Cell and Gene Regulatory

  1. Regulatory Compliance In Clinical Research 3/28/2025

    Understand the critical aspects of regulatory compliance, and gain insights into how you can safeguard participant rights and ensuring the integrity of clinical research.

  2. Why Biotechs Should Leverage Australia's Clinical Research Ecosystem 3/28/2025

    With a proven track record across diverse therapeutic areas, Australia is a cost-effective option as well as a strategic ally for biotech firms.

  3. Alternatives To Testing Sterility In Cell- And Tissue-Based Products 3/28/2025

    Testing depletes precious product, and regulators increasingly support using other methods if they're backed by robust validation data.

  4. Harnessing RWE For Effective External Control Arms In Clinical Trials 3/24/2025

    Real-world evidence (RWE) is transforming clinical trials by enabling the use of external control arms (ECAs), which serve as an alternative to traditional randomized control groups.

  5. What To Look For In An Oncology CRO 3/24/2025

    Learn seven of the critical factors for choosing an oncology-focused CRO that enable sponsors to identify partners aligning with their clinical research objectives.

  6. A 5-Step Guide To Achieving Your Biosimilar Milestones On Time 3/24/2025

    As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.

  7. FAQs On The siRNA Therapeutics 3/21/2025

    Stay ahead in the rapidly evolving field of siRNA therapeutics by exploring the latest clinical trends, breakthrough delivery technologies, combination strategies, and global regulatory pathways.

  8. Optimizing siRNA Therapeutics: Addressing Manufacturing Complexities 3/21/2025

    Discover key strategies to optimize siRNA therapeutics by addressing critical nonclinical and manufacturing challenges for a smoother path to commercialization.

  9. Minimize Off-Target Effects With Precision Genome Editing 3/20/2025

    On the path to successfully delivering a safe and efficacious gene editing therapy to patients, drug sponsors must leverage a robust arsenal of tools to mitigate off-target effects on the genome. Said tools include in silico prediction software, especially those that consider epigenetic features when predicting off-target effects.

  10. MilliporeSigma Bio-Expo Live February 2025: Upstream Bioprocessing 3/18/2025

    Review the benefits of implementing a closed and sterile sampling system, such as NovaSeptum®, to improve sampling procedures and meet regulatory expectations.