will discuss it with them each time they come back for a clinic visit.   [14:19] Holly is a speech pathologist, but also sees people for feeding and swallowing. The local gastroenterologist refers patients who choose not to treat their EoE to her. Holly teaches them things they should be looking out for.   [14:39] If your pills get stuck or if you're downing 18 ounces during a mealtime, maybe it's time to treat it. People don't see these coping mechanisms they use that are impacting their quality of life. They've normalized it.   [15:30] Dr. Dellon says, of these people who aren't treated, there's probably a subset who appropriately are being observed and don't have a medicine treatment or are on a diet elimination.   [15:43] There's also probably a subset who are inappropriately not on treatment. It especially can happen with students who were under good control with their pediatric provider, but moved away to college and didn't transfer to adult care.   [16:08] They ultimately come back with a lot of symptoms that have progressed over six to eight years.   [16:18] Ryan meets newly diagnosed adult patients at APFED's conferences, who say they have no symptoms, but chicken gets caught in their throat. They got diagnosed when they went to the ER with a food impaction.   [16:38] Ryan says you have to wonder at what point that starts to get reflected in patient charts. Are those cases documented where someone is untreated and now has EoE?   [16:49] Ryan asks in the study, "What is the target EGID Cohort and why was it selected to study EoE? What sort of patients were captured as part of that data set?"   [16:58] Dr. Jensen said they identified patients with the ICD-10 code for a diagnosis of EoE. Then they looked to see if there was evidence of symptoms or complications in relation to EoE. This was hard; some of these are relatively non-specific symptoms.   [17:23] These patients may have been seeking care and may have been experiencing some symptoms that may or may not have made it into the chart. That's one of the challenges with real-world data analyses.   [17:38] Dr. Jensen says they are using data that was collected for documenting clinical care and for billing for clinical care, not for research, so it comes with some caveats when doing research with this data.   [18:08] Research using electronic health records gives a real-world perspective on patients who are seeking care or have a diagnosis of EoE, as opposed to a study trying to enroll a patient population that potentially isn't representative of the breadth of individuals living with EoE.   [18:39] Dr. Dellon says another advantage of real-world data is the number of patients. The largest randomized controlled trials in EoE might have 400 patients, and they are incredibly expensive to do.   [18:52] A study of electronic health records (EHR) is reporting on the analysis of just under 1,000. The cohort, combined from three different centers, has more than 1,400 people, a more representative, larger population.    [19:16] Dr. Dellon says when you read the results, understand the limitations and strengths of a study of health records, to help contextualize the information.   [19:41] Dr. Dellon says it's always easier to recognize the typical presentations. Materials about EoE and studies he has done that led to medicine approvals have focused on trouble swallowing. That can be relatively easily measured.   [20:01] Patients often come to receive care with a food impaction, which can be impactful on life, and somewhat public, if in a restaurant or at work. Typical symptoms are also the ones that get you diagnosed and may be easier to treat.   [20:26] Dr. Dellon wonders if maybe people don't treat some of the atypical symptoms because it's not appreciated that they can be related to EoE.   [20:42] Holly was diagnosed as an adult. Ryan was diagnosed as a toddler. Holly asks what are some of the challenges people face in getting an EoE diagnosis.   [20:56] Dr. Jensen says symptoms can sometimes be fairly non-specific. There's some ongoing work by the CEGIR Consortium trying to understand what happens when patients come into the emergency department with a food bolus impaction.   [21:28] Dr. Jensen explains that we see there's quite a bit of variation in how that gets managed, and if they get a biopsy. You have to have a biopsy of the esophagus to get a diagnosis of EoE.   [21:45] If you think about the steps that need to happen to get a diagnosis of EoE, that can present barriers for some groups to ultimately get that diagnosis.   [21:56] There's also been some literature around a potential assumption about which patients are more likely to be at risk. Some of that is still ongoing. We know that EoE occurs more commonly in males in roughly a two-to-one ratio. Not exclusively in males, obviously, but a little more often in males.   [22:20] We don't know anything about other groups of patients that may be at higher risk. That's ongoing work that we're still trying to understand. That in itself can also be a barrier when there are assumptions about who is or isn't likely to have EoE.   [23:02] Dr. Dellon says that in adolescents and adults, the typical symptoms are trouble swallowing and food sticking, which have many causes besides EoE, some of which are more common.   [23:18] In that population, heartburn is common. Patients may report terrible reflux that, on questioning, sounds more like trouble swallowing than GERD. Sometimes, with EoE, you may have reflux that doesn't improve. Is it EoE, reflux, or both?   [24:05] Some people will have chest discomfort. There are some reports of worsening symptoms with exercise, which brings up cardiac questions that have to be ruled out first.   [24:19] Dr. Dellon mentions some more atypical symptoms. An adult having pain in the upper abdomen could have EoE. In children, the symptoms could be anything in the GI tract. Some women might have atypical symptoms with less trouble swallowing.   [24:58] Some racial minorities may have those kinds of symptoms, as well. If you're not thinking of the condition, it's hard to make the diagnosis.   [25:08] Dr. Jensen notes that there are different cultural norms around expressing symptoms and dietary patterns, which may make it difficult to parse out a diagnosis.   [25:27] Ryan cites a past episode where access to a GI specialist played a role in diagnosing patients with EoE. Do white males have more EoE, or are their concerns just listened to more seriously?   [25:57] Ryan's parents were told when he was two that he was throwing up for attention. He believes that these days, he'd have a much easier time convincing a doctor to listen to him. From speaking to physicians, Ryan believes access is a wide issue in the field.   [26:23] Dr. Dellon tells of working with researchers at Mayo in Arizona and the Children's Hospital of Phoenix. They have a large population of Hispanic children with EoE, much larger than has been reported elsewhere. They're working on characterizing that.   [26:49] Dr. Dellon describes an experience with a visiting trainee from Mexico City, where there was not a lot of EoE reported. The trainee went back and looked at the biopsies there, and it turned out they were not performing biopsies on patients with dysphagia in Mexico City.   [27:13] When he looked at the patients who ended up getting biopsies, they found EoE in 10% of patients. That's similar to what's reported out of centers in the developed world. As people are thinking about it more, we will see more detection of it.   [27:30] Dr. Dellon believes those kinds of papers will be out in the next couple of months, to a year.   [27:36] Holly has had licensure in Arizona for about 11 years. She has had nine referrals recently of children with EoE from Arizona. Normally, it's been one or two that she met at a conference.   [28:00] Ryan asks about the research on patients not having their EoE treated pharmacologically. Some treat it with food avoidance and dietary therapy. Ryan notes that he can't have applesauce, as it is a trigger for his EoE.   [28:54] Dr. Jensen says that's one of the challenges in using the EHR data. That kind of information is only available to the researchers through free text. That's a limitation of the study, assessing the use of dietary elimination approaches.   [29:11] Holly says some of her patients have things listed as allergies that are food sensitivities. Ryan says it's helpful for the patients to have their food sensitivities listed along with their food allergies, but it makes records more difficult to parse for research.   [30:14] Dr. Dellon says they identify EoE by billing code, but the codes are not always used accurately. Natural Language Processing can train a computer system to find important phrases. Their collaborators working on the real-world data are using it.   [30:59] Dr. Dellon hopes that this will be a future direction for this research to find anything in the text related to diet elimination.   [31:32] Dr. Jensen says that older patients were less likely to seek medication therapy. She says it's probably for a couple of reasons. First, older patients may have been living with the disease for a long time and have had compensatory mechanisms in place.   [32:03] The other reason may be senescence or burnout of the disease, long-term. Patients may be less symptomatic as they get older. That's a question that remains to be answered for EoE. It has been seen in some other disease processes.   [32:32] Dr. Dellon says there's not much data specifically looking at EoE in the older population. Dr. Dellon did work years ago with another doctor, and they found that older patients had a better response to some treatments, particularly topical steroids.   [32:54] It wasn't clear whether it was a milder aspect of the disease, easier to treat, or because they were older and more responsible, taking their medicines as prescribed, and having a better response rate. It's the flip side of work in the pediatric population.   [33:16] There is an increasingly aging population with EoE. Young EoE patients will someday be over 65. Dr. Dellon hopes there will be a cure by that point, but it's an expanding population now.   [33:38] Dr. Jensen says only a few sites are contributing data, so they hope to add additional sites to the study. For some of the less common outcomes, they need a pretty large patient sample to ask some of those kinds of questions.   [33:55] They will continue to follow up on some of the work that this abstract touched on and try to understand some of these issues more deeply.   [34:06] Dr. Dellon mentions other work within the cohort. Using Natural Language Processing, they are looking at characterizing endoscopy information and reporting it without a manual review of reports and codes. You can't get that from billing data.   [34:29] Similarly, they are trying to classify patient severity by the Index of Severity with EoE, and layer that on looking at treatments and outcomes based on disease severity. Those are a couple of other directions where this cohort is going.   [34:43] Holly mentions that this is one of many research projects Dr. Jensen and Dr. Dellon have collaborated on together. They also collaborate through EGID Partners. Holly asks them to share a little bit about that.   [34:53] Dr. Jensen says EGID Partners is an online registry where individuals, caregivers, and parents of children affected with EGIDs can join.   [35:07] EGID Partners also needs people who don't live with an EGID to join, as controls. That gives the ability to compare those who are experiencing an EGID relative to those who aren't.   [35:22] When you join EGID Partners, they provide you with a set of questionnaires to complete. Periodically, they push out a few more questionnaires.   [35:33] EGID Partners has provided some really great information about patient experience and answered questions that patients want to know about, like joint pain and symptoms outside the GI tract.   [36:04] To date, there are close to 900 participants in the registry from all over the world. As it continues to grow, it will give the ability to look at the patient experience in different geographical areas.   [36:26] Dr. Dellon says we try to have it be interactive, because it is a collaboration with patients. The Steering Committee works with APFED and other patient advocacy groups from around the world.    [36:41] The EGID Partners website shows general patient locations anonymously. It shows the breakdown of adults with the condition and caregivers of children with the condition, the symptom distribution, and the treatment distribution.   [37:03] As papers get published and abstracts are presented, EGID Partners puts them on the website. Once someone joins, they can suggest a research idea. Many of the studies they have done have come from patient suggestions.   [37:20] If there's an interesting idea for a survey, EGID Partners can push out a survey to everybody in the group and answer questions relatively quickly.   [37:57] Dr. Dellon says a paper came out recently about telehealth. EoE care, in particular, is a good model for telehealth because it can expand access for patients who don't have providers in their area.   [38:22] EoE is a condition where care involves a lot of discussion but not a lot of need for physical exams and direct contact, so telehealth can make things very efficient.    [38:52] EGID Partners surveyed patients about telehealth. They thought it was efficient and saved time, and they had the same kind of interactions as in person. In general, in-state insurance covered it. Patients were happy to do those kinds of visits again.   [39:27] Holly says Dr. Furuta, herself, and others were published in the Gastroenterology journal in 2019 about starting to do telehealth because patients coming to the Children's Hospital of Colorado from out of state had no local access to feeding therapy.   [39:50] Holly went to the board, and they allowed her to get licensure in different states. She started with some of the most impacted patients in Texas and Florida in 2011 and 2012. They collected data. They published in 2019 about telehealth's positive impact.   [40:13] When 2020 rolled around, Holly had trained a bunch of people on how to do feeding therapy via telehealth. You have to do all kinds of things, like make yourself disappear, to keep the kids engaged and in their chairs!   [40:25] Now it is Holly's primary practice. She has licenses in nine states. She sees people all over the country. With her diagnosis, her physicians at Mass General have telehealth licensure in Maine. She gets to do telehealth with them instead of driving two hours.   [40:53] Dr. Jensen tells of two of the things they hope to do at EGID Partners. One is trying to understand more about reproductive health for patients with an EGID diagnosis. Only a few studies have looked at this question, and with very small samples.   [41:15] As more people register for EGID Partners, Dr. Jensen is hoping to be able to ask some questions related to reproductive health outcomes.   [41:27] The second goal is a survey suggested by the Student Advisory Committee, asking questions related to the burden of disease specific to the teen population.   [41:48] This diagnosis can hit that population particularly hard, at a time when they are trying to build and sustain friendships and are transitioning to adult care and moving away from home. This patient population has a unique perspective we wanted to hear.   [42:11] Dr. Jensen and Dr. Dellon work on all kinds of other projects, too.   [42:22] Dr. Dellon says they have done a lot of work on the early-life factors that may predispose to EoE. They are working on a large epidemiologic study to get some insight into early-life factors, including factors that can be measured in baby teeth.   [42:42] That's outside of EGID Partners. It's been ongoing, and they're getting close, maybe over the next couple of years, to having some results.   [43:03] Ryan says all of those projects sound so interesting. We need to have you guys back to dive into those results when you have something finalized.   [43:15] For our listeners who want to learn more about eosinophilic disorders, we encourage you to visit apfed.org and check out the links in the show notes below.   [43:22] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder at apfed.org/specialist.   [43:31] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at apfed.org/connections.   [43:41] Ryan thanks Dr. Dellon and Dr. Jensen for joining us today. This was a fantastic conversation. Holly also thanks APFED's Education Partners GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Evan S. Dellon, MD, MPH, Academic Gastroenterologist, University of North Carolina School of Medicine   Elizabeth T. Jensen, MPH, PhD, Epidemiologist, Wake Forest University School of Medicine, University of North Carolina at Chapel Hill   Predictors of Patients Receiving No Medication for Treatment of Eosinophilic Esophagitis in the United States: Data from the TARGET-EGIDS Cohort   Episode 15: Access to Specialty Care for Eosinophilic Esophagitis (EoE)   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/specialist apfed.org/connections apfed.org/research/clinical-trials   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   "I've been working on eosinophilic gastrointestinal diseases for about 15 years. I started some of the early work around understanding possible risk factors for the development of disease. I've gone on to support lots of other research projects." — Elizabeth T. Jensen, MPH, PhD   "You can think of EoE as asthma of the esophagus or eczema of the esophagus, although in general, people don't grow out of EoE, like they might grow out of eczema or asthma. When people have it, it really is a long-term condition." — Evan S. Dellon, MD, MPH   "There are two general approaches to treating the underlying condition, … using medicines and/or eliminating foods from the diet that we think may trigger EoE. I should say, for a lot of people, EoE is a food-triggered allergic condition." — Evan S. Dellon, MD, MPH   "I didn't find it that surprising [that there are patients who had no treatment]. Some patients are relatively asymptomatic, and others are not interested in pursuing medications initially or are … still exploring dietary treatment options." — Elizabeth T. Jensen, MPH, PhD   "We have a bunch of studies now that look at how long people have symptoms before they're diagnosed. There's a wide range. Some people get symptoms and are diagnosed right away. Other people might have symptoms for 20 or 30 years." — Evan S. Dellon, MD, MPH   "EGID Partners is an online registry where individuals, caregivers, and parents of children affected with EGIDs can join. EGID Partners also needs people who don't live with an EGID to join, as controls." — Elizabeth T. Jensen, MPH, PhD

Subscribe to our channel:    / @optispan  Get Our Newsletter (It's Free): https://www.optispan.life/Join me for a fascinating conversation with Dr. Jamie Justice, Executive Director of the $101 Million XPRIZE Healthspan. In this podcast, we discuss the world of longevity science, from the ambitious goals of this global competition to the lessons learned from the stalled TAME trial.Dr. Justice explains how the XPRIZE is structured to find real-world solutions to extend human healthspan.Chapters:00:01:31 - Jamie's Role & The Mission of XPRIZE Healthspan00:02:29 - What is the XPRIZE Foundation?00:05:36 - The Genesis of the Healthspan Prize00:09:39 - Why Commercial Success Matters for the Prize00:10:51 - How to Win: The Competition Structure & Timeline00:18:50 - The 3 Key Healthspan Pillars: Cognitive, Physical, and Immune Function00:22:03 - Clinical Trial Design: Crossover Trials & "Responder" Analysis00:27:12 - The Types of Teams & Interventions (From Gene Therapy to Public Health)00:32:06 - Handling "Wild West" Clinics & The Importance of Data Transparency00:35:02 - How Many Teams Will Make it to the Finals?00:37:41 - Safety, Ethics, and Regulatory Hurdles00:43:42 - The FDA's Role and the Challenge of Approving "Aging" Interventions00:51:18 - The Story of the TAME Trial: Goals, Design, and Why It Stalled00:58:23 - The Real Reasons TAME Wasn't Funded (NIH Peer Review & More)01:07:09 - The Future of Large-Scale Aging Trials01:13:25 - The Good, The Bad, and The "Pheromones": Crazy XPRIZE Submissions01:16:49 - Breakdown of Finalist Categories: Drugs, Biologics, Supplements, and Multimodal Approaches01:22:20 - A Companion Prize for Biomarker Discovery01:27:30 - The Problem with "Biological Age" and Epigenetic Clocks01:31:44 - The Ethics of Using Direct-to-Consumer Age Tests in ClinicsAbout XPRIZE:XPRIZE's mission is to inspire and empower humanity to achieve breakthroughs that accelerate an equitable, abundant future.Website: https://www.xprize.org/Get Involved: https://www.xprize.org/get-involvedLinkedIn:   / x-prize-foundation  YouTube:    / xprize  X: http://x.com/xprizeInstagram:   / xprize  TikTok:   / xprize  Facebook:   / xprize  This video was produced by One Billion Media, an agency that specializes in YouTube virality for health brands and experts. Learn more about their work here:https://onebillionmedia.com/DISCLAIMER: The information provided on the Optispan podcast is intended solely for general educational purposes and is not meant to be, nor should it be construed as, personalized medical advice. No doctor-patient relationship is established by your use of this channel. The information and materials presented are for informational purposes only and are not a substitute for professional medical advice, diagnosis, or treatment. We strongly advise that you consult with a licensed healthcare professional for all matters concerning your health, especially before undertaking any changes based on content provided by this channel. The hosts and guests on this channel are not liable for any direct, indirect, or other damages or adverse effects that may arise from the application of the information discussed. Medical knowledge is constantly evolving; therefore, the information provided should be verified against current medical standards and practices.More places to find us:Twitter: https://x.com/Optispan_IncTwitter: https://x.com/mkaeberlein Linkedin:   / optispan  Instagram:   / optispan_   TikTok:   / optispan  https://www.optispan.life/Discover how teams worldwide are competing to prove they can reverse human aging by 10+ years, and why the winner might not be a drug at all.

What happens when you go all in on a generic injectable that no one else wants, and it turns into a one hundred million dollar product in the first year?In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Usman Ahmad, former CEO of Nexus Pharmaceuticals and now CEO of Quetzal Therapeutics. Together they trace his journey from corporate finance to building a generics powerhouse with his parents, scaling a sterile injectable facility, and ultimately selling it to Eli Lilly for just under one billion dollars.They discuss the philosophy of finding the "right to win," what most companies miss about manufacturing capacity and equipment selection, how to build a team with deep industry know-how, and why Usman is now focused on bringing therapies to patients with rare diseases.This is a practical, personal, and strategic look at building something from the ground up, deciding not to sell too early, and learning how to do the hard things with intention.Topics include:-How to select the right generic molecules beyond patent expiry-Early success with isoproterenol and API sourcing-Why Nexus turned down acquisition offers-Building a commercial salesforce from scratch-Designing a facility with high speed prefilled syringe and lyo capacity-Why most other sterile sites failed-The billion dollar sale to Lilly-Launching Quetzal and developing oral arsenic for APL-The brain-eating amoeba drug and ultra rare disease strategy-Faith, confidence, and decision making under pressureTimestamps: 00:00 Introduction and Guest Welcome00:24 From Wall Street Finance to Pharma01:42 How Usman Selected Winning Generics02:58 Early Challenges Building a Generics Company05:29 Family R&D Expertise and Business Dynamics11:44 First Generic Launch and Commercial Impact16:28 Building Sterile Injectable Manufacturing Capacity18:16 Sterile Facility and Equipment Strategy22:40 Prefilled Syringe and Vial Line Capabilities23:07 Big Pharma Interest and Selling the Facility26:02 Nexus Pharma Services and the Lilly Deal27:23 Post‑Sale Reflections and New Ventures28:30 Launching Quetzal Therapeutics and Rare Disease Focus33:30 New Challenges and Confidence in Drug Development39:55 Importance of People, Teams, and Relationships41:40 Books That Shaped Usman's Thinking42:29 Where to Connect with UsmanLearn more: https://quetzaltx.comConnect with Usman: https://www.linkedin.com/in/usman-ahmed-a351b928More episodes: https://letscombinate.comUsman Ahmad is the Founder and CEO of Quetzal Therapeutics, and former CEO of Nexus Pharmaceuticals, where he led the company through explosive growth and the billion-dollar sale of its manufacturing facility to Eli Lilly. With a background in finance and a deep passion for healthcare innovation, Usman now focuses on bringing treatments to patients with rare and underserved diseases.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.Leonel shares how integrating Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) is essential to successful combination-product development. He discusses his journey from chemist to regulatory-affairs expert, uncovering common disconnects between pharma and device cultures, and the critical role of design controls, risk management, and timelines.The conversation also explores GMP and process validation, IDE vs. IND pathways, the challenges of rare-disease programs, and how understanding the cost of quality can reshape testing strategies. Leonel closes by reflecting on becoming a Lean Six Sigma Black Belt and what continuous improvement really looks like in combination-product development.⏱ Timestamps00:00 – Welcome & Introduction00:52 – Integrating GLP, GCP & GMP02:22 – Challenges in Developing Combination Products04:02 – Device-Led Combination Products07:35 – Working with Rare Diseases09:58 – GMP & Process Validation15:08 – Clinical Trials: Drug vs Device19:22 – Cost of Quality & Six Sigma25:12 – Conclusion & Contact InformationLeonel Venegas is the Founder of Precision Regulatory Consulting LLC and an expert in quality and regulatory affairs with over two decades of experience across six global pharma and medtech leaders, including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.He is certified by ASQ as a CMQ/OE, CQE, CBA, and CSSBB, and holds an M.S. in Regulatory Affairs. Leonel specializes in combination products, medical devices, and IVDs, integrating GLP, GCP, GMP, and GVP principles into complex global development programs.

