LSL Web-Exclusive Content

  1. The State Of IT Security In The Pharma Industry Today

    The current state of cybersecurity -- especially pharmaceutical, biotechnology, or other high sensitive environments such as those in the financial sectors -- has never been more pressing than it is right now.

  2. CMC For Cell & Gene Therapies — 4 Topics To Discuss During Pre-IND Meetings With FDA

    Seeking early guidance from regulators can be invaluable when navigating preliminary product development strategies. The need for feedback increases significantly when working with cell and gene therapy products (CT/GT). These therapies, once considered a kind of “wild-west,” are becoming more widely accepted. Still, the task of seeking approval from the FDA can be extremely challenging. It’s become vital to get your relationship with the FDA off to a solid start from day one.

  3. Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

    I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.

  4. How To Respond To A Failed Batch In A Virtual Supply Chain

    You just discovered a batch of commercial product made by your company’s outsourced supply chain has failed and, at first glance, the failure isn’t due to an analytical error. What do you do next?

  5. Continuous Manufacturing: Why Isn’t It Ubiquitous Yet? (When It Should Be)

    The question is no longer, “Will continuous manufacturing work?”, but “When will everyone be doing it?” But surprisingly, there are still many objections to continuous manufacturing within the biopharma industry.

  6. State Of The Cell And Gene Therapy Sector — Clinical, Financial, And Regulatory Perspectives

    The regenerative medicine sector is at a remarkable moment. Transformative products are now on the market and accessible to greater numbers of patients every day. Dozens of additional therapies are in late stage studies. The regulatory and policy environment has evolved rapidly alongside the science, enabling a surge of incoming innovation.

  7. Others Talk About Creating Good Stories; We Write Them

    Good storytelling is the crux of every article in Life Science leader, and our October issue is no exception. Here are a few examples of what not to miss in our next issue.

  8. How FDA, Industry, And Academia Are Guiding AI Development In Biopharma

    Continuously learning systems (CLS) are artificial intelligence (AI) algorithms that constantly and automatically update themselves as they recognize patterns and behaviors from real-world data — enabling companies to become predictive, rather than reactive, with quality assurance. 

  9. Beyond Informed Consent — How To Better Engage Millennials (And Others) In Clinical Trials

    Companies developing new healthcare products for Millennials have implemented a lot of the pieces of the puzzle of how to serve them better; unfortunately, disconnects in how those pieces link together to track the entire patient journey reduce the effectiveness of those efforts.

  10. Bridging The Public Knowledge Gap Around Cell And Gene Medicine

    According to a review of recent research studies that measured U.S. public opinion related to gene medicine, the public is not yet aware of gene medicine, is unfamiliar with the terms being used to describe the topic, and, when faced with multiple therapeutic options, is worried about making informed decisions.