We love to hear from our listeners. Send us a message. Purespring Therapeutics launched in 2020 on the back of IP developed by renowned kidney researcher Prof. Moin Saleem, who spent decades working on podocytes when podocytes weren’t cool. Just two years later, the company boasts three gene therapy assets and a platform developed expressly to identify new therapeutic targets to address kidney disease. These assets promise to change the "dialysis or transplant" ultimatums associated wi...
May 02, 2022•57 min
We love to hear from our listeners. Send us a message. Opus Genetics is an early-stage gene therapy company launched just last year and in unique fashion on the back of the patient advocacy group the Retinal Degeneration Fund. Already, its pipeline has developed into three candidates, the lead among them addressing Leber congenital amaurosis. Opus CEO Ben Yerxa, Ph.D. serves in triplicate as CEO at the RD Fund, Foundation Fighting Blindness, and Opus Genetics. His plate is full, but he's a ...
Apr 25, 2022•46 min
We love to hear from our listeners. Send us a message. Context Therapeutics Co-Founder & CEO Martin Lehr shares stories from his self-described "recovery from venture capital," the work his company is doing in gynecological cancers, and how his small company manages a modality-agnostic approach and investigator-sponsored trials across multiple clinical candidates, four of which are in phase 2 clinical trials. We also discuss his "extracurricular" work with BioBreak , Life...
Apr 18, 2022•47 min
We love to hear from our listeners. Send us a message. When Tuyen Ong was a child, he and his family escaped Vietnam by boat in the dead of the night, bound for an Indonesian refugee camp. They spent a year in that camp before emigrating to the U.K., where Ong’s underprivileged adolescence found him growing up in the projects of London. Against the odds, Ong worked his way to UCL for an education that culminated with an M.D. Today, he’s CEO of Ring Therapeutics , a promising emerging biotech bac...
Apr 11, 2022•47 min
We love to hear from our listeners. Send us a message. In this wide-ranging discussion, IgGenix CEO Jessica Grossman, M.D. discusses the application of and market opportunity for antibody therapy for severe allergies, the gender gap in the biopharma c-suite, why women work harder than men, what it means to be a female biopharma leader, and IgGenix's approach at isolating and re-engineering allergen-specific IgE antibodies into IgG antibodies designed to alleviate — and possibly prevent — al...
Apr 04, 2022•39 min
We love to hear from our listeners. Send us a message. Since assuming the President and CEO role at Sparingvision in August, 2020, Stéphane Boissel has been making big moves in the arenas of talent acquisition and IP expansion. Those efforts are securing the company's development of a number of genomic medicines to address inherited retinal disease. On this episode of the Business of Biotech, Boissel shares the company's foundation story and the role venture philanthropy played in it, ...
Mar 28, 2022•56 min
We love to hear from our listeners. Send us a message. On this episode of the Business of Biotech, Allan Shaw waxes on his expectations for mergers, acquisitions, and collaborative partnership opportunities for new and emerging biotechs in 2022 and beyond. We tackle questions biotech leaders should be asking about intentionality, what's attractive to potential suitors, and why startups that aren't prepared to take a candidate to the finish line have already conceded a major factor in p...
Mar 21, 2022•50 min
We love to hear from our listeners. Send us a message. This episode of the Business of Biotech is fire. In fact, it's an interview with SalioGen Therapeutics Chairman and CEO Ray Tabibiazar, M.D., whose last name literally translates to "Dr. Fire." Learn how he got that name, what's shaped his technology-agnostic philosophy on therapeutic development, the advantages of a genome engineering technology that leverages proprietary mammal-derived enzymes, rather than viruses, and ...
Mar 14, 2022•50 min
We love to hear from our listeners. Send us a message. While success has been seen in animal models, solid tumors have proved a vexing challenge for CAR T-cell therapies. On this week's episode of the Business of Biotech, we're joined by Anixa Biosciences Chairman, President, & CEO Amit Kumar, Ph.D. Dr. Kumar shares on the company's progress with a CAR T-cell therapy that aims to attack both tumor cells and the tumor vasculature, in hopes that it might be the first to destroy ...
Mar 07, 2022•56 min
We love to hear from our listeners. Send us a message. With its hypothesis-free, target-free, AI-driven drug discovery platform, Fountain Therapeutics is turning the traditional drug discovery pathway on its ear to address a variety of age-related disease. On this week's episode of the Business of Biotech, Fountain CEO William Greene, M.D. joins us to discuss the approach, its rationale, and how the company is applying substantial support from the likes of Eli Lilly, Alexandria Venture Inve...
