Industry Insights

1. AI Vs. Humans In Novel Drug Target Identification 4/30/2025

   Artificial intelligence is beginning to replace humans in drug discovery, one expert warns — but the industry isn’t ready for the shift.

2. Lean Thinking For Pharma — Flow Without Facility Upheaval 4/28/2025

   Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.

3. A Checklist For Mechanism-Based Potency Testing In Cell Therapy 4/25/2025

   New research concludes that potency cannot be decoupled from a product's mechanism of action because surrogate markers fail to capture functional relevance.

4. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

   Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.