How Generative AI is Unlocking Insights to Expand Drug Development with Dr. Chris Bouton Certara

Yoona Kim, CEO of Arine,  a medication intelligence company, works with health plans and payers to ensure safe and effective medication therapy for patients. The Arine platform addresses polypharmacy, medication mismanagement, drug interactions, and proper dosing. Using AI and integrated databases, Arine is identifying patients who would benefit from medication management and shifting from reactive to proactive and preventative care. Yoona explains, "Our clients are health plans and risk-bearing providers. So these are the payers of the healthcare system, those who bear the financial burden of healthcare costs because medications can be very powerful, they can cure, or they can lead to detrimental consequences and even unnecessary fatalities and high-cost events like hospitalizations. So it's important to these customers to make sure that their members are on the right medications to avoid these unnecessary clinical and financial outcomes."  "I think it pertains to all of these situations. One of our biggest problems in healthcare is that 66% of Americans are on some prescription drugs, and in fact, more than 50% use more than three drugs a year. We need to search through a population and find who would benefit from a medication change with the population-based approach. This is why we spent so much time at Arine building our patient targeting model to identify in which patients would a small medication change lead to a difference in outcomes." "We're looking through all that patient's data, their medication history, their medical history, their demographics, and what their current clinical social, and behavioral risk factors are so we can identify that they're on the best medications, the safest and most effective for where they are in their health trajectory today. And, of course, the challenge is that their patient evolving health needs constantly change over time. On top of that, we have new medications being approved constantly and new advances being made. Our platform puts all this information together so that we can ensure that the best medication regimen is prescribed to the patients." #Arine #Medication #MedicationManagement #MedicationMismanagement #Prescription #SDOH #ArtificialIntelligence #Polypharmacy #Deprescribing #Overprescribing  #MedicationAdherence Arine.io Download the transcript here

Andrew Spier is the Vice President of Advanced Cyber Solutions and Commercial Services at Core4ce, a company specializing in protecting healthcare organizations and critical infrastructure from cyber threats. The healthcare environment has outdated software, weak access controls, insecure network connectivity, and a large Internet of Things network with many connected medical devices vulnerable to cyberattacks. Core4ce provides cybersecurity services, risk assessment, and education so that healthcare organizations can be more proactive in recognizing vulnerabilities and protecting against cyber criminals.  Andrew explains, "Core4ce is a data-centric national and enterprise security organization primarily specializing in protecting the nation and healthcare organizations. Critical infrastructure is mostly from cyber threats, which could be insider threats, cybersecurity or cyber criminals, or adversarial nation-states. We also provide a full suite of cybersecurity solutions in support of those customers." "I think that primarily in the healthcare environment, individually, you've got a giant IoT footprint, and for the listeners at home, IoT is the internet of things. This creates some challenges for healthcare organizations and medical device providers. The cybersecurity services that those customers typically use are vulnerabilities, vulnerability assessments, network assessments, network design, and penetration testing. I mean everything from policy reviews. The list goes on and on, but it's full spectrum of cybersecurity services." "If you think about the complications associated with a number of IoT or medical devices inside an organization or a hospital, it can be quite daunting. But many of the fixes are available. It's just a lot of time, bandwidth, and budget, and periodically, it's just a lack of staff and knowledge. Frankly, that's where we can come in and supplement, educate, help get them remediated, get them set up, protect their network, and work with them on an ongoing educational or iterative basis." #Core4ce #HealthcareCybersecurity #MedicalDevices #MedicalDeviceSecurity #HealthcareThreats #IoT core4ce.com Download the transcript here

