Biotech Business with Fexingo: Life Sciences Startups, Drug Discovery, and FDA Approvals

Episode 60 of Biotech Business with Fexingo dives into organoids—miniature 3D organ models grown from stem cells that are reshaping drug testing. Lucas explains how a startup called Organome used colon organoids to screen a library of 50,000 compounds for inflammatory bowel disease, cutting preclinical timelines by 18 months. Luna questions whether these lab-grown tissues can truly mimic human physiology, and they discuss the recent FDA decision to accept organoid data as alternative to animal studies. This is a concrete look at how engineering biology is speeding up the long, expensive road to market for new therapies. #Organoids #BiotechStartups #DrugDiscovery #StemCells #Organome #IBD #FDA #PreclinicalTesting #3DCellCulture #PersonalizedMedicine #Business #Technology #LifeSciences #FexingoBusiness #BusinessPodcast #BiotechBusiness #StartupStrategy #DrugDevelopment Keep every episode free: buymeacoffee.com/fexingo

In this episode, Lucas and Luna explore how biotech startups are using liquid biopsies — blood tests that detect circulating tumor DNA — to catch cancer earlier than traditional imaging or tissue biopsies. They dive into the case of Guardant Health, which has processed over 700,000 liquid biopsy tests, and discuss the technical challenge of picking up a single mutated DNA fragment among 50,000 normal ones. Luna challenges Lucas on sensitivity trade-offs, and they touch on how companies like Grail are aiming for multi-cancer screening at Stage I or II. No hype, just the data on what this technology can actually deliver today. Perfect for operators and builders in the life sciences who want to understand the clinical and business reality behind the headlines. #LiquidBiopsy #EarlyCancerDetection #CirculatingTumorDNA #GuardantHealth #Grail #BiotechStartups #PrecisionOncology #CancerScreening #CellFreeDNA #NextGenSequencing #Business #Technology #LifeSciences #DrugDiscovery #FDAApprovals #FexingoBusiness #BusinessPodcast #BiotechBusiness Keep every episode free: buymeacoffee.com/fexingo

Lucas and Luna explore how biotech startups are repurposing lipid nanoparticles — the delivery technology that made mRNA vaccines possible — for gene editing, protein replacement, and cancer immunotherapy. They dive into the story of a startup called ReCode Therapeutics, which uses LNP technology to deliver mRNA to the lungs of cystic fibrosis patients, bypassing the limitations of current small-molecule drugs. The episode explains how tuning the lipid chemistry can target specific organs, and why this matters for rare genetic diseases. Lucas breaks down the key numbers: ReCode's lead candidate targets a mutation that affects 10 percent of cystic fibrosis patients, but the LNP platform could apply to dozens of other conditions. Luna asks the tough questions about manufacturing complexity and competition from viral vectors. The conversation stays grounded in the science and the business, with no hype — just a clear look at an enabling technology that's quietly becoming central to the biotech toolbox. #LipidNanoparticles #DrugDelivery #BiotechStartups #GeneTherapy #CysticFibrosis #ReCodeTherapeutics #mRNATherapeutics #TargetedDelivery #RareDisease #CancerImmunotherapy #CRISPR #Nanomedicine #BiotechBusiness #FexingoBusiness #BusinessPodcast #LifeSciences #Technology #StartupFunding Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business with Fexingo, Lucas and Luna explore how antibody-drug conjugates (ADCs) are transforming cancer treatment by delivering potent toxins directly to tumor cells while sparing healthy tissue. They break down the real-world example of Enhertu, the ADC developed by AstraZeneca and Daiichi Sankyo, which has shown remarkable results in breast, lung, and gastric cancers. The hosts explain the three key components of an ADC—the antibody, the linker, and the payload—and how biotech startups are innovating on each element to improve efficacy and reduce side effects. Lucas shares data from a recent trial where Enhertu shrank tumors in over 60% of patients with a specific HER2 mutation, and Luna discusses the engineering challenges of designing linkers that stay stable in the bloodstream but release the drug once inside the cancer cell. They also touch on the competitive landscape, with over 100 ADCs in clinical development and a market projected to reach $20 billion by 2028. The episode ends with a candid note on how listener support via buy me a coffee dot com slash fexingo keeps the show ad-free. #Biotech #ADCs #AntibodyDrugConjugates #Enhertu #AstraZeneca #DaiichiSankyo #CancerTreatment #TargetedTherapy #DrugDelivery #Oncology #HER2 #LinkerTechnology #Payload #ClinicalTrials #BiotechStartups #BusinessAndTechnology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

In Episode 56 of Biotech Business, Lucas and Luna explore how biotech startups use mass spectrometry imaging (MSI) to visualize exactly where drugs go in tissues. They discuss the technology's evolution from bulky lab instruments to commercial platforms, a case study of a startup using MSI to map a cancer drug's penetration into tumors, and how this technique is changing pharmacokinetics and FDA submissions. The hosts also touch on the broader trend of spatial biology and why investors are paying attention to companies like Waters and Bruker that supply these tools. #MassSpectrometryImaging #BiotechStartup #DrugDistribution #Pharmacokinetics #SpatialBiology #TumorPenetration #MALDI #DESI #WatersCorporation #Bruker #FDAApproval #Preclinical #Business #Technology #LifeSciences #FexingoBusiness #BusinessPodcast #BiotechBusiness Keep every episode free: buymeacoffee.com/fexingo

Episode 55 of Biotech Business with Fexingo dives into circular RNA, the cutting-edge molecule that biotech startups are engineering for more stable, longer-lasting therapies. Lucas explains why circular RNA resists degradation better than linear mRNA, and Luna highlights a specific startup—Orna Therapeutics—that raised $221 million to develop circular RNA-based immunotherapies. They discuss how the circular structure avoids the immune detection that plagued early mRNA, the potential for one-shot treatments, and the manufacturing challenges that remain. If you want to understand the next wave of RNA medicine beyond vaccines, this episode gives you the concrete science and business angle. #CircularRNA #RNATherapeutics #BiotechStartups #OrnaTherapeutics #DrugDiscovery #mRNA #Immunotherapy #Biotechnology #LifeSciences #GeneTherapy #RNAStability #BiotechFunding #Business #Technology #FexingoBusiness #BusinessPodcast #HealthcareInnovation #StartupFunding Keep every episode free: buymeacoffee.com/fexingo

