GUEST COLUMNISTS

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  FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating

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

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  ICH Revises Q1 Guideline, Advancing Stability Testing Standards

  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.

• Common Manufacturing Challenges For LBP Formulations

  As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.

• What CDMOs Wish Biotechs Knew Before Submitting An RFP

  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.

• 8 Actions To Redefine Sponsor–CDMO Relationships

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

• Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers

  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. 

• Pharmaceutical Sovereignty: The Resilience We Cannot Outsource

  Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration.