BioTalk Unzipped

In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe welcome Dr. Alex Friedman, a seasoned expert in regulatory affairs for medical devices and AI as Software as a Medical Device. Chapters 02:26 Introduction to BioTalk Unzipped 03:40 Charity Spotlight: Americares 05:01 Dr. Alex Friedman's Career Journey 11:52 The Regulatory Landscape of Medical Device Classifications 18:52 Regulatory Gameshow!: Classifying Medical Devices 22:28 AI Enabled Software as a Medical Device: An Overview  25:25 New News!! - Innovative Cardiac Health App: The Case of Antshrike 30:31 The Evolution of Wearable Health Technology 41:17 Liability and Risk in Medical Device Development 43:57 Clinical Decision Support Software - Challenges in Regulating AI in Healthcare 47:13 Self Updating AI Doctors?? - The Future of AI in Public Health 49:00 Navigating FDA Regulations for AI Technologies and Doc in a Box 56:27 New News!! - The Intersection of AI, Regulation, and Innovation 01:07:28 Measuring Success in Life and Work HOW TO REACH US: Alex Friedman https://www.linkedin.com/in/alexfriedman/ [https://www.linkedin.com/in/alexfriedman/]  Alex’s Charity: Americares https://www.americares.org/ [https://www.americares.org/]  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   New News Story - Innovative app from Before Health Intelligence identifies early signs of cardiac issues using wearable device data * https://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424 [https://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424] New News - 2025 forecast: How will AI, regulators and the government intersect? From Fierce MedTech * https://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersect [https://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersect] Mentioned in the podcast: Concussion Mouthguard Sensors: SISU Sense - https://www.sisuguard.com/sisusense/ [https://www.sisuguard.com/sisusense/]  HIT-IQ - https://www.hitiq.com/smart-mouthguard [https://www.hitiq.com/smart-mouthguard]  Prevent Biometrics - https://preventbiometrics.com/ [https://preventbiometrics.com/]  IDX-DR - Diagnosing Software https://www.healthvisors.com/en/idx-dr/ [https://www.healthvisors.com/en/idx-dr/]  Sound Bites "The common thread is the science." "Regulatory has to catch up." "You can't sell snake oil." "It's a multidisciplinary effort." "Software as a medical device is a hot thing." Image Credits: Aliens -  https://www.reddit.com/r/LV426/comments/9i8omb/mildly_disappointing_according_to_the_viewscreens/ https://filmmusiccentral.com/2018/10/16/my-thoughts-on-aliens-1986/ keywords medical devices, regulatory affairs, FDA, bioengineering, clinical decision support, AI in healthcare, Americares, healthcare innovation, medical technology, software as a medical device, AI in healthcare, regulatory challenges, wearable technology, health apps, FDA regulations, medical device liability, cardiovascular health, quality management system, innovative health solutions, AI, healthcare, clinical decision support, FDA regulations, public health, adaptive software, medical devices, innovation, technology, regulatory affairs

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe continue their conversation with Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. They discuss the challenges and opportunities presented by new technologies, particularly in drug development and patient engagement. The conversation highlights the evolution of pharmaceuticals, and the potential of virtual clinical trials. In this conversation, Nathan Teuscher discusses the importance of optimizing drug dosages in oncology, the challenges faced in cell therapy, and the complexities of treating immunocompromised patients. He emphasizes the need for collaboration in the scientific community and shares his perspective on measuring success in life and career. Additionally, Nathan talks about his podcast, Clinical Pharmacology (https://creators.spotify.com/pod/show/clinical-pharmacology [https://creators.spotify.com/pod/show/clinical-pharmacology]), which aims to educate listeners on clinical pharmacology and related topics. Chapters 00:51 The Changing Landscape of Pharmaceuticals 03:49 Virtual Clinical Trials and Patient Engagement 08:06 Optimizing Drug Dosage in Oncology 10:55 New News! - FDA Approvals (Mesoblast) and Challenges in Cell Therapy 14:26 The Complexities of Cell Therapy 17:33 Navigating Immunocompromised States in Treatment 20:09 Advice to Young Scientists in Biopharma  23:04 Defining Success in Life and Career 24:47 The Purpose and Impact of Nathan's Podcast, Clinical Pharmacology HOW TO REACH US: Nathan Teuscher https://www.linkedin.com/in/nathanteuscher/ [https://www.linkedin.com/in/nathanteuscher/]  Aplos Analytics - https://aplosanalytics.com/ [https://aplosanalytics.com/]  Email: nathan@aplosanalytics.com Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast https://teuschersolutions.com/ [https://teuschersolutions.com/]  Collaboration with BioTalk Unzipped (Ep. 40) https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 [https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951]  Podcast (on Spotify): https://creators.spotify.com/pod/show/clinical-pharmacology [https://creators.spotify.com/pod/show/clinical-pharmacology] Podcast (on Apple): https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234 Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/]  ECI - https://eci-rx.com [https://eci-rx.com] /  Takeaways Nathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics. Virtual clinical trials can enhance patient engagement and diversity in research. Finding the right dosage is a critical challenge in drug development. Project Optimus aims to redefine oncology drug development practices. AI and data analysis can help identify ideal candidates for clinical trials. Ethical considerations are paramount in the use of patient data for research. The right dose for each patient varies significantly. Understanding individual immune system capacities is crucial in treatment. Collaboration is key to success in the scientific community. Success is measured by the happiness of loved ones. Finding joy in helping others is essential for career fulfillment. Podcasts serve as valuable educational resources. Engaging with diverse disciplines enhances scientific understanding. Sound Bites “If you want to be successful, seek first to understand, then be understood.” “If you’re looking to help people and in collaboration, you’ll be successful.” “Success in life is the happiness of loved ones around you.” New News Story:  After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy https://www.fiercepharma.com/pharma/fda-nod-gvhd-cell-therapy-gives-australian-biotech-mesoblast [https://www.fiercepharma.com/pharma/fda-nod-gvhd-cell-therapy-gives-australian-biotech-mesoblast?utm_medium=email&utm_source=nl&utm_campaign=LS-NL-FiercePharma&oly_enc_id=5122A1550889G2Y] keywords BioTalk, pharmacology, AI in pharma, drug development, Nathan Teuscher, pharmacometrics, virtual clinical trials, clinical research, pharmaceuticals, virtual trials, healthcare innovation, drug development, patient engagement, medical technology, drug dosage, oncology, FDA approval, cell therapy, immunocompromised, collaboration, success, clinical pharmacology, podcast, healthcare

