Industry Insights

51. The Deep Roots Of Gene Therapy In Florida 12/18/2024

    Discover how Ascend builds on a legacy of AAV innovation in Florida, advancing gene therapy with cutting-edge expertise, GMP manufacturing, and deep academic collaboration.

52. Overcome Potency Assay Development Challenges In Gene Therapies 4/22/2022

    In gene therapy development and manufacturing, developing and validating appropriate potency assays that reflect the mechanism of action acceptable to regulators is a process fraught with challenges. The FDA advocates the use of a matrix approach, and this article shares best practices of this approach.

53. Real-World Evidence In Clinical Research: We're Not In Kansas Anymore 9/19/2019

    This is the first article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules.

54. Unlocking The Future: Exploring Cutting-Edge Cell And Gene Therapies 8/12/2024

    Explore the transformative potential of cutting-edge cell and gene therapies, focusing on CAR-T cell therapy, CRISPR-Cas9 gene editing, and other advanced approaches.

55. From Good To Great: Innovative Biopharmaceutical Manufacturing Is Key 4/22/2022

    Advanced manufacturing can produce new technology like mRNA within cGMP requirements and demanding timelines. What does this mean for scalability and continuous manufacturing?

56. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-Based Decisions 2/28/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

57. 4 Best Practices That Kept A Biotech's Clinical Trial Moving In The COVID-19 Era 8/12/2020

    The timely enrollment and progression of clinical trials is critical for a pre-commercial biotech company, as delays can keep treatments from getting to patients and cost an organization significant money and reputation. When you throw in a worldwide pandemic, it’s a whole new ball game.

58. Digital Health Companies Chasing US, EU Markets Need To Move With The Regulatory Pendulum 12/5/2018

    By addressing four areas of common requirement, medical device companies will be in a stronger position to secure authorization and maintain products on both the US and EU markets.

59. How Our Recent Innovative Solutions Meet Today's Supply Chain Challenges 3/25/2025

    When advanced therapy organizations place innovation at the heart of their strategy for overcoming supply chain challenges, they ultimately prioritize the most important stakeholder — the waiting patient.

60. The 5-Step Checklist For A More Mature, Robust Quality Management System 8/20/2021

    Whether you are preparing for a pre-approval inspection, have the corporate desire for continuous inspection readiness, or are engaged in a LEAN initiative to clean up and strengthen your quality management system (QMS), further maturing your QMS can be helpful to ensuring a robust, comprehensive, and compliant QMS.