Episode 54 of Biotech Business with Fexingo explores how generative AI is transforming antibody design. Lucas and Luna dive into the story of startup Absci, which used a generative model to create a novel antibody against a difficult target—HER2—in just 23 days. They discuss the difference between traditional phage display and AI-driven de novo design, the challenges of computational vs. experimental validation, and why Big Pharma is paying attention. The hosts also touch on the broader shift from AI-assisted discovery to AI-driven creation in biotech. A concrete look at how protein language models and diffusion models are moving beyond small molecules into biologics, and what it means for the speed and cost of bringing new drugs to patients. #GenerativeAI #AntibodyDesign #Biotech #AbSci #ProteinEngineering #DrugDiscovery #Biologics #HealthcareInnovation #AIinBiotech #LifeSciences #Startups #Business #Technology #FexingoBusiness #BusinessPodcast #BiotechBusiness #MachineLearning #Therapeutics Keep every episode free: buymeacoffee.com/fexingo

Episode 53 of Biotech Business with Fexingo dives into the world of Bayesian adaptive clinical trials — a statistical approach that lets biotechs learn from data mid-study and potentially cut trial costs by 30%. Lucas and Luna explore how startups like Berry Consultants and Cytel are helping drug developers reduce patient numbers while increasing the chance of hitting endpoints. They unpack a real case: how a mid-stage Parkinson's trial used Bayesian modeling to stop early for futility, saving $40 million. The episode also touches on regulators' growing comfort with Bayesian methods, especially in rare disease trials where patient pools are tiny. No algorithm hype — just a clear look at how smarter math is changing drug development timelines. #Biotech #ClinicalTrials #BayesianStatistics #AdaptiveTrials #DrugDevelopment #Startups #BerryConsultants #Cytel #ParkinsonsDisease #RareDisease #FDA #StatisticalDesign #Business #Technology #FexingoBusiness #BusinessPodcast #LifeSciences #Podcast Keep every episode free: buymeacoffee.com/fexingo

Episode 52 of Biotech Business with Fexingo explores how life sciences startups are integrating wearable sensors — smartwatches, continuous glucose monitors, and patch-based ECG devices — into clinical trials to collect continuous, real-world data outside the clinic. Lucas and Luna break down the specific case of a fictional startup called VitalWave, which uses a wrist-worn sensor to capture heart rate, activity, and sleep data in a Phase 2 heart failure trial. They discuss how this approach reduces patient burden, cuts trial costs by up to 30%, and provides richer endpoints than periodic clinic visits. The hosts compare VitalWave's strategy to how Apple and Fitbit have opened their sensor platforms for research. They also address regulatory challenges: the FDA's guidance on digital health technologies and the need for sensor validation. The episode closes with a forward look at how passive monitoring might eventually replace some in-clinic assessments, especially for chronic conditions. This is a concrete, number-driven conversation about a trend reshaping drug development in 2026. #WearableSensors #ClinicalTrials #BiotechStartups #DigitalHealth #FDA #VitalWave #AppleWatch #RealWorldData #DrugDevelopment #HeartFailure #ContinuousGlucoseMonitor #ECG #RemoteMonitoring #PatientCentric #LifeSciences #Business #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business with Fexingo, Lucas and Luna explore how biotech startups are engineering the human microbiome to treat chronic diseases. They focus on the case of Synlogic, a company that developed a genetically engineered probiotic to treat phenylketonuria (PKU), a rare genetic disorder. The discussion covers how Synlogic's approach works, the challenges of using living therapeutics, and why big pharma is investing in microbiome startups. Lucas explains the science behind engineering bacteria to break down toxic metabolites, while Luna questions the regulatory hurdles and scalability. The episode also touches on the broader trend of microbiome engineering for metabolic and inflammatory diseases, with specific numbers on market growth and clinical trial results. A concrete look at how synthetic biology is turning gut bacteria into programmable medicines. #MicrobiomeEngineering #Synlogic #ProbioticTherapeutics #PKU #SyntheticBiology #LivingTherapeutics #GutBacteria #MetabolicDisease #BiotechStartup #DrugDiscovery #FDAApprovals #ClinicalTrials #RareDisease #GeneEditing #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode 50 of Biotech Business with Fexingo explores how startups are engineering microbes to produce rare plant compounds — like the cancer drug paclitaxel (Taxol) and the malaria treatment artemisinin — without harvesting endangered plants. Lucas and Luna break down the synthetic biology toolbox: metabolic pathway engineering, enzyme optimization, and fermentation scale-up. They discuss the case of Amyris, which famously produced artemisinic acid in yeast, and Antheia, a current startup using similar approaches for opioid precursors and neuroactive compounds. The hosts explain why this matters for drug security: many plant-derived medicines are threatened by overharvesting, climate change, and long supply chains. They also touch on the economic hurdle: fermentation costs versus field cultivation, and how continuous improvements in synthetic biology are closing the gap. The episode closes with a look ahead: could we eventually make any plant molecule on demand? A specific, numbers-driven conversation that gives listeners one concrete insight about the intersection of biology and manufacturing. #SyntheticBiology #Biotech #DrugDiscovery #PlantCompounds #Amyris #Antheia #Artemisinin #Paclitaxel #MetabolicEngineering #Fermentation #DrugSecurity #Business #Technology #FexingoBusiness #BusinessPodcast #BiotechBusiness #Startups #FDA Keep every episode free: buymeacoffee.com/fexingo

Episode 49 of Biotech Business with Fexingo explores the emerging field of RNA editing — a therapeutic approach that corrects disease-causing mutations at the RNA level without altering the genome. Hosts Lucas and Luna focus on a specific startup, Ascidian Therapeutics, and their lead candidate for Stargardt disease, a form of juvenile macular degeneration. The episode explains how RNA exon editing works, contrasting it with CRISPR-based gene editing, and discusses the regulatory landscape as the field approaches its first clinical data. Ascidian recently raised a $100 million Series A in 2024, reflecting investor enthusiasm for this safer alternative to permanent gene edits. The hosts also touch on competition from other modalities like base editing and the potential for RNA editing to treat large genes that are difficult to deliver via traditional gene therapy. A concrete example: the ABCA4 gene, which causes Stargardt disease, is too large for standard AAV vectors, but RNA editing can target it without needing to deliver the full gene. The episode concludes with the question of whether RNA editing will become a mainstream platform or remain a niche approach for specific diseases. #RNAEditing #Biotech #AscidianTherapeutics #StargardtDisease #GeneTherapy #FDA #DrugDevelopment #Business #Startup #LifeSciences #CRISPR #BaseEditing #ABCA4 #ClinicalTrials #Neuroscience #Ophthalmology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business with Fexingo, Lucas and Luna explore the emerging field of PROTACs—proteolysis-targeting chimeras—that are revolutionizing drug discovery by degrading rather than inhibiting disease-causing proteins. They dive into how startups like Arvinas and Kymera Therapeutics are leading the charge, with a focus on Arvinas's lead candidate ARV-471 for breast cancer, now in Phase 3 trials. Lucas explains the mechanism: a PROTAC is a bifunctional molecule that tags a target protein for destruction by the cell's ubiquitin-proteasome system. The hosts discuss the potential to drug previously 'undruggable' targets, the challenges of oral bioavailability and selectivity, and the competitive landscape. Luna questions whether these degraders will face resistance, and Lucas outlines the manufacturing hurdles and regulatory path forward. The episode also touches on the pivotal role of patient advocacy and data transparency in biotech. #PROTAC #TargetedProteinDegradation #Arvinas #KymeraTherapeutics #DrugDiscovery #BiotechStartups #Undruggable #ARV471 #BreastCancer #UbiquitinProteasome #Phase3Trials #OralBioavailability #Selectivity #BiotechBusiness #FexingoBusiness #BusinessPodcast #LifeSciences #FDAApprovals Keep every episode free: buymeacoffee.com/fexingo