Elizabeth Vernon is a beekeeper-activist, herbalist, and founder of Queen Bees Farmacy, dedicated to bringing together the world of wild-crafted remedies, advocacy, and deep terrain insight.In this episode, we dive into the hidden dimensions of health and resistance — from how screen time is reshaping our bodies and nervous systems to the untested and unknown dangers of biologics. Elizabeth pulls no punches as we unpack how certain systems of “controlled opposition” (yes, we talk about RKF Jr., Elizabeth's experiences with him and his team, and what it means) muddy the waters of health freedom, and how reconnecting with nature's rhythms — bees, herbs, terrain, community — is the original rebellious medicine.Look beyond the surface and discover what really supports your body, mind, and environment in a world of distraction and distraction's design. This conversation with Elizabeth will challenge you — and empower you — to take back your terrainLearn more about Elizabeth at https://www.queenbeesfarmacy.comSupport Terrain Theory on Patreon! Our recently-launched member platform gives you access to a ton of free & exclusive content. Check it out: https://www.patreon.com/TerrainTheoryHelp support Ryan and Briana's road to recovery by donating to our GoFundMe set up in their name. Every penny will go to cover the costs of associated with healing their terrain using alternative, terrain-friendly methods. Donate here: https://www.gofundme.com/f/help-ryan-briana-heal-from-pfas-exposureTerrain Theory episodes are not to be taken as medical advice. You are your own primary healthcare provider.If you have a Terrain Transformation story you would like to share, email us at ben@terraintheory.net.Learn more at www.terraintheory.netFollow Terrain Theory:Instagram: https://www.instagram.com/terrain_theory/Facebook: https://www.facebook.com/Terrain-TheoryX: https://twitter.com/terraintheory1YouTube: https://www.youtube.com/@terraintheoryMusic by Chris Merenda

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA's Office of Combination Products (OCP). Mark takes us on a deep dive into the history of how combination products have been regulated in the U.S., starting with the Safe Medical Devices Act of 1990 and how the process evolved into the formation of OCP in 2002.We explore questions such as: What challenges did industry and the FDA face in the early days of combination products? How did the “Request for Designation” process come about, and how is regulatory identity determined? What is the “Primary Mode of Action” (PMOA) rule and why does it matter? How do user fees, cross-center coordination, and post-market regulations shape how combination products get to market and are monitored? Mark also highlights current regulatory gapssuch as cross-labeling and site registration issues that continue to impact developers.Whether you're working in med-tech, pharma, or regulatory affairs, this episode offers historical perspective, technical insights, and strategic take-aways for navigating the combination-product space. Tune in for a candid conversation with one of the leading figures in this field.Timestamps:00:00 Introduction & Guest Welcome00:35 Historical Background of Combination Products03:05 Creation of Office of Combination Products (OCP)04:29 Early Challenges and Developments04:54 MDUFA, PDUFA, User Fee Programs & Legislative Impact14:24 Defining Primary Mode of Action (PMOA)18:35 OCP's Role & Responsibilities26:49 Industry Adoption & Challenges38:48 Regulatory Gaps & Future Directions46:00 Conclusion & Contact InformationContact & Resources:Connect with Mark Kramer on LinkedIn or via email at Mark.Kramer@greenleafhealth.comMark Kramer is Principal of the Medical Devices & Combination Products regulatory practice at Eliquent Life Sciences (formerly Greenleaf Health). He has more than 35 years experience at FDA and in regulated industry. At FDA, he established and directed the Office of Combination Products and was a scientific reviewer and later supervisor of the premarket review of devices in a variety of medical discipline areas. Following his FDA career, he served as Regulatory Affairs Executive and Chief Regulatory Strategist at GE Healthcare and then as an independent regulatory consultant for over 10 years before joining Greenleaf. Mark served as a board member of the Regulatory Affairs Professionals Society (RAPS) and in 2021, he was awarded the RAPS Founders Award, the profession's highest honor, recognizing exemplary regulatory professionals who have shaped regulatory policy and practice and have made a positive impact on the profession.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some of the most significant shifts and strategies shaping our industry.Novartis's acquisition of Avidity Biosciences for a staggering $12 billion marks a pivotal moment in the pharmaceutical landscape this year. With this acquisition, Novartis underscores its commitment to bolstering its neuromuscular disease pipeline. Avidity Biosciences has made a name for itself with its cutting-edge RNA therapeutic technologies, particularly its Antibody Oligonucleotide Conjugates (AOCs). This platform uniquely combines monoclonal antibodies with oligonucleotides, enhancing precision in targeting specific cell types. The integration of Avidity's technology into Novartis's research efforts could accelerate the development of new therapies, potentially transforming patient care with more effective and targeted treatment options. This move not only highlights the industry's focus on specialized therapeutic areas but also anticipates future advances in RNA therapeutics, extending beyond neuromuscular disorders to areas like oncology.In a similar vein, the FDA has shown its willingness to reconsider drugs that previously faced setbacks. GSK's Blenrep has made a return to the U.S. market after receiving approval for treating certain myeloma patients. This approval is particularly noteworthy given the drug's earlier negative advisory committee vote and postponed decision. It marks a significant rebound for GSK's oncology portfolio and reflects the FDA's dynamic approach towards drugs that show potential in specific therapeutic combinations.Meanwhile, Sanofi continues to make waves with Dupixent, achieving over €4 billion in quarterly sales due to its expanded indications. This success contrasts with a decline in Sanofi's vaccine sales, demonstrating shifting dynamics within pharmaceutical portfolios where biologics and specialty drugs are increasingly pivotal. Sanofi's recent financial report highlighted a notable 17% drop in vaccine sales due to reduced demand and pricing challenges in Europe. In response, companies must navigate fluctuating public health demands and economic pressures effectively.On the global stage, efforts to make transformative therapies like Vertex's Trikafta more accessible are gaining momentum through innovative trade-policy workarounds. A buyers club aims to introduce a lower-cost alternative produced by Bangladesh's Beximco, highlighting ongoing challenges and creative strategies in global drug accessibility.Roche's expansion through Chugai's $200 million M&A deal for an IgA nephropathy asset underscores the strategic importance of regional markets in driving growth. Similarly, Lonza's acquisition of a California biologics site aligns with its goals to meet increasing biomanufacturing demands.The industry is also adapting to technological advancements, with AI integration into life sciences commercialization being touted as a frontier for growth. Despite this potential, many organizations remain unprepared to harness AI fully. Leading companies embedding AI solutions aim for measurable outcomes that could significantly drive strategic decision-making and operational efficiencies.Eli Lilly's acquisition of Adverum Biotechnologies aligns with its strategic interests in gene therapy, focusing on promising therapeutic programs that address unmet medical needs. This acquisition centers around Ixo-vec for wet age-related macular degeneration (AMD), highlighting broader industry trends towards investing heavily in innovative therapies that address unmet needs.Conversely, Sanofi's halt on an RSV vaccine development highlights the inherent risks in vaccine development pipelines. Meanwhile, Regeneron's decision to discontinue a CAR T candidate acquired from 2seventy bio showcases ongoing reassessment witSupport the show

Japan's health ministry has started considering ways to promote the use of follow-on products of very expensive original biological drugs.

In Western countries, type 2 inflammation is the underlying cause of CRSwNP in ~ 80% of patients. Credit available for this activity expires: 10/24/2026 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/chronic-rhinosinusitis-nasal-polyps-reimagined-bridging-2025a1000saf?ecd=bdc_podcast_libsyn_mscpedu

Your process works perfectly at two-liter bench scale. Then you hit fifty liters and titer drops 20%. By two hundred liters, aggregation appears and charge variants shift. Your management team asks: "How long to fix this?" The honest answer? Three to twelve month, because you're flying blind.In Part 2 of this Quality by Design Master Class, David Brühlmann reveals why scale-up chaos isn't inevitable. It's a solvable engineering problem. Drawing on experience leading bioprocess innovation at Merck and guiding biotech companies through CMC development, David delivers the process control framework that transforms reactive troubleshooting into predictive manufacturing.The core truth: eighty percent of quality problems stem from twenty percent of your process variables. David shows how to identify Critical Process Parameters, implement intelligent control strategies, and leverage hybrid modeling that reduces experiments by 60-80%. With case studies from Genentech and Amgen, you'll gain the blueprint that turns QbD requirements into competitive advantage.Part 1 taught you what to build and measure. Part 2 shows you how to control your process to consistently deliver commercial-scale quality.Topics Discussed:The common pitfalls of scaling up manufacturing from bench to production, and why process control must go beyond end-product testing (02:10)Overview of the QbD framework: Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), and the focus of this episode - Control Strategies for manufacturing (05:00)Identifying and monitoring Critical Process Parameters (CPPs) and their impact on quality, with real-world examples from Genentech's monoclonal antibody platform (08:20)Structure of an effective manufacturing control strategy: Input, process, and output controls - including practical details on real-time monitoring and release testing (11:00)The role of hybrid modeling and machine learning in accelerating process optimization, and how this approach can dramatically reduce the experimental burden (13:30)Real examples of improved outcomes and efficiency through model-based control strategies, and why training and process understanding are essential for team success (16:10)A quick, actionable exercise biotech teams can use to map process risks and identify critical control points (16:55)Whether you're part of a start-up or a large biotech firm, this episode offers clear, strategic steps for implementing QbD and improving process reliability. Don't forget to listen to Part 1 for more on QTPP and CQA, and visit www.bruehlmann-consulting.com for additional resources.Next step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? We're building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105

I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer do? What's Regulatory Affairs? How does R&D fit in?In this video, I walk through eight of the most common roles you'll find in pharma, medtech, biotech, and diagnostics companies. We'll talk about what each team does, how they connect, and how to think about which one might fit your strengths and interests.If you're trying to figure out where you belong in industry, this one's for you.Please like, share, and subscribe if you find it helpful!Timestamps00:00 Introduction and Background01:07 Overview of Industry Roles02:43 Quality Assurance06:14 Regulatory Affairs08:22 Research & Development09:46 Clinical Affairs11:07 Manufacturing & Operations12:09 Quality Control / Analytical Testing14:05 Supply Chain & Procurement15:13 Validation & Technical Services16:39 Career Path Insights and ConclusionSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Description: Listen as NPF Medical Board Members, dermatologist Dr. Robert Kalb and rheumatologist Dr. Sergio Schwartzman discuss the connections between psoriasis and psoriatic arthritis, from cytokines to triggers, current and future treatments.   Join moderator Alan Simmons as he gains insights on what connects psoriasis and psoriatic arthritis with leading experts in psoriatic disease and NPF Medical Board members, dermatologist Dr. Robert Kalb with Buffalo Medical Group Dermatology, and rheumatologist Dr. Sergio Schwartzman from Schwartzman Rheumatology, as they discuss the known drivers of psoriasis and psoriatic arthritis, common triggers, benefits of targeted treatments, remission of disease, and upcoming treatment trends. The intent of this episode is to identify potential connections between psoriasis and psoriatic arthritis, and how targeted treatments have changed the outlook for management of psoriatic disease. This episode is sponsored by Novartis. Timestamps: (0:41) Intro to Psoriasis Uncovered and guest welcome dermatologist Dr. Robert Kalb and rheumatologist Dr. Sergio Schwartzman who are both involved in clinical care and research of psoriasis and psoriatic arthritis.  (1:15) Current known pro-inflammatory cytokines and cells found in psoriasis and psoriatic arthritis.   (5:33) Types of psoriasis that may lead to a higher risk of developing psoriatic arthritis. (9:33) Common triggers for psoriasis and psoriatic arthritis that could cause flares of the disease. (12:59) Key factors that are considered when choosing a treatment plan for any individual with psoriatic arthritis and psoriasis. (18:04) What treatment remission means for psoriasis. (19:36) Use of minimal disease activity (MDA) in psoriatic arthritis and what it means. (22:14) How a better understanding of the disease has led to more effective treatment choices and what choices are used by Dr. Kalb and Dr. Schwartzman for the management of psoriasis and psoriatic arthritis. (28:39) New developments in treatment and research in psoriatic arthritis and psoriasis. (36:01) Given treatment advancements it's a wonderful time to treat psoriatic disease. 3 Key Takeaways: ·       Cytokines are chemicals in the body that moderate various processes. In psoriasis and psoriatic arthritis,  an unknown trigger stimulates some cells to overproduce pro-inflammatory cytokines such as TNF-alpha, IL-17 or IL-23 leading to the development of skin and joint disease.  ·       Treating psoriasis and psoriatic arthritis helps move the body towards normalizing the over reactive immune system especially with more targeted treatments that safely and effectively block specific cytokines without affecting other organ systems.  ·       Given advancements in targeted treatments the goal is to reach and maintain remission of psoriatic disease. Guest Bios:   Leading dermatologist Robert Kalb, M.D. is the Chair of the Buffalo Medical Group Dermatology Department and the Director of the Buffalo Medical Group Phototherapy Center, one of the leading centers for psoriasis care in Western New York. He is also a Clinical Professor of Dermatology at the State University of New York at Buffalo School of Medicine and Biomedical Sciences (SUNY Buffalo), as well as an Adjunct Professor of Dermatology at the Perelman School of Medicine at the University of Pennsylvania where he plays a significant role in medical education, mentoring both medical students and dermatology residents. Dr. Kalb has extensive experience managing psoriasis, atopic dermatitis, and other inflammatory skin diseases. He has authored 70+ publications and is actively involved in clinical research, particularly focused on new treatment options for psoriasis. He is a member of the NPF Medical Board, American Academy of Dermatology, and is a member of the International Psoriasis Council.  Sergio Schwartzman, MD, is a world-renowned rheumatologist based in New York City who brings almost 40 years of experience and personalized clinical care for those who have psoriatic disease. Along with being in private practice at Schwartzman Rheumatology, Dr. Schwartzman is a Clinical Associate Professor of Medicine at Weill Cornell Medical College of Cornell University, the New York-Presbyterian Hospital, and the Hospital for Special Surgery in New York City where he has played a role in educating medical students, residents, fellows, and peers in rheumatology. Additionally, Dr. Schwartzman is the emeritus Franchellie M. Cadwell Clinical Associate Professor at the Hospital for Special Surgery. Dr. Schwartzman's current research interests include psoriatic arthritis, the spondyloarthritis group of diseases, ankylosing spondylitis, rheumatoid arthritis, as well as defining and treating autoimmune diseases of the eye. He has authored, co-authored, and edited over 150 papers, abstracts, books and book chapters on topics including psoriatic arthritis, ankylosing spondylitis, axial spondylarthritis, rheumatoid arthritis, lupus, autoimmune eye disorders, and other rheumatological and autoimmune conditions. He is a member of the NPF Medical Board. He is also a member of the American College of Rheumatology, the Association for Research in Vision and Ophthalmology, the Spondyloarthritis Research and Treatment Network (SPARTAN), the American Uveitis Society, and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Resources: Ø  “Redefining Remission. A new definition for patients, providers, and payers.” Advance Online, National Psoriasis Foundation. S. Schlosser. July 14, 2025.   Ø  Treatment and Management of Psoriasis     Ø  Treatment and Management of Psoriatic Arthritis  