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. The conversation explores Nathan's career journey, the innovative charity Light the World, and the transformative role of AI in drug development. They discuss the challenges and opportunities presented by AI, particularly in automating data analysis and rethinking traditional reporting methods in the pharmaceutical industry. The episode emphasizes the potential for small companies to leverage cloud-based tools and APIs to enhance efficiency and drive innovation in drug development. In this conversation, the speakers explore the intersection of data analysis, AI tools, and advancements in gene editing with organ transplants. Chapters 00:00 Episode Preview 00:55 Introduction to BioTalk Unzipped 02:06 Charity Spotlight: Light of the World 04:51 Nathan Teuscher's Career Journey 07:34 Differentiating AI Types in Life Science 12:41 Challenges with Large Language Models 15:39 Rethinking Reporting in Pharma 17:56 The Future of AI and Analytics in Pharma? 18:52 Leveraging APIs (Application Programming Interfaces) for Small Companies 23:05 Leveraging Data, AI, and APIs in 3 Dimensions 26:22 NEW NEWS! - Gene Editing Breakthroughs in Medicine How to reach us: Light the World Charity - Church of Jesus Christ Latter Day Saints https://www.churchofjesuschrist.org/comeuntochrist/light-the-world [https://www.churchofjesuschrist.org/comeuntochrist/light-the-world]  Nathan Teuscher https://www.linkedin.com/in/nathanteuscher/ [https://www.linkedin.com/in/nathanteuscher/]  Aplos Analytics - https://aplosanalytics.com/ [https://aplosanalytics.com/]  Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast https://teuschersolutions.com/ [https://teuschersolutions.com/]  Collaboration with BioTalk Unzipped (Ep. 40) https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 [https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951]  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/]  ECI - https://eci-rx.com [https://eci-rx.com] /  Sound Bites "We don't need to write reports anymore." Takeaways * Nathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics. * Light the World charity offers unique giving machines for donations. * AI can automate repetitive tasks in drug development, freeing up human capital for innovation. * There are two types of AI: large language models and automated data analysis. * Large language models can be unreliable in scientific contexts. * Pharmaceutical companies spend significant resources on report writing, which may not add value. * Small companies can leverage APIs to access standardized calculations and data analysis. * The pharmaceutical industry is often insular, limiting the potential of AI. * AI could potentially eliminate the need for extensive written reports in drug development. * Collaboration and data sharing are crucial for advancing AI in the pharmaceutical industry. Leveraging data effectively requires combining various data sets and tools. * The evolution of AI tools is crucial for navigating new technologies. * Gene editing represents a significant breakthrough in organ transplantation. New News Story:  * A woman in the US is the third person to receive a gene-edited pig kidney * https://www.technologyreview.com/2024/12/17/1108905/a-woman-in-the-us-is-the-third-person-to-receive-a-gene-edited-pig-kidney/ [https://www.technologyreview.com/2024/12/17/1108905/a-woman-in-the-us-is-the-third-person-to-receive-a-gene-edited-pig-kidney/] Image Credits * Pig Kidney, https://ny1.com/nyc/all-boroughs/news/2023/08/16/pig-kidney-works-in-a-donated-body-for-over-a-month--a-step-toward-animal-human-transplants [https://ny1.com/nyc/all-boroughs/news/2023/08/16/pig-kidney-works-in-a-donated-body-for-over-a-month--a-step-toward-animal-human-transplants]  Keywords BioTalk, pharmacology, AI in pharma, drug development, pharmacometrics, software development, clinical research, Light the World, charity, data analysis, AI tools, gene editing, kidney transplant, pharmaceuticals, virtual trials, healthcare innovation, drug development, patient engagement, medical technology, drug dosage, oncology, FDA approval, cell therapy, immunocompromised, collaboration, success, clinical pharmacology, podcast, healthcare