Feb 28, 2022•50 min
We love to hear from our listeners. Send us a message. If you're taking a candidate into clinical trials that will be monitored by multiple international regulatory bodies, this episode is an absolute must-listen. Dr. Daniela Drago , Chief Regulatory Officer at Aurion Biotech, shares her encyclopedic knowledge of the dynamic regulatory harmonization landscape. Along the way, she offers concrete advice on creating multijurisdictional regulatory efficiencies that will smooth your journey thro...
Feb 21, 2022•42 min
We love to hear from our listeners. Send us a message. iBio COO Randy Maddux walks us through the Bryan, Texas-based biopharma's attempt to turn the CHO cell biologic development paradigm on its ear with hydroponically-grown N. benthamiana. His company's FastPharming approach to protein production, he says, could be modularized to speed cycle times and dramatically reduce upstream costs at scales large and small. For its part, iBio is proving out the approach on a host of therapeutic a...
Feb 14, 2022•51 min
We love to hear from our listeners. Send us a message. Shoreline Biosciences CEO Kleanthis Xanthopoulos, Ph.D. joins the Business of Biotech to share the company's strategy for the development, manufacture, and commercialization of off-the-shelf NK (natural killer) cell therapy. On this episode, Dr. Xanthopoulos shares why the cell and gene immunotherapeutic market has underperformed to date, why he believes autologous is not the long-term path forward, and the safety and accessibility adva...
Feb 07, 2022•38 min
We love to hear from our listeners. Send us a message. Post-operative venous thromboembolism (VTE) is a serious and prevalent post-operative risk that has several contributing factors. John Glasspool, CEO at Anthos therapeutics, is on a mission to address the issue—and a host of other cardiovascular and metabolic conditions—with monoclonal antibodies that inhibit coagulation Factor XI and its activated form XIa. On this episode of the Business of Biotech, Glasspool discusses the advantages and c...
Jan 31, 2022•45 min
We love to hear from our listeners. Send us a message. As Allan Shaw likes to say, "there have never been so many people with their hands out, and there has never been so much money to go around." But how sustainable is this seemingly perennial boom in the biotech capital markets? Will the road go on forever and the party never end, or are there signs of a slowdown on the horizon? Shaw once again joins us to break down the market activity he's seeing, and what he anticipates for e...
Jan 24, 2022•48 min
We love to hear from our listeners. Send us a message. The JDRF's T1D Fund is exemplary of an indication-specific advocacy group's aggressive pursuit of a cure through venture philanthropy. Put simply, unlike traditional VC firms who entertain myriad and often diverse pitches from biotech startups, the T1D fund creates financial and advisory incentives for the biotechs in its portfolio to pursue candidates and formalize programs around Type 1 Diabetes therapies. A growing number of the...
Jan 17, 2022•46 min
We love to hear from our listeners. Send us a message. Locus Biosciences CEO Paul Garofolo built his biotech leadership career on the back of an MIS degree, having learned the business from the inside out via the tentacles of the IT networks at companies including Genentech, The Broadlane Group, Valeant Pharmaceuticals and Patheon. On today's episode of the Business of Biotech, Garofolo shares how a technologist's approach has helped shape the effort to develop precision therapeutics f...
Jan 10, 2022•57 min
We love to hear from our listeners. Send us a message. Humacyte COO Dr. Heather Prichard joins the Business of Biotech for a discussion on the company's pipeline of candidates for the repair, replacement, and reconstruction of human vascular vessels. The company recently scaled the production of its implantable bioengineered human tissues from 10 to 200 per day to meet Phase 3 vascular trauma and arteriovenous access trials. On today's episode, Dr. Prichard shares the company's sc...
Jan 03, 2022•41 min
We love to hear from our listeners. Send us a message. Join your host Matt Pillar and guest Allan Shaw for a no-hold-barred retrospective on the year's top stories and trends. From the frontlines of the COVID-19 pandemic to the questionable approval of Aduhelm to leadership instability at the FDA and more, Shaw dissects the year past and predicts how those stories will influence the biotech industry in 2022 and beyond. Access this and hundreds of episodes of the Business of Biotech videocas...
Dec 27, 2021•45 min
We love to hear from our listeners. Send us a message. Cellectis' decision to build and operate its own trans-Atlantic manufacturing facilities was a strategic one. On this week's episode of the Business of Biotech, SVP of U.S. Manufacturing Steve Doares talks internal manufacturing rationale, discusses interoperability between its Paris and Raleigh, N.C. plants, and shares how the company keeps meeting the challenges presented by COVID-fueled supply chain disruptions head-on. Access t...