Over 40% of biotherapeutic failures during clinical development stem from stability problems—and most trace back to protein aggregation that could have been prevented. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann exposes the hidden manufacturing crisis that derails promising biologics programs and delivers the systematic Quality by Design framework that elite biotech companies use to build quality into every process step.David brings two decades of bioprocess expertise from his time leading technology innovation at Merck and now guiding emerging biotech companies through CMC development as Managing Director of Brühlmann Consulting. Drawing on FDA and EMA regulatory guidance as well as landmark industry case studies he transforms complex QbD principles into an actionable roadmap for IND submission.This isn't theoretical regulatory compliance. It's competitive survival. Companies implementing these QbD foundations achieve predictable manufacturing scale-up, accelerated regulatory approval, and significant cost advantages. If your team is navigating CMC development for the first time or struggling with scale-up challenges, this episode provides the blueprint to transform process uncertainty into manufacturing confidence.What You'll Learn in This Episode:The high clinical failure rate for biologics due to protein aggregation and stability problems, and one company's costly lesson in the scale-up phase. (00:00)An introduction to Quality by Design (QbD)—how it differs from traditional development and why “the process is the product” in biologics. (03:09)The three foundational pillars of QbD, with today's focus on product understanding and quality requirements. (05:46)Constructing your Quality Target Product Profile (QTPP): what to include and why starting with the patient is key. (07:05)A real-world QTPP example—the AMAP case study—and how it shaped formulation, packaging, and critical quality standards. (09:45)Defining and prioritizing Critical Quality Attributes (CQAs): measuring what truly matters for safety and efficacy. (11:50)Lessons from Roche/Genentech's QbD journey: regulatory insights and the business value of robust CQA identification. (15:55)The “CQA Reality Check” exercise: a step-by-step method to focus your team on attributes that impact patients. (21:05)How early, candid dialogue with regulators and using management tools like the Notion CMC Dashboard can streamline the development roadmap and reassure investors. (23:30)Ready to flip the odds in your favor and make QbD your competitive edge? Stream this episode to catch actionable strategies and real-world cautionary tales that could change your CMC development playbook for good.Next step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? We're building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105

Pushing biologics beyond 200 mg/mL isn't just a formulation challenge - it's a delivery, manufacturing, and regulatory challenge too. Aggregation, precipitation, and sky-high viscosity make scaling these therapies a gauntlet for drug developers.In this episode of Life Science Solutions, host Chris Adkins continues the conversation on hyper-concentrated biologics with Ryan Doxey, VP of Tech Ops & CMC at Kymanox, and Nick Letourneau, PhD, Associate Director of Product Development & Commercialization. Together, they unpack how dehydrated protein microparticles suspended in hydrophobic carriers (like MCT oils or ethyl oleate) can dissolve instantly upon injection, and why this breakthrough could dramatically ease the patient experience.The conversation dives deep into what this means for manufacturing, device compatibility, and regulatory pathways, revealing how the future of injectables depends on solving problems once thought unsolvable.Topics include:Why ultra-concentrated biologics often fail in aqueous solutionsHow microparticle suspensions dissolve rapidly in vivo to avoid depot effectsRheology 101: viscosity curves, shear-thinning fluids, and device designThe shift to aseptic manufacturing when sterile filtration isn't an optionPreclinical safety considerations and scaling studies from rodents to NHPsWhy early conversations with FDA's Emerging Technology Program matterThis is part two of our deep dive on concentrated biologics - picking up where our Podcast Marathon live episode left off.  This episode offers a rare look inside the formulation frontier — where drug science, delivery design, and patient experience intersect.

Episode Description:  Not sure if you should receive a vaccine given your psoriasis or psoriatic arthritis medication?  Dermatologist Dr. Jason Hawkes explores this question along with vaccination recommendations for adults receiving biologics and oral therapies for psoriasis and psoriatic arthritis. Listen as hosts Jeff Brown and LB Herbert discuss key questions about vaccine use and psoriatic disease with dermatologist and NPF Medical Board member Dr. Jason Hawkes who is co-owner, Chief Scientific Officer, and investigator with the Oregon Medical Research Center. Hear what the difference is between live and non-live vaccines, how type of vaccine and immunosuppressive medications impact the timing of vaccines in relation to treatment half-lives. Get your questions answered. The intent of this episode is to offer answers to questions about vaccine use for people with psoriasis and psoriatic arthritis who take immunosuppressive treatments.   Timestamps: (0:23) Intro to Psoriasis Uncovered & guest welcome dermatologist Dr. Jason Hawkes. (1:15) In general, what is a vaccine and how it works in the body. (2:08) Will vaccines provide the same level of protection in people with psoriatic disease who are         on treatments that influence the immune system. (4:53) The difference between live and non-live vaccines.   (8:57) Summary of NPF Vaccine Recommendations in relation to live and non-live vaccines and             specific medications for psoriatic disease, including a definition of medication half-lives. (13:38) Vaccines that may be recommended prior to starting a systemic medication or biologic. (18:27) The mRNA vaccine – how it works in comparison to other vaccines. (22:31) How long immunity lasts from childhood vaccines. (25:24) The vaccine guidelines apply to both psoriasis and psoriatic arthritis with some nuances.      (28:38) Which healthcare provider to turn to for advice about vaccines and why. (31:54) Questions to ask your health care provider about vaccines. (33:26) How clinical trials and registries are evolving to assess the effect of vaccines with specific             medications and the need for greater understanding. (36:44) Develop a good relationship with your health care provider and don't be afraid to ask                 questions about your psoriatic disease, vaccines, or specific medications. Key Takeaways: ·       Vaccines work to help protect the body or stimulate protection against common infections or pathogens. There are different types that can be classified as either live or non-live vaccines.   ·       Evidence-based vaccine recommendations are available for people with psoriasis and psoriatic arthritis to help guide timing of when to receive live and non-live vaccines when taking immunosuppressive oral systemic medications and/or biologics.   ·       It's important to discuss which vaccines to consider, and how current psoriasis medication could impact the intended response and timing  with your health care team which includes a primary care physician, a dermatologist, and/or rheumatologist.    Guest Bio: Dermatologist Jason Hawkes, M.D., MS is Co-owner, Chief Scientific Officer and Investigator with Oregon Medical Research Center (OMRC) in Portland, Oregon. He is also a Clinical Assistant Professor of Dermatology at Oregon Health and Science University and the President and Sole Member of Hawkes Dermatology. Prior to joining the Oregon Medical Research Center, Dr. Hawkes held academic faculty appointments in the Departments of Dermatology at the University of Utah School of Medicine, Icahn School of Medicine at Mount Sinai, and University of California-Davis. Dr. Hawkes' principal clinical and research interests are the treatment of complex inflammatory skin diseases, such as psoriasis, hidradenitis suppurativa, chronic urticaria (hives), and eczema. He has a special interest in translational human research and the development of novel biologics and small molecules used for the treatment of inflammatory conditions. Dr. Hawkes is also a Councilor of the International Psoriasis Council (IPC) and serves on the Medical Board and Scientific Advisory Committee of the National Psoriasis Foundation (NPF) where he participates in the development of clinical consensus statements. Resources:         “Does Having Psoriatic Disease Impact Vaccine Choices?” Psound Bytes™ podcast with Dr. Sandy Chat (University of California) and Dr. Christoph Ellebrecht (Dept. of Dermatology, University of Pennsylvania).       Medical Board Clinical Statements                

As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersection of AI, GMP, and Quality 4.0, exploring both the promise and the challenges of applying intelligent systems in regulated environments.Key topics covered:- Current applications of AI in GMP, including CAPA and deviation management- The role of validation and why algorithmic opacity poses regulatory challenges- How Process Analytical Technology (PAT) enables real-time release decisions- The importance of Design of Experiments (DOE) for process optimizationContinuous manufacturing and how yield can signal process performanceChapters00:00 Introduction to AI in Pharma00:40 Current Applications of AI in GMP02:32 Challenges and Validation in AI03:22 Process Analytical Technology (PAT)09:50 Design of Experiments (DOE) in Pharma13:27 Continuous Manufacturing Explained15:40 Yield Calculation in Manufacturing22:12 Conclusion and Contact InformationBen Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Summary In this truncated replay, Dr. Shyam Joshi explores the intersection between allergy and dermatology—focusing on how chronic spontaneous urticaria (CSU), atopic dermatitis, and food allergies often overlap. Learn how emerging biologics like omalizumab and dupilumab are reshaping treatment decisions, why comorbidities matter, and how collaboration between allergists and dermatologists creates better outcomes for patients with complex allergic and dermatologic conditions. This episode dives into real-world case studies, FDA updates on antihistamines, and the multidisciplinary approach to managing eczema and CSU in pediatric and adult populations. Takeaways - FDA Advisory on Antihistamines: Long-term use of cetirizine or levocetirizine can lead to rebound pruritus upon discontinuation—but gradual tapering minimizes symptoms. - Biologic Selection Depends on Comorbidities: - Omalizumab is effective for IgE-mediated food allergies and chronic urticaria. - Dupilumab is preferred for patients with eosinophilic esophagitis (EoE) or moderate-to-severe atopic dermatitis. - CSU Is Systemic: Symptoms may extend beyond hives—impacting joints, sleep, and energy levels. - Comorbid Conditions Are Common: Up to 20 % of CSU patients have asthma, allergic rhinitis, or food allergies; identifying these helps guide treatment and patient education. - Unified Messaging Builds Trust: Consistent communication from both dermatologists and allergists reduces unnecessary testing and supports adherence to treatment plans. Chapters 00:00 - Introduction: Bridging Allergy and Dermatology 00:45 - Case Study: An 18-Year-Old with Chronic Urticaria 02:00 - FDA Warning: Antihistamine Withdrawal Itch 03:45 - Selecting the Right Biologic: Food Allergy Considerations 04:45 - Eosinophilic Esophagitis and CSU         05:35 - The Systemic Nature of CSU 06:40 - Comorbidities in CSU and Atopic Patients 07:30 - Multidisciplinary Collaboration in Practice 08:00 - Closing Thoughts & Educational Disclaimer

In today's pharma landscape, patient convenience and drug delivery innovation go hand in hand. But how do you deliver life-saving biologics at higher concentrations without sacrificing safety, stability, or patient comfort?In this live-recorded episode of Life Science Solutions, host Chris Adkins sits down with Ryan Doxey, Vice President of Technical Services at Kymanox, for part one of their conversation together. Ryan unpacks the opportunities and challenges of hyper-concentrated formulations, from why patients stand to benefit to how technical hurdles like viscosity, stability, and scale-up shape the path forward.Chris and Ryan dig into what makes high-concentration biologics both technically challenging and clinically promising.Topics Include:Why high-concentration biologics matter for patient convenience and complianceThe science of formulation: balancing potency, viscosity, and stabilityScale-up and manufacturing barriers innovators must solveLifecycle management and the competitive edge of delivery innovationThis is part one of a two-part conversation with Ryan Doxey, offering an inside look at how advanced biologics are being reimagined for the patients who need them most.