Episode 47 of Biotech Business with Fexingo dives into targeted protein degradation — a drug discovery approach that destroys disease-causing proteins rather than inhibiting them. Lucas and Luna unpack how startups like Arvinas and Kymera are leveraging the cell's own garbage disposal, the proteasome, to tackle targets previously considered undruggable. They discuss the first FDA approval of a PROTAC drug in 2025, what it means for the industry, and the specific design challenges — from ternary complex formation to oral bioavailability. This episode includes a brief, sincere pitch for listener support to keep the show ad-free. #TargetedProteinDegradation #PROTACs #Arvinas #KymeraTherapeutics #Undruggable #DrugDiscovery #BiotechStartup #Proteasome #FDAApproval #MolecularGlue #TernaryComplex #OralBioavailability #LifeSciences #BusinessAndTechnology #FexingoBusiness #BusinessPodcast #Biotech #StartupFunding Keep every episode free: buymeacoffee.com/fexingo

Episode 46 of Biotech Business with Fexingo dives into how biotech startups are using DNA barcoding to track cell lineages in vivo. Lucas and Luna explore a startup called Cellarity that uses barcoded cells to understand which cell types respond to a drug candidate, reducing failure rates in Phase II. They discuss the technology's origins in cancer research, its application in metabolic disease, and why investors are paying attention. The hosts compare it to other high-throughput techniques like CRISPR screens and single-cell RNA sequencing, explaining why barcoding offers higher resolution and lower cost. The episode also touches on how the method helps de-risk preclinical models and shorten development timelines. Specific numbers include a 30 percent reduction in late-stage attrition cited by early adopters, and a $50 million Series B round for Cellarity in early 2026. #DNABarcoding #CellLineage #Cellarity #DrugDiscovery #Biotech #Startups #PreclinicalModels #SingleCell #HighThroughput #InVivo #MetabolicDisease #CancerResearch #SeriesB #Business #Technology #FexingoBusiness #BusinessPodcast #BiotechBusiness Keep every episode free: buymeacoffee.com/fexingo

In this episode, Lucas and Luna explore spatial transcriptomics, a technology that lets scientists see exactly where genes are active inside a tissue sample. They break down how this works using a concrete example: a startup mapping the tumor microenvironment to understand why some cancer cells resist treatment. The hosts discuss the key number — the ability to measure RNA expression across thousands of locations in a single slice — and compare it to earlier methods like RNA-seq and single-cell sequencing. They also touch on the business side, including the cost of instruments and the race between companies like 10x Genomics and NanoString. If you're curious about how biology is becoming a spatial science, this episode gives you a clear, specific picture. #SpatialTranscriptomics #Biotech #DrugDiscovery #TumorMicroenvironment #10xGenomics #NanoString #RNAseq #SingleCell #PrecisionMedicine #CancerResearch #TissueBiology #GeneExpression #LifeSciences #Startups #Business #FexingoBusiness #BusinessPodcast #Technology Keep every episode free: buymeacoffee.com/fexingo

Drug repurposing is one of the fastest, cheapest ways to bring new treatments to patients. But finding which existing drug might work for a different disease has historically been a shot in the dark. In this episode, Lucas and Luna explore how biotech startups are using machine learning to systematically match approved drugs to new indications. They dig into the story of Recursion Pharmaceuticals, whose AI platform screened over 2 million drug-disease pairs in silico before testing candidates in the lab. Lucas explains how the company's approach cut early-stage R&D costs by roughly 70% compared to traditional discovery. Luna asks about the regulatory path — does the FDA treat repurposed drugs differently? They also discuss the recent wave of partnerships between big pharma and repurposing-focused startups, including a notable deal from early 2026 where a top-10 pharma company licensed two repurposed candidates from a startup using AI-driven transcriptomics. The episode closes with a look at the biggest risk: failure rates in phase 2 trials remain high, even for repurposed drugs. A focused, data-rich conversation for operators and builders in life sciences. #DrugRepurposing #AIinBiotech #MachineLearning #RecursionPharmaceuticals #Transcriptomics #DrugDiscovery #FDA #ClinicalTrials #BigPharma #Business #Technology #Startups #LifeSciences #Biotech #RepurposedDrugs #Phase2Trials #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business, Lucas and Luna explore fragment-based drug discovery (FBDD), a method that starts with tiny molecular fragments instead of huge compound libraries. They break down how the approach works, why it’s gaining traction, and the story of vemurafenib — the melanoma drug that proved FBDD could deliver blockbusters. They also discuss how startups like Relay Therapeutics are combining fragments with computational tools like machine learning and molecular dynamics simulations to target proteins once considered undruggable. Plus, a look at the economics: how the upfront cost of fragment screening has dropped from millions to hundreds of thousands, making it accessible to early-stage biotechs. Finally, Lucas and Luna share a personal note on listener support that keeps the show ad-free. #FragmentBasedDrugDiscovery #FBDD #Biotech #DrugDiscovery #RelayTherapeutics #Vemurafenib #TargetValidation #UndruggableProteins #BiotechStartup #SmallMolecule #StructureBasedDesign #LeadOptimization #KinaseInhibitors #DrugDevelopment #BusinessAndTechnology #PharmaceuticalInnovation #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode 42 of Biotech Business with Fexingo explores how biotech startups are using digital twins—virtual replicas of biological systems, organs, and entire clinical trials—to accelerate drug development and reduce costs. Lucas and Luna dive into the case of Insilico Medicine, which used a digital twin of a patient population to simulate a Phase 2 trial for a novel fibrosis drug, cutting pre-clinical time by 40% and saving an estimated $8 million. They also discuss how startups like Unlearn AI and Novadiscovery are running virtual control arms, replacing placebo groups with synthetic data to shrink trial sizes. The episode touches on the FDA's evolving stance on in silico evidence and the hurdles of validation. By the end, listeners will understand how digital twins could shave years off the typical 10-15 year drug development timeline and why big pharma is already investing billions in simulation platforms. #DigitalTwins #DrugDevelopment #InsilicoMedicine #UnlearnAI #Novadiscovery #FDA #InSilicoTrials #VirtualControlArms #BiotechStartups #Simulation #PrecisionMedicine #ClinicalTrials #ArtificialIntelligence #DrugDiscovery #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

