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/  Alex’s Charity: Americares https://www.americares.org/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  Celerion - 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 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 Mentioned in the podcast: Concussion Mouthguard Sensors: SISU Sense - https://www.sisuguard.com/sisusense/  HIT-IQ - https://www.hitiq.com/smart-mouthguard  Prevent Biometrics - https://preventbiometrics.com/  IDX-DR - Diagnosing Software 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), 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/  Aplos Analytics - https://aplosanalytics.com/  Email: nathan@aplosanalytics.com Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast https://teuschersolutions.com/  Collaboration with BioTalk Unzipped (Ep. 40) 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 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/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - 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 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  Nathan Teuscher https://www.linkedin.com/in/nathanteuscher/  Aplos Analytics - https://aplosanalytics.com/  Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast https://teuschersolutions.com/  Collaboration with BioTalk Unzipped (Ep. 40) https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - 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/ 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  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. Chapters00:00 Introduction to BioTalk Unzipped at AAPS PharmSci 36003:45 Samaritan's Purse Charity and Community Impact05:16 Most impactful talk at AAPS?11:50 Comparative Analysis of FDA and EU Regulations17:37 The Drive Behind Bioanalytical Work22:24 NEW NEWS! - Innovations in RNA Editing and BioanalysisTakeaways​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/ How to reach us:Please donate to: Samaritan’s Pursehttps://www.samaritanspurse.org/ Mark Arnoldhttps://www.linkedin.com/in/markearnoldphd/ Blog - https://bioanalysisandbiomarkers.blogspot.com/  Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - 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/  X - https://x.com/tomashelikar  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - 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/ Image Credits MIT Molecule, https://news.mit.edu/topic/algorithms?page=2 

Dr. Tomas Helikar, a leading researcher in bioinformatics and systems biology, delves into groundbreaking work on developing a personalized immune digital twin, which aims to revolutionize the understanding and treatment of immune-related diseases.  Chapters 00:00 Introduction to BioTalk Unzipped 01:50 Meet Dr. Tomas Helikar 04:34 The Journey into Systems Biology 10:03 Understanding Digital Twins in Immunology 14:19 The Importance of Personalized Medicine 17:20 Digital Twin Research Funding and Its Impact 18:38 The Role of Digital Twins in Disease Management 21:11 Digital Twin Efforts for Organ Transplants 24:05 Computational Challenges in Modeling 26:36 Mathematical Models in Biological Research 28:11 - NEW NEWS! - Twist Joins Absci in AI Antibody Collaboration How to reach us: Tomas Helikar  https://www.linkedin.com/in/tomashelikar/  X - https://x.com/tomashelikar  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Charity Mentioned: https://saintpeterlincoln.com/school  FOLLOW ► LinkedIn: https://www.linkedin.com/company/biotalk-unzipped Twitter: https://x.com/BiotalkUnzipped Instagram: https://www.instagram.com/biotalkunzipped/  Takeaways Dr. Helikar's research focuses on the immune system's network and disease. Systems biology integrates computer science and biology for better understanding. Digital twins can provide personalized models for immune system analysis. Your digital twin model could tell you how you might respond to a particular disease and if you really need to go to the hospital. The immune digital twin reflects an individual's unique immune baseline. Research funding is crucial for advancing innovative medical technologies. Personalized medicine can improve public health outcomes significantly. Computational power is essential for processing complex biological data. Mathematical models are vital for simulating biological processes. Digital twins can enhance drug discovery and clinical trial efficiency. Sound Bites "The immune system is a network of networks." “Each of our immune system baselines are different.” "We need to build out this multi-scale model." New News Story:  Supplier-Turned-Partner: Twist Joins Absci in AI Antibody Collaboration https://www.genengnews.com/topics/drug-discovery/supplier-turned-partner-twist-joins-absci-in-ai-antibody-collaboration/ Image Credits Signal Transduction, www.scientificanimations.com - http://www.scientificanimations.com/wiki-images/ Computational Model, https://computationstructures.org/notes/models/notes.html  Holland computer center, https://newsroom.unl.edu/announce/cse/16380/90600  https://news.unl.edu/article/husker-football-game-day-information-announced-for-2023 https://hcc.unl.edu/office-locations

Dr. Mark Arnold, a distinguished bioanalytical thought leader with an impressive track record in supporting drug development programs. Mark is the Owner and Principal at Bioanalytical Solution Integration, where he provides strategic counsel on complex bioanalytical assays and regulatory compliance. With over 35  years of experience, including leadership roles at BMS and Labcorp, Mark has become a key figure in the biotech and pharma industries. He is also an AAPS Fellow and a founder of the Global Bioanalysis Consortium.  01:05 - Career Reflections and Contributions to Drug Development 05:28 - Understanding the Integration of Drug Development 09:30 - What Would You Change? Embracing Career Risks in Pharma 11:32 - Navigating Career Paths: Small vs. Large Companies 16:09 - NEW NEWS! - Can Electrical Fields Disrupt Cancer? 23:28 - The Role of AI in Drug Development 31:13 - Encouraging Innovation in a Regulated Industry Follow Mark, Chad and Gregory: Please donate to: Samaritan’s Purse https://www.samaritanspurse.org/  Mark Arnold - https://www.linkedin.com/in/markearnoldphd/  Blog - https://bioanalysisandbiomarkers.blogspot.com/    Dr. Chad Briscoe - https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin - https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  BioTalk Unzipped on LinkedIn - https://www.linkedin.com/company/biotalk-unzipped/  New News Story:  Novocure wins FDA approval for electric field device in lung cancer https://www.biopharmadive.com/news/novocure-fda-lung-cancer-approval-optune-lua-tumor-treating-field/729997 Two articles on finding 1000’s of dark matter RNA viruses:   https://www.fiercebiotech.com/research/deep-learning-ai-model-scans-dark-matter-genomic-data-and-finds-70000-never-seen-rna https://www.nature.com/articles/d41586-024-03320-6 Image Credits Novocure images courtesy of Novocure: www.novocure.com 

