Manufacturing

31. CDMO With A Pipeline Featuring Forge Biologics President & CEO Dr. Timothy J. Miller 10/6/2021

    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. 

32. 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.

33. A More NIIMBL Biotech Workforce With John Balchunas 5/4/2023

    What are biopharma's greatest skilled manufacturing labor needs, and what's the industry doing to fill them? John Balchunas is on the front lines in his position as Workforce Director at NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals, and he says advanced degrees and pedigrees aren't the answer. The breadth and depth of NIIMBL's efforts to influence the next generation of the biopharma workforce — from high school vocational programs to community colleges and on-the-job development—might surprise you. Listen in as Balchunas brings the Business of Biotech up to speed on a training and development agenda that plants seeds early and often.

34. CDMO Collab with Scorpius BioManufacturing's Steve Lavezoli + Fina Biosolutions' Dr. Andrew Lees 12/27/2023

    A new year marks a fresh start for biotech partnerships, and to kick off 2024, we're highlighting a good one. Fina Biosolutions' Dr. Andrew Lees recently signed on with Scorpius BioManufacturing to support his company's growth plan. On the Business of Biotech, Lees sits down with Scorpius VP of commercial operations Steve Lavezoli for a frank conversation on the ups, downs, and expectations of a biotech + CDMO relationship. If you're considering signing on with an outsourced manufacturing partner, or thinking about making a switch, you won't want to miss this episode.

35. Managing Momentum With Rezolute Bio's Nevan Charles Elam, JD 8/16/2023

    Since we last spoke in the Spring of 2021, Nevan Charles Elam, JD has managed to advance both of small-but-mighty Rezolute Bio's candidates onto the next phases of their journey. This year, on the back of a $130 million investment, Rezolute Bio is prepping its RZ358 candidate, a monoclonal antibody for congenital hyperinsulinism, for a pivotal phase 3 trial. On this week's episode of the Business of Biotech, we're settling in for an interrogation of Elam on the management principles of maintaining multi-candidate clinical momentum among highly disparate candidates and raising big dollars as a small biotech.

36. Observations On Outsourcing With Molecule To Market's Raman Sehgal 8/15/2022

    Raman Sehgal has made a career out of putting his energy— and he's got a lot of it— into building biotech outsourcing companies and the people who make them run. After years spent supporting several from within, he launched ramarketing, a firm dedicated to helping CROs, CDMOs, CPOs, and other providers to the biotech ecosystem build their businesses, in 2009. He's also an international best-selling author (The Floundering Founder), co-founder of life sciences recruitment firm Lead Candidate, and founder & host of the Molecule to Market podcast.

37. Propagating Peptides With Peptilogics' Jonathan Steckbeck, Ph.D. 5/24/2023

    Peptilogics CEO and founder Dr. Jonathan Steckbeck walks us through his transition from academic work into a clinical-stage company, how he's sustaining the company in a lean capital market, and more.

38. Cold Chain Integrity & Sustainability With Celyad Oncology's Thomas Lequertier 8/18/2021

    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.

39. 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. 

40. Acepodia's Approach To ACC & CAR Manufacturing Scalability 1/19/2021

    Acepodia CEO, President, & Co-founder Dr. Sony Hsiao and Dr. Mark Gilbert, SVP of R&D, join Erin Harris and Matt Pillar for a discussion on the company's approach to dramatically reducing the cost of cell therapy development, manufacturing, and administration via its oNK, CAR, and ACC candidates.