In episode 41, Lucas and Luna explore the emerging field of synthetic gene switches — biological circuits that allow biotech startups to precisely control when and where therapeutic proteins are made inside a patient's body. The conversation centers on a real startup called Senti Biosciences, which has engineered logic-gated gene circuits that can distinguish between healthy and diseased cells. Lucas explains how a company can use a synthetic 'kill switch' to turn off a therapy if dangerous side effects emerge, and how inducible promoters respond to small molecules like doxycycline to toggle gene expression on and off. The episode also touches on the promise of cell-based therapies and the regulatory challenges facing these programmable biologics. #GeneSwitches #SyntheticBiology #SentiBiosciences #CellTherapy #GeneTherapy #ProteinProduction #InduciblePromoters #KillSwitch #LogicGates #BiotechStartups #DrugDevelopment #Biologics #LifeSciences #BusinessAndTechnology #Podcast #FexingoBusiness #BusinessPodcast #BiotechBusiness Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business with Fexingo, Lucas and Luna explore how biotech startups are leveraging induced pluripotent stem cells (iPSCs) to revolutionize drug discovery and personalized medicine. They dive into the story of one startup—Fate Therapeutics—which uses iPSCs to create off-the-shelf cancer immunotherapies, and discuss the technical breakthroughs and business challenges that come with reprogramming adult cells into any cell type. Lucas breaks down the key advantage: iPSCs eliminate the need for embryonic stem cells and allow for mass production of standardized cells for therapies. Luna questions the scalability and cost hurdles, especially around manufacturing consistency and regulatory approval. The episode anchors on a 2025 milestone where a biotech startup, using iPSC-derived natural killer cells, reported a 70% response rate in a Phase 1 trial for relapsed lymphoma. The conversation also touches on the broader implications for neurodegenerative diseases and organ regeneration. If you're curious about how cellular reprogramming is moving from academic labs to commercial pipelines, this episode offers a clear, specific look at the science and the business. #InducedPluripotentStemCells #iPSCs #FateTherapeutics #CellTherapy #DrugDiscovery #BiotechStartups #CancerImmunotherapy #NaturalKillerCells #RegenerativeMedicine #PersonalizedMedicine #StemCells #Biotech #Business #Technology #FexingoBusiness #BusinessPodcast #LifeSciences #FDAApprovals Keep every episode free: buymeacoffee.com/fexingo

Episode 39 of Biotech Business with Fexingo dives into organ-on-a-chip technology—tiny devices lined with living human cells that mimic organs like lungs, livers, and hearts. Lucas and Luna explore how startups such as Emulate and TissUse are replacing animal models with these chips to accelerate drug development and cut costs. They break down the science behind the chips, highlight a case where a liver chip predicted a drug's toxicity that animal tests missed, and discuss the regulatory push from the FDA's recent mandate to reduce animal testing. The episode also touches on the market—projected to reach $5.6 billion by 2030—and the challenges of scaling manufacturing. If you're in biotech or curious about how drugs actually get approved, this is a concrete look at a technology reshaping preclinical research. #OrganOnAChip #OrgansOnChips #AnimalTestingAlternatives #DrugDiscovery #PreclinicalResearch #EmulateBio #TissUse #FDA #FDAModernizationAct #BiotechStartups #LifeSciences #Microfluidics #LiverChip #LungChip #HeartChip #Business #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode 38 of Biotech Business with Fexingo dives into how biotech startups are using CRISPR screens to systematically identify drug targets. Lucas and Luna break down the technology behind pooled CRISPR knockout screens, explain how they differ from traditional target discovery, and walk through a real example: how a startup called Maze Therapeutics used CRISPR screens to uncover a novel target for kidney disease. They also discuss the challenges of off-target effects and the shift toward in vivo screens. The episode ends with a brief, low-key note on listener support at buy me a coffee dot com slash fexingo. Perfect for anyone curious about how genomics is accelerating the first step of drug development. #CRISPR #DrugDiscovery #TargetIdentification #BiotechStartup #Genomics #MazeTherapeutics #PooledScreens #InVivoCRISPR #GeneEditing #KidneyDisease #Ganovo #BiotechBusiness #BusinessAndTechnology #FexingoBusiness #BusinessPodcast #DrugDevelopment #FunctionalGenomics #Biotech Keep every episode free: buymeacoffee.com/fexingo

Episode 37 of Biotech Business with Fexingo dives into cell painting — a high-content imaging technique that biotech startups are using to profile drug mechanisms, predict toxicity, and accelerate hit-to-lead decisions. Lucas explains how automated microscopy and machine learning turn thousands of cellular images into a 'morphological fingerprint' for each compound. Luna asks about scalability and how startups compete with big pharma's legacy assays. The episode walks through a concrete example: Recursion Pharmaceuticals, which uses cell painting at industrial scale, and how a new startup called Syzgy Bio is applying the method to phenotypic screens for rare diseases. Lucas closes with a forward-looking question about whether cell painting could replace traditional target-based screens. #CellPainting #DrugDiscovery #BiotechStartups #HighContentImaging #MorphologicalProfiling #PhenotypicScreen #MachineLearning #RecursionPharmaceuticals #SyzgyBio #HitToLead #DrugToxicity #LifeSciences #LabAutomation #Business #Technology #FexingoBusiness #BiotechPodcast #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Base editing is a newer gene-editing technology that can change a single DNA letter without cutting the double helix. In this episode, Lucas and Luna explore how biotech startups are applying base editing to treat genetic diseases like sickle cell disease and progeria. They discuss the story of Beam Therapeutics, the first company to take a base editor into clinical trials, and contrast base editing with both traditional CRISPR and newer prime editing. The hosts break down the science behind adenine and cytosine base editors, the business of licensing foundational IP from the Broad Institute, and the regulatory path for in vivo therapies. They also touch on the ethical considerations and what this means for patients with currently untreatable conditions. Specific numbers: Beam's lead program in sickle cell disease, the estimated patient population, and the timeline for early-phase data. This episode is for anyone interested in the frontier of precision genetic medicine beyond CRISPR-Cas9. #BaseEditing #GeneEditing #BeamTherapeutics #SickleCellDisease #Progeria #DavidLiu #BroadInstitute #PrimeEditing #CRISPR #PrecisionMedicine #GeneticDisease #AdenineBaseEditor #CytosineBaseEditor #BiotechStartups #FDA #ClinicalTrials #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode 35 of Biotech Business with Fexingo dives into the world of liquid biopsies — blood tests that detect tumor DNA before symptoms appear. Lucas and Luna discuss how startups like Guardant Health and Grail are driving this technology, the science of circulating tumor DNA, and why regulatory shifts in 2026 are accelerating adoption. They also explore the economics: how liquid biopsies could cut screening costs by 60% and what that means for insurers. A compelling look at a field that's reshaping oncology from the ground up. #LiquidBiopsy #CancerDetection #GuardantHealth #Grail #CirculatingTumorDNA #EarlyCancerDetection #Oncology #BiotechStartups #FDAApprovals #PrecisionMedicine #LungCancer #ColorectalCancer #Diagnostics #BloodTest #Genomics #HealthcareInnovation #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

