Industry Insights

  1. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

    Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

  2. Navigating CGT Biotech's Financial Headwinds And The Path Forward 4/24/2025

    Dr. Ali Pashazadeh, Founder of Treehill Partners shares how CGT companies can navigate today’s biotech downturn by embracing integrated strategies, disciplined capital use, and bold leadership willing to rethink traditional models across innovation, manufacturing, and commercialization.

  3. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

  4. What CDMOs Wish Biotechs Knew Before Submitting An RFP 4/23/2025

    This author has worked with CDMOs across different programs and therapeutic modalities. Each experience reinforced the same lesson: a strong RFP can make or break a partnership.

  5. 8 Actions To Redefine Sponsor–CDMO Relationships 4/22/2025

    When viewing a CDMO as merely a service provider, interactions are often limited to completing tasks. This mindset can stifle innovation and problem-solving.

  6. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

    The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

  7. Why You Need A Raw Material Control Strategy 4/17/2025

    You should start with the end goal in mind, but the first draft is almost never the last. These living documents should evolve as your team gains process knowledge.

  8. Why Pharma Risk Assessments Should Include 'Working Together Alone' 4/16/2025

    When understood and managed properly, subjectivity becomes a source of creativity. It reveals hidden hazards and unlocks more effective risk controls.

  9. How CAR-NKs Offer Powerful Therapeutic Flexibility 4/15/2025

    Induced pluripotent stem cells have emerged as a promising platform for producing CAR-engineered NK cells in a standardized, renewable, and scalable way.

  10. Ramping Up GMP-Compliant CAR-NK Manufacturing At Scale With iPSCs 4/15/2025

    The ability to produce billions of NK cells in a single production run represents a transformative shift in the economics and logistics of cell therapy.