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

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 applicatio...

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...

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...

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 sci...

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...

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 Pr...

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 s...

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...

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 exampl...

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...

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:...

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 ti...

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 r...

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 need...

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...

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...

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 ar...

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...

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 mont...

In this episode, Lucas and Luna explore how real-world data (RWD) is transforming the FDA approval process, using the case of Pfizer's Ibrance (palbociclib) for male breast cancer. They discuss the growing role of electronic health records, insurance claims, and wearable data in supplementing or replacing traditional clinical trials, with a focus on the 2021 FDA approval that expanded Ibrance's la...

Episode 9 of Biotech Business with Fexingo: Lucas and Luna dig into radiopharmaceuticals — a fusion of radiation therapy and precision targeting that is quietly becoming one of biotech's most promising frontiers. They focus on the success of Novartis' Pluvicto for prostate cancer, which generated over $1.3 billion in revenue last year, and explore why large pharma is now snapping up smaller player...

Episode 8 of Biotech Business with Fexingo takes you inside the unsung crisis in life sciences: manufacturing capacity. Lucas and Luna break down why a promising cell therapy from a small startup can't get to patients because there aren't enough sterile vats. They look at the case of ElevateBio, a company that raised over $2 billion just to build contract manufacturing facilities, and how big phar...

Episode 7 of Biotech Business with Fexingo dives into the emerging field of psychedelic-assisted therapies. Lucas and Luna explore how companies like Compass Pathways and Mind Medicine are navigating FDA trials for psilocybin and MDMA to treat PTSD and depression. They discuss the regulatory hurdles, the shift from recreational to medical frameworks, and the economic viability of these treatments....

Lucas and Luna explore the new wave of mRNA-based therapies targeting cancer, rare diseases, and even organ repair. They discuss Moderna and BioNTech's post-COVID pipelines, the promise of lipid nanoparticle delivery, and the regulatory hurdles ahead. A concrete look at how the platform that saved millions is being retooled for a much bigger mission. #mRNA #Moderna #BioNTech #LipidNanoparticles #C...

This episode of Biotech Business with Fexingo dives into the emerging field of microbiome-based therapeutics. Lucas and Luna explore how startups like Pendulum Therapeutics and Vedanta Biosciences are moving beyond probiotics to develop live biotherapeutic products targeting metabolic disease, cancer immunotherapy response, and even mental health. They break down the science of how gut bacteria in...