In this episode, Lucas and Luna explore the science and business behind antibody-drug conjugates (ADCs), a targeted cancer therapy that combines monoclonal antibodies with potent chemotherapy. They unpack the case of Enhertu, an ADC developed by Daiichi Sankyo and AstraZeneca, which has shown remarkable efficacy in HER2-positive cancers. The hosts discuss how ADCs work like 'guided missiles' for cancer cells, the engineering challenges of linker technology, and the deal-making landscape around ADCs. They also highlight the growing interest from big pharma in ADC platforms, with more than 100 ADCs in clinical trials as of mid-2026. Lucas shares data on the ADC market, projected to exceed $30 billion by 2030, while Luna questions whether these therapies can overcome toxicity limitations. The episode ties in the broader trend of biologics and targeted drug delivery, offering listeners a concrete understanding of a technology that is reshaping oncology treatment. #AntibodyDrugConjugates #ADC #CancerTherapy #Oncology #Biotech #DrugDiscovery #TargetedTherapy #Enhertu #DaiichiSankyo #AstraZeneca #MonoclonalAntibodies #LinkerTechnology #Payload #HER2 #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode 33 of Biotech Business with Fexingo: Lucas and Luna dive into the emerging field of personalized cancer vaccines. They focus on a specific case: how the startup Neon Therapeutics (now part of BioNTech) developed a neoantigen vaccine pipeline using AI to predict which mutations on a patient's tumor are most likely to trigger an immune response. The hosts walk through the key number: a phase 1 trial showed that 60% of patients with advanced melanoma had a T-cell response against their own tumor's neoantigens after receiving a personalized vaccine. Lucas explains the computational challenge—analyzing a patient's whole-exome sequencing data within weeks—and how platforms like Moderna's mRNA-4157 are now combining vaccines with checkpoint inhibitors. Luna asks tough questions about scalability, manufacturing costs (currently estimated at $100,000–$200,000 per dose), and whether the model can work for solid tumors beyond melanoma. They also touch on the FDA's recent guidance on neoantigen vaccines issued in March 2026. This episode is a deep look at how AI, genomics, and immunotherapy are converging to make truly individualized medicine a commercial reality. #PersonalizedCancerVaccines #Neoantigens #AIinBiotech #NeonTherapeutics #BioNTech #Moderna #CheckpointInhibitors #Melanoma #Immunotherapy #WholeExomeSequencing #PrecisionMedicine #ClinicalTrials #FDA #Business #Technology #FexingoBusiness #BusinessPodcast #BiotechBusiness Keep every episode free: buymeacoffee.com/fexingo

Episode 32 of Biotech Business with Fexingo dives into adaptive clinical trial designs — a statistical approach that lets biotech startups modify trial parameters mid-study based on interim data. Lucas and Luna explore how this flexibility saves time and money, using the example of a mid-stage oncology trial that cut enrollment by 40% without sacrificing statistical power. They discuss Bayesian vs. frequentist methods, the FDA's adaptive design guidance (updated in 2023), and why small biotechs are leading adoption over Big Pharma. Specific numbers: how an adaptive Phase 2 trial can reduce sample size by 30–50% and shorten development timelines by 12–18 months. The episode also covers risks like operational bias and regulatory scrutiny. A concrete case: how a startup using adaptive basket trials tested three drugs simultaneously in biomarker-defined subgroups. Perfect for founders, investors, and anyone curious about smarter clinical development. #AdaptiveTrialDesign #ClinicalTrials #BiotechStartup #FDA #BayesianStatistics #DrugDevelopment #OncologyTrials #BasketTrial #PlatformTrial #Phase2 #Biostatistics #RareDisease #PrecisionMedicine #Business #Technology #FexingoBusiness #BusinessPodcast #LifeSciences Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business, Lucas and Luna explore how biotech startups are beginning to leverage quantum computing to accelerate drug discovery. They discuss the specific problem quantum computers are good at — simulating molecular interactions that classical computers struggle with — and highlight real companies like Menten AI and ProteinQure that are already running quantum chemistry calculations. The hosts explain the difference between noisy intermediate-scale quantum (NISQ) devices and fault-tolerant quantum computers, and why today's hybrid classical-quantum algorithms matter for drug developers in 2026. They also touch on the race between pharma giants like Roche and JPMorgan's quantum investments, and the funding landscape for quantum-native biotech. A concrete look at a cutting-edge intersection of physics, biology, and computing. #QuantumComputing #DrugDiscovery #BiotechStartups #MentenAI #ProteinQure #NISQ #QuantumChemistry #MolecularSimulation #PharmaInnovation #Roche #JPMorgan #HybridAlgorithms #ComputationalBiology #BusinessAndTechnology #FexingoBusiness #StartupFunding #DrugDevelopment #BiotechBusiness Keep every episode free: buymeacoffee.com/fexingo

For decades, drug manufacturing has been done in batches — a slow, expensive process that adds billions to healthcare costs. But a growing number of biotech startups are switching to continuous manufacturing, where ingredients flow through a closed system 24/7, producing drugs faster, cheaper, and more consistently. In this episode, Lucas and Luna explore how continuous manufacturing works, why the FDA is encouraging it, and which startups are leading the charge. They look at a specific case: how a small biotech called Continuus Pharmaceuticals cut production time for a common hypertension drug from weeks to hours, and how the approach could lower the cost of gene therapies and biologics. They also discuss the challenges — high upfront capital, regulatory hurdles, and the need for specialized talent — and why some incumbents are still reluctant to abandon batch processing. If these conversations are useful for what you're building or running, stick around for a quick honest moment about how this show stays ad-free. #ContinuousManufacturing #Biotech #DrugManufacturing #Pharmaceuticals #FDA #GenericDrugs #GeneTherapy #Biologics #CostReduction #Startups #ContinuusPharmaceuticals #BatchProcessing #RegulatoryScience #Business #BusinessPodcast #FexingoBusiness #BiotechBusiness #LifeSciences Keep every episode free: buymeacoffee.com/fexingo

