44 episodes

The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing's print and online coverage, which follows the industry's biggest issues surrounding scale-up, technology innovations, regulations and more. Off Script is hosted by Pharma Manufacturing editors Karen Langhauser and Meagan Parrish.

Off Script: A Pharma Manufacturing Podcast Pharma Manufacturing

    • News

The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing's print and online coverage, which follows the industry's biggest issues surrounding scale-up, technology innovations, regulations and more. Off Script is hosted by Pharma Manufacturing editors Karen Langhauser and Meagan Parrish.

    [Solutions Spotlight] Streamlining oral dose packaging design

    [Solutions Spotlight] Streamlining oral dose packaging design

    By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset,  drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase, thereby reducing the need for prolonged probe stability testing and potential reformulations or packaging redesign. 
    To understand more about the issues at hand, senior editor Andrea Corona recently spoke with Adrian Possumato, president and Chris Gilmor, director of sales, at Sanner of America.
    Learn more about Sanner of America: https://www.sanner-group.com/
     

    • 32 min
    FDA backs Lilly Alzheimer’s drug; Pfizer Duchenne gene therapy fails; Talc plaintiffs seek J&J bankruptcy restraining order [The good, the bad, the ugly]

    FDA backs Lilly Alzheimer’s drug; Pfizer Duchenne gene therapy fails; Talc plaintiffs seek J&J bankruptcy restraining order [The good, the bad, the ugly]

    Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
    The good — FDA AdComm backs Eli Lilly Alzheimer’s drugThe bad — Pfizer gene therapy fails phase 3 Duchenne trialThe ugly — Talc plaintiffs seek restraining order on J&J bankruptcy tactic

    • 4 min
    AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site [The good, the bad, the ugly]

    AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site [The good, the bad, the ugly]

    Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
    The good —  AstraZeneca’s Tagrisso delivers 84% progression-free survival in trialThe bad — BMS to let go of 863 employees at NJ site The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Pharmaceuticals site

    • 3 min
    J&J depression drug aces trial, Takeda plans layoffs, FDA delays review of Sanofi-Regeneron's Dupixent [The good, the bad, the ugly]

    J&J depression drug aces trial, Takeda plans layoffs, FDA delays review of Sanofi-Regeneron's Dupixent [The good, the bad, the ugly]

    Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
    The good — J&J depression drug aces late-stage trialThe bad — Takeda plans layoffs at Massachusetts sitesThe ugly —  FDA delays review of Sanofi-Regeneron's Dupixent in COPD

    • 3 min
    Mining pharma's reshoring rush

    Mining pharma's reshoring rush

    When the pandemic hit and Americans found themselves looking to China for critical medical supplies, the idea of reshoring — a concept that had drifted along the currents of the manufacturing sector for over a decade — embedded itself into pharma discourse with renewed luster.
    During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, Mining pharma's reshoring rush, and discuss where the industry stands amid the U.S. movement to bring the manufacturing of generic drugs, APIs and ingredients home.
     

    • 4 min
    FDA approves biosim to Regeneron Eylea, Evotec exits gene therapy, J&J reports deaths in radioligand trial [The good, the bad, the ugly]

    FDA approves biosim to Regeneron Eylea, Evotec exits gene therapy, J&J reports deaths in radioligand trial [The good, the bad, the ugly]

    Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
    The good —  FDA approves first interchangeable biosims to Regeneron Eylea The bad — Evotec exits gene therapyThe ugly —  J&J reports deaths in early-stage radioligand trial

    • 3 min

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