Manufacturing

  1. The Peptide Promise With NervGen's Mike Kelly 10/6/2024

    Mike Kelly faced a self-reckoning before he took the job as CEO at NervGen Pharma, a company developing peptide therapeutics targeted specifically at central nervous system repair. The veteran of life sciences business development knew the ropes of the biotech C-suite. He’d been a CEO twice before. He knew how to launch drugs. He even knew how to sell them. On this episode of the Business of Biotech, we learn how Kelly reconciled that truth, and how NervGen is now leading the way for peptide therapeutics in spinal cord injury and beyond. 

  2. A Hybrid mAb Manufacturing Model With John Glasspool 1/30/2022

    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 challenges of the hybrid manufacturing approach at Anthos, and how its strategy has enabled phase 1 and 2 clinical studies that have demonstrated an 80% reduction of the rate of VTE in post-operative total knee arthroplasty patients compared to the standard of care (enoxaparin).

  3. Gene Therapy Manufacturing Advances With Aruvant CTO Dr. Palani Palaniappan 9/7/2021

    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.

  4. Solving The COVID-19 Workforce Crisis 8/13/2020

    Obsidian Therapeutics CEO Dr. Paul Wotton didn't let pandemic-induced workforce restrictions impede his biopharma's progress. Instead, his team developed a software system purpose-built for biotechs to manage personnel and equipment per ever-changing guidelines. On this episode of The Business Of Biotech: Summer Executive Sessions, Wotton tells us how the application, dubbed SWIFT, was built, how it's working, and why Obsidian has made it available to more than 30 (and growing) other biotechs, free of charge.

  5. Commercial Readiness with Orca Bio's Dan Kirby 9/14/2023

    Orca Bio's Dan Kirby has played a hand in prepping more than a few approved biologic therapeutic candidates for commercialization. Equally important, he knows firsthand what makes or breaks post-approval commercial efforts, having played virtually every role there is to play in drug sales and marketing.

  6. Regenerative Wound Care With BioStem Technologies' Jason Matuszewski & Andrew VanVurst 9/29/2022

    Here's the story of BioStem, its young founders, and how they reached commercial status in short order with a portfolio of proprietary regenerative wound care products developed from perinatal tissue. Fueled by a personal story of resilience and inspiration, Jason Matuszewski (CEO) and Andrew VanVurst (COO) built a company that's developed a local microenvironment activation platform drawing on a combination of small molecules, cytokines, and growth factors to promote tissue repair and regrowth. The company's internal development and cGMP manufacturing facilities have already yielded three approved products poised to change the paradigm for diabetic, traumatic, and other wound care.

  7. Antibody-Cytokine Combinations With Philogen's Dr. Dario Neri 6/29/2022

    Swiss-Italian biopharma company Philogen was co-founded in 1996 by three brothers, all of them PhDs. This unique family affair has fueled the development of an incredibly deep and advanced pipeline of no fewer than ten therapeutic products, most of them in oncology, contributing to 16 active clinical trials, three of them at Phase 3. On this episode of the Business of Biotech, co-founder, CEO, and CSO Prof. Dario Neri shares the incredible story of the company's progress and explains Philogen's approach to delivering bioactive agents to the site of disease using antibodies or small organic ligands, thus increasing therapeutic activity and helping spare normal tissues.

  8. Commercial Readiness with ImmunityBio's Bobby Reddy, M.D. 4/14/2024

    This episode of the Business of Biotech begins with a personal story about my dad and the standard of care in bladder cancer, before shifting to the work that Dr. Bobby Reddy and his team at ImmunityBio are doing to change that standard of care. They're painfully close. Dr. Reddy, Chief Medical Officer at ImmunityBio, gives us a long look behind the curtain at the commercial preparations the company is making as its lead Phase 3 candidate, Anktiva, nears the goal line in non-muscle invasive bladder cancer (NMIBC). 

  9. Episode 6: Building An All-Star Biotech Team With Vivek Ramaswamy 8/13/2020

    Roivant Sciences, founded by Vivek Ramaswamy, is parent company to some 20 emerging biopharma entities with dozens of candidates in their collective pipelines. On this episode of The Business Of Biotech, Ramaswamy shares practical and applicable advice on the people, positions, and characteristics that constitute a winning biopharma team, and best practices for recruiting and retaining them.

  10. Cornering The Antibody Market With Akesobio CEO Dr. Michelle Xia, Ph.D. 11/23/2021

    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.