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

How Biotech Startups Use Base Editing for Genetic Therapies 30.07.2026 8min

CRISPR made gene editing famous, but its blunt cuts carry risks. Base editing changes a single DNA letter without breaking the helix—a precision tool that startups like Beam Therapeutics and Verve Therapeutics are betting on for sickle cell disease and heart disease. This episode explains how base editing works, why it matters for patients, and the business challenges of turning a one-time edit into a viable therapy. Hosts Lucas and Luna break down the science, the clinical milestones, and the tough questions around pricing and delivery that will determine whether these startups become the next big thing or cautionary tales. If you're curious about the next wave of genetic medicine, this is a clear, grounded look at where the field stands in mid-2026. #BaseEditing #CRISPR #GeneTherapy #BiotechStartups #BeamTherapeutics #VerveTherapeutics #SickleCell #PCSK9 #HeartDisease #DrugDiscovery #PrecisionMedicine #Business #Technology #BiotechBusiness #FexingoBusiness #BusinessPodcast #Podcast #GeneticDiseases Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use Cryo-EM to Design Better Drugs 30.07.2026 8min

Cryo-electron microscopy, or cryo-EM, has transformed structural biology since winning the Nobel Prize in 2017. Once limited to academic labs with massive budgets, the technology is now within reach of biotech startups, enabling them to visualize proteins at atomic resolution and design drugs with unprecedented precision. In this episode, Lucas and Luna explore how one startup reduced a two-year target identification phase to six months using cryo-EM, the economics of building in-house vs. outsourcing, and why the Protein Data Bank now holds over 20,000 cryo-EM structures. They also discuss the business implications: faster drug development, better success rates in clinical trials, and the rise of contract research organizations specializing in cryo-EM for smaller companies. Tune in to understand why this technology is considered one of the most impactful in modern drug discovery. #Biotech #CryoEM #DrugDiscovery #StructuralBiology #Startups #Business #Technology #FDA #CRO #NobelPrize #ProteinDesign #MembraneProteins #GPCRs #DrugDevelopment #LifeSciences #FexingoBusiness #BusinessPodcast #BiotechBusiness Keep every episode free: buymeacoffee.com/fexingo

How Real-World Evidence Is Changing Biotech Drug Approvals 29.07.2026 6min

This episode of Biotech Business with Fexingo explores how biotech startups are leveraging real-world evidence (RWE) to accelerate FDA approvals, especially for rare diseases. Lucas and Luna discuss the FDA's latest guidance on RWE, the types of data used (electronic health records, wearables, patient registries), and the advantages over traditional randomized controlled trials. They examine a case study of a fictional startup using natural history data to support a gene therapy for Duchenne muscular dystrophy, highlighting the challenges of data quality and selection bias. The conversation also covers how startups can build RWE strategies through partnerships with health systems and AI-driven data cleaning. The hosts emphasize that RWE is leveling the playing field, allowing smaller companies to bring treatments to patients faster and at lower cost. The episode includes a brief, low-key mention of listener support via Buy Me a Coffee to keep the show ad-free. #Biotech #Business #FDA #RealWorldEvidence #DrugApproval #Startups #RareDiseases #GeneTherapy #ClinicalTrials #DigitalHealth #Wearables #AI #RegulatoryScience #PatientRegistries #ElectronicHealthRecords #HealthcareInnovation #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Are Engineering Antibodies to Cross the Blood-Brain Barrier 29.07.2026 5min

The blood-brain barrier (BBB) has long been the bane of CNS drug development, blocking over 98% of small molecules and virtually all large biologics. But in 2026, that wall is finally cracking. This episode examines how biotech startups like Denali Therapeutics are hijacking the brain's own transport systems—specifically the transferrin receptor—to shuttle antibodies and enzymes across the BBB. We walk through the science of transporter-mediated transcytosis, the role of focused ultrasound as an alternative approach, and the recent FDA approval of an Alzheimer's antibody that relies on similar shuttle technology. We also look at the clinical prospects: Denali's candidate for Hunter syndrome, a potential treatment for Parkinson's, and the broader implications for unlocking the CNS drug market, which represents over 40% of unmet medical need. This is not a distant promise—it's happening now, and it's reshaping how we think about treating the brain. #Biotech #BloodBrainBarrier #BBB #AntibodyEngineering #DrugDelivery #CNS #Alzheimers #Parkinsons #DenaliTherapeutics #TransferrinReceptor #FocusedUltrasound #Neurodegeneration #BiotechStartups #DrugDevelopment #FDAApproval #ClinicalTrials #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use Exosomes for Drug Delivery 28.07.2026 8min

