Increasing Focus of Medical Device Companies on Regulations and Compliance with Sonia Veluchamy Celegence

Dr. Jeng Her, Founder and CEO of AP Biosciences, is developing T-Cube bispecific antibodies that can target cancer cells and engage T-cells to kill them more effectively and safely than existing treatments. The company is focused on treating hard-to-treat cancers such as HER2-positive breast cancer, lung cancer, head and neck cancer, and pancreatic cancer. The T-Cube bispecific antibodies use CD137 instead of CD3 to activate T-cells, which can lead to better efficacy and safety compared to other T-cell engager antibodies. Jeng explains, "So why not just take two, let's say, monospecific antibodies and then put them together and give them to the patient in the combination therapy? Instead, we wanted to develop bispecific antibodies by fusing two antibodies together into one single molecule. So what's the advantage? Eventually, what it comes down to is the therapeutic window of bispecific antibodies. This means you want your antibodies, your bispecific, to have better efficacy, better safety, and sometimes lower cost of goods since you are only expressing or producing one single drug molecule. So, the way we look at bispecific and the real advantage is not just the additive effect. It's not even the synergistic effect, which means we would like our bispecific antibodies to do something combination therapy cannot do. And that's the value of our bispecific antibodies." "Basically, we have two technology platforms. The first one is an antibody phage display library. We call it Omni-mAb. This library is a live library, which means it has more than 100 billion antibody sequences. That's a collection of the 100 billion sequences. And whatever antigen, whatever conformation of the structure of antigens you have, you could isolate a very high-affinity antibody from the library in probably 4-6 weeks."  #APBiosciences #Antibody #Biotech #Bispecific #ImmunoOncology #Cancer #SolidTumors APBioInc.com Download the transcript here

Sonia Veluchamy, CEO and Co-founder of Celegence discusses the increasing regulatory requirements and complexities faced by the medical device industry. Celegence works with companies to streamline their regulatory data management processes and adopt advanced technology solutions to manage compliance efficiently. Medical device companies are often slower than pharmaceutical companies to recognize the need to invest in data governance and process optimization to maintain compliance and avoid fines, delays in product approval, and loss of market access. Sonia explains, "The awareness is there, but medical device companies have traditionally been a bit slower in adapting and bringing in consultancy, expertise, and technology. That is partly because the sector’s regulations have not evolved at the same pace as in the pharmaceutical industry. More recently, though, the regulations have become more complex. For instance, the requirements under the EU MDR- Medical Device Regulation – are very heavy in terms of the information that needs to be submitted on an ongoing basis. So, the industry is starting to recognize what it takes to maintain documentation, specifically detailing post-market surveillance activities, which is required to be compliant with the regulations worldwide." "When you think about how medical devices are evolving, you get a sense of the growing complexity. For instance, there is now software that serves as a medical device. You also have AI being embedded into medical devices.   But ultimately, it’s about ensuring that the products placed on the market are safe and efficacious. The ability to prove that via proper documentation is important. That, in turn, enables different regulatory authorities to feel comfortable with the products that are being approved and being marketed in each region." #Celegence #RegulatoryAffairs #RegTech #RegulatoryStrategy #Pharmaceuticals celegence.com Download the transcript here

Dr. Ethan Korngold is the chief medical officer and divisional vice president of medical affairs at Abbott’s vascular business, which has developed a dissolvable stent technology to treat peripheral artery disease. PAD disproportionately affects Black and Hispanic communities and is often overlooked because early symptoms can be mistaken for other conditions. The Esprit BTK stent can help open up the smaller arteries below the knee and improve blood flow to the legs and feet to treat PAD and prevent severe complications and amputations. Ethan explains, "So peripheral artery disease refers to blockages in the arteries to the legs. When those blockages build up, it’s because of cholesterol typically that builds up in the walls of the artery and causes limited blood flow. Initially, people can have cramping or soreness in their legs when they walk. That gets better with rest. As the blockages get worse, people can develop infections, ulcers, or non-healing wounds of their legs with what we call chronic limb-threatening ischemia. And ultimately, that can put people at risk for amputation." "A lot of people aren’t aware of how common it is, and a lot of people aren’t attuned to the symptoms of it. People just sort of slow down. They do less and less, and they wind up being limited in their activities, and that really affects their health and their life, and ultimately, that can threaten their limbs. One of the things that Abbott is emphatic about is spreading awareness of the disease, trying to educate patients, trying to educate families, and trying to educate physicians so that people are more on guard for looking out for the signs and symptoms of the disease." "We have been working at Abbott for many years on techniques to help open up these blockages in the arteries of the legs. They start at about the belly button and go all the way down to the toes. At the belly button, the iliac arteries are quite large. They are about a half an inch in diameter. And then, as they go down all the way to the toes, they get narrower and narrower so that they’re about a quarter of an inch to an eighth of an inch in diameter. There are a variety of different techniques to get through those blockages, such as using catheters, and wires balloons, and stents and scaffolds to help open up those arteries and change people’s lives. One of the biggest challenges in this space has been those smaller arteries below the knee." #Abbott #AbbottVascular #PeripheralArteryDisease #PAD #DissolvableStentTechnology abbott.com PAD-info.com Download the transcript here