Dr. Sam Lee, Co-CEO of Cocrystal Pharma, is an expert in developing small-molecule antiviral drugs to treat COVID-19, Norovirus, influenza, avian flu, West Nile virus, Dengue, Zika, and other RNA viruses. Cocrystal uses its structure-based drug discovery platform to identify promising drug targets for potent broad-spectrum oral and inhaled antiviral therapeutics. The COVID-19 pandemic highlighted the need for vaccines and effective therapeutics to respond to viral outbreaks and prevent further transmission. Sam elaborates, "Before we talk about avian flu, let's just step back up about the strains. Influenza, as you know, includes influenza A strains, influenza B, and the C. But the public health point of view is the influenza A strains are important. These cause the pandemic flu, as well as the seasonal flu. Influenza B is roughly less than 20% of flu patients that have this influenza B. It's seasonal. It doesn't cause a pandemic influenza infection." "So we're talking about avian flu. Avian flu is mostly an influenza A strain. So, it's often classified as H5N1 or H7N9, depending on the antigen. So, why is it so important? We know this year that people isolate the avian H5N1 from cow and cow milk and humans. Avian flu is normally avian influenza that stays with the birds, the wild birds. What we see here is already past the host barrier. So instead of staying with avian, the birds, or domestic animals, now it's passed to a human. So it's a serious issue that the avian flu, H5N1, actually we see here, not only cow and farm workers are infected with it. That's a really serious concern." "We believe we have a pretty good understanding. If you look at the 1918 Spanish flu, that was actually classified as an H1N1, but several years ago, with a beautiful molecular analysis, people completed the sequencing analysis with the patient sample from 1918 Spanish flu victims. They isolated the gene. They showed that even those with H1N1 contained the avian flu sequence." #CocrystalPharma #AvianFlu #Influenza #WestNileVirus #AntiviralTherapeutics #RNAViruses #COVID19 CocrystalPharma.com Download the transcript here

Dr. Mark Campbell, Chief Pharmacy Officer at RxBenefits, a prescription benefit optimizer that works with self-funded employers to help them get the best clinical and economic value from their pharmacy benefit manager relationships. As the healthcare landscape has become more complex with the rise of specialty and high-cost drugs, a significant portion of an employer's pharmacy costs can be impacted by a small population. A key challenge is managing the volatility introduced each year by changes in the health of employees and their families while also managing costs for the broader covered population. Mark explains, "The landscape for prescription benefits has shifted a lot over the course of my career. In 1998, for example, 35% of the prescriptions were generic, and 65% were branded. There was no appreciable amount of specialties at that time. And the average cost for a plan was probably in the mid-thirties per member per month. But with the shift we've seen where generics have grown to roughly 88% of the prescriptions for most of our groups, now the remaining 12% of brand and specialty drugs make up about 85% of the cost." "And you could narrow that even further to say that roughly 2% of the members make up about 65% to 70% of the cost of a plan. And now we're getting into conditions, diabetes, and the non-specialty realm, which is a very large influence on the overall cost for a plan. Also we are getting into specialty therapies for a variety of conditions, whether it's inflammatory conditions like rheumatoid arthritis, psoriasis, ulcerative colitis, or certain types of cancers where we have new therapies that we didn't have several years ago." "Even in many orphan conditions, we've seen new products come to market. That can be a significant benefit for patients who have either had limited or no therapy options for them in the past. So, beginning to help employers understand how to address that 2% of their population in a way that will get an elegant response for the member, getting the right drug for the right patient, and getting it at the right cost is where a lot of our emphasis is."  #RxBenefits @RxBenefits @MarkCampbell #PharmacyBenefit #PharmacyBenefitOptimizer #PBO #PrescriptionDrugCost #HighCostDrugs  rxbenefits.com Download the transcript here  

Dr. Vicky Demas, CEO of identifeye HEALTH, is using AI-powered diagnostic algorithms and automation to improve the accessibility and quality of retinal imaging, focusing on the early detection of diabetic retinopathy. The identifeye technology makes it easier for patients to get screened for eye conditions in primary care or retail settings. The goal is to leverage the information from retinal scans to detect other eye conditions and identify biomarkers for other systematic diseases.   Vicky explains, "In general, we leverage AI and automation to solve workflow problems to make, first and foremost the capturing of good-quality retinal imaging. It's really easy to make sure that, for example, we can remove the barriers and access for that. We don't need to be at a specialist office for a lot of the screening conditions. Very specifically too, for our first application, we're focusing on diabetic retinopathy, which is a huge problem and one where accessibility to good quality screenings and early detection or early detection is a huge problem that we're hoping to help with." "What it comes to is not about the camera or the resolution. Still, it is really about making sure that the capturing is of good quality, high quality. I'll call it an image that can be analyzed and interpreted. It can be done with someone with very little training upfront. Also, the information that you have to retain to run an exam is low. So, if you didn't run the device and are not operating it routinely, you don't have to remember what menu I opened and where the data is. And now I'm going to go and open this. We have used consumer product development principles to bring in usability and intuitive design, and of course, all powered by AI to automate all of that work." #identifeyeHEALTH #HealthcareInnovation #DigitalHealth #PrecisionMedicine #DiabeticRetinopathy #VisionHealth #Biomarkers identifeye.health  Download the transcript here