EP-23. In the second half of this compelling conversation on BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe continue their deep dive with Scott Ogle, CEO of TruLab. They explore the surprising parallels between the banking and pharma industries, the game-changing role of digital twinning in clinical trials, and the biotech funding landscape. Scott also shares his thoughts on leadership, mentorship, and the impact of the Inflation Reduction Act on pharma innovation. This episode offers listeners valuable insights into the future of drug development and the challenges of balancing professional and personal life in a fast-paced industry. Chapters 1:09 - Comparison of the Banking Industry to the Pharma Industry 5:18 - Data Integrity, Same For Decentralized Trials? 8:33 - Biotech Funding Trends 11:18 - NEW NEWS! – Digital Twinning in Clinical Trials 16:15 - What Advice Would You Give to Your Younger Self? 20:57 - Mentorship and Its Impact, How it Shaped Scott 23:45 - Balancing Work and Personal Life 24:32 - The Inflation Reduction Act and Innovation Takeaways The regulatory environment in pharma can slow down innovation. Digital twinning in clinical trials could revolutionize drug development. Family influences play a significant role in shaping business perspectives. The need for a strong company culture to maintain values during growth. Biotech funding trends are influenced by macroeconomic factors like interest rates. The importance of mentorship in professional development. Sound Bites “The similarities between the banking industry and the pharma industry is eerily similar.” “Quality is really what we do.” “Being quality is core to software.” “It’s really clear people care more about their money than they do their healthcare.” “Biotech and large pharma seem to balance each other out.” “The career for you is at the intersection of what you are good at and what you like to do.”  “If you’re good at something and you like to do it, it fuels your energy to keep getting better.” “Enjoy the impact in what you’re doing and accomplishing!” New News Story:  Digital “Twinning”: Clinical Trials Powered by AI https://www.sanofi.com/en/magazine/our-science/digital-twinning-clinical-trials-ai   How to reach us: Scott Ogle https://www.linkedin.com/in/scott-ogle/  TruLab - https://trulab.com/    Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Image Credits Digital Twinning - Credit Getty Images Simulation - Credit: andrush / Adobe Stock Tomáš Helikar - https://www.linkedin.com/in/tomashelikar/  Nebraska Swan computer - https://newsroom.unl.edu/announce/cse/16380/90600 Brian Hamilton - https://inmatestoentrepreneurs.org/board/brian-hamilton/ 

Summary In this 22nd episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Scott Ogle, CEO of TrueLab, discussing his journey from finance to the pharmaceutical industry, the impact of personal experiences on innovation, and the importance of technology in clinical trials. They explore how to hire the best employees in this climate, the significance of company culture, and the influence of family on business perspectives.  Chapters 00:00 Introduction to BioTalk Unzipped 03:15 The Impact of Personal Experience on Innovation 08:47 TruLab's Technology and Its Role in Clinical Trials 14:33 The Importance of Sample Management and the Genesis of TruLab 20:33 NEW NEWS! – The Future of Cancer Treatments 23:34 Hiring Patterns and the value of Company Culture Takeaways Scott Ogle's personal experience with his father's illness inspired the creation of TruLab. TruLab focuses on eliminating inefficiencies in clinical trial sample management. The importance of having fun in one's career for productivity and happiness. Hiring for energy and cultural fit is crucial for company success. More young people out of college actually prefer working in the office, so it’s a hiring advantage. Sound Bites “Entrepreneurs get excited about their solution but can forget about what problem they’re solving.” "We need to iterate on technology in clinical trials." “20-25% of biological samples get tossed out.” "You can't coach energy in a candidate." “Company values. Senior leadership must beat it like a drum.” “Interviewing candidates on company values is your North Star.” “Go by what people do, not by what they say.”  “Hallway meetings, that’s where stuff gets done.” New News Story:  ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells https://www.nature.com/articles/s43018-024-00821-1 How to reach us: Scott Ogle https://www.linkedin.com/in/scott-ogle/  TruLab - https://trulab.com/  Leukemia & Lymphoma Society - https://www.lls.org/    Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Keywords: Scott Ogle, TruLab, clinical trial technology, biotech innovation, sample management in clinical trials, hiring for company culture, company values in leadership, finance to pharma journey, revolutionizing clinical trials, impact of personal experience on innovation, biotechnology leadership, clinical trial inefficiencies, cancer treatment news, digital transformation in pharma, family influence in business, company culture in biotech, pharmaceutical funding challenges, ISB 2001 trispecific T cell engager. Tags: #ScottOgle, #TruLab, #ClinicalTrials, #Biotech, #PharmaInnovation, #Sample Management, #Company Culture, #Hiring Tips, #BiotechLeadership, #PharmaTechnology, #CancerTreatment, #PersonalInnovation, #BiotechFunding, #LeadershipInPharma, #BusinessLeadership, #PharmaceuticalIndustry.

Mentoring in Pharmaceutical Science with Dr. Jim Shen Summary In Episode 21 of BioTalk Unzipped, host Gregory Austin and co-host Dr. Chad Briscoe interview Dr. Jim Shen, the executive director and head of regulated bioanalysis operations at BMS. Jim discusses his early career in bioanalysis and the importance of mentorship. He emphasizes the need to recognize and appreciate the success and expertise of others, as well as the importance of building a network of champions, allies, and sponsors. The conversation also touches on the topic of psychedelics as a drug therapy and the recent retraction of scientific papers on MDMA-assisted therapy. Jim shares his passion for photography, particularly infrared photography, and the resurgence of film photography. Chapters 01:14 - Jim’s Favorite Publication and His Journey into Bioanalysis 04:15 - Finding Joy in Your Work: Pursuing Your Interests and Making a Difference  05:10 - Early Career in Bioanalysis 07:35 - The Importance of Mentorship and Dealing With Adversaries 17:35 - NEW NEWS: Retraction of Scientific Papers on Drug Therapy 24:55 - Personal Interests: Photography and Gaming Takeaways Dr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans. Building a supportive and collaborative community is crucial in the field of bioanalysis, where knowledge sharing and networking play a significant role in advancing research and innovation. Recognize and appreciate the success and expertise of others Build a network of champions, allies, and sponsors Be open to new career opportunities and emerging fields Maintain integrity and transparency in scientific research Explore different hobbies and interests outside of work Sound Bites “Sponsors are those with the power to change your career. Those people don't come along very often, so you need to really grab them when you see them.” “EQ is so important in being successful in your larger pharmaceutical company.” “I first tell my staff to divide people into 3 groups, champions, allies, and sponsors.” “And it is very hard to be in this field, to be a scientist, but you know, it's the people that make it worthwhile.” New News Story:  Following FDA rejection, a journal retracts papers on MDMA-assisted therapy https://www.biopharmadive.com/news/lykos-journal-mdma-retractions-maps-ptsd-unethical-conduct/723945/  How to reach us: Dr. Jim Shen https://www.linkedin.com/in/jimxshen/  Bristol Myers Squibb - https://www.bms.com/    Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Image Credits Travis Kelce: https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DQY8xlVldVp8&psig=AOvVaw2yCKg3oh923dt0beIIR8w3&ust=1726284386832000&source=images&cd=vfe&opi=89978449&ved=0CBcQjhxqFwoTCICN_OD8vogDFQAAAAAdAAAAABB2 https://www.te-university.com/posts https://people.com/travis-kelce-says-hes-his-own-worst-critic-on-the-field-8684839 https://www.marca.com/en/nfl/kansas-city-chiefs/2023/07/12/64aec11a268e3e242d8b458e.html https://www.newheightshow.com/  https://www.aol.com/fans-think-moment-travis-kelce-185629668.html World of Warcraft Guilds https://www.dexerto.com/world-of-warcraft/wow-players-critical-of-unrealistic-guild-expectations-for-season-of-discovery-2392361/  Infrared Photography: Jim Shen Keywords Pharmaceutical, Mentor, Mentorship, Mentoring, Science, Biotech, Biotechnology, Gaming, Photography, Bioanalysis

In this episode (EP20) of BioTalk Unzipped, host Gregory Austin and co-host Dr. Chad Briscoe interview Dr. Jim Shen, the Executive Director and Head of Regulated Bioanalysis Operations at BMS. They discuss topics such as the advancements in cancer therapies, the integration of AI and mechanistic modeling in drug development, and the complexities of regulatory submissions. Dr. Shen shares his journey into bioanalysis and his passion for mass spectrometry.  Chapters 01:15 - Introduction, Background, and Passion for The American Cancer Society 03:46 - Advancements in Cancer Therapies, Opdualag  08:03 - From Small Molecule to Large to Hybrid 12:52 - NEW NEWS! - Halda Raises $126M for a New Targeted Cancer Therapy 18:30 - Dr. Shen’s Journey from Computers to Chemistry into Bioanalysis 27:00 - The Integration of AI and Mechanistic Modeling in Drug Development 34:30 - Navigating the Complexities of Regulatory Submissions Takeaways Advancements in cancer therapies, such as immunotherapy and antibody drug conjugates, have revolutionized the treatment landscape and improved patient outcomes. The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy. More research and collaboration between software and hardware engineers are needed to fully realize its potential. Navigating the complexities of regulatory submissions requires adherence to international guidelines and validation of analytical methods to ensure accuracy and precision. Dr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans. Sound Bites "Advancements in cancer therapies have revolutionized the treatment landscape." "Antibody drug conjugates are one of the most exciting and interesting types of molecules." "The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy." New News Story:  Startup Halda raises $126M to advance new type of targeted cancer therapy https://www.biopharmadive.com/news/halda-series-b-riptac-prostate-cancer/723933/ How to reach us: American Cancer Society https://www.cancer.org/  Dr. Jim Shen https://www.linkedin.com/in/jimxshen/  Bristol Myers Squibb - https://www.bms.com/    Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Images ADC Mechanism of Action https://www.researchgate.net/figure/Antibody-drug-conjugate-ADC-structure-and-mechanistic-schematic-Inset-in-upper-right_fig1_364183953  https://www.researchgate.net/figure/General-structure-of-antibody-drug-conjugate_fig1_355319441  Keywords Bioanalysis, Cancer, Oncology, Research, Drug Development, Compliance, Regulatory Compliance, AI, ADC, Antibody Drug Conjugates, immunotherapy, Pharmaceutical, Biotechnology, Podcast, Science, Pharmaceutical Science

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe continue their conversation with Zealic CEO, Chuck Piccirillo. They delve into the unique challenges of the patient journey and the increasing demand for hybrid healthcare solutions that offer more flexibility. The discussion highlights the rise of virtual health, particularly in Europe, and introduces exciting developments in ion channels as a goldmine for new medicines. They also explore the financial intricacies of drug development, the importance of leadership through incremental steps, the value of in-person interactions, and hard-earned lessons in the industry. Finally, Chuck offers invaluable advice for entrepreneurs in the life sciences sector. Chapters 00:17 - Adapting to what is unique in the patient journey. 07:08 - Push for hybrid solutions - more flexibility. 09:20 - Virtual health is emerging, especially in Europe. 14:02 - New News! - Ion Channels are a goldmine for new medicines 19:23 - The Financial Side of Drug Development 21:50 - Leadership - Incremental Steps, the Value of In-Person Interactions, Learning Hard Lessons 30:58 - Advice For Entrepreneurs in Life Science Takeaways Building blocks to build the digital patient experience, then tweak it to the individual drug and form a complex digital and personal adaptive health journey. The healthcare industry needs to find a balance between safety and innovation to ensure patients have access to the best possible care. Remote patient monitoring and decentralized clinical trials are crucial in improving patient engagement and outcomes in the healthcare industry. Virtual visits and technology integration can enhance patient engagement and make healthcare more accessible. While there has been an increase in decentralized trials, the focus is currently on commercial solutions due to the crowded nature of the clinical trial technology space. Virtual health and routine monitoring have the potential to alleviate the burden on healthcare providers and improve patient care. Ion channel research holds promise for developing new medicines and treatments for various conditions. Incremental progress and persistence are key in entrepreneurship and leadership. Sound Bites (regarding adaptability in clinical software) “Imagine if LinkedIn only every 6 months. How engaging would that be?” "And it would actually integrate with like Uber, for example, and help them get a ride if they had to go to the doctor and actually, and all of that is based on these building blocks that we're able to assemble and then press a button." “I think everybody wants whatever aspect of life nowadays to be hybrid anything.” “It’s why we always talk about pragmatic innovation.” “Persistence in the face of opposition of all sorts.” New News Story:  These microscopic tunnels are a goldmine for new medicines https://www.biopharmadive.com/news/ion-channels-drug-research-vertex-biohaven-jazz/719337/  How to reach us: Crohn's & Colitis Foundation https://www.crohnscolitisfoundation.org/  Chuck Piccirillo https://www.linkedin.com/in/cpiccirillo/  Zealic Health - http://www.zealichealth.com   Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Keywords Patient Journey, Hybrid Healthcare Solutions, Drug Development Finance, Leadership in Life Sciences, Entrepreneurship in Life Sciences, Remote Patient Monitoring, Decentralized Clinical Trials, Healthcare Technology Integration, Digital Patient Experience, Clinical Software Adaptability, Pragmatic Innovation, Persistence in Entrepreneurship, Leadership #HealthcareInnovation #VirtualHealth #DrugDevelopment #LifeSciences #Entrepreneurship #DigitalHealth #HybridHealthcare #IonChannels #PatientCare #RemoteMonitoring #ClinicalTrials #Leadership #HealthTech #PragmaticInnovation #Persistence #pharmaceutical #biotech #science #CEO

Summary In this conversation, Dr. Jonathon Hill discusses the unique partnership between his lab and the university, which allows students to become entrepreneurs, develop their own projects, and become the CEO. Dr. Hill discusses the potential for AI to better diagnose disease based on the individual’s genome. He also talks about Lumicell's fluorescent system for highlighting residual breast cancer tissue and the importance of genetic diagnostics in personalized medicine. Dr. Hill shares his advice for students interested in genetics and biotechnology research, emphasizing the value of research experience and taking risks. He also discusses the challenges of regulatory pathways in the biotech industry.  Takeaways The unique partnership between academic institutions and companies can provide students with opportunities to develop their own ideas and become entrepreneurs, fostering innovation and impact in the biotechnology industry.  Lumicell's fluorescent system can help detect residual breast cancer tissue, reducing the need for additional surgeries Genetic diagnostics will play a crucial role in personalized medicine, but there are limitations to relying solely on genetic sequencing Navigating regulatory pathways is a challenge in the biotech industry Sound Bites “We like to say that we are creating CEOs in our labs … CEO at age 23.” “When you go to the doctor, they do a guess and check model.” “Why did you not carefully diagnose the problem and give me the right treatment the first time?” “And medicine needs to go in the direction of AI-aided diagnosis because it's going to lower costs, make things faster and more efficient and better in the long run if we can create if we can create accurate diagnoses.” “Typically about 50% of high school seniors indicate they will go to college. This year it’s down to 37%” Chapters 01:01-The balance between being professor and running a lab 02:00-The unique partnership between university and industry 03:55-More students are looking to pursue entrepreneurship out of college 06:31-How will AI affect genetics research and the industry?  The impact of AI in future diagnoses. 12:58-New News! Lumcell’s breakthrough in residual breast cancer imaging detection. 16:10-Dr Hill’s passions within and outside his professional life. 17:37-Advice for young scientists and budding biotech entrepreneurs. 21:00-Growth of bioinnovations and training scientific students for business success vs. backlash of the cost of education. 28:48-The regulatory hurdles and progress for Wasatch and their DNA research. New News Article The FDA has granted a groundbreaking approval to a fluorescent light system that illuminates leftov...https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer  How to reach us: Dr. Jonathon Hill https://www.linkedin.com/in/jonathon-t-hill/  Wasatch Labs: https://www.wasatchbiolabs.com/  Rainforest Trust - https://www.rainforesttrust.org/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Image Credits Gattaca https://www.justwatch.com/us/movie/gattaca Lumicell Fluorescent System https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer  https://www.laserfocusworld.com/bio-life-sciences/article/14294960/fluorescence-imaging-system-may-improve-cancer-care  https://vimeo.com/807609920  https://healthandpharma.net/fda-approves-imaging-tumor-detection-breast-cancer-surgeries#google_vignette  Keywords nanopore sequencing, genetic research, epigenetics, rainforest preservation, AI, tobacco addiction, addiction treatment, Alzheimer's disease, DNA methylation #nanopore, #geneticresearch, #epigenetics, #AI, #addiction, #alzheimers, #DNA