Dec 20, 2021•40 min
We love to hear from our listeners. Send us a message. Elevation Oncology is taking a new approach to leveraging the genome to guide development of its precision therapeutic development efforts. Its first step is improving both the accuracy of and accessibility to genomic testing for cancer patients, In tandem, the company is in the clinic with its lead candidate seribantumab for cancer patients with a solid tumor of any origin that expresses a genomic change called an NRG1 fusion. On this episo...
Dec 13, 2021•49 min
We love to hear from our listeners. Send us a message. Glenn Mattes' TFF Pharmaceuticals is looking to break the parenteral barrier by manufacturing biologics — mAbs and vaccines, more specifically — that can be inhaled, rather than injected. It's a timely endeavor, and TFF's business model is a collaborative one that seeks to explore dry powder biologic options through partnership, in addition to its own pipeline. On this episode of the Business of Biotech, the veteran biopharma ...
Dec 06, 2021•50 min
We love to hear from our listeners. Send us a message. Making powerful and curative biologic therapies accessible to patients from all walks of life, and all corners of the globe, requires radically innovative thinking. On this episode of the Business of Biotech, Lumen Bioscience's Co-Founder and CEO Brian Finrow, J.D. and EVP of Production/Development Craig Behnke, Ph.D. discuss a novel approach: developing therapeutic proteins from readily-available food algae spirulina. It's driving...
Nov 29, 2021•50 min
We love to hear from our listeners. Send us a message. In business for just a decade, Akesobio's stats are mindboggling: 20 drug development programs, including 12 antibodies in clinical-stage development, six bi-specific antibodies (two at clinical stage), four antibodies with IND approvals from the FDA, and 22 clinical trials initiated. The company's CEO, Michelle Xia, Ph.D., sat down with the Business of Biotech for a conversation about how the company has managed such supercharged ...
Nov 22, 2021•48 min
We love to hear from our listeners. Send us a message. Homology Medicines' approaches to gene therapy and gene editing have the potential to seriously disrupt both the cell/gene therapy space and the mAb manufacturing and administration paradigms as we know them. On this episode of the Business of Biotech, Homology President & CEO Arthur Tzianabos, Ph.D. shares the company's approach and supports its rationale for investing in its own development and manufacturing capacity. Access ...
Nov 15, 2021•50 min
We love to hear from our listeners. Send us a message. Dr. James Taylor believes that genomic medicine will prove the most revolutionary thing the life sciences industries have ever seen, and that it will ultimately become the largest therapeutic class. Dr. Taylor is president an CEO at Precision Nanosystems. He chalks up the genomic nature of biology, the fact that genomes are information-based, the breadth and validation of the genomic medicine toolbox, and the democratization of genomic medic...
Nov 08, 2021•42 min
We love to hear from our listeners. Send us a message. Is "flexible manufacturing" just another empty buzz concept concocted by the biopharma equipment marketing community, or does it demonstrate real benefit to bioprocess pros and their companies? On this episode, we sit down with Sarepta Therapeutics Director of Pharmaceutical Engineering Brian Winstead and Project Farma VP Tony Khoury to discuss what flexible manufacturing means, where it works, and where it doesn't. Listen in ...
Nov 01, 2021•55 min
We love to hear from our listeners. Send us a message. While nary a day goes by without a shovel breaking ground on a new CDMO buildout, biopharmas remain hard-pressed to secure the outsourced manufacturing space and expertise needed to meet timelines, satisfy investors, and drive competitive advantage. On this episode of the Business of Biotech, we're tackling the CDMO capacity crunch from every angle in a spirited discussion with Discovery Labs & Center for Breakthrough Medicines Co-F...
Oct 25, 2021•48 min
We love to hear from our listeners. Send us a message. The clinical trials status quo is a roadblock. They're slow, they're inefficient, and they're expensive. On this episode of the Business of Biotech, friend and frequent guest Allan Shaw shares some strong opinions on what's wrong with clinical trials, and what the industry (read: you) and the FDA need to do to make them right. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen &...
Oct 18, 2021•37 min
We love to hear from our listeners. Send us a message. Fresh on the heels of an outstanding talk with AltruBio President & CEO Judy Chou, Ph.D., the company's VP of Technology Development, Gene Lee, Ph.D., joins the Business of Biotech for a deep dive into the importance of CMC developability assessments. On this episode we cover the key points CMC developability assessments must address, when to begin them, how to go about them efficiently, and why they're integral to early milest...
Oct 11, 2021•36 min