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
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 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
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
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
Last Mile Logistics: How Manufacturers Can Help Ensure Product Integrity for Patients
Last mile logistics, the final leg of the supply chain from distribution centers or pharmacies to the point of administration,…
Perspective
Life After DSCSA Compliance
In September, the FDA provided the pharmaceutical industry with a 12-month extension to the Drug Supply Chain Security Act (DSCSA). The…
Perspective
Event Recap: Digitization of the Supply Planning Process
Many emerging and mid-sized biopharma companies work to digitize their supply planning process as they grow, as part of larger…
Perspective
How Phase 3 Companies Can Better Navigate DSCSA Serialization Requirements
Ulpiano Flores, a business analyst with Converge Consulting, speaks about Phase 3 companies navigating DSCSA serialization requirements in an interview…
Perspective
ERP Implementations: Understanding Technical Versus Business Go-Live
Many life science companies rely on enterprise resource planning (ERP) to help manage and integrate essential parts of the business.…
Perspective
Event Recap: Supply Chain Planning for Today’s Uncertain World
Uncertainty and risk have been consistent themes inherent to biopharmaceutical supply chains. The recent pandemic has only amplified this notion.…