Lucas and Luna explore a emerging biotech technology called gene writing — a platform that writes new genetic code directly into the genome, unlike CRISPR which cuts DNA. They focus on the startup Tessera Therapeutics, which has raised over $500 million to develop this approach. The episode explains how gene writing works, why it could be safer and more versatile than CRISPR for certain applications, and where it stands in preclinical development as of June 2026. They also touch on the key technical challenge: delivering the gene-writing machinery into the right cells. A concrete example: treating sickle cell disease by rewriting the faulty hemoglobin gene in a patient's own blood stem cells. The conversation balances scientific promise with realistic timelines, noting that human clinical trials are likely still two to three years away. #GeneWriting #TesseraTherapeutics #CRISPR #GeneEditing #SickleCellDisease #Biotech #DrugDiscovery #TherapeuticDelivery #AAV #LNP #PrimeEditing #BaseEditing #GenomeEngineering #FlagshipPioneering #CellTherapy #BiotechBusiness #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

This episode explores how biotech startups are engineering the human microbiome to treat chronic diseases like inflammatory bowel disease and metabolic disorders. Lucas and Luna break down the science behind microbiome therapies, focusing on a case study of a company that recently published phase 2 data for a live biotherapeutic product targeting ulcerative colitis. They discuss the challenges of manufacturing live bacteria as drugs, the regulatory path for these novel treatments, and why big pharma is paying attention. Specific numbers include the size of the microbiome therapeutics market projected to reach $9.5 billion by 2030 and the success rate of phase 2 trials in this space. The hosts also touch on the role of AI in analyzing microbiome data to identify therapeutic targets. No prior episodes have covered microbiome therapies, making this a fresh angle on the intersection of biology and technology. #MicrobiomeTherapies #BiotechStartups #ChronicDisease #UlcerativeColitis #LiveBiotherapeuticProducts #MicrobiomeEngineering #Phase2Trials #IBD #MetabolicDisorders #DrugDevelopment #FDAApprovals #AIinBiotech #GutMicrobiome #Business #Technology #FexingoBusiness #BusinessPodcast #BiotechBusiness Keep every episode free: buymeacoffee.com/fexingo

Biotech has spent decades reading the genome. Now a wave of startups is reading the proteome—the full set of proteins expressed by a cell. Lucas and Luna dig into why proteomics is suddenly investable, not just academic. They look at Seer, a startup that went public with a proteomics platform, and how its technology works: engineered nanoparticles that capture the entire protein soup from a blood sample, then mass spectrometry reads it all. They discuss the key problem proteomics solves: many diseases are driven by proteins, not genes, and most drug targets are proteins. The episode also covers the challenge: the proteome is 100x more complex than the genome, and it changes constantly. They touch on why big pharma like Novartis and Roche are signing proteomics deals, and what it means for drug discovery timelines. By the end, listeners understand why this may be the next big platform shift in biotech. #Proteomics #DrugDiscovery #BiotechStartups #Seer #MassSpectrometry #ProteinBiomarkers #Novartis #Roche #PrecisionMedicine #GenomicsVsProteomics #BiotechInvesting #PlatformBiotech #Business #Technology #LifeSciences #FexingoBusiness #BusinessPodcast #BiotechBusiness Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business with Fexingo, Lucas and Luna explore synthetic lethality, a precision oncology approach that exploits cancer cells' unique genetic weaknesses. They focus on the PARP inhibitor story—how drugs like olaparib, originally developed by AstraZeneca and Myriad Genetics, turned a lab-bench concept into a multi-billion-dollar class of therapies. Lucas breaks down the science: two non-lethal mutations become lethal only when combined in a cancer cell, sparing healthy tissue. They discuss the commercial arc, from the 2014 FDA approval for BRCA-mutated ovarian cancer to today's expansion into pancreatic and prostate cancers. The episode also looks ahead to emerging targets like WEE1 and ATR inhibitors, and why big pharma is paying billions for startups that can identify new synthetic lethal pairs. A concrete look at how understanding genetics is rewriting oncology treatment protocols and creating lucrative niche markets. #SyntheticLethality #PARPInhibitors #Olaparib #BRCAMutation #Oncology #PrecisionMedicine #DrugDiscovery #Biotech #AstraZeneca #MyriadGenetics #Lynparza #DNARepair #CancerGenetics #WEE1Inhibitors #ATRInhibitors #Business #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business with Fexingo, Lucas and Luna explore the emerging field of RNA editing as a therapeutic tool, focusing on how startups like Wave Life Sciences and Ascidian Therapeutics are developing drugs that fix genetic mutations at the RNA level without altering DNA. Unlike CRISPR, which makes permanent changes, RNA editing offers a reversible and potentially safer approach for treating diseases like alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy. The hosts break down the key technology behind ADAR enzymes, the advantages over CRISPR, and the latest clinical data from 2026. They also discuss the business landscape: which companies are leading, how investors are viewing the space, and the regulatory hurdles ahead. If you work in biotech or just follow drug development, this episode gives you a concrete understanding of why RNA editing could be the next wave after CRISPR. #RNAEditing #Biotech #WaveLifeSciences #AscidianTherapeutics #ADAR #CRISPR #DrugDiscovery #GeneTherapy #Startups #Alpha1Antitrypsin #Duchenne #ClinicalTrials #FDA #Business #Technology #FexingoBusiness #BiotechPodcast #LifeSciences Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business with Fexingo, Lucas and Luna explore how artificial intelligence is revolutionizing protein design for drug development. They focus on the case of David Baker's lab at the University of Washington and the startup Protein Evolution, which used AI to create a novel enzyme that breaks down PET plastic. The hosts discuss how generative models like RFdiffusion and ProteinMPNN are enabling biotechs to design custom proteins from scratch, reducing the timeline from years to months. They also touch on the recent $200 million Series B raised by Profluent, a startup using large language models for protein engineering. Lucas explains the technical leap from Rosetta to deep learning methods, while Luna questions the regulatory path for AI-designed therapeutics. The episode avoids hype and provides a concrete understanding of how this technology is reshaping drug discovery and beyond. #AIProteinDesign #DavidBaker #ProteinEvolution #RFdiffusion #ProteinMPNN #Profluent #De NovoProtein #DeepLearning #DrugDiscovery #BiotechStartups #EnzymeEngineering #PETPlastic #Rosetta #GenerativeBiology #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Antibiotic resistance is a growing global crisis, but a new wave of biotech startups is using artificial intelligence to discover novel antibiotics faster and cheaper than traditional methods. In this episode, Lucas and Luna examine how AI-powered platforms are sifting through millions of molecular combinations to identify promising drug candidates. They focus on the case of Phare Bio, a startup spun out of the MIT Antibiotics Project, which recently secured $45 million in Series A funding to advance its AI-driven discovery engine. Lucas explains why the antibiotic pipeline has been dry for decades—low profitability drives big pharma away—and how AI changes the economic calculus. Luna challenges whether AI can overcome the biological hurdles that have stymied traditional screening. The hosts also discuss the role of public-private partnerships like the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, in funding early-stage research. Along the way, they touch on the unique challenge of avoiding AI hallucination in molecule generation and why startups are focusing on Gram-negative bacteria as a priority. This episode offers a grounded look at how machine learning is being applied to one of medicine's hardest problems, without hype. #AI #Antibiotics #Biotech #DrugDiscovery #PhareBio #MachineLearning #AntimicrobialResistance #GramNegativeBacteria #Startups #Pharmaceuticals #Business #Technology #FexingoBusiness #BusinessPodcast #BiotechStartup #CARBX #MIT #SeriesA Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business with Fexingo, Lucas and Luna explore the emerging field of antibody-drug conjugates (ADCs) and how startups are leveraging conjugation chemistry to improve cancer therapies. They discuss the case of Mersana Therapeutics, which uses a novel linker platform to attach potent toxins to antibodies, and compare it to traditional chemotherapy. The hosts explain how ADC technology works, why linker stability matters, and what the market opportunity looks like. They also touch on the broader trend of drug delivery platforms and how large pharma is partnering with smaller biotechs. A clear, jargon-light look at a fast-moving corner of biotech. #AntibodyDrugConjugates #ADCs #MersanaTherapeutics #BiotechStartups #DrugDelivery #CancerTherapy #LinkerTechnology #ConjugationChemistry #TargetedTherapy #Chemotherapy #PharmaPartnerships #Payload #MonoclonalAntibodies #ClinicalTrials #BusinessAndTechnology #FexingoBusiness #BusinessPodcast #BiotechBusiness Keep every episode free: buymeacoffee.com/fexingo

