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On the show
From 11 epsHosts
Recent guests
Recent episodes
The Future of Oncology Drug Development | Dr. Lakshmi Amaravadi
Jun 11, 2026
29m 41s
Active Machine Learning for Drug Discovery & Nanomedicine with Dr. Daniel Reker
Apr 25, 2026
50m 37s
Why Haven’t We Cured Cancer Yet? | Dr. Bob Liu Explains
Mar 19, 2026
1h 00m 16s
The Intersection of Biotech, Patent Law, and AI with Dr. Kate Neville, IP Attorney
Feb 16, 2026
52m 45s
Long-acting Cell-Based Gene Therapy, Fabry Disease and Beyond with Glafabra CEO, Dr. Chris Hopkins
Dec 22, 2025
49m 00s
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| Date | Episode | Topics | Guests | Brands | Places | Keywords | Sponsor | Length | |
|---|---|---|---|---|---|---|---|---|---|
| 6/11/26 | The Future of Oncology Drug Development | Dr. Lakshmi Amaravadi✨ | oncology drug developmentbioanalysis+4 | Dr. Lakshmi Amaravadi | AstraZeneca | San Antonio | oncologybioanalysis+5 | Leucentra | 29m 41s | |
| 4/25/26 | Active Machine Learning for Drug Discovery & Nanomedicine with Dr. Daniel Reker✨ | active machine learningdrug discovery+4 | Dr. Daniel Reker | Duke University | — | artificial intelligencedrug delivery systems+6 | Leucentra | 50m 37s | |
| 3/19/26 | Why Haven’t We Cured Cancer Yet? | Dr. Bob Liu Explains✨ | cancer biologyimmunotherapy+3 | Dr. Bob Liu | GenentechRoche | — | cancerimmunotherapy+5 | LEUCENTRA | 1h 00m 16s | |
| 2/16/26 | The Intersection of Biotech, Patent Law, and AI with Dr. Kate Neville, IP Attorney✨ | biotechpatent law+4 | Dr. Kate Neville | Marshall, Gerstein & Borun | — | biotechpatent prosecution+5 | — | 52m 45s | |
| 12/22/25 | Long-acting Cell-Based Gene Therapy, Fabry Disease and Beyond with Glafabra CEO, Dr. Chris Hopkins✨ | cell-based gene therapyFabry disease+4 | Dr. Chris Hopkins | Glafabra | — | gene therapyCRISPR+5 | — | 49m 00s | |
| 10/23/25 | Fail Fast, Learn Faster: Drug Development in Rare Disease with Dr. Binodh DeSilva✨ | drug developmentrare diseases+5 | Dr. Binodh DeSilva | Ultragenyx PharmaceuticalAAPS+1 | Sri LankaUniversity of Kansas | drug developmentrare diseases+5 | — | 31m 28s | |
| 9/12/25 | Unlocking Antibody Development with AI with Dr. Pin-Kuang Lai✨ | AI in antibody developmentmolecular engineering+3 | Dr. Pin-Kuang Lai | Stevens Institute of TechnologyCelerion | — | antibody developmentAI validation+5 | — | 17m 52s | |
| 7/3/25 | The Science and Hope of Brain Cancer with Dr. Robert Thorne, Denali Therapeutics✨ | brain cancer treatmentCNS drug delivery+4 | Dr. Robert Thorne | focused ultrasoundmolecular engineering approaches+3 | — | brain cancerCNS drug delivery+5 | — | 22m 17s | |
| 6/8/25 | Inside AAPS NBC with AAPS President Dr. Russ Weiner✨ | rare disease researchtherapeutic modalities+4 | Dr. Russ Weiner | AAPS NBCAAPS+1 | Boston | rare diseasetherapeutics+5 | — | 28m 24s | |
| 5/12/25 | Building Successful Life Science Companies with Katrina Rogers✨ | life sciencesbiotech innovation+4 | Katrina Rogers | Evergreen Bioscience InnovationKatrina Rogers Consulting+2 | — | life sciencesbiotech+5 | — | 59m 53s | |
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| 4/7/25 | ![]() Navigating Challenges in Drug Discovery with Dr. Alfred Botchway✨ | drug discoveryAI in biomedical science+5 | Dr. Alfred Botchway | Attentive ScienceXenometrics+1 | — | drug discoveryAI+6 | — | 51m 52s | |
| 3/17/25 | 2024 Year In Review: BioTalk Unzipped | In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe reflect on their journey over the past year, discussing key themes and insights gained from their guests. They explore the humanistic approach to healthcare, the impact of AI in drug development, common threads among successful individuals, personal growth through conversations, and the importance of leadership and mentorship in the industry. The episode concludes with exciting plans for future series focused on drug development and global healthcare innovations. Thanks to CREO Consulting for hosting this episode! https://creoconsulting.com/ (https://creoconsulting.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/) Celerion - https://www.celerion.com/ (https://www.celerion.com/) Takeaways Every sample is a person, a patient, a loved one. Embrace the fear, take more risks. The importance of human connection in drug development. AI is becoming integral in drug discovery and development. Successful individuals often wish they had taken more risks. Leadership in the industry is about raising others up. Mentorship plays a crucial role in professional growth. Personal growth can come from listening and engaging with others. Innovative approaches are essential in addressing industry challenges. Keywords BioTalk, drug development, AI, mentorship, leadership, podcast, healthcare, innovation, personal growth, industry insights | — | ||||||
| 3/3/25 | Women in Pharmaceutical Sciences and their Allies with Dr. Ines Santos and Dr. Julie Sable | In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Ines Santos and Dr. Julia Sable to discuss their experiences and contributions in the pharmaceutical sciences, particularly focusing on women's roles in the field. The conversation covers their personal journeys into science, the importance of STEAMpark.org in education, exciting projects they've worked on, challenges in CMC for cell and gene therapies, innovations in chiral bioanalysis, and recent industry developments. The panel emphasizes the significance of collaboration and mentorship in advancing medical progress. This conversation delves into the evolving landscape of cancer treatment, particularly the integration of combination therapies like CAR T and oncolytic viruses. It also highlights the importance of empowering women in pharmaceutical sciences through mentorship and community engagement, while emphasizing the role of allyship in fostering an inclusive environment.01:20 Introduction to BioTalk Unzipped02:01 Celebrating Women in Pharmaceutical Sciences03:21 The Importance of STEAM Education04:09 Personal Journeys into Science08:02 Exciting Projects and Discoveries13:52 Challenges in CMC for Cell and Gene Therapies18:51 Innovations in Chiral Bioanalysis22:46 NEW NEWS! - New ADC Approved28:33 Exploring Combination Therapies in Cancer Treatment32:26 Empowering Women in Pharmaceutical Sciences37:30 Mentorship and Community Engagement45:18 The Role of Allyship in Science47:19 Breaking Barriers and Challenging Stereotypes54:15 Engaging Diverse Voices in Discussions56:49 Creating Inclusive Spaces for Feedback & Speaking Up01:01:15 Avoiding Assumptions in Professional Settings01:02:04 Setting Boundaries for Work-Life Balance01:05:24 Measuring Success in Life01:07:06 Connecting and Networking EffectivelyDr. Ines Santoshttps://www.linkedin.com/in/insantos/ Dr. Julia Sablehttps://www.linkedin.com/in/julia-sable-5b794385/ STEAMparkhttps://www.steampark.org/ WIPS in AAPShttps://community.aaps.org/communities/community-home?CommunityKey=fbfeb62a-884a-46cf-a5ed-24ef7eb43100 https://www.aaps.org/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ New News Story: In Fierce Pharma - Pfizer's blockbuster ADC Adcetris nabs FDA approval to treat large B-cell lymphomahttps://www.fiercepharma.com/pharma/pfizers-blockbuster-adc-adcetris-nabs-fda-approval-treat-large-b-cell-lymphoma Journal Article mentioned:Emerging applications of quantitative supercritical fluid chromatography-tandem mass spectrometry for chiral bioanalysishttps://www.sciencedirect.com/science/article/abs/pii/S0021967325000767 Sound Bites"We want to build our next generation.""We all want the same result.""You have to have a level of extrovert.""If you see something, say something.""Take action this year."Image Credits:AAPS & WIPS logos: https://www.aaps.org/ KeywordsBioTalk, pharmaceutical sciences, women in science, CMC challenges, chiral bioanalysis, CAR-T therapies, STEAM education, innovations in medicine, healthcare advancements, biotechnology, cancer treatment, CAR T therapy, women in science, mentorship, allyship, pharmaceutical sciences, community engagement, combination therapies, empowerment, gender equality, engagement, feedback, inclusivity, allyship, professional development, work-life balance, success, networking#pharmaceutical #women #womenempowerment #science #drugdevelopment #biotech #biopharma #mentor #mentorship #AAPS #WIPS | — | ||||||
| 2/3/25 | ![]() Can AI Become Your Doctor? FDA Regulation, Medical Devices & the Future of Healthcare | Could artificial intelligence become your doctor someday? In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Alex Friedman, a regulatory affairs expert with deep experience in medical devices, FDA submissions, quality systems, and AI-enabled Software as a Medical Device. Alex helps unpack one of the most important questions in healthcare innovation: when does software become a regulated medical device, and what happens when AI begins influencing clinical decisions? The conversation moves from classic medical device classifications to 510(k) submissions, De Novo pathways, wearable health technology, clinical decision support software, adaptive AI, liability risk, and the future of “doctor-in-a-box” tools for underserved communities. This episode is especially relevant for medical device developers, digital health founders, regulatory affairs professionals, biotech leaders, clinicians, investors, and anyone trying to understand how AI will be safely integrated into healthcare. Alex explains why regulatory strategy is not just bureaucracy. It is a public health safeguard designed to protect patients, validate claims, and prevent companies from selling unproven technology into high-stakes clinical environments. As he puts it in the episode, “You can’t sell snake oil.” In this episode How FDA classifies medical devices by risk Why many Class II devices follow the 510(k) pathway What “substantial equivalence” means When software becomes a medical device Why AI-enabled software raises new regulatory questions How wearable technology may change cardiovascular monitoring Why medical claims create liability risk What makes adaptive AI especially difficult to regulate How FDA may approach predetermined change control plans Why inclusive training data matters for AI in healthcare How AI tools could improve care access in underserved communities Featured guest Dr. Alex Friedman is a bioengineer and regulatory affairs professional with more than a decade of experience in medical devices, quality systems, FDA submissions, and regulatory strategy. His work includes AI-enabled hospital software, clinical decision support, and Software as a Medical Device. Connect with Alex Friedman: https://www.linkedin.com/in/alexfriedman/ Charity spotlight Alex selected Americares, a nonprofit organization that delivers emergency medical aid and health programs to people affected by poverty and disaster. Learn more: https://www.americares.org/ Links and resources All BioTalk Unzipped episodes: https://www.youtube.com/@BioTalkUnzipped/videos BioTalk Unzipped LinkedIn: https://www.linkedin.com/company/biotalk-unzipped Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/ Mentioned in the episode Antshrike cardiac health app from Before Health Intelligence: https://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424 Fierce MedTech 2025 forecast on AI, regulators, and government: https://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersect SISU Sense concussion mouthguard: https://www.sisuguard.com/sisusense/ HITIQ smart mouthguard: https://www.hitiq.com/smart-mouthguard Prevent Biometrics: https://preventbiometrics.com/ IDX-DR diagnostic software: https://www.healthvisors.com/en/idx-dr/ | — | ||||||
| 1/20/25 | ![]() Collaborating for Innovation: Biopharma Success with Dr. Nathan Teuscher | 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.Chapters00:51 The Changing Landscape of Pharmaceuticals03:49 Virtual Clinical Trials and Patient Engagement08:06 Optimizing Drug Dosage in Oncology10:55 New News! - FDA Approvals (Mesoblast) and Challenges in Cell Therapy14:26 The Complexities of Cell Therapy17:33 Navigating Immunocompromised States in Treatment20:09 Advice to Young Scientists in Biopharma 23:04 Defining Success in Life and Career24:47 The Purpose and Impact of Nathan's Podcast, Clinical PharmacologyHOW TO REACH US:Nathan Teuscherhttps://www.linkedin.com/in/nathanteuscher/ Aplos Analytics - https://aplosanalytics.com/ Email: nathan@aplosanalytics.comNathan Teuscher’s Podcast: Clinical Pharmacology Podcasthttps://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-pharmacologyPodcast (on Apple): https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / TakeawaysNathan 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 therapyhttps://www.fiercepharma.com/pharma/fda-nod-gvhd-cell-therapy-gives-australian-biotech-mesoblastkeywordsBioTalk, 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 | — | ||||||
| 1/6/25 | ![]() The Future of Pharmacometrics with Dr. Nathan Teuscher | 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.Chapters00:00 Episode Preview00:55 Introduction to BioTalk Unzipped02:06 Charity Spotlight: Light of the World04:51 Nathan Teuscher's Career Journey07:34 Differentiating AI Types in Life Science12:41 Challenges with Large Language Models15:39 Rethinking Reporting in Pharma17:56 The Future of AI and Analytics in Pharma?18:52 Leveraging APIs (Application Programming Interfaces) for Small Companies23:05 Leveraging Data, AI, and APIs in 3 Dimensions26:22 NEW NEWS! - Gene Editing Breakthroughs in MedicineHow to reach us:Light the World Charity - Church of Jesus Christ Latter Day Saintshttps://www.churchofjesuschrist.org/comeuntochrist/light-the-world Nathan Teuscherhttps://www.linkedin.com/in/nathanteuscher/ Aplos Analytics - https://aplosanalytics.com/ Nathan Teuscher’s Podcast: Clinical Pharmacology Podcasthttps://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 Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Sound Bites"We don't need to write reports anymore."TakeawaysNathan 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 kidneyhttps://www.technologyreview.com/2024/12/17/1108905/a-woman-in-the-us-is-the-third-person-to-receive-a-gene-edited-pig-kidney/Image CreditsPig 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 KeywordsBioTalk, 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 | — | ||||||
| 12/30/24 | ![]() Insights from AAPS PharmSci 360 Live with Dr. Mark Arnold | 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 | — | ||||||
| 12/16/24 | ![]() Digital Twins: The Future of Drug Discovery with Dr. Tomáš Helikar | 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 | — | ||||||
| 12/2/24 | ![]() Transforming Immunology: The Promise of Digital Twins with Dr. Tomáš Helikar | 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 | — | ||||||
| 11/18/24 | ![]() How AI is Transforming Drug Development: Reflections from AAPS - PharmSci 360 with Dr. Mark Arnold | 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 | — | ||||||
| 10/21/24 | ![]() Biotech Funding Trends and the Rise of Digital Twinning with CEO Scott Ogle | 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/ | — | ||||||
| 10/1/24 | ![]() Technology Meets Purpose: Transforming Clinical Trials at TruLab with CEO Scott Ogle | 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. | — | ||||||
| 9/29/24 | ![]() Mentoring in Pharmaceutical Science with Dr. Jim Shen | 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 | — | ||||||
| 9/1/24 | ![]() Great Advances in Cancer Research with Dr. Jim Shen | 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 | — | ||||||
| 8/15/24 | ![]() The Future of Hybrid Healthcare: Insights from Zealic CEO Chuck Piccirillo | 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 | — | ||||||
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