Industry Insights

  1. Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis 7/8/2026

    Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

  2. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program 7/7/2026

    In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

  3. Wondering If Your Org Should Purchase R&D Datasets? 7/1/2026

    Pharma/biotech companies are increasingly looking to access large-scale data sets to fill gaps in their computational biology capabilities. Be prepared for the investment.

  4. Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines 6/30/2026

    Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.

  5. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools 6/30/2026

    Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.

  6. How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale 6/29/2026

    Our latest Cell & Gene Live examined how CGT developers can choose manufacturing models that support long-term commercial success by aligning biology, operations, supply chain, and scalability from the earliest stages of development.

  7. Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression 6/29/2026

    While circular RNA platforms can enhance protein expression, developing effective delivery strategies remains the key challenge to achieving therapeutic efficacy.

  8. FDA Explains How To Respond To Form 483 Observations In New Draft Guidance 6/29/2026

    In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look.

  9. Organizing Digital Systems Around Novel Modalities 6/24/2026

    Cell therapies represent an important advancement in our ability to treat difficult cancers, but continued exploration of this new modality will require new digital tools and equipment.

  10. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures 6/23/2026

    A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.