Expert Insights on GCT Cold Chain Logistics

1. A Road Map For Transitioning From A Research-Focused To Commercialization Mindset 6/3/2025

   As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?

2. Clues To Mapping A Crisis-Ready Tech Transfer Playbook 5/28/2025

   One of the many people behind AstraZeneca's COVID-19 response describes lessons learned during the biggest global health emergency of the modern era.

3. Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services 5/22/2025

   The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

4. Good Distribution Practice Is Evolving — Here's How 5/15/2025

   Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

5. A Case For Paying Allogeneic Cell Therapy Product Donors 5/9/2025

   The debate over whether to pay donors for cell therapy starting materials comes down to four areas of disagreement: altruism, availability, ethics, and safety.

6. From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025 5/7/2025

   The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.

7. 8 Ways To Drive Resilience In Oncology Drug Supply Chains 5/2/2025

   From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.

8. 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.

9. 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.

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.