Summary In this conversation, Gregory Austin and Chad Briscoe interview Chuck Piccirillo, CEO of Zealic Health, about his experience in the healthcare industry and the focus on patient-centric solutions. Chuck shares his personal journey with colitis and how it ultimately inspired him to start Zealic Health. The company aims to provide highly patient-centric digital platforms to improve care and treatment in the healthcare industry. Chuck also shares the story of how Zealic Health adapted to the war in Ukraine and relocated their employees to Poland. The panel tackles the tough questions around the new LDT as a Medical Device final ruling by the FDA. They then discuss how AI is helping doctors detect cancer and in making better diagnostic decisions. Takeaways Zealic Health focuses on providing patient-centric digital platforms to improve care and treatment in the healthcare industry. The use of AI in healthcare can help accelerate drug development, improve diagnostics, and enhance patient engagement. Zealic Health adapted to the war in Ukraine by relocating their employees to Poland, demonstrating their commitment to their team and their mission. The FDA final ruling is clearly to improve safety but the confusion is in the interpretation of that ruling and  Sound Bites “The biggest challenge is the interpretation of these (LDT) rules.” “Typically I’m not in favor of what Congress is doing.” “Trying to understand how we’re going to navigate the space … it’s just been confusing.” "The FDA is trying to protect us, but they need to navigate these things and engage industry experts." “(regarding AI) Where does marketing end and reality begin?” "AI isn't going to say, 'We don't need the doctor, just use AI.'" “The people who are out of their jobs won't be the ones using AI. The people who are out of their jobs will be the ones who don't.” “The whole promise of AI is taking massive amounts of data and finding those patterns Chapters 01:33 Introduction and Background 04:03 The Crohn’s & Colitis Foundation and Chuck’s struggle with Colitis 07:49 Patient-Centric Solutions in Healthcare and Zealic Health 13:26 Plan B - Moving offices from Ukraine to Poland 20:02 New News!! - The Controversy of LDTs Becoming Medical Devices 27:20 Implications of healthcare and regulations as it applies to AI 30:07 How AI Aids in Diagnosis New News Story: House committee tells FDA to suspend lab developed test rule https://www.healthcaredive.com/news/house-committee-fda-suspend-ldt-rule/721362/  How to reach us: Crohn's & Colitis Foundation https://www.crohnscolitisfoundation.org/  Chuck Piccirillo https://www.linkedin.com/in/cpiccirillo/  Zealic Health - http://www.zealichealth.com   Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Image credits: https://www.crohnscolitisfoundation.org/  LDT/FDA, https://x.com/FDADeviceInfo/status/1784965525522493657  Congress, https://worldstrides.com/blog/2013/07/u-s-capitol/  Cost, https://www.freepik.com/photos/increasing-costs  Cancer patient, https://www.freepik.com/free-photo/sick-asian-man-sitting-chair-side-view_33753979.htm  CAD - Computer Aided Detection, https://researchoutreach.org/articles/assessing-performances-computer-aided-diagnosis-breast-cancer/  #BioTalkUnzipped #Podcast #HealthcareInnovation #PatientCare #AIinHealthcare #FDARegulations #Ukraine #LifeSciences #DigitalHealth #AI #pharmaceutical #biotechnology #medicaldevice

