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 for infectious diseases at Locus, the company's decision to build its own cGMP manufacturing facility in Research Triangle, and the massive business opportunity the field addresses in the effort to overcome antibiotic resistance. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 scale-up story and the science and engineering behind a unique approach to regenerative medicine using human tissue. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 episode of the Business of Biotech, Founder & CEO Shawn Leland, PharmD, RPh takes us inside the company's unique approach. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 CEO shares the company's vision and the technology that's bringing it into focus. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 a diverse pipeline of candidates into the clinic, for indications reaching from the gut to the heart and lungs.  Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 growth.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 medicine development as reasons to be bullish. Join Dr. Taylor and me for a conversation on why RNA and DNA delivery are game-changers, and what Precision Nanosystems is doing to push the ball downfield.  Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 as Winstead shares the flexible manufacturing philosophy at Sarepta. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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-Founder Audrey Greenberg, Iovance SVP of Commercial Manufacturing Sumit Verma, and Project Farma CEO Anshul Mangal.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

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 milestones and rapid entry into Phase 1 clinical trials. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Inspired to develop a treatment for Infantile Krabbe Disease, the founders of Forge Biologics picked a unique but strategic approach to funding the initiative. They built a CDMO that aims to become one of the largest on the planet in the cell and gene therapy space. On this week's episode of the Business of Biotech podcast, co-founder, President, & CEO Timothy J. Miller, Ph.D. joins us to discuss the strategy, why it was a no-brainer given the white-hot market for contract development and manufacturing space, the state of the biologics manufacturing capacity crunch,  and what companies like Forge are doing about it. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Eric Ostertag, M.D., Ph.D., wanted to launch a biotech. When University of Pennsylvania department heads said no to a licensing deal for lack of a CEO, Dr. Ostertag convinced them he could run the company. Many bold moves later, Dr. Ostertag is founder and CEO at Poseida Therapeutics, a company that's doing things never seen before in the field of CAR T-cell and gene therapies for multiple myeloma and prostate cancer. On this week's episode of The Business of Biotech, Dr. Ostertag gives us a tour of the architecture supporting Poseida's unique 3-tiered development and manufacturing platform. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Judy Chou, Ph.D. was a big-pharma MVP. She earned her academic stripes in the hallowed halls of Yale, the Max Planck Institute, and Harvard Medical School before taking on principal scientist roles at AbbVie, Pfizer, and Genentech. That experience parlayed into SVP positions at Tanvex, Medvation, back to Pfizer, and on to Bayer, where she was most recently SVP and Global Head of Biotech before taking the leap into the startup scene as President & CEO at AltruBio in 2020.  On today's episode of the Business of Biotech, Dr. Chou shares personal and professional insight into how she's applied what she learned in Big Bio to transform a clinical-stage developer of mAbs designed to treat a broad range of immunological diseases.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. The biologic therapy market is crowded, and judging by the recent parade of IPOs, competition for investment, mindshare, talent, and ultimately share of market is only getting stiffer. On this week's episode of the Business of Biotech, our friend and biotech business guru Allan Shaw joins us for a foundational conversation on creating competitive differentiation at every stage of biopharma growth. We cover the connections between developmental strategy and the competitive commercial landscape, the moral obligation to differentiate between promise and plausibility, the commoditization of brilliant science, and the necessity to align balanced plans with wild dreams.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Aruvant Chief Technology Officer Palani Palaniappan, Ph.D. joins the Business of Biotech with special guest Tony Khoury, EVP at Project Farma to discuss recent advances in gene therapy manufacturing. We cover the role of artificial intelligence in the discovery of AAV  capsids that can avoid the immune system, the growth of non-viral vectors, the scale up advantages of suspension technologies versus adherence, the evolution of the regulatory environment, manufacturing capacity and talent constraints, and much, much more. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Dr. Ian Walters' company, Portage Biotech, is focused on addressing the 75% of cancer patients who show no, or limited, response to existing therapies such as checkpoint inhibitors. Leading that charge are the company's invariant natural killer T cell agonists, designed to activate the innate and adaptive immune system, as well as a growing portfolio of proteins, antibodies, and small molecules. On this episode of the Business of Biotech, Dr. Walters shares what's fueling the company's progress, including its unique financing strategy and its approach to de-risking platform development for novel immuno oncology therapies.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Everyone in the business is looking for breakthroughs, but only a select few win breakthrough therapy designation from the FDA. Under the guidance of Ira Gupta, M.D. and Shanthi Ganeshan, Ph.D, GSK has a few BTDs under its belt. Dr. Gupta is VP of Medicine Development at GSK and Dr. Ganeshan is formerly VP of Global Regulatory Affairs there, having recently joined Gilead as Head of Regulatory for Oncology. On this episode, we go deep on how to apply for--and win--breakthrough therapy designation with two women who couldn't be more qualified for the discussion.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Maintaining therapeutic integrity through cryopreservation and super cold supply chains have challenged, and continue to vex, biologics producers. On this episode of the Business of Biotech, Celyad Oncology Head of Cell Therapy Manufacturing Thomas Lequertier shares best practices for the cryopreservation of cell therapies while minimizing cell degradation, maintaining their integrity on the journey from the lab to the patient, and what the future holds for cold chain biologic therapy logistics. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Revolo Biotherapeutics has entered phase 2 clinical studies of two molecules for autoimmune or allergic diseases that act to reset the immune system “upstream,” or ahead of the inflammatory cascade. On this episode of the Business of Biotech, Revolo CEO Jonathan Rigby shares the outsourced manufacturing strategy behind the endeavor, why it's so important to avoid immune suppression and how the therapies work to avoid it, and how the company managed to raise a $53 million Series B to fund development in the midst of a raging global pandemic.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. As Leyden Labs Founder & CEO Koenraad Wiedhaup puts it, we breathe in galaxies of viruses on a daily basis. As those viruses multiply and mutate, our approach to mitigating their risks is largely reactive. That's why his new company is busy developing a prophylactic approach to protecting populations from a host of influenza and coronaviruses via a self-administered intranasal spray. Learn how the company came to be, how its development efforts were buoyed by a recent $40 million series A investment, and why Wiedhaup believes intranasal prophylactics are ready to play a role in prevention of the next pandemic on this episode of the Business of Biotech podcast.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Special-purpose acquisition companies, or SPACs, are all the rage as start-up financing vehicles go, and they're particularly well-suited for emerging biopharma companies. On this episode of the Business of Biotech, we dig deep into the advantages, limitations, and potential pitfalls of the SPAC with a man who was executing SPAC deals before SPAC deals were cool. Whether you're a biotech investor or a biopharma leader looking to acquire or be acquired, you'll want to tune in to this episode for insight into the special-purpose acquisition company strategy.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. As leaders at Diamyd Medical made plans to manufacture clinical supply of therapies aimed at preserving and restoring insulin production in Type 1 diabetes patients, outsourced production was on the table. Then, the company doubled down on its intentions and built out its own manufacturing facility. On this week's episode of The Business of Biotech, Diamyd Medical President & CEO Dr. Ulf Hannelius tells us all about the therapies his company is developing, plus the why and the how behind the company's choice to manufacture them in-house. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Kite Pharma Global Head of Technical Operations Chuck Calderaro joins the Business of Biotech for a conversation on a dichotomy in the CAR T-cell supply chain: the inherent source material advantages and subsequent logistical challenges associated with the distribution of cell therapies. Calderaro discusses the implementation of manufacturing automation at Kite, the manufacturing hurdles that remain, and reflects on the company's autologous and allogeneic roadmaps. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. When is the appropriate time for a new life sciences company to wind up the PR machine? What's the difference between public and investor relations, and how do they complement each other? What's newsworthy? What's not? What are the latest tools of the trade in an increasingly social-driven PR practice? What results should you expect, and how are those results measured? On this episode of the Business of Biotech, we address these questions with  physician and professor-turned public relations practitioner extraordinaire Matt Middleman, M.D. , founding partner and CEO at LifeSci Communications, LLC.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. When the pandemic hit, Solis Biodyne found its manufacturing capacity stretched to its limit. In short order, it doubled, and then tripled, its manufacturing capacity. Then it doubled, and then tripled, its workforce. Meanwhile, it adopted a host of new platforms to serve the demand of its clients. Drs. Kadri Artma and Angela Vassa join this episode of the Business of Biotech to take us behind the scenes and tell us the scale up story that's allowing the renowned producer of reagents to the life sciences industry to meet market demands.  Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. BridgeBio has a whopping  18+ pre-clinical to clinical-stage candidates in its pipeline representing an impressive array of modalities and targets. It boasts a couple of commercial wins under its belt. The company is no stranger to developing business strategies for success. Central to that success are partnerships with scientists and researchers to fuel pipeline expansion. On this episode of The Business of Biotech, BridgeBio Chief Business Officer Michael Henderson, M.D. walks us through the formula behind the company's academia-led growth strategy. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Michael Mehler honed his cell therapy chops at Adaptimmune before joining GSK as Senior Clinical Development Manager, Cell Therapy Oncology in 2017. He and Cell & Gene chief editor Erin Harris joined the Business of Biotech podcast for a candid and detailed discussion on finding, hiring, and retaining cell and gene therapy professionals, facilitating their on-going training, bridging the gap between academia and industry, why clinical feedback is an underappreciated source of intelligence, and the resources available to cell and gene developers to further their "pipelines" of bench-level talent.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Cartesian President & CEO Murat Kalayoglu, M.D., Ph.D.  has led three of his company's six autoimmune, oncology, and respiratory candidates through Phase I/II clinical trials and two more of them are on the cusp of entering Phase I this year.  With so many programs in and entering the clinic, he's a great choice for a conversation on GMP expectations for phase I first-in-human trials. Glean insight from Cartesian's experiences and learn about the company's novel approach to RNA-engineered cell therapies for oncology and beyond on this episode of The Business of Biotech. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. On this episode of the Business of Biotech, we're going deep with Glympse Bio President & CEO Dr. Caroline Loew to explore the possibilities and implications of the in-vivo, bioengineered, tunable sensors the company is developing for diagnostic and prognostic purposes in protease-mediates diseases. Currently in the clinic with applications for Non-Alcoholic Steatohepatitis and other fibrotic diseases as well as Non-Small Cell Lung Cancer and other solid tumors, Glympse is unlocking an unprecedented view of near-real-time therapeutic response and therapeutic efficacy that could have big implications on the way biologics are developed, refined, and studied in the clinic.  Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Fresh on the heels of a significant data readout on its AXO-AAV-GM1 candidate at the recent ASGCT meeting, Sio Gene Therapies CEO Pavan Cheruvu, M.D. joins the Business of Biotech podcast.  We discuss Dr. Cheruvu's formative years and inspiration, his company's origins, its progress developing AAV and lentiviral gene therapies to treat GM1 gangliosidosis, Tay-Sachs / Sandhoff disease, and Parkinson's disease, and the challenges the company has overcome in a hybrid manufacturing environment that will ultimately transfer entirely in-house. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. OncoSec CEO & Director Dan O'Connor, J.D. joins the Business of Biotech to discuss his company's development of proprietary application and injection technologies for direct delivery of its pipeline of immunotherapeutic candidates and combination therapies into the tumor environment. O'Connor shares leadership lessons gleaned from his service as a Captain in the United States Marine Corps during Operation Desert Shield, and how he's applied those lessons as his company charts the manufacturing and regulatory challenges along its unique development timeline. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. CFO to the biopharma stars and frequent Business of Biotech guest Allan Shaw joins us for a candid discussion on the keys to efficiency as you move your candidate from the bench to the bedside. Shaw shares the common perils of insular thinking in biopharma and offers practical advice for avoiding those pitfalls. We discuss the value of being early in the context of the current biopharma market —  early to study, early to differentiate, early to kill if necessary, and early to fund your project on its journey to the clinic. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Drs. Mari Mitrani, CSO and Michael Bellio, Laboratory Director are young pioneers in the study of the therapeutic potential of exosomes. Their research leans heavily into the digital realm, leveraging computational biology, bioinformatics, large-scale sequencing, proteomics, and mass spectrometry to analyze perinatal tissue-secreted exosomes and their impact on a host of indications the company is exploring. On this episode of The Business Of Biotech, Drs. Mitrani and Bellio offer insight into the digital discovery and manufacturing automation technologies in use at Organicell.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Scott Cleve brings an entire career dedicated to the mastery of global biopharma regulatory standards to his role as Vice President of Regulatory Operations and Compliance at bluebird bio. Join Cleve, host Matt Pillar, and Erin Harris, chief editor at Cell & Gene, for a candid discussion on the regulatory trends shaping the advance of bluebird's pipeline of gene therapies for the treatment of serious, life-altering diseases including Cerebral Adrenoleukodystrophy, Multiple Myeloma, Transfusion-Dependent β-Thalassemia, and Sickle Cell Disease.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message.  CUE Biopharma CEO Dan Passeri, J.D. joins us for a discussion on the development of the company's Immuno-STAT platform for the selective targeting and alteration of T cells. Passeri shares the rationale behind his belief in the company's immunotherapeutic approach, and how the CUE-100 series of candidates in its pipeline are being developed to address the scourge of HPV-related head, neck, and other cancers expected in pre-HPV vaccine populations. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. SOTIO isn't your typical single-molecule, single-platform biopharma. Since its inception, the company has supported 14 clinical trials of oncology therapeutics developed leveraging multiple platform technologies. On this episode of The Business of Biotech, SOTIO Global CEO Radek Špíšek takes a deep dive into the development, HR, and funding strategies the company has deployed to build its IL-15, immune cell therapy, and antibody-drug conjugate candidates.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Nevan Charles Elam, JD founded Rezolute Bio ten years ago on the heels of a complex career intersecting law, high tech, and life sciences. On this episode of the Business of Biotech, Elam shares the company's rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses Rezolute's approach to process development and manufacturing.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Learn how Precigen is advancing a deep pipeline of immuno-oncology, infectious disease, and autoimmune disorder candidates through the clinic on the back of its UltraCAR-T platform. CEO Dr. Helen Sabzevari describes the promise of the platform to change the CAR T complexity paradigm with an overnight manufacturing process to affect patients in urgent need of timely therapy.  Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Friend of the show and life sciences CFO extraordinaire Allan Shaw joins us for a discussion on the steps to biopharma success from an insider's perspective.  We discuss the incremental steps that are necessary and common to success in the biologic therapy space, and the mistakes Shaw has seen in his many engagements with new and emerging biotech firms. From capital resource allocation to personnel decision making to preparing for the bubble to burst, listen in as Shaw shares his unfiltered advice.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Dr. Anat Cohen-Dayag transformed her company from a computational biology service provider to a clinical-stage biopharma with multiple cancer immunotherapy candidates, and she did it in a remarkably short period of time. Listen in as she discusses the human resources, financial, and capital strategies she deployed to build a biotech on the back of computational science, and shares her vision for the future of drug discovery. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Amolyt Pharma is developing a therapeutic peptide program targeting rare endocrine and metabolic diseases including  hypoparathyroidism and acromegaly. Fresh on the heels of its lead candidate's foray into phase 1 clinical trials, we're joined by the company's founder and CEO, Thierry Abribat, Ph.D., for a deep dive into Amolyt Pharma's pre-clinical preparation, including his financing, talent acquisition, and clinical study strategies. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Cidara Therapeutics President and CEO Dr. Jeff Stein joins the Business of Biotech to discuss his career mission to battle microbial organisms and his company's development of a novel approach to producing immunotherapeutic antivirals that couple potent antivirals to a human antibody fragment. We discuss the company's manufacturing approach, which Dr. Stein anticipates yielding a low-cost alternative to standards of care in multiple antiviral indications.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. From his Fellowship at the NIH Human Genome Research Institute to his leadership as CEO at NeuBase Therapeutics, Dr. Dietrich Stephan is recognized as a pioneer in the field of genomic precision medicine. On this episode of The Business of Biotech, Dr. Stephan shares how artificial intelligence is shaping the acceleration of genomic medicine discovery at NeuBase and beyond, with plenty of practical insight on how to adopt and leverage the technology.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Allan Shaw rejoins the Business of Biotech with candid and deep commentary on the unprecedented pace of biopharma innovation, and how the FDA is doing in its equally unprecedented effort to keep pace. In particular, Shaw shares his take on the advance of cell and gene therapies, his observation on the outsized approval rate for orphan disease and oncology therapies, and much, much more. *Editor's note: the review of Biogen's Aducanumab, referenced here as taking place in the March timeframe, was extended shortly after this episode was recorded. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/