Navigating China IIT Importation Without Losing the Speed Advantage
China IITs Are Unique and Operationally Challenging Across the Clinical Supply Chain China IITs can offer advanced therapy sponsors a…
Perspective
Quarantines, Complaints, Temperature Excursions & Other Debacles: Mitigating the Impact of Clinical Supply Disruption
While the best way to avoid clinical supply disruption is through careful planning and setting up a robust supply chain,…
Perspective
Event Recap: Successful Gating Strategies When Building Your Commercial Supply Chain
Today’s landscape combines heightened uncertainty spanning scientific, regulatory, clinical, and operational risks with an economic environment where many emerging companies…
Perspective
Depot-to-Site Supply Strategy: 10 Key Considerations for Clinical Success
Depot-to-site clinical supply strategy ensures that the investigational product (IP) is available at the right site, in the right quantity,…
Perspective
Event Recap: Supply Risk Management in 2025
With geopolitical tensions creating significant instability in global supply chains, on top of continuing economic uncertainty and regulatory shifts, many…
Perspective
Navigating Tariff Volatility: Strategic Pathways for Emerging Life Sciences Companies
New perspective from Gartner highlights that Chief Supply Chain Officers must plan for long-term volatility, considering potential countermeasures, escalations, and de-escalations.…
Perspective
The Strategic Imperative of Supplier Risk Management for Biopharmaceuticals
In recent years, the biopharmaceutical industry has faced an increasingly complex and volatile supply chain risk landscape. The lasting effects…
Perspective
The BIOSECURE Act: Safeguarding U.S. Biotechnology
The BIOSECURE Act is a pivotal U.S. legislative measure designed to safeguard national security by restricting federal contracts and funding…
Perspective
Avoiding Approval Risks at Your CMO Facility
In August 2024, Regeneron received a Complete Response Letter (CRL) from the FDA for its multiple myeloma treatment candidate. The…
Perspective
Event Recap: TraceLink FutureLink Barcelona Conference 2024
TraceLink recently hosted FutureLink Barcelona 2024, their annual European meeting for supply chain participants. Since Europe enacted serialization requirements back…
Perspective
Rightsizing a Business Continuity Program
Many emerging biopharmaceutical companies neglect to develop business continuity plans because they are operating with constrained resources. Even with the…
Perspective
The Evolving Ecosystem for Biopharma Manufacturing
A significant – even seismic – shift is taking place in biopharma manufacturing and technical operations right now. It is…
Perspective
US-China Trade Tension: Increasing Uncertainty for Biopharma
In recent years, the US government has increasingly leveraged trade policy as a tool for broader U.S. foreign policy. This…
Perspective
Highlights from Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline Webinar
2024 is a crucial year for the life science industry. November marks the end of the DSCSA stabilization period and…
Perspective
Impact of Rejecting Chevron Deference on Biopharma
On June 28, the Supreme Court of the United States (SCOTUS) overruled the most cited legal case in its history, colloquially…
Perspective
Event Recap: FutureLink 2024
At the end of May 2024, TraceLink hosted its annual conference – FutureLink 2024. The event brings together manufacturers, brand…