In this episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Dr. Mark Arnold, a distinguished bioanalytical thought leader. They discuss the impact of recent FDA regulations on drug development, the importance of community support through the Samaritan Purse charity, especially on recent hurricane victims, and the exciting advancements in RNA editing technologies. The conversation highlights the collaborative nature of the pharmaceutical industry and the drive behind bioanalytical work, emphasizing the ultimate goal of delivering effective therapies to patients.  Chapters 00:00 Introduction to BioTalk Unzipped at AAPS PharmSci 360 03:45 Samaritan's Purse Charity and Community Impact 05:16 Most impactful talk at AAPS? 11:50 Comparative Analysis of FDA and EU Regulations 17:37 The Drive Behind Bioanalytical Work 22:24 NEW NEWS! - Innovations in RNA Editing and Bioanalysis Takeaways * The FDA's new rules on lab-developed tests could delay biomarker utilization in clinical trials. * Community support through charities like Samaritan's Purse is crucial during crises. * The importance of collaboration in advancing drug development and bioanalytical methods. * Innovations in RNA editing present new bioanalytical challenges. * The drive to help patients is a key motivator for professionals in the field. * Sound Bites * "I worked on that drug and there's a clear benefit." * "It's getting that new therapy to a patient." * "This is going to change and potentially delay biomarkers." * New News Story:  * Wave sees RNA editing validation in early trial results ◦https://www.biopharmadive.com/news/wave-rna-editing-aatd-first-trial-data/729981/ [https://www.biopharmadive.com/news/wave-rna-editing-aatd-first-trial-data/729981/]  How to reach us: Please donate to: Samaritan’s Purse https://www.samaritanspurse.org/ [https://www.samaritanspurse.org/]  Mark Arnold https://www.linkedin.com/in/markearnoldphd/ [https://www.linkedin.com/in/markearnoldphd/]  Blog - https://bioanalysisandbiomarkers.blogspot.com/ [https://bioanalysisandbiomarkers.blogspot.com/]    Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/]  ECI - https://eci-rx.com [https://eci-rx.com/] /  Image Credits * AAPS

BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe engage with Dr. Tomas Helikar in an exciting discussion on the future of AI, digital twins, and personalized medicine. From mathematical models and immune system simulations to groundbreaking collaborations with the Department of Defense, this episode uncovers how digital twins have the potential to transform drug discovery and clinical trials. Don’t miss insights on the ethical challenges of data privacy, the promise of animal digital twins, and the latest AI breakthroughs like MIT’s Sparrow algorithm! Chapters 01:00 How the mathematical models work. Normalization and Scaling in Computational Biology 07:55 Focus on the Immune System and Organ Models 09:05 Collaboration with the Department of Defense 11:03 Drug Discovery and Digital Twins 13:43 NEW NEWS! - AI in Drug Discovery: The MIT Sparrow Algorithm 17:51 Future of Digital Twins in Clinical Trials 18:59 Personalized Medicine and Individualized Treatments 23:33 The Potential of Animal Digital Twins 24:59 Building a Research Infrastructure for Digital Twins 26:03 Privacy and Ownership of Digital Twin Data 30:14 Encouraging Publication and Literature Engagement How to reach us: Tomas Helikar  https://www.linkedin.com/in/tomashelikar/ [https://www.linkedin.com/in/tomashelikar/]  X - https://x.com/tomashelikar [https://x.com/tomashelikar]  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/]  ECI - https://eci-rx.com [https://eci-rx.com] /  Sound Bites "Publications are the currency in academia." New News Story:  * MIT’s SPARROW Redefines Drug Discovery With Smart Synthesis * https://scitechdaily.com/mits-sparrow-redefines-drug-discovery-with-smart-synthesis/ [https://scitechdaily.com/mits-sparrow-redefines-drug-discovery-with-smart-synthesis/] Image Credits * MIT Molecule, https://news.mit.edu/topic/algorithms?page=2 [https://news.mit.edu/topic/algorithms?page=2]