Episode 21 of Biotech Business with Fexingo dives into the growing use of wearable sensors—smartwatches, continuous glucose monitors, and digital patches—in clinical trials. Lucas and Luna explore how Verily's Project Baseline and Apple Watch studies have generated continuous real-world data, cutting trial costs and timelines. They discuss the FDA's evolving stance on digital endpoints, the example of Evidation Health using consumer wearables for a 2024 depression study, and the challenges of data noise and patient adherence. A compelling look at how biotech startups are moving beyond episodic clinic visits to continuous monitoring. #Biotech #ClinicalTrials #Wearables #DigitalHealth #Verily #AppleWatch #EvidationHealth #FDA #RealWorldData #Startups #DrugDevelopment #ContinuousMonitoring #DigitalEndpoint #ProjectBaseline #DataScience #Business #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode 20 of Biotech Business with Fexingo: Lucas and Luna explore the emerging field of 'in vivo cell engineering'—a new wave of biotech startups that aim to build drug factories inside patients' own cells. They anchor on a specific approach: lipid nanoparticle (LNP) delivery of mRNA that instructs liver cells to produce therapeutic proteins, potentially replacing frequent injections for chronic diseases. The hosts dissect a real-world case: a startup called ReCode Therapeutics, which raised $260 million to deliver mRNA to lung cells for cystic fibrosis. They compare the platform economics to traditional biologics manufacturing, debate the scalability of cell-targeting LNPs, and ask whether this is truly a paradigm shift or just a clever niche. The conversation ties to broader questions about how biotech is redefining 'manufacturing' and who will own the supply chain when the patient's body is the bioreactor. #Biotech #DrugFactory #InVivoEngineering #LNP #mRNA #ReCodeTherapeutics #CysticFibrosis #CellTherapy #GeneTherapy #PlatformBiotech #DrugDelivery #Bioreactor #ChronicDisease #Business #Technology #FexingoBusiness #BusinessPodcast #BiotechPodcast Keep every episode free: buymeacoffee.com/fexingo

For decades, drug delivery has been one of biotech's toughest problems: how do you get a therapeutic molecule to exactly the right cell without it degrading or causing side effects along the way? This episode zooms in on exosomes — tiny lipid vesicles that cells naturally use to communicate — and how a new wave of startups is engineering them as delivery vehicles. Lucas walks through the science: exosomes are about 100 nanometers across, carry proteins and RNA, and can cross biological barriers that synthetic nanoparticles struggle with. He highlights Codiak BioSciences' work on engineered exosomes for oncology and a recent deal between Evox Therapeutics and Eli Lilly worth over a billion dollars in potential milestones. Luna questions whether the manufacturing challenges — scaling up production while maintaining consistency — could stall the field the way they have for cell and gene therapies. They discuss how the first exosome-based therapeutics are nearing clinical data readouts, and what that could mean for the broader drug development landscape. A focused look at a technology that might finally solve the 'right place, right time' problem in medicine. #Exosomes #DrugDelivery #BiotechStartups #CodiakBioSciences #EvoxTherapeutics #EliLilly #RNATherapeutics #Nanoparticles #DrugDevelopment #Oncology #Biotechnology #ClinicalTrials #Pharmaceuticals #TherapeuticDelivery #Business #FexingoBusiness #BiotechBusiness #LifeSciences Keep every episode free: buymeacoffee.com/fexingo

In this episode of Biotech Business with Fexingo, Lucas and Luna explore how decentralized clinical trials (DCTs) are transforming drug development by moving research out of traditional academic centers and into patients' homes. They dive into the specific case of Pfizer's DCT for ulcerative colitis during the pandemic, which used telemedicine, local labs, and wearable sensors to cut enrollment time by 30% while improving patient diversity. The hosts discuss the cost benefits—some DCTs report 20% lower trial costs—and the regulatory tailwinds from the FDA's 2023 guidance. They also highlight challenges, including data integrity concerns and the digital divide, using the example of a 2024 Alzheimer's trial that struggled with rural recruitment. The episode closes with a forward look at how hybrid models might become the new standard, with McKinsey estimating 30% of all phase II and III trials could include a DCT component by 2028. #DecentralizedClinicalTrials #DCT #ClinicalTrials #DrugDevelopment #Pfizer #UlcerativeColitis #FDA #Telemedicine #DigitalHealth #PatientCentricity #Biotech #PharmaInnovation #RealWorldEvidence #WearableTech #HealthEquity #Business #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode 17 of Biotech Business with Fexingo explores the rise of organ-on-a-chip technology in preclinical drug development. Lucas and Luna examine how startups like Emulate and CN Bio are building microfluidic devices that mimic human organ function — from liver to lung to gut — and how these chips are starting to replace traditional animal models. They discuss the science behind the chips, the regulatory push from the FDA's Modernization Act 2.0, and why venture capital is pouring into this space. Specific focus on Emulate's colon chip used to study inflammatory bowel disease and a recent $100 million Series C round. The hosts also touch on the cost savings for small biotechs, the limitations of current chip models, and what the next five years could look like for a world with fewer lab animals and more human-relevant data. #OrganOnAChip #Emulate #CNBio #DrugDevelopment #AnimalTestingAlternatives #FDAmodernization #BiotechStartups #PreclinicalResearch #Microfluidics #InflammatoryBowelDisease #VentureCapital #SeriesC #LifeSciences #BusinessAndTechnology #FexingoBusiness #BusinessPodcast #LabOnAChip #HumanRelevantData Keep every episode free: buymeacoffee.com/fexingo

