LSL Web-Exclusive Content

  1. A Regulator Looks Back On What We Learned From Accelerated SARS-CoV-2 Neutralizing mAbs Development 3/29/2023

    Prior knowledge, platforms, parallel backup programs, and strategic timing all come into play when rapidly scaling up a mAbs development program in response to a public health emergency.

  2. Beyond Moderna's Regulatory Legacy: (Re)defining The mRNA Regulatory “Norm” 3/22/2023

    It’s unlikely we will need to burn nearly as much “midnight oil” as Moderna and the regulatory bodies did during the pandemic. However, I share Moderna's unique experiences because they’re a great reminder that the mRNA therapeutics industry is set to face a much different regulatory challenge moving forward.

  3. Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance 3/22/2023

    We may no longer be living in the fast-and-furious days of Emergency Use Authorization, nor are we all working strictly on mRNA vaccines. But after listening to Moderna’s Director of Regulatory CMC Chris Kelly share his whirlwind regulatory experiences, there were still several broad takeaways for companies navigating this nascent space.

  4. How Can Life Sciences Navigate M&A In 2023? 3/21/2023

    As we close out the first quarter of 2023, let's take a look at how life sciences executives can conduct better M&A deals despite this unpredictable business environment.

  5. How To Approach Ambiguity: Tools To Help You Innovate Through Change And Discomfort 3/21/2023

    Ambiguity is not your enemy. But ambiguity is unavoidable. This is especially true if you work in innovation, where the focus is always on disruption and reinvention and we’re exploring things that have never been done before.

  6. Draft FDA Labeling Guidance Proposes More Clarity For Providers 3/7/2023

    The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape. 

  7. Cell & Gene Therapy COGS: Words Of Wisdom To 'Keep The End In Mind' 3/7/2023

    As a delightfully diverse space, it goes without saying that understanding a product’s process and COGS drivers will be a highly individualized and complex undertaking. However, there were a few valuable points that came up in my conversation with Dark Horse Consulting's Katy Spink that were worthy of sharing as we step back and consider what "keeping the end in mind" will look like for our development paradigm and its COGS.

  8. Financing For Emerging Biotechs: Recent Trends & Predictions For 2023 3/6/2023

    After a stellar 2020 and 2021, overall early-stage financing for small and midsize biotechs declined significantly in 2022 due to a range of factors. Ernst & Young provides insights into those factors and trends, as well as the key focus areas for biotechs in 2023.

  9. February 2023 — CDMO Opportunities And Threats Report 3/2/2023

    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.

  10. Global Market Outlook On Stem Cell Manufacturing 3/1/2023

    The stem cell manufacturing market is rapidly growing and is expected to grow from $11.22 billion in 2022 to approximately $23.89 billion by 2030. What are the key market drivers, restraints and challenges, and advancements to watch?