Dr. Jonathon Hill, VP of Science and Technology and Co-Founder of Wasatch Bio Labs has developed the Next-Generation Sequencing 3.0, NESSI-Seq platform, which can analyze blood to detect epigenetic changes and provide insights into current health and predisposition for diseases. This native-read third-generation sequencing tool can provide longer sequence reads and analyze epigenetic modifications to DNA. Epigenetics can change over time in response to diet, environment, and lifestyle. Advanced genetic testing has the potential to provide biomarkers to support personalized medicine for earlier detection and tailored interventions. Jonathon explains, "The biggest limitation with the Illumina sequencing was that it was only short sequences, so you had to get a lot of them to stitch them together and figure out what the human genome looked like. With this third-generation sequencing, we can get much longer reads, sometimes to the order of a hundred thousand nucleotide bases at a time. So we get these big complex reads." "The other thing we can do now with this third-generation sequencing is look at certain chemical modifications the body makes to the DNA to help regulate that DNA and help the body function. And looking at those chemical modifications can tell us a lot about someone's health. It can tell us their age, and it can tell us what disease they might have. We can get a lot of information out of that that just wasn't available to us in the previous two generations."  "If you think of classical genetics, it's the DNA sequence and the mutations you might have that might give you a propensity for the disease, etc. Those don't change throughout your life. Every cell in your body has that exact same sequence from birth until death. It never changes. But the epigenetics, these chemical modifications change. They change as you age. They are different in different tissues and organs within your body, changing even in response to pathogens or certain disease states. So they have a lot of information that we would not get otherwise." #WasatchBioLabs #Epigenetics #GeneticResearch #PersonalizedMedicine #DNAInnovation #GeneticTesting #NextGenSequencing #BiotechBreakthroughs #GeneRegulation #HealthcareInnovation #FutureofMedicine Wasatchbiolabs.com Download the transcript here

Bob Zemke, Director at Extreme Networks, provides network infrastructure and security solutions to help hospitals build resilient and secure networks. Critical security challenges hospitals face in managing networks include the proliferation of connected devices and the vulnerability of medical devices to cyber threats. In addition to education and collaboration between stakeholders, strategies for reducing security risks include network segmentation, AI-powered monitoring, and behavior analysis to help hospitals proactively address possible threats. Bob explains, "There are multiple factors that we take into play. First, how do we build a resilient network that can handle the amount of devices and traffic types? How do we prioritize the type of traffic flowing through, like the wires of the infrastructure and the wireless connectivity? And then how do we understand through analytics the behavior of those applications so that the healthcare organization, the security team can understand what is standard traffic or potentially rogue behaviors or traffic? What is performance impacting? So, visibility becomes just as important as the segmentation of device types and users on a network." "It's a security and performance risk. And if you think back to guest WiFi, when we started designing this about 20 years ago, we always laughed. It was like, well, we're building it, but how many people will bring a laptop into a hospital and want to connect as a guest user? Or even how many wireless devices compared to wired would be in a hospital network. Fast forward 20 years, you now have more mobile or wireless connected devices than wired in a given hospital network. So, you have to deal with RF performance management and security. And then you have the personal devices, which again, now with the mobile phone, people expect it."  #ExtremeNetworks #Cybersecurity #Hospitals #CyberThreats #MedicalDevices #AI #NetworkSecurity #HospitalNetworkSecurity #SecurityRisks #HealthTech #EnhancePatientCare #WiFi extremenetworks.com Download the transcript here

Wardah Inam is the CEO of Overjet, which uses AI to analyze dental X-rays to help dentists provide more comprehensive and objective diagnoses and treatment recommendations for patients. The Overjet platform can quantify dental disease progression and provide visualizations to help patients better understand their oral health. The use of AI in dentistry can improve patient outcomes, practice workflows, and the ability of dentists to communicate with patients about personalized data-driven care. Wardah explains, "One of our main challenges is that the dentist and the patients speak different languages when talking to each other. For example, a dentist licenses dental X-rays to communicate. Patients don't read X-rays, so they do not understand what the dentist says. So, for example, they might say, Hey, I see a radiolucency on tooth number four. The patient doesn't know what tooth number four is, and they don't know what atypical radiolucency is. And then they're squinting and trying to see what the dentist sees. And if you're not trained in reading dental X-rays, you don't see much. You see a lot of gray, white, and black, which causes confusion and lack of acceptance around the treatment and, in the end, what patients think. If it doesn't hurt, I don't need the treatment." "Overjet analyzes the dental data and identifies disease similarly how a dentist would, but we quantify the disease as well. So, for example, rather than just saying that there is bone loss, we'll measure the bone levels and say there are four millimeters of bone loss. And that helps look at what this state is. But also, you can start to say, how has it progressed since the last time you came and has there been a more longitudinal progression of disease as well?" #Overjet #Dentistry #Dentists #OralHealth #Xrays #DentalAI overjet.com Download the transcript here 

Dan Gallagher, Vice President for Strategy and Partnerships at Lyric, describes how Lyric uses advanced analytics to improve the coordination of benefits by proactively identifying coverage changes, verifying eligibility at the time of service, and transitioning patients to the correct payer. Coordination of benefits can be complex due to job changes, data lags, and situations like workplace accidents where multiple payers may be involved. Improving coordination of benefits can reduce patients' out-of-pocket costs and get providers paid faster.   Dan explains, "Simply stated, coordination of benefits is determining who or what entity has financial responsibility for an individual during a course of treatment. So, for a large portion of the population, it's pretty straightforward. You may have commercial insurance, and you may have one insurance card for your family, but there's not a lot to coordinate for other members of the population. You may have Medicare and you're still working over the age of 65. You may be under the age of 65 and have some conditions that make you Medicare eligible. You may have another spouse or two insured in the same family." "Then there are always remnant issues like work comp. Maybe you got hurt at work, had a motor vehicle accident, or had a slip and fall where there's another party responsible for the medical bills. Coordination of benefits is the process of identifying all the parties that might have a responsibility and then putting those parties in the right order so that the member pays the correct amount if they owe anything and that all the other parties pay their fair share." #LyricAI #CoordinationofBenefits #HealthInsurance #MedicalBills  lyric.ai Download the transcript here 

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