Summary Dr. Andy Vick shares some of the things that surprised him throughout his career and he discusses his passion for reptiles and his experience discussing the pharmaceutical potential of venom with future toxicologists at Ashland University. Next, Andrew Vick discusses his role as an adjunct professor at Ohio State University, his involvement in academia, and how he got into it. We discuss a story about a clinical study that restored hearing in children with gene therapy. The conversation concludes with a discussion about the impact of professional organizations like AAPS on the industry and the importance of networking and fellowship. Takeaways Cancer doesn’t have the same death sentence - fear factor it used to have 30+ years ago. It takes about 10 years for a newly discovered compound to make it on the market. Andrew Vick is passionate about reptiles and has a collection of rare reptiles. He enjoys educating others about reptiles and their pharmaceutical potential, particularly venom. There’s a shift from small molecules to biologics in the past 5 years. Andrew Vick visited Ashland University to discuss the pharmaceutical potential of venom with future toxicologists, combining his passion for reptiles and pharmaceutical science. Andrew Vick is an adjunct professor at Ohio State University, where he teaches in the College of Pharmacy Division of Pharmaceutical Chemistry. His role as an adjunct professor involves giving guest lectures, providing career and professional development for students, and serving on the Dean's Corporate Council. Andrew Vick is also involved in evaluating assets developed in academia and collaborating with industry to develop strategies for bringing products to the clinic. We discuss a study by Regeneron that used gene therapy to restore hearing in children with mutations in the otoferlin gene. Regarding Cell-Gene Therapy we have a lot to learn both from the positive pharmacological potential, but also from a safety and tolerability standpoint. Professional organizations like AAPS play a crucial role in networking and fellowship, providing opportunities for collaboration and learning in the pharmaceutical industry. Sound Bites "I have just a passion for reptiles and have accumulated a small and pretty rare collection of reptiles from around the world." “It's probably a good 10 years from the glimmer in a biochemist's eyes to on the market.” “There’s a logarithmic difference between great and good.” “Just use your imagination on a way to tackle a disease and then find a way.” “Cell and gene therapy opens the door to a whole different category of opportunities.” “AAPS is just kind of part of my DNA.” Chapters 00:21 - Surprises in Dr. Vick’s Career 02:24 - The Cyclical Nature of Technology 03:30 - Exploring the Pharmaceutical Potential of Venom 05:35 - Improvements in Cancer and Other Diseases In The Past 30 Years 10:13 - Educating Future Toxicologists about Reptiles and Pharmaceuticals 15:45 - Andrew Vick's Role as an Adjunct Professor at Ohio State University 21:21 - New News!! - Restoring Hearing in Children with Gene Therapy 27:27 - The Impact of Professional Organizations on the Industry, AAPS New News Story:  The 'little protein factory' that could: Regeneron gene therapy restores hearing in 2 children https://www.fiercebiotech.com/biotech/little-protein-factory-could-regeneron-gene-therapy-restores-hearing-2-kids  How to reach us: Dr. Andy Vick https://www.linkedin.com/in/andy-vick-4467189/   Attralus: https://www.attralus.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Image credits: Pharmacognosy - https://pharmacognosy-phytochemistry-natural-products.pharmaceuticalconferences.com/events-list/industrial-pharmacognosy #biotechnology #science #research #toxicology #reptiles  #academia #cellgenetherapy #AAPS

Summary Dr. Andy Vick discusses his work at Attralus Therapeutics, a biotech company focused on developing treatments for systemic amyloidosis. He explains the etiology of the disease and how Attralus is attacking it using therapeutic antibodies with a pan amyloid reactive peptide sequence. The company is also developing a diagnostic tool to visualize amyloid burden in patients. Dr. Vick emphasizes the importance of toxicology in drug discovery and development, describing its role in evaluating the adverse side effects of drugs and ensuring safety. He also highlights the challenges of finding animal models for rare diseases like amyloidosis. In this part of the conversation, Andrew Vick discusses his transition from working in a contract research organization (CRO) to a small biotech company. He highlights the similarities and differences between working in biotech, pharma, and CROs, emphasizing the motivation to help others and improve the quality of life. The conversation then shifts to a discussion about a novel mRNA-based cancer vaccine for glioblastoma, which shows promise in early research. The vaccine wraps the RNA specific to a patient's tumor in lipid nanoparticles, stimulating a robust immune response against the cancer.  Takeaways Attralus Therapeutics is focused on developing treatments for systemic amyloidosis using therapeutic antibodies with a panamyloid reactive peptide sequence. The company is also developing a diagnostic tool to visualize amyloid burden in patients. Toxicology plays a crucial role in drug discovery and development, evaluating the adverse side effects of drugs and ensuring safety. Finding animal models for rare diseases like amyloidosis can be challenging. Andrew Vick transitioned from working in a contract research organization (CRO) to a small biotech company, highlighting the similarities and differences between the two. The motivation to help others and improve the quality of life is a common thread in biotech, pharma, and CROs. A novel mRNA-based cancer vaccine for glioblastoma shows promise in early research, stimulating a robust immune response against the cancer. Sound Bites "Attralus Therapeutics is focusing on biologic-based therapeutics and diagnostics related to amyloidosis." "Toxicology is the science of evaluating the adverse side effects of drugs." "Attralus Therapeutics' lead product is a therapeutic antibody with a panamyloid reactive peptide sequence." "This novel mRNA vaccine shows promise against deadly brain cancer."   Chapters 02:22 Dr. Vick’s Charity Work in Brazil 06:30 Introduction to Attralus Therapeutics 07:41 Developing Treatments for Systemic Amyloidosis 10:35 The Role of Toxicology in Drug Discovery and Development 16:38 Using Animal Models Studying Amyloidosis  22:06 The History of Attralus and Dr. Vick’s Transition There from CRO 32:45 New News! - Promising Results of an mRNA-Based Brain Cancer Vaccine New News Story:  Glioblastoma vaccine turns brain tumors from cold to hot in humans and dogs https://www.fiercebiotech.com/research/glioblastoma-vaccine-turns-brain-tumors-cold-hot-humans-and-dogs  Media credits: Pilot https://www.amazon.com/Military-Aircraft-Cockpit-Photograph-Picture/dp/B07Z2KM6KY UF https://www.clickorlando.com/news/florida/2024/03/11/university-of-florida-axes-diversity-and-inclusion-office-under-gop-led-law-aimed-at-ridding-similar-programs/  Music Track: "CLARITY", Mifune Music provided by https://slip.stream  Download / Stream: https://get.slip.stream/KFCilm    Keywords Attralus Therapeutics, systemic amyloidosis, therapeutic antibodies, panamyloid reactive peptide sequence, diagnostic tool, toxicology, drug discovery, drug development, animal models, rare diseases, transition, contract research organization, CRO, biotech, pharma, motivation, quality of life, mRNA-based cancer vaccine, glioblastoma, lipid nanoparticles, immune response #biotechnology #science #research #toxicology #glioblastoma #braincancer #vaccine #amyloidosis

A Diagnostic Breakthrough for Alzheimer’s Summary In this conversation, Dr. Jonathan Hill discusses his work in nanopore sequencing-based technology and its applications in genetic and epigenetic research. He shares his experiences working in Brazil and his passion for preserving the rainforest. The conversation also explores the use of AI in analyzing the genetic underpinnings of tobacco addiction and the potential impact on addiction treatment. Dr. Hill highlights his lab's breakthrough in identifying early biomarkers for Alzheimer's disease using DNA methylation signatures.  Takeaways Nanopore sequencing is a powerful technology that allows for real-time analysis of native DNA and RNA, regardless of length, and provides valuable insights into genetic and epigenetic research. Preserving the rainforest is crucial, and initiatives like the Rainforest Trust play a vital role in protecting the biodiversity and resources found in these ecosystems. AI technologies, when used in conjunction with genetic research, can accelerate the identification of candidate genes associated with complex conditions like tobacco addiction, leading to personalized approaches for smoking cessation and addiction treatment. The integration of AI technologies in genetic research should be approached with caution, as the black box nature of AI can limit our understanding of the underlying biology. It is important to carefully test and explain AI models to build trust among users. The use of nanopore sequencing and DNA methylation signatures shows promise in the early detection of Alzheimer's disease, potentially allowing for personalized approaches to treatment and intervention. Sound Bites "One of my bucket list items, one of my dreams would be to set up a nanopore sequencing lab in the Amazon and just sequence that biodiversity and create that data so we could glean it for everything it's worth and learn so much about how our world works." "Nanopore sequencing is based on protein nanopores that exist in nature, and these particular nanopores can pass DNA through the pore." "AI technologies, when used in conjunction with genetic research, can accelerate the identification of candidate genes associated with complex conditions like tobacco addiction, leading to personalized approaches for smoking cessation and addiction treatment." “Biology is not rocket science, it’s much harder.” "Better diagnosis comes better treatment." Chapters 00:00 Introduction  02:51 Donation to the Rainforest Trust & Time in Brazil 06:37 How Nanopore Sequencing Works 12:45 New News!  AI and the Genetic Code of Tobacco Addiction 15:20 Using AI in Nanopore Sequencing at Wasatch Labs and Diagnostics 21:14 Finding Cell-Free DNA for Fertility Treatments 22:56 Breakthrough - Finding Early Biomarkers for Alzheimer’s New News Article Breaking the Genetic Code of Tobacco Addiction https://neurosciencenews.com/genetics-tobacco-addiction-ai-25937/  How to reach us: Dr. Jonathan Hill https://www.linkedin.com/in/jonathon-t-hill/  Wasatch Labs: https://www.wasatchbiolabs.com/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Image Credits Rainforest Trust - https://www.rainforesttrust.org/  https://www.envirobuild.com/blog/rainforest-trust Fire Sponge https://stock.adobe.com/  Amazon Photos: Shutterstock  Medicine Man https://www.rollingstone.com/music/music-lists/stills-from-the-movie-medicine-man-32217/medicine-man-5-159239/  https://www.solarnavigator.net/films_movies_actors/medicine_man.htm Oxford Nanopore Technologies How nanopore sequencing works https://www.youtube.com/watch?v=RcP85JHLmnI  Keywords nanopore sequencing, genetic research, epigenetics, rainforest preservation, AI, tobacco addiction, addiction treatment, Alzheimer's disease, DNA methylation #nanopore, #geneticresearch, #epigenetics, #AI, #addiction, #alzheimers, #DNA

The AI Prescription: Revolutionizing Pharma & Patient Care with Jason Burke Summary In Episode 13, Jason Burke discusses the unique approach of the Duke program in providing real-world healthcare data to students. He also highlights the breakthrough in AI-generated drug discovery and its potential impact on investors and startups. The process of assessing technologies for companies and patients is explored, with a focus on evaluating business and technology aspects. The importance of unique intellectual property is emphasized, and the future of AI and software is discussed. The conversation concludes with insights into using AI in everyday life and the role of search engine companies in AI. In this conversation, Chad and Jason discuss the interface between pharma companies and the healthcare industry, highlighting the lack of interplay between the two. They explore the challenges faced by the healthcare industry, including the complexity of the operating environment and the limited infrastructure for research. Jason emphasizes the potential for life sciences firms to become service companies and overcome these challenges. They also delve into Jason's interest in amateur radio and the fascinating world of ham radio, where he has been learning and discovering new things. Takeaways The Duke program provides students with real-world healthcare data, giving them a unique advantage in the job market. AI-generated drug discovery has the potential to revolutionize the pharmaceutical industry and attract more investment to startups. Assessing technologies for companies and patients involves evaluating both the business and technology aspects, including intellectual property. The future of AI and software will see the emergence of new forms of experiences and collaboration between humans and machines. Search engine companies have been late to adopt AI technologies like ChatGPT, but they have already been utilizing AI in their search algorithms.  \There is a need for more interplay between pharma companies and the healthcare industry to ensure better understanding of customer needs and feedback. The healthcare industry faces challenges due to the complexity of the operating environment and limited infrastructure for research. Life sciences firms have the potential to become not just product companies, but service companies and provide valuable solutions to overcome the challenges in the healthcare industry. Doctors want to help patients at the highest level possible but continually grapple with the complexity of the healthcare environment and the sheer volume of patients. Amateur radio, or ham radio, offers a fascinating world of learning and discovery, with a community of innovators constantly finding new and creative ways to use the technology. Chapters 00:29 Unique Approach in Duke Program 05:14 New News! The First AI-Generated Drug Discovery 09:33 Assessing Technologies for Companies and Patients.  11:52 The Importance of Unique Intellectual Property 12:35 The Future of AI and Software 13:36 Data as a Commodity 15:10 Innovation Curves and Technology, AI Compressing it 16:41 Using AI in Everyday Life 19:04 Why were Search Engine Companies Late to the Generative AI Game? 20:05 New Forms of Software and Experiences 22:53 The Future of Healthcare and Pharma - Enough Interfacing? 25:08 The Difficulty of Doctors in Complex Environments and Implementing Precision Medicine 29:03 Jason's Interest in Amateur Radio and Exploring the Ham Radio Community 31:39 Bouncing a Radio Signal Off the Moon & Sending Emails over Radio Waves How to reach us: Jason Burke https://www.linkedin.com/in/jasonburke/ Creo Inc. -  https://www.creoinc.net/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com/  #AI  #pharmaceutical #healthcare #drugdiscovery #futuretech #lifesciences