Most people think about heart disease and metabolism when they talk about longevity, but too few talk about joint health. In this episode, you'll discover how to biohack your joints to prevent pain, reverse damage, and move like you're decades younger. Host Dave Asprey reveals how functional movement, core stability, and recovery can transform joint health, helping you maintain pain-free performance for life. Watch this episode on YouTube for the full video experience: https://www.youtube.com/@DaveAspreyBPR Dr. Jason Snibbe is a globally recognized, board-certified orthopedic surgeon and a pioneer in advanced, minimally invasive, and robotic surgeries of the shoulder, elbow, hip, and knee. Fellowship-trained in Sports Medicine and Robotic Joint Reconstruction, he has achieved the lowest complication rate at Cedars-Sinai Medical Center and is the official orthopedic surgeon for the Los Angeles Clippers. He also serves as an orthopedic consultant for the Los Angeles Lakers, Los Angeles Sparks, Los Angeles Angels of Anaheim, and Los Angeles Kings. As a founding and managing partner in DOCS Spine and Orthopedics and Docs Surgical Hospital, Dr. Snibbe lectures and trains surgeons around the world in his specialized techniques. Host Dave Asprey and Dr. Snibbe uncover how weak glutes, poor core engagement, and bad footwear accelerate joint aging, and how functional movement training and fascia care can protect your body from surgery. You'll learn why proper biomechanics are central to human performance and longevity, how hypermobility and fascia impact neuroplasticity, and the latest biohacking tools for recovery and joint regeneration. You'll Learn: • The real cause of joint damage and how to prevent it • How to build a stronger core and glutes for long-term joint stability • Why footwear choices can make or break your movement quality • The truth about fascia, stretching, and strength training • When to use PRP, stem cells, and biologics for healing • How hypermobility affects your joints, brain, and longevity • Daily mobility and recovery habits that prevent future surgery They explore how biologics like PRP, stem cells, and exosomes are changing orthopedic recovery and joint repair, and why functional medicine is moving beyond surgery toward regeneration. You'll hear how precision movement, fascia work, and strength training protect your joints and enhance human performance and longevity. This is essential listening for anyone serious about biohacking, hacking human performance, improving mobility, and extending longevity. You'll also learn how neuroplasticity, metabolism, and brain optimization all connect to the way you move. Dave Asprey is a four-time New York Times bestselling author, founder of Bulletproof Coffee, and the father of biohacking. With over 1,000 interviews and 1 million monthly listeners, The Human Upgrade brings you the knowledge to take control of your biology, extend your longevity, and optimize every system in your body and mind. Each episode delivers cutting-edge insights in health, performance, neuroscience, supplements, nutrition, biohacking, emotional intelligence, and conscious living. New episodes are released every Tuesday, Thursday, Friday, and Sunday (BONUS). Dave asks the questions no one else will and gives you real tools to become stronger, smarter, and more resilient. Keywords: Joint biohacking, Orthopedic regeneration, Functional movement patterns, Core stability training, Glute activation exercises, Fascia mobility, Hypermobility syndrome, Ehlers-Danlos collagen disorder, Foot biomechanics, Pronation and supination, Arch support orthotics, Barefoot gait training, Stem cell joint repair, PRP knee therapy, Exosome orthopedic recovery, Meniscus tear alternatives, Robotic joint surgery, Posture correction, Gait analysis technology, Pain-free longevity Thank you to our sponsors! TRU KAVA | Go to https://trukava.com/ and use code DAVE10 for 10% off. BON CHARGE | Go to https://boncharge.com and use code DAVE for 15% off. OneSkin | For a limited time, try OneSkin for 15% off with code DAVE at https://www.oneskin.co/DAVE Business of Biohacking Summit | Register to attend October 20-23 in Austin, TX https://businessofbiohacking.com/ Resources: • Learn more about Dr. Snibbe's work: https://www.drjasonsnibbe.com/ • Danger Coffee: https://dangercoffee.com/discount/dave15 • Dave Asprey's BEYOND Conference: https://beyondconference.com • Dave Asprey's New Book – Heavily Meditated: https://daveasprey.com/heavily-meditated • Upgrade Collective: https://www.ourupgradecollective.com • Upgrade Labs: https://upgradelabs.com • 40 Years of Zen: https://40yearsofzen.com Timestamps: • 0:00 — Trailer • 1:28 — Introduction • 2:38 — The Kinetic Chain • 9:34 — Core and Glutes • 12:18 — Stretching and Fascia • 17:32 — Sleep and Recovery • 18:49 — Vibration Therapy • 23:47 — Gait and Compensation • 30:47 — Robotic Surgery • 34:28 — Future of Medicine • 39:23 — Footwear Mistakes • 48:48 — Wearables and Tech • 55:13 — Stem Cells and Biologics • 1:01:20 — Final Takeaways See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Time is of the essence when it comes to drug discovery. MindWalk (NASDAQ: HYFT) combines bio-native AI with in-house wet lab capabilities to accelerate therapy development, making the process safer, faster, and more reliable.President and CEO Dr. Jennifer Bath shares the strategy behind the company's rebranding, the competitive edge of their LensAI™ platform, and the impact of AI-driven immunogenicity on patient care. From their proven track record to their precise AI technology, discover how MindWalk stands out in the healthcare industry. To learn more about their technology, explore their website: https://www.mindwalkai.com/Discover MindWalk as an investor: https://ir.ipatherapeutics.com/overview/default.aspxWatch the full YouTube interview here: https://youtu.be/07jQObacjvEAnd follow us to stay updated: https://www.youtube.com/@GlobalOneMedia?sub_confirmation=1

In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotrophic lateral sclerosis). Jesse explains the process of discovering molecules that modulate biological pathways, the difference between structure-based and phenotype-based drug design, and the role computational methods play in drug development. The conversation also explores the challenges of crossing the blood-brain barrier, the importance of validating target response, and the complexities of progressing from a theoretical compound to preclinical studies. Additionally, Jesse touches on the significance of target product profiles, CNS drug design characteristics, and the iterative nature of medicinal chemistry. He concludes by discussing his current projects at Cortex, including fundraising strategies and timelines for drug development.00:00 Introduction to Medicinal Chemistry00:37 Drug Discovery Approaches02:01 Computational Methods in Medicinal Chemistry03:21 Challenges in ALS Drug Discovery04:23 Blood-Brain Barrier and Drug Design05:29 Key Properties for CNS Drug Design08:58 Day-to-Day in Drug Discovery09:45 Early Stage Drug Development12:28 Validating Drug Targets16:15 From Theory to Animal Testing22:46 Funding and Timeline Considerations25:45 Regulatory and Manufacturing Considerations28:32 Conclusion and Contact InformationDr. Jesse Gordon-Blake is an independent biotechnology and drug discovery consultant with expertise in medicinal chemistry and neurotherapeutics. He has led efforts in small molecule and peptide therapeutic development, AI-enabled drug discovery, and biotech startup formation, and currently serves as the CSO of Cortexa Therapeutics. He earned his PhD in Medicinal Chemistry from the University of Illinois at Chicago, focusing on developing innovative small-molecule enzyme modulators for Alzheimer's disease.https://www.linkedin.com/in/jesse-gordon-blake-phd-52a26274/https://www.cortexatherapeutics.com/Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Listen in as we discuss considerations, challenges, and strategies related to the use and switching of biosimilars in clinical practice.  You'll hear communication tips to address patient and prescriber concerns as well as operational considerations for integrating biosimilars into practice.  Special guests:Bharati Bhardwaja, PharmD, BCPS, LSSBBRheumatology Clinical Pharmacy SpecialistKaiser Permanente ColoradoMegan May, PharmD, BCOP, FHOPA, FAPOClinical Oncology Pharmacy SpecialistBaptist Health Lexington/Hamburg Cancer Care CenterYou'll also hear practical advice from TRC's Editorial Advisory Board member:Craig D. Williams, PharmD, FNLA, BCPSClinical Professor of Pharmacy PracticeOregon Health and Science UniversityFor the purposes of disclosure, Dr. Megan May reports relevant financial relationships [lung cancer] with Amgen, AstraZeneca, Pharmacosmos (speakers bureau). The other speakers have nothing to disclose.  All relevant financial relationships have been mitigated.This podcast is an excerpt from one of TRC's monthly live CE webinars, the full webinar originally aired in August 2025.TRC Healthcare offers CE credit for this podcast. Log in to your Pharmacist's Letter, Pharmacy Technician's Letter,or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.Claim CreditThe clinical resources mentioned during the podcast are part of a subscription to Pharmacist's Letter, Pharmacy Technician's Letter, and Prescriber Insights: FAQ: Facts About BiosimilarsChart: Comparison of Insulins (United States)Chart: Biologics for Rheumatoid ArthritisChart: Biologics for Crohn's DiseaseUse code mt1025 at checkout for 10% off a new subscription.Send us a text****

In this episode, Subhi Saadeh sits down with Alan Stevens, CAPT, to break down the concept of five nines (99.999% reliability) in medical devices. They cover where the standard came from, why FDA introduced it in their 2020 draft guidance, and what it means for life-saving products like epinephrine and naloxone injectors.Alan explains how manufacturers can demonstrate reliability through fault tree analysis, robust process controls, and challenge testing—without needing impossible sample sizes.If you work in pharma, medtech, or quality, this episode will help you understand what “five nines” really means and how to meet FDA expectations while ensuring patient safety.Chapters00:00 – What is Five Nines Reliability?Intro to 99.999% and why it matters for medical devices.00:33 – FDA Guidance & Common Misconceptions2020 draft guidance, sample size myths, and industry confusion.01:17 – How to Demonstrate ReliabilityFeasibility, practical approaches, and FDA expectations.02:31 – High-Stakes Use CasesEpinephrine, naloxone, glucagon injectors.04:00 – Fault Tree Analysis ExplainedBreaking down failures and linking to design/manufacturing.05:25 – Why FDA Chose Five NinesBalancing feasibility, safety, and ISO 14971 influences.09:02 – Verification vs. ReliabilityDesign verification testing vs. true reliability demonstration.23:16 – Key Takeaways for IndustryClosing thoughts on meeting and maintaining reliability standards.Alan Stevens CAPT is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Please visit answersincme.com/860/MED-RESP-03359-replay to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, ENT and allergy experts present strategies for incorporating the latest biologic therapies for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) via case-based challenges. Upon completion of this activity, participants should be better able to: Identify patients with CRSwNP who are candidates for biologic therapies according to guideline recommendations; Select appropriate biologic therapies for patients with CRSwNP based on patient-, disease-, and drug-related factors; Apply guideline recommendations for monitoring response to biologic treatment of CRSwNP; and Outline treatment sequencing strategies to optimize the management of CRSwNP.