Felicia Janovich is a founding member of the American IV Association, which advocates for safe and effective IV therapies, including hydration, vitamin infusions, and treatments to support patients with chronic conditions or undergoing chemotherapy. While there is limited research on the effectiveness of these IV therapies, AIVA is working to collect and analyze clinical data to understand better the impact these therapies might have on individuals to help with recovery and overall health. Felicia explains, "Right now, in our space, we struggle with clear guidelines. And there's kind of misunderstanding that there's a bunch of IV cowboys out there, and they're just starting IVs, and they don't have regulations. It's just entirely untrue. The IV Association and its members bring in this amazing opportunity to collaborate, not compete, which is huge within this IV industry because it is relatively new, so we need all the data, all the information, and all the science to back it up. What AIVA has done is welcome all these other business owners who are doing the absolute best they can without having a clear-cut rule book, if you will." "But the main thing we all share is that it's intravenous, so we supply our nutrients and medications through an IV line directly to work on the cell at the cellular level. So, there might be different variations depending on the treatment, the goals, and what the provider and that client are trying to obtain, but the similarity is it's all going through an intravenous line." #AIVA #IVTherapy #VitaminInfusions #IntravenousTherapy americaniv.com Download the transcript here

Michael McFadden is the CEO of Alpha Cognition, a biopharmaceutical company focused on developing treatments for brain diseases such as Alzheimer's, ALS, and traumatic brain injury. Their drug ZUNVEYL, recently approved by the FDA, is an oral treatment for mild to moderate Alzheimer's that improves symptoms such as memory loss, mental processing speed, and mood changes. A key feature of the drug is fewer gastrointestinal side effects compared to other Alzheimer's drugs coming onto the market.   Michael explains, "ZUNVEYL is a class of medications known as acetylcholinesterase inhibitors. It’s the second oral compound approved by the FDA to treat Alzheimer’s disease in the last decade. So, it is a momentous accomplishment by our company, and it is an accomplishment that will serve patients and physicians well. It’s designed to treat symptoms of mild to moderate Alzheimer’s disease that many patients suffer from. These are things like memory loss, mental health processing speed, ability to solve problems or remember short-term and long-term things. Also, it affects or allows patients to manage changes in mood or personality that often accompany Alzheimer’s disease. So, these are drugs that are used very commonly to treat Alzheimer’s disease. We think this drug will have a lot of utility in helping patients and offering physicians a new choice."   "About 55% of patients who take a drug for Alzheimer’s disease will have some side effect that’s so significant they have to stop taking their medicine. So side effects are a primary reason that patients cannot stay on their therapy. The side effects that are most common are GI-related side effects, GI side effects, diarrhea, nausea, or vomiting. We are excited about our compound because we believe if you can’t tolerate a medicine, the medicine certainly can’t be efficacious for the patients." #AlphaCognition #Alzheimers #AlzheimersDisease #AlzheimersDrug #ZUNVEYL #Dementia  alphacognition.com Download the transcript here

George Pappas, CEO of Intraprise Health, works with various healthcare organizations across the healthcare industry and healthcare ecosystem to help address cybersecurity risks. While recent cyber attacks have raised awareness about the need for better cybersecurity measures, the complexity of healthcare IT systems creates significant challenges for comprehensive risk management. Proactive measures, including employee training, enhanced identity confirmation, and limiting access, are critical to mitigating the risk of cyber attacks.   George explains, "The net situation is that these large technology companies that serve healthcare and hospital systems and large medical practices change are clearinghouses, revenue cycle managers, and manage real-time price transparency. What medication management companies manage is so complicated, and they have so many ways that something can be attacked. As you mentioned at the beginning, the attackers are getting very clever and sharing a lot of their methods, so you have to do a comprehensive continuous review of your entire cybersecurity posture. Because if you don’t, there are invariably going to be challenges and small things that are small at the time that end up not being small and being the way that an attacker got in." "And in the case of Change, it was a multifactor authentication problem accessing a certain system through a certain technology stack that was rather old. But these things exist in companies this size. They have tens of thousands of machines and have accumulated different companies they acquired over time with different technology systems that don’t all work together. So, the vulnerabilities are there, and they require comprehensive risk management and some candidly, more investment than we’ve seen to address fully." "I’ll give you another example. So maybe it helps your listeners place this a little better. If you think about someone who has a home and is trying to protect their home from all the various threats or things that can happen. Well, their home insurance company requires them to have a smoke detector and carbon monoxide sensor. They get a credit on their policy. If they have a burglar alarm system, they might have a ring doorbell camera or any number of things like that. What you see across the industry is these large hospital systems, small hospital systems, doctor’s offices, and they’re doing those basic things. But here’s the issue. In that same house that I mentioned, you could have 30 windows, the roof might be a little old, you might have a ground floor, and a door that has glass could be easily broken if someone tried to break in." #IntrapriseHealth #HealthcareCybersecurity #PatientDataProtection #CyberThreats #HITRUSTCompliance #RiskManagement #DataPrivacy intraprisehealth.com Download the transcript here

Ketan Mehta, Founder and CEO of Tris Pharma, is focused on developing non-addictive pain medication. Their lead drug candidate is designed to be an effective pain drug without the respiratory-depressive and addictive side effects of traditional opioid drugs. This drug works by targeting the nociceptin receptor and has also shown promise to help curb cravings and dependence on opioids. The goal is to provide doctors and patients with a non-opioid pain medication option that can help reduce reliance on highly addictive prescription opioids.  Ketan explains, "Tris is focused on neuroscience-based products, especially CNS, at a high level. More specifically, we focused on ADHD and neurodevelopmental disorders and the products that treat them. And also, more recently, we have been more active in the pain space." "We're developing a drug, which is currently an investigational drug in Phase three clinical trials. It's called cebranopadol. And what we have seen is that it has an efficacy just on par with your typical traditional opioid. It’s highly effective from what we have seen in more than 2,000 patients to date. But also, what we're seeing thus far is that there is no indication that it creates dependency. You can just taper off the patients, meaning you don't have to give lesser dose even after pain has subsided. And it does not give you the level of respiratory depression or failure that we see with the traditional opioid." "Right now, we're conducting our first trials in acute pain, and then we will look at any kind of moderate to severe pain. Essentially like chronic pain, lower back pain, for example, the pain in arthritis, cancer pain, other disease conditions like fibromyalgia, or just any kind of injury that gives you pretty much any nociceptive pain that one would encounter, we expect, like diabetic peripheral neuropathy and so forth." #TrisPharma #PainManagement #ClinicalTrial #Innovation #PainTherapy #Cebranopadol  trispharma.com Download the transcript here

Beth Houck, Chief Executive Officer at SonarMD, works with payers and physician practices to provide proactive, value-based care for patients with chronic GI conditions. They use a digital platform to monitor self-reported patient symptoms and enable physicians to identify those patients that need attention. This approach aims to improve patient outcomes and reduce emergency room visits and hospitalizations.   Beth explains, "SonarMD manages patients with chronic gut health conditions, and specifically, we started with something called inflammatory bowel disease, which is the encompassing word for patients with Crohn's and ulcerative colitis. We develop a value-based contract with a payer, so somebody at risk for the cost of care of a patient, and then we bring that cost of care program to a physician's office. In collaboration with that physician, we manage a population of patients to have better outcomes for their chronic GI conditions." "We just talk about this as a shift to proactive care from reactive care. So rather than the loudest patients being seen, we will have patients that we surface as the most important patients for them to see. So we reach out to our patients and do it very lightly with a text message or email. We tell them a little bit about the program. We talk to them about how we're doing this on behalf of their physician practice and in collaboration with them. So this isn't something that's being forced on you by a payer. We ping those patients, which is the term we use on a regular basis, to collect their reported outcomes or the symptoms they're having with their disease."  #SonarMD #DigitalHealth #Healthcare #VBC #ValuebasedCare #GI #IBD SonarMD.com Download the transcript here