Summary In this episode of BioTalk Unzipped, the hosts discuss the applications and ethical concerns surrounding organoids, which are 3D cell clusters that mimic the features of full-sized organs. They explore the potential of brain organoids in brain-computer interfaces and neuroplasticity. The conversation then shifts to the impact of AI and data sciences in healthcare, with a focus on the challenges and opportunities in implementing AI strategies. The hosts also discuss the future of quantum computing in healthcare and the FDA's IT strategy with 21 CFR Part 11.  Chapters 01:14 - Introduction to BioTalk Unzipped 03:30 - NEW NEWS: Discussion on Organoids and Their Applications  04:45 - Ethical Concerns with Brain Organoids as mini bio-computers 06:31 - Organoid Possibilities in Drug Discovery Research and Brain Interfaces 08:59 - The Potential of Brain Training and Neuroplasticity 10:51 - The Impact of AI and Data Sciences in Healthcare 11:18 - Jason’s Background and Emerging Technologies Transforming Clinical Research 13:43 - The Role of AI in Precision Medicine, Quantum Computing and Business Growth 24:15 - FDA's IT Strategy and the Challenges of Implementing AI 26:32 - The Importance of Strategy and Prioritization in IT, Data Integrity, and 21 CFR Part 11 How to reach us: Jason Burke https://www.linkedin.com/in/jasonburke/ Creo Inc. -  https://www.creoinc.net/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com/  New News Link: The many uses of mini-organs https://www.technologyreview.com/2024/03/08/1089612/the-many-uses-of-mini-organs/  Image Credits Brain - https://www.vecteezy.com/vector-art/658977-kawaii-cute-happy-brain-with-arms-and-legs UFO - https://www.pinterest.com/pin/swampthingy--675891856570360044/ #HealthcareInnovation #Organoids #AI #QuantumComputing #Podcast #BioTalkUnzipped #drugdiscovery

Welcome to the premiere of BioTalk Unzipped, the podcast where the complex world of biotechnology gets unzipped by your hosts, Gregory Austin and Dr. Chad Briscoe. In this inaugural episode, we invite you to pull up a virtual chair and join us in an enlightening conversation that transcends the boundaries of traditional scientific discussions. What's on the Table? Discover the pulse of the biotech industry as we dive into the latest headlines and unravel the stories shaping the future. Gregory and Dr. Chad bring their unique perspectives to the table, shedding light on the trends and surprises that define the ever-evolving landscape of biotechnology. Meet Gregory and Chad and get a feel for their backgrounds and careers. Facing the Unknown: When Biotech Companies Fail Explore the candid dialogue as we navigate the often uncharted territory of failure in biotech companies. What happens when the best-laid plans go awry? How do setbacks contribute to the industry's overall resilience? Join us as we share insights, lessons learned, and the silver linings that emerge from the challenges. Behind the Curtain: Dr. Chad Briscoe's Biotech Revelations Join us as we delve into the riveting world of biotech surprises with none other than our co-host, Dr. Chad Briscoe. In this episode, Dr. Briscoe unveils the moments in his distinguished career that left him utterly surprised. Blueprints for Success: Navigating the Scientist's Journey Ever wondered what it takes to be a successful scientist in the fast-paced world of biotech? Gregory and Dr. Chad pull back the curtain on their own experiences, offering valuable insights, tips, and strategies for aspiring scientists. Whether you're a seasoned professional or just starting your journey, this episode is a compass for success in the field. Join the Conversation BioTalk Unzipped isn't just a podcast; it's an invitation to join a community of curious minds passionate about biotechnology. Engage with us as we unravel the complexities, share stories, and explore the fascinating intersection of great science and life. Tune in to the BioTalk Unzipped Premiere and embark on a journey through the realms of biotech that goes beyond the ordinary. Don't miss out on the conversation - because the future of biotechnology is unzipped here! To connect with the Cohosts directly, visit their LinkedIn pages: Gregory Austin - https://www.linkedin.com/in/gregoryaustin1/  Dr. Chad Briscoe - https://www.linkedin.com/in/chadbriscoe/To see Gregory Austin’s book, “Stellar Resume Writing: Secrets From a Corporate Recruiter”, visit Amazon: https://www.amazon.com/dp/B07NTK6RG2 #biotechnology #pharmaceutical #science #drugdevelopment #drugdiscovery #research