In this episode of the Braun Performance & Rehab Podcast, Dan is joined by Dr. Jason Scopp to discuss biological agents such as PRP and their use in sports medicine.Dr. Scopp is a board certified orthopaedic surgeon and a pioneer in the field of cartilage restoration, a procedure for joint pain available in only a handful of medical centers across the country. In addition to his biotechnology research on joint preservation, Dr. Scopp specializes in the treatment and prevention of sports-related injuries. He is an internationally featured speaker on the topics of joint preservation, cartilage defects and restorative treatment options.Fellowship trained in Sports Medicine and a lifelong athlete himself, Dr. Scopp has been team physician for the United States Soccer Team, University of Maryland Eastern Shore, Salisbury University and the Delmarva Shorebirds (a Baltimore Orioles organization), among others.Dr. Scopp received his medical degree from the Hahnemann University School of Medicine in Philadelphia. His residency in orthopaedic surgery was completed at University of Maryland Medical Systems, and he completed his fellowship in sports medicine, arthroscopy and articular cartilage restoration at the Santa Monica Orthopaedic and Sports Medicine Group in California. For more on Dr. Scopp and his team at POA, be sure to check out https://www.peninsulaortho.com/*SEASON 6 of the Braun Performance & Rehab Podcast is brought to you by Isophit. For more on Isophit, please check out isophit.com and @isophit -BE SURE to use coupon code BraunPR25% to save 25% on your Isophit order!**Season 6 of the Braun Performance & Rehab Podcast is also brought to you by Firefly Recovery, the official recovery provider for Braun Performance & Rehab. For more on Firefly, please check out https://www.recoveryfirefly.com/ or email jake@recoveryfirefly.com***This episode is also powered by Dr. Ray Gorman, founder of Engage Movement. Learn how to boost your income without relying on sessions. Get a free training on the blended practice model by following @raygormandpt on Instagram. DM my name “Dan” to @raygormandpt on Instagram and receive your free breakdown on the model.Episode Affiliates:MoboBoard: BRAWNBODY10 saves 10% at checkout!AliRx: DBraunRx = 20% off at checkout! https://alirx.health/MedBridge: https://www.medbridgeeducation.com/brawn-body-training or Coupon Code "BRAWN" for 40% off your annual subscription!CTM Band: https://ctm.band/collections/ctm-band coupon code "BRAWN10" = 10% off!Ice shaker affiliate link: https://www.iceshaker.com?sca_ref=1520881.zOJLysQzKeMake sure you SHARE this episode with a friend who could benefit from the information we shared!Check out everything Dan is up to by clicking here: https://linktr.ee/braun_prLiked this episode? Leave a 5-star review on your favorite podcast platform!

Artificial Intelligence is moving fast but how do you regulate it in industries where precision and risk management are everything?In this episode of Let's Combinate, Subhi Saadeh sits down with Dominick Romano, founder of Drainpipe.io, to unpack the future of AI in pharma, medtech, and drug/device regulation. The conversation goes deep into how AI could reshape dossier preparation, regulatory submissions, and quality oversight — and what strategies regulators and companies need to make sure speed doesn't come at the cost of trust.We explore:- Why pharma's unique risk profile makes AI regulation different from other industries-How ICH guidelines and process validation can be applied to AI systems-What “combinatorial problem sets” mean for pharma and AI models-The role of AI in regulatory affairs and dossier preparation-How regulators may use AI to accelerate reviews and approvals-The balance between speed, accuracy, and zero hallucinations in regulatory contexts-The future of AI in quality control, biologics, and beyondIf you work in pharma, medtech, or drug/device combination products, this episode will give you a clear look at how AI could change your world and what needs to happen before it earns the regulator's trust.Episode Chapters00:00 Introduction: Regulating AI in Pharma/MedTech01:01 Pharma's Unique Risk Profile02:14 AI in Regulatory Affairs03:44 Combinatorial Problem Sets in Pharma04:24 ICH Guidelines and AI Regulation08:22 Process Validation in AI10:20 AI in Regulatory Submissions15:54 Ensuring Accuracy and Consistency17:02 Regulatory Agencies and AI18:28 Accelerating Drug Approval with AI21:36 Time Savings in Dossier Formation25:44 AI in Quality Control for Biologics27:42 Challenges in AI Integration29:25 The Future of Pharma & MedTech with AI30:40 Where to Find Dominick RomanoDominick Romano is the founder and CEO of Drainpipe.io, focused on building trustworthy AI systems for regulated industries like pharma and medtech. A graduate of Full Sail University in video game development, his career spans game design, programmatic advertising, and voice applications before moving into AI. He was named one of Technology Innovators' Top 50 AI CEOs and has contributed to global initiatives such as the WHO/ITU AI for Health program. Today, he helps organizations explore how AI can be validated and integrated without compromising compliance or trust.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

About 1-in-6 Americans suffer from an Autoimmune Disease, which is actually a growing problem.  In this episode, we talk about:—How Dr. Prather's career was inspired by his own battle with Graves' Disease, which is an Autoimmune Disease.  And why making sure the Atlas is in proper place is "critical" for Autoimmune Disease and needs to be corrected first before there can be any progress.—The various categories of Autoimmune Disease:  Joints and Muscles (Rheumatoid Arthritis, Lupus, Myositis), Skin and Blood Vessels (Sjogren's Syndrome, Psoriatic Arthritis, Vitiligo), Digestive (Celiac Disease, Crohn's Disease, Ulcerative Colitis), the Endocrine System (Type I Diabetes, Addison's Disease, Hashimoto's, Thyroiditis, Graves' Disease), the Nervous System (Multiple Sclerosis, Myasthenia Gravis, Guillain-Barre), the Lymphatic System (Fibromyalgia), and many more.—The different infections that can kick off Autoimmune Disease, including Viruses, Bacteria, Parasitic, or Fungal.   And how Heavy Metal Toxicities and Stress can cause of Autoimmune Disease.—Why the underlying cause of the Autoimmune Disease is more important to determine in Dr. Prather's Structure-Function Health Care model, while the Disease Care approach focuses on managing and suppressing the symptoms.  And the "huge" role that the Gut plays in Autoimmune Diseases.—The new cutting-edge area of drugs called Biologics and how they work.  And how Vaccines are actually classified as Biologics.—How Immunosuppressant Drugs can be helpful and life-saving, but can also increase your chances of Cancer and a shortened life-span.  And why Dr. Prather says, "The more drugs that you take, the longer you take them, the more likely you are to have an issue."—Why your ability to fight infections, viruses, fungal, and parasites "go way down" if you are taking an Immunosuppressant Drug.—How Dr. Prather himself and many of his patients are a "testament" that Medical Doctors are wrong when taught to believe that there is no hope of getting well from Autoimmune Disease.  And how the Structure-Function Care results he sees in his office disprove the Medical model's belief that symptoms should just be managed and that the patient will always get worse.—Why Dr. Prather says "we're not going to get anywhere" with an Autoimmune Disease if you have Heavy Metal toxicity.  And the importance of thorough diagnostics in Structure-Function Care to determine the root cause of the Autoimmune Disease that needs to be corrected.—The effectiveness of Structure-Function Care, which is "the only way you're going to make headway in an Autoimmune Disease".  And the reason Homeopathics are described by Dr. Prather as "a real key" for making dramatic changes in Autoimmune Disease.http://www.TheVoiceOfHealthRadio.com

Drs. Dall'Era and Chaichian discuss earlier use of targeted biologics for treating lupus.

Nearly two-thirds of companies believe Quality 4.0 will transform their operations in the next five years yet fewer than 20% have started, and most haven't even reached the planning stage. In this conversation, Larry Mager breaks down what Quality 4.0 really is, why life sciences lag other industries, and how to move from compliance-only thinking to a business-driving quality strategy. We cover digital twins, data continuity, culture change, and Larry's Quantum Quality Management (QQM) framework as a practical roadmap.Timestamps00:00 Introduction to Quality 4.000:20 Defining Quality 4.001:39 The Role of Quality Professionals02:50 Industry Examples & Cultural Differences04:04 Implementing Quality 4.0 (people, process, tech)08:49 The Digital Twin Concept (why legacy EQMS falls short)13:34 The Importance of a Roadmap 30:28 Quantum Quality Management (5-phase framework)35:05 Final Thoughts & Contact InformationLarry Mager is the Founder and Principal at MGMT-CTRL, where he specializes in applying strategic quality management that goes beyond mere compliance. With three decades of experience in the medical device industry, Larry has held leadership roles spanning quality systems, operations management, CAPA, supplier control, risk management, lean manufacturing, and continuous improvement. He is also the architect of the Quantum Quality Management (QQM) framework, a phased methodology that marries people, process, and technology to help organizations adopt Quality 4.0, drive operational excellence, and use quality as a strategic business advantage.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

As we move later in the growing season the weather has been a bit unusual compared to what we have seen in recent years with good amounts of rain. Although this helps soybeans grow, it also allows one of their diseases to grow. That being white mold. Research is ongoing to figure out the best way to deal with this fungus using biological control agents. Damon Smith, a professor in plant pathology, is here to share some information on their study that looks to find the best practices when using the agent commonly known as Contans.See omnystudio.com/listener for privacy information.

Renowned rhizosphere ecologist Dr. Jill Clapperton heads to Australia to participate in a series of events designed to showcase regenerative farming Down Under. In this episode, Jill joins BEAR Biologics' Sarah Fea to discuss the upcoming field events, farmer gatherings, and an experiential dinner highlighting local food producers—hosted by Sarah's company, BEAR Biologics.Stay tuned for future episodes, where Jill shares more insights from her month-long trip through Australia!Topics Covered in This Episode:How soil health directly impacts the flavor and quality of foodInsights from field events and farmer gatherings in AustraliaExperiential dinner highlighting local producersThe role of BEAR Biologics in supporting regenerative agricultureSarah Fea's work and expertise in soil biology and farming solutionsPractical takeaways for growers and food enthusiastsFollow & Support:YouTube: @jillclappertonsoilhealthSupport us: Buy Me a CoffeeBlog: rhizoterra.com/blogHashtags:#HealthySoil #BetterFlavor #RegenerativeAgriculture #SoilHealth #FarmToTable #BEARBiologics #JillClapperton #AustraliaFood #FoodScience #SoilScience

In this episode of Let's ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the persistent and evolving challenge of terminology in combination products—a problem that continues to create confusion and regulatory risk even in 2025.Susan emphasizes the need for alignment on terminology and regulatory expectations, highlighting that true progress requires a science- and risk-based perspective. The discussion also covers how GMP requirements are interpreted differently in pharma versus medtech, the ongoing challenges of global harmonization, and why cohesive language is essential for compliance, inspection readiness, and effective product development.Episode Chapters00:00 Introduction and Welcome00:25 The Lexicon Problem in Drug-Device Combination Products01:01 Historical Efforts and Challenges02:12 Regulatory Frameworks and Definitions04:47 Industry and Regulatory Alignment Issues06:55 Science and Risk-Based Perspectives10:08 Terminology and Definitions in Practice14:05 Global Regulatory Differences17:22 Challenges in Harmonizing Standards23:13 Key Terms and Their Impact32:23 Conclusion and Contact InformationSusan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press. Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development. Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries. She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees. Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request. She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums. Susan can be reached at sneadle@combinationprod.com Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Mark Durante's story of going from a surprise heart transplant to not improving post-surgery to being introduced to stem cells and regenerative therapies changed his life for the better. He is on a mission to help everyone learn about all of their options for reversing symptoms and maybe even the complete reversal of all damage. In this episode, we cover a variety of therapies and how to talk to your doctor about them. I hope you learn as much as I have from this conversation.  Connect with Mark and Rize Up Medical:  https://www.rizeupmedical.com/ https://www.instagram.com/rizeupmedical/ https://www.linkedin.com/in/mark-durante/   Connect with Marian:  https://www.roadtolivingwhole.com/therapeuticfoodframework/   Disclaimer: The goal of this podcast is to help you take control of your health and feel the best you possibly can! These episodes are not meant to take the place of working with a qualified healthcare professional and are not designed to diagnose or treat any diseases or medical conditions. Any advice provided is not a medical diagnosis or medical treatment plan.

We're taking a breather this August as we work on bringing you more great episodes of the ATS Breathe Easy podcast. But we're not going off the air - instead, we're bringing back some of our best episodes of the last season. See you in September for season two! Amy Attaway, MD, hosts the latest ATS Breathe Easy episode with former ATS President Monica Kraft, MD, and Asthma and Allergy Network's Chief Research Officer, De De Gardner, DrPH, discuss the benefits and challenges of biologics for asthma. What factors guide selection of a specific biologic for asthma? When should a patient transition from one biologic to another? This episode of the ATS Breathe Easy podcast is supported in part by AstraZeneca.

In this episode of Let's Combinate, host Subhi Saadeh is joined by long-time friend and Senior Technical Program Manager Joey Frechin, who brings a wealth of experience in med tech consulting. They discuss the intricacies of risk assessments for medical devices and drugs, focusing on differences and improvements in methodologies over the years. Joey shares insights on the challenges of aligning risk processes across different organizations and the importance of adaptable strategies. He also recounts his unique career path that blends design engineering with extensive process and risk management expertise. The conversation covers trends such as the shift toward off-the-shelf platforms and the balancing act between innovative design and market readiness. Joey emphasizes the value of stepping into roles and tasks that others may overlook, which has been key to his professional growth.00:00 Welcome and Introduction00:49 Discussing Risk Assessments in Med Tech04:34 Challenges in Aligning Risk Processes09:44 Understanding P1 and P2 in Risk Management12:55 Joey's Career Journey and Strategic Choices24:12 Trends in Combination Product Design31:48 Conclusion and Where to Find JoeyJoey Frechin is a technical program lead in the medical device and combination product development space.https://www.linkedin.com/in/joey-frechinSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's ComBinate, Subhi Saadeh sits down with Jeff Gensler, a quality and regulatory leader with 30+ years in MedTech, pharma, and combination products.Jeff takes us inside FDA warning letters, consent decrees, and massive remediation efforts—including the 1,400 DHF Zimmer Biomet project and achieving 99.999% reliability with the EpiPen. He shares the CAPA playbook he's refined over decades, the high-stakes negotiations with FDA, and the critical role of containment, third-party reviews, and inspection readiness.The conversation shifts to Quality 4.0 how electronic batch records (EBRs), AI, and digital systems can move quality from reactive to preventive. Jeff also introduces his new Quality 4.0 Consortium, designed to bring proven digital solutions to small and mid-sized pharma companies.Timestamps:00:00 – Introduction & Guest Welcome00:42 – Facing a Warning Letter: The Zimmer Experience02:05 – Remediation Strategies & Challenges06:03 – Orthopedic Industry Insights09:58 – Transition to Pfizer & Meridian12:54 – Navigating FDA Negotiations16:18 – Balancing Risk & FDA Visibility16:55 – Implementing Quality Systems & Processes18:15 – Leveraging Third-Party Reviews & Audits20:26 – Inspection Readiness & CAPA Processes25:08 – Mergers, Acquisitions & Facility Upgrades27:32 – Digital Transformation in Quality Management31:12 – The Future of Quality Systems & AI Integration33:01 – Benefits of Electronic Batch Records34:13 – Conclusion & Contact InfoJeff Gensler is a veteran quality and regulatory executive with more than 30 years of leadership experience in MedTech, pharmaceuticals, and combination products. Over his career, Jeff has navigated some of the industry's most complex compliance challenges, including FDA warning letters, consent decrees, and large-scale quality system remediations. He has held senior leadership roles at Zimmer Biomet, where he oversaw the remediation of 1,400 design history files involving $300M in resources and 1,500 contractors, and at Pfizer's Meridian Medical Technologies, where his team achieved 99.999% reliability for the EpiPen through advanced quality processes and close FDA engagement. Jeff later served as Vice President of Quality at Kindeva Drug Delivery, where he helped lead a state-of-the-art facility buildout recognized by ISPE as a Facility of the Year finalist. A recognized advocate for modernizing quality systems, Jeff has championed Quality 4.0, integrating electronic batch records, AI, and advanced analytics to shift organizations from reactive to preventive quality management. Most recently, he founded the Quality 4.0 Consortium, a collaborative platform bringing proven digital solutions to small and mid-sized pharma companies.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

How do we integrate biologics into the existing stepwise treatment model for chronic rhinosinusitis with nasal polyps (CRSwNP)? In this episode, Dr. Reena Mehta, an allergist from Uptown Allergy and Asthma in New Orleans, discusses the use of biologics for treating chronic rhinosinusitis with nasal polyps. ---SYNPOSISDr. Mehta elaborates on the common presentations of patients, the role of biologics such as dupilumab and tezepelumab, and the nuances of patient management post-sinus surgery. Dr. Mehta also covers the workup process, the significance of patient comorbidities like asthma and allergies, and the future perspectives on biologic treatments. Practical aspects of biologic therapy, including insurance hurdles, patient compliance, and the effectiveness of various biologics are thoroughly examined.---TIMESTAMPS00:00 - Introduction 02:27 - Understanding Chronic Rhinosinusitis with Nasal Polyps & Presentation05:22 - Workup and Management of Nasal Polyps07:31 - Treatment Options: Steroids and Biologics15:28 - Tezepelumab: A New Tool in the Toolkit25:03 - Side Effects and Safety of Biologics28:59 - Insurance and Approval Challenges36:14 - Long-Term Safety and Efficacy38:47 - Pediatric Considerations and Future Directions41:37 - Collaboration Between ENT and Allergy Specialists45:07 - Conclusion and Final Thoughts---RESOURCESDr. Reena Mehtahttps://uptownallergyasthma.com/allergist-dr-reena-mehta/

Pediatric rheumatologist Dr. Pamela Weiss speaks with Michael and his 12 year old daughter Ava about  navigating the challenge of living with psoriasis and psoriatic arthritis together as a family.   Join moderator Kaleigh Welch as she discusses the challenges of living with psoriasis and juvenile psoriatic arthritis (JPsA) from diagnosis, misconceptions about psoriatic disease, to management and treatment with pediatric rheumatologist, Dr. Pamela Weiss from Children's Hospital of Philadelphia, Division of Rheumatology, along with Michael and Ava, whose psoriatic disease is truly a family affair. The intent of this episode is to raise awareness about the complexities and nuances associated with living with psoriasis and psoriatic arthritis as a child or an adult and not letting the disease stop you from doing what you love to do. This episode is sponsored by Amgen. Mike, Ava, and Dr. Weiss were compensated for their time. Timestamps: ·       (0:00) Intro to Psoriasis Uncovered and guest welcome pediatric rheumatologist Dr. Pamela Weiss, Michael and Ava Sayles who both have been diagnosed with psoriasis and psoriatic        arthritis.   ·       (1:28) What the psoriatic disease diagnosis process could be like for children and adults.   ·       (5:34) Misconceptions associated with psoriasis leading to delayed diagnosis of psoriatic arthritis. ·       (7:36) What people misunderstand about plaque psoriasis and psoriatic arthritis. ·       (11:06) Challenges to finding the right treatment while living life with psoriatic disease. ·       (17:24) What drives treatment choices for psoriatic disease in youth. ·       (19:59) Assessing what's most important in reaching treatment goals. ·       (23:57) What the future holds for management of Juvenile Psoriatic Arthritis (JPsA). ·       (26:10) Living with psoriatic disease is challenging but find what's right for you and don't give up on what you love to do. Key Takeaways: ·       Diagnosis of plaque psoriasis and psoriatic arthritis can be challenging given subtleties that can occur in the presentation of the disease in adults and children. ·       There are a variety of treatments that work either alone or in combination to treat plaque psoriasis and psoriatic arthritis with choice of treatment dependent on what is the primary goal for the individual's physical and emotional health. ·       The future is bright as understanding of the disease increases and treatment options expand and become more targeted to more effectively address skin and joint issues associated with psoriatic disease. Guest Bios:   Pamela Weiss, M.D., MSCE, is a pediatric rheumatologist and the Clinical Research Director of the Division of Rheumatology at Children's Hospital of Philadelphia. Dr. Weiss is also the Distinguished Endowed Chair in the Department of Pediatrics. She has advanced training in clinical epidemiology with a focus on early diagnosis, and targeted treatment of children with spondyloarthritis (SpA). Dr. Weiss is also a Professor of Pediatrics and Epidemiology at the Perelman School of Medicine at the University of Pennsylvania. She is a member of the American Academy of Pediatrics, American College of Rheumatology, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the Spondylitis Association of America, and the SPondyloArthritis Research & Treatment Network (SPARTAN). Michael and Ava Sayles, psoriatic disease is a family affair. Both father and daughter, successfully navigate living with plaque psoriasis and psoriatic arthritis. Michael or Mike was diagnosed in his twenties, and Ava at age 7 and then later on juvenile psoriatic arthritis. She is now 12 years old.  They have experienced issues with diagnosis, and a long journey of finding treatment options that worked for them. Mike found the best solution was establishing a routine or rhythm of treatment around work and school to avoid flare-up's if possible, saying “keeping on top of what you need to do for the psoriasis and the arthritis becomes a big part of your life".  Resources: Our Spot: What is Psoriatic Arthritis  

Is it scalp psoriasis or something else? If it is scalp psoriasis what do I do about it? These questions and more are answered by leading dermatologist Dr. Ronald Prussick as we uncover what is scalp psoriasis. Join host Corinne Rutkowski as she talks with dermatologist and Vice Chair of the NPF Medical Board, Dr. Ronald Prussick from Washington Dermatology Center in Rockville and Frederick, MD about scalp psoriasis compared to dandruff, seborrheic dermatitis or eczema, and how characteristics may differ, along with what treatments and actions are effective to address scalp psoriasis.  This episode offers helpful insights and tips to address symptoms and care of scalp psoriasis.  Timestamps: ·       (0:00) Intro to Psoriasis Uncovered & guest welcome dermatologist Dr. Ronald Prussick. ·       (1:19) What is dandruff and key characteristics. ·       (2:28) Treatments for dandruff. ·       (3:28) What is seborrheic dermatitis and characteristics.   ·       (4:18) Treatment options for seborrheic dermatitis. ·       (7:04) How scalp psoriasis compares to dandruff, seborrheic dermatitis or eczema, and what are the key  differences. ·       (9:24) Why scalp psoriasis is a high impact site and how itching of  the scalp leads to Koebnerization. ·       (12:46) Prescription and over the counter treatment options for scalp psoriasis. ·       (18:11) Tips for using shampoos and applying treatments on the scalp.   ·       (24:08) Hair loss or alopecia with scalp psoriasis. ·       (25:22) Upcoming treatments for scalp psoriasis. ·       (27:38) Most important point to know about scalp psoriasis. Key Takeaways: ·       Some skin diseases may be confused with scalp psoriasis, however psoriasis does have key characteristics which helps lead to a definitive diagnosis. ·       Scalp psoriasis is a high impact area meaning body surface area (BSA) is less than 10% however impact on quality of life is significant and is a factor in determining choice of treatment(s) whether prescription or over the counter. ·       Be aware of the risks for Koebnerization of the scalp and take precautions to minimize itching and scratching through application of treatments and care of the scalp. Guest Bio: Leading dermatologist Ronald Prussick, M.D., is Vice Chair of the Medical Board for the National Psoriasis Foundation and the Medical Director of Washington Dermatology Center in Rockville and Frederick, MD where he specializes in the treatment of psoriasis along with other diseases of the skin, hair, and nails using the latest technology and products. Dr. Prussick is also a Clinical Associate Professor in Dermatology at George Washington University in Washington, DC.  He has been published many times and frequently speaks at medical conferences across the country and internationally including providing podcast episodes, such as on Psound Bytes addressing facts about nutrition and psoriasis in episode #196 “Facts About Nutrition, Diets and Psoriatic Disease”.  Dr. Prussick has been voted one of the top doctors by the Washingtonian Magazine time after time and has been repeatedly named one of America's Top Physicians by the Consumers Research Council. Resources: Ø  Medicated Psoriasis Shampoos Your Scalp Will Love  Ø  To find a dermatologist if needed: Patient Navigation Center Ø  NPF Seal of Recognition Product Directory   

In this milestone episode, I reflect on what it's taken to record, edit, and release 200 episodes focused on medical devices, pharma, and combination products.I share three hard-earned lessons not just about the industry, but about how we grow, lead, and keep learning inside it. From the sheer scope of the work to the surprising, non-linear paths people take, and the difference between credentials and true insight this episode is about what finally clicked… and what still hasn't.It's a thank-you to you, the listener, and a reminder that mastery isn't a finish line it's a mindset.

In this episode of Let's Combinate, host Subhi Saadeh is joined by Mark Burchnall, Director of Engineering at PSN Labs, to break down the evolving role of mechanical modeling and simulation in medical device and combination product development.Mark, an expert in mechanical modeling & finite element analysis (FEA) and a licensed professional engineershares how modeling can dramatically reduce prototyping cycles, support regulatory submissions, and lower test burden when applied appropriately.Mark disucsses:Why modeling is often misunderstoodWhen it can replace (or complement) traditional testingWhat makes a model “credible” under ASME V&V 40How to build internal processes for regulatory-grade modelsAnd what every skeptic (or startup) needs to know before adopting modeling⏱️ Timestamps:00:00 Introduction and Guest Welcome00:17 Mark's Expertise in Mechanical Modeling01:28 Subhi's Foundational Experience04:09 The Importance of Modeling in Engineering05:44 Challenges and Misconceptions in Modeling10:52 Life Cycle and Inputs of a Model16:21 Types of Models and Their Applications17:49 Numerical Solvers and Sensitivity Analysis21:28 CAD, Fluid Properties, and Starting a Model22:00 Defining the “Question of Interest”23:21 Modeling Cycle and Initial Steps24:35 Verification and Validation in Modeling25:40 Assessing Model Risk and Credibility31:43 Regulatory Guidelines and Industry Practices39:15 Implementing Modeling in Product Development42:17 Conclusion and Contact InformationMark is a product development consultant with over 15 years of experience in the Medical and Combination device sectors. As the Director of Engineering at PSN Labs, Mark leads the engineering department, offering invaluable support to clients in new product development, computational modeling and simulation, test method development, functional prototyping, contract manufacturing, and on-market remediation. His team specializes in designing devices that incorporate various design principles, including manufacturing, assembly, sustainability, biocompatibility, reprocessing, and reliability. Mark's background encompasses the development of innovative healthcare solutions in areas such as drug delivery, surgical robotics, pharmaceutical packaging, and catheters. His expertise ensures patient safety and regulatory compliance throughout the design process. Mark holds a Bachelor of Science in Mechanical Engineering from Purdue University and a Master of Science in Mechanical Engineering from the University of Cincinnati.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

July 15, 2025 | Are licensing fees required or gatekeeping? In this episode of The Chain, host Nimish Gera, vice president of Biologics at Mythic Therapeutics, and Ian Wilkinson, CEO of Gamma Proteins, discuss accessing antibody discovery technology through licensing fees and royalties—and whether these fees are justified or not. Wilkinson delves into the current landscape of antibody discovery technologies, including if AI-based technology warrants fees, how royalties affect both small companies and big pharma, and his background as one of the first experts in the field who offered purely free-for-service options. He also shares what excites him about antibody engineering and beyond. Links from this episode:  Mythic Therapeutics Gamma Proteins 

In this episode of Let's Combinate, host Subhi Saadeh highlights five critical aspects of the FDA's new Quality Management System Regulation (QMSR) that you may have missed. Subhi explains the historical context of QSR and ISO 13485, their 1996 origins, and the drive for harmonization that began in 2018. Key insights include the alignment with ISO 13485, additional FDA-specific expectations, the continued importance of risk management, the removal of certain industry exemptions, and the urgent two-year compliance timeline ending in February 2026. Subhi emphasizes the necessity of updating internal quality management systems and training staff to meet these new regulatory requirements.Timelines:00:00 Introduction to FDA QMSR00:29 Historical Context and Timeline02:22 Key Takeaway 1: Harmonization with ISO 1348504:06 Key Takeaway 2: FDA's Additional Expectations05:18 Key Takeaway 3: Risk Management Expectations06:18 Key Takeaway 4: Removal of Exemptions07:44 Key Takeaway 5: Compliance Deadline09:13 Conclusion and Final ThoughtsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, host Subhi Saadeh breaks down the critical role of quality agreements in the pharmaceutical and medical device industries.A quality agreement is a written document that defines GxP responsibilities between parties—such as sponsors, product owners, and contract partners. It doesn't cover business terms like payments or IP: instead, it focuses on quality responsibilities and operational accountability.Subhi explores regulatory expectations from the FDA, ICH Q10, and ISO 13485, emphasizing that even when work is outsourced, responsibility always stays with the product owner. He outlines five key sections every quality agreement should cover:-Deviation & Non-Conformance Handling-Change Control-Audits & Regulatory Inspections-Complaint Handling & Field Actions-Documentation & Record RetentionThis episode highlights common pitfalls, vague language to avoid, and why quality agreements must be clear, specific, and actionable—especially when something goes wrong.⏱️ Timestamps00:00 – Intro: Why Quality Agreements Matter01:23 – What Is a Quality Agreement?03:24 – Regulatory Expectations (FDA, ICH Q10, ISO 13485)04:51 – FDA's Quality Agreement Guidance Explained06:34 – Common Pitfalls & Misunderstandings08:00 – The 5 Critical Sections Every Agreement Needs12:34 – Final Thoughts: Make It Real. Make It WorkSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Feeling adventurous but not sure how to travel with your psoriasis and psoriatic arthritis? Listen as certified physician assistant Rosemary Son offers tips to help make your care easier while traveling near or far.        Join hosts LB Herbert and Kaitlin Walden as they talk tips for making travel easier whether in the US or abroad with certified Physician Assistant Rosemary Son from UT Southwestern Medical Center. Listen in as they discuss what to pack, keeping medications including biologics cool, where to find help if needed, tips for navigating airline travel, vaccines for traveling abroad, managing travel stress, infection precautions, and more. This episode offers information to help you prepare in advance for that trip of a lifetime while maintaining management of your psoriasis and psoriatic arthritis so you can feel free to live your life to its fullest. Timestamps: ·       (0:00)  Intro to Psoriasis Uncovered & guest welcome certified Physician Assistant Rosemary Son. ·       (2:43)  Tips for keeping medications (including biologics) cool when traveling in hot weather.  ·       (5:37)  Types of skin and pain management products to pack. ·       (8:41)  Where to find help for psoriatic disease if needed in unfamiliar places. ·       (10:43) Preparing for airline travel including liquid limitations and developing a “psoriasis passport”. ·       (14:33) Travel to other countries and how to find over-the-counter medications if needed. ·       (16:43)  Vaccine recommendations for out of the country travel. ·       (19:02)  Cold weather protection recommendations. ·       (21:27)  Precautions for reducing risk of infection and should you purchase travel insurance. ·       (24:17)  Tips for managing stress as a disease trigger while traveling. ·       (28:56)  What to avoid when traveling. ·       (31:36)  Live life to the fullest with psoriatic disease and enjoy the adventure travel offers. 3 Key Takeaways: ·       Managing psoriasis and psoriatic arthritis while traveling near or far is possible with advance preparation and use of precautions to help avoid stress associated with travel in changing environments. ·       What and how you pack is key to reducing potential health issues that occur while traveling. ·       A “psoriasis passport” or letter from your physician and a list of generic names for your medications can make travel in and out of the country easier. Guest Bio: Rosemary Son, M.P.A.S., PA-C, RDN is a board-certified physician assistant in the Department of Dermatology at the University of Texas (UT) Southwestern Medical Center and Parkland Health and Hospital System. As a dual-certified Physician Assistant and Registered Dietitian with over a decade of experience in dermatology, Rosemary has a passion for treating complex inflammatory skin diseases such as psoriasis, atopic dermatitis, hidradenitis suppurativa, as well as, treating diseases that impact skin of color, and identifying social determinants of dermatologic health. She also has a personal passion for travel. Ms. Son is a Director at Large and member of the Society of Dermatology Physician Assistants and the American Academy of Physician Associates serving as a liaison to the American Academy of Dermatology. Resources: Ø  Taking Care of Your Skin in the Summer  Ø  Patient Navigation Center

About a week ago, we published an episode on this program detailing how two Chinese nationals (a researcher at the University of Michigan and her boyfriend) were caught by the FBI trying to smuggle in a dangerous pathogen into the United States—a type of deadly fungus that can target crops.And we ended that episode by considering out loud: How many other Chinese researchers here in the United States are possibly doing the same thing?And wouldn't you believe it, within a week, another Chinese researcher, also from the University of Michigan, also at the Detroit Metropolitan Airport, was also caught by the feds for trying to smuggle in biological material. Although this time, it wasn't a fungus—it was instead a type of roundworm.And perhaps the best part of it all—which was probably more coincidence than anything—was that this Chinese scholar came here from everyone's favorite city: Wuhan, China.Let's go through the details together.

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Why is autoimmune disease in menopause becoming more prevalent? And why are college-age patients a growing autoimmune demographic?  In your 60s, when the world is thinking of retirement, would you ever consider being a founder of a new business instead of spending days on the golf course or traveling?  Answers to the increase in autoimmune disease in menopause and more in this special episode I think you may find both alarming and fascinating; both a shot of reality and hope.    My Guest: Dr. Bonnie Feldman, 69, Co-founder and Chief Patient Officer of Rheumission, is an entrepreneur, health practitioner, researcher, financial analyst, digital health advisor and autoimmune patient and advocate.  Since 2010, Dr. Feldman integrates digital tech, virtual-first care, and lifestyle interventions with conventional care to improve outcomes for autoimmune patients. She spent the past decade raising awareness of the underserved and growing autoimmune market opportunity for private investment. Her experience as an autoimmune patient have fueled Bonnie's passion for prevention, earlier diagnosis and improved care for all autoimmune patients.   Questions We Answer in This Episode: [00:04:50] Tell me about your own journey - why become a startup founder at an age (now 69) that most people are already in retirement? [00:09:16] What are autoimmune diseases? [00:13:18] What do people not understand about autoimmune disease? [00:18:21] Why do you say that autoimmune disease is a women's health crisis? [00:22:39] What is fundamentally wrong and needs to change in the way autoimmune patients are treated and diagnosed? What are doing to change this? [00:24:42] What is biologics? What are the negative side effects of biologics?  [00:33:04] What is the legacy you hope to leave (for your 10 grandchildren)?   Know if You May Have Autoimmune Disease in Menopause   What is Autoimmune Disease? Old Definition When the immune system attacks itself. 100 different kinds e.g. multiple sclerosis, rheumatoid arthritis, psoriatic arthritis, all sort of colitis and Crohn's New Definition Now includes the inflammatory spectrum and autism spectrum   Autoimmune Disease Is a Women's Health Crisis 80% of autoimmune patients are women, around 40 million people Hormones influence during puberty, pregnancy, menopause Late-onset autoimmune diagnoses are on the rise. The biggest growth is in young adult women who are college age.   Treatment for an Autoimmune Disease Patient Conventional Medicine The patient sees different kinds of specialized doctors that do not necessarily talk to each other (e.g. dermatologists, rheumatologists, etc.) Rheumission A Care Team is provided under one virtual roof with access to the patient digitally 24/7 if needed. This includes lifestyle medicine physician, an autoimmune psychologist, an autoimmune dietitian, an exercise program, and a care coordinator. Uses lifestyle medicine as the first lever of defense like diet, sleep, psychological, etc. Medicines are used in the lowest dose when needed.   Connect with Dr. Bonnie: Dr. Sharon's Website - Rheumission Facebook - rheumission Instagram - @rheumissionhlth YouTube - @rheumission   Other Episodes You Might Like: Previous Episode - Supplements I Take in Menopause Next Episode - What's Best Total Body or Split Routine in Menopause More Like This - How to Have and Still Thrive with Autoimmunity in Menopause   Resources: GYROTONIC® Feldenkrais Gait Therapy Pelvic Floor Therapy Short & Easy Exercise videos in this 5 Day Flip Challenge. Don't know where to start? Book your Discovery Call with Debra.