Manufacturing
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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.
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AAV & Lentiviral Gene Therapies With Sio Gene Therapies' Dr. Pavan Cheruvu
5/24/2021
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.
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In-Vivo CAR T Update With Umoja Biopharma's David Fontana, Ph.D.
11/28/2022
2023 is just around the corner, and it's shaping up to be a big year for Umoja Biopharma. The company is on the leading edge of the effort to break the solid tumor barrier with in vivo CAR T-cell therapies, with one such effort currently enrolling patients for a phase 1 trial. It's planning two more INDs in the coming year. This episode of the Business of Biotech finds us getting the inside story from Umoja Chief Operating Officer David Fontana, Ph.D., whose storied career includes leadership positions at heavyweights including Sanofi, SeaGen, Pfizer, Juno, and BMS. Fontana shares on how he applies his experience playing a lead role in the success of Breyanzi, Adcetris, Bavencio, and Relatlimab in his new role at Umoja, the outsourcing battle scars that motivated the company to build its own 146,000 square foot development and manufacturing facility, and much more.
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A Multiple Target Approach To Universal Influenza Vaccine Development
9/7/2022
With a unique multi-target approach, what it considers the world's best adjuvant, and a host of learnings from the successes and failures of COVID-19 vaccine efforts, Longhorn Vaccines & Diagnostics is gaining steam in its pursuit of a universal influenza vaccine. On this episode of the Business of Biotech, Longhorn Vaccines Co-Founder and President Jeff Fischer gives us a transparent look at the science and the partnerships that are giving him cause to believe his company will succeed where so many have failed.
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CMC Developability Assessments For Rapid Ph.1 Entry With AltruBio's Gene Lee, Ph.D.
10/12/2021
Fresh on the heels of an outstanding talk with AltruBio President & CEO Judy Chou, Ph.D., the company's VP of Technical 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.
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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.
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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.
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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.
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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.
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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.