Exosomes, tiny vesicles that cells naturally secrete, are becoming a powerful drug delivery vehicle for biotech startups. This episode explores how companies like Evox Therapeutics and Codiak BioSciences are engineering exosomes to deliver RNA therapies, proteins, and small molecules to tissues that were previously hard to reach. We break down the science, the manufacturing challenges, and why big pharma is taking notice. Learn about the key advantages over lipid nanoparticles and viral vectors, and what regulatory hurdles remain for exosome-based medicines. #BiotechStartups #DrugDelivery #Exosomes #EvoxTherapeutics #CodiakBioSciences #RNATherapies #GeneTherapy #ViralVectors #LipidNanoparticles #ExtracellularVesicles #RareDiseases #Neurology #Oncology #Biotech #FexingoBusiness #BusinessPodcast #Startups #FDAApprovals Keep every episode free: buymeacoffee.com/fexingo

Biotech Startups Target the Gut-Brain Axis for Depression 28.07.2026 8min

Episode 136 of Biotech Business explores how biotech startup Mendel Biotech is developing a live biotherapeutic for major depressive disorder. With promising Phase 2 data showing a 4-point reduction on the Hamilton Depression Rating Scale, we break down the gut-brain axis science, the challenges of manufacturing live bacterial therapies, and the regulatory path for FDA approval. We also discuss the business landscape, including competition from Seres Therapeutics and Pendulum, and what it means for the future of psychiatric treatment. This is the business and technology of the microbiome revolution. #Biotech #MicrobiomeTherapeutics #GutBrainAxis #Depression #MentalHealth #DrugDiscovery #FDA #Phase2Trials #MendelBiotech #GABA #LiveBiotherapeutic #Manufacturing #Startups #ClinicalData #Business #Science #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use Lipid Nanoparticles Beyond the Liver 27.07.2026 9min

In this episode, Lucas and Luna explore how biotech startups are engineering lipid nanoparticles to deliver gene therapies to organs beyond the liver—the traditional target for these delivery vehicles. They spotlight ReCode Therapeutics and its lung-targeting LNP platform, discuss the chemistry innovations that make tissue-specific delivery possible, and examine the clinical and manufacturing challenges startups face as they race to bring the first non-liver LNP gene therapy to market. With concrete examples and numbers, the hosts explain why this technology could unlock the next wave of precision medicine. #LipidNanoparticles #GeneTherapy #BiotechStartups #DrugDelivery #ReCodeTherapeutics #IntelliaTherapeutics #LungTargeting #NonviralDelivery #CRISPR #ClinicalTrials #Manufacturing #BiotechBusiness #FexingoBusiness #BusinessPodcast #LifeSciences #DrugDiscovery #FDA #StartupFunding Keep every episode free: buymeacoffee.com/fexingo

How Directed Evolution Helps Biotech Startups Engineer Better Enzymes 27.07.2026 9min

This episode of Biotech Business with Fexingo explores how biotech startups use directed evolution, the Nobel-winning technique, to engineer custom enzymes for drug manufacturing and therapeutics. Lucas and Luna break down the story of Codexis, which evolved an enzyme that slashed waste in the production of the blockbuster diabetes drug Januvia (sitagliptin) by 80 percent. They discuss how directed evolution mimics natural selection in the lab—mutating genes, screening for improved activity, and iterating over generations. The conversation also covers broader applications: startups like Inscripta using directed evolution to enhance CRISPR enzymes for precision gene editing, and others evolving antibodies with stronger binding. Along the way, they touch on the practical challenges—screening billions of variants, choosing the right starting enzyme, and the iterative speed that can accelerate drug development. The hosts connect the technique to the business of biotech, explaining why manufacturing efficiency and therapeutic innovation both benefit from this approach. A donation segment at the 25% mark highlights listener support as key to keeping the show ad-free. #DirectedEvolution #EnzymeEngineering #BiotechStartup #DrugDiscovery #FrancesArnold #Codexis #Merck #Sitagliptin #CRISPR #Inscripta #ProteinEngineering #Biocatalysis #PharmaceuticalManufacturing #GreenChemistry #IndustrialBiotech #LifeSciences #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Engineer Probiotics to Deliver Drugs 26.07.2026 8min

In June 2026, the FDA approved the first engineered live biotherapeutic product for a rare metabolic disorder, signaling a new era for programmable medicines. This episode explores how startups are engineering probiotics to sense disease and release therapies directly in the gut. Lucas and Luna discuss the science behind these living drugs—how bacteria are reprogrammed with genetic circuits to produce anti-inflammatory molecules, break down toxins, or deliver cancer immunotherapies. They examine the regulatory path, manufacturing challenges, and why big pharma is taking notice. Specific examples include a California-based startup's clinical trial for phenylketonuria and another using probiotic E. coli to treat ulcerative colitis. The hosts also address concerns about containment and evolution of engineered strains. The episode concludes with a look at the next frontier: combining probiotics with CRISPR for in vivo gene editing. #Biotech #Probiotics #DrugDelivery #SyntheticBiology #FDA #Startups #Microbiome #Therapeutics #Engineering #ClinicalTrials #GeneTherapy #Pharma #Innovation #Business #Technology #FexingoBusiness #BusinessPodcast #LifeSciences Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use DNAEncoded Libraries for Drug Discovery 26.07.2026 8min

Lucas and Luna explore how DNA-encoded libraries (DELs) are transforming drug discovery, allowing startups to screen billions of compounds in a single test tube. They break down the technology behind DELs—how DNA barcodes encode each compound's structure and how sequencing reveals the hits. The conversation covers advantages over traditional high-throughput screening, common pitfalls like false positives, and why DELs are especially powerful for targeting 'undruggable' proteins. They also touch on a Cambridge-based startup using DELs to hunt for novel antibiotics, and how AI is being layered on top to improve hit rates. A concrete look at a technology that's shrinking the drug discovery timeline from years to months. #DNAEncodedLibraries #DELs #DrugDiscovery #Biotech #Startups #HighThroughputScreening #UndruggableTargets #Antibiotics #AIinPharma #HitIdentification #Libraries #Screening #Chemistry #MolecularBiology #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use CRISPR Diagnostics 25.07.2026 8min

Lucas and Luna explore the emerging field of CRISPR-based diagnostics, where startups like Sherlock Biosciences and Mammoth Biosciences are turning gene-editing enzymes into rapid, portable tests for infectious diseases and beyond. They break down how Cas12 and Cas13 enzymes detect specific DNA or RNA sequences, creating signals that can be read on a simple lateral flow strip — similar to a pregnancy test but able to distinguish between flu, COVID, and RSV from a single sample. The episode covers the key regulatory milestone: the FDA's first emergency use authorization for a CRISPR diagnostic in 2020, and how companies are now targeting cancer screening, antibiotic resistance, and at-home testing. Lucas and Luna discuss the technical hurdles — sensitivity, sample prep, and scalability — and why venture capital is flooding into this space. A concrete case: Mammoth's partnership with a global health nonprofit to deploy low-cost tests in sub-Saharan Africa. The conversation closes with the question of whether CRISPR diagnostics can finally deliver on the promise of affordable, decentralized precision medicine. #CRISPR #Diagnostics #Biotech #Startup #PointOfCare #GeneEditing #FDA #SherlockBio #MammothBio #InfectiousDisease #CancerScreening #Business #Technology #FexingoBusiness #BusinessPodcast #BiotechBusiness #LucasAndLuna #LifeSciences Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use Liquid Biopsies for Early Cancer Detection 24.07.2026 10min

Lucas and Luna dive into the rapidly evolving world of liquid biopsies—blood tests that detect cancer DNA fragments. They explore a landmark 2025 study from the PATHFINDER 2 trial, which screened over 6,600 adults and found early-stage signals in 1.4% of participants, with a positive predictive value above 40%. The hosts discuss how startups like Guardant Health and Grail are pushing the technology toward multi-cancer screening, the technical challenge of distinguishing tumor DNA from benign clonal hematopoiesis mutations, and why the economics of a $900 test remain a barrier to broad adoption. They also consider how liquid biopsies could reshape the relationship between biotech startups and primary care, moving cancer detection from symptomatic to pre-symptomatic. This episode is grounded in specific trial data and real-world hurdles, offering concrete insights for anyone following the intersection of diagnostics, tech, and business. #LiquidBiopsy #EarlyCancerDetection #GuardantHealth #Grail #PATHFINDER2 #ctDNA #MultiCancerScreening #ClonalHematopoiesis #PCR #NextGenerationSequencing #BiotechStartup #Diagnostics #Oncology #HealthcareBusiness #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use Automated Patch Clamp for Drug Discovery 23.07.2026 9min