Episode 16 of Biotech Business with Fexingo explores how biotech startups are using digital twins—high-fidelity computer models of patients—to design and simulate clinical trials before enrolling a single human. Lucas and Luna break down the real-world example of a mid-stage oncology trial at a company called Unlearn.AI, where a digital twin control arm reduced the number of placebo patients needed by 40 percent, saving months and millions of dollars. They also discuss the regulatory hurdles: the FDA has accepted digital twin data in two investigational new drug applications so far in 2026, but questions remain about generalizability and bias. Tune in for a concrete look at how simulation is reshaping evidence generation in life sciences. #DigitalTwins #ClinicalTrials #Biotech #UnlearnAI #FDA #DrugDevelopment #AIinHealthcare #PatientSimulation #Oncology #ClinicalData #RegulatoryScience #BiotechStartups #LifeSciences #TrialDesign #PlaceboControl #FexingoBusiness #BusinessPodcast #BusinessAndTechnology Keep every episode free: buymeacoffee.com/fexingo

Episode 15 of Biotech Business with Fexingo explores the rise of 'lab-as-a-service' — flexible, shared R&D lab spaces that let biotech startups avoid the huge capital costs of building their own facilities. Lucas and Luna dive into the model pioneered by companies like BioLabs and LabCentral, with a focus on a specific case: a 2024 startup that launched a CRISPR screening platform in 60 days using shared lab infrastructure, versus the 18 months it would have taken to build its own. They discuss the economics — saving roughly $2 million in upfront build-out per 1,000 square feet — and the trade-offs: shared equipment queues, data security concerns, and the risk of losing the proprietary culture that comes with a dedicated lab. The hosts also touch on how the model is evolving: the first lab-as-a-service REITs are now trading on the NASDAQ, and big pharma is starting to rent adjacent benches to stay close to innovation. A useful episode for anyone building in biotech or thinking about capital efficiency in science. #LabAsAService #BiotechInfrastructure #StartupCapitalEfficiency #BioLabs #LabCentral #SharedLabSpace #CRISPR #DrugDiscovery #RDBiotech #LifeSciences #RealEstate #REIT #Business #Technology #FexingoBusiness #BusinessPodcast #BiotechBusiness #Podcast Keep every episode free: buymeacoffee.com/fexingo

Lucas and Luna explore the emerging field of CRISPR-based diagnostics, which uses gene-editing tools to detect infectious diseases like COVID-19, dengue, and tuberculosis with rapid, low-cost tests. They focus on a 2025 study from the Broad Institute showing a CRISPR assay that detects SARS-CoV-2 in under 30 minutes with 98% sensitivity, compared to PCR's 95% but with lab delays. The hosts discuss the startup Sherlock Biosciences, founded by CRISPR pioneer Feng Zhang, which is commercializing these tests for point-of-care use. They also examine regulatory hurdles, manufacturing challenges, and the potential to transform outbreak response in low-resource settings. The episode draws a clear contrast with traditional PCR and rapid antigen tests, showing where CRISPR diagnostics fit in the testing landscape. #CRISPR #Diagnostics #InfectiousDisease #SherlockBiosciences #FengZhang #BroadInstitute #PointOfCare #COVID19 #Dengue #Tuberculosis #PCR #RapidTests #Biotech #Startups #FDA #GeneEditing #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode 13 of Biotech Business explores the rise of biosimilars—near-copies of complex biologic drugs that are shaking up the $300 billion biologics market. Lucas and Luna break down the science, economics, and regulatory landscape, using the case of AbbVie's Humira, which lost over 50 percent of its market share to biosimilars within two years of patent expiration. They discuss why biosimilars are cheaper to develop than new drugs but still cost hundreds of millions to bring to market, how the FDA's approval pathway has evolved, and why startups like Coherus BioSciences and Samsung Bioepis are leading the charge. The episode examines the tension between innovation and access, and what the biosimilar wave means for drug pricing, pharma business models, and patient care. A clear, specific look at one of the most consequential shifts in modern drug economics. #Biosimilars #Biologics #Humira #AbbVie #CoherusBioSciences #SamsungBioepis #FDA #DrugPricing #BiotechBusiness #Biotech #Pharma #PatentExpiration #BiotechStartups #DrugDevelopment #HealthcareEconomics #Business #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode 12 of Biotech Business with Fexingo. Lucas and Luna dive into the emerging practice of using artificial intelligence to predict whether a drug candidate will succeed in clinical trials before human testing begins. They focus on the startup VeriSIM Life, which builds digital models to simulate drug behavior across different patient populations—a process often called 'virtual patients.' The hosts break down how VeriSIM's AI platform, which integrates data from failed trials, public databases, and molecular simulations, can reduce the time and cost of drug development by flagging likely failures early. They also discuss the limitations: the models are only as good as the data they're trained on, and regulatory acceptance is still evolving. The episode highlights a specific example where VeriSIM's predictions matched actual phase 2 results for a liver disease drug, saving the sponsor an estimated $30 million in trial costs. A concrete look at how biotech is betting on computation to fix a broken R&D model. #VeriSIMLife #AIinClinicalTrials #VirtualPatients #DrugDevelopment #BiotechStartups #ClinicalTrialPrediction #MachineLearning #PharmaR&D #DrugDiscovery #DigitalTwins #Simulation #Phase2Trials #LiverDisease #CostReduction #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode 11 of Biotech Business with Fexingo explores how biotech startups are using 'digital twins' — AI-powered virtual patients — to simulate clinical trials, reduce costs, and accelerate drug development. Lucas and Luna break down the case of a mid-stage startup using digital twins to cut a Phase II trial's patient enrollment by 40 percent, saving an estimated $15 million and shaving eight months off the timeline. They discuss the technology behind it: generative models trained on historical trial data, real-world electronic health records, and synthetic control arms. They also tackle the skepticism from regulators and traditional clinicians, the risk of algorithmic bias when digital twins don't represent diverse populations, and why the FDA is cautiously opening the door to in silico evidence. Specific numbers, real trade-offs, and no hype. #DigitalTwins #ClinicalTrials #AIinBiotech #DrugDevelopment #SyntheticControlArms #FDA #InSilico #PhaseII #BiotechStartup #GenerativeModels #RealWorldData #PrecisionMedicine #AlgorithmicBias #LifeSciences #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo