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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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-braine...
Oct 04, 2021•35 min•Transcript available on Metacast 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'...
Sep 27, 2021•45 min•Transcript available on Metacast 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 Presid...
Sep 20, 2021•45 min•Transcript available on Metacast 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 develo...
Sep 13, 2021•49 min•Transcript available on Metacast 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 ...
Sep 06, 2021•59 min•Transcript available on Metacast 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 B...
Aug 30, 2021•49 min•Transcript available on Metacast 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 ...
Aug 23, 2021•47 min•Transcript available on Metacast 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 ...
Aug 16, 2021•33 min•Transcript available on Metacast 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 com...
Aug 09, 2021•38 min•Transcript available on Metacast 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 develop...
Aug 02, 2021•33 min•Transcript available on Metacast 