Lucas and Luna explore how automated patch clamp (APC) technology is transforming ion channel drug discovery. They discuss the shift from manual to automated electrophysiology, the role of companies like Sophion and Nanion, and how startups are using APC to screen for cardiac safety and develop new pain therapeutics. The episode dives into the numbers: how APC has reduced screening time from months to days, and why ion channels are still an underexplored target class despite being the third largest drug target family after GPCRs and enzymes. Lucas explains the science behind patch clamp in plain terms, and Luna challenges him on whether automation sacrifices data quality. A concrete example: how a 2024 study used APC to identify a new Nav1.7 inhibitor for chronic pain. The hosts also touch on the FDA's evolving stance on ion channel assays for QT prolongation testing. No prior biotech knowledge needed. #AutomatedPatchClamp #IonChannels #DrugDiscovery #BiotechStartups #Electrophysiology #Sophion #Nanion #Nav1.7 #PainTherapeutics #CardiacSafety #QTProlongation #LabelFreeScreening #HighThroughput #TargetIdentification #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use Lysosomal Targeting for Drug Delivery 23.07.2026 9min

In this episode of Biotech Business with Fexingo, Lucas and Luna explore how biotech startups are leveraging lysosomal targeting to deliver drugs precisely where they're needed inside cells. They focus on the case of Lysogene, a French biotech that used a lysosomal enzyme replacement therapy to treat a rare neurological disorder called Sanfilippo syndrome type A. The hosts break down the science behind lysosomal targeting—how mannose-6-phosphate receptors guide therapeutic enzymes to lysosomes—and discuss the startup's pivotal Phase 3 trial results from 2025. They also examine the broader landscape: why companies like M6P Therapeutics and Lysoclear are betting on lysosomal delivery for everything from Gaucher disease to cancer immunotherapy. The episode offers a concrete look at a niche but rapidly growing area of precision medicine, with real numbers and trial outcomes listeners can cite. #Biotech #Business #Technology #DrugDelivery #LysosomalTargeting #Lysogene #SanfilippoSyndrome #M6PTherapeutics #Lysoclear #EnzymeReplacementTherapy #RareDisease #PrecisionMedicine #Phase3 #ClinicalTrials #FexingoBusiness #BusinessPodcast #BiotechStartups #DrugDiscovery Keep every episode free: buymeacoffee.com/fexingo

Why Biotech Startups Are Betting on RNA Editing 22.07.2026 9min

Lucas and Luna explore the emerging field of RNA editing as a therapeutic platform. They break down how startups like Ascidian Therapeutics and Wave Life Sciences are using RNA editing to correct disease-causing mutations without permanently altering the genome. The episode dives into the key distinction between RNA editing and CRISPR gene editing: reversibility and safety. Lucas explains the two main approaches — adenosine deamination and ADAR recruitment — and why the space is heating up after the first clinical trial data in 2025. Luna brings up the challenge of delivery and off-target effects, and they discuss why big pharma is paying attention. A concrete episode for anyone tracking the next wave of genetic medicine. #RNAEditing #Biotech #Startups #GeneTherapy #CRISPR #AscidianTherapeutics #WaveLifeSciences #ADAR #AdenosineDeamination #DrugDiscovery #PrecisionMedicine #ClinicalTrials #Therapeutics #LifeSciences #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use Proteomics to Find New Drug Targets 22.07.2026 11min

Lucas and Luna explore the emerging field of proteomics in drug discovery, focusing on how biotech startups are using mass spectrometry and AI to measure thousands of proteins simultaneously. They discuss the case of Seer, a company that raised over $150 million to commercialize its proteograph platform, and compare it to the older approach of affinity-based proteomics. The hosts explain why measuring the proteome has been historically harder than the genome, how startups like PrognomiQ are applying proteomics to early cancer detection, and why investors are pouring money into this space. They also touch on the challenge of turning protein-level data into druggable targets, and the role of companies like Nautilus Biotechnology in pushing the field forward. By the end, listeners will understand what proteomics offers that genomics alone cannot, and why it's becoming a key tool for precision medicine. #Proteomics #DrugDiscovery #BiotechStartups #MassSpectrometry #Seer #PrognomiQ #NautilusBiotechnology #PrecisionMedicine #AIinBiotech #Biomarkers #CancerDetection #Proteograph #Business #Technology #LifeSciences #FexingoBusiness #BusinessPodcast #Startups Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use Proteolysis Targeting Chimeras for Drug Discovery 21.07.2026 7min

In this episode of Biotech Business with Fexingo, Lucas and Luna explore the emerging field of PROTACs—proteolysis targeting chimeras—as a new modality for drug discovery. They focus on how startups like Arvinas and Kymera Therapeutics are leveraging this technology to degrade disease-causing proteins rather than inhibiting them. The hosts discuss the mechanism of action, key clinical milestones, and the challenges of oral bioavailability and E3 ligase selectivity. They also touch on the competitive landscape, including partnerships with big pharma and the potential for PROTACs to address previously 'undruggable' targets. A must-listen for anyone interested in the future of targeted protein degradation and biotech innovation. #ProteolysisTargetingChimera #PROTAC #DrugDiscovery #BiotechStartup #Arvinas #KymeraTherapeutics #TargetedProteinDegradation #UndruggableTargets #E3Ligase #UbiquitinProteasomeSystem #OralBioavailability #ClinicalTrials #SmallMolecule #CancerTherapy #Neurodegeneration #BigPharmaPartnerships #Business #FexingoBusiness Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use Organoids to Model Disease 21.07.2026 12min

Episode 124 of Biotech Business with Fexingo dives into organoids — miniature, lab-grown organs derived from stem cells that are transforming drug discovery and disease modeling. Lucas and Luna discuss how startups like Emulate and Organovo are using these 3D structures to test drugs on human tissues without animal models, focusing on a specific case: a colorectal cancer organoid platform that predicted patient drug response with over 90% accuracy in a 2025 study. They explore the technology's potential to reduce clinical trial failures, challenges around vascularization and scalability, and why venture capital is pouring into the space — with over $800 million invested in organoid startups in the first half of 2026. The conversation also touches on the ethical and regulatory shifts, as the FDA begins accepting organoid data for rare disease drug applications. A focused look at how tiny human organs in a dish are reshaping biotech R&D. #Organoids #DrugDiscovery #DiseaseModeling #StemCells #PrecisionMedicine #ColorectalCancer #FDA #VentureCapital #BiotechStartups #Emulate #Organovo #LabGrownOrgans #3DCellCulture #RareDisease #DrugDevelopment #Business #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Use Cell Painting for Drug Discovery 20.07.2026 10min

Episode 123 of Biotech Business with Fexingo dives into cell painting, an image-based profiling technique that is transforming early-stage drug discovery. Lucas and Luna explore how startups like Recursion Pharmaceuticals and the Broad Institute's teams use fluorescent dyes and automated microscopy to capture thousands of cellular features per well, creating a 'phenotypic fingerprint' of how compounds affect cells. They discuss how this approach helped identify a new candidate for a rare genetic disease in months rather than years, and how it's being combined with AI to predict mechanism of action. The hosts also touch on the practical challenges: data reproducibility, computational costs, and the skepticism from traditional target-based screening. A must-listen for anyone interested in the intersection of high-content imaging, machine learning, and biotech innovation. #CellPainting #DrugDiscovery #PhenotypicScreening #HighContentImaging #RecursionPharmaceuticals #BroadInstitute #MachineLearning #ImageProfiling #RareDisease #AIinBiotech #AssayDevelopment #TargetAgnostic #PhenotypicFingerprint #BiotechStartups #LifeSciences #Business #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

How Biotech Startups Are Using Circular RNA for Therapeutics 20.07.2026 9min

In this episode of Biotech Business with Fexingo, hosts Lucas and Luna explore the emerging field of circular RNA therapeutics. They explain how these stable, non-linear RNA molecules are being engineered by startups like Orna Therapeutics and Laronde (now part of Flagship Pioneering) to create durable protein expression without the immune activation seen in linear mRNA. The conversation covers the unique 3D structure of circRNA, its advantages for sustained treatment, and the technical challenges in large-scale synthesis and delivery. Lucas and Luna also discuss recent funding rounds and the timeline for clinical trials, giving listeners a clear picture of why circular RNA is the next frontier in nucleic acid medicine. #CircularRNA #BiotechStartups #RNATherapeutics #OrnaTherapeutics #Laronde #FlagshipPioneering #mRNA #GeneTherapy #DrugDiscovery #BiotechBusiness #LifeSciences #FDA #TherapeuticDelivery #ProteinExpression #NucleicAcidMedicine #Business #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo