LSL Web-Exclusive Content

  1. Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials 5/10/2023

    The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.

  2. AI-Driven Medtech Begins To Deliver On Its Potential 5/9/2023

    The successful use of artificial intelligence (AI) has been a long time coming. Today, more than 530 AI/ML-enabled medical devices have been authorized by the FDA. This article highlights some promising examples.

  3. Is Technology The New Science Of Outsourcing? 5/4/2023

    That’s the abstruse thought with which I left the 2023 CDMO Leadership Awards ceremony in Manhattan. I’ve subsequently tried to sort this out by referring back to a series of interviews I did with CDMO leaders at the event. I think now I can explain this to readers. 

  4. Why We Should Care About Rare Disease Research 5/1/2023

    Public support, through raising awareness and highlighting the challenges faced by those with rare diseases, is essential in driving progress forward. I encourage everyone to join the conversation and help spread the word about the importance of finding treatments for under-represented populations.

  5. New FDA Guidance: Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics 4/21/2023

    On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). The move highlights some of the limitations that have been identified with the accelerated approval pathway and provides insight into the rationale for new FDA draft guidance.

  6. Recent FDA Inspections In India Indicate New Focus On Tablet Press Operations 4/21/2023

    Over the past few years, the FDA investigators in India have shifted their focus away from laboratory and data manipulation and toward a closer look at tablet press operations. The new interest centers on critical process parameters, the automatic weight control system, and more.

  7. A Day In The Life Of A Wannabe Clinical Trial Participant: Desperately Seeking Recruitment 4/19/2023

    Over 80% of clinical trials experience low or slow enrollment. And to compound the issue, more than 90% of sites have said they do not have adequate staff to perform recruitment activities. No wonder Leanne Woehlke's attempt at becoming a trial participant didn't pan out quite as she expected.

  8. March 2023 – CDMO Opportunities And Threats Report 4/13/2023

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  9. Protecting Cell And Gene Therapy R&D Against Cyber Threats 4/10/2023

    Depending on the size of the organization, the transparency of its CGT R&D laboratories, and the timeframe for accelerated approval, the concept of building cyber resiliency in these spaces may seem daunting. Nevertheless, there are common first steps taken across the industry that can help support these efforts.

  10. Final Guidance Locks In FDA's Definitions For Suspect And Illegitimate Drug Product 4/7/2023

